Availability of Environmental Assessment for Field Test of Genetically Engineered Organisms

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 a confined field of corn plants genetically engineered to express the protein trypsinogen. This environmental assessment is available for public review and comment.

DATES:

We will consider all comments we receive on or before July 26, 2004.

ADDRESSES:

You may submit comments by any of the following methods:

• Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. 04-041-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 04-041-1.
• E-mail: Address your comment to regulations@aphis.usda.gov. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and “Docket No. 04-041-1” on the subject line.
• Agency Web site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html for a form you can use to submit an e-mail comment through the APHIS Web site.

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 (202) 690-2817 before coming.

Other Information: You may view APHIS documents published in the Federal Register and related information, including the names of groups and individuals who have commented on APHIS dockets, on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT:

Dr. Michael Wach, BRS, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-0485. To obtain a copy of the environmental assessment, contact Ms. Kay Peterson at (301) 734-4885; e-mail: Kay.Peterson@aphis.usda.gov. The environmental assessment is also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/04_11402r_ea.pdf.

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 into the United States. The regulations set forth the permit application requirements and the notification procedures for the importation, interstate movement, and release into the environment of a regulated article.

On April 23, 2004, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 04-114-02r) from ProdiGene, Inc., College Station, TX, for a permit for a confined field test of corn (Zea mays L.) plants genetically engineered to express a gene coding for the enzyme trypsinogen. The field test is to be conducted in Frio County, TX. The subject corn plants have been genetically engineered to express a trypsinogen amino acid sequence that is identical to bovine (Bos taurus L.) trypsin precursor. The subject corn plants also express the pat gene from Streptomyces viridochromogenes, a common soil bacterium. The pat gene expresses a phosphinothricin acetyltransferase enzyme, which confers tolerance to the herbicide glufosinate, and is useful as a marker gene. The experimental genes were transferred into corn plants through use of the Agrobacterium tumefaciens transformation system, and expression of the added genes is controlled in part by the plant pathogen cauliflower mosaic virus. The genetically engineered corn 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 proposed field trial is threefold: (1) Grain production; (2) hybrid seed production; and (3) line development in a nursery. The tests will be conducted through use of a combination of biological and physical containment measures. In addition, the experimental protocols and field plot design, as well as the procedures for termination of the field tests, are designed to ensure that none of the subject corn plants persist in the environment beyond the termination of the experiments.

To provide the public with documentation of APHIS” review and analysis of any potential environmental impacts and plant pest risk associated with the proposed confined field test of the subject corn plants, an environment 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).

Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.