E6-1992. Availability of Environmental Assessment for a Proposed Field Trial of Genetically Engineered Tall Fescue and Genetically Engineered Italian Ryegrass

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice of availability and request for comments.

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, and 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. The environmental assessment is available to the public for review and comment.

DATES:

We will consider all comments that we receive on or before March 15, 2006.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov and, in the “Search for Open Regulations” box, select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click on “Submit.” In the Docket ID column, select APHIS-2006-0016 to submit or view public comments and to view supporting and related materials available electronically. After the close of the comment period, the docket can be viewed using the “Advanced Search” function in Regulations.gov.
• Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2006-0016, 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-2006-0016.

Reading Room: You may read the environmental assessment and any comments that we receive 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.

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. Andrea Huberty, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone]. To obtain copies of the environmental assessment, 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 tall fescue line, 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.

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts and plant pest risk associated with the proposed release of these transgenic grasses, 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 7th day of February 2006.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.