[Federal Register Volume 76, Number 124 (Tuesday, June 28, 2011)]
[Notices]
[Pages 37771-37772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16123]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2011-0046]
Monsanto Co.; Availability of Petition, Plant Pest Risk
Assessment, and Environmental Assessment for Determination of
Nonregulated Status for Soybean Genetically Engineered To Have a
Modified Fatty Acid Profile and for Tolerance to the Herbicide
Glyphosate
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 for soybean designated
as MON 87705, which has been genetically engineered to have a modified
fatty acid profile and for tolerance to the herbicide glyphosate. 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
August 29, 2011.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2011-0046-0001.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2011-0046, 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-
0046 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
[[Page 37772]]
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_20101p.pdf,
http://www.aphis.usda.gov/brs/aphisdocs/09_20101p _dea.pdf, and
http://www.aphis.usda.gov/brs/aphisdocs/09_20101p _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, e-mail:
[email protected]. To obtain copies of the petition, draft
environmental assessment, or plant pest risk assessment, contact Ms.
Cindy Eck at (301) 734-0667, e-mail: [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 09-201-01p)
from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a
determination of nonregulated status for soybean (Glycine max)
designated as event MON 87705, which has been genetically engineered to
have a modified fatty acid profile and for tolerance to the herbicide
glyphosate, 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 87705 has been
genetically engineered to suppress endogenous delta-12 desaturase
(FAD2) and Acyl-ACP thioesterase (FATB) genes which encode two enzymes
in the soybean fatty acid biosynthetic pathway in order to produce
soybean seeds with decreased levels of saturated (palmitic and stearic)
and polyunsaturated (linoleic) fatty acids and increased levels of
monounsaturated (oleic) fatty acid. Soybean event MON 87705 have 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. Soybean
event MON 87705 is currently regulated under 7 CFR part 340. Interstate
movements and field tests of soybean event MON 87705 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 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 87705 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 87705 and it would
continue to be a regulated article, or (2) make a determination of
nonregulated status for soybean event MON 87705.
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 for
soybean event MON 87705. 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 87705 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 22nd day of June 2011.
John R. Clifford,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-16123 Filed 6-27-11; 8:45 am]
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