Syngenta Seeds, Inc.; Availability of Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance, 13736-13737 [E7-5345]
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13736
Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 / Notices
Done in Washington, DC, this 19th day of
March 2007.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E7–5344 Filed 3–22–07; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2006–0157]
Syngenta Seeds, Inc.; Availability of
Determination of Nonregulated Status
for Corn Genetically Engineered for
Insect Resistance
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public of
our determination that a corn line
developed by Syngenta, designated as
transformation event MIR604, which
has been genetically engineered for
resistance to corn rootworm, 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
Syngenta Seeds, Inc., in their 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 an
environmental assessment. This notice
also announces the availability of our
written determination and our finding
of no significant impact.
DATES: Effective Date: March 16, 2007.
ADDRESSES: You may read the petition,
the environmental assessment, the
determination, the 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, click on the
‘‘Advanced Search’’ tab, and select
‘‘Docket Search.’’ In the Docket ID field,
enter APHIS–2006–0157, then click
sroberts on PROD1PC70 with NOTICES
SUMMARY:
VerDate Aug<31>2005
16:41 Mar 22, 2007
Jkt 211001
‘‘Submit.’’ Clicking on the Docket ID
link in the search results page will
produce a list of all documents in the
docket.
FOR FURTHER INFORMATION CONTACT: Dr.
Catherine Preston, Biotechnology
Regulatory Services, APHIS, 4700 River
Road Unit 147, Riverdale, MD 20737–
1236; (301) 734–5874. To obtain copies
of the petition or the environmental
assessment (EA) and finding of no
significant impact (FONSI), contact Ms.
Cynthia Eck at (301) 734–0667, e-mail:
cynthia.a.eck@aphis.usda.gov. The
petition, EA, and FONSI are also
available on the Internet at: https://
www.aphis.usda.gov/brs/aphisdocs/
04_36201p.pdf and https://
www.aphis.usda.gov/brs/aphisdocs/
04_36201p_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 December 24, 2004, APHIS
received a petition (APHIS No. 04–362–
01p) from Syngenta Seeds, Inc.
(Syngenta) of Research Triangle Park,
NC, requesting a determination of
nonregulated status under 7 CFR part
340 for corn (Zea mays L.) designated as
transformation event MIR604, which
has been genetically engineered for
resistance to corn rootworm (CRW). In
response to APHIS’ subsequent requests
for additional information and
clarification, Syngenta submitted a
revised final petition on August 2, 2006.
The Syngenta petition states that the
subject corn should not be regulated by
APHIS because it does not present a
plant pest risk.
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
Analysis
As described in the petition, corn
transformation event MIR604 has been
genetically engineered to express two
transgenes: (1) The modified cry3A
(mcry3A) gene derived from a wellcharacterized gene sequence from
Bacillus thuringiensis, encoding the
mCRY3A insect control protein and (2)
the pmi (manA) gene from Escherichia
coli, which encodes the enzyme
phosphomannose isomerase (PMI) for
use as a selectable marker. Expression of
the mcry3A gene by corn plants renders
the corn line resistant to CRW.
Regulatory elements for the mcry3A and
pmi genes were derived from maize and
Agrobacterium tumefaciens. These
regulatory sequences are not transcribed
and do not encode proteins. The DNA
was introduced into corn cells using
Agrobacterium-mediated transformation
methodology with the T–DNA
transformation vector designated
pZM26. In addition to transgenes
necessary for insertion into the plant
genome, the T–DNA vector also
contained two additional genetic
elements: (1) A gene conferring bacterial
resistance to the antibiotics
erythromycin, streptomycin, and
spectinomycin and (2) the bacterial
origin of replication. Plant cells
containing the introduced DNA were
then selected by culturing in the
presence of mannose. After the initial
incubation with Agrobacterium, the
broad-spectrum antibiotic cefotaxime
was included in the culture medium to
kill any remaining Agrobacterium.
In a notice published in the Federal
Register on January 10, 2007 (72 FR
1212–1214, Docket No. APHIS–2006–
0157), APHIS announced the
availability of the Syngenta petition and
an environmental assessment (EA).
APHIS solicited comments on whether
the subject corn would present a plant
pest risk for 60 days ending on March
12, 2007, and on the EA for 30 days
ending on February 9, 2007. In order to
provide interested persons additional
time to prepare and submit comments
on the draft EA, APHIS extended the
comment period for the EA until March
9, 2007, i.e., the date 15 days after the
publication of our notice of extension.
APHIS received 14 comments on the EA
and 27 comments on the petition by the
close of their respective comment
periods. There were 20 comments
submitted in support of the petition to
grant nonregulated status to MIR604
corn and 7 that were opposed. With
regard to the EA prepared by APHIS to
examine the potential environmental
impacts of granting nonregulated status
to MIR604 corn, there were seven
E:\FR\FM\23MRN1.SGM
23MRN1
Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 / Notices
comments submitted in support of the
conclusions drawn in the EA and seven
comments opposed to the conclusions
drawn in the EA. APHIS’ responses to
these comments can be found in an
attachment to the finding of no
significant impact (FONSI).
sroberts on PROD1PC70 with NOTICES
Determination
Based on APHIS’ analysis of field,
greenhouse, and laboratory data
submitted by Syngenta, references
provided in the petition, other relevant
information described in the EA, and
comments provided by the public,
APHIS has determined that MIR604 will
not pose a plant pest risk for the
following reasons: (1) Gene
introgression from MIR604 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; (2) it exhibits no characteristics
that would cause it to be weedier 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 mCry3A protein is limited to
target pest species, namely corn
rootworm; (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 MIR604 corn should not
impact standard agricultural practices in
corn cultivation and controlling
volunteer corn, including those for
organic farmers; and (6) disease
susceptibility and compositional
profiles of MIR604 corn are similar to
those of its parent variety and other corn
cultivars grown in the United States,
therefore no direct or indirect plant pest
effects on raw or processed plant
commodities are expected.
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
MIR604, an EA was prepared. The EA
VerDate Aug<31>2005
16:41 Mar 22, 2007
Jkt 211001
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 Syngenta corn line
MIR604 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 20th day of
March 2007.
W. Ron DeHaven,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. E7–5345 Filed 3–22–07; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Food and Nutrition Service
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Food Stamp
Program Regulations, Part 275—
Quality Control
Food and Nutrition Service,
USDA.
ACTION: Notice.
AGENCY:
SUMMARY: As required by the Paperwork
Reduction Act of 1995, this notice
invites the general public and other
public agencies to comment on the
proposed information collection for
Food Stamp Program Regulations, Part
275—Quality Control. Specifically, this
is the burden associated with the
collection of information for the
sampling plan, the arbitration process,
and the good cause process. This
proposed collection is a revision of a
collection currently approved under
OMB No. 0584–0303.
DATES: Written comments must be
submitted on or before May 22, 2007.
ADDRESSES: Comments are invited on:
(a) Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
13737
of the burden of the proposed collection
of information, including the validity of
the methodology and assumptions used;
(c) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on those who are to respond, including
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Send comments and requests for
copies of this information collection to:
Daniel Wilusz, Chief, Quality Control
Branch, Program Accountability
Division, Food and Nutrition Service,
U.S. Department of Agriculture, 3101
Park Center Drive, Room 822,
Alexandria, VA 22302. You may FAX
comments on this notice to (703) 305–
0928. You may also download an
electronic version of this notice at
https://www.fns.usda.gov/fsp/rules/
Regulations/default.htm and comment
via e-mail at
Daniel.Wilusz@fns.usda.gov.
All responses to this notice will be
included in the request for OMB
approval.
All comments will also become a
matter of public record.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of the information collection
should be directed to Daniel Wilusz at
(703) 305–2460.
SUPPLEMENTARY INFORMATION:
Title: Food Stamp Program
Regulations, Part 275—Quality Control.
OMB Number: 0584–0303.
Expiration Date: August 31, 2007.
Type of Request: Revision of a
currently approved collection of
information.
Abstract: There are three components
of the Quality Control (QC) system that
are covered in this proposed
information collection. They are: (1) The
sampling plan; (2) the arbitration
process; and (3) the good cause process.
Each State is required to develop a
sampling plan that demonstrates the
integrity of its case selection
procedures. The QC system is designed
to measure each State agency’s payment
error rate based on a statistically valid
sample of food stamp cases. A State
agency’s payment error rate represents
the proportion of cases that were
reported through a QC review as being
ineligible, overissued and underissued
food stamp benefits.
The QC system contains procedures
for resolving differences in review
findings between State agencies and
FNS. This is referred to as the
arbitration process. The QC system also
E:\FR\FM\23MRN1.SGM
23MRN1
]]>Agencies
[Federal Register Volume 72, Number 56 (Friday, March 23, 2007)]
[Notices]
[Pages 13736-13737]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5345]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2006-0157]
Syngenta Seeds, Inc.; Availability of Determination of
Nonregulated Status for Corn Genetically Engineered for Insect
Resistance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public of our determination that a corn
line developed by Syngenta, designated as transformation event MIR604,
which has been genetically engineered for resistance to corn rootworm,
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
Syngenta Seeds, Inc., in their 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
an environmental assessment. This notice also announces the
availability of our written determination and our finding of no
significant impact.
DATES: Effective Date: March 16, 2007.
ADDRESSES: You may read the petition, the environmental assessment, the
determination, the 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, click on the ``Advanced
Search'' tab, and select ``Docket Search.'' In the Docket ID field,
enter APHIS-2006-0157, then click ``Submit.'' Clicking on the Docket ID
link in the search results page will produce a list of all documents in
the docket.
FOR FURTHER INFORMATION CONTACT: Dr. Catherine Preston, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5874. To obtain copies of the petition or the
environmental assessment (EA) and finding of no significant impact
(FONSI), contact Ms. Cynthia Eck at (301) 734-0667, e-mail:
cynthia.a.eck@aphis.usda.gov. The petition, EA, and FONSI are also
available on the Internet at: https://www.aphis.usda.gov/brs/aphisdocs/
04_36201p.pdf and https://www.aphis.usda.gov/brs/aphisdocs/04_36201p_
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 December 24, 2004, APHIS received a petition (APHIS No. 04-362-
01p) from Syngenta Seeds, Inc. (Syngenta) of Research Triangle Park,
NC, requesting a determination of nonregulated status under 7 CFR part
340 for corn (Zea mays L.) designated as transformation event MIR604,
which has been genetically engineered for resistance to corn rootworm
(CRW). In response to APHIS' subsequent requests for additional
information and clarification, Syngenta submitted a revised final
petition on August 2, 2006. The Syngenta petition states that the
subject corn should not be regulated by APHIS because it does not
present a plant pest risk.
Analysis
As described in the petition, corn transformation event MIR604 has
been genetically engineered to express two transgenes: (1) The modified
cry3A (mcry3A) gene derived from a well-characterized gene sequence
from Bacillus thuringiensis, encoding the mCRY3A insect control protein
and (2) the pmi (manA) gene from Escherichia coli, which encodes the
enzyme phosphomannose isomerase (PMI) for use as a selectable marker.
Expression of the mcry3A gene by corn plants renders the corn line
resistant to CRW. Regulatory elements for the mcry3A and pmi genes were
derived from maize and Agrobacterium tumefaciens. These regulatory
sequences are not transcribed and do not encode proteins. The DNA was
introduced into corn cells using Agrobacterium-mediated transformation
methodology with the T-DNA transformation vector designated pZM26. In
addition to transgenes necessary for insertion into the plant genome,
the T-DNA vector also contained two additional genetic elements: (1) A
gene conferring bacterial resistance to the antibiotics erythromycin,
streptomycin, and spectinomycin and (2) the bacterial origin of
replication. Plant cells containing the introduced DNA were then
selected by culturing in the presence of mannose. After the initial
incubation with Agrobacterium, the broad-spectrum antibiotic cefotaxime
was included in the culture medium to kill any remaining Agrobacterium.
In a notice published in the Federal Register on January 10, 2007
(72 FR 1212-1214, Docket No. APHIS-2006-0157), APHIS announced the
availability of the Syngenta petition and an environmental assessment
(EA). APHIS solicited comments on whether the subject corn would
present a plant pest risk for 60 days ending on March 12, 2007, and on
the EA for 30 days ending on February 9, 2007. In order to provide
interested persons additional time to prepare and submit comments on
the draft EA, APHIS extended the comment period for the EA until March
9, 2007, i.e., the date 15 days after the publication of our notice of
extension. APHIS received 14 comments on the EA and 27 comments on the
petition by the close of their respective comment periods. There were
20 comments submitted in support of the petition to grant nonregulated
status to MIR604 corn and 7 that were opposed. With regard to the EA
prepared by APHIS to examine the potential environmental impacts of
granting nonregulated status to MIR604 corn, there were seven
[[Page 13737]]
comments submitted in support of the conclusions drawn in the EA and
seven comments opposed to the conclusions drawn in the EA. APHIS'
responses to these comments can be found in an attachment to the
finding of no significant impact (FONSI).
Determination
Based on APHIS' analysis of field, greenhouse, and laboratory data
submitted by Syngenta, references provided in the petition, other
relevant information described in the EA, and comments provided by the
public, APHIS has determined that MIR604 will not pose a plant pest
risk for the following reasons: (1) Gene introgression from MIR604 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; (2) it exhibits no characteristics that would
cause it to be weedier 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 mCry3A
protein is limited to target pest species, namely corn rootworm; (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 MIR604 corn should not impact standard agricultural
practices in corn cultivation and controlling volunteer corn, including
those for organic farmers; and (6) disease susceptibility and
compositional profiles of MIR604 corn are similar to those of its
parent variety and other corn cultivars grown in the United States,
therefore no direct or indirect plant pest effects on raw or processed
plant commodities are expected.
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 MIR604, 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, APHIS has
reached a FONSI with regard to the determination that Syngenta corn
line MIR604 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 20th day of March 2007.
W. Ron DeHaven,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-5345 Filed 3-22-07; 8:45 am]
BILLING CODE 3410-34-P
