[Federal Register Volume 73, Number 32 (Friday, February 15, 2008)]
[Notices]
[Pages 8850-8851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2911]


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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 and Finding of No Significant Impact for a Field Release To 
Produce Antibodies in Genetically Engineered Nicotiana Hybrids

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. 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, the Animal and Plant Health 
Inspection Service has determined that an environmental impact 
statement need not be prepared for this field release.

Effective Date: February 15, 2008.

ADDRESSES: You may read the 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_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 EA, FONSI and 
decision notice, and responses to comments, 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. 05-354-03r) 
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.
    On June 13, 2007, APHIS published a notice \1\ in the Federal 
Register (72 FR 32607-32608, Docket No. APHIS-2007-0029) announcing the 
availability of an environmental assessment (EA) for the proposed 
release of a transgenic Nicotiana hybrid line. During the 30-day 
comment period, APHIS received six comments. All six comments were 
opposed to APHIS' issuance of this permit and genetically engineered 
crops in general, but only one raised specific issues regarding the EA. 
APHIS has provided responses to these comments as an attachment to the 
finding of no significant impact (FONSI).
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    \1\ To view the notice, the EA, and the comments we received, go 
to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0029.
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    Pursuant to the regulations promulgated under the Plant Protection 
Act, APHIS has determined that this field release will not pose a risk 
of introducing or disseminating a plant pest. Additionally, based upon 
analysis described in the EA, APHIS has determined that the action 
proposed in Alternative B of the EA (the preferred alternative), to 
issue the permit with supplemental permit conditions, will not have a 
significant impact on the quality of the human environment. Therefore, 
APHIS has determined that a FONSI is appropriate for this proposed 
action. You may read the FONSI and Decision Notice on the Internet or 
in the

[[Page 8851]]

APHIS reading room (see ADDRESSES above). Copies may also be obtained 
from the person listed under the FOR FURTHER INFORMATION CONTACT 
section of this notice.
    The 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 11th day of February 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E8-2911 Filed 2-14-08; 8:45 am]
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