Biosafety Protocol: Is There A Need For One?

By John M. Seguin

Outline

Thesis statement: An international biosafety protocol should be created to
establish and maintain control over the products designed with biotechnology.

I. The existing laws and regulations that govern the release of
transgenic
organisms are inadequate or nonexistent.
A. The developed nations of the world are using regulations
that were designed to control and monitor crops created with
traditional technologies.
B. Biotechnology is regulated by three different agencies.
C. The undeveloped nations have virtually no regulations
governing transgenic organisms.
1. This indicates that biotechnological research can and is
being conducted in these countries without regulation.
2. There are many biotech companies based in developed
countries that have branches or joint ventures around
the world.
II. The potential risks of transgenic organisms to the environment
is still being determined.
A. Some experts warn that there is a danger that biotechnology
can create mutant hybrids.
B. Biotechnology has the potential to harm the economies of some
developing nations.
C. The last and possible the most important argument for an
international biosafety protocol is in the name of ignorance
and caution
III. The United States, Germany, Japan, and Australia are the only
countries opposed to the biosafety protocol.
IV. The need for a change in the world of agriculture is undeniable.



As the world moves closer to the 21st century, research and development
in the area of biotechnology has increased dramatically. According to Bette
Hileman of Chemical and Engineering News, the world population will increase by
3 billion people in the next thirty years while the amount of land available for
agriculture cannot be greatly expanded. "Biotechnology - specifically that
aspect involved in transferring genes from one species into the [DNA] of another
- has the potential to alleviate . . ." (8) this and many other problems facing
the world in the near future. Even though biotechnology has already shown
dramatic results in the creation of beneficial transgenic (genetically
engineered) species, many countries and researchers are ". . . quite leery about
the uses of biotechnology" (8). Therefore, an international biosafety protocol
should be created to establish and maintain control over the products designed
with biotechnology.
The existing laws and regulations that govern the release of transgenic
organisms are inadequate or nonexistent. In general, the developed nations of
the world are using regulations that were designed to control and monitor crops
created with traditional technologies like hybridization and cross-breeding
(Hileman 8). Pamela Weintraub, of the National Audubon Society, states that
many expected problems with biotechnology can be kept under control with proper
regulations, but the regulations (where there are any) governing biotechnology
today are "tangled and obscure" (164).
In the United States for example, biotechnology is regulated by three
different agencies: the United States Department of Agriculture (USDA), the Food
and Drug Administration (FDA), and the Environmental Protection Agency (EPA).
These three agencies regulate product research and commercialization of
transgenic organisms depending upon their nature and intended use. The USDA
regulates transgenic plants grown on a large scale. If a product of transgenic
origin is to be used as a food, then it falls under FDA regulations. The EPA
has jurisdiction over all transgenic organisms that express or function as a
pesticide, and all genetically engineered microorganisms. Because Congress has
elected not to instate a law specifically regulating transgenic organisms, all
three of these agencies are using existing regulations designed for crops
created by traditional methods. According to Bette Hileman of Chemical and
Engineering News, "Under the existing legal framework, environmental releases of
most gene tically engineered animals are essentially unregulated" (9).
The undeveloped nations on the other hand have virtually no regulations
governing transgenic organisms. This means that research can and is being
conducted in these countries without regulation to protect the ecology. A
resolution passed by the European Parliament confirmed this when they stated,
"Deliberate releases of genetically modified organisms are being carried out in
many developing countries, which have no legislation or infrastructure to ensure
their safe use. . . "(Hileman 8). Further proof that this is taking place is
the speed with which transgenic crops are being commercially produced in these
nations. China, for example, has transgenic vegetables engineered for
resistance to viruses that have been on the market for about 18 months. Similar
transgenic crops in the United States are still in the testing and approval
stages at the USDA (Moffat186).
There are many biotech companies based in developed countries that have
branches or joint ventures around the world, especially in undeveloped