Animal and Plant Health Inspection Service, USDA.
We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment for confined field release of rice plants genetically engineered to express the human proteins lactoferrin, lysozyme, or serum albumin. After assessment of the application, review of pertinent scientific information, and consideration of comments provided by the public, we have concluded that these field releases will not present a risk of introducing or disseminating a plant pest. We have completed the environmental assessment and concluded that this field release 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 these field releases.
May 16, 2007.
You may read the environmental assessment (EA), the finding of no significant impact (FONSI), and any 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 the following links:
FOR FURTHER INFORMATION CONTACT:
Mr. John Cordts, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-5531. To obtain copies of the EA, FONSI and decision notice, and response to comments, contact Ms. Cynthia Eck at (301) 734-0667; e-mail: email@example.com.End Further Info End Preamble Start Supplemental 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 Start Printed Page 27540reason 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 5, 2006, the Animal and Plant Health Inspection Service (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 release of rice (Oryza sativa) plants genetically engineered to express genes coding for the proteins lactoferrin, lysozyme, or serum albumin, respectively. The proposed field releases 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 recombinant 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 seed. 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 these field releases is 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.
On February 28, 2007, APHIS published a notice  in the Federal Register (72 FR 8959-8960, Docket No. APHIS-2007-0006) announcing the availability of an environmental assessment (EA) for the proposed field release of rice genetically engineered to express lactoferrin, lysozyme, or serum albumin. During the designated 30-day comment period, which ended March 30, 2007, APHIS received 20,034 comments. Of the 20,034 comments received, 20,005 were opposed to APHIS' approval of these permits. Respondents opposing APHIS' approval of these permits were four public interest groups, academic professionals, organic food producers, rice growers, millers (or from related industries), and individuals. One public interest group submitted 13,289 nearly identical comments, and 5,621 nearly identical comments were submitted by another public interest group. There were 29 comments supporting APHIS' approval of these permits. Respondents supporting the approval of these permits were from academia, a farm bureau, a corn and grain sorghum growers association, a corporation, a State government agency, and individuals. APHIS has addressed the issues raised during the comment period and has provided responses to these comments as an attachment to the finding of no significant impact (FONSI).
Pursuant to the regulations in 7 CFR part 340 promulgated under the Plant Protection Act, APHIS has determined that these field releases 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 3 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 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 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).Start Signature
Done in Washington, DC, this 9th day of May, 2007.
W. Ron DeHaven,
Administrator, Animal and Plant Health Inspection Service.
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-2007-0006, 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.Back to Citation
[FR Doc. E7-9432 Filed 5-15-07; 8:45 am]
BILLING CODE 3410-34-P