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Ref:513/03 |
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AUSTRALIA
- Jan 18, 2003 |
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GM fish have promise - if
the technology is reviewed appropriately |
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by Suzi Fraser
It is unclear whether the approach currently being used by
government regulators gives them the tools to effectively
evaluate environmental issues surrounding transgenic
(genetically modified) fish, according to Future Fish:
Issues in Science and Regulation of Transgenic Fish, a new
report released today by the Washington D.C.-based Pew
Initiative on Food and Biotechnology.
The report, which provides an overview of current research
efforts to apply genetic engineering technology to
aquaculture and discusses the food safety and environmental
issues associated with transgenic fish, carefully examines
FDA’s proposed plan to evaluate transgenic fish through the
same process the Agency uses to evaluate new animal drugs.
Although the new animal drug application (NADA) process
appears to give FDA adequate legal authority and risk
management tools to evaluate potential food safety concerns
associated with transgenic fish, the report finds that FDA
may not be equally empowered to address the environmental
and ecological concerns some associate with genetically
modified (GM) fish.
Specifically, the report questions whether the Agency’s
review process provides the necessary levels of transparency
and public participation needed to ensure public confidence,
and asks whether the Agency has the expertise, authority and
resources necessary to conduct a comprehensive review of
transgenic fish.
“Although the regulatory review system currently in place
has been adequate for those biotechnology products that are
already on the market, the introduction of genetically
modified fish raises questions about capacity,” said Michael
Rodemeyer, executive director of the Pew Initiative on Food
and Biotechnology. “Regulators will increasingly have to
stretch their authority to make old laws and regulations
address the evolving next wave of products. We seem to be
treading in uncharted legal waters,” noted Rodemeyer.
A type of transgenic fish may be the first genetically
engineered animal to undergo regulatory review by the U.S.
government. Researchers have experimented with a number of
traits, creating numerous potential products such as
Atlantic salmon that grow faster than traditional salmon and
tilapia which may be a good resource for Factor VII, a
compound essential to clotting human blood.
These new genetically modified products have drawn some
public controversy: Biotechnology proponents claim
transgenic fish may be a cost-effective way to supply an
ever-increasing human population with a healthy source of
protein. They also believe that biotechnology could reap
other benefits such as seafood products with fewer human
allergens or fish that have been genetically engineered to
allow researchers to examine genetic damage caused by
exposure to chemicals.
On the other hand, opponents are particularly concerned
about the possible environmental and ecological impacts
associated with transgenic fish that might escape from fish
farms and mate with wild relatives.
There is currently no official guidance by the federal
government on how transgenic fish will be reviewed. At the
present time, these products are being regulated under
existing statutory authority. Federal biotechnology policy
was established in the mid-1980s and it was decided at that
time that no new laws were needed to regulate the products
of agricultural biotechnology. Instead, in 1986, the
Coordinated Framework for Regulation of Biotechnology was
established, requiring three federal agencies (the FDA, the
Department of Agriculture and the Environmental Protection
Agency) to use at least ten different laws and numerous
agency regulations and guidelines to address biotechnology
products. Each of the laws currently used was developed
before the advent of biotechnology products and reflects
widely different regulatory approaches and procedures.
“Both the industry and the public crave clarity,” concluded
Rodemeyer. “Without a clear and transparent road map for
regulation, not only is it difficult for developers to bring
new products to market, it is also hard for the public to
trust that a careful consideration of risks and benefits is
taking place before — not after — new products come to
market.” |
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