[Federal Register: February 23, 2005 (Volume 70, Number 35)]
[Notices]
[Page 8763]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23fe05-21]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 05-006-1]
Ventria Bioscience; Availability of Environmental Assessment for
Field Test of Genetically Engineered Rice Expressing Lactoferrin
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 prepared an environmental assessment for a
confined field planting of rice plants genetically engineered to
express the protein lactoferrin. This environmental assessment is
available for public review and comment.
DATES: We will consider all comments we receive on or before March 25,
2005.
ADDRESSES: You may submit comments by either of the following methods:
EDOCKET: Go to http://www.epa.gov/feddocket to submit or
view public comments, access the index listing of the contents of the
official public docket, and to access those documents in the public
docket that are available electronically. Once you have entered
EDOCKET, click on the ``View Open APHIS Dockets'' link to locate this
document.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 05-006-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 05-006-1.
Reading Room: You may read the environmental assessment and 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.
Other Information: You may view APHIS documents published in the
Federal Register and related information on the Internet at http://www.aphis.usda.gov/
ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Levis Handley, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5721. To obtain copies of the environmental
assessment, contact Ms. Ingrid Berlanger, at (301) 734-4885; e-mail
ingrid.e.berlanger@aphis.usda.gov. The environmental assessment is also
available on the Internet at http://www.aphis.usda.gov/ brs/aphisdocs/
04--30201r--ea.pdf.
SUPPLEMENTARY INFORMATION: 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.'' A permit must be
obtained or a notification acknowledged before a regulated article may
be introduced into the United States. The regulations set forth the
permit application requirements and the notification procedures for the
importation, interstate movement, and release into the environment of a
regulated article.
On October 28, 2004, the Animal and Plant Health Inspection Service
(APHIS) received a permit application (APHIS permit number 04-302-01r)
from Ventria Bioscience, Sacramento, CA, for a permit for a confined
field planting of rice (Oryza sativa) plants genetically engineered to
express a gene coding for the protein lactoferrin, rice line LF164-12.
The field planting is to be conducted in Scott County, MO. The subject
rice plants have been genetically engineered, using micro-projectile
bombardment, to express human lactoferrin protein. Expression of the
gene is controlled by the rice glutelin 1 promoter, the rice glutelin 1
signal peptide, and the NOS, (nopaline synthase) terminator sequence
from Agrobacterium tumefaciens. The gene is expressed only in the
endosperm. In addition, the plants contain the coding sequence for the
gene hygromycin phosphotransferase (hpt), an enzyme which confers
tolerance to the antibiotic hygromycin. This gene is a selectable
marker that is only expressed during plant cell culture and is not
expressed in any tissues of the mature plant. Expression of the gene is
controlled by the rice glucanase 9 (Gns 9) promoter and the Rice Alpha
Amylase 1A (RAmy1A) terminator. The genetically engineered rice plants
are considered regulated articles under the regulations in 7 CFR part
340 because they contain gene sequences from plant pathogens.
The purpose of the field planting is for pure seed production and
for the extraction of lactoferrin for a variety of research and
commercial products. The planting will be conducted using physical
confinement measures. In addition, the experimental protocols and field
plot design, as well as the procedures for termination of the field
planting, are designed to ensure that none of the subject rice plants
persist in the environment beyond the termination of the experiments.
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts and plant pest risk
associated with the proposed confined field planting of the subject
rice plants, an environment assessment (EA) has been 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 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). Copies of the EA are
available from the individual listed under FOR FURTHER INFORMATION
CONTACT.
Done in Washington, DC, this 16th day of February 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-703 Filed 2-22-05; 8:45 am]
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