Michael Buzby

Environmental Policy & Law

Professor Hossay
11/7/13
GMO Policy in the United States
Humans have been altering the DNA of organisms for thousands of years. The
practice of artificial selection has allowed humans to exploit desirable traits in plants and
animals for our own benefit. This old practice has been taken a step further since the year
1972. Technology has allowed us to manipulate DNA on the molecular level, and in 1973
this technology allowed for the creation of the first Genetically Modified Organism
(Traavik 1). A Genetically Modified Organism (GMO) is an organism thas has had its DNA
altered using the techniques of genetic engineering. Although this new technology has
seemingly endless possible benefits such as drought resistance, nutrient boosting, and
pest resistance, it also comes with special risks which must be properly accounted for and
regulated. The risks that they carry with them, which I will discuss later, could be
catastrophic and irreversible. This is why the United States should implement a more
unified regulation of GMOs that embodies a strong interpretation of the precautionary
principle. It is important to properly assess and manage these risks, not only for the
health of humanity but also to maintain the health of the environment.
Genetically Modified Organisms carry with them many risks. The most dangerous
category of these risks concern the environment. These risks include the spread of
superweeds, negative effects to non-target species, and an increased use of pesticides.
When GMOs first emerged they came with the promise that they would be able to reduce
global pesticide use. This is possible because crops can be genetically engineered (GE)
to be resistant to certain pesticides or produce its own pesticide. One would think that
this would allow farmers to use fewer pesticides in their fields but the opposite has been

true. GE crops were estimated to be responsible for a 383 million pound increase in
pesticide use between 1996-2008 (Bratspies 928). Because so many farmers are using
these crops they can only use glyphosate to control their weeds, which has resulted in a
overreliance on this one pesticide. The result has been millions of acres now infested
with glyphosate-resistant horseweed, pigweed, ragweed, and waterhemp with many
fields harboring two or more resistant weeds (Anderson 10). These superweeds have to
be killed with much stronger herbicides or by using extreme tillage techniques, both of
which are worse for the environment than using glyphosate alone (Anderson 10).
Farmers also report that glyphosate resistant weeds significantly increase their cost per
acre. Currently, "a total of 19 weeds have evolved resistance to glyphosate Worldwide.
(Bratspies 930)
Another risk that is carried by GMOs are the possible effects on non-target species.
These species can include native insects that do not pose a significant risk to crops and
also microorganisms that live in the soil. Some GMO crops produce their own toxins
which are stronger than any found in nature and these toxins end up in the soil and water
when the plants die and degrade (Khanna 5). But the toxins arent only a threat when
the plants are dead. Although the toxins kill the pests that it is meant to, it can also kill
other species of organisms. An example of this is the Monarch butterfly. In May 1999,
entomologist John Losey, behavioral ecologist Linda Rayor, and biologist Maureen Carter
published a study in the journal Nature that found the pollen of Bt corn is lethal to the
monarch butterfly caterpillar (Khanna 4). This was a threat because the monarch
butterflies' migration took them directly through the US Corn Belt. Even though the
butterflies dont feed on corn, the pollen from the corn drifted all over the surrounding
plants which the butterflies fed on. Although the threat to this non target organism may
be minimal, this just shows the possible unpredictable side effects that GMOs can carry.
Even worse is the fact that if these toxins are eventually returning to the soil they could

harm microorganisms that are present in healthy and productive soils (Seidler 4).
Horizontal gene transfer and cross pollination are also notable risks. Both of these
things involve traits from GMOs beings unintentionally transferred to native species.
These traits could give native plants competitive advantages which would then allow
them to spread uncontrollably into new niches (Rajan 4). This would threaten biodiversity
and cause a genetic pollution spill, the magnitude of which would be almost impossible to
clean. Although this risk is probably slim and there has not been much research
conducted on the subject, it should still be accounted for.
Along with environmental health risks are risks to human health. GMOs contain
genes that are naturally present in other organisms. This has the potential to cause
unpredictable allergic reactions, especially in the US where GMO labeling is voluntary and
there is no information to know where the genes came from in the GMO. A study
reported in the New England Journal of Medicine by Dr. Julie Nordlee of the University of
Nebraska and colleagues found that soybeans modified to contain genes from Brazilian
nuts triggered allergic reactions for some people allergic to the unmodified nuts (Khanna
4). In another study at York Nutritional Laboratory in England, researchers found a
substantial increase in soy allergies in conjunction with the introduction of GM soybeans
in that country (Khanna 4). Both of these cases show that unpredictable risks to human
health are possible.
Not only can GMOs cause an increase in allergic reaction, another study showed
results that the Bt spore-crystals genetically modified to express individually Cry1Aa,
Cry1Ab, Cry1Ac or Cry2A can cause some hematological risks to vertebrates, increasing
their toxic effects with long-term exposure, (Mezzomo 10). In other words, this GMO can
cause damage to red blood cells and is even linked to leukemia. Another study showed
Pigs fed a GMO diet exhibited heavier uteri and a higher rate of severe stomach

inflammation than pigs fed a comparable non-GMO diet (Carman 10). This causes a
concern because this is the result of a long term study of a GMO that is already used in
animal feed.
Besides these obvious human and environmental risks, there are also other
additional types of risks. GMOs carry Ethical, Religious, and Cultural risks with them
which could also affect some people. To some people the cultivation, preparation, and
consumption of foods is a way of life and GMOs threaten it, so when you change their
food you change their culture. Natural food sources have grown and evolved for millions
of years on their own and this raises the question, is it ethical to play God and change
the fundamental building block of life? Some people argue that something that is
created in a lab cant fit into a natural world. These are all risks that must be considered.
Along with these known risks is a huge uncertainty and unpredictability present
which are risks within themselves. Even if the chances are very slim, this technology
could have catastrophic, uncontrollable, and irreversible effects on the environment. The
problem is that risk assessment cant accurately weigh these risks. This is because
scientific information involving GMOs is insufficient and incomplete. Knowledge about the
probability of horizontal gene transfer from GMOs to other organisms in also incomplete
(Traavik 3), and the complexity of the ecological system and its vast web of interactions
may make it impossible to identify certain important risks (Rajan 2). GMO research and
testing is also difficult because it has strict guidelines to follow and these guidelines take
away from the realism of the tests (Traavik 5). This means that the true effects of the
GMOs could be different than those in the tests. Not only is it not realistic but there is
also seldom enough data collected to draw conclusive results (Rajan 4). This is mainly
because there is very little funding for biosafety research. According to US Department of
Agriculture's (USDA) farm bill documents, at least $220million is spent by the USDA
annually on biotechnology related research; $4 million is available for the USDA

biotechnology risk assessment research grants in fiscal year 2012 (Rajan 5). This is
hardly enough funding to test all of the different risks involved with GMOs and this has
resulted in inadequate control. Every GMO is different in some way and could possibly
carry its own risks. Whether those risks are to human health or environmental health,
funding always falls short to collect enough data for long periods of time to deem the
GMOs safe.
The risks of GMOs have been talked about in the US since their first successful
creation on 1972. After the first successful GMO was created, scientists gathered at The
Asilomar Conference in California in 1975 to discuss the risks involved with Recombinant
DNA and the safety guidelines that should be established. They set up guidelines
regarding the cautious use of this new technology, but the recommendations were only
voluntary (Bratspies 927).
In 1976 a branch of the US Department of Health and Human Services, the Nation
Institute of Health (NIH), formed an rDNA advisory board which became the regulatory
authority. The formation of this board meant that all rDNA research was now tightly
regulated under the Recombinant DNA Research Guidelines (Bratspies 928). The first test
of its authority was in 1983 when researchers asked permission to field test the GMO Iceminus, which in its natural form is a bacterium responsible for causing ice damage on
plants in freezing weather (Bratspies 928). NIH gave them approval but they were sued
under NEPA because they did not make an Environmental Impact Statement before
approving the releases. The Court decided that they needed to consider the broader
environmental issues attendant on deliberate release and they failed to display rigorous
attention to environmental concerns (Bratspies 928). This total failure of regulation in
1983 involving biotechnology forced the government to create a new framework for
regulation.

In 1984 the White House decided to give regulatory authority to the Cabinet
Council on Economic Affairs (CCEA) regarding biotechnology. They set up a working
group of experts from many different agencies who came together to issue the
Coordinated Framework for the Regulation of Biotechnology. Since its creation, the job of
this new framework was to set up the regulations to be sensible and not to stifle
innovation (Bratspies 929).
The Coordinated Framework for the Regulation of Biotechnology has remained
mainly unchanged since its creation in 1986 and still continues to govern the use of
biotechnologies. One of the main assumptions of this framework is substantial
equivalence, which means that the products of GMO crops are legally the same as their
natural counterparts and have to be treated accordingly. This assumption led to the
development of the US regulatory approach based on four key principles which are; 1)
biotechnology poses no unique risks; 2) the products of biotechnology are what is to be
regulated and not the process they are created with; 3) existing laws are sufficient in
regulating biotechnology; 4) any gaps in regulation should be addressed through the
coordination of the three regulatory agencies (Bratspies 930).
This leaves the EPA, USDA, and FDA responsible for patching together a regulatory
framework even though they all have very different mandates and responsibilities. This
has allowed for some major risks to fall through the cracks of this makeshift framework
and has left some problems unsolved.
The EPA is only allowed to regulate GMO that produce pesticides but not those that
are nutritionally enhanced or disease resistant. It has its authority because of the Federal
Insecticide, Fungicide, and Rodenticide Act which allows the EPA to decide whether the
insecticide is targeting its intended pest without having an adverse side effect on the
environment (Bratspies 920). Enforcement is impossible because they dont have

authority over the crop, only the pesticide it produces.

The USDA has a wide scope of responsibility for regulating all transgenic plants.
They have authority under the Plant Protection act to regulate plant pests and noxious
weeds that might have an effect on the environment or interstate commerce (Bratspies
924). The problem is that they only assess risks associated with traditional pests and
weeds, not the new possible risks associated with GMOs.
The FDA is responsible for biotechnically derived medical products. It has authority
under the Federal Food, Drug, and Cosmetics Act which prohibits the introduction of any
food, drug, device, or cosmetic into interstate commerce that contains a dangerous
substance or is mislabeled (Bratspies 927). It would have authority in testing GMOs for
safety, but because of substantial equivalence all GMO products are considered to be
generally recognized as safe so they dont test them.
All of these agencies fall short of what they should be protecting and have little
power or authority in the matter. On paper the jobs the three regulatory agencies are
responsible for seem clear. The EPA should decide if the plant is safe for the
environment; the USDA should decide if the plant is safe to grow; and the FDA should
decide if the plant is safe to eat. This does not work in practice, however, because of the
compartmentalized responsibilities for each agency. The mutual job of all the three of
the regulatory agencies involved in biotechnology regulation is to protect human and
environmental health. To prevent risks these agencies must properly assess possible
risks and to manage those risks, but regulatory gaps allow for risks to slip through the
cracks.
In 2012 Roundup Ready plantings constituted 88% of the com crop, 94% of the
cotton crop, and 93% of the soybean crop (Khanna 4). Instead of decreasing herbicide
use, GE crops were responsible for a 383 million pound increase in herbicide use from

1996-2008 (Bratspies 924). This increase in pesticide use is because weeds are becoming
resistant to glyphosate, which is the primary herbicide used by most farmers. Not only
do the farmers have to pay more for the herbicide, they also have to pay more to get rid
of the weeds that arent affected by it and have to use environmentally harming practices
to get rid of them (Khanna 10). It is well documented that the more glyphosate resistant
plants there are, the faster glyphosate resistant weeds will arise. This issue was brought
up in court and even though data existed showing this danger the court did not have the
authority to deny the approval of the crop. The crops can only be considered on a case
by case basis and they cannot be denied one at a time because it doesnt have enough of
an environmental impact alone (Khanna 7). This will allow for Roundup Ready crops to
continue being approved for deregulation even though they will cause harm to all farmers
in the long run because the problem in collective.
Another major failure of the current system involves the contamination of organic
crops with pollen from GMO crops that are nearby. Organic farmers took major GMO seed
producers to court when they applied for deregulation of their product which could
contaminate organic crops, saying they didnt consider pollen contamination on their
Environmental Impact Statement. They ended up doing a new EIS saying that it was a
significant effect. Even though the effects of pollen contamination are proven and will
cause monetary loss for organic farmers, it is the organic farmers responsibility to create
a plan to manage this risk themselves. The court allowed for the deregulation of the
GMO so it could be planted anywhere even though this risk was proven (Bratspies 925).
Yet another regulatory shortcoming is the fact that in a 2010 Thompson Reuters
poll, 93% of respondents thought that foods should be labeled to indicate that they have
been genetically engineered or contain GE ingredients (Bratspies 930). This doesnt
mean an unwillingness to eat GM crops, just a right to know. The reason that this isnt
happening is because of a lack of transparency in the regulatory process where

stakeholders have no say in regulation. GMO producers can voluntarily give the FDA data
about their crops but they dont have to.
These examples show that there are many gaps for risks to slip through in the USs
GMO regulatory policy. This failure of the framework is similar to the failure of the old US
framework in 1983 which caused a total changing of the system, and that is what needs
to be done today. Not only do we need to create or designate a single agency to have
authority over GMO regulation, we must also consider one of the guiding principles in
science; the precautionary principle. This principle will take effect should a policy possibly
harm human health or the environment. If it can, then we must not continue to allow it to
do so until we know for certain what its effects will be. Also, it is up to those proposing
the action or policy to prove that it is not harmful (Aslaksen 13).
With high uncertainty and possibility of catastrophic and unknown risks, the
precautionary principle is the best option. It is a widely accepted policy worldwide for
dealing with environmental risks with high uncertainty and probability for large scale
disaster. The principle states In order to achieve sustainable development, policies must
be based on the precautionary principle, environmental measures must anticipate,
prevent, and attack the causes of environmental degradation. Where there are threats of
serious or irreversible damage, lack of scientific uncertainty should not be used as a
reason for postponing measures to prevent environmental degradation (Anadn 3). The
reason for a stronger implementation of the principle is because cost benefit analysis
always falls short at putting an accurate value on nature and ecosystem services it
provides us (D'Arge 1). We have to have a healthy skepticism and also a strong sense of
environmental ethics regarding the use of GMOs in future policy making.
In conclusion, with the use of GMOs come environmental and human health risks
which include the spread of superweeds, negative effects to non-target species, and an

increased use of pesticides, unintentional genetic contamination, and food safety issues
regarding GMO consumption. These risks are hard to address using the classic risk
paradigm because of the limits of science and data collection, mostly due to a lack of
funding and time. This makes it difficult to assess and account for these possible risks
due to the high level of uncertainty and complexity of the problem. The current
regulatory framework in the US does not address these risks properly and many problems
are slipping through the cracks because the GMOs are legally substantially equivalent to
their natural counterparts. This is not only because of the difficulty of risk assessment,
but also because the US framework does not embody the precautionary principle. It also
fails because of the lack of proper unification between the agencies in charge of
regulating GMOs and also because of transparency within this process. Not only does the
US have to designate a single authority to regulate GMOs, it also must embody a strong
interpretation of the precautionary principle until there is no uncertainty that GMOs carry
no major risks. GMOs must be looked at on a case by case basis and proven to be safe
without uncertainty before they can be implemented into nature.
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