Mycogen Seeds/Dow AgroSciences LLC and Pioneer Hi-Bred International Inc.; Availability of Determination of Nonregulated Status for Genetically Engineered Corn, 58663-58664 [05-20194]
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Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices
Total Burden Hours: 5.
Charlene Parker,
Departmental Information Collection
Clearance Officer.
[FR Doc. 05–20166 Filed 10–6–05; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. 04–113–2]
Mycogen Seeds/Dow AgroSciences
LLC and Pioneer Hi-Bred International
Inc.; Availability of Determination of
Nonregulated Status for Genetically
Engineered Corn
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public of
our determination that the Mycogen
Seeds/Dow AgroSciences LLC and
Pioneer Hi-Bred International Inc. corn
designated as corn line DAS–59122–7,
which has been genetically engineered
for resistance to a corn rootworm
complex and for tolerance to the
herbicide glufosinate, 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
Mycogen Seeds/Dow AgroSciences LLC
and Pioneer Hi-Bred International Inc.
in their petition for a determination of
non-regulated 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 an
environmental assessment. This notice
also announces the availability of our
written determination and our finding
of no significant impact.
DATE: Effective September 23, 2005.
FOR FURTHER INFORMATION CONTACT: Dr.
Michael Watson, Biotechnology
Regulatory Services, APHIS, 4700 River
Road Unit 147, Riverdale, MD 20737–
1236; (301) 734–0486; e-mail:
michael.t.watson@aphis.usda.gov. To
obtain copies of the petition or, the
determination, the environmental
assessment (EA), or the finding of no
significant impact (FONSI) contact Ms.
Ingrid Berlanger at (301) 734–4885; email: ingrid.e.berlanger@aphis.usda.gov.
The petition and the EA, including the
FONSI and determination, are also
available on the Internet at https://
www.aphis.usda.gov/brs/aphisdocs/
VerDate Aug<31>2005
18:27 Oct 06, 2005
Jkt 208001
03_35301p.pdf and https://
www.aphis.usda.gov/brs/aphisdocs/
03_35301p_ea.pdf.
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 December 19, 2003, APHIS
received a petition (APHIS No. 03–353–
01p) from Mycogen Seeds/Dow
AgroSciences LLC of Indianapolis, IN,
and Pioneer Hi-Bred International of
Johnston, IA (Dow AgroSciences/
Pioneer), requesting a determination of
nonregulated status under 7 CFR part
340 for corn (Zea mays) designated as
corn line DAS–59122–7, which has been
genetically engineered for resistance to
corn rootworm and for tolerance to the
herbicide glufosinate. The Dow
AgroSciences/Pioneer petition states
that the subject corn should not be
regulated by APHIS because it does not
present a plant pest risk.
In a notice published in the Federal
Register on July 1, 2005 (70 FR 38094–
38096, Docket No. 04–113–1), APHIS
announced the availability of the Dow
AgroSciences/Pioneer petition and an
environmental assessment (EA). APHIS
solicited comments on whether the
subject corn would present a plant pest
risk and on the environmental
assessment. The notice also discussed
the role of APHIS, the Environmental
Protection Agency, and the Food and
Drug Administration in regulating the
subject corn and products developed
from it.
APHIS received two comments by the
close of the comment period on August
30, 2005. One comment was from a
trade association, which supported the
petition. The other comment was from
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
58663
a private individual who did not
support the petition. The response to
these comments can be found in an
attachment to the finding of no
significant impact (FONSI).
APHIS has amended the section of the
EA titled ‘‘Potential impacts on
threatened and endangered arthropods.’’
The amended section includes a
reference to a process for assessment of
impacts on threatened and endangered
species that has been mutually agreed
upon by the U.S. Fish and Wildlife
Service and APHIS. The change in
language merely provides clarity to the
reader; it is not substantive and did not
change the analysis described in the EA.
As described in the petition, corn line
DAS–59122–7 has been genetically
engineered to express a plant
incorporated protectant (PIP) that
controls certain corn rootworm. The PIP
is an insecticidal crystal protein (ICP)
from Bacillus thuringiensis strain
PS149B1. The ICP is made of two
proteins Cry34Ab1, approximately 14
kDa, and Cry35Ab1, approximately 44
kDa in molecular weight. Transcription
of the Cry34Ab1 coding sequence is
controlled by the maize ubiquitin
promoter (UBI1ZM PRO). Transcription
of Cry35Ab1 is controlled by a wheat
(Triticum aestivum) peroxidase (TA
Peroxidase) promoter. The termination
sequences for these two genes were
derived from the potato (Solanum
tuberosum) proteinase inhibitor II
(PINII). The PIP is expressed throughout
the plant and confers resistance to
northern corn rootworm (nCRW),
western corn rootworm (wCRW), and
Mexican corn rootworm (mCRW).
Corn line DAS–59122–7 has also been
genetically engineered to express the
enzyme phosphinothricin
acetyltransferase (PAT), which confers
tolerance to the herbicide glufosinate.
The expression of the pat gene, derived
from the bacterium Streptomyces
viridochromogenes, is under the control
of the cauliflower mosaic virus (CaMV)
35S RNA promoter and a CaMV
termination sequence (CaMV35S
TERM). The DAS–59122–7 corn line
was generated through Agrobacteriummediated transformation of the publicly
available corn line Hi-II.
Determination
Based on its analysis of the data
submitted by Dow AgroSciences/
Pioneer, a review of other scientific
data, field tests of the subject corn, and
the comments submitted by the public,
APHIS has determined the following
with respect to corn line DAS–59122–7:
(1) It exhibits no plant pathogenic
properties; although a plant pathogen
was used in the development of this
E:\FR\FM\07OCN1.SGM
07OCN1
58664
Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices
corn, these plants are not infected by
this organism, nor do they contain
genetic material from this pathogen that
can cause plant disease; (2) it exhibits
no characteristics that would cause it to
be more weedy than the non-transgenic
parent corn line or other cultivated
corn; (3) gene introgression from DAS–
59122–7 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 nor adversely affect
genetic diversity of related plants any
more than would introgression from
traditional corn hybrids; (4) disease and
insect susceptibility and compositional
profiles of the kernel is similar to nontransgenic corn and should have no
adverse impact on raw or processed
agricultural commodities; (5) it exhibits
no potential to have significant adverse
impact on organisms beneficial to
agriculture; (6) compared to current
agricultural practices, cultivation of
DAS–59122–7 should not reduce the
ability to control pests and weeds in
corn or other crops. In addition to our
finding of no plant pest risk, there will
be no effect on threatened or
endangered species resulting from a
determination of non-regulated status
for DAS–59122–7 and its progeny.
Therefore, APHIS has concluded that
the subject corn and any progeny
derived from hybrid crosses with other
non-transformed corn varieties will be
as safe to grow as corn varieties in
traditional breeding programs that are
not subject to regulation under 7 CFR
part 340. The effect of this
determination is that Dow
AgroSciences/Pioneer corn line DAS–
59122–7 is no longer considered a
regulated article under APHIS’
regulations in 7 CFR part 340.
Therefore, the requirements
pertaining to regulated articles under
those regulations no longer apply to the
subject corn or its progeny. However,
importation of corn line DAS–59122–7
and seeds capable of propagation are
still subject to the restrictions found in
APHIS’ foreign quarantine notices in 7
CFR part 319 and imported seed
regulations in 7 CFR part 361.
National Environmental Policy Act
An EA was prepared to examine any
potential environmental impacts and
plant pest risk associated with the
determination of nonregulated status for
the Dow AgroSciences/Pioneer corn line
DAS–59122–7. 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
VerDate Aug<31>2005
18:27 Oct 06, 2005
Jkt 208001
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, APHIS has reached
a FONSI with regard to the
determination that Dow AgroSciences/
Pioneer corn line DAS–59122–7 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 from the individual
listed in the FOR FURTHER INFORMATION
CONTACT section of this notice.
Authority: 7 U.S.C. 1622n and 7701–7772;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 3rd day of
October 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 05–20194 Filed 10–6–05; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. 05–062–2]
University of Kentucky; Availability of
an Environmental Assessment and a
Finding of No Significant Impact for
Field Tests of Genetically Engineered
Neotyphodium
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public
that the Animal and Plant Health
Inspection Service has prepared an
environmental assessment for a field
trial of genetically engineered strains of
an endophytic fungus of perennial
ryegrass, Neotyphodium sp. isolate Lp1.
The fungi have been genetically
engineered to disrupt the ergovaline
synthesis pathway. The environmental
assessment provides a basis for our
conclusion that these field tests will not
present a risk of introducing or
disseminating a plant pest and will not
have a significant impact on the quality
of the human environment. Based on its
finding of no significant impact, the
Animal and Plant Health Inspection
Service has determined that an
environmental impact statement need
not be prepared for these field tests.
DATES: A permit may be issued on or
after October 7, 2005.
FOR FURTHER INFORMATION CONTACT: Mr.
Michael Blanchette, Biotechnology
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
Regulatory Services, APHIS, 4700 River
Road, Unit 147, Riverdale, MD 20737–
1236; (301) 734–5141; e-mail:
michael.p.blanchette@aphis.usda.gov.
To obtain copies of the petition, the
environmental assessment (EA), or the
finding of no significant impact
(FONSI), contact Ms. Ingrid Berlanger at
(301) 734–4885; e-mail:
ingrid.e.berlanger@aphis.usda.gov. The
EA and FONSI are also available on the
Internet at: https://www.aphis.usda.gov/
brs/aphisdocs/05_15201r_ea.pdf.
SUPPLEMENTARY INFORMATION: 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.’’ A permit must be obtained or
a notification acknowledged before a
regulated article may be introduced. The
regulations set forth the permit
application requirements and the
notification procedures for the
importation, interstate movement, or
release into the environment of a
regulated article.
On June 1, 2005, the Animal and
Plant Health Inspection Service (APHIS)
received a permit application (APHIS
No. 05–152–01r) from the University of
Kentucky, Department of Plant
Pathology, for a confined field release of
two mutant strains of Neotyphodium sp
isolate Lp1, which is an endophytic
fungus of Lolium perenne (perennial
ryegrass). These two mutants were
generated by inserting a gene construct
containing a hygromycin
phosphotransferase gene (hph) into
specific genes in the ergovaline
synthesis pathway. The literature is
obscure regarding the specific donor of
the hph gene to the plasmid that was
used to create this construct. The
identical hph gene has been identified
in three bacterial species, Klebsiella sp.,
Streptomyces hygroscopicus, and
Escherichia coli. Expression of the hph
gene is regulated by the Neurospora
crassa cross-pathway control gene (cpc1) promoter and a transcription
termination sequence from the trpC
gene of Aspergillus nidulans.
Strain Lp1–4175 results from an
insertion of the hph construct in the
dimethylallyltryptophan synthase
E:\FR\FM\07OCN1.SGM
07OCN1
]]>Agencies
[Federal Register Volume 70, Number 194 (Friday, October 7, 2005)]
[Notices]
[Pages 58663-58664]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20194]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-113-2]
Mycogen Seeds/Dow AgroSciences LLC and Pioneer Hi-Bred
International Inc.; Availability of Determination of Nonregulated
Status for Genetically Engineered Corn
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public of our determination that the
Mycogen Seeds/Dow AgroSciences LLC and Pioneer Hi-Bred International
Inc. corn designated as corn line DAS-59122-7, which has been
genetically engineered for resistance to a corn rootworm complex and
for tolerance to the herbicide glufosinate, 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 Mycogen Seeds/Dow AgroSciences LLC
and Pioneer Hi-Bred International Inc. in their petition for a
determination of non-regulated 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 an environmental assessment. This notice also announces the
availability of our written determination and our finding of no
significant impact.
DATE: Effective September 23, 2005.
FOR FURTHER INFORMATION CONTACT: Dr. Michael Watson, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-0486; e-mail: michael.t.watson@aphis.usda.gov. To
obtain copies of the petition or, the determination, the environmental
assessment (EA), or the finding of no significant impact (FONSI)
contact Ms. Ingrid Berlanger at (301) 734-4885; e-mail:
ingrid.e.berlanger@aphis.usda.gov. The petition and the EA, including
the FONSI and determination, are also available on the Internet at
https://www.aphis.usda.gov/brs/aphisdocs/03_35301p.pdf and https://
www.aphis.usda.gov/brs/aphisdocs/03_35301p_ea.pdf.
SUPPLEMENTARY INFORMATION: 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 December 19, 2003, APHIS received a petition (APHIS No. 03-353-
01p) from Mycogen Seeds/Dow AgroSciences LLC of Indianapolis, IN, and
Pioneer Hi-Bred International of Johnston, IA (Dow AgroSciences/
Pioneer), requesting a determination of nonregulated status under 7 CFR
part 340 for corn (Zea mays) designated as corn line DAS-59122-7, which
has been genetically engineered for resistance to corn rootworm and for
tolerance to the herbicide glufosinate. The Dow AgroSciences/Pioneer
petition states that the subject corn should not be regulated by APHIS
because it does not present a plant pest risk.
In a notice published in the Federal Register on July 1, 2005 (70
FR 38094-38096, Docket No. 04-113-1), APHIS announced the availability
of the Dow AgroSciences/Pioneer petition and an environmental
assessment (EA). APHIS solicited comments on whether the subject corn
would present a plant pest risk and on the environmental assessment.
The notice also discussed the role of APHIS, the Environmental
Protection Agency, and the Food and Drug Administration in regulating
the subject corn and products developed from it.
APHIS received two comments by the close of the comment period on
August 30, 2005. One comment was from a trade association, which
supported the petition. The other comment was from a private individual
who did not support the petition. The response to these comments can be
found in an attachment to the finding of no significant impact (FONSI).
APHIS has amended the section of the EA titled ``Potential impacts
on threatened and endangered arthropods.'' The amended section includes
a reference to a process for assessment of impacts on threatened and
endangered species that has been mutually agreed upon by the U.S. Fish
and Wildlife Service and APHIS. The change in language merely provides
clarity to the reader; it is not substantive and did not change the
analysis described in the EA.
As described in the petition, corn line DAS-59122-7 has been
genetically engineered to express a plant incorporated protectant (PIP)
that controls certain corn rootworm. The PIP is an insecticidal crystal
protein (ICP) from Bacillus thuringiensis strain PS149B1. The ICP is
made of two proteins Cry34Ab1, approximately 14 kDa, and Cry35Ab1,
approximately 44 kDa in molecular weight. Transcription of the Cry34Ab1
coding sequence is controlled by the maize ubiquitin promoter (UBI1ZM
PRO). Transcription of Cry35Ab1 is controlled by a wheat (Triticum
aestivum) peroxidase (TA Peroxidase) promoter. The termination
sequences for these two genes were derived from the potato (Solanum
tuberosum) proteinase inhibitor II (PINII). The PIP is expressed
throughout the plant and confers resistance to northern corn rootworm
(nCRW), western corn rootworm (wCRW), and Mexican corn rootworm (mCRW).
Corn line DAS-59122-7 has also been genetically engineered to
express the enzyme phosphinothricin acetyltransferase (PAT), which
confers tolerance to the herbicide glufosinate. The expression of the
pat gene, derived from the bacterium Streptomyces viridochromogenes, is
under the control of the cauliflower mosaic virus (CaMV) 35S RNA
promoter and a CaMV termination sequence (CaMV35S TERM). The DAS-59122-
7 corn line was generated through Agrobacterium-mediated transformation
of the publicly available corn line Hi-II.
Determination
Based on its analysis of the data submitted by Dow AgroSciences/
Pioneer, a review of other scientific data, field tests of the subject
corn, and the comments submitted by the public, APHIS has determined
the following with respect to corn line DAS-59122-7: (1) It exhibits no
plant pathogenic properties; although a plant pathogen was used in the
development of this
[[Page 58664]]
corn, these plants are not infected by this organism, nor do they
contain genetic material from this pathogen that can cause plant
disease; (2) it exhibits no characteristics that would cause it to be
more weedy than the non-transgenic parent corn line or other cultivated
corn; (3) gene introgression from DAS-59122-7 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
nor adversely affect genetic diversity of related plants any more than
would introgression from traditional corn hybrids; (4) disease and
insect susceptibility and compositional profiles of the kernel is
similar to non-transgenic corn and should have no adverse impact on raw
or processed agricultural commodities; (5) it exhibits no potential to
have significant adverse impact on organisms beneficial to agriculture;
(6) compared to current agricultural practices, cultivation of DAS-
59122-7 should not reduce the ability to control pests and weeds in
corn or other crops. In addition to our finding of no plant pest risk,
there will be no effect on threatened or endangered species resulting
from a determination of non-regulated status for DAS-59122-7 and its
progeny.
Therefore, APHIS has concluded that the subject corn and any
progeny derived from hybrid crosses with other non-transformed corn
varieties will be as safe to grow as corn varieties in traditional
breeding programs that are not subject to regulation under 7 CFR part
340. The effect of this determination is that Dow AgroSciences/Pioneer
corn line DAS-59122-7 is no longer considered a regulated article under
APHIS' regulations in 7 CFR part 340.
Therefore, the requirements pertaining to regulated articles under
those regulations no longer apply to the subject corn or its progeny.
However, importation of corn line DAS-59122-7 and seeds capable of
propagation are still subject to the restrictions found in APHIS'
foreign quarantine notices in 7 CFR part 319 and imported seed
regulations in 7 CFR part 361.
National Environmental Policy Act
An EA was prepared to examine any potential environmental impacts
and plant pest risk associated with the determination of nonregulated
status for the Dow AgroSciences/Pioneer corn line DAS-59122-7. 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, APHIS has reached a FONSI with regard to the
determination that Dow AgroSciences/Pioneer corn line DAS-59122-7 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
from the individual listed in the FOR FURTHER INFORMATION CONTACT
section of this notice.
Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.3.
Done in Washington, DC, this 3rd day of October 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-20194 Filed 10-6-05; 8:45 am]
BILLING CODE 3410-34-P
