E7-11481. 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.

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 [phone] 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; [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. 05-354-03r) 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 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.