[Federal Register Volume 72, Number 134 (Friday, July 13, 2007)]
[Notices]
[Pages 38555-38556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13660]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0038]


Availability of an Environmental Assessment and Finding of No 
Significant Impact for a Field Release to Produce Antibodies in 
Genetically Engineered Tobacco

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 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 provides a basis 
for our conclusion that this field release will not present a risk of 
introducing or disseminating a plant pest and will not have a 
significant impact on the quality of the human environment. Based on 
its finding of no significant impact, we have determined that an 
environmental impact statement need not be prepared for this field 
release.

EFFECTIVE DATE: July 13, 2007.

ADDRESSES: You may read the final environmental assessment (EA), the 
finding of no significant impact (FONSI), and the comments we received 
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, FONSI and 
decision notice, and responses to comments are available on the 
Internet at: http://www.aphis.usda.gov/brs/aphisdocs/05_35401r_ea.pdf.

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 release 
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 
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 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.
    On March 27, 2007, APHIS published a notice \1\in the Federal 
Register (72 FR 14259, Docket No. APHIS-2006-0038) announcing the 
availability of an environmental assessment (EA) for the proposed 
release of the transgenic tobacco line. During the 30-day

[[Page 38556]]

comment period, which ended on April 26, 2007, APHIS received two 
comments. Both comments were opposed to APHIS' issuance of this permit 
and genetically engineered crops in general, but did not raise any 
specific issues regarding the EA. APHIS has provided responses to these 
comments as an appendix to the final EA.
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    \1\ To view the notice, EA, and the comments we received, go to 
http://www.regulations.gov, click on the ``Advanced Search'' tab, 
and select ``Docket Search.'' In the Docket ID field, enter APHIS-
2006-0038, then click on ``Submit.'' Clicking on the Docket ID link 
in the search results page will produce a list of all documents in 
thedocket.
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    Pursuant to the regulations in 7 CFR part 340 promulgated under the 
Plant Protection Act, APHIS has determined that this field release will 
not pose a risk of the introduction or dissemination of a plant pest. 
Additionally, based upon analysis described in the final EA, APHIS has 
determined that the action proposed in Alternative C of the EA, issue 
the permit with supplemental permit conditions, will not have a 
significant impact on the quality of the human environment. You may 
read the finding of no significant impact (FONSI) and decision notice 
on the Internet or in the APHIS reading room (see ADDRESSES above). 
Copies may also be obtained from the person listed under FOR FURTHER 
INFORMATION CONTACT.
    The final EA and FONSI were 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).

    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 5th day of July 2007.
 Kevin Shea,
 Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E7-13660 Filed 7-12-07; 8:45 am]
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