[Federal Register: May 21, 2004 (Volume 69, Number 99)]
[Notices]
[Page 29259-29260]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my04-42]
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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:
Kay.Peterson@aphis.usda.gov. 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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