Monsanto Co.; Availability of Petition, Plant Pest Risk Assessment, and Environmental Assessment for Determination of Nonregulated Status of Soybean Genetically Engineered To Produce Stearidonic Acid, 80871-80872 [2011-33002]
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Federal Register / Vol. 76, No. 248 / Tuesday, December 27, 2011 / Notices
fruit fly (Anastrepha fraterculus). As a
result of these comments, APHIS
contacted the Argentine NPPO, which
requested that, in addition to the pestfree status for C. capitata, the Mendoza
province of Argentina also be
recognized as free of A. fraterculus.
We published a second notice in the
Federal Register on August 19, 2011 (76
FR 51934–51935, Docket No. APHIS–
2010–0032), in which we announced
the availability, for review and
comment, of a CIED evaluating the
information presented by Argentina in
support of its request to recognize
additional areas as pest-free areas for the
South American fruit fly and all other
economically important species of
Anastrepha in Argentina. We solicited
comments on the notice for 60 days
ending on October 18, 2011. We
received no comments by that date.
Therefore, in accordance with
§ 319.56–5(c), we are announcing the
Administrator’s determination that the
Southern and Central Oases in the
southern half of Mendoza Province in
Argentina meet the criteria of § 319.56–
5(a) and (b) with respect to freedom
from Medfly, South American fruit fly,
and all other economically important
species of Anastrepha. Accordingly, we
are recognizing these areas as pest-free
areas for Medfly, South American fruit
fly, and all other economically
important species of Anastrepha and
have added them to the list of pest-free
areas. A list of pest-free areas currently
recognized by APHIS can be found at
https://www.aphis.usda.gov/import_
export/plants/manuals/ports/
downloads/DesignatedPest
FreeAreas.pdf.
Done in Washington, DC, this 19th day of
December 2011.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2011–33110 Filed 12–23–11; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
sroberts on DSK5SPTVN1PROD with NOTICES
[Docket No. APHIS–2011–0095]
Monsanto Co.; Availability of Petition,
Plant Pest Risk Assessment, and
Environmental Assessment for
Determination of Nonregulated Status
of Soybean Genetically Engineered To
Produce Stearidonic Acid
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
VerDate Mar<15>2010
22:00 Dec 23, 2011
Jkt 226001
We are advising the public
that the Animal and Plant Health
Inspection Service has received a
petition from the Monsanto Company
seeking a determination of nonregulated
status of soybean designated as MON
87769, which has been genetically
engineered to produce stearidonic acid,
an omega-3 fatty acid not found in
conventional soybean. The petition has
been submitted in accordance with our
regulations concerning the introduction
of certain genetically engineered
organisms and products. We are
soliciting comments on whether this
genetically engineered soybean is likely
to pose a plant pest risk. We are making
available for public comment the
Monsanto petition, our plant pest risk
assessment, and our draft environmental
assessment for the proposed
determination of nonregulated status.
DATES: We will consider all comments
that we receive on or before February
27, 2012.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2011-00950001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2011–0095, 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 https://
www.regulations.gov/
#!docketDetail;D=APHIS-2011-0095 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) 690–2817
before coming.
The petition, draft environmental
assessment, and plant pest risk
assessment are also available on the
APHIS Web site at https://
www.aphis.usda.gov/brs/aphisdocs/
09_18301p.pdf, https://
www.aphis.usda.gov/brs/aphisdocs/
09_18301p _dea.pdf, and https://
www.aphis.usda.gov/brs/aphisdocs/
09_18301p _dpra.pdf.
FOR FURTHER INFORMATION CONTACT: Mr.
Evan Chestnut, Policy Analyst,
Biotechnology Regulatory Services,
APHIS, 4700 River Road Unit 147,
Riverdale, MD 20737–1236; (301) 734–
0942, email:
evan.a.chestnut@aphis.usda.gov. To
SUMMARY:
PO 00000
Frm 00004
Fmt 4703
Sfmt 4703
80871
obtain copies of the petition, draft
environmental assessment, or plant pest
risk assessment, contact Ms. Cindy Eck
at (301) 734–0667, email:
cynthia.a.eck@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
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 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 09–183–01p) from the
Monsanto Company (Monsanto) of St.
Louis, MO, seeking a determination of
nonregulated status of soybean (Glycine
max) designated as event MON 87769,
which has been genetically engineered
to produce stearidonic acid, an omega3 fatty acid not found in conventional
soybean, stating that this soybean is
unlikely to pose a plant pest risk and,
therefore, should not be a regulated
article under APHIS’ regulations in 7
CFR part 340.
As described in the petition, soybean
event MON 87769 has been genetically
engineered to express high levels of the
fatty acid stearidonic acid and smaller
amounts of three other fatty acids, as
well as for reduced expression of
linoleic acid. Soybean event MON
87769 is currently regulated under 7
CFR part 340. Interstate movements and
field tests of soybean event MON 87769
have been conducted under permits
issued or notifications acknowledged by
APHIS.
Field tests conducted under APHIS
oversight allowed for evaluation in a
natural agricultural setting while
imposing measures to minimize the risk
E:\FR\FM\27DEN1.SGM
27DEN1
sroberts on DSK5SPTVN1PROD with NOTICES
80872
Federal Register / Vol. 76, No. 248 / Tuesday, December 27, 2011 / Notices
of persistence in the environment after
completion of the test. 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.
In section 403 of the Plant Protection
Act, ‘‘plant pest’’ is defined as any
living stage of any of the following that
can directly or indirectly injure, cause
damage to, or cause disease in any plant
or plant product: A protozoan, a
nonhuman animal, a parasitic plant, a
bacterium, a fungus, a virus or viroid, an
infectious agent or other pathogen, or
any article similar to or allied with any
of the foregoing. APHIS has prepared a
plant pest risk assessment to determine
if soybean event MON 87769 is unlikely
to pose a plant pest risk.
APHIS has also prepared a draft
environmental assessment (EA) in
which it presents two alternatives based
on its analyses of data submitted by
Monsanto, a review of other scientific
data, and field tests conducted under
APHIS oversight. APHIS is considering
the following alternatives: (1) Take no
action, i.e., APHIS would not change the
regulatory status of soybean event MON
87769 and it would continue to be a
regulated article, or (2) make a
determination of nonregulated status of
soybean event MON 87769.
The draft EA has been prepared to
provide the APHIS decisionmaker with
a review and analysis of any potential
environmental impacts associated with
the proposed determination of
nonregulated status of soybean event
MON 87769. The draft EA was prepared
in accordance with (1) the National
Environmental Policy Act of 1969
(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).
In accordance with § 340.6(d) of the
regulations, 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. We are also
soliciting written comments from
interested or affected persons on the
plant pest risk assessment and the draft
EA prepared to examine any potential
environmental impacts of the proposed
determination for the deregulation of
the subject soybean line. The petition,
VerDate Mar<15>2010
22:00 Dec 23, 2011
Jkt 226001
draft EA, and plant pest risk assessment
are available for public review, and
copies of the petition, draft EA, and
plant pest risk assessment are available
as indicated under ADDRESSES and FOR
FURTHER INFORMATION CONTACT above.
After the comment period closes,
APHIS will review all written comments
received during the comment period
and any other relevant information. All
comments received regarding the
petition, draft EA, and plant pest risk
assessment will be available for public
review. After reviewing and evaluating
the comments on the petition, the draft
EA, plant pest risk assessment, and
other data, APHIS will furnish a
response to the petitioner, either
approving or denying the petition.
APHIS will also publish a notice in the
Federal Register announcing the
regulatory status of soybean event MON
87769 and the availability of APHIS’
written environmental decision and
regulatory determination.
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 19th day of
December 2011.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2011–33002 Filed 12–22–11; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2010–0103]
Dow AgroScience LLC; Availability of
Petition, Plant Pest Risk Assessment,
and Environmental Assessment for
Determination of Nonregulated Status
of Corn Genetically Engineered for
Herbicide Tolerance
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service has received a
petition from Dow AgroScience LLC
seeking a determination of nonregulated
status of corn designated as DAS–
40278–9, which has been genetically
engineered for increased resistance to
broadleaf herbicides in the phenoxy
auxin group (such as the herbicide 2,4D) and resistance to grass herbicides in
the aryloxyphenoxypropionate acetyl
coenzyme A carboxylase inhibitor group
(such as quizalofop herbicides). The
petition has been submitted in
SUMMARY:
PO 00000
Frm 00005
Fmt 4703
Sfmt 4703
accordance with our regulations
concerning the introduction of certain
genetically engineered organisms and
products. We are soliciting comments
on whether this genetically engineered
corn is likely to pose a plant pest risk.
We are making available for public
comment the Dow AgroScience LLC
petition, our plant pest risk assessment,
and our draft environmental assessment
for the proposed determination of
nonregulated status.
DATES: We will consider all comments
that we receive on or before February
27, 2012.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS–2010–
0103–0001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2010–0103, 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 https://
www.regulations.gov/
#!docketDetail;D=APHIS–2010–0103 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) 690–2817
before coming.
The petition, draft environmental
assessment, and plant pest risk
assessment are also available on the
APHIS Web site at https://
www.aphis.usda.gov/brs/aphisdocs/
09_23301p.pdf, https://
www.aphis.usda.gov/brs/aphisdocs/
09_23301p _dea.pdf, and https://
www.aphis.usda.gov/brs/aphisdocs/
09_23301p _dpra.pdf.
FOR FURTHER INFORMATION CONTACT: Mr.
Evan Chestnut, Policy Analyst,
Biotechnology Regulatory Services,
APHIS, 4700 River Road Unit 147,
Riverdale, MD 20737–1236; (301) 734–
0942, email:
evan.a.chestnut@aphis.usda.gov. To
obtain copies of the petition, draft
environmental assessment, or plant pest
risk assessment, contact Ms. Cindy Eck
at (301) 734–0667, email:
cynthia.a.eck@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
Under the authority of the plant pest
provisions of the Plant Protection Act (7
E:\FR\FM\27DEN1.SGM
27DEN1
]]>Agencies
[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80871-80872]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33002]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2011-0095]
Monsanto Co.; Availability of Petition, Plant Pest Risk
Assessment, and Environmental Assessment for Determination of
Nonregulated Status of Soybean Genetically Engineered To Produce
Stearidonic Acid
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 received a petition from the Monsanto Company
seeking a determination of nonregulated status of soybean designated as
MON 87769, which has been genetically engineered to produce stearidonic
acid, an omega-3 fatty acid not found in conventional soybean. The
petition has been submitted in accordance with our regulations
concerning the introduction of certain genetically engineered organisms
and products. We are soliciting comments on whether this genetically
engineered soybean is likely to pose a plant pest risk. We are making
available for public comment the Monsanto petition, our plant pest risk
assessment, and our draft environmental assessment for the proposed
determination of nonregulated status.
DATES: We will consider all comments that we receive on or before
February 27, 2012.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2011-0095-0001.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2011-0095, 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 https://www.regulations.gov/#!docketDetail;D=APHIS-2011-
0095 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) 690-2817 before coming.
The petition, draft environmental assessment, and plant pest risk
assessment are also available on the APHIS Web site at https://www.aphis.usda.gov/brs/aphisdocs/09_18301p.pdf, https://www.aphis.usda.gov/brs/aphisdocs/09_18301p _dea.pdf, and https://www.aphis.usda.gov/brs/aphisdocs/09_18301p _dpra.pdf.
FOR FURTHER INFORMATION CONTACT: Mr. Evan Chestnut, Policy Analyst,
Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147,
Riverdale, MD 20737-1236; (301) 734-0942, email:
evan.a.chestnut@aphis.usda.gov. To obtain copies of the petition, draft
environmental assessment, or plant pest risk assessment, contact Ms.
Cindy Eck at (301) 734-0667, email: cynthia.a.eck@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
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 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 09-183-01p)
from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a
determination of nonregulated status of soybean (Glycine max)
designated as event MON 87769, which has been genetically engineered to
produce stearidonic acid, an omega-3 fatty acid not found in
conventional soybean, stating that this soybean is unlikely to pose a
plant pest risk and, therefore, should not be a regulated article under
APHIS' regulations in 7 CFR part 340.
As described in the petition, soybean event MON 87769 has been
genetically engineered to express high levels of the fatty acid
stearidonic acid and smaller amounts of three other fatty acids, as
well as for reduced expression of linoleic acid. Soybean event MON
87769 is currently regulated under 7 CFR part 340. Interstate movements
and field tests of soybean event MON 87769 have been conducted under
permits issued or notifications acknowledged by APHIS.
Field tests conducted under APHIS oversight allowed for evaluation
in a natural agricultural setting while imposing measures to minimize
the risk
[[Page 80872]]
of persistence in the environment after completion of the test. 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.
In section 403 of the Plant Protection Act, ``plant pest'' is
defined as any living stage of any of the following that can directly
or indirectly injure, cause damage to, or cause disease in any plant or
plant product: A protozoan, a nonhuman animal, a parasitic plant, a
bacterium, a fungus, a virus or viroid, an infectious agent or other
pathogen, or any article similar to or allied with any of the
foregoing. APHIS has prepared a plant pest risk assessment to determine
if soybean event MON 87769 is unlikely to pose a plant pest risk.
APHIS has also prepared a draft environmental assessment (EA) in
which it presents two alternatives based on its analyses of data
submitted by Monsanto, a review of other scientific data, and field
tests conducted under APHIS oversight. APHIS is considering the
following alternatives: (1) Take no action, i.e., APHIS would not
change the regulatory status of soybean event MON 87769 and it would
continue to be a regulated article, or (2) make a determination of
nonregulated status of soybean event MON 87769.
The draft EA has been prepared to provide the APHIS decisionmaker
with a review and analysis of any potential environmental impacts
associated with the proposed determination of nonregulated status of
soybean event MON 87769. The draft EA was prepared in accordance with
(1) the National Environmental Policy Act of 1969 (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).
In accordance with Sec. 340.6(d) of the regulations, 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. We are also soliciting written
comments from interested or affected persons on the plant pest risk
assessment and the draft EA prepared to examine any potential
environmental impacts of the proposed determination for the
deregulation of the subject soybean line. The petition, draft EA, and
plant pest risk assessment are available for public review, and copies
of the petition, draft EA, and plant pest risk assessment are available
as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
After the comment period closes, APHIS will review all written
comments received during the comment period and any other relevant
information. All comments received regarding the petition, draft EA,
and plant pest risk assessment will be available for public review.
After reviewing and evaluating the comments on the petition, the draft
EA, plant pest risk assessment, and other data, APHIS will furnish a
response to the petitioner, either approving or denying the petition.
APHIS will also publish a notice in the Federal Register announcing the
regulatory status of soybean event MON 87769 and the availability of
APHIS' written environmental decision and regulatory determination.
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 19th day of December 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-33002 Filed 12-22-11; 8:45 am]
BILLING CODE 3410-34-P
