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Availability of Environmental Assessment for Field Test of Genetically Engineered Organism

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Information about this document as published in the Federal Register.

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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 a confined release into the environment of genetically engineered nonpathogenic (avirulent) strains of a bacterium, Erwinia amylovora, the causal agent of fire blight disease. The purpose of the release is to determine whether the avirulent strains are effective as disease suppression agents of pathogenic fire blight disease on apple and pear trees. This environmental assessment is available for public review and comment.


We will consider all comments we receive on or before April 21, 2004.


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. 04-012-1, 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. 04-012-1.
  • E-mail: Address your comment to 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. 04-012-1” on the subject line.
  • Agency Web Site: Go to​ppd/​rad/​cominst.html for a form you can use to submit an e-mail comment through the APHIS Web site.
  • Federal eRulemaking Portal: Go to and follow the instructions for locating this docket and submitting comments.

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​ppd/​rad/​webrepor.html.

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Mr. John Cordts, BRS, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-5531. To obtain a copy of the environmental assessment, contact Ms. Kay Peterson at (301) 734-4885; e-mail: The environmental assessment is also available on the Internet at​brs/​aphisdocs/​03_​27901r_​ea.pdf.

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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 October 6, 2003, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 03-279-01r) from Oregon State University, Corvalis, OR, for a permit to release into the environment avirulent strains 153 HrpS− and 153 HrpL− of the bacterial pathogen, Erwinia amylovora, the causal agent of fire blight disease, on apple and pear trees in Benton and Jackson Counties, OR. The avirulent strains of E. amylovora have been genetically engineered using the neomycin phosphotransferase (nptII) gene of transposon 10 from Escherichia coli strain DH5α and the hrp gene from E. amylovora strain Ea321. Insertion of the transposon within the coding region of the E. amylovora hrp gene results in inactivation of the gene and disruption of the disease-causing mechanism within the bacterium, thereby rendering the bacterium nonpathogenic or avirulent. Use of the nptII gene also confers resistance to the antibiotic kanamycin, which is used as a marker for the avirulent strains. The introduction of the avirulent strains, alone and in combination with other non-pathogenic bacteria, is expected to protect susceptible plants from infection Start Printed Page 13281by wild type E. amylovora. The purpose of the field trial is to determine whether the avirulent Hrp− strains are effective as suppression agents of fire blight, one of the most destructive bacterial diseases of apple, pear, and other trees in the family Rosaceae.

The genetically engineered strains of E. amylovora are considered regulated articles under the regulations in 7 CFR part 340 because the recipient organism is a plant pathogen. The tests will be conducted in both screenhouse and field trials, and access to both sites is restricted by fences and/or chained gates. Data collection and monitoring on bacterial populations and incidence of disease will be conducted during the testing periods. Containment protocols have been designed to limit dispersal of the recombinant bacterium and are expected to provide the necessary degree of both biological and physical containment. In 13 years of similar testing using non-recombinant organisms, the applicants have not detected E. amylovora strains overwintering on trees and none is expected.

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 the subject avirulent mutant strains of E. amylovora, 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).

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

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Done in Washington, DC, this 17th day of March, 2004.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

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[FR Doc. 04-6327 Filed 3-19-04; 8:45 am]