[Federal Register Volume 72, Number 148 (Thursday, August 2, 2007)]
[Notices]
[Pages 42373-42375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15001]


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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; 
[email protected]. 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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