[Federal Register Volume 70, Number 35 (Wednesday, February 23, 2005)]
[Notices]
[Page 8763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-703]


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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 
[email protected]. 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]
BILLING CODE 3410-34-P