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The primary source
for this section:
Marine
Biotechnology in the Twenty-first Century: Problems, Promise, and Products.
The National Academies Press, 2002.
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Ecological
Responsibility
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we pursue useful developments from marine resources, it is imperative
that we carefully consider the ecological health of marine species
and habitats. |
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Product
development based on the wild harvesting of marine organisms often has
not been a sustainable undertaking. Many commercially suitable
marine organisms, such as coral species, have limited distributions. Moreover,
individual organisms often contain only trace amounts of a desired compound.
Obtaining sufficient raw material needed for pharmaceutical development
could devastate a species and damage the surrounding ecological community.
Therefore, researchers
supported by National Sea Grant are using modern molecular methods in
attempts to discern and duplicate promising bioactive resources.
A second environmental
concern is the effect of bioremediation strategies. A
cleanup remedy that does not entail a holistic approach to the environment
can cause more harm than good. Bioremediation potentially offers
cost-effective and environmentally appropriate treatments for polluted
areas, but sustained scientific research and field studies are necessary
before the best use of microbial metabolic potential can be understood.
Clearly, new technologies
should not be used without a thorough understanding of a habitat's ecology.
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Milestones
in the Policy Debate
1989
Ecological Society of America questions ecological effects of transgenic
organisms.
1990
American Fisheries Society urges environmental caution and improved
regulations regarding development of transgenic fish.
1995
Convention of Biological Diversity, United Nations, adopts precautionary
principle.
1998
Edmonds Institute publishes Manual with science-based protocols for
assessing risks of transgenic organisms.
2003
Cartegena Protocol on Biosafety is ratified by 79 nations. Goes into
effect Sept.
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For the
last decade the use of genetically engineered
organisms has been of increasing public concern. Even before the scope
of public scrutiny was raised, scientists from various backgrounds and
institutions were investigating possible human and ecological health
risks engendered by transgenic organisms. Biosafety of transgenic
species has been the focus of research papers, manuals, and national
and international conventions. As early as 1989, the Ecological Society
of America published a paper raising questions about the ecological
effects of genetically engineered organisms. Since then, the discourse
and debate has involved a wide range of scientists, public interest
and environmental groups, biotechnology firms, and government representatives.
The
crux of national and international debate
Central
to national and international discussions on biosafety is the "Precautionary
Principle." Adopted by the Convention on Biological Diversity,
United Nations Environment
Programme, in 1995, the
Precautionary Principle states:
"...lack
of full scientific certainty should not be used as a reason for postponing
measures to avoid or minimize...a threat.'
Adherence
to the Precautionary Principle places the burden of proof of biosafety
on the shoulders of those seeking approval for the release of transgenic
organisms. Although
the biosafety debate is far from over, agreement appears to be converging
towards the use of scientific protocols based on this principle.
A
second point of controversy is proof. How do we scientifically assess
the environmental and human health risks of a transgenic species --
what is the scientific process and who performs the assessments?
Dr.
Anne R. Kapuscinski, University of Minnesota and Minnesota Sea Grant,
and Dr.
Eric M. Hallerman, Wildlife Sciences at Virginia Polytechnic Institute
and State University, have participated greatly in the development of
scientific protocols and in providing scientific information on the
ecological risks posed by transgenic organisms. With support from Sea
Grant, both scientists contributed to US Department of Agriculture guidelines
for the biotechnology projects occurring under its wings. Kapucinski
has since participated in development of the Manual
for Assessing Ecological and Human Health Effects of Genetically Engineered
Organisms, now being used to help shape national biosafety policies.
The
resources at the bottom of this page
can lead to a more in depth understanding of the above issues.
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Potential
Human Hazards
In
the area of food safety for humans, scientists have raised two
primary concerns.
One
is that genetically-enhanced traits might increase a species'
resistance to environmental toxins. Thus, the transgenic organism
could tolerate higher levels of toxins and pose an increased
health risk to humans if ingested. A second concern is that
genetic changes to a fish or shellfish might induce allergic
reactions in humans.
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Uncontrolled
release of transgenic fish, shellfish, or algae into the
environment would threaten natural genetic characteristics
and biodiversity and the balance of ecological systems.
Transgenic
fish would be raised in aquaculture settings, either in
closed-system fisheries or in open-water cages. Open-water
cages are most common due to lower costs. The risk of
fish escaping from damaged cages is high, and this is
where the environmental risks from transgenic fish arise.
In
the wild, transgenic
fish could threaten species
diversity and ecological balance. They could interbreed
and alter natural genetic make-up of the wild species,
which could lead to a decline in the wild species. Even
if sterile, transgenic fish could compete with a natural
species and change the natural ecological balance or proliferate
and become a nuisance species.
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Photo: New Jersey Sea Grant
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Developing
safeguards in the laboratory
The
most agreed-upon safeguard to the unintentional interbreeding
of transgenic and wild species is the incorporation of sterility
in the transgenic organisms. Research in this area is occurring
in numerous laboratories across the nation, both privately
and through Sea Grant supported projects. Redundant safeguards
will, however, be necessary as sterility is not 100% effective;
nor does can it end the mating or competitive behaviors
of transgenic fish.
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U.S.
Regulatory Authority: Where It Stands
The Food
and Drug Administration (FDA) has indicated that it will review and
regulate transgenic fish under the Federal Food, Drug and Cosmetic
Act. In doing so, it will also refer
to standards adopted by the United
States Department of Agriculture (USDA) in 1996 as voluntary guidelines
for research and development of fish and shellfish supported by USDA
funds.
Whereas the Federal Food,
Drug and Cosmetic Act provides a thorough process for the FDA to determine
if fish are "safe and effective" for human consumption,
critics have questioned its provisions for protecting ecological health.
Environmental
Safety
Several concerns have been raised regarding
current environmental safeguards for transgenic organisms.
At this point,
no laws give a Federal agency authority to assess environmental
impact of a transgenic species. (One exception is when the impacted
species is protected by the Endangered Species Act.) Primary
responsibility for environmental impacts falls to states.
Therefore, the FDA,
using the Federal Food, Drug and Cosmetic Act (FFDCA),
stands as the primary reviewer of environmental impacts at
the Federal level.
Various organizations have raised concerns that the FFDCA does
not provide for transparent review or for adequate public input.
Neither does the law give the FDA enforcement power for its
environmental recommendations.
Lastly,
some critics feel that the FDA has not been provided with the
necessary scientific criteria or expertise for assessing possible
environmental hazards.
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Ecological
Concerns:
- No agency
with authority for environmental impact studies
- Insufficient
public input provided under FFDCA
- Lack of
enforcement power for environmental recommendations.
- Lack of
scientific-based assessment tools
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It is increasingly apparent that regulatory issues surrounding marine
biotechnology and the release of transgenic organisms require resolution
before private companies can safely invest research and development
funds in the area of marine biotechnology. |
International Developments
In
September 2003, the Cartagena
Protocol on Biosafety became the first international agreement concerned
solely with genetically modified living organisms and the protection
of species diversity. Formulated by the nations and states in the Convention
on Biological Diversity, United Nations Environment Programme, the Protocol
is based on the Precautionary Principle and seeks to protect biological
diversity from potential risks that may be posed by living modified
organisms resulting from modern biotechnology. It establishes an advance
informed agreement procedure for ensuring that countries are provided
with prior written notification and information necessary to make informed
decisions before agreeing to the first import of living modified organisms
that are to be introduced into the environment.
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Resources
& References
American
Fisheries Society Policy Statement #21: Transgenic Fishes
(Abbreviated), American Fisheries Society, 5410 Grosvenor Lane, Bethesda,
MD 20814
Cartagena
Protocol on Biosafety, Convention on Biological
Diversity, 393, Saint Jacques Street, Suite 300, Montreal, Quebec, Canada,
H2Y 1N9
Developed by
the nations and states participating in the Convention on Biological
Diversity, United Nations Environment Programme, the Protocol, which
went into effect September 2003, establishes procedures for ensuring
that countries are provided necessary information to make informed decisions
before agreeing to the first import of living modified organisms that
are to be intentionally introduced into the environment.
Controversies
in Designing Useful Ecological Assessments of Genetically Engineered Organisms,
Kapuscinski, A. In Genetically Engineered Organisms: Assessing Environmental
and Human Health Effects. Editors: D. Letourneau, B. Burrows. CRC Press,
2002. Free reprint available from Minnesota Sea Grant.
This chapter starts with a brief
history of risk assessment. The bulk of the chapter presents questions,
steps, participants, and goals to be addressed in a scientifically based,
precautionary approach to risk assessment of genetically modified organisms.
Particularly useful to researchers, regulatory officials, and biosafety
professionals.
Economic
and Regulatory Aspects of Marine Biotechnology,
Ramond A. Zilinskas. Chapter from Opportunities for Environmental Applications
of Marine Biotechnology: Proceedings of the October 5-6, 1999, Workshop,
Commission on Life Sciences, Ocean Studies Board, National Science
Foundation. The National Academies Press, 2000.
Future
Fish Issues in Science and Regulation of Transgenic Fish. The Pew
Initiative on Food and Biotechnology, 1331 H Street, Suite 900, Washington,
DC 20005.
Multiple scientists prepared this
report for the Pew Initiative on Food and Biotechnology Pew Initiative
on Food and Biotechnology, January 2003. An excellent resource, it provides
a comprehensive overview of the issues surrounding transgenic fish,
including benefits, environmental risks, food safety, and regulatory
status.
Governance
of Genetically Modified Marine Organisms, University
of Minnesota. Institute for Social, Economic, and Ecological Sustainability
(ISEES), 186 McNeal Hall, 1985 Buford Ave., St. Paul, MD 55108.
The goal of
this project is to improve U.S. environmental governance of marine transgenic
organisms. The project describes its efforts and provides links to other
sites useful to those involved in policy making.
Manual
for Assessing Ecological and Human Health Effects of Genetically Engineered
Organisms, Edmonds Institute, 20319-92nd Avenue West Edmonds, Washington
98020
Authored by a wide range of scientists,
this risk assessment manual was the first attempt to identify a scientific-based
process of risk assessment for genetically engineered organisms (GEO).
The two-volume manual, reviewed in a double blind peer review, has been
used by public, governmental, and private groups to evaluate specific
proposals to import transgenic organisms. Available in PDF format from
the Edmonds Institute. Researchers and regulators may obtain it on CD
from the Edmonds
Institute.
Marine
Biotechnology Briefs,
University of Minnesota, Institute for Social, Economic, and Ecological
Sustainability (ISEES), 186 McNeal Hall, 1985 Buford Ave., St. Paul, MD
55108.
Marine Biotechnology
Briefs serve to encourage a broader understanding of the development
of marine genetically engineered organisms and other forms of marine
biotechnology, marine conservation implications, and options for improving
the effectiveness of the governance of this technology. Issue one includes
a table of genetically modified organisms "in the pipeline."
Performance
Standards for Safely Conducting Research with Genetically Modified Fish
and Shellfish, Information
Systems for Biotechnology (ISB), 207 Engel Hall; Virginia Tech; Blacksburg,
VA 24061.
A U.S. Department
of Agriculture-sanctioned working group developed this 2-volume guide
as a tool for risk assessment and risk management. The USDA approved
these voluntary standards in 1995 for research conducted under its auspices.
Distributed widely, the standards are expected to guide evaluations
of the performance and environmental safety of genetically modified
marine organisms in the United States and abroad. To facilitate use
of the Performance Standards, a computer-based decision-support tool
is available at this site, as are downloadable copies.
Uncharted
Waters? A Briefing On Transgenic Fish. The Pew Initiative on Food
and Biotechnology, 1331 H Street, Suite 900, Washington, DC 20005.
Two Powerpoint presentations from
1/2003: Eric M. Hallerman, Ph.D., Associate Professor of Fisheries and
Wildlife Sciences at Virginia Polytechnic Institute and State University;
Elliot Entis President of Aqua Bounty Farms, a biotechnology company
dedicated to the improvement of productivity in aquaculture through
the biotechnology.
See links
for more resources.
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other
countries are reviewing proposals for the regulation and marketing of