[Federal Register Volume 72, Number 58 (Tuesday, March 27, 2007)]
[Notices]
[Page 14259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5570]


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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: 
[email protected].

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]
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