E6-5878. Availability of an 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 an environmental assessment has been prepared 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 completed an environmental assessment 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: April 19, 2006.

ADDRESSES:

You may read the environmental assessment (EA), 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 EA, FONSI, and responses to comments 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.

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 feasability of using F1 sterility systems in a sterile insect program, which is designed to depress PBW populations. 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 no more than four 3-acre field sites of cotton that are adjacent to cotton expressing the Bt toxin, which is toxic to PBW. This release is part of 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 environmental assessment (EA) prepared for the Southwest Pink Bollworm Eradication Program may be found at http://www.aphis.usda.gov/​ppd/​es/​pdf%20files/​swpbwea.pdf.

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 EA for the proposed field trial. During the 30-day comment period, APHIS received two comments. One comment was from an individual and the other was from a government research scientist. One comment generally objected to the field release. The commenter made several unsupported, sweeping statements suggesting that the trial is poorly designed and will result in “health problems.” APHIS finds no basis for these statements and disagrees with the comment. Additionally, the commenter suggests that APHIS should be required to get “sign off of the neighbors.” APHIS has carefully evaluated the design of the field trial and has determined that it will not result in the establishment of the regulated article outside of the field test. Additionally, APHIS has informed the public of the proposed field test and requested comment on the EA. APHIS is confident that this field test will not impact the human environment, including the neighbors, and has given adequate notice of the field test. The second comment supported the field trial described in the EA and suggested that the “* * * results will be vital to the progress of agricultural pest control.” APHIS agrees with the comment.

Pursuant to its regulations (7 CFR part 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 and the EGFP transgenic insect's fecundity in the EGFP PBW to be released is significantly lower than non-EGFP insects. 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:

• All the surrounding cotton 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.
• The area of release is less than 12 acres with no more than 3 acres per plot.
• If adverse persistence is detected, 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 and finding of significant impact 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 13th day of April 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.