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.

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: 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. 05-354-03r) 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 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).

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 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.