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Availability of Environmental Assessment and Finding of No Significant Impact for Field Test of Genetically Engineered Organism

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Animal and Plant Health Inspection Service, USDA.




We are advising the public that an environmental assessment and finding of no significant impact have been prepared relative to the issuance of a permit to allow the confined field testing of genetically engineered nonpathogenic (avirulent) strains of a bacterium, Erwinia amylovora, the causal agent of fire blight disease. The environmental assessment provides a basis for our conclusion that this field test will not present a risk of introducing or disseminating a plant pest and 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 this field test.


Effective Date: May 11, 2004.


You may read the environmental assessment and finding of no significant impact and the comment received on an earlier notice of availability 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.

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 and finding of no significant impact, contact Ms. Kay Peterson at (301) 734-4885; e-mail: The environmental assessment and finding of no significant impact are 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 field test 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.

APHIS published a notice in the Federal Register on March 22, 2004 (69 FR 13280-13281, Docket No. 04-012-1), announcing the availability for public comment of an environmental assessment (EA) for the proposed confined field test of genetically engineered avirulent strains of Erwinia amylovora. Comments were to have been received by APHIS on or before April 21, 2004. APHIS received one comment on the EA during the designated comment period. The comment, which was from a private individual, simply stated that the organism to be tested was worse than the nonengineered fire blight and that the engineered strains were not safe, without reference to any supporting data or information. APHIS evaluated the safety of the engineered avirulent strains of Erwinia in the EA, and we have responded to this comment in an attachment to the finding of no significant impact (FONSI), which is available as indicated under FOR FURTHER INFORMATION CONTACT. 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 Start Printed Page 29260nonpathogenic bacteria, is expected to protect susceptible plants from infection by 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.

An EA was prepared to examine any potential environmental impacts and plant pest risk associated with the proposed field testing of the subject avirulent mutant strains of E. amylovora. Based on that EA, APHIS has reached a FONSI relative to issuance of a permit for the confined field testing of the subject strains of Erwinia. In summary, we have based our FONSI on the following conclusions: (1) The test bacterium, Erwinia amylovora, has been rendered incapable of causing disease; (2) virulent strains of this bacterium are indigenous to the area of the test; (3) dissemination of the bacteria will be prevented through physical methods, normal site security, the small size of the trials, and decontamination or appropriate disposal of application equipment; (4) the host range of the engineered bacteria has not changed; (5) the bacterium has never been associated with animal or human disease and will not therefore pose a health risk; (6) neomycin phosphotransferase from the marker gene does not confer any plant pest characteristics to E. amylovora; (7) native floral and faunal communities, including threatened and endangered species, are not in the host range of E. amylovora and therefore will not be affected by the trials.

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).

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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 13th day of May, 2004.

Peter Fernandez,

Acting Administrator, Animal and Plant Health Inspection Service.

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[FR Doc. 04-11530 Filed 5-20-04; 8:45 am]