[Federal Register: June 13, 2007 (Volume 72, Number 113)]
[Notices]
[Page 32607-32608]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn07-27]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0029]
Planet Biotechnology, Inc.; Availability of an Environmental
Assessment for a Field Release of Nicotiana Hybrids Genetically
Engineered To Produce Antibodies
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public that we have prepared an
environmental assessment for a proposed field release involving a
Nicotiana hybrid line that has been genetically engineered to produce
an antimicrobial antibody that binds to a bacterium (Streptococcus
mutans) associated with tooth decay in humans. The purpose of this
field release is to generate plant biomass from which the antibody will
be extracted after harvest. We are making the environmental assessment
available to the public for review and comment.
DATES: We will consider all comments received on or before July 13,
2007.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov
, select ``Animal and Plant Health Inspection
Service'' from the agency drop-down menu, then click ``Submit.'' In the
Docket ID column, select APHIS-2007-0029 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-
2007-0029, 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-2007-0029.
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 http://www.aphis.usda.gov/brs/aphisdocs/05_35403r_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: Dr. Margaret Jones, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-4880. 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 December 21, 2005, the Animal and Plant Health Inspection
Service (APHIS) received a permit application (APHIS No. 05-354-03r)
from Planet Biotechnology, Inc., of Hayward, CA, for a field trial
using a transgenic Nicotiana hybrid. Permit application 05-354-03r
describes a Nicotiana hybrid line (Nicotiana tabacum X Nicotiana
glauca), designated as 06PBCarHG1, that produces a chimeric
antimicrobial antibody (trade name CaroRx)TM that binds to
the bacterium (Streptococcus mutans) associated with tooth decay in
humans. Expression of the gene sequence is controlled by the
cauliflower mosaic virus (CaMV) promoter and terminated by NOS from
Agrobacterium tumefaciens and utilizes the selectable marker NPTII from
Escherichia coli. Constructs were inserted into the recipient organisms
via a disarmed Agrobacterium tumefaciens vector system. The antibodies
generated from this planting will be extracted after harvest.
The subject Nicotiana hybrid is considered a regulated article
under the regulations in 7 CFR part 340 because it has been genetically
engineered using genetic sequences from plant pathogens.
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 Nicotiana hybrids, we
have prepared an environmental assessment (EA). 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).
The EA may be viewed on the Regulations.gov Web site or in our
reading room. (Instructions for accessing
[[Page 32608]]
Regulations.gov and information on the location and hours of the
reading room are provided under the heading ADDRESSES at the beginning
of this notice.) In addition, copies may be obtained by calling or
writing to 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 7th day of June, 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-11481 Filed 6-12-07; 8:45 am]
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