02-741. Availability of Environmental Assessment and Finding of No Significant Impact for Confined Field Test 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 and finding of no significant impact have been prepared relative to the issuance of a permit to allow the field testing of pink bollworm genetically engineered to express green fluorescence as a marker. The environmental assessment provides a basis for our conclusion that the confined field testing of the genetically engineered pink bollworm will not present a risk of introducing or disseminating a plant pest and will not have a significant impact on the quality of the human environment. Based on its finding of no significant impact, the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared for this field test.

EFFECTIVE DATE:

October 1, 2001.

ADDRESSES:

You may read a copy of the environmental assessment and the finding of no significant impact and comments received on an earlier notice of the availability of the environment assessment at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. To be sure that someone is there to help you, please call [phone] before coming.

APHIS documents published in the Federal Register, and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at http://www.aphis.usda.gov/​ppd/​rad/​webrepor.html.

FOR FURTHER INFORMATION CONTACT:

Dr. Robert I. Rose, Biotechnology Assessments Section, PPQ, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone]. To obtain a copy of the environmental assessment and finding of no significant impact, contact Ms. Kay Peterson at [phone]; e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The regulations in 7 CFR part 340 (referred to as the regulations) regulate the introduction (importation, interstate movement, and release into the environment) of genetically engineered organisms and products that are plant pests or that there is reason to believe are plant pests (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 January 29, 2001, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 01-029-01r) from APHIS' Plant Protection Center in Phoenix, AZ, for a permit to field test the plant pest pink bollworm (PBW), Pectinophora gossypiella (Lepidoptera: Gelechiidae).

APHIS published a notice in the Federal Register on June 21, 2001 (66 FR 33226, Docket No. 01-024-1), announcing the availability for public comment of an environmental assessment (EA) for the proposed confined field test of the genetically engineered PBW. Comments were to have been received by APHIS on or before July 23, 2001. APHIS received nine comments on the EA during the designated comment period. The comments were from universities, environmental and consumer groups, a university medical research center, a crop protection association, a cotton industry organization, and a cotton growers group. Four comments were in favor of the proposed field test, while three were opposed. (We counted as a single comment three separate comments critical of the proposed field test that were written by the same commenter and were identical in content.) The commenters favoring the field test stressed the thoroughness of the control and containment measures proposed, the negligible risks of the experiment because of the planned safeguards, the adequacy of the EA, and the need for gathering data on PBW control. The commenters who opposed the proposed field test expressed concern about the need for additional data on transgene stability, the need for an independent assessment of the permit application, the adequacy of the proposed containment procedures, potential human health risks, and alleged deficiencies in APHIS' compliance with the requirements of the Endangered Species Act and the National Environmental Policy Act (NEPA), including the need for an Environmental Impact Statement (EIS) for a transgenic PBW sterile insect technique program. APHIS identified and addressed the majority of these issues in the EA prepared for the subject field trial, and we have provided a response to comments as an attachment to our finding of no significant impact (FONSI), which is available from the person listed under FOR FURTHER INFORMATION CONTACT. With regard to the comment concerning the need for an EIS, APHIS is committed to considering the long-term issues associated with the release of certain transgenic arthropods through the NEPA EIS process.

The subject PBW has been genetically engineered to express an enhanced green fluorescent protein (EGFP) derived from a jellyfish, Aequora victoria. The PBW expresses EGFP fluoresces when viewed under an ultraviolet light source. 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 the Drosophila melanogaster hsp70 and Bombyx mori actin A3 promoters. 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 and because it contains gene sequences from a plant pest. The field test will be conducted under carefully controlled and confined conditions.

The transgenic PBW with EGFP as a marker has been developed for use in confined, on-site experimentation and field performance studies in the PBW sterile insect program, which is designed to depress PBW populations. The transgenic PBW will be reared in the Phoenix PBW insect-rearing facility, sterilized with radiation, and placed in escape-proof screen field cages near the facility, where they will undergo a series of fitness and related tests.

An EA was prepared to examine any potential environmental impacts and plant pest risk associated with the confined field testing of the transgenic EGFP PBW. Based on that EA, APHIS has reached a FONSI relative to the issuance of a permit for the confined field testing of the subject PBW with EGFP. In summary, we have based our FONSI on the following conclusions: (1) The possibility of the genetically engineered organism reverting to or undergoing unanticipated genetic transformation is exceedingly low; (2) it is highly unlikely that the EGFP gene would persist in the environment because it provides no fitness advantage to the PBW; (3) multiple levels of physical and biological confinement in the proposed research are designed to contain the transgenic PBW; (4) the PBW is not native to the United States and there are no known sexually compatible species in North America; (5) there is no current evidence that this gene can be transferred through predation, natural decay, or parasitism; (6) the confined research would not result in an additional pesticide load on the environment; (7) the research will not disproportionately affect minority or low income populations, or disproportionately affect children, or result in any environmental health risks or safety risks to children; and (8) APHIS has determined that, based on the location of the test field and the measures designed to contain the transgenic PBW, the proposed test will have no effect on listed, threatened, endangered, or candidate species.

The EA and FONSI were prepared in accordance with: (1) 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).

Done in Washington, DC, this 7th day of January 2002.

W. Ron DeHaven,

Acting Administrator, Animal and Plant Health Inspection Service.