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Availability of an Addendum to Environmental Assessment and Finding of No Significant Impact for Field Release of Genetically Engineered Pink Bollworm

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: July 26, 2006 (Volume 71, Number 143)]
[Notices]
[Page 42348-42350]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy06-31]

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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2006-0015]
 
Availability of an Addendum to Environmental Assessment and 
Finding of No Significant Impact for Field Release of Genetically 
Engineered Pink Bollworm

AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.

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SUMMARY: We are advising the public that we have supplemented with an 
addendum the environmental assessment for a proposed field trial of 
pink bollworm genetically engineered to express green fluorescence as a 
marker. The Animal and Plant Health Inspection Service (APHIS) proposes 
to use this marked strain to assess the effectiveness of lower doses of 
radiation to create sterile insects for its pink bollworm sterile 
insect program. This program, using sterile insect technique, has been 
conducted by APHIS, with State and grower cooperation, since 1968. Data 
gained from this field experiment will be used to improve the current 
program. APHIS has supplemented its environmental assessment in order 
to evaluate a new location and new conditions for the field test and 
has concluded that this field test will not have a significant impact 
on the quality of the human environment. Based on its finding of no 
significant impact, APHIS has determined that an environmental impact 
statement need not be prepared for this field test.

DATES: Effective Date: July 26, 2006.

ADDRESSES: You may read the environmental assessment (EA), the 
supplement, the finding of no significant impact (FONSI), and any 
comments that we received on Docket No. APHIS-2006-0015 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. The supplemented EA and FONSI 
are also available on the Internet at 
http://www.aphis.usda.gov/brs/aphisdocs/05_09801r_ea.pdf. Exit Disclaimer

FOR FURTHER INFORMATION CONTACT: Dr. Robyn Rose, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-0489. To obtain copies of the EA,

[[Page 42349]]

FONSI, and response to comments, contact Ms. Ingrid Berlanger at (301) 
734-4885; e-mail: ingrid.e.berlanger@aphis.usda.gov.

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. The regulations set forth the permit application 
requirements and the notification procedures for the importation, 
interstate movement, or release into the environment of a regulated 
article.
    On April 8, 2005, the Animal and Plant Health Inspection Service 
(APHIS) received a permit application (APHIS No. 05-098-01r) from 
APHIS' Plant Protection and Quarantine (PPQ) Center for Plant Health 
Science and Technology (CPHST) Decision Support and Pest Management 
Systems Laboratory in Phoenix, AZ, for a field trial using the pink 
bollworm (PBW), Pectinophora gossypiella (Lepidoptera: Gelechiidae), 
that has been genetically engineered to express an enhanced green 
fluorescent protein (EGFP) derived from the jellyfish Aequora victoria. 
A piggyBac transposable element derived from the plant pest cabbage 
looper (Trichoplusia ni) was used to transform the subject PBW, and 
expression of the EGFP is controlled through use of a Bombyx mori 
cytoplasmic actin promoter.
    On February 13, 2006, APHIS published a notice \1\ in the Federal 
Register (70 FR 7503-7504, Docket No. APHIS-2006-0015) announcing the 
availability of an environmental assessment (EA) for the proposed field 
trial. During the 30-day comment period, APHIS received two comments. 
The two comments were not site-specific in nature.
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    \1\ To view the notice, EA, and the comments we received, go to 
http://www.regulations.gov, Exit Disclaimer click on the ``Advanced Search'' 
tab, and select ``Docket Search.'' In the Docket ID field, enter APHIS-
2006-0015, then click on ``Submit.'' Clicking on the Docket ID link 
in the search results page will produce a list of all documents in 
the docket.
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    On April 19, 2006, APHIS published a notice in the Federal Register 
(71 FR 20068-20069, Docket No. APHIS-2006-0015) announcing the 
availability of a final EA and a finding of no significant impact 
(FONSI) to issue this permit. The two comments we received in response 
to our February 2006 notice were also addressed in this notice. The 
FONSI was signed on April 10, 2006. On April 12, 2006, APHIS received a 
request to amend this permit application. The amendment includes a 
change of location from Pima County, AZ, to Yuma County, AZ. This 
change is necessary because the Southwest Pink Bollworm Eradication 
Program has moved into Phase 2, which includes Pima County. The program 
and the field trial must be spatially isolated to ensure that the data 
collected in the field trial is not influenced by the eradication 
program. The changes also included new field conditions, including 
releasing fewer insects over a smaller area. These changes have 
resulted from factors associated with moving the field trial. None of 
these changes raised new plant pest issues.
    To inform the public of the changes described above, APHIS 
published a notice of availability for an addendum to the EA in the 
Federal Register on June 20, 2006 (71 FR 35408-35409, Docket No. APHIS-
2006-0015). The notice provided for a 14-day comment period, which 
ended on July 5, 2006. APHIS received no comments by that date.
    The subject transgenic PBW is considered a regulated article under 
the regulations in 7 CFR part 340 because the recipient organism is a 
plant pest. The proposed field test will evaluate the mating efficiency 
and competitiveness of the transgenic insects in the field. The 
transgenic PBW will be reared in the Phoenix PBW genetic rearing 
facility and treated with radiation levels suitable to induce F1 
sterility. The irradiated insects will be released into a 4.6 acre 
field site in the middle of a 40 to 80 acre field of cotton expressing 
the Bt toxin, which is toxic to PBW. This release is part of the 
research to support and improve CPHST's PBW sterile insect program. 
Information resulting from this research will be used in support of 
APHIS' efforts to eradicate the PBW in the United States.
    Additional information on the PBW eradication plan for the United 
States may be found at http://www.aphis.usda.gov/ppq/pdmp/cotton/
pinkbollworm/eradication/eradication.pdf. Exit Disclaimer An EA prepared for 
the Southwest Pink Bollworm Eradication Program may be found at 
http://www.aphis.usda.gov/ppd/es/pdf%20files/swpbwea.pdf. Exit Disclaimer
    Pursuant to its regulations (7 CFR 340) promulgated under the Plant 
Protection Act, APHIS has determined that this field trial will not 
pose a risk of the introduction or dissemination of a plant pest for 
the following reasons:
    EGFP transgenic insects will not persist in the environment. They 
will be sterilized by irradiation (Tothova and Merec, 2001). The EGFP 
PBW line to be released has significantly lower fecundity than wild-
type PBW. Redundant mitigation measures are incorporated into the 
experimental procedures to ensure that genetically modified EGFP PBW 
will not become established in the environment. These measures are as 
follows:
    ? The cotton in the proposed release site expresses Bacillus 
thuringiensis (Bt) toxin that kills PBW larvae.
    ? There are no sexually compatible relatives of the PBW in 
the United States, so the transgene cannot spread via hybridization 
with other species.
    ? The piggyBac-derived transposable element used to make the 
transforming construct has no functional transposase gene, thereby 
eliminating its ability to mobilize itself.
    ? The release area will be monitored intensively with 
pheromone traps that attract and collect PBW male moths. Traps will be 
set up to 5 miles away from the site.
    ? If adverse persistence is observed, unwanted bollworms 
will be killed with insecticides. Larvae from eggs oviposited on Bt 
cotton will not survive.
    ? PBW populations can be suppressed by flooding the area 
with a high ratio of sterilized bollworms to field insects.
    ? All moths will be securely managed and contained in 
production and transport using standard operating procedures with 
extremely high reliability developed for a long-running sterile insect 
technique program.
    ? All living bollworms reared for this field trial that are 
not used as part of the environmental release will be killed.
    Based on the factors described above and the analysis contained in 
the EA, APHIS has determined that the proposed field trial will not 
have a significant impact on the quality of the human environment.
    The EA, the addendum to the EA, and the 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

[[Page 42350]]

implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing 
Procedures (7 CFR part 372). Copies of the EA and FONSI are available 
from the individual listed under FOR FURTHER INFORMATION CONTACT.

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 20th day of July 2006 .
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-11939 Filed 7-25-06; 8:45 am]
BILLING CODE 3410-34-P

 
 

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