[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Pages 27303-27304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-11485]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2011-0023]
Monsanto Co.; Availability of Petition, Plant Pest Risk
Assessment, and Environmental Assessment for Determination of
Nonregulated Status for Corn Genetically Engineered for Drought
Tolerance
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 corn designated as
MON 87460, which has been genetically engineered for drought tolerance.
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 corn 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 July
11, 2011.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2011-0023 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send one copy of
your comment to Docket No. APHIS-2011-0023, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2011-0023.
Reading Room: You may read any comments that we receive on this
docket 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.
Availability of Documents: The petition, draft environmental
assessment, and plant pest risk assessment are on available on the
Regulations.gov Web site (see link above) or on the APHIS Web site at
http://www.aphis.usda.gov/brs/aphisdocs/09_05501p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/09_05501p _dea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/09_05501p _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 09-055-01p)
from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a
determination of nonregulated status for corn (Zea mays L.) designated
as event MON 87460, which has been genetically engineered for drought
tolerance, stating that this corn 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, an introduced gene called cold shock
protein B, derived from the bacterium Bacillus subtilis, appears to
help maintain plant cellular functions and is expected to reduce yield
loss under water-limited conditions compared to conventional corn. Corn
event MON 87460 is currently regulated under 7 CFR part 340. Interstate
movements and field tests of corn event MON 87460 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 data are used by APHIS to determine if the new
variety poses a plant pest risk. Monsanto has petitioned APHIS to make
a determination that corn event MON 87460 should not be regulated under
7 CFR part 340.
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 corn event MON 87460 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
[[Page 27304]]
the following alternatives: (1) Take no action, i.e., APHIS would not
change the regulatory status of corn event MON 87460 and it would
continue to be a regulated article, or (2) approve the petition based
on a determination of the nonregulated status of corn event MON 87460
in whole.
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
corn event MON 87460. 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 corn 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 corn event MON 87460 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 4th day of May 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-11485 Filed 5-10-11; 8:45 am]
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