[Federal Register: August 2, 2007 (Volume 72, Number 148)]
[Notices]
[Page 42373-42375]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02au07-49]
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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.
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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 http://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 http://www.aphis.usda.gov/brs/aphisdocs/06_17801p.pdf and
http://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.
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\1\ To view the notice, the EA, and the comments we received, go
to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0195.
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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
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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]
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