E7-13660. 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.

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 [phone] 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; [phone]. To obtain copies of the environmental assessment, contact Ms. Cynthia Eck at [phone]; e-mail: [e-mail].

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 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.

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.

Footnotes

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 the docket.