[Federal Register: May 13, 2005 (Volume 70, Number 92)]
[Notices]
[Page 25521-25522]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13my05-27]
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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
ingrid.e.berlanger@aphis.usda.gov. 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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