[Federal Register: February 28, 2007 (Volume 72, Number 39)]
[Notices]
[Page 8959-8960]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28fe07-18]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0006]
Ventria Bioscience; Availability of an Environmental Assessment
for Field Tests of Rice Genetically Engineered To Express Lactoferrin,
Lysozyme, or Serum Albumin
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
confined field plantings of rice plants genetically engineered to
express the human proteins lactoferrin, lysozyme, or serum albumin.
This environmental assessment is available for public review and
comment.
DATES: We will consider all comments received on or before March 30,
2007.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov
and, in the lower ``Search Regulations and Federal
Actions'' box, select ``Animal and Plant Health Inspection Service''
from the agency drop-down menu, and then click on ``Submit.'' In the
Docket ID column, select APHIS-2007-0006 to submit or view public
comments and to view supporting and related materials available
electronically. Information on using Regulations.gov, including
instruction for accessing documents, submitting comments, and viewing
the docket after the close of the comment period, is available through
the site's ``User Tips'' link.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. APHIS-
2007-0006, 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-2007-0006.
Reading Room: You may read the environmental assessment (EA) and
any comments 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. The EA is available on the internet at the following links:
http://www.aphis.usda.gov/brs/aphisdocs/06_27801r_ea.pdf, http://www.aphis.usda.gov/brs/aphisdocs/06_27802r_ea.pdf, http://
[[Page 8960]]
http://www.aphis.usda.gov/brs/aphisdocs/06_28502r_ea.pdf
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Mr. John Cordts, Biotechnology
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD
20737-1236; (301) 734-5531. To obtain copies of the environmental
assessment, contact Ms. Cynthia Eck at (301) 734-0667; e-mail:
cynthia.a.eck@aphis.usda.gov.
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. The regulations set forth the permit application
requirements and the notification procedures for the importation,
interstate movement, or release in the environment of a regulated
article.
On October 2, 2006, APHIS received two Permit applications (06-278-
01r and 06-278-02r) followed by a third Permit application (06-285-02r)
received on October 12, 2006, from Ventria Bioscience, Sacramento, CA,
for confined field plantings of rice (Oryza sativa) plants genetically
engineered to express gene coding for the proteins lactoferrin,
lysozyme, or serum albumin, respectively. The proposed field plantings
are to be conducted in Geary County, KS. The subject plants have been
genetically engineered, using techniques of micro-projectile
bombardment or disarmed Agrobacterium-mediated transformation, to
express proteins for human lactoferrin, lysozyme, or serum albumin.
Expression of the genes is controlled by the rice glutelin 1 promoter
(GT1), the rice glutelin 1 signal peptide (gt1), and the nopaline
synthase (NOS) terminator sequence from Agrobacterium tumefaciens. The
genes are expressed only in the endosperm. In addition, the plants may
contain either or both of the coding sequences for the genes hygromycin
phosphotransferase (hpt) or phosphinothricin acetyltransferase (pat),
which are marker genes that allow for the selection of transgenic
tissues in the laboratory using the antibiotic hygromycin and/or the
herbicide bialaphos. Neither selectable marker gene is expressed in
mature rice tissues, nor do they have any inherent plant pest
characteristics or enhance gene transfer from plants to other
organisms. 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 plantings are for pure seed production and
for the extraction of lactoferrin, lysozyme, and serum albumin for a
variety of research and commercial products. There is currently no
commercial rice production in Geary County or in any other location in
the state of Kansas. The planting will be conducted using physical
confinement measures. In addition, the protocols and field plot design,
as well as the procedures for termination of the field plantings, are
designed to ensure that none of the subject rice plants persist in the
environment after the crop is harvested.
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts and plant pest risks
associated with the proposed release of these transgenic rice plants,
an environmental 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.
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 22nd day of February 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service. 1
[FR Doc. E7-3484 Filed 2-27-07; 8:45 am]
BILLING CODE 3410-34-P