Biosafety Protocol: Is There A Need For One?
By John M. Seguin
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
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
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
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
C. The last and possible the most important argument for an
international biosafety protocol is in the name of ignorance
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
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 countries.
One of the biggest, Pioneer Hi-Bred International based in Des Moines, Iowa,
has branches in over thirty countries (Hileman 16). Many of these companies
conduct enough research to adequately ensure that there are minimal
environmental and ecological risks, but Rebecca Goldburg, chairman of the
biotechnology program at the Environmental Defense Fund, ". . . warns that other
companies may follow through only if adequate regulations are in place" (qtd. in
The potential risks of transgenic organisms to the environment is still
being determined. Some experts warn that there is a danger that biotechnology
can create mutant hybrids that can seriously endanger the ecosystem (Dalglish
41). As stated by Heike Dornenburg, quoted in The Reference Shelf: Genetics and
Society, "The number of genetically engineered products at the brink of
commercialization is growing. A number of environmental and ecological risks
remain unanswered" (152). One concern is that transgenic plants could either
become weeds that could raise the cost of weed control, or could transfer genes
into wild relatives that could then develop into weeds. Other risks include the
inadvertent spread of new virus strains which could gain resistance to virus
resistant plants, as well as possible detrimental effects on insects, birds, and
other animals that feed on transgenic plants (Dornenburg 152-53).
Biotechnology also has the potential to harm the economies of some
developing nations. According to Lawrence Busch, a Michigan State University
sociologist, if it becomes feasible ". . . to use plant cell culture techniques
to make high-value materials, such as vanilla and cocoa butter . . . " (qtd in
Moffat 187) then these products can be made in the laboratory, instead of having
to extract them from tropical plants. The economies of the nations that have
traditionally produced these materials rely heavily on them for income. If
these materials can now be produced cheaper and easier in a laboratory, then the
developing country will lose one of its major exports (Moffat 187).
The last and possibly the most important argument for an international
biosafety protocol is in the name of ignorance and caution. Burke K. Zimmerman,
author of the book Biofuture: Confronting the Genetic Era, expounds on the
uncertainties of biotechnology:
Perhaps we all have a need for certainty in our lives, or the assurance
of knowing the limits to our lives or the fates that could befall us. Here,
however, we cannot allow ourselves that comfort. The knowledge we have gained
about living cells in recent years has been vast, but it has also showed us how
much more we have yet to learn. We will simply have to accept the fact that
there are uncertainties in our lives with which we will have to contend for some
time to come. One of those uncertainties is the absolute assurance that there
can never be a biological disaster (150)
Many researchers argue that there hasn't been enough testing and
virtually no working experience in this field. Referring to the detrimental
effects modern agriculture has already had on the environment, Jack Brown, a
plant breeder geneticist at the University of Idaho, states, "Modern agriculture
has happened at a price. We should learn from our experiences what disasters
could befall us before we jump into large-scale production of gene-modified
plants" (qtd in Hileman 15). Jeremy Rifkin, president of the Washington-based
Foundation on Economic Trends, sums up the sentiment on the release of
transgenic organisms by stating, "Every introduction is a hit-or-miss ecological
roulette" (qtd. in Weintraub 160).
The United States, Germany, Japan, and Australia are the only countries
opposed to the biosafety protocol. They maintain that voluntary guidelines are
all that is needed to regulate international biotechnology. The opponents of a
biosafety protocol also argue that it will harm international trade and
corporate profits ( Hileman 8). A few researchers, typically in the private
sector, maintain that "Biotechnology is simply an extension of traditional
agricultural practices like hybridization and cross-breeding" (Mather 18).
According to John C. Sorenson, general manager of Asgrow, ". . . bioengineering
does not threaten plant or animal diversity, any more than conventional seed and
animal breeding programs do" (qtd. in Mather 162).
The need for a change in the world of agriculture is undeniable. The
world population is expected to approximately double in the next thirty years.
To feed this many new mouths with the same agricultural practices, the amount of
land available for agriculture must approximately double in size. The only
available land that is not being used for agriculture already is the endangered
and protected natural areas (Hileman 8). When the amount of land used for food
production increases, then so does the amount of chemicals used in today's
agricultural processes increase. These chemicals are vital because they offset
or prevent the losses from weeds, pests, and diseases. Hopefully with new
technologies, biotechnology being one of them, plants will be created that can
grow and survive without the use of these environmentally harmful chemicals
(Hileman 14). While many people agree that biotechnology will be at least part
of the solution, they are also concerned about the safety of transgenic
that are released into the environment (Barker 126).
Barker, Penelope, ed. The Reference Shelf: Genetics and Society. New York: H.W.
Wilson Company, 1995.
Dalglish, Brenda. "Changing the face of the farm." Macleans 06 March 1995:
Dornenburg, Heike, and Christine Lang-Hinrichs. "Genetic Engineering in Food
Biotechnology." The Reference Shelf: Genetics and Society. Ed. Penelope Barker.
New York: H.W. Wilson Company, 1995. 145-153.
Hileman, Bette. "Views differ sharply over benefits, risks of agricultural
biotechnology." Chemical and Engineering News 73 (1995): 8-17.
Mather, Robin. A Garden of Unearthly Delights: Bioengineering and the Future of
Food. New York: Penguin Group, 1995.
Moffat, Ann S. "Developing Nations Adapt Biotech for own needs." Science 08
July 1994: 186-187.
Weintraub, Pamela. "The Coming of the High-Tech Harvest." The Reference Shelf:
Genetics and Society. Ed. Penelope Barker, New York: H.W. Wilson Company, 1995.
Zimmerman, Burke K. Biofuture: Confronting the Genetic Era. New York: Plenum