Pioneer Hi-Bred International, Inc.; Determination of Nonregulated Status for Soybean Genetically Engineered for Tolerance to Glyphosate and Acetolactate Synthase-Inhibiting Herbicides, 43203-43205 [E8-16950]
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Federal Register / Vol. 73, No. 143 / Thursday, July 24, 2008 / Notices
ebenthall on PRODPC60 with NOTICES
determination of nonregulated status for
the MON 89034 corn event.
We received 29 comments by the
close of the 60-day comment period,
which ended on February 11, 2008.
There were 5 comments submitted in
support of the petition to grant
nonregulated status to MON 89034 corn
and 24 that were opposed. APHIS’
responses to these comments can be
found as an attachment to the finding of
no significant impact.
Determination
Based on APHIS’ analysis of field,
greenhouse and laboratory data
submitted by Monsanto, references
provided in the petition, other relevant
information described in the
environmental assessment, and
comments provided by the public,
APHIS has determined that MON 89034
will not pose a plant pest risk for the
following reasons: (1) Gene
introgression from MON 89034 corn
into wild relatives in the United States
and its territories is extremely unlikely
and is not likely to increase the
weediness potential of any resulting
progeny or adversely affect genetic
diversity of related plants any more than
would introgression from traditional
corn hybrids; (2) it exhibits no
characteristics that would cause it to be
more weedy than the non-genetically
engineered parent corn line or other
cultivated corn; (3) it does not pose a
risk to non-target organisms, including
beneficial organisms and threatened or
endangered species, because the
insecticidal activity of the Cry1A.105
and Cry2Ab2 proteins are limited to
lepidopteran target pest species; (4) it
does not pose a threat to biodiversity as
it does not exhibit traits that increase its
weediness and its unconfined
cultivation should not lead to increased
weediness of other cultivated corn, it
exhibits no changes in disease
susceptibility, and it is unlikely to harm
non-target organisms common to the
agricultural ecosystem or threatened or
endangered species recognized by the
U.S. Fish and Wildlife Service; (5)
compared to current corn pest and weed
management practices, cultivation of
MON 89034 corn should not impact
standard agricultural practices in corn
cultivation and controlling volunteer
corn any differently than any other
deregulated corn line expressing Cry
proteins. Moreover, MON 89034 should
not present any new or different impacts
on organic farmers from those Bt corn
lines that are currently cultivated; and
(6) disease susceptibility and
compositional profiles of MON 89034
corn are similar to those of its parent
variety and other corn cultivars grown
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15:14 Jul 23, 2008
Jkt 214001
in the United States, therefore no direct
or indirect plant pest effects on raw or
processed plant commodities are
expected.
In conclusion, APHIS has determined
that there will be no effect on the
federally listed threatened or
endangered species, species proposed
for listing, or their designated or
proposed critical habitat resulting from
a determination of nonregulated status
for MON 89034 and its progeny. APHIS
also concludes that new varieties bred
from MON 89034 corn are unlikely to
exhibit new plant pest properties, i.e.,
properties substantially different from
any observed for corn event MON
89034, or those observed for other corn
varieties not considered regulated
articles under 7 CFR part 340.
National Environmental Policy Act
An EA was prepared to provide the
APHIS decisionmaker with a review and
analysis of any potential environmental
impacts associated with the
determination of nonregulated status for
MON 89034. The 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). Based on that EA, and other
pertinent scientific data, APHIS has
reached a FONSI with regard to the
determination that Monsanto corn line
MON 89034 and lines developed from it
are no longer regulated articles under its
regulations in 7 CFR part 340. Copies of
the EA and FONSI 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 18th day of
July 2008.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E8–16947 Filed 7–23–08; 8:45 am]
BILLING CODE 3410–34–P
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43203
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2007–0019]
Pioneer Hi-Bred International, Inc.;
Determination of Nonregulated Status
for Soybean Genetically Engineered
for Tolerance to Glyphosate and
Acetolactate Synthase-Inhibiting
Herbicides
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public of
our determination that a soybean line
developed by Pioneer Hi-Bred
International, Inc., designated as
transformation event 356043, which has
been genetically engineered for
tolerance to glyphosate and acetolactate
synthase-inhibiting herbicides, is no
longer considered a regulated article
under our regulations governing the
introduction of certain genetically
engineered organisms. Our
determination is based on our
evaluation of data submitted by the
Pioneer Hi-Bred International, Inc., in
its petition for a determination of
nonregulated status, our analysis of
other scientific data, and comments
received from the public in response to
a previous notice announcing the
availability of the petition for
nonregulated status and its associated
environmental assessment. This notice
also announces the availability of our
written determination and finding of no
significant impact.
DATES: Effective Date: July 24, 2008.
ADDRESSES: You may read the petition,
environmental assessment,
determination, finding of no significant
impact, the comments we received on
our previous notice, and our responses
to those comments in our reading room.
The reading room 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. To view those documents on
the Internet, go to https://
www.regulations.gov/fdmspublic/
component/
main?main=DocketDetail&d=APHIS2007-0019.
FOR FURTHER INFORMATION CONTACT: Mr.
John Cordts, Biotechnology Regulatory
Services, APHIS, 4700 River Road Unit
147, Riverdale, MD 20737–1236; (301)
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24JYN1
43204
Federal Register / Vol. 73, No. 143 / Thursday, July 24, 2008 / Notices
734–5531,
john.m.cordts@aphis.usda.gov. To
obtain copies of the petition,
environmental assessment, or the
finding of no significant impact, contact
Ms. Cynthia Eck at (301) 734–0667; email: cynthia.a.eck@aphis.usda.gov.
Those documents are also available on
the APHIS Web site at https://
www.aphis.usda.gov/brs/aphisdocs/
06_27101p.pdf and https://
www.aphis.usda.gov/brs/aphisdocs/
06_27101p_ea.pdf.
SUPPLEMENTARY INFORMATION:
Background
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.
On September 28, 2006, APHIS
received a petition seeking a
determination of nonregulated status
(APHIS petition number 06–271–01p)
from Pioneer Hi-Bred International, Inc.,
of Johnston, IA (Pioneer), for soybean
(Glycine max L.) designated as
transformation event 356043, which has
been genetically engineered for
tolerance to glyphosate and acetolactate
synthase (ALS)-inhibiting herbicides,
stating that soybean line 356043 does
not present a plant pest risk.
ebenthall on PRODPC60 with NOTICES
Analysis
As described in the petition, 356043
soybean plants have been genetically
engineered to express modified
glyphosate acetyltransferase (GAT 4601)
and ALS proteins, which confers
tolerance to glyphosate and ALSinhibiting herbicides. The gat4601 gene
is derived from gat genes from Bacillus
licheniformis, a common soil bacterium.
Expression of the gat4601 gene is driven
VerDate Aug<31>2005
15:14 Jul 23, 2008
Jkt 214001
by a synthetic constitutive promoter
(SCP1). The gene that confers tolerance
to ALS-inhibiting herbicides is gm-hra
and is a modified soybean ALS gene.
Expression of the gm-hra gene is driven
by a constitutive soybean S-adenosyl-Lmethionine synthetase (SAMS)
promoter. A single copy of these genes
and their regulatory sequences were
introduced into soybean somatic
embryos using microprojectile
bombardment.
Pioneer’s 356043 soybean plants have
been considered regulated articles under
the regulations in 7 CFR part 340
because they contain gene sequences
from plant pathogens. Pioneer’s 356043
soybean plants have been field tested in
the United States since 2003 under
permits issued by APHIS. In the process
of reviewing the permits for field trials
of the subject soybean plants, APHIS
determined that the vectors and other
elements were disarmed and that trials,
which were conducted under conditions
of reproductive and physical
confinement or isolation, would not
present a risk of plant pest introduction
or dissemination.
In a notice 1 published in the Federal
Register on October 5, 2007 (72 FR
56981–56983, Docket No. APHIS–2007–
0019), APHIS announced the
availability of the Pioneer petition and
a draft environmental assessment (EA)
for public comment. APHIS solicited
public comments on whether the subject
soybean would present a plant pest risk
and on the EA. APHIS received 110
comments by the close of the 60-day
comment period, which ended on
December 4, 2007. There were 18
comments submitted in support of the
petition to grant nonregulated status to
356043 soybean plants and 92 that were
opposed. APHIS’ responses to these
comments can be found as an
attachment to the finding of no
significant impact.
Determination
Based on APHIS’ analysis of field,
greenhouse, and laboratory data
submitted by Pioneer, references
provided in the petition, other relevant
information described in the EA, and
comments provided by the public,
APHIS has determined that 356043
soybean will not pose a plant pest risk
for the following reasons: (1) Gene
introgression from 356043 soybean into
wild relatives in the United States and
its territories is extremely unlikely; (2)
APHIS does not expect 356043 soybean
1 To view the notice, the EA, and the comments
we received, go to https://www.regulations.gov/
fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0019.
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Fmt 4703
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to have any impacts on non-target
organisms, including beneficial
organisms and threatened or endangered
species, because all the studies
conducted on 356043 soybean and
specific proteins show no evidence of
toxicity and GAT4601 and GM–HRA
protein assessments showed low
likelihood of allergenicity; (3) soybean
(Glycine max) is not considered to be a
weed and it does not persist in
unmanaged ecosystems; (4) APHIS does
not expect cultivation of 356043
soybean to have significant impacts on
non-target organisms, including
beneficial organisms and threatened or
endangered species, as a result of the
use of EPA-registered glyphosate and
ALS-inhibitor herbicides as these have
been used safely on soybeans for many
years; (5) analysis of available
information demonstrates that 356043
soybean does not exhibit any traits that
should cause increased weediness, and
that its unconfined cultivation should
not lead to increased weediness of other
sexually compatible relatives (of which
there are none in the United States); (6)
if 356043 soybeans were to be grown
commercially, the effects on agricultural
practices (e.g., cultivation, spray
programs, crop rotation practices,
planting rates, etc.) from introducing
356043 soybean into the environment
should not be significantly different
than previously deregulated glyphosate
tolerant or RR/STS soybean lines; (7)
APHIS does not expect 356043 soybean
to cause significant impact on the
development of herbicide tolerant
weeds or cumulative impacts in
combination with other glyphosate
tolerant or Roundup Ready/STS
(sulfonylurea tolerant soybean) crops;
(8) if 356043 soybean were to be grown
commercially, APHIS expects 356043
soybean will be used to breed soybean
varieties suitable to a range of
environments and maturity zones and
replace some of the presently available
glyphosate and ALS-inhibitor tolerant
soybeans; deregulation of 356043
soybean should not alter the current
potential impact to organic farming,
organic farmers will still be able to
purchase and grow non-transgenic
soybeans and will be able to coexist
with biotech soybean producers as they
do now; (9) APHIS’ analysis of
agronomic performance, disease and
insect susceptibility, and compositional
profiles of 356043 soybean and its nongenetically engineered counterpart
indicates no significant differences in
composition between the two that
would be expected to cause significant
effects on raw or processed plant
commodities from the deregulation of
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Federal Register / Vol. 73, No. 143 / Thursday, July 24, 2008 / Notices
356043 soybean; and (10) when
considered in light of other past,
present, and reasonably foreseeable
future actions, and considering potential
environmental effects associated with
adoption of 356043 soybean, APHIS
could not identify significant
environmental impacts that would
result from granting nonregulated status
to 356043 soybean.
National Environmental Policy Act
To provide the public with
documentation of APHIS’ review and
analysis of any potential environmental
impacts associated with the
determination of nonregulated status for
356043 soybeans, an EA was prepared.
The 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). Based on
that EA and other pertinent scientific
data, APHIS has reached a finding of no
significant impact with regard to the
determination that Pioneer 356043
soybean line and lines developed from
it are no longer regulated articles under
its regulations in 7 CFR part 340. Copies
of the EA and finding of no significant
impact 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 18th day of
July, 2008.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E8–16950 Filed 7–23–08; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Commodity Credit Corporation
Agricultural Management Assistance
Program
Commodity Credit Corporation,
USDA.
ACTION: Notice of availability of program
funds for the Agricultural Management
Assistance (AMA) Program.
ebenthall on PRODPC60 with NOTICES
AGENCY:
SUMMARY: The Food, Conservation, and
Energy Act of 2008 (2008 Act) expanded
the geographic scope of the AMA
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15:14 Jul 23, 2008
Jkt 214001
Program to include the State of Hawaii.
The Commodity Credit Corporation
(CCC) administers AMA under the
general supervision of the Chief of the
Natural Resources Conservation Service
(NRCS), who is one of the vice
presidents of CCC.
CCC announces the availability of an
additional $2.5 million of technical and
financial assistance funds in fiscal year
(FY) 2008 to participating States. AMA
is available to States which have
historically low participation in the
Federal crop insurance program. These
States are: Connecticut, Delaware,
Maine, Maryland, Massachusetts,
Nevada, New Hampshire, New Jersey,
New York, Pennsylvania, Rhode Island,
Utah, Vermont, West Virginia,
Wyoming, and Hawaii. Under AMA, a
participant may use financial assistance
to adopt conservation practices that will
reduce or mitigate risks to their
agricultural enterprises.
AMA is authorized by Section 524(b)
of the Federal Crop Insurance Act (7
U.S.C. 1524(b)), and administered under
regulations found at 7 CFR part 1465.
NRCS will, at a later date, formally
amend the final rule located in 7 CFR
part 1465 to add Hawaii as an area
which is eligible for AMA assistance.
DATES: July 24, 2008 to September 30,
2008.
FOR FURTHER INFORMATION CONTACT:
Harry Slawter, Director, Financial
Assistance Programs Division, NRCS,
Post Office Box 2890, Washington, DC
20013; telephone: (202) 720–1845;
facsimile: (202) 720–4265; e-mail:
harry.slawter@wdc.usda.gov.
SUPPLEMENTARY INFORMATION: CCC
hereby announces the availability of up
to $2.5 million in FY 2008 to provide
technical and financial assistance to
producers under AMA. AMA assistance
helps producers develop and implement
conservation practices that reduce or
mitigate agricultural production risks.
Conservation practices, available under
AMA, reduce soil erosion, improve
watershed management or irrigation
structures, utilize integrated pest
management principles, and assist
producers in transitioning to organicbased farming.
AMA was established in 2000. Since
that time, AMA has been made available
to 15 States, listed in statutory
authority, in which participation in the
Federal crop insurance program has
been historically low. The 15 States
include: Connecticut, Delaware, Maine,
Maryland, Massachusetts, Nevada, New
Hampshire, New Jersey, New York,
Pennsylvania, Rhode Island, Utah,
Vermont, West Vermont, West Virginia,
and Wyoming. The 2008 Act expanded
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43205
AMA’s geographic scope to include the
State of Hawaii.
The 2008 Act provided for the
continuation of conservation programs
in 2008. AMA will continue to use the
policies and operating procedures
outlined in AMA’s regulation (7 CFR
part 1465) for program implementation
in 2008. Individuals interested in
applying for AMA assistance may
contact their local Department of
Agriculture (USDA) service center in
participating AMA States. For a listing
of local USDA service centers, consult:
https://offices.sc.egov.usda.gov/locator/
app?agency=nrcs.
Signed in Washington, DC, on July 17,
2008.
Arlen L. Lancaster,
Vice President, Commodity Credit
Corporation and Chief, Natural Resources
Conservation Service.
[FR Doc. E8–16920 Filed 7–23–08; 8:45 am]
BILLING CODE 3410–16–P
DEPARTMENT OF AGRICULTURE
Forest Service
Notice of New Fee Site; Federal Lands
Recreation Enhancement Act (Title VIII,
Pub. L. 108–447)
Caribou-Targhee National
Forest, USDA Forest Service.
ACTION: Notice of New Fee Site.
AGENCY:
SUMMARY: The Teton Basin Ranger
District of the Caribou-Targhee National
Forest will begin charging $100.00 for
the overnight rental of Driggs Cabin.
Rentals of other cabins and guard
stations on the Caribou-Targhee
National Forest have shown that the
public appreciates and enjoys the
availability of this type of facility.
Funds from the rental will be used for
the continued operation and
maintenance of the Driggs Cabin.
DATES: The Driggs Cabin will become
available for rent in January 2009. The
Cabin will be open for the public to rent
between November 1st and April 30th
annually. The Driggs Cabin will
continue to function as seasonal
employee housing annually from May
1st to October 31st.
ADDRESSES: Forest Supervisor, CaribouTarghee National Forest, 1405 Hollipark
Dr., Idaho Falls, ID 83401.
FOR FURTHER INFORMATION CONTACT: Kurt
Kluegel, Natural Resource Specialist,
Teton Basin Ranger District, (208) 354–
2312.
SUPPLEMENTARY INFORMATION: The
Federal Recreation Lands Enhancement
Act (Title VII, Pub. L. 108–447) directed
the Secretary of Agriculture to publish
E:\FR\FM\24JYN1.SGM
24JYN1
]]>Agencies
[Federal Register Volume 73, Number 143 (Thursday, July 24, 2008)]
[Notices]
[Pages 43203-43205]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16950]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0019]
Pioneer Hi-Bred International, Inc.; Determination of
Nonregulated Status for Soybean Genetically Engineered for Tolerance to
Glyphosate and Acetolactate Synthase-Inhibiting Herbicides
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public of our determination that a soybean
line developed by Pioneer Hi-Bred International, Inc., designated as
transformation event 356043, which has been genetically engineered for
tolerance to glyphosate and acetolactate synthase-inhibiting
herbicides, is no longer considered a regulated article under our
regulations governing the introduction of certain genetically
engineered organisms. Our determination is based on our evaluation of
data submitted by the Pioneer Hi-Bred International, Inc., in its
petition for a determination of nonregulated status, our analysis of
other scientific data, and comments received from the public in
response to a previous notice announcing the availability of the
petition for nonregulated status and its associated environmental
assessment. This notice also announces the availability of our written
determination and finding of no significant impact.
DATES: Effective Date: July 24, 2008.
ADDRESSES: You may read the petition, environmental assessment,
determination, finding of no significant impact, the comments we
received on our previous notice, and our responses to those comments in
our reading room. The reading room 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. To view those documents on
the Internet, go to https://www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0019.
FOR FURTHER INFORMATION CONTACT: Mr. John Cordts, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301)
[[Page 43204]]
734-5531, john.m.cordts@aphis.usda.gov. To obtain copies of the
petition, environmental assessment, or the finding of no significant
impact, contact Ms. Cynthia Eck at (301) 734-0667; e-mail:
cynthia.a.eck@aphis.usda.gov. Those documents are also available on the
APHIS Web site at https://www.aphis.usda.gov/brs/aphisdocs/06_
27101p.pdf and https://www.aphis.usda.gov/brs/aphisdocs/06_27101p_
ea.pdf.
SUPPLEMENTARY INFORMATION:
Background
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.
On September 28, 2006, APHIS received a petition seeking a
determination of nonregulated status (APHIS petition number 06-271-01p)
from Pioneer Hi-Bred International, Inc., of Johnston, IA (Pioneer),
for soybean (Glycine max L.) designated as transformation event 356043,
which has been genetically engineered for tolerance to glyphosate and
acetolactate synthase (ALS)-inhibiting herbicides, stating that soybean
line 356043 does not present a plant pest risk.
Analysis
As described in the petition, 356043 soybean plants have been
genetically engineered to express modified glyphosate acetyltransferase
(GAT 4601) and ALS proteins, which confers tolerance to glyphosate and
ALS-inhibiting herbicides. The gat4601 gene is derived from gat genes
from Bacillus licheniformis, a common soil bacterium. Expression of the
gat4601 gene is driven by a synthetic constitutive promoter (SCP1). The
gene that confers tolerance to ALS-inhibiting herbicides is gm-hra and
is a modified soybean ALS gene. Expression of the gm-hra gene is driven
by a constitutive soybean S-adenosyl-L-methionine synthetase (SAMS)
promoter. A single copy of these genes and their regulatory sequences
were introduced into soybean somatic embryos using microprojectile
bombardment.
Pioneer's 356043 soybean plants have been considered regulated
articles under the regulations in 7 CFR part 340 because they contain
gene sequences from plant pathogens. Pioneer's 356043 soybean plants
have been field tested in the United States since 2003 under permits
issued by APHIS. In the process of reviewing the permits for field
trials of the subject soybean plants, APHIS determined that the vectors
and other elements were disarmed and that trials, which were conducted
under conditions of reproductive and physical confinement or isolation,
would not present a risk of plant pest introduction or dissemination.
In a notice \1\ published in the Federal Register on October 5,
2007 (72 FR 56981-56983, Docket No. APHIS-2007-0019), APHIS announced
the availability of the Pioneer petition and a draft environmental
assessment (EA) for public comment. APHIS solicited public comments on
whether the subject soybean would present a plant pest risk and on the
EA. APHIS received 110 comments by the close of the 60-day comment
period, which ended on December 4, 2007. There were 18 comments
submitted in support of the petition to grant nonregulated status to
356043 soybean plants and 92 that were opposed. APHIS' responses to
these comments can be found as an attachment to the finding of no
significant impact.
---------------------------------------------------------------------------
\1\ To view the notice, the EA, and the comments we received, go
to https://www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0019.
---------------------------------------------------------------------------
Determination
Based on APHIS' analysis of field, greenhouse, and laboratory data
submitted by Pioneer, references provided in the petition, other
relevant information described in the EA, and comments provided by the
public, APHIS has determined that 356043 soybean will not pose a plant
pest risk for the following reasons: (1) Gene introgression from 356043
soybean into wild relatives in the United States and its territories is
extremely unlikely; (2) APHIS does not expect 356043 soybean to have
any impacts on non-target organisms, including beneficial organisms and
threatened or endangered species, because all the studies conducted on
356043 soybean and specific proteins show no evidence of toxicity and
GAT4601 and GM-HRA protein assessments showed low likelihood of
allergenicity; (3) soybean (Glycine max) is not considered to be a weed
and it does not persist in unmanaged ecosystems; (4) APHIS does not
expect cultivation of 356043 soybean to have significant impacts on
non-target organisms, including beneficial organisms and threatened or
endangered species, as a result of the use of EPA-registered glyphosate
and ALS-inhibitor herbicides as these have been used safely on soybeans
for many years; (5) analysis of available information demonstrates that
356043 soybean does not exhibit any traits that should cause increased
weediness, and that its unconfined cultivation should not lead to
increased weediness of other sexually compatible relatives (of which
there are none in the United States); (6) if 356043 soybeans were to be
grown commercially, the effects on agricultural practices (e.g.,
cultivation, spray programs, crop rotation practices, planting rates,
etc.) from introducing 356043 soybean into the environment should not
be significantly different than previously deregulated glyphosate
tolerant or RR[supreg]/STS[supreg] soybean lines; (7) APHIS does not
expect 356043 soybean to cause significant impact on the development of
herbicide tolerant weeds or cumulative impacts in combination with
other glyphosate tolerant or Roundup Ready[supreg]/STS[supreg]
(sulfonylurea tolerant soybean) crops; (8) if 356043 soybean were to be
grown commercially, APHIS expects 356043 soybean will be used to breed
soybean varieties suitable to a range of environments and maturity
zones and replace some of the presently available glyphosate and ALS-
inhibitor tolerant soybeans; deregulation of 356043 soybean should not
alter the current potential impact to organic farming, organic farmers
will still be able to purchase and grow non-transgenic soybeans and
will be able to coexist with biotech soybean producers as they do now;
(9) APHIS' analysis of agronomic performance, disease and insect
susceptibility, and compositional profiles of 356043 soybean and its
non-genetically engineered counterpart indicates no significant
differences in composition between the two that would be expected to
cause significant effects on raw or processed plant commodities from
the deregulation of
[[Page 43205]]
356043 soybean; and (10) when considered in light of other past,
present, and reasonably foreseeable future actions, and considering
potential environmental effects associated with adoption of 356043
soybean, APHIS could not identify significant environmental impacts
that would result from granting nonregulated status to 356043 soybean.
National Environmental Policy Act
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with the
determination of nonregulated status for 356043 soybeans, an EA was
prepared. The 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). Based on that EA
and other pertinent scientific data, APHIS has reached a finding of no
significant impact with regard to the determination that Pioneer 356043
soybean line and lines developed from it are no longer regulated
articles under its regulations in 7 CFR part 340. Copies of the EA and
finding of no significant impact 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 18th day of July, 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-16950 Filed 7-23-08; 8:45 am]
BILLING CODE 3410-34-P
