[Federal Register Volume 72, Number 113 (Wednesday, June 13, 2007)]
[Notices]
[Pages 32607-32608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11481]


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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: 
[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.
    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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