Pioneer Hi-Bred International, Inc.; Availability of Petition for Determination of Nonregulated Status of Canola Genetically Engineered for Herbicide Tolerance, 41364-41366 [2012-17135]
Download as PDF
41364
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
www.aphis.usda.gov/brs/aphisdocs/
09_01501p.pdf.
FOR FURTHER INFORMATION CONTACT: Dr.
John Turner, Director, Environmental
Risk Analysis Programs, Biotechnology
Regulatory Services, APHIS, 4700 River
Road Unit 147, Riverdale, MD 20737–
1236; (301) 851–3954, email:
john.t.turner@aphis.usda.gov. To obtain
copies of the petition, contact Ms. Cindy
Eck at (301) 851–3892, 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 (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 09–015–01p)
from BASF Plant Science LP of Research
Triangle Park, NC, seeking a
determination of nonregulated status of
soybean (Glycine max) designated as
event BPS–CV127–9, which has been
genetically engineered for tolerance to
herbicides in the imidazolinone family,
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 BPS–CV127–9 has been
genetically engineered for tolerance to
herbicides in the imidazolinone family
through the introduction of the
imidazolinone-tolerant
acetohydroxyacid synthase large
subunit (ahas) gene csr1–2 with its
native promoter from the plant
Arabidopsis thaliana. Soybean event
BPS–CV127–9 is currently regulated
VerDate Mar<15>2010
17:08 Jul 12, 2012
Jkt 226001
under 7 CFR part 340. Interstate
movements and field tests of soybean
event BPS–CV127–9 have been
conducted under notifications
acknowledged by APHIS.
For this petition, most field tests were
conducted by BASF in Brazil, which
allowed for evaluation in a natural
agricultural setting. 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 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. We also
request that, when possible,
commenters provide relevant
information regarding specific localities
or regions as soybean growth, crop
management, and crop utilization may
vary considerably by geographic region.
view the notice, go to https://
www.regulations.gov/#!docketDetail;D=APHIS2011-0129.
PO 00000
1 To
Frm 00015
Fmt 4703
Sfmt 4703
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 decisionmaking
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 pestrisk 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.
Done in Washington, DC, this 9th day of
July 2012.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2012–17139 Filed 7–12–12; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2012–0031]
Pioneer Hi-Bred International, Inc.;
Availability of Petition for
Determination of Nonregulated Status
of Canola 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 (APHIS) has received
a petition from Pioneer Hi-Bred
SUMMARY:
E:\FR\FM\13JYN1.SGM
13JYN1
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
International, Inc., (Pioneer) seeking a
determination of nonregulated status of
canola designated as DP–073496–4,
which has been genetically engineered
for tolerance to the herbicide
glyphosate. The petition has been
submitted in accordance with our
regulations concerning the introduction
of certain genetically engineered
organisms and products. We are making
the Pioneer 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 September
11, 2012.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2012-00310001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2012–0031, 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-2012-0031 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) 799–7039 before
coming.
The petition is also available on the
APHIS Web site at https://www.aphis.
usda.gov/brs/aphisdocs/11_06301p.pdf.
FOR FURTHER INFORMATION CONTACT: Dr.
John Turner, Director, Environmental
Risk Analysis Programs, Biotechnology
Regulatory Services, APHIS, 4700 River
Road Unit 147, Riverdale, MD 20737–
1236; (301) 851–3954, email: john.t.
turner@aphis.usda.gov. To obtain copies
of the petition, contact Ms. Cindy Eck at
(301) 851–3892, 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
VerDate Mar<15>2010
17:08 Jul 12, 2012
Jkt 226001
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 11–063–01p) from
Pioneer Hi-Bred International, Inc., of
Johnston, IA, seeking a determination of
nonregulated status of canola (Brassica
napus) designated as event DP–073496–
4, which has been genetically
engineered for tolerance to the herbicide
glyphosate, stating that this canola 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, canola
event DP–073496–4 has been genetically
engineered to express the glyphosate
acetyltransferase (GAT4621) protein,
which gives the plant tolerance to the
herbicide glyphosate. The gat4621 gene
is a variant of three gat genes from the
common soil bacterium Bacillus
licheniformis. The GAT4621 protein is
encoded by the gat4621 gene, which
confers tolerance to glyphosatecontaining herbicides by acetylating
glyphosate and thereby rendering it
nonphytotoxic. Canola event DP–
073496–4 is currently regulated under 7
CFR part 340. Interstate movements and
field tests of canola event DP–073496–
4 have been conducted under
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
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.
Paragraph (d) of § 340.6 provides that
APHIS will publish a notice in the
PO 00000
Frm 00016
Fmt 4703
Sfmt 4703
41365
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 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. We also
request that, when possible,
commenters provide relevant
information regarding specific localities
or regions as canola growth, crop
management, and crop utilization may
vary considerably by geographic region.
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 decisionmaking
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
1 To view the notice, go to https://www.
regulations.gov/#!docketDetail;D=APHIS-20110129.
E:\FR\FM\13JYN1.SGM
13JYN1
41366
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices
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.
Done in Washington, DC, this 9th day of
July 2012.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2012–17135 Filed 7–12–12; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2012–0024]
Syngenta Biotechnology, Inc.;
Availability of Petition, Plant Pest Risk
Assessment, and Environmental
Assessment for Determination of
Nonregulated Status of Corn
Genetically Engineered for Insect
Resistance
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 Syngenta Biotechnology,
Inc., seeking a determination of
nonregulated status of corn designated
as SYN–05307–1, which has been
genetically engineered for resistance to
corn rootworm, an insect pest of corn.
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
corn is likely to pose a plant pest risk.
We are making available for public
comment the Syngenta Biotechnology,
Inc., petition, our plant pest risk
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:08 Jul 12, 2012
Jkt 226001
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 September
11, 2012.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!documentDetail;D=APHIS-2012-00240001.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2012–0024, 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-2012-0024 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) 799–7039
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/
10_33601p.pdf, https://
www.aphis.usda.gov/brs/aphisdocs/
10_33601p_dea.pdf, and https://
www.aphis.usda.gov/brs/aphisdocs/
10_33601p_dpra.pdf.
FOR FURTHER INFORMATION CONTACT: Dr.
John Turner, Director, Environmental
Risk Analysis Programs, Biotechnology
Regulatory Services, APHIS, 4700 River
Road Unit 147, Riverdale, MD 20737–
1236; (301) 851–3954, email:
john.t.turner@aphis.usda.gov. To obtain
copies of the petition, draft
environmental assessment, or plant pest
risk assessment, contact Ms. Cindy Eck
at (301) 851–3892, 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
PO 00000
Frm 00017
Fmt 4703
Sfmt 4703
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 10–336–01p) from
Syngenta Biotechnology, Inc.,
(Syngenta) of Research Triangle Park,
NC, seeking a determination of
nonregulated status of corn (Zea mays
L.) designated as event SYN–05307–1,
which has been genetically engineered
for resistance to corn rootworm, an
insect pest of corn. The petition states
that this corn 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, corn
event SYN–05307–1 has been
genetically engineered to contain the
transgene ecry3.1Ab encoding a novel
rootworm-control protein, eCry3.1Ab,
and the transgene pmi (also known as
manA) encoding the enzyme
phosphomannose isomerase (PMI). The
eCry3.1Ab protein is an engineered
chimera of the modified Cry3A
(mCry3A) and Cry1Ab proteins,
members of a class of insecticidal
proteins derived from Bacillus
thuringiensis. Corn event SYN–05307–1
is currently regulated under 7 CFR part
340. Interstate movements and field
tests of corn event SYN–05307–1 have
been conducted under 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
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
E:\FR\FM\13JYN1.SGM
13JYN1
Agencies
[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41364-41366]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17135]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2012-0031]
Pioneer Hi-Bred International, Inc.; Availability of Petition for
Determination of Nonregulated Status of Canola Genetically Engineered
for Herbicide Tolerance
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 Pioneer Hi-Bred
[[Page 41365]]
International, Inc., (Pioneer) seeking a determination of nonregulated
status of canola designated as DP-073496-4, which has been genetically
engineered for tolerance to the herbicide glyphosate. The petition has
been submitted in accordance with our regulations concerning the
introduction of certain genetically engineered organisms and products.
We are making the Pioneer 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
September 11, 2012.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!documentDetail;D=APHIS-2012-0031-0001.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2012-0031, 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-2012-
0031 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) 799-7039 before coming.
The petition is also available on the APHIS Web site at https://www.aphis.usda.gov/brs/aphisdocs/11_06301p.pdf.
FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director,
Environmental Risk Analysis Programs, Biotechnology Regulatory
Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236;
(301) 851-3954, email: john.t.turner@aphis.usda.gov. To obtain copies
of the petition, contact Ms. Cindy Eck at (301) 851-3892, 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 (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 11-063-01p)
from Pioneer Hi-Bred International, Inc., of Johnston, IA, seeking a
determination of nonregulated status of canola (Brassica napus)
designated as event DP-073496-4, which has been genetically engineered
for tolerance to the herbicide glyphosate, stating that this canola 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, canola event DP-073496-4 has been
genetically engineered to express the glyphosate acetyltransferase
(GAT4621) protein, which gives the plant tolerance to the herbicide
glyphosate. The gat4621 gene is a variant of three gat genes from the
common soil bacterium Bacillus licheniformis. The GAT4621 protein is
encoded by the gat4621 gene, which confers tolerance to glyphosate-
containing herbicides by acetylating glyphosate and thereby rendering
it nonphytotoxic. Canola event DP-073496-4 is currently regulated under
7 CFR part 340. Interstate movements and field tests of canola event
DP-073496-4 have been conducted under 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 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.
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 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. We also request that, when possible, commenters provide
relevant information regarding specific localities or regions as canola
growth, crop management, and crop utilization may vary considerably by
geographic region.
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 decisionmaking 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
[[Page 41366]]
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.
Done in Washington, DC, this 9th day of July 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2012-17135 Filed 7-12-12; 8:45 am]
BILLING CODE 3410-34-P