[Federal Register Volume 69, Number 55 (Monday, March 22, 2004)]
[Notices]
[Pages 13280-13281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6327]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
[email protected]. 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: [email protected]. 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]
BILLING CODE 3410-34-P