[Federal Register: March 22, 2004 (Volume 69, Number 55)]
[Notices]
[Page 13280-13281]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr04-33]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-012-1]
Availability of Environmental Assessment 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 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.
DATES: We will consider all comments we receive on or before April 21,
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. 04-012-1, 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
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. 04-012-1'' 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.
Federal eRulemaking Portal: Go to http://www.regulations.gov
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
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, 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/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 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 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 non-pathogenic
bacteria, is expected to protect susceptible plants from infection
[[Page 13281]]
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. 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).
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 17th day of March, 2004.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-6327 Filed 3-19-04; 8:45 am]
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