Washington, DC
January 22, 2004
Lack of Regulatory Plan Could Slow Scientific Advancement and
Deter Public Confidence
Researchers are using biotechnology to develop genetically
modified (GM) insects for a wide variety of purposes,
including fighting insect-borne diseases like malaria and
controlling destructive insect agricultural pests, but the
federal government lacks a clear regulatory framework for
reviewing environmental safety and other issues associated
with GM insects, according to Bugs in
the System? Issues
in the Science and Regulation of Genetically Modified Insects,
a new
report released today by the Pew
Initiative on Food and Biotechnology.
The report provides an overview
of current research efforts to apply genetic engineering
technology to insects, and looks at the benefits, risks and
scientific uncertainties associated with transgenic insects.
After examining the strengths and weaknesses of the legal
authorities EPA, FDA and USDA could use to conduct a
regulatory review, the report finds the major concern
regarding regulation is the absence of a clear articulation of
how transgenic insects will be regulated. While a number of
laws could potentially apply to GM insects, federal regulators
have not indicated if they would regulate GM insects, how a
regulatory review would be conducted, which agencies would be
involved, or how those agencies would coordinate.
“Although it may be several
years before scientists are ready to conduct a wide scale
release of transgenic insects, the research threatens to
outpace regulatory preparedness,” said Michael
Rodemeyer, executive director of
the Pew Initiative on Food and Biotechnology. “The benefits of
GM insects could be significant, but the federal government
needs to move quickly to clarify how it will provide an
adequate review of these insects and the many questions they
raise regarding the environment, public health,
agriculture and food safety.”
Scientists are currently working
to genetically modify insects to address important economic
and human health concerns. If successful, GM insects could
dramatically improve public health and enhance agricultural
production. Examples include:
-
Mosquitoes
incapable of transmitting malaria, which is contracted by 300
- 500 million people annually and kills between one and three
million people worldwide each year.
-
Honeybees
genetically engineered so they are resistant to diseases and
parasites, which have devastated the honeybee population in
the last decade.
-
Silkworms
made to produce pharmaceutical and industrial proteins, like
those used to create a particularly strong spider silk that
could be used to make bulletproof vests, parachutes, and
artificial ligaments.
-
Kissing bugs
unable to transmit Chagas’
disease, which currently infects 16 - 18 million people
annually and kills nearly 50,000 people worldwide each year.
However, there is uncertainty
about the lasting effects these insects could have on
ecosystems, public health and food safety once released. For
instance, the success of some GM insects is contingent on the
ability of fertile GM insects to replace wild insect populations
and become established in the environment. Release of fertile GM
insects increases the potential that transgenic traits could
spread throughout the insect population, potentially making
pre-existing pest problems worse or creating altogether new
challenges. It is also possible that GM insects released to
control the spread of disease could actually have the unintended
consequence of enabling an insect to more effectively spread
disease or even carry a human disease it was never before able
to transmit. Lastly, there is the possibility that modifying the
genetic composition of honeybees could alter the composition of
the honey they produce, potentially creating a food safety
concern. All of these uncertainties will need to be addressed
by regulators prior to the introduction and release of GM
insects.
The federal government currently
has no comprehensive policy on how transgenic insects will be
reviewed. Under existing laws, at least three different
agencies – the Food and Drug Administration (FDA), the
Environmental Protection Agency (EPA), and the Department of
Agriculture (USDA) – could have some authority over certain
kinds of GM insects. But only USDA has issued regulations
that cover any type of GM insect (USDA requires regulatory
approval of any field trials of GM insects that are potential
plant pests.) No single agency appears to have authority to
consider all of the issues raised by the many different types
of GM insects being developed, and agencies have not indicated
how, or if, they intend to coordinate their respective
authorities to provide a comprehensive framework for
regulation. Without clarification about how transgenic insects
will be regulated, it is difficult to determine if the unique
issues raised by transgenic insects will be addressed in a
manner that inspires public confidence and provides the
scientific community with adequate guidance.
The absence of regulatory
clarity regarding domestic GM insect activity has broader
implications. The mobility and range of insects pose
international regulatory challenges never faced with GM crops,
and much of the public health research underway seeks to
address insect-borne diseases most prevalent outside the U.S,
meaning international regulatory bodies will likely be engaged
before any insects are released. Because U.S. regulatory
policies will be an important building block in the
development of international policies regarding GM insects,
domestic stagnation impedes development on an international
level.
“Clarity from U.S. regulators
would benefit both the scientific community and the public at
large,” concluded Rodemeyer.
“Without a clear and transparent roadmap for regulation, it is
difficult for scientists to know how to proceed with research
efforts and the public has little reason to trust that the
risks and benefits are being appropriately weighed and
measured.”
Read the executive summary or
full report online at
http://pewagbiotech.org/research/bugs
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