[Federal Register Volume 70, Number 92 (Friday, May 13, 2005)]
[Notices]
[Pages 25521-25522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9606]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 05-006-2]


Ventria Bioscience; Availability of Revised Environmental 
Assessment, With Consideration for an Additional Test Site in North 
Carolina, for Field Tests 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 revised an environmental assessment for confined 
field tests of rice plants genetically engineered to express the 
protein lactoferrin and has included information on an additional field 
test site. This environmental assessment is available for public review 
and comment.

DATES: We will consider all comments that we receive on or before June 
2, 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. 05-006-2, 
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. 05-006-2.
    Reading Room: You may read the environmental assessment and any 
comments that we receive 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

[[Page 25522]]

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/05_11701r_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 test of rice (Oryza sativa) plants genetically engineered to 
express a gene coding for the protein lactoferrin, rice line LF164-12. 
According to the permit application, the field test would be conducted 
in Scott County, MO. On February 23, 2005, APHIS published a notice in 
the Federal Register (70 FR 8763, Docket No. 05-006-1), announcing the 
availability of an environmental assessment (EA) for the proposed field 
test and soliciting public comments for 30 days. This 30-day comment 
period closed on March 25, 2005. During the 30-day comment period, 
APHIS received 309 comments. Comments were received from rice growers, 
rice marketing and processing groups, agricultural support businesses, 
consumer groups, university professionals, private individuals, 
industry trade organizations, large rice purchasers, growers of crops 
other than rice, and Federal, State and local government 
representatives.
    On April 27, 2005, while APHIS was evaluating these comments, we 
received a request from Ventria Biosciences to plant rice line LF164-12 
in a second site in Washington County, NC (APHIS permit number 05-117-
01r). At this time, Ventria Biosciences has not withdrawn its 
application to conduct a field test in Scott County, MO. However, it is 
likely that conducting a field test for this growing season is not 
feasible due to climatic factors in this location. Because APHIS has 
not yet considered all of the comments associated with the earlier EA 
and the issues raised in North Carolina are similar to those in 
Missouri, APHIS has amended the EA to evaluate the issues in North 
Carolina as well as Missouri. These are covered in Appendices V and VI. 
In addition to evaluating site-specific issues presented by the North 
Carolina application, this revised EA also corrects errors in the 
original EA. These changes are described in the summary of the EA.
    APHIS is seeking comments on the additional information provided in 
this revised EA. We are particularly interested in comments related to 
Appendices V and VI that address issues in North Carolina. APHIS will 
consider all comments received during the previous comment period (70 
FR 8763, Docket No. 05-006-1) as well as any new comments received 
during this comment period (see DATES above). The expanded EA will be 
open for public comment for an additional 20 days.
    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 9th day of May 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-9606 Filed 5-12-05; 8:45 am]
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