Monsanto Company; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance, 70817-70819 [E7-24174]
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Federal Register / Vol. 72, No. 239 / Thursday, December 13, 2007 / Notices
Surveys, NAHMS Study Participant
Surveys, and NAHMS Descriptive
Reports Surveys. NVSL staff plans to
obtain feedback from the annual NVSL
Performance Surveys. Feedback from
these surveys will be used to improve
the U.S. Animal Health Report, to
improve NAHMS Descriptive Reports,
and to evaluate customer/stakeholder
satisfaction in an effort to increase
participation rates for NAHMS studies.
The NVSL surveys will help monitor the
NVSL’s performance.
We are asking the Office of
Management and Budget (OMB) to
approve our use of these information
collection activities for 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
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(2) Evaluate the accuracy of our
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(3) Enhance the quality, utility, and
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(4) Minimize the burden of the
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appropriate, of automated, electronic,
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technologies; e.g., permitting electronic
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Estimate of burden: The public
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Respondents: Livestock, poultry, and
catfish producers; information users;
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practicing veterinarians; animal
importers/exporters; State and
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Estimated annual number of
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responses: 9,230.
Estimated total annual burden on
respondents: 2,471 hours. (Due to
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reporting burden per response.)
All responses to this notice will be
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Done in Washington, DC, this 7th day of
December 2007.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E7–24171 Filed 12–12–07; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2007–0030]
Monsanto Company; Availability of
Petition and Environmental
Assessment for Determination of
Nonregulated Status for Corn
Genetically Engineered for Insect
Resistance
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 the Monsanto Company
seeking a determination of nonregulated
status for insect-resistant corn derived
from a transformation event designated
as MON 89034. 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 or could be a plant
pest. We are also making available for
public comment a draft environmental
assessment for the proposed
determination of nonregulated status.
DATES: We will consider all comments
we receive on or before February 11,
2008.
You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov, select
‘‘Animal and Plant Health Inspection
Service’’ from the agency drop-down
menu, then click ‘‘Submit.’’ In the
Docket ID column, select APHIS–2007–
0030 to submit or view public
comments and to view supporting and
related materials available
electronically. Information on using
Regulations.gov, including instructions
for accessing documents, submitting
comments, and viewing the docket after
the close of the comment period, is
available through the site’s ‘‘User Tips’’
link.
• Postal Mail/Commercial Delivery:
Please send four copies of your
ADDRESSES:
PO 00000
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70817
comment (an original and three copies)
to Docket No. APHIS–2007–0030,
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–
2007–0030.
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.
Robyn Rose, Biotechnology Regulatory
Services, APHIS, 4700 River Road Unit
147, Riverdale, MD 20737–1236; (301)
734–0489, e-mail:
robyn.i.rose@aphis.usda.gov. To obtain
copies of the petition or the
environmental assessment, contact Ms.
Cindy Eck at (301) 734–0667, e-mail:
cynthia.a.eck@aphis.usda.gov. The
petition and the environmental
assessment are also available on the
Internet at https://www.aphis.usda.gov/
brs/aphisdocs/06_29801p.pdf and
https://www.aphis.usda.gov/brs/
aphisdocs/06_29801p_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
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Federal Register / Vol. 72, No. 239 / Thursday, December 13, 2007 / Notices
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must take and the information that must
be included in the petition.
On October 26, 2006, APHIS received
a petition seeking a determination of
nonregulated status (APHIS No. 06–
298–01p) from the Monsanto Company
(Monsanto) of St. Louis, MO, for corn
(Zea mays L.) designated as
transformation event MON 89034,
which has been genetically engineered
for resistance to European corn borer
(ECB) and other lepidopteran pests,
stating that corn line MON 89034 does
not present a plant pest risk and,
therefore, should not be a regulated
article under APHIS’ regulations in 7
CFR part 340. Monsanto responded to
APHIS’ subsequent request for
additional information and clarification
and submitted an addendum to their
petition on January 23, 2007. The
petition is available for public review
and comment.
Analysis
As described in the petition, corn
transformation event MON 89034 has
been genetically engineered to express
the transgenes cry1A.105 and cry2Ab2,
both of which were derived from a wellcharacterized gene sequence from
Bacillus thuringiensis, and encode
insect control proteins. The neomycin
phosphotransferase II (nptII) gene was
used as a selectable marker, but was
eliminated by traditional breeding
methods in the later stages of
development of MON 89034. Thus,
MON 89034 contains only the
cry1A.105 and cry2Ab2 expression
cassettes. Expression of the transgenes
by corn plants renders the corn line
resistant to European corn borer, as well
as other lepidopteran pests. Regulatory
elements for the transgenes were
obtained from 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 binary
transformation vector designated PV–
ZMIR245.
Transformation event MON 89034 has
been considered a regulated article
under the regulations in 7 CFR part 340
because it contains gene sequences from
plant pathogens. MON 89034 corn has
been field tested in the United States
since 2001 under notifications and
permits authorized by the U.S.
Department of Agriculture (USDA).
APHIS has presented two alternatives in
the draft environmental assessment (EA)
based on its analyses of data submitted
by Monsanto, a review of other
scientific data, and field tests conducted
under APHIS oversight. APHIS may: (1)
VerDate Aug<31>2005
17:10 Dec 12, 2007
Jkt 214001
Take no action (MON 89034 remains a
regulated article), or (2) deregulate MON
89034.
In § 403 of the Plant Protection Act (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 definition broadly 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.
MON 89034 corn is subject to
regulation by other Federal agencies.
The U.S. Environmental Protection
Agency (EPA) is responsible for the
regulation of pesticides under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended (7
U.S.C. 136 et seq.). FIFRA requires that
all pesticides, including herbicides, be
registered prior to distribution or sale,
unless exempt from EPA regulation. In
cases in which genetically engineered
plants allow for a new use of a pesticide
or involve a different use pattern for the
pesticide, EPA must approve the new or
different use. On July 17, 2006, the EPA
announced a temporary exemption from
the requirement of a tolerance for
residues of the Bacillus thuringiensis
Cry1A.105 protein and the genetic
material necessary for its production in
corn on field corn, sweet corn, and
popcorn when applied/used as a plantincorporated protectant (PIP). The
temporary tolerance exemption will
expire on June 30, 2009 (71 FR 40427–
40431). On July 17, 2006, EPA
announced a temporary exemption from
the requirement of a tolerance for
residues of the Bacillus thuringiensis
Cry2Ab2 protein and the genetic
material necessary for its production in
corn on field corn, sweet corn, and
popcorn when applied/used as a PIP.
The temporary tolerance exemption will
expire on June 30, 2009 (71 FR 40431–
40436). Pursuant to its authority under
the Federal Food, Drug, and Cosmetic
Act (FFDCA, 21 U.S.C. 301 et seq.), EPA
conducted a comprehensive assessment
of the Cry1A.105 and Cry2Ab2 proteins
and the genetic material necessary for
their production in corn concluding that
there was a reasonable certainty of no
harm from consumption of the protein,
as it is digestible in gastric fluid and not
considered an allergen.
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Under the FFDCA, pesticides added
to (or contained in) raw agricultural
commodities generally are considered to
be unsafe unless a tolerance or
exemption from tolerance has been
established. Residue tolerances for
pesticides are established by EPA under
the FFDCA and the Food and Drug
Administration (FDA) enforces
tolerances set by EPA under the FFDCA.
FDA’s policy statement concerning
regulation of products derived from new
plant varieties, including those
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.
Monsanto submitted a summary of their
safety assessment to the FDA on October
13, 2006. The FDA consultation for
MON 89034 corn as food and feed is
currently underway.
National Environmental Policy Act
A draft EA has been prepared to
provide the APHIS decisionmaker with
a review and analysis of any potential
environmental impacts associated with
the proposed determination of
nonregulated status for MON 89034.
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 any
environmental impacts of the proposed
determination for the deregulation of
the subject corn event. The petition, the
draft EA, and any comments received
are available for public review, and
copies of the petitions and the draft EA
are available as indicated under
ADDRESSES and FOR FURTHER
INFORMATION CONTACT above.
After the comment period closes,
APHIS will review all written comments
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Federal Register / Vol. 72, No. 239 / Thursday, December 13, 2007 / Notices
received during the comment period
and any other relevant information.
After reviewing and evaluating the
comments on the petition and the EA
and other data and information, 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
Monsanto’s insect-resistant corn event
MON 89034 and the availability of
APHIS’ written regulatory and
environmental decisions.
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 7th day of
December 2007.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E7–24174 Filed 12–12–07; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2007–0150]
Public Meeting; Veterinary Biologics
Animal and Plant Health
Inspection Service, USDA.
ACTION: Advance notice of public
meeting and request for suggested
agenda topics.
mstockstill on PROD1PC66 with NOTICES
AGENCY:
SUMMARY: We are issuing this notice to
inform producers and users of
veterinary biological products, and
other interested individuals, that we
will be holding our 14th public meeting
to discuss regulatory and policy issues
related to the manufacture, distribution,
and use of veterinary biological
products. We are planning the meeting
agenda and are requesting suggestions
for topics of general interest to
producers and other interested
individuals.
DATES: The public meeting will be held
Monday, April 7, through Wednesday,
April 9, 2008, from noon to
approximately 5 p.m. on Monday, from
8:30 a.m. to approximately 5 p.m. on
Tuesday, and from 8 a.m. to
approximately noon on Wednesday.
ADDRESSES: The public meeting will be
held in the Scheman Building at the
Iowa State Center, Iowa State
University, Ames, IA.
FOR FURTHER INFORMATION CONTACT: For
further information on agenda topics,
contact Dr. Byron E. Rippke, Director,
Policy, Evaluation, and Licensing,
VerDate Aug<31>2005
17:10 Dec 12, 2007
Jkt 214001
Center for Veterinary Biologics,
Veterinary Services, APHIS, 510 South
17th Street, Suite 104, Ames, IA 50010–
8197; phone (515) 232–5785, fax (515)
232–7120, or e-mail
CVB@aphis.usda.gov. For registration
information, contact Ms. Betty Light at
the same address and fax number;
phone (515) 232–5785 extension 127; or
e-mail Betty.J.Light@aphis.usda.gov.
Since
1989, the Animal and Plant Health
Inspection Service (APHIS) has held 13
public meetings in Ames, IA, on
veterinary biologics. The meetings
provide an opportunity for the exchange
of information between APHIS
representatives, producers and users of
veterinary biological products, and
other interested individuals. APHIS is
in the process of planning the agenda
for the 14th such meeting, which will be
held April 7 through 9, 2008.
The agenda for the meeting is not yet
complete. The theme for this year’s
meeting is influenza. Topics that have
been suggested include: (1) Avian,
swine, and equine influenza-related
topics; (2) pandemic influenza
preparedness and related issues; (3)
conditional licenses for canine
influenza vaccines; (4) influenza
diagnostics (rapid and otherwise); and
(5) Veterinary Services and Center for
Veterinary Biologics related issues.
Before finalizing the agenda, APHIS is
seeking suggestions for additional
meeting topics from the interested
public.
We would also like to invite
interested individuals to use this
meeting to present their ideas and
suggestions concerning the licensing,
manufacturing, testing, distribution, and
regulation of products designed to
diagnose, prevent, or treat animal
diseases.
Please submit suggested meeting
topics and proposed presentation titles
to Dr. Byron E. Rippke (see FOR FURTHER
INFORMATION CONTACT above) on or
before January 30, 2008. For proposed
presentations, please include the
name(s) of the presenter(s) and the
approximate amount of time that will be
needed for each presentation.
After the agenda is finalized, APHIS
will announce the agenda topics in the
Federal Register.
SUPPLEMENTARY INFORMATION:
Done in Washington, DC, this 7th day of
December 2007.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E7–24170 Filed 12–12–07; 8:45 am]
BILLING CODE 3410–34–P
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70819
DEPARTMENT OF COMMERCE
Foreign–Trade Zones Board
[Docket 49–2007]
Foreign–Trade Zone 22 Chicago,
Illinois
Application for Subzone: Sony
Electronics Inc. (Audio, Video,
Communications and Information–
Technology Products and
Accessories), Romeoville, Illinois
An application has been submitted to
the Foreign–Trade Zones Board (the
Board) by the Illinois International Port
District, grantee of FTZ 22, requesting
special–purpose subzone status for the
warehousing and distribution facility of
Sony Electronics Inc. (Sony), located in
Romeoville, Illinois. The application
was submitted pursuant to the
provisions of the Foreign–Trade Zones
Act, as amended (19 U.S.C. 81a–81u),
and the regulations of the Board (15 CFR
part 400). It was formally filed on
December 4, 2007.
The Sony facility (50–150 employees,
25 acres, 562,624 square feet) is located
at 99 North Pinnacle Drive, in
Romeoville, Illinois. The facility is used
for the storage, distribution, packaging,
kitting, inspecting, testing and repair of
audio, video, communications and
information–technology products and
accessories.
Zone procedures would exempt Sony
from customs duty payments on
products that are re–exported. Some 5
percent of the products are re–exported.
On its domestic sales, the company
would be able to defer duty payments
until merchandise is shipped from the
facilities and entered for consumption.
FTZ designation would further allow
Sony to utilize certain customs
procedures resulting in increased
efficiencies for its logistics and
distribution operations. In addition,
Sony is requesting authority to choose
the duty rates during customs entry
procedures that apply to kits and
accessory sets, including digital camera
and camcorder kits (duty rate ranges
from duty–free to 2.1%) for the
following imported components:
memory sticks, digital still cameras,
digital camcorders, refill paper packs,
photo printers, DVD players, home
theaters and rechargeable battery packs
(duty rate ranges from duty–free to
4.5%). The company has also indicated
that it will import soft carrying cases
(HTS 4202 and 5911, duty rate ranges
from 2–17.6%), but that they will be
admitted to the zone in privileged
foreign status. The request indicates that
the savings from FTZ procedures would
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]]>Agencies
[Federal Register Volume 72, Number 239 (Thursday, December 13, 2007)]
[Notices]
[Pages 70817-70819]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24174]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0030]
Monsanto Company; Availability of Petition and Environmental
Assessment for 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 that the Animal and Plant Health
Inspection Service has received a petition from the Monsanto Company
seeking a determination of nonregulated status for insect-resistant
corn derived from a transformation event designated as MON 89034. 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 or could be a
plant pest. We are also making available for public comment a draft
environmental assessment for the proposed determination of nonregulated
status.
DATES: We will consider all comments we receive on or before February
11, 2008.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://
www.regulations.gov, select ``Animal and Plant Health Inspection
Service'' from the agency drop-down menu, then click ``Submit.'' In the
Docket ID column, select APHIS-2007-0030 to submit or view public
comments and to view supporting and related materials available
electronically. Information on using Regulations.gov, including
instructions for accessing documents, submitting comments, and viewing
the docket after the close of the comment period, is available through
the site's ``User Tips'' link.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. APHIS-
2007-0030, 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-2007-0030.
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. Robyn Rose, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-0489, e-mail: robyn.i.rose@aphis.usda.gov. To
obtain copies of the petition or the environmental assessment, contact
Ms. Cindy Eck at (301) 734-0667, e-mail: cynthia.a.eck@aphis.usda.gov.
The petition and the environmental assessment are also available on the
Internet at https://www.aphis.usda.gov/brs/aphisdocs/06_29801p.pdf and
https://www.aphis.usda.gov/brs/aphisdocs/06_29801p_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
[[Page 70818]]
must take and the information that must be included in the petition.
On October 26, 2006, APHIS received a petition seeking a
determination of nonregulated status (APHIS No. 06-298-01p) from the
Monsanto Company (Monsanto) of St. Louis, MO, for corn (Zea mays L.)
designated as transformation event MON 89034, which has been
genetically engineered for resistance to European corn borer (ECB) and
other lepidopteran pests, stating that corn line MON 89034 does not
present a plant pest risk and, therefore, should not be a regulated
article under APHIS' regulations in 7 CFR part 340. Monsanto responded
to APHIS' subsequent request for additional information and
clarification and submitted an addendum to their petition on January
23, 2007. The petition is available for public review and comment.
Analysis
As described in the petition, corn transformation event MON 89034
has been genetically engineered to express the transgenes cry1A.105 and
cry2Ab2, both of which were derived from a well-characterized gene
sequence from Bacillus thuringiensis, and encode insect control
proteins. The neomycin phosphotransferase II (nptII) gene was used as a
selectable marker, but was eliminated by traditional breeding methods
in the later stages of development of MON 89034. Thus, MON 89034
contains only the cry1A.105 and cry2Ab2 expression cassettes.
Expression of the transgenes by corn plants renders the corn line
resistant to European corn borer, as well as other lepidopteran pests.
Regulatory elements for the transgenes were obtained from 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 binary
transformation vector designated PV-ZMIR245.
Transformation event MON 89034 has been considered a regulated
article under the regulations in 7 CFR part 340 because it contains
gene sequences from plant pathogens. MON 89034 corn has been field
tested in the United States since 2001 under notifications and permits
authorized by the U.S. Department of Agriculture (USDA). APHIS has
presented two alternatives in the draft environmental assessment (EA)
based on its analyses of data submitted by Monsanto, a review of other
scientific data, and field tests conducted under APHIS oversight. APHIS
may: (1) Take no action (MON 89034 remains a regulated article), or (2)
deregulate MON 89034.
In Sec. 403 of the Plant Protection Act (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 definition broadly 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.
MON 89034 corn is subject to regulation by other Federal agencies.
The U.S. Environmental Protection Agency (EPA) is responsible for the
regulation of pesticides under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA
requires that all pesticides, including herbicides, be registered prior
to distribution or sale, unless exempt from EPA regulation. In cases in
which genetically engineered plants allow for a new use of a pesticide
or involve a different use pattern for the pesticide, EPA must approve
the new or different use. On July 17, 2006, the EPA announced a
temporary exemption from the requirement of a tolerance for residues of
the Bacillus thuringiensis Cry1A.105 protein and the genetic material
necessary for its production in corn on field corn, sweet corn, and
popcorn when applied/used as a plant-incorporated protectant (PIP). The
temporary tolerance exemption will expire on June 30, 2009 (71 FR
40427-40431). On July 17, 2006, EPA announced a temporary exemption
from the requirement of a tolerance for residues of the Bacillus
thuringiensis Cry2Ab2 protein and the genetic material necessary for
its production in corn on field corn, sweet corn, and popcorn when
applied/used as a PIP. The temporary tolerance exemption will expire on
June 30, 2009 (71 FR 40431-40436). Pursuant to its authority under the
Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 301 et seq.),
EPA conducted a comprehensive assessment of the Cry1A.105 and Cry2Ab2
proteins and the genetic material necessary for their production in
corn concluding that there was a reasonable certainty of no harm from
consumption of the protein, as it is digestible in gastric fluid and
not considered an allergen.
Under the FFDCA, pesticides added to (or contained in) raw
agricultural commodities generally are considered to be unsafe unless a
tolerance or exemption from tolerance has been established. Residue
tolerances for pesticides are established by EPA under the FFDCA and
the Food and Drug Administration (FDA) enforces tolerances set by EPA
under the FFDCA.
FDA's policy statement concerning regulation of products derived
from new plant varieties, including those 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. Monsanto submitted a summary of their safety
assessment to the FDA on October 13, 2006. The FDA consultation for MON
89034 corn as food and feed is currently underway.
National Environmental Policy Act
A draft EA has been prepared to provide the APHIS decisionmaker
with a review and analysis of any potential environmental impacts
associated with the proposed determination of nonregulated status for
MON 89034. 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 any environmental impacts of the proposed determination for
the deregulation of the subject corn event. The petition, the draft EA,
and any comments received are available for public review, and copies
of the petitions and the draft EA are available as indicated under
ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
After the comment period closes, APHIS will review all written
comments
[[Page 70819]]
received during the comment period and any other relevant information.
After reviewing and evaluating the comments on the petition and the EA
and other data and information, 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 Monsanto's insect-resistant corn event MON 89034 and the
availability of APHIS' written regulatory and environmental decisions.
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 7th day of December 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-24174 Filed 12-12-07; 8:45 am]
BILLING CODE 3410-34-P
