E6-9661. Availability of an Addendum to an Environmental Assessment 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. The addendum is available to the public for review and comment.

DATES:

We will consider all comments that we receive on or before July 5, 2006.

ADDRESSES:

You may submit comments by either of the following methods:

Federal eRulemaking Portal: Go to http://www.regulations.gov and, in the lower “Search Regulations and Federal Actions” box, select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click on “Submit.” In the Docket ID column, select APHIS-2006-0015 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link.

Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2006-0015, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2006-0015.

Reading Room: You may read the environmental assessment, the addendum, and any comments that we have received 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 addendum is also available on the Internet at http://www.aphis.usda.gov/​brs/​aphisdocs/​05_​09801r_​ea.pdf.

Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

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 supplemented EA and FONSI, 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 April 19, 2006, APHIS published a notice ^[1] in the Federal Register (Docket No. APHIS-2006-0015, 71 FR 20068-20069) in which we announced the availability of a final environmental assessment (EA) and finding of no significant impact (FONSI) to issue this permit. The FONSI was signed on April 10, 2006. On April 12, 2006, APHIS received a request to amend the 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, AZ. The program and the field trial must be spatially isolated to ensure that the data collected in the field trial are 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.

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.

On February 13, 2006, APHIS published a notice ^[2] 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. You may read the response to comments in the April 19, 2006, Federal Register notice (Docket No. APHIS-2006-0015, 71 FR 20068-20069). The two comments were not site-specific in nature.

APHIS has prepared an addendum to the EA to address the potential impacts on the human environment and threatened or endangered species that may have arisen from changing the field site and field trial design. This document is available as an attachment to the EA [see ADDRESSES above]. APHIS is opening a 15-day comment period for the addendum due to the limited change in circumstances resulting from the change in locations of the field test trials, and the extreme similarities of facts, locations, and circumstances between the two locations.The EA and addendum 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).

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 15th day of June 2006.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  To view the notice, EA, and FONSI, follow the directions for accessing the Federal eRulemaking Portal in the ADDRESSES section of this notice.

2.  To view the notice, EA, and the comments we received, follow the directions for accessing the Federal eRulemaking Portal in the ADDRESSES section of this notice.