[Federal Register Volume 69, Number 99 (Friday, May 21, 2004)]
[Notices]
[Pages 29259-29260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11530]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-012-2]


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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: 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.

DATES: Effective Date: May 11, 2004.

ADDRESSES: 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 http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: 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: 
[email protected]. The environmental assessment and finding 
of no significant impact are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/03_27901r_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 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 DH5[alpha] 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

[[Page 29260]]

nonpathogenic 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).

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

    Done in Washington, DC, this 13th day of May, 2004.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-11530 Filed 5-20-04; 8:45 am]
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