[Federal Register Volume 67, Number 8 (Friday, January 11, 2002)]
[Notices]
[Pages 1434-1435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-741]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 01-024-2]


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.

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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 (202) 690-2817 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; (301) 734-8723. To obtain a copy of the environmental 
assessment and finding of no significant impact, contact Ms. Kay 
Peterson at (301) 734-4885; e-mail: [email protected].

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

[[Page 1435]]

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.
[FR Doc. 02-741 Filed 1-10-02; 8:45 am]
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