E7-3484. Ventria Bioscience; Availability of an Environmental Assessment for Field Tests of Rice Genetically Engineered To Express Lactoferrin, Lysozyme, or Serum Albumin

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment for confined field plantings of rice plants genetically engineered to express the human proteins lactoferrin, lysozyme, or serum albumin. This environmental assessment is available for public review and comment.

DATES:

We will consider all comments received on or before March 30, 2007.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov and, in the lower “Search Regulations and Federal Actions” box, select “Animal and Plant Health Inspection Service” from the agency drop-down menu, and then click on “Submit.” In the Docket ID column, select APHIS-2007-0006 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-2007-0006, 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-2007-0006.

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 the following links: http://www.aphis.usda.gov/​brs/​aphisdocs/​06_​27801r_​ea.pdf,, http://www.aphis.usda.gov/​brs/​aphisdocs/​06_​27802r_​ea.pdf,, http://www.aphis.usda.gov/​brs/​aphisdocs/​06_​28502r_​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:

Mr. John Cordts, 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 October 2, 2006, APHIS received two Permit applications (06-278-01r and 06-278-02r) followed by a third Permit application (06-285-02r) received on October 12, 2006, from Ventria Bioscience, Sacramento, CA, for confined field plantings of rice (Oryza sativa) plants genetically engineered to express gene coding for the proteins lactoferrin, lysozyme, or serum albumin, respectively. The proposed field plantings are to be conducted in Geary County, KS. The subject plants have been genetically engineered, using techniques of micro-projectile bombardment or disarmed Agrobacterium-mediated transformation, to express proteins for human lactoferrin, lysozyme, or serum albumin. Expression of the genes is controlled by the rice glutelin 1 promoter (GT1), the rice glutelin 1 signal peptide (gt1), and the nopaline synthase (NOS) terminator sequence from Agrobacterium tumefaciens. The genes are expressed only in the endosperm. In addition, the plants may contain either or both of the coding sequences for the genes hygromycin phosphotransferase (hpt) or phosphinothricin acetyltransferase (pat), which are marker genes that allow for the selection of transgenic tissues in the laboratory using the antibiotic hygromycin and/or the herbicide bialaphos. Neither selectable marker gene is expressed in mature rice tissues, nor do they have any inherent plant pest characteristics or enhance gene transfer from plants to other organisms. The genetically engineered rice plants are considered regulated articles under the regulations in 7 CFR part 340 because they contain gene sequences from plant pathogens.

The purpose of the field plantings are for pure seed production and for the extraction of lactoferrin, lysozyme, and serum albumin for a variety of research and commercial products. There is currently no commercial rice production in Geary County or in any other location in the state of Kansas. The planting will be conducted using physical confinement measures. In addition, the protocols and field plot design, as well as the procedures for termination of the field plantings, are designed to ensure that none of the subject rice plants persist in the environment after the crop is harvested.

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 transgenic rice plants, an environmental assessment (EA) has been prepared. 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). Copies of the EA are available from 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 22nd day of February 2007.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

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