E6-11939. 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.

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 [phone] 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.

FOR FURTHER INFORMATION CONTACT:

Dr. Robyn Rose, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone]. To obtain copies of the EA, FONSI, and response to comments, contact Ms. Ingrid Berlanger at [phone]; e-mail: [e-mail].

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.

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. 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.

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 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.

Footnotes

1.  To view the notice, EA, and the comments we received, go to http://www.regulations.gov,, 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.