Syngenta Seeds, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Corn Genetically Engineered To Produce an Enzyme That Facilitates Ethanol Production, 69602-69604 [E8-27479]
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69602
Federal Register / Vol. 73, No. 224 / Wednesday, November 19, 2008 / Notices
• Postal Mail/Commercial Delivery:
Please send two copies of your comment
to Docket No. APHIS–2008–0122,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road, Unit 118, Riverdale, MD
20737–1238. Please state that your
comment refers to Docket No. APHIS–
2008–0122.
Reading Room: You may read any
comments that we receive on this
docket 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.
Other Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: For
information on regulations for requests
to amend import regulations, contact
Ms. Shirley A. Wager-Page, Branch
Chief, Commodity Import Analysis and
Operations, PPQ, APHIS, 4700 River
Road, Unit 133, Riverdale, MD 20737;
(301) 734–8453. For copies of more
detailed information on the information
collection, contact Mrs. Celeste Sickles,
APHIS’ Information Collection
Coordinator, at (301) 851–2908.
SUPPLEMENTARY INFORMATION:
Title: Requirements for Requests To
Amend Import Regulations.
OMB Number: 0579–0261.
Type of Request: Extension of
approval of an information collection.
Abstract: As authorized by the Plant
Protection Act (7 U.S.C. 7701 et seq.),
the Secretary of Agriculture may
prohibit or restrict the importation,
entry, exportation, or movement in
interstate commerce of any plant, plant
product, biological control organism,
noxious weed, means of conveyance, or
other article if the Secretary determines
that the prohibition or restriction is
necessary to prevent a plant pest or
noxious weed from being introduced
into or disseminated within the United
States. This authority has been
delegated to the Animal and Plant
Health Inspection Service (APHIS).
Regulations governing the importation
of plants, fruits, vegetables, roots, bulbs,
seeds, unmanufactured wood articles,
and other plant products are contained
in 7 CFR part 319, ‘‘Foreign Quarantine
Notices.’’
Persons who wish to import plants,
plant parts, or plant products that are
not already authorized under 7 CFR part
VerDate Aug<31>2005
15:14 Nov 18, 2008
Jkt 217001
319 must file a request with APHIS in
order for APHIS to consider whether the
new commodity may be safely imported
into the United States. The requestor
must also provide information required
by 7 CFR 319.5, including, but not
limited to, information about the
requestor, the commodity to be
imported, the volume or quantity
expected to be shipped, pests and
diseases associated with the commodity,
risk mitigation or management
strategies, and additional information as
may be requested by APHIS in order to
complete a pest risk analysis in
accordance with international
standards.
We are asking the Office of
Management and Budget (OMB) to
approve our use of these information
collection activities for an additional 3
years.
The purpose of this notice is to solicit
comments from the public (as well as
affected agencies) concerning our
information collection. These comments
will help us:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
Agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the collection
of information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, through use, as
appropriate, of automated, electronic,
mechanical, and other collection
technologies; e.g., permitting electronic
submission of responses.
Estimate of burden: The public
reporting burden for this collection of
information is estimated to average 40
hours per response.
Respondents: Importers and foreign
plant protection organizations and
producers.
Estimated Annual Number of
Respondents: 35.
Estimated Annual Number of
Responses per Respondent: 3.
Estimated Annual Number of
Responses: 105.
Estimated Total Annual Burden on
Respondents: 4,200 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.)
All responses to this notice will be
summarized and included in the request
for OMB approval. All comments will
also become a matter of public record.
PO 00000
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Fmt 4703
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Done in Washington, DC, this 13th day of
November 2008.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E8–27483 Filed 11–18–08; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2007–0016]
Syngenta Seeds, Inc.; Availability of
Petition and Environmental
Assessment for Determination of
Nonregulated Status for Corn
Genetically Engineered To Produce an
Enzyme That Facilitates Ethanol
Production
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 received a
petition from Syngenta Seeds, Inc.,
seeking a determination of nonregulated
status for corn designated as
transformation event 3272, which has
been genetically engineered to produce
a microbial enzyme that facilitates
ethanol production. The petition has
been submitted in accordance with our
regulations concerning the introduction
of certain genetically engineered
organisms and products. In accordance
with those regulations, we are soliciting
comments on whether this genetically
engineered corn is likely to pose a plant
pest risk. We are also making available
for public comment an environmental
assessment for the proposed
determination of nonregulated status.
DATES: We will consider all comments
we receive on or before January 20,
2009.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/fdmspublic/
component/
main?main=DocketDetail&d=APHIS2007-0016 to submit or view comments
and to view supporting and related
materials available electronically.
• Postal Mail/Commercial Delivery:
Please send two copies of your comment
to Docket No. APHIS–2007–0016,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road, Unit 118, Riverdale, MD
20737–1238. Please state that your
comment refers to Docket No. APHIS–
2007–0016.
E:\FR\FM\19NON1.SGM
19NON1
Federal Register / Vol. 73, No. 224 / Wednesday, November 19, 2008 / Notices
Reading Room: You may read any
comments that we receive on this
docket 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.
Other Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Andrea Huberty, Biotechnology
Regulatory Services, APHIS, 4700 River
Road, Unit 146, Riverdale, MD 20737–
1236; (301) 734–0485, e-mail:
andrea.f.huberty@aphis.usda.gov. To
obtain copies of the petition or the draft
environmental assessment, contact Ms.
Cindy Eck at (301) 734–0667, e-mail:
cynthia.a.eck@aphis.usda.gov. The
petition and the draft environmental
assessment are also available on the
Internet at https://www.aphis.usda.gov/
brs/aphisdocs/05_28001p.pdf and
https://www.aphis.usda.gov/brs/
aphisdocs/05_28001p_ea.pdf.
SUPPLEMENTARY INFORMATION:
cprice-sewell on PROD1PC64 with NOTICES
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 October 7, 2005, APHIS received
a petition seeking a determination of
nonregulated status (APHIS Petition No.
05–280–01p) from Syngenta Seeds, Inc.,
of Research Triangle Park, NC
(Syngenta), for corn (Zea mays L.)
VerDate Aug<31>2005
15:14 Nov 18, 2008
Jkt 217001
designated as transformation event
3272, which has been genetically
engineered to produce a microbial
enzyme that facilitates ethanol
production. The petition stated that
Event 3272 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, Event
3272 corn has been genetically
engineered to contain two transgenes:
(1) The amy797E gene encoding the
thermostable AMY797E alpha-amylase
enzyme and (2) the pmi (manA) gene
from Escherichia coli, which encodes
the enzyme phosphomannose
isomerase, used as a selectable marker.
The AMY797E alpha-amylase enzyme is
a chimeric, thermostable enzyme
derived from three alpha-amylase genes
originating from three
hyperthermophilic microorganisms of
the archael order Thermococcales. The
expression of amy797E is driven by the
promoter from a corn seed storage
(gamma-zein) gene, which directs the
accumulation of alpha-amylase in the
corn kernel. The pmi gene is from one
of the main species of bacteria living in
mammal intestines, E. coli, and is
driven by the polyubiquitin promoter
from corn.
This genetic insert also contains the
terminator sequences from two plant
pests, cauliflower mosaic virus and
Agrobacterium tumefaciens. Both of
these sequences are well-characterized,
and are noncoding regulatory regions
only. These sequences will not cause
Event 3272 corn to promote plant
disease.
DNA was introduced into corn cells
from a proprietary corn line using
disarmed (non-plant pest causing)
Agrobacterium tumefaciens-mediated
transformation methodology with the
transformation vector designated
pNOV7013. Plant cells containing the
introduced DNA were selected by
culturing in the presence of mannose.
After the initial transformation, broadspectrum antibiotic cefotaxime was
included in the culture medium to kill
any remaining Agrobacterium.
Therefore, no part of the plant pest A.
tumefaciens is remaining in Event 3272
corn due to the transformation method.
Event 3272 corn has been considered
a regulated article under the regulations
in 7 CFR part 340 because it contains
gene sequences from plant pathogens.
Event 3272 corn has been field-tested in
the United States since 2002, as
authorized by APHIS notifications and
permits. In the process of reviewing the
permits for field trials of the subject
corn, APHIS determined that the vectors
and other elements used to introduce
PO 00000
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Fmt 4703
Sfmt 4703
69603
the new genes were disarmed and that
the trials, which were conducted under
conditions of reproductive and physical
confinement or isolation, would not
present a risk of plant pest introduction
or dissemination.
Field tests conducted under APHIS
regulatory 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 field test
data, in turn, are used by APHIS to
determine whether the regulated corn
event poses a plant pest risk. Syngenta
has petitioned APHIS to make a
determination that Event 3272 corn and
the progeny derived from its crosses
with other nonregulated corn will no
longer be considered regulated articles
under 7 CFR part 340.
APHIS has prepared an
environmental assessment (EA) in
which it presents two alternatives for
the determination of nonregulated status
based on its analyses of data submitted
by Syngenta, a review of other scientific
data, and field tests conducted under
APHIS oversight. APHIS is considering
the following alternatives: (1) Take no
action, i.e., APHIS would not change the
regulatory status of Event 3272 corn and
it would continue to be a regulated
article; or (2) the preferred alternative,
grant nonregulated status to Event 3272
corn in whole. The EA also describes
other alternatives that were initially
evaluated but rejected from further
consideration in the decision process for
reasons explained in the EA.
In section 403 of the Plant Protection
Act (PPA) (7 U.S.C. 7701 et seq.), ‘‘plant
pest’’ is defined as any living stage of
any of the following that can directly or
indirectly injure, cause damage to, or
cause disease in any plant or plant
product: A protozoan, a nonhuman
animal, a parasitic plant, a bacterium, a
fungus, a virus or viroid, an infectious
agent or other pathogen, or any article
similar to or allied with any of the
foregoing. APHIS views this PPA
definition to cover direct or indirect
injury, disease, or damage not just to
agricultural crops, but also to other
plants, for example, native species, as
well as to plant parts and plant products
whether natural, manufactured, or
processed.
Event 3272 corn is also subject to
regulation by other Federal agencies.
The Food and Drug Administration
(FDA) policy statement concerning
regulation of products derived from new
plant varieties, including those
E:\FR\FM\19NON1.SGM
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69604
Federal Register / Vol. 73, No. 224 / Wednesday, November 19, 2008 / Notices
cprice-sewell on PROD1PC64 with NOTICES
genetically engineered, was published
in the Federal Register on May 29, 1992
(57 FR 22984–23005). Under this policy,
FDA uses what is termed a consultation
process to ensure that human and
animal feed safety issues or other
regulatory issues (e.g., labeling) are
resolved prior to commercial
distribution of a bioengineered food. In
compliance with the FDA policy,
Syngenta submitted a food and feed
safety and nutritional assessment
summary to FDA for Event 3272 corn
which was completed in August 2007
acknowledging that based on the
information available, Event 3272 corn
did not raise safety or other issues that
would require pre-market review or
approval by the FDA. As Event 3272
corn does not produce a pesticide or
have a tolerance to any pesticide, the
Environmental Protection Agency is not
involved with evaluating Event 3272.
National Environmental Policy Act
A draft EA has been prepared to
inform the public of, and to provide the
APHIS decisionmaker with, a review
and analysis of potential environmental
impacts associated with the proposed
determination of nonregulated status for
Event 3272 corn. The draft EA was
prepared in accordance with (1) the
National Environmental Policy Act of
1969 (NEPA), as amended (42 U.S.C.
4321 et seq.), (2) regulations of the
Council on Environmental Quality for
implementing the procedural provisions
of NEPA (40 CFR parts 1500–1508), (3)
USDA regulations implementing NEPA
(7 CFR part 1b), and (4) APHIS’ NEPA
Implementing Procedures (7 CFR part
372).
In accordance with § 340.6(d) of the
regulations, we are publishing this
notice to inform the public that APHIS
will accept written comments regarding
the petition for a determination of
nonregulated status from interested or
affected persons for a period of 60 days
from the date of this notice. We are also
soliciting written comments from
interested or affected persons on the
draft EA prepared to examine potential
environmental impacts of the proposed
determination for the deregulation of
the subject corn line. The petition and
the draft EA are available for public
review, and copies of the petition and
the draft EA are available as indicated
under ADDRESSES and FOR FURTHER
INFORMATION CONTACT above.
After the comment period closes,
APHIS will evaluate all written
comments received during the comment
period and any other relevant
information. All public comments
received regarding the petition and draft
EA will be available for public review.
VerDate Aug<31>2005
15:14 Nov 18, 2008
Jkt 217001
After reviewing and evaluating the
comments on the petition and the draft
EA and other data, APHIS will furnish
a response to the petitioner, either
approving or denying the petition.
APHIS will then publish a notice in the
Federal Register announcing the
regulatory status of Event 3272 corn and
the availability of APHIS’ written
regulatory and environmental decision.
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 13th day of
November 2008.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E8–27479 Filed 11–18–08; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Forest Service
Information Collection; 4-Rivers
Application and Drawing
Forest Service, USDA.
Notice; request for comment.
AGENCY:
ACTION:
SUMMARY: In accordance with the
Paperwork Reduction Act of 1995, the
Forest Service is seeking comments
from all interested individuals and
organizations on the new information
collection, 4-Rivers Application and
Drawing.
Comments must be received in
writing on or before January 20, 2009 to
be assured of consideration. Comments
received after that date will be
considered to the extent practicable.
ADDRESSES: Comments concerning this
notice should be mailed to: Linda
Walton, River Manager, North Fork
Ranger Station, P.O. Box 180, North
Fork, ID 83466.
Comments also may be submitted via
facsimile to 208–865–2738 or by e-mail
to: lwalton@fs.fed.us.
The public may inspect comments
received at North Fork Ranger Station,
P.O. Box 180, 11 Casey Rd., North Fork,
ID, during normal business hours.
Visitors are encouraged to call ahead to
208–865–2700 to facilitate entry to the
building. Comments may also be
reviewed by accessing Forest Service
Web Page listed:
https://www.fs.fed.us/r4/sc/recreation/
whitewaterrafting/index.shtml.
FOR FURTHER INFORMATION CONTACT:
Linda Walton, River Manager, SalmonChallis National Forest, 208–865–2737.
Individuals who use telecommunication
devices for the deaf (TDD) may call the
DATES:
PO 00000
Frm 00006
Fmt 4703
Sfmt 4703
Federal Relay Service (FRS) at 1–800–
877–8339 twenty-four hours a day,
every day of the year, including
holidays.
SUPPLEMENTARY INFORMATION:
Title: 4–Rivers Application and
Drawing.
OMB Number: 0596–NEW.
Type of Request: New.
Abstract: The 4–Rivers application
and drawing provides an opportunity
for private river runners to compete for
a river permit on one of four rivers in
Idaho. Public demand for use permits
on the Main Salmon, Middle Fork,
Selway, and Snake Rivers are high. The
drawing provides a means to assist
managers and public by accommodating
greater numbers of people.
The drawing allows all applicants
equal probability of receiving a river
permit. Selection of permit recipients is
via a computer driven random selection
process. Upon selection, applicants
receive river use permits from the Forest
Service.
The following Federal Acts provide
participating forests with management
direction, limiting the number of river
users during high demand seasons
while still providing river recreation
opportunities to visitors. These Acts
allow for management controls
necessary to protect river resources and
enhance river ecosystems previously
determined to have superior
characteristics.
1. The Frank Church River of No
Return Wilderness Plan 1982, updated
2003.
2. The Wild and Scenic Rivers Act
1968.
3. The Wilderness Act of 1964.
4. Central Idaho Wilderness Act
(CIWA) of 1980.
Drawing participants enter required
information electronically into a Forest
Service database. Forest Service
personnel (river managers and clerks) in
Forest offices associated with each river,
check received hardcopy applications
for completeness and errors prior to
entry into database. Applicants are
encouraged to submit applications
electronically.
Applicants provide:
1. Photo Identification Number.
2. State of Identification and type of
ID (Driver’s license, Passport, Other).
3. Name.
4. Mailing Address.
5. Other contact information: e-mail
address, day and evening phone
numbers, fax number.
6. Choice of launch dates and rivers
(up to four choices).
7. Payment information (i.e. check or
money order number) or if paying by
E:\FR\FM\19NON1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 224 (Wednesday, November 19, 2008)]
[Notices]
[Pages 69602-69604]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27479]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0016]
Syngenta Seeds, Inc.; Availability of Petition and Environmental
Assessment for Determination of Nonregulated Status for Corn
Genetically Engineered To Produce an Enzyme That Facilitates Ethanol
Production
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from Syngenta Seeds, Inc.,
seeking a determination of nonregulated status for corn designated as
transformation event 3272, which has been genetically engineered to
produce a microbial enzyme that facilitates ethanol production. The
petition has been submitted in accordance with our regulations
concerning the introduction of certain genetically engineered organisms
and products. In accordance with those regulations, we are soliciting
comments on whether this genetically engineered corn is likely to pose
a plant pest risk. We are also making available for public comment an
environmental assessment for the proposed determination of nonregulated
status.
DATES: We will consider all comments we receive on or before January
20, 2009.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://
www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0016 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send two copies of
your comment to Docket No. APHIS-2007-0016, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2007-0016.
[[Page 69603]]
Reading Room: You may read any comments that we receive on this
docket 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.
Other Information: Additional information about APHIS and its
programs is available on the Internet at https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Andrea Huberty, Biotechnology
Regulatory Services, APHIS, 4700 River Road, Unit 146, Riverdale, MD
20737-1236; (301) 734-0485, e-mail: andrea.f.huberty@aphis.usda.gov. To
obtain copies of the petition or the draft environmental assessment,
contact Ms. Cindy Eck at (301) 734-0667, e-mail:
cynthia.a.eck@aphis.usda.gov. The petition and the draft environmental
assessment are also available on the Internet at https://
www.aphis.usda.gov/brs/aphisdocs/05_28001p.pdf and https://
www.aphis.usda.gov/brs/aphisdocs/05_28001p_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 October 7, 2005, APHIS received a petition seeking a
determination of nonregulated status (APHIS Petition No. 05-280-01p)
from Syngenta Seeds, Inc., of Research Triangle Park, NC (Syngenta),
for corn (Zea mays L.) designated as transformation event 3272, which
has been genetically engineered to produce a microbial enzyme that
facilitates ethanol production. The petition stated that Event 3272
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, Event 3272 corn has been genetically
engineered to contain two transgenes: (1) The amy797E gene encoding the
thermostable AMY797E alpha-amylase enzyme and (2) the pmi (manA) gene
from Escherichia coli, which encodes the enzyme phosphomannose
isomerase, used as a selectable marker. The AMY797E alpha-amylase
enzyme is a chimeric, thermostable enzyme derived from three alpha-
amylase genes originating from three hyperthermophilic microorganisms
of the archael order Thermococcales. The expression of amy797E is
driven by the promoter from a corn seed storage (gamma-zein) gene,
which directs the accumulation of alpha-amylase in the corn kernel. The
pmi gene is from one of the main species of bacteria living in mammal
intestines, E. coli, and is driven by the polyubiquitin promoter from
corn.
This genetic insert also contains the terminator sequences from two
plant pests, cauliflower mosaic virus and Agrobacterium tumefaciens.
Both of these sequences are well-characterized, and are noncoding
regulatory regions only. These sequences will not cause Event 3272 corn
to promote plant disease.
DNA was introduced into corn cells from a proprietary corn line
using disarmed (non-plant pest causing) Agrobacterium tumefaciens-
mediated transformation methodology with the transformation vector
designated pNOV7013. Plant cells containing the introduced DNA were
selected by culturing in the presence of mannose. After the initial
transformation, broad-spectrum antibiotic cefotaxime was included in
the culture medium to kill any remaining Agrobacterium. Therefore, no
part of the plant pest A. tumefaciens is remaining in Event 3272 corn
due to the transformation method.
Event 3272 corn has been considered a regulated article under the
regulations in 7 CFR part 340 because it contains gene sequences from
plant pathogens. Event 3272 corn has been field-tested in the United
States since 2002, as authorized by APHIS notifications and permits. In
the process of reviewing the permits for field trials of the subject
corn, APHIS determined that the vectors and other elements used to
introduce the new genes were disarmed and that the trials, which were
conducted under conditions of reproductive and physical confinement or
isolation, would not present a risk of plant pest introduction or
dissemination.
Field tests conducted under APHIS regulatory 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 field test data, in turn, are used by APHIS to
determine whether the regulated corn event poses a plant pest risk.
Syngenta has petitioned APHIS to make a determination that Event 3272
corn and the progeny derived from its crosses with other nonregulated
corn will no longer be considered regulated articles under 7 CFR part
340.
APHIS has prepared an environmental assessment (EA) in which it
presents two alternatives for the determination of nonregulated status
based on its analyses of data submitted by Syngenta, a review of other
scientific data, and field tests conducted under APHIS oversight. APHIS
is considering the following alternatives: (1) Take no action, i.e.,
APHIS would not change the regulatory status of Event 3272 corn and it
would continue to be a regulated article; or (2) the preferred
alternative, grant nonregulated status to Event 3272 corn in whole. The
EA also describes other alternatives that were initially evaluated but
rejected from further consideration in the decision process for reasons
explained in the EA.
In section 403 of the Plant Protection Act (PPA) (7 U.S.C. 7701 et
seq.), ``plant pest'' is defined as any living stage of any of the
following that can directly or indirectly injure, cause damage to, or
cause disease in any plant or plant product: A protozoan, a nonhuman
animal, a parasitic plant, a bacterium, a fungus, a virus or viroid, an
infectious agent or other pathogen, or any article similar to or allied
with any of the foregoing. APHIS views this PPA definition to cover
direct or indirect injury, disease, or damage not just to agricultural
crops, but also to other plants, for example, native species, as well
as to plant parts and plant products whether natural, manufactured, or
processed.
Event 3272 corn is also subject to regulation by other Federal
agencies. The Food and Drug Administration (FDA) policy statement
concerning regulation of products derived from new plant varieties,
including those
[[Page 69604]]
genetically engineered, was published in the Federal Register on May
29, 1992 (57 FR 22984-23005). Under this policy, FDA uses what is
termed a consultation process to ensure that human and animal feed
safety issues or other regulatory issues (e.g., labeling) are resolved
prior to commercial distribution of a bioengineered food. In compliance
with the FDA policy, Syngenta submitted a food and feed safety and
nutritional assessment summary to FDA for Event 3272 corn which was
completed in August 2007 acknowledging that based on the information
available, Event 3272 corn did not raise safety or other issues that
would require pre-market review or approval by the FDA. As Event 3272
corn does not produce a pesticide or have a tolerance to any pesticide,
the Environmental Protection Agency is not involved with evaluating
Event 3272.
National Environmental Policy Act
A draft EA has been prepared to inform the public of, and to
provide the APHIS decisionmaker with, a review and analysis of
potential environmental impacts associated with the proposed
determination of nonregulated status for Event 3272 corn. The draft EA
was prepared in accordance with (1) the National Environmental Policy
Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2)
regulations of the Council on Environmental Quality for implementing
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA
Implementing Procedures (7 CFR part 372).
In accordance with Sec. 340.6(d) of the regulations, we are
publishing this notice to inform the public that APHIS will accept
written comments regarding the petition for a determination of
nonregulated status from interested or affected persons for a period of
60 days from the date of this notice. We are also soliciting written
comments from interested or affected persons on the draft EA prepared
to examine potential environmental impacts of the proposed
determination for the deregulation of the subject corn line. The
petition and the draft EA are available for public review, and copies
of the petition and the draft EA are available as indicated under
ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
After the comment period closes, APHIS will evaluate all written
comments received during the comment period and any other relevant
information. All public comments received regarding the petition and
draft EA will be available for public review. After reviewing and
evaluating the comments on the petition and the draft EA and other
data, APHIS will furnish a response to the petitioner, either approving
or denying the petition. APHIS will then publish a notice in the
Federal Register announcing the regulatory status of Event 3272 corn
and the availability of APHIS' written regulatory and environmental
decision.
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 13th day of November 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-27479 Filed 11-18-08; 8:45 am]
BILLING CODE 3410-34-P
