E6-5572. Availability of an Environmental Assessment and Finding of No Significant Impact for a Field Release of Genetically Engineered Tall Fescue and Genetically Engineered Italian Ryegrass

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public that an environmental assessment has been prepared for a proposed field trial using three transgenic grass lines. The trial consists of tall fescue plants that are genetically engineered for hygromycin resistance and that express the marker beta-glucuronidase; Italian ryegrass plants that are genetically engineered for hygromycin resistance; and Italian ryegrass plants that are genetically engineered to lower the expression of the pollen allergen gene, Lol p 1, that are also hygromycin resistant, and express the marker beta-glucuronidase. The purpose of the field trial is to study pollen viability, outcrossing, and hybridization between the two types of grasses. The study will also examine the effect of down-regulating the Lol p 1 gene. Data gained from this field experiment will also be used to evaluate current confinement practices for these species of transgenic grasses. After assessment of the application, review of the relevant scientific information, and consideration of comments provided by the public, we have concluded that these field tests will not present a risk of introducing or disseminating a plant pest. We have completed an environmental assessment and have concluded that these field tests 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 tests.

EFFECTIVE DATE:

April 14, 2006.

ADDRESSES:

You may read the environmental assessment (EA), the finding of no significant impact (FONSI), and any comments that we received on Docket No. APHIS-2006-0016 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_​27801r_​ea.pdf.

FOR FURTHER INFORMATION CONTACT:

Dr. Andrea Huberty, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone]. To obtain copies of the EA, FONSI, and response to comments, contact Ms. Ingrid Berlanger 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 into the environment of a regulated article.

On October 5, 2005, the Animal and Plant Health Inspection Service (APHIS) received permit applications (APHIS Nos. 05-278-01r and 05-278-02r) from the Samuel Robert Noble Foundation in Ardmore, OK, for a field trial using three strains of transgenic grasses. The two permit applications are for three lines of transgenic grasses to be used in a single field trial.

Permit application 05-278-01r describes a line of tall fescue, Festuca arundinacea, that has been genetically engineered to express beta-glucuronidase (gus A) derived from Escherichia coli. Expression of this gene is controlled by cauliflower mosaic virus (CaMV) 35S gene promoter and terminator sequences and a rice tungro virus (RTBV) intron. This regulated article also contains a separate insertion of a hygromycin phosphotransferase (hph) gene that is regulated by the rice actin promoter and intron sequences and the terminator from the CaMV 35S gene.

Permit application 05-278-02r describes two transgenic lines of Italian ryegrass (Lolium multiflorium). Both lines have the same hph gene construct as the regulated article described in permit application 05-278-01r. One line of Italian ryegrass also contains an insertion of a second construct that codes for an antisense Lol p 1 gene derived from perennial ryegrass (Lolium perenne), and a gus A gene derived from E. coli. The antisense Lol p 1 gene is under the control of the Zea mays pollen specific Zm 13 promoter and a nos polyadenylation terminator sequence from Agrobacterium tumefaciens.

The subject transgenic grasses are considered regulated articles under the regulations in 7 CFR part 340 because they were created using donor sequences from plant pests. The purpose of this proposed introduction is for research on transgenic tall fescue and Italian ryegrass plants, particularly to investigate:

• The distance transgenic pollen can travel and still remain viable;
• The frequency of pollination at different distances from the pollen source;
• The probability/frequency of cross-hybridization between transgenic tall fescue, transgenic Italian ryegrass, and related species under field conditions; and
• The effects of down-regulation of a major pollen allergen on pollen dispersal in transgenic Italian ryegrass.

Additionally, the data gathered during this study will be used to assess the confined status of this field release and refine the confinement conditions necessary for future releases of these grass species.

On February 13, 2006, APHIS published a notice ^[1] in the Federal Register (70 FR 7504-7505, Docket No. APHIS-2006-0016) announcing the availability of an environmental assessment (EA) for the proposed field trial. During the 30-day comment period, APHIS received two comments. One comment was from an individual and the other was from a public interest group. Both commenters objected to the field release described in the EA. APHIS' response to those comments can be found as an attachment to the finding of no significant impact (FONSI) and decision notice.

Pursuant to its regulations (7 CFR part 340) promulgated under the Plant Protection Act, APHIS has determined that this field trial will not pose a risk of the introduction or dissemination of a plant pest. Additionally, based upon analysis described in the EA, APHIS has determined that the action proposed in Alternative C of the EA, to issue the permit with additional 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).

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). Copies of the EA and FONSI 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 10th day of April, 2006.

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-2006-0016, 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.