[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]
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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.
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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]
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