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Availability of an Environmental Assessment for a Field Release of Tobacco Genetically Engineered To Produce Antibodies

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: March 27, 2007 (Volume 72, Number 58)]
[Notices]
[Page 14259]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27mr07-16]

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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2006-0038]

Availability of an Environmental Assessment for a Field Release
of Tobacco 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
transgenic tobacco 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. The environmental assessment is available
to the public for review and comment.

DATES: We will consider all comments received on or before April 26, 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-2006-0038 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-
2006-0038, 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-2006-0038.
    Reading Room: You may read the environmental assessment 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 environmental assessment is available on the Internet at
http://aphis.usda.gov/brs/aphisdocs/05_35401r_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. 05-354-01r)
from Planet Biotechnology, Inc., of Hayward, CA, for a field trial
using a line of transgenic tobacco. Permit application 05-354-01r
describes a transgenic tobacco line (Nicotiana tabacum L.), designated
as H8-105, that produces a chimeric antimicrobial antibody (trade name
CaroRxTM) that binds to the bacterium Streptococcus mutans,
which is 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 tobacco is considered a regulated article under the
regulations in 7 CFR part 340 because it has been genetically
engineered using the recombinant DNA technique using a vector derived
from Agrobacterium tumefaciens.
    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 tobacco
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).
    The EA may be viewed on the Regulations.gov Web site or in our
reading room. (Instructions for accessing 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
individuals 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 21st day of March 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-5570 Filed 3-26-07; 8:45 am]
BILLING CODE 3410-34-P

 
 

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