[Federal Register Volume 74, Number 87 (Thursday, May 7, 2009)]
[Notices]
[Pages 21314-21316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10633]


-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0166]


Use of Genetically Engineered Fruit Fly and Pink Bollworm in 
APHIS Plant Pest Control Programs; Record of Decision

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice advises the public of the Animal and Plant Health 
Inspection Service's record of decision for the Use of Genetically 
Engineered Fruit Fly and Pink Bollworm in APHIS Plant Pest Control 
Programs Final Environmental Impact Statement.

ADDRESSES: Copies of the record of decision and the final environmental 
impact statement on which the record of decision is based are available 
for public inspection 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 someone is 
there to help you, please call (202) 690-2817 before coming.
    The record of decision may also be viewed on the APHIS Web site at 
http://www.aphis.usda.gov/plant_health/ea/geneng.shtml. Supporting and 
related materials, including the final environmental impact statement, 
may also be viewed on the Internet at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0166.

FOR FURTHER INFORMATION CONTACT: Mr. David A. Bergsten, APHIS 
Interagency NEPA Contact, Environmental Services, PPD, APHIS, 4700 
River Road, Unit 149, Riverdale, MD 20737-1238; (301) 734-6103.

SUPPLEMENTARY INFORMATION: This notice advises the public that the 
Animal and Plant Health Inspection Service (APHIS) has prepared a 
record

[[Page 21315]]

of decision based on its final environmental impact statement (FEIS) 
for the Use of Genetically Engineered Fruit Fly and Pink Bollworm in 
APHIS Plant Pest Control Programs, October 2008.
    The FEIS was prepared in compliance with the National Environmental 
Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), and its 
implementing regulations.
    On December 19, 2006, APHIS published in the Federal Register (71 
FR 75933-75934, Docket No. APHIS-2006-0166) a notice of its intent to 
prepare the environmental impact statement (EIS) for the purpose of 
analyzing the use of and alternatives to genetic engineering technology 
applied to sterile insect releases in agency pest control programs. On 
May 30, 2008, the Environmental Protection Agency (EPA) published in 
the Federal Register (73 FR 31115) a notice of the availability of the 
draft EIS. The official comment period on the draft EIS ended on July 
14, 2008. APHIS accepted late comments on that document until August 6, 
2008.
    In October 2008, APHIS published and distributed the FEIS, which 
included discussion of the seven public comments received on the draft 
EIS. On November 14, 2008, EPA published in the Federal Register (73 FR 
67511) a notice of the availability of the FEIS. The NEPA implementing 
regulations in 40 CFR 1506.10 require a 30-day waiting period between 
the time a final EIS is published and the time an agency makes a 
decision on an action covered by the EIS. APHIS did not receive any 
comments on the FEIS by the time this waiting period ended on December 
15, 2008.
    APHIS has reviewed the FEIS and has concluded that it has fully 
analyzed the issues covered by the draft EIS and those comments and 
suggestions submitted by commenters. APHIS has now prepared a record of 
decision on the FEIS and is making that record available to the public.
    The Record of Decision for the Use of Genetically Engineered Fruit 
Fly and Pink Bollworm in APHIS Plant Pest Control Programs Final 
Environmental Impact Statement, as prepared pursuant to the Council on 
Environmental Quality's NEPA implementing regulations at 40 CFR 1505.2, 
is set out below in its entirety.

Record of Decision for the Use of Genetically Engineered Fruit Fly and 
Pink Bollworm in APHIS Plant Pest Control Programs Final Environmental 
Impact Statement

    This Record of Decision (ROD) has been developed in compliance 
with the agency decision-making requirements of NEPA. The purpose of 
this ROD is to document APHIS' decision to adopt the preferred 
alternative of the Final Environmental Impact Statement (FEIS), that 
is, the alternative to permit integration of genetically engineered 
insects into its plant pest control and eradication programs. The 
alternatives have been fully described and evaluated in the FEIS.
    This ROD is intended to: (a) State the APHIS decision, present 
the rationale for its selection, and describe its implementation; 
(b) identify the alternatives considered in reaching the decision; 
and (c) state whether all means to avoid or minimize environmental 
harm from implementation of the selected alternative have been 
adopted (40 CFR 1505.2).

National Environmental Policy Act

    On November 14, 2008, the U.S. Environmental Protection Agency 
(EPA) published in the Federal Register [73 FR 67511] a notice of 
availability of the final environmental impact statement titled 
``Use of Genetically Engineered Fruit Fly and Pink Bollworm in APHIS 
Plant Pest Control Programs.'' The FEIS considered the environmental 
impacts from integration of genetically engineered insects into 
sterile insect technique components of APHIS plant pest control 
programs that could result from our adoption of the proposed new 
technologies.
    Pursuant to the implementing regulations for NEPA in cases 
requiring an EIS, APHIS must prepare a record of decision to express 
the agency determination from review of the EIS documentation. The 
NEPA implementing regulations require that a record of decision 
state what decision is being made; identify alternatives considered 
in the environmental impact statement process; specify the 
environmentally preferred alternative; discuss preferences based on 
relevant factors, including economic and technical considerations, 
as well as national policy considerations, where applicable; and 
state how all of the factors discussed entered into the decision. In 
addition, the record of decision must indicate whether the ultimate 
decision has been designed to avoid or minimize environmental harm 
and, if not, why not.

The Decision

    This decision described in the ROD addresses impacts from the 
preferred alternative of the FEIS whose availability was published 
in the Federal Register on November 14, 2008 (73 FR 67511, Docket 
No. ER-FRL-8587-5). After a thorough evaluation of the potential 
impacts of the alternatives considered in the FEIS, APHIS has 
decided to integrate the use of genetically engineered insects into 
the sterile insect technique used in agency plant pest control 
programs. This includes the adherence to specific agency 
requirements for mass-rearing and release of these new strains of 
plant pests. It also involves adherence to certain procedures for 
program-specific evaluations of these strains prior to release in 
any pest control or pest eradication applications. As with any new 
sterile insect technique, there are some containment, handling, 
species/strain-specific, and associated release issues that will 
need to be addressed as part of the NEPA documentation for future 
advances in the application-specific technologies.

Alternatives Considered in the Impact Statement Process

    The FEIS considers the alternatives of (1) No action, 
essentially maintaining sterile insect technique through irradiation 
of mass-reared insects in plant pest control programs as is 
currently practiced, (2) expansion of existing programs in overall 
size, capacity, and diversity of plant pest species, and (3) 
integration of genetically engineered insects into APHIS' plant pest 
control programs.

Environmentally Preferable Alternative

    The environmentally preferable alternative for the use of 
sterile insect technique in plant pest control programs is the 
alternative that minimizes potential impacts to human health, 
nontarget species, and environmental quality. Among the alternatives 
considered in this EIS, the preferred alternative, which involves 
integration of genetically engineered insects into programs, is also 
the environmentally preferable alternative. This alternative is 
environmentally preferable because the potential environmental 
impacts of this alternative are minimized by program use of 
genetically engineered strains of sterile and marker-gene insects 
maintained in biologically secure containment facilities, by the 
reduced use of irradiation with its associated hazards, by the 
reduced need for large numbers of insects due to the release of 
males that are more competitive in mating, and by the reduced need 
to apply pesticides from a more effective genetic sterile insect 
technique and improved monitoring of pest populations through the 
use of genetic markers.

Preferences Among Alternatives

    The preference among the alternatives for the final EIS is to 
integrate genetically engineered insects into the sterile insect 
technique of APHIS' plant pest control programs. In review of the 
alternatives considered, APHIS could use the present methods without 
further development (no action), APHIS could expand on the present 
methods without genetic engineering technology, or APHIS could 
integrate genetic technology into the sterile insect technique 
components of the plant pest programs. Each alternative involves 
potential impacts, but the context and intensity of those impacts 
relate largely to the methods and their respective relative 
effectiveness of sterile insect production. The potential 
environmental impacts from methods under alternatives other than the 
preferred alternative are reduced under the preferred alternative to 
the extent that genetically engineered insects are incorporated. For 
example, the use of genetically engineered insects has the potential 
to decrease the need for insecticide applications, to decrease the 
need to produce both male and female insects for use in sterile 
insect releases, to increase production of males that are more 
competitive in mating than radiation-sterilized males, and to 
eliminate the need to use, operate, and maintain strong gamma 
radiation sources.

[[Page 21316]]

    The no action alternative (alternative 1 above) was rejected 
because continuation of this approach does not contribute to 
increased mitigation of present or future plant pest risks. It does 
provide a baseline for the present state of sterile insect technique 
in plant pest control programs, but it does not provide APHIS 
program managers the flexibility to apply new methods or new 
technologies for the control of fruit flies or pink bollworm. In 
particular, this alternative lacks clear options to expand the use 
of irradiation, to expand the use of fluorescent dye, to expand 
development and use of classical selective genetic gender selection 
processes, and to increase the overall fitness of released 
radiation-sterilized insects. Any improvement of the insect mass-
rearing production as a result of genetic engineering would not 
occur under this alternative.
    The alternative of expansion of existing programs (alternative 2 
above) involves an increase in the present plant pest control 
actions and inputs to improve the effectiveness of sterile insect 
technique currently used in APHIS plant pest control programs. This 
alternative could include expansion of the pest insect mass-rearing 
operations, the irradiation treatment capacity, the development of 
classical genetic selection methods for separation of insect sexes 
for more fruit fly species, the use of sterile insect technique for 
more plant pest species, the sterile insect dispersal capacity, the 
monitoring and surveillance capacity, and the pest mitigation 
capacity including the increased use of chemical pesticides. 
Although this approach could meet the increasing demand for sterile 
insects, the selection of this alternative would incur higher 
program costs, greater mass-rearing facility construction, longer 
timeframes for development, and more extensive pest mitigation 
efforts than would be afforded by the integration of genetically 
engineered insects into APHIS sterile insect technique programs.
    The preferred alternative (alternative 3 above), integration of 
genetically engineered insects into programs, provides program 
managers with several methods for pest risk reduction in an 
environmentally safe and efficient manner. Although the present 
plant pest control program benefits apply to fruit flies and pink 
bollworm, long-term program activities are likely to be extended to 
other plant pest species and new technologies. APHIS plant pest 
programs could augment their use of sterile insect technique by 
mass-rearing only male fruit flies that have a marker gene and are 
subject to sterilization by radiation, mass-rearing genetically 
sterilized male fruit flies that have a marker gene and that compete 
more effectively for mates than radiation-sterilized male insects, 
mass-rearing fruit flies that produce only male offspring which 
carry a sterility gene resulting in only males that pass on this 
sterility gene and no female offspring, mass-rearing both male and 
female pink bollworm that have a marker gene and are subject to 
sterilization by radiation, and mass-rearing of both male and female 
pink bollworm that are genetically sterile and more competitive in 
mating with wild bollworms than radiation-sterilized bollworms. The 
benefits to fruit fly programs are long-term in consideration of the 
continuing introductions that occur from abroad. There are also 
long-term benefits to cotton growers from successful eradication of 
pink bollworm that may result from this new technology being 
incorporated into APHIS program actions.
    Please see the FEIS for a full discussion of the reasons why 
APHIS is proposing to adopt the preferred alternative.

Factors in the Decision

    APHIS' authority for action and cooperation with other agencies 
in these plant pest control programs is based upon the Plant 
Protection Act (PPA, 7 U.S.C. 7701 et seq.), which authorizes the 
Secretary of Agriculture to carry out operations to eradicate insect 
pests and to use measures to prevent the dissemination of plant 
pests that are new or not known to be widely prevalent or 
distributed within or throughout the United States. There is an 
impending need for the development of more efficient, lower cost, 
and more effective control and eradication methods for the pink 
bollworm and invasive fruit fly species because of the continuing 
and increasing frequency of detection of fruit flies and other 
invasive and crop destructive insects. In order to achieve these 
objectives, the use of genetically engineered insects provides 
biological traits that are of value for use in sterile insect 
technique control methodologies. These novel biological traits are 
not available to present programs and could not be readily developed 
or adopted for program use by APHIS using other methods.
    This record of decision authorizes the development and use of 
genetically engineered insects in sterile insect technique 
applications for APHIS plant pest control programs in order to 
achieve the mandates of the PPA. In addition, this selection of the 
environmentally preferable alternative for these control programs is 
in keeping with the ongoing effort at the agency to promote 
environmental quality through ongoing efforts to identify and add to 
our regulations valid technical and economically feasible 
alternatives to fulfill regulatory mandates.

Avoid or Minimize Environmental Harm

    The environment can be harmed by the presence of invasive plant 
pest insect species and the mitigations applied to decrease the pest 
damage to crops. Actions such as those considered in the preferred 
alternative reduce pest risks through applications of sterile insect 
technique in control programs and preventive release programs. The 
extent to which such actions reduce the pest damage, reduce the need 
for use of chemical pesticides, and reduce the need to expand 
facilities and insect production are the basis for minimizing 
environmental impacts. Adequate enforcement of effective quarantine 
measures is required to protect the environment from these pest 
risks. APHIS is committed to monitoring these efforts through the 
NEPA process, and otherwise.

Other

    A considerable amount of research and development of 
alternatives to ongoing program actions has been done since the 
early applications of sterile insect technique over a half century 
ago. Much of this work has involved developing improved strains, 
developing more effective methods for handling and transport of 
insects, and developing more effective techniques of insect 
sterilization. APHIS has attempted to adapt new technologies to our 
pest control programs as these methods become available and 
logistically feasible for program applications. The use of 
genetically engineered insects to improve agency sterile release 
programs involves genetic engineering technologies that are new to 
the agency, but many of the sterile release methods have involved 
extensive testing over many years. The work on improved markers, 
more effective pest strains (including genetically engineered 
strains), improved handling, and more efficient rearing is expected 
to continue to be an important part of APHIS' future innovations to 
agency pest control programs.
    In a notice summarizing EPA comments on recent environmental 
impact statements and proposed regulations that was published in the 
Federal Register on August 15, 2008 (73 FR 47947-47948), EPA 
expressed their lack of objection to the draft EIS and APHIS' 
adoption of the preferred alternative to permit integration of 
genetically engineered insects into the sterile insect release 
components of plant pest control programs.

    The record of decision has been prepared in accordance with: (1) 
NEPA, (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 1st day of May 2009.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-10633 Filed 5-6-09; 8:45 am]
BILLING CODE 3410-34-P