Monsanto Company; Determination of Nonregulated Status for Soybean Genetically Engineered for Glyphosate Herbicide Tolerance, 42373-42375 [E7-15001]
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Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices
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 regarding regulations for
the black stem rust quarantine and
regulations, contact Dr. Vedpal S. Malik,
Agriculturist, Emergency and Domestic
Programs, PPQ, APHIS, 4700 River Road
Unit 134, Riverdale MD 20737; (301)
734–6774. For copies of more detailed
information on the information
collection, contact Mrs. Celeste Sickles,
APHIS’ Information Collection
Coordinator, at (301) 734–7477.
SUPPLEMENTARY INFORMATION:
Title: Black Stem Rust; Identification
Requirements for Addition of RustResistant Varieties.
OMB Number: 0579–0186.
Type of Request: Extension of
approval of an information collection.
Abstract: The Plant Protection Act (7
U.S.C. 7701 et seq.) authorizes the
Secretary of Agriculture to prohibit or
restrict the importation, entry, or
interstate movement of plants and plant
products to prevent the introduction of
plant pests into the United States or
their dissemination within the United
States.
Black stem rust is one of the most
destructive plant diseases of small
grains that is known to exist in the
United States. The disease is caused by
a fungus that reduces the quality and
yield of infected wheat, oat, barley, and
rye crops by robbing host plants of food
and water. In addition to infecting small
grains, the fungus lives on a variety of
alternate host plants that are species of
the genera Berberis, Mahoberberis, and
Mahonia. The fungus is spread from
host to host by wind-borne spores.
The black stem rust quarantine and
regulations, contained in 7 CFR 301.38
through 301.38–8 (referred to below as
the regulations), quarantine the
conterminous 48 States and the District
of Columbia and govern the interstate
movement of certain plants of the
genera Berberis, Mahoberberis, and
Mahonia, known as barberry plants. The
species of these plants are categorized as
either rust-resistant or rust-susceptible.
Rust-resistant plants do not pose a risk
of spreading black stem rust or of
contributing to the development of new
races of the rust; rust-susceptible plants
do pose such risks.
Persons who request the Animal and
Plant Health Inspection Service to add
a variety to the list of rust-resistant
barberry varieties in the regulations
must provide the Agency with a
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description of the variety, including a
written description and color pictures
that can be used by State nursery
inspectors to clearly identify the variety
and distinguish it from other varieties.
This requirement helps to ensure that
State plant inspectors can clearly
determine whether plants moving into
or through their States are rust-resistant
varieties listed in 7 CFR 301.38–2.
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 activity. APHIS
needs this outside input to help
accomplish the following:
(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 4
hours per response.
Respondents: Nurseries.
Estimated Annual Number of
Respondents : 4.
Estimated Annual Number of
Responses per Respondent: 2.
Estimated Annual Number of
Responses: 8.
Estimated Total Annual Burden on
Respondents: 32 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 27th day of
July 2007.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E7–15009 Filed 8–1–07; 8:45 am]
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42373
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2006–0195]
Monsanto Company; Determination of
Nonregulated Status for Soybean
Genetically Engineered for Glyphosate
Herbicide Tolerance
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
SUMMARY: We are advising the public of
our determination that a soybean line
developed by the Monsanto Company,
designated as transformation event
MON 89788, which has been genetically
engineered 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 the
Monsanto Company in its 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 finding of no
significant impact.
DATES: Effective Date: July 23, 2007.
ADDRESSES: You may read the petition,
environmental assessment,
determination, finding of no significant
impact, the comments we received on
our previous notice, and our responses
to those comments in our reading room.
The reading room is located in room
1141 of the USDA South Building, 14th
Street and Independence Avenue, SW.,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 690–2817 before
coming. To view those documents on
the Internet, go to https://
www.regulations.gov, click on the
‘‘Advanced Search’’ tab, and select
‘‘Docket Search.’’ In the Docket ID field,
enter APHIS–2006–0195, then click
‘‘Submit.’’ Clicking on the Docket ID
link in the search results page will
produce a list of all documents in the
docket.
Dr.
Virgil Meier, Biotechnology Regulatory
Services, APHIS, 4700 River Road, Unit
147, Riverdale, MD 20737–1236; (301)
734–3363. To obtain copies of the
FOR FURTHER INFORMATION CONTACT:
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Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices
petition, environmental assessment, or
the finding of no significant impact,
contact Ms. Cynthia Eck at (301) 734–
0667; cynthia.a.eck@aphis.usda.gov.
Those documents may also be viewed
on the Internet at https://
www.aphis.usda.gov/brs/aphisdocs/
06_17801p.pdf and https://
www.aphis.usda.gov/brs/aphisdocs/
06_17801p_ea.pdf.
SUPPLEMENTARY INFORMATION:
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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 June 27, 2006, APHIS received a
petition seeking a determination of
nonregulated status (APHIS Petition
Number 06–178–01p) from Monsanto
Company of St. Louis, MO (Monsanto),
for soybean (Glycine max L.) designated
as transformation event MON 89788,
which has been genetically engineered
for tolerance to the herbicide
glyphosate, stating that soybean line
MON 89788 does not present 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, MON
89788 soybean plants have 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 the added
gene is controlled, in part, by gene
sequences derived from Arabidopsis
thaliana and the plant pathogen figwort
mosaic virus. The Agrobacterium
tumefaciens transformation method was
used to transfer the added genetic
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17:42 Aug 01, 2007
Jkt 211001
material into the recipient parental
soybean line A3244.
MON 89788 soybean plants have been
considered regulated articles under the
regulations in 7 CFR part 340 because
they contain gene sequences from plant
pathogens. MON 89788 soybean plants
have been field tested in the United
States since 2001 under notifications
authorized by APHIS. In the process of
reviewing the notifications for field
trials of the subject soybean plants,
APHIS determined that the vectors and
other elements were disarmed and that
field trials, which were conducted
under conditions of reproductive and
physical confinement or isolation,
would not present a risk of plant pest
introduction or dissemination.
In a notice 1 published in the Federal
Register on February 5, 2007 (72 FR
5261–5263, Docket No. APHIS–2006–
0195), APHIS announced the
availability of Monsanto’s petition and
the associated environmental
assessment (EA). APHIS solicited
comments on whether the subject
soybean would present a plant pest risk
for 60 days ending April 6, 2007. APHIS
received 23 comments during the
comment period, with 12 comments
submitted in support of the conclusions
drawn in the EA and 11 opposed.
APHIS’ responses to these comments
can be found in an attachment to the
finding of no significant impact.
Determination
Based on APHIS’ analysis of field,
greenhouse, and laboratory data
submitted by Monsanto, references
provided in the petition, other relevant
information described in the EA, and
comments provided by the public,
APHIS has determined that Monsanto’s
soybean line, designated as MON 89788,
will not pose a plant pest risk for the
following reasons: (1) Gene
introgression from MON 89788 soybean
into its sexually compatible relatives in
the United States and its territories is
extremely unlikely and consequently
the potential impact of introgression is
not foreseeable; (2) the subgenus
Glycine max, on which MON 89788 is
based, is not considered to be a weed
and does not persist in unmanaged
ecosystems; (3) it does not pose a risk
to non-target organisms, including
beneficial organisms and threatened or
endangered species, because the CP4
EPSPS protein is not known to have any
toxic properties and has minimal
potential to be a food allergen; (4) MON
1 To view the notice, the EA, and the comments
we received, go to https://www.regulations.gov/
fdmspublic/component/
main?main=DocketDetail&d=APHIS–2006–0195.
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89788 exhibits no traits that should
cause increased weediness, and that its
unconfined cultivation should not lead
to increased weediness of other sexually
compatible relatives (of which there are
none in the United States); (5) if MON
89788 were to be grown commercially,
the effect on agricultural practices from
introducing MON 89788 into the
environment should be no different than
for the previously deregulated Roundup
Ready 40–3–2 soybean line expressing
the same CP4 EPSPS protein from
Agrobacterium sp. Strain CP4, with
which APHIS has over 10 years of
experience; (6) APHIS does not expect
MON 89788 to have any impacts on the
development of herbicide resistant
weeds or a cumulative impact in
combination with other glyphosate
tolerant crops; (7) there should be no
significant impact from the stacking of
herbicide resistant traits; (8) if MON
89788 were to be grown commercially,
the potential impact on organic farming
should not change from the current
situation where close to 90 percent of
soybeans produced are Roundup Ready
and organic farmers or other farmers
who choose not to plant or sell
Roundup Ready soybean or other
transgenic soybeans will still be able to
purchase and grow nontransgenic
soybeans and will be able to coexist
with biotech soybean producers as they
do now; (9) APHIS’ analysis of data on
agronomic performance, disease and
insect susceptibility, and compositional
profiles of MON 89788 and its nongenetically engineered counterpart
indicates no significant differences
between the two that would be expected
to cause either a direct or indirect plant
pest effect on raw or processed plant
commodities from the deregulation of
MON 89788; (10) APHIS has reviewed
field performance data submitted by the
petitioner, and these data indicate that
the engineered plant is not different in
any fitness characteristics from its
parent that might cause MON 89788 to
become invasive; and (11) none of the
alternatives proposed in the EA are
expected to have significant human
health or environmental effects.
National Environmental Policy Act
To provide the public with
documentation of APHIS’ review and
analysis of any potential environmental
impacts associated with the
determination of nonregulated status for
MON 89788, an EA was prepared. The
EA was prepared in accordance with (1)
The National Environmental Policy Act
of 1969 (NEPA), as amended (42 U.S.C.
4321 et seq.), (2) regulations of the
Council on Environmental Quality for
implementing the procedural provisions
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Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices
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 finding of no significant
impact with regard to the determination
that Monsanto soybean line MON 89788
and lines developed from it are no
longer regulated articles under its
regulations in 7 CFR part 340. Copies of
the EA and finding of no significant
impact are available as indicated in the
ADDRESSES and FOR FURTHER
INFORMATION CONTACT sections of this
notice.
Authority: 7 U.S.C. 7701–7772 and 7781–
7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
371.3.
Done in Washington, DC, this 27th day of
July 2007.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E7–15001 Filed 8–1–07; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2007–0106]
Secretary’s Advisory Committee on
Foreign Animal and Poultry Diseases;
Meeting
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice of meeting.
AGENCY:
Pursuant to the Federal
Advisory Committee Act (5 U.S.C. App.
II), we are giving notice of a meeting of
the Secretary’s Advisory Committee on
Foreign Animal and Poultry Diseases.
DATES: A session open to the public will
be held on August 21, 2007, from 8 a.m.
to 5 p.m.
ADDRESSES: The meeting will be held in
the Jamie L. Whitten Federal Building,
12th Street and Jefferson Drive, SW.,
Washington, DC, in room 107A.
FOR FURTHER INFORMATION CONTACT: Dr.
Bethany O’Brien, Acting Director
Interagency Coordination, National
Center for Animal Health Emergency
Management, VS, APHIS, 4700 River
Road, Unit 41, Riverdale, MD 20737;
(301) 734–0825.
SUPPLEMENTARY INFORMATION: The
Secretary’s Advisory Committee on
Foreign Animal and Poultry Diseases
(the Committee) advises the Secretary of
Agriculture on actions necessary to
prevent the introduction of foreign
diseases of livestock and poultry into
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SUMMARY:
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17:42 Aug 01, 2007
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the United States. In addition, the
Committee advises the Secretary on
contingency planning and on
maintaining a state of preparedness to
deal with these diseases, if introduced.
The meeting will focus on the U.S.
animal health emergency management
system and on the foreign animal
disease situation worldwide and its
relevance to the United States. The
session will be open to the public.
However, due to time constraints, the
public will not be allowed to participate
in the Committee’s discussions.
You may obtain an agenda for the
meeting by contacting Dr. Bethany
O’Brien at the address listed under FOR
FURTHER INFORMATION CONTACT. Written
statements on meeting topics may be
filed with the Committee before or after
the meeting by sending them to the
person listed under FOR FURTHER
INFORMATION CONTACT. Written
statements may also be filed at the
meeting. Please refer to Docket No.
APHIS–2007–0106 when submitting
your statements.
Upon entering the Whitten Building,
visitors should inform security
personnel that they are attending the
Advisory Committee meeting on Foreign
Animal and Poultry Diseases. Photo
identification is required. Visitor badges
must be worn at all times while inside
the building.
Done in Washington, DC, this 27th day of
July 2007.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E7–14987 Filed 8–1–07; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS–2007–0027]
National Advisory Committee on Meat
and Poultry Inspection
Food Safety and Inspection
Service, USDA.
ACTION: Notice of public meeting.
AGENCY:
SUMMARY: Pursuant to the Federal
Advisory Committee Act, 5 U.S.C. App.,
the National Advisory Committee on
Meat and Poultry Inspection (NACMPI)
will hold a public meeting on August 8–
9, 2007, to review and discuss the
following issues: (1) Data Collection and
Analysis at the Food Safety and
Inspection Service (FSIS): Standard
Operating Procedures, (2) Linking FSIS
Activities to its Public Health Goals, and
(3) Pilot Project to Explore Mechanisms
for Sharing Industry Data with FSIS.
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42375
The first issue, Data Collection and
Analysis at FSIS: Standard Operating
Procedures, will be presented to the
entire Committee for discussion during
the morning session on August 8, 2007.
The other two issues will be presented
to the entire Committee in the afternoon
session. The committee will then divide
into two subcommittees. These
subcommittees will meet in the
afternoon of August 8, 2007, to discuss
the issues Linking FSIS Activities to its
Public Health Goals and Pilot Project to
Explore Mechanisms for Sharing
Industry Data with FSIS. Each
subcommittee will provide a report of
their comments and recommendations
to the full committee on the morning of
August 9, 2007.
DATES: The full Committee will hold a
public meeting on Wednesday, August
8, and Thursday, August 9, 2007, from
8:30 a.m. to 2 p.m. Subcommittees will
hold open meetings on Wednesday,
August 8, 2007, from 2 p.m. to 6 p.m.
ADDRESSES: All Committee meetings
will take place at George Mason
University, 3401 N. Fairfax Drive,
Arlington, VA 22201. A meeting agenda
is available on the Internet at the
NACMPI Web site, https://
www.fsis.usda.gov/about_fsis/nacmpi/
index.asp. The NACMPI meeting
agenda, together with information and
resource materials on public healthbased inspection, is also available on
the Internet at, https://
www.fsis.usda.gov/
Regulations_&_Policies/
Risk_Based_Inspection/index.asp. FSIS
welcomes comments on the topics to be
discussed at the NACMPI public
meeting. Comments may be submitted
by any of the following methods:
Electronic mail:
NACMPI@fsis.usda.gov.
Mail, including floppy disks or CD–
ROMs: Send to National Advisory
Committee on Meat and Poultry
Inspection, United States Department of
Agriculture, Food Safety and Inspection
Service, 14th & Independence Avenue,
SW., Mail Drop 405 Aerospace,
Washington, DC 20250.
Hand- or courier-delivered items:
Deliver to Loraine Cannon at 901 D
Street SW., Washington, DC. To deliver
these items, the building security guard
must first call (202) 690–6520.
Facsimile: Send to Loraine Cannon,
(202) 690–6519. All submissions
received must include the Agency name
and docket number FSIS–2007–0027.
FOR FURTHER INFORMATION CONTACT:
Robert Tynan for technical information
at (202) 720–3884, or e-mail
robert.tynan@fsis.usda.gov and Loraine
Cannon for meeting information at (202)
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]]>Agencies
[Federal Register Volume 72, Number 148 (Thursday, August 2, 2007)]
[Notices]
[Pages 42373-42375]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15001]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2006-0195]
Monsanto Company; Determination of Nonregulated Status for
Soybean Genetically Engineered for Glyphosate Herbicide Tolerance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public of our determination that a soybean
line developed by the Monsanto Company, designated as transformation
event MON 89788, which has been genetically engineered 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 the Monsanto Company in its 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 finding of no significant
impact.
DATES: Effective Date: July 23, 2007.
ADDRESSES: You may read the petition, environmental assessment,
determination, finding of no significant impact, the comments we
received on our previous notice, and our responses to those comments in
our reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue, SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming. To view those documents on
the Internet, go to https://www.regulations.gov, click on the ``Advanced
Search'' tab, and select ``Docket Search.'' In the Docket ID field,
enter APHIS-2006-0195, then click ``Submit.'' Clicking on the Docket ID
link in the search results page will produce a list of all documents in
the docket.
FOR FURTHER INFORMATION CONTACT: Dr. Virgil Meier, Biotechnology
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD
20737-1236; (301) 734-3363. To obtain copies of the
[[Page 42374]]
petition, environmental assessment, or the finding of no significant
impact, contact Ms. Cynthia Eck at (301) 734-0667;
cynthia.a.eck@aphis.usda.gov. Those documents may also be viewed on the
Internet at https://www.aphis.usda.gov/brs/aphisdocs/06_17801p.pdf and
https://www.aphis.usda.gov/brs/aphisdocs/06_17801p_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 June 27, 2006, APHIS received a petition seeking a determination
of nonregulated status (APHIS Petition Number 06-178-01p) from Monsanto
Company of St. Louis, MO (Monsanto), for soybean (Glycine max L.)
designated as transformation event MON 89788, which has been
genetically engineered for tolerance to the herbicide glyphosate,
stating that soybean line MON 89788 does not present 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, MON 89788 soybean plants have 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 the added
gene is controlled, in part, by gene sequences derived from Arabidopsis
thaliana and the plant pathogen figwort mosaic virus. The Agrobacterium
tumefaciens transformation method was used to transfer the added
genetic material into the recipient parental soybean line A3244.
MON 89788 soybean plants have been considered regulated articles
under the regulations in 7 CFR part 340 because they contain gene
sequences from plant pathogens. MON 89788 soybean plants have been
field tested in the United States since 2001 under notifications
authorized by APHIS. In the process of reviewing the notifications for
field trials of the subject soybean plants, APHIS determined that the
vectors and other elements were disarmed and that field trials, which
were conducted under conditions of reproductive and physical
confinement or isolation, would not present a risk of plant pest
introduction or dissemination.
In a notice \1\ published in the Federal Register on February 5,
2007 (72 FR 5261-5263, Docket No. APHIS-2006-0195), APHIS announced the
availability of Monsanto's petition and the associated environmental
assessment (EA). APHIS solicited comments on whether the subject
soybean would present a plant pest risk for 60 days ending April 6,
2007. APHIS received 23 comments during the comment period, with 12
comments submitted in support of the conclusions drawn in the EA and 11
opposed. APHIS' responses to these comments can be found in an
attachment to the finding of no significant impact.
---------------------------------------------------------------------------
\1\ To view the notice, the EA, and the comments we received, go
to https://www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2006-0195.
---------------------------------------------------------------------------
Determination
Based on APHIS' analysis of field, greenhouse, and laboratory data
submitted by Monsanto, references provided in the petition, other
relevant information described in the EA, and comments provided by the
public, APHIS has determined that Monsanto's soybean line, designated
as MON 89788, will not pose a plant pest risk for the following
reasons: (1) Gene introgression from MON 89788 soybean into its
sexually compatible relatives in the United States and its territories
is extremely unlikely and consequently the potential impact of
introgression is not foreseeable; (2) the subgenus Glycine max, on
which MON 89788 is based, is not considered to be a weed and does not
persist in unmanaged ecosystems; (3) it does not pose a risk to non-
target organisms, including beneficial organisms and threatened or
endangered species, because the CP4 EPSPS protein is not known to have
any toxic properties and has minimal potential to be a food allergen;
(4) MON 89788 exhibits no traits that should cause increased weediness,
and that its unconfined cultivation should not lead to increased
weediness of other sexually compatible relatives (of which there are
none in the United States); (5) if MON 89788 were to be grown
commercially, the effect on agricultural practices from introducing MON
89788 into the environment should be no different than for the
previously deregulated Roundup Ready 40-3-2 soybean line expressing the
same CP4 EPSPS protein from Agrobacterium sp. Strain CP4, with which
APHIS has over 10 years of experience; (6) APHIS does not expect MON
89788 to have any impacts on the development of herbicide resistant
weeds or a cumulative impact in combination with other glyphosate
tolerant crops; (7) there should be no significant impact from the
stacking of herbicide resistant traits; (8) if MON 89788 were to be
grown commercially, the potential impact on organic farming should not
change from the current situation where close to 90 percent of soybeans
produced are Roundup Ready and organic farmers or other farmers who
choose not to plant or sell Roundup Ready soybean or other transgenic
soybeans will still be able to purchase and grow nontransgenic soybeans
and will be able to coexist with biotech soybean producers as they do
now; (9) APHIS' analysis of data on agronomic performance, disease and
insect susceptibility, and compositional profiles of MON 89788 and its
non-genetically engineered counterpart indicates no significant
differences between the two that would be expected to cause either a
direct or indirect plant pest effect on raw or processed plant
commodities from the deregulation of MON 89788; (10) APHIS has reviewed
field performance data submitted by the petitioner, and these data
indicate that the engineered plant is not different in any fitness
characteristics from its parent that might cause MON 89788 to become
invasive; and (11) none of the alternatives proposed in the EA are
expected to have significant human health or environmental effects.
National Environmental Policy Act
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with the
determination of nonregulated status for MON 89788, an EA was prepared.
The EA was prepared in accordance with (1) The National Environmental
Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2)
regulations of the Council on Environmental Quality for implementing
the procedural provisions
[[Page 42375]]
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 finding of no
significant impact with regard to the determination that Monsanto
soybean line MON 89788 and lines developed from it are no longer
regulated articles under its regulations in 7 CFR part 340. Copies of
the EA and finding of no significant impact are available as indicated
in the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this
notice.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 27th day of July 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-15001 Filed 8-1-07; 8:45 am]
BILLING CODE 3410-34-P
