Monsanto Company; Availability of Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance and Glyphosate Tolerance, 906-908 [06-88]
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Federal Register / Vol. 71, No. 4 / Friday, January 6, 2006 / Notices
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
recognizing the animal health status of
foreign regions, contact Dr. Gary
Colgrove, Director, National Center for
Import and Export, VS, APHIS, 4700
River Road Unit 38, Riverdale, MD
20737–1231; (301) 734–4356. For copies
of more detailed information on the
information collection, contact Mrs.
Celeste Sickles, APHIS’ Information
Collection Coordinator, at (301) 734–
7477.
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SUPPLEMENTARY INFORMATION:
Title: Requirements for Recognizing
the Animal Health Status of Foreign
Regions.
OMB Number: 0579–0219.
Type of Request: Extension of
approval of an information collection.
Abstract: The Animal and Plant
Health Inspection Service (APHIS) of
the U.S. Department of Agriculture is
responsible for, among other things,
protecting the health of our Nation’s
livestock and poultry populations by
preventing the introduction and spread
of serious diseases and pests of livestock
and poultry and for eradicating such
diseases and pests from the United
States when feasible.
The regulations in 9 CFR part 92,
Importation of Animals and Animal
Products: Procedures for Requesting
Recognition of Regions, set out the
process by which a foreign government
may request recognition of the animal
health status of a region or approval to
export animals or animal products to
the United States based on the risk
associated with animals or animal
products from that region. Each request
must include information about the
region, including information on the
veterinary services organization of the
region; the extent to which movement of
animals and animal products is
controlled from regions of higher risk,
and the level of biosecurity for such
movements; livestock demographics and
marketing practices in the region;
diagnostic laboratory capabilities in the
region; and the region’s policies and
infrastructure for animal disease
control. Specifically, in § 92.2, we
require regions that have been granted
status under the regulations to provide
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15:23 Jan 05, 2006
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information, or allow us to access
information, to confirm the regions’
animal health status when we request it.
The types of information collected will
vary based on the information required
to adequately assess a region’s animal
health status.
We are asking the Office of
Management and Budget (OMB) to
approve our use of this information
collection activity 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
information collection, 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
information collection 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: Veterinary authorities
in regions that have been granted a
particular animal health status for a
specified animal disease.
Estimated annual number of
respondents: 3.
Estimated annual number of
responses per respondent: 1.
Estimated annual number of
responses: 3.
Estimated total annual burden on
respondents: 120 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.
Done in Washington, DC, this 29th day of
December, 2005.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 06–89 Filed 1–5–06; 8:45 am]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. 04–114–2]
Monsanto Company; Availability of
Determination of Nonregulated Status
for Corn Genetically Engineered for
Insect Resistance and Glyphosate
Tolerance
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public of
our determination that the Monsanto
corn line designated as transformation
event MON 88017, which has been
genetically engineered for resistance to
a corn rootworm complex and for
tolerance to the herbicide glyphosate, 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
Monsanto 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: December 14,
2005.
ADDRESSES: You may read the petition,
the environmental assessment, the
determination, the finding of no
significant impact, and the comments
that we received on Docket No. 04–114–
1 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.
FOR FURTHER INFORMATION CONTACT: Dr.
Robyn Rose, Biotechnology Regulatory
Services, APHIS, 4700 River Road Unit
147, Riverdale, MD 20737–1236; (301)
734–0489. To obtain copies of the
petition, EA, determination, FONSI, or
response to comments, contact Ms.
Ingrid Berlanger at (301) 734–4885; email:
Ingrid.E.Berlanger@aphis.usda.gov. The
petition and the draft environmental
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06JAN1
Federal Register / Vol. 71, No. 4 / Friday, January 6, 2006 / Notices
assessment (EA) and the final EA with
the determination, finding of no
significant impact, and response to
comments are also available on the
Internet at: https://www.aphis.usda.gov/
brs/aphisdocs/04_12501p.pdf, https://
www.aphis.usda.gov/brs/aphisdocs/
04_12501p_pea.pdf, and https://
www.aphis.usda.gov/brs/aphisdocs2/
04_12501p_com.pdf.
SUPPLEMENTARY INFORMATION:
cprice-sewell on PROD1PC66 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 May 4, 2004, APHIS received a
petition (APHIS Petition Number 04–
125–01p) from Monsanto Company
(Monsanto) of St. Louis, MO, requesting
a determination of nonregulated status
under 7 CFR part 340 for corn (Zea
mays L.) designated as transformation
event MON 88017 which has been
genetically engineered for resistance to
corn rootworm and for tolerance to the
herbicide glyphosate. The Monsanto
petition states that the subject corn
should not be regulated by APHIS
because it does not present a plant pest
risk.
In a notice published in the Federal
Register on August 12, 2005 (70 FR
47168–47169, Docket No. 04–114–1),
APHIS announced the availability of the
Monsanto petition and an
environmental assessment (EA). APHIS
solicited comments on whether the
subject corn would present a plant pest
risk and on the EA. The August 2005
notice also discussed the role of APHIS,
the Environmental Protection Agency
(EPA), and the Food and Drug
Administration (FDA) in regulating the
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15:23 Jan 05, 2006
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subject corn and products developed
from it.
APHIS received 19 comments by the
close of the 60-day comment period,
which ended on October 11, 2005.
Comments were submitted by university
professionals, growers associations, and
private individuals. Eight comments
supported granting nonregulated status
to corn line MON 88017. These
comments cited corn rootworm as a
significant problem and supported the
use of technologies to help combat the
problem. One commenter submitted a
request to ‘‘treat MON 88017 with
suspicion until proven otherwise
[safe],’’ but provided no basis for the
concern and neither requested the
petition be approved nor denied. Ten
comments were opposed to the action.
Several of those comments reflected a
general disapproval of genetically
engineered crops. Several other
comments cited the similarity of MON
88017 to MON 863 and cited an article
that reviewed the acute toxicology
studies commissioned by European
Food Safety Agency and did not address
a plant-pest risk. APHIS conferred with
both FDA and EPA about the results of
that study. The response to these
comments can be found in an
attachment to the finding of no
significant impact (FONSI).
APHIS has amended the EA. A list of
changes is included as an attachment to
the EA. The changes correct
typographical errors and provide clarity
to the reader; these changes are not
substantive and do not change the
analysis described in the EA.
As described in the petition, event
MON 88017 corn has been genetically
engineered to express a Cry3Bb1
insecticidal protein derived from
Bacillus thuringiensis (Bt) subspecies
kumamotoensis strain EG4691. This
gene has been modified to encode six
specific amino acid substitutions when
compared to strain EG4691. Cry3Bb1
expression is regulated by the enhanced
35S promoter (e35S) from cauliflower
mosaic virus, the rice actin intron (ract1
intron), 5′ leader sequence from wheat
chlorophyll a/b-binding protein (wt
CAB), and the 3′ nontranslated region of
the 17.3 kDa heat shock protein from
wheat. Event MON 88017 has also been
genetically engineered to express a 5enolpyruvylshikimate-3-phosphate
synthase protein from Agrobacterium
sp. strain CP4 (CP4 EPSPS), which
confers tolerance to the herbicide
glyphosate. Expression of cp4 epsps is
regulated by the rice actin 1 (ract1) 5′
untranslated region containing the
promoter and first intron and nopaline
synthase 3′ polyadenylation signal (NOS
3′) from Agrobacterium tumefaciens. A
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907
construct containing both genes was
delivered to the recipient corn variety,
A xHi-II, through Agrobacteriummediated gene transfer. The petitioner
states that the Cry3Bb1 protein
expressed in MON 88017 is 99.8 percent
identical to the Cry3Bb1 protein
expressed in nonregulated corn line
MON 863. The CP4 EPSPS protein is
identical to corn line NK603.
Determination
Based on its analysis of the data
submitted by Monsanto, a review of
other scientific data, field tests of the
subject corn, and the comments
submitted by the public, APHIS has
determined that corn line MON 88017 is
no longer a regulated article under
APHIS’ regulations at 7 CFR part 340 for
the following reasons: (1) It exhibits no
plant pathogenic properties (although a
plant pathogen was used in the
development of this corn, these plants
are not infected by this organism, nor do
they contain genetic material from this
pathogen that can cause plant disease);
(2) it exhibits no characteristics that
would cause it to be weedier than the
nontransgenic parent corn line or other
cultivated corn; (3) gene introgression
from MON 88017 corn into wild
relatives in the United States and its
territories is extremely unlikely and is
not likely to increase the weediness
potential of any resulting progeny nor
adversely affect genetic diversity of
related plants any more than would
introgression from traditional corn
hybrids; (4) disease and susceptibility
and compositional profiles of the plants
of MON 88017 are similar to those of its
parent variety and other corn cultivars
grown in the United States; therefore, no
direct or indirect plant pest effect on
raw or processed plant commodities is
expected; (5) field observations,
compositional analyses, and data on the
safety of the engineered EPSPS and
Cry3Bb1 proteins all indicate that MON
88017 should not have greater potential
than other cultivated corn to damage or
harm organisms beneficial to
agriculture; (6) compared to current
corn pest and weed management
practices, cultivation of MON 88017
should not reduce the ability to control
pests and weeds in corn or other crops.
In addition to our finding of no plant
pest risk, there will be no effect on the
threatened or endangered species
resulting from a determination of
nonregulated status for MON 88017 and
its progeny.
Therefore, APHIS has concluded that
the subject corn and any progeny
derived from hybrid crosses with other
nontransformed corn varieties will be as
safe to grow as corn varieties in
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06JAN1
908
Federal Register / Vol. 71, No. 4 / Friday, January 6, 2006 / Notices
traditional breeding programs that are
not subject to regulation under 7 CFR
part 340. The effect of this
determination is that Monsanto corn
line MON 88017 is no longer considered
a regulated article under APHIS’
regulations in 7 CFR part 340.
Therefore, the requirements
pertaining to regulated articles under
those regulations no longer apply to the
subject corn or its progeny. However,
the importation of corn line MON 88017
and seeds capable of propagation is still
subject to the restrictions found in
APHIS’ foreign quarantine notices in 7
CFR part 319 and imported seed
regulations in 7 CFR part 361.
National Environmental Policy Act
An EA was prepared to examine any
potential environmental impacts and
plant pest risk associated with the
determination of nonregulated status for
the Monsanto corn line MON 88017.
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 Monsanto corn line
MON 88017 and lines developed from it
are no longer regulated articles under its
regulations in 7 CFR part 340. Copies of
the EA and FONSI are available from
the individual listed under FOR FURTHER
INFORMATION CONTACT.
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 29th day of
December, 2005.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 06–88 Filed 1–5–06; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
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Food and Nutrition Service
Agency Information Collection
Activities: Proposed Collections;
Comment Request—A Case Study:
Modernization of the Food Stamp
Program in Florida
Food and Nutrition Service,
USDA.
ACTION: Notice.
AGENCY:
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15:23 Jan 05, 2006
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SUMMARY: In accordance with the
Paperwork Reduction Act of 1995, this
notice invites the general public and
other public agencies to comment on
proposed information collections.
This notice announces the Food and
Nutrition Service’s (FNS) intent to
request approval from the Office of
Management and Budget (OMB) for new
information collection in the state of
Florida. The Food and Nutrition Service
(FNS) plans to systematically examine
Florida’s modernization model in order
to understand better the relationship
between Food Stamp Program structure,
operations, costs, and performance. This
review will consist of both a
quantitative study using extant data and
a qualitative study relying on the
responses of state and local food stamp
staff, community partners, food stamp
applicants and participants and eligible
non-participants. Project results will
inform FNS policy discussion, provide
technical information to States, and
offer Florida’s Department of Children
and Family Services a tool for
responding efficiently to the variety of
stakeholder queries received.
DATES: Written comments must be
received on or before March 7, 2006.
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
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.
Comments may be sent to Erika Jones,
Project Officer, Food and Nutrition
Service, U.S. Department of Agriculture,
3101 Park Center Drive, Alexandria, VA
22302. Comments may also be
submitted via fax to the attention of
Erika Jones at 703–305–2576 or via email to erika.jones@fns.usda.gov.
All written comments will be open for
public inspection at the office of the
Food and Nutrition Service, through
prior arrangement with the project
officer, during regular business hours
(8:30 a.m. to 5 p.m., Monday through
Friday) at 3101 Park Center Drive,
Alexandria, Virginia 22302, Room 1014.
All responses to this notice will be
summarized and included in the request
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for OMB approval. All comments will
be a matter of public record.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of this information collection
should be directed to Erika Jones on
703–305–2124.
SUPPLEMENTARY INFORMATION:
Title: A Case Study: Modernization of
the Food Stamp Program in Florida.
OMB Number: Not Yet Assigned.
Form Number: N/A.
Expiration Date: To be determined.
Type of Request: New collection of
information.
Abstract: The Florida Department of
Family and Children’s Services (DCFS)
is implementing organizational changes,
simplifying policies, streamlining
procedures and introducing a variety of
technology improvements to improve
access and customer service while
improving administrative efficiency.
DCFS is in the process of modernizing
its program districts which are at
different stages of implementation. Key
features of the State’s organizational
changes include toll-free phone access
to regional call centers, an interactive
voice response system, an Internetbased application, document scanning,
and automated support for some
verification procedures. DCFS also is
developing partnerships with
community-based service providers to
engage them in client application
support and other customer assistance
activities.
In an effort to understand outcomes
associated with program modernization,
The Food and Nutrition Service (FNS)
plans to systematically examine
Florida’s modernization model in order
to understand better the relationship
between Food Stamp Program structure,
operations, costs and performance.
Project results will inform FNS policy
discussions, provide technical and
procedurally relevant information to
States, and offer Florida DCFS a tool for
assessing potential model enhancements
and responding efficiently to the variety
of stakeholder queries received.
Specifically, the project will be
guided by following objectives: (1)
Developing a description of changes to
food stamp policies and procedures that
have been made in support of
Automated Community Connection to
Economic Self-Sufficiency Florida
(ACCESS Florida), (2) Identifying how
technology is used to support the range
of food stamp eligibility determination
and case management functions; (3)
Describing the roles and experiences of
State food stamp staff, vendors, and
community partners working at
different levels; (4) Understanding the
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]]>Agencies
[Federal Register Volume 71, Number 4 (Friday, January 6, 2006)]
[Notices]
[Pages 906-908]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-88]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-114-2]
Monsanto Company; Availability of Determination of Nonregulated
Status for Corn Genetically Engineered for Insect Resistance and
Glyphosate Tolerance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public of our determination that the
Monsanto corn line designated as transformation event MON 88017, which
has been genetically engineered for resistance to a corn rootworm
complex and for tolerance to the herbicide glyphosate, 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 Monsanto
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: December 14, 2005.
ADDRESSES: You may read the petition, the environmental assessment, the
determination, the finding of no significant impact, and the comments
that we received on Docket No. 04-114-1 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.
FOR FURTHER INFORMATION CONTACT: Dr. Robyn Rose, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-0489. To obtain copies of the petition, EA,
determination, FONSI, or response to comments, contact Ms. Ingrid
Berlanger at (301) 734-4885; e-mail: Ingrid.E.Berlanger@aphis.usda.gov.
The petition and the draft environmental
[[Page 907]]
assessment (EA) and the final EA with the determination, finding of no
significant impact, and response to comments are also available on the
Internet at: https://www.aphis.usda.gov/brs/aphisdocs/04_12501p.pdf,
https://www.aphis.usda.gov/brs/aphisdocs/04_12501p_pea.pdf, and http:/
/www.aphis.usda.gov/brs/aphisdocs2/04_12501p_com.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 May 4, 2004, APHIS received a petition (APHIS Petition Number
04-125-01p) from Monsanto Company (Monsanto) of St. Louis, MO,
requesting a determination of nonregulated status under 7 CFR part 340
for corn (Zea mays L.) designated as transformation event MON 88017
which has been genetically engineered for resistance to corn rootworm
and for tolerance to the herbicide glyphosate. The Monsanto petition
states that the subject corn should not be regulated by APHIS because
it does not present a plant pest risk.
In a notice published in the Federal Register on August 12, 2005
(70 FR 47168-47169, Docket No. 04-114-1), APHIS announced the
availability of the Monsanto petition and an environmental assessment
(EA). APHIS solicited comments on whether the subject corn would
present a plant pest risk and on the EA. The August 2005 notice also
discussed the role of APHIS, the Environmental Protection Agency (EPA),
and the Food and Drug Administration (FDA) in regulating the subject
corn and products developed from it.
APHIS received 19 comments by the close of the 60-day comment
period, which ended on October 11, 2005. Comments were submitted by
university professionals, growers associations, and private
individuals. Eight comments supported granting nonregulated status to
corn line MON 88017. These comments cited corn rootworm as a
significant problem and supported the use of technologies to help
combat the problem. One commenter submitted a request to ``treat MON
88017 with suspicion until proven otherwise [safe],'' but provided no
basis for the concern and neither requested the petition be approved
nor denied. Ten comments were opposed to the action. Several of those
comments reflected a general disapproval of genetically engineered
crops. Several other comments cited the similarity of MON 88017 to MON
863 and cited an article that reviewed the acute toxicology studies
commissioned by European Food Safety Agency and did not address a
plant-pest risk. APHIS conferred with both FDA and EPA about the
results of that study. The response to these comments can be found in
an attachment to the finding of no significant impact (FONSI).
APHIS has amended the EA. A list of changes is included as an
attachment to the EA. The changes correct typographical errors and
provide clarity to the reader; these changes are not substantive and do
not change the analysis described in the EA.
As described in the petition, event MON 88017 corn has been
genetically engineered to express a Cry3Bb1 insecticidal protein
derived from Bacillus thuringiensis (Bt) subspecies kumamotoensis
strain EG4691. This gene has been modified to encode six specific amino
acid substitutions when compared to strain EG4691. Cry3Bb1 expression
is regulated by the enhanced 35S promoter (e35S) from cauliflower
mosaic virus, the rice actin intron (ract1 intron), 5' leader sequence
from wheat chlorophyll a/b-binding protein (wt CAB), and the 3'
nontranslated region of the 17.3 kDa heat shock protein from wheat.
Event MON 88017 has also been genetically engineered to express a 5-
enolpyruvylshikimate-3-phosphate synthase protein from Agrobacterium
sp. strain CP4 (CP4 EPSPS), which confers tolerance to the herbicide
glyphosate. Expression of cp4 epsps is regulated by the rice actin 1
(ract1) 5' untranslated region containing the promoter and first intron
and nopaline synthase 3' polyadenylation signal (NOS 3') from
Agrobacterium tumefaciens. A construct containing both genes was
delivered to the recipient corn variety, A xHi-II, through
Agrobacterium-mediated gene transfer. The petitioner states that the
Cry3Bb1 protein expressed in MON 88017 is 99.8 percent identical to the
Cry3Bb1 protein expressed in nonregulated corn line MON 863. The CP4
EPSPS protein is identical to corn line NK603.
Determination
Based on its analysis of the data submitted by Monsanto, a review
of other scientific data, field tests of the subject corn, and the
comments submitted by the public, APHIS has determined that corn line
MON 88017 is no longer a regulated article under APHIS' regulations at
7 CFR part 340 for the following reasons: (1) It exhibits no plant
pathogenic properties (although a plant pathogen was used in the
development of this corn, these plants are not infected by this
organism, nor do they contain genetic material from this pathogen that
can cause plant disease); (2) it exhibits no characteristics that would
cause it to be weedier than the nontransgenic parent corn line or other
cultivated corn; (3) gene introgression from MON 88017 corn into wild
relatives in the United States and its territories is extremely
unlikely and is not likely to increase the weediness potential of any
resulting progeny nor adversely affect genetic diversity of related
plants any more than would introgression from traditional corn hybrids;
(4) disease and susceptibility and compositional profiles of the plants
of MON 88017 are similar to those of its parent variety and other corn
cultivars grown in the United States; therefore, no direct or indirect
plant pest effect on raw or processed plant commodities is expected;
(5) field observations, compositional analyses, and data on the safety
of the engineered EPSPS and Cry3Bb1 proteins all indicate that MON
88017 should not have greater potential than other cultivated corn to
damage or harm organisms beneficial to agriculture; (6) compared to
current corn pest and weed management practices, cultivation of MON
88017 should not reduce the ability to control pests and weeds in corn
or other crops. In addition to our finding of no plant pest risk, there
will be no effect on the threatened or endangered species resulting
from a determination of nonregulated status for MON 88017 and its
progeny.
Therefore, APHIS has concluded that the subject corn and any
progeny derived from hybrid crosses with other nontransformed corn
varieties will be as safe to grow as corn varieties in
[[Page 908]]
traditional breeding programs that are not subject to regulation under
7 CFR part 340. The effect of this determination is that Monsanto corn
line MON 88017 is no longer considered a regulated article under APHIS'
regulations in 7 CFR part 340.
Therefore, the requirements pertaining to regulated articles under
those regulations no longer apply to the subject corn or its progeny.
However, the importation of corn line MON 88017 and seeds capable of
propagation is still subject to the restrictions found in APHIS'
foreign quarantine notices in 7 CFR part 319 and imported seed
regulations in 7 CFR part 361.
National Environmental Policy Act
An EA was prepared to examine any potential environmental impacts
and plant pest risk associated with the determination of nonregulated
status for the Monsanto corn line MON 88017. 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 Monsanto corn line MON 88017 and lines developed
from it are no longer regulated articles under its regulations in 7 CFR
part 340. Copies of the EA and FONSI are available from the individual
listed under FOR FURTHER INFORMATION CONTACT.
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 29th day of December, 2005.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 06-88 Filed 1-5-06; 8:45 am]
BILLING CODE 3410-34-P
