[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80871-80872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33002]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2011-0095]


Monsanto Co.; Availability of Petition, Plant Pest Risk 
Assessment, and Environmental Assessment for Determination of 
Nonregulated Status of Soybean Genetically Engineered To Produce 
Stearidonic Acid

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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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 of soybean designated as 
MON 87769, which has been genetically engineered to produce stearidonic 
acid, an omega-3 fatty acid not found in conventional soybean. The 
petition has been submitted in accordance with our regulations 
concerning the introduction of certain genetically engineered organisms 
and products. We are soliciting comments on whether this genetically 
engineered soybean is likely to pose a plant pest risk. We are making 
available for public comment the Monsanto petition, our plant pest risk 
assessment, and our draft environmental assessment for the proposed 
determination of nonregulated status.

DATES: We will consider all comments that we receive on or before 
February 27, 2012.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2011-0095-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2011-0095, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2011-
0095 or in our reading room, which 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.
    The petition, draft environmental assessment, and plant pest risk 
assessment are also available on the APHIS Web site at http://www.aphis.usda.gov/brs/aphisdocs/09_18301p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/09_18301p _dea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/09_18301p _dpra.pdf.

FOR FURTHER INFORMATION CONTACT: Mr. Evan Chestnut, Policy Analyst, 
Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-0942, email: 
[email protected]. To obtain copies of the petition, draft 
environmental assessment, or plant pest risk assessment, contact Ms. 
Cindy Eck at (301) 734-0667, email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    Under the authority of the plant pest provisions of the Plant 
Protection Act (7 U.S.C. 7701 et seq.), 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.
    APHIS has received a petition (APHIS Petition Number 09-183-01p) 
from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a 
determination of nonregulated status of soybean (Glycine max) 
designated as event MON 87769, which has been genetically engineered to 
produce stearidonic acid, an omega-3 fatty acid not found in 
conventional soybean, stating that this soybean is unlikely to pose 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, soybean event MON 87769 has been 
genetically engineered to express high levels of the fatty acid 
stearidonic acid and smaller amounts of three other fatty acids, as 
well as for reduced expression of linoleic acid. Soybean event MON 
87769 is currently regulated under 7 CFR part 340. Interstate movements 
and field tests of soybean event MON 87769 have been conducted under 
permits issued or notifications acknowledged by APHIS.
    Field tests conducted under APHIS oversight allowed for evaluation 
in a natural agricultural setting while imposing measures to minimize 
the risk

[[Page 80872]]

of persistence in the environment after completion of the test. Data 
are gathered on multiple parameters and used by the applicant to 
evaluate agronomic characteristics and product performance. These and 
other data are used by APHIS to determine if the new variety poses a 
plant pest risk.
    In section 403 of the Plant Protection Act, ``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 has prepared a plant pest risk assessment to determine 
if soybean event MON 87769 is unlikely to pose a plant pest risk.
    APHIS has also prepared a draft environmental assessment (EA) in 
which it presents two alternatives based on its analyses of data 
submitted by Monsanto, a review of other scientific data, and field 
tests conducted under APHIS oversight. APHIS is considering the 
following alternatives: (1) Take no action, i.e., APHIS would not 
change the regulatory status of soybean event MON 87769 and it would 
continue to be a regulated article, or (2) make a determination of 
nonregulated status of soybean event MON 87769.
    The 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 of 
soybean event MON 87769. 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 plant pest risk 
assessment and the draft EA prepared to examine any potential 
environmental impacts of the proposed determination for the 
deregulation of the subject soybean line. The petition, draft EA, and 
plant pest risk assessment are available for public review, and copies 
of the petition, draft EA, and plant pest risk assessment are available 
as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. All comments received regarding the petition, draft EA, 
and plant pest risk assessment will be available for public review. 
After reviewing and evaluating the comments on the petition, the draft 
EA, plant pest risk assessment, and other data, APHIS will furnish a 
response to the petitioner, either approving or denying the petition. 
APHIS will also publish a notice in the Federal Register announcing the 
regulatory status of soybean event MON 87769 and the availability of 
APHIS' written environmental decision and regulatory determination.

    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 19th day of December 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-33002 Filed 12-22-11; 8:45 am]
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