[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Pages 27301-27303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-11519]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0130]
Syngenta Biotechnology, Inc.; Availability of Petition, Plant
Pest Risk Assessment, and Environmental Assessment of Determination of
Nonregulated Status for Lepidopteran-Resistant Cotton
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 Syngenta Biotechnology,
Inc., seeking a determination of nonregulated status for cotton
designated as event COT67B, which has been genetically engineered to
express a protein to protect cotton plants from lepidopteran insect
damage. 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 cotton is likely to pose a plant
pest risk. We are making available for public comment the Syngenta
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-2007-0130 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
[[Page 27302]]
to Docket No. APHIS-2007-0130, 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-
2007-0130.
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 available on the
Regulations.gov Web site (see link above) or on the APHIS Web site at
http://www.aphis.usda.gov/brs/aphisdocs/07_10801p.pdf, http://www.aphis.usda.gov/brs/aphisdocs/07_10801p _dea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/07_10801p _dpra.pdf.
FOR FURTHER INFORMATION CONTACT: Mr. Rick Coker, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5720, 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 07-108-01p)
from Syngenta Biotechnology, Inc. (Syngenta), seeking a determination
of nonregulated status for cotton (Gossypium spp.) designated as
COT67B, which has been genetically engineered to express a Cry1Ab
protein to protect cotton plants from lepidopteran insect damage,
stating that cotton event COT67B 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, COT67B cotton produces a full-length
Cry1Ab protein originally derived from Bacillus thuringiensis subsp.
kurstaki HD-1 which has activity against several important lepidopteran
pest species of cotton. These include, but are not limited to,
Helicoverpa zea (cotton bollworm), Heliothis virescens (tobacco
budworm), Pectinophora gossypiella (pink bollworm), and Trichoplusia ni
(cabbage looper). Cotton event COT67B is currently regulated under 7
CFR part 340. Interstate movements and field tests of cotton event
COT67B have been conducted under 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. Syngenta has petitioned APHIS to make
a determination that cotton event COT67B 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 cotton event COT67B 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 Syngenta, 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 cotton event COT67B and it would
continue to be a regulated article, or (2) approve the petition based
on a determination of the nonregulated status of cotton event COT67B 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
cotton event COT67B. 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 of the nonregulated
status of the subject cotton 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 as
indicated under ADDRESSES above. 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 cotton event
[[Page 27303]]
COT67B 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. 2011-11519 Filed 5-10-11; 8:45 am]
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