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TRANSCRIPT
Public Well Being Must Trump the Profit Motives
A Call for More Adequate Regulation of GMOs in the United States
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To: The General Public of the United States
From: Emily Wheeler, GMO Activist & Ph. D in Natural Health
Date: May 7, 2015
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Executive Summary
Genetically modified organisms (GMOs) have become a large percentage of the
American diet since their initial founding in 1973 when two scientists, Stanley N. Cohen
and Herbert Boyer, determined how to directly transfer the DNA of one organism into
another. The primary GMOs- corn, soybeans, cotton and canola are some of the staple
crops that are part of many products in the human food supply. Given the science behind
GMOs, biotechnology, involves an unnatural manipulation of DNA there is public
concern over the safety of the genetically engineered products.
The importance of public health and the well being of the environment is debated
with biotechnology corporations for the profits they reap from GMOs. The corporations
are able to dictate both the level of detail and quantity of the scientific research that is
made publically available by funding the research. Furthermore, they influence the
regulation of GMOs by lobbying with the regulatory agencies. This colluding with the
science and the regulation of GMOs enables the biotech corporations to positively
influence their bottom line. In turn, the safety of GMOs is not scrutinized.
The regulation currently in place under the United States Department of
Agriculture (USDA), Food and Drug Administration (FDA), and Environmental
Protection Agency (EPA) regulates GMOs as their final products rather than through the
process of genetic engineering through the gene manipulation. There have been multiple
cases that present the current regulation of GMOs as inadequate. Therefore, policy needs
to be put in place to refocus the regulation so that the biotechnology corporations no
longer dominate the industry and to bring greater concern over the safety of the public’s
health and the environment.
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Table of Contents
Executive Summary………………………………………………………………….. 2
Background …………………………………………………………………………... 4
Problem ……………………………………………………………………………..... 6
Initial Regulation…………….……………………………………………………..…. 7
Interplay of Business, Science and Government …………………………………..…. 9
A Profitable Business ………………………………………………………..... 9
Funding Effect………………………………………………………...……… 10
Biotechnology Corporations are the Kings ………………………………....... 12
The Revolving Door ……………………………………………………….…. 13
New Regulation……………………………………………………………………….. 15
A Call for New Regulation …………………………………….……………... 15
Coordinated Framework for the Regulation of Biotechnology ……………… 16
Process or Product? ………………………………………………………….... 17
FDA………………………………………………………………………….… 17
EPA……………………………………………………………………....…….. 19
USDA…………………………………………………………………………... 21
Recommendations ………………………………………………………………..…….. 23
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Background
Currently in the United States, biotechnology has become a large and growing field of
science with the introduction of genetically engineered products, otherwise known as
genetically modified organisms (GMOs). Gene modification, done by humans to
selectively breed, dates back to prehistoric times. The deliberate manipulation of genes
through DNA transfer is much more recent (Genomes News Network).
GMOs are the products of deliberate and unnatural gene transfer from one organism
to another through biotechnology. In 1973, scientists Stanly N. Cohen and Herbert Boyer
were the first scientists to successfully connect two different pieces of DNA, forming
recombinant DNA (rNDA) and sparking the initiation of biotechnology as a field of
science. Biotechnology allows for DNA from separate species to be injected in one
another in order to create new products all together. The results are combinations of
plant, animal, bacteria and viral genes that do not occur in nature or through traditional
crossbreeding. (Genetically Modified Organisms, NON-GMO Project)
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http://books.google.com/books?id=IUErAAAAYAAJ&printsec=frontcover#v=onepage&q&f=false
Given that GMOs combine two unfamiliar forms of DNA to produce a new result,
there is debate over the potential risks that can come with doing so. Beth Harrison, Ph.
D. explains in her book “Shedding Light on Genetically Engineered Food” how “to date,
only about 3-5% of DNA function is understood…without understanding 95-97% of
DNA function, no one can rationally claim to foresee and control the effects of
genetically engineered food” (Harrison 2). There is risk with inserting DNA of one form
into an organism with DNA of another form. It is important to realize, as Harrison
explains, that there is no direct correspondence between individual genes of different
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organisms, and therefore certain traits and characteristics are never guaranteed to be the
result of manipulated gene sequences through genetic engineering.
The Problem
The widespread popularity for GMOs has been linked to such factors of cost-
reduction, higher-crop yields, longer shelf life, and increased quality and variety, to name
a few of the claims. The problem here is that there is not adequate scientific research to
back these claims. It is a corrupted system in which the research and regulation of these
products is dictated by the economic motives of the biotechnology corporations. These
biotech corporations rule the industry as they collude with scientists and regulatory
agencies in order to get their way. Both the research institutes and the government listen
because they are left to lose if they choose not to. Biotech companies fund much of the
scientific research behind GMOs and the companies have made significant financial
contributions within the political arena (Harrison, xiii). Harrison explains that “support
of the biotech industry is not an issue of party politics. It is simply and purely an issue of
money and power. In the midst of this, what happened to the government’s responsibility
to protect the American public’s health?” (Harrison 54). I argue that there needs to be
more adequate government regulation to prevent the biotech corporations from
continuing to influentially dominate the industry.
There are two main stances on the regulation over GMOs. Some believe it is only
the end product of biotechnology that needs to be regulated, while others believe the
process that goes into creating genetically engineered crops should be regulated. The
basis of the need for regulation needs to be the focus on the adverse impacts GMOs can
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have on human and animal health, the environment, and the economy through increased
corporate control of food. It is important to understand what the regulation of GMOs has
been like over the years.
Initial Regulation
The first debate over the risks of GMOs was raised in 1971 in response to a test of E.
coli, a common intestinal microorganism, being infected with DNA from a tumor-
inducing virus, Avian Tumor Virus RNA (Rosenthal, Robinson and Hanafusa). As
GMOs became more widely spread, a concern began to rise regarding the threat these
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organisms could pose on human health and the environment. Health concerns for
humans and animals include the “fears that toxins contained in GM crops
could pose a threat to humans; proteins introduced through genetic
engineering may cause allergenetic reactions in humans; and the use
of antibiotic marker genes in plants would lead to human resistance to
commonly prescribed antibiotic medicines.” The environmental threats
include the “…potential for gene transfer from target plants to non-target
plants, leading to the creation of, for example, herbicide-resistant
weeds; increased herbicide use in the production of GM crops that are
herbicide-tolerant; and negative effects on insect populations, and
ultimately bird populations, from the widespread use of insect-resistant
GM plants” (Falkner 18).
By 1974, the National Institutes of Health (NIH) established the Recombinant DNA
Advisory Committee to address some of these threats posed by GMOs. Then in 1975, a
conference was held in Asilomar, California in which 140 professionals including
biologists, lawyers and physicians met to discuss cautionary measures to take with the
use of biotechnology. These were voluntary suggestions established at the conference.
The NIH followed up by forming an rDNA advisory committee to put forward a set of
rules regulating rDNA research in federally funded programs. The United States
Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and
the Food and Drug Administration (FDA) also established compulsory mandates. The
goal was to “…make rDNA research tightly regulated across the USA, as virtually all
rDNA research was conducted with either funding from or in association with one or
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more of these agencies” (McHughen and Smyth). The cautionary regulatory environment
surrounding GMOs would soon be in competition with the increased commercialization
of GMOs and the realization of the attractive profits that could be reaped. The focus
would shift from the well being of the public, toward the biotech corporations’ bottom
lines.
The Interplay of Business, Science and Regulation
A Profitable Business
By the 1980’s, the level of GMOs being introduced to the environment had risen.
The production of GMO’s was also beginning to be seen as a profitable form of business.
Large biotechnology corporations began to form as a result. These corporations began to
reap profits from the commercialization of GMOs through different means. This profit
motive would influence the course of action with how biotechnology would progress in
the U.S. with both the scientific research behind GMOs and the regulations over GMOs.
Many corporations began monoculture practices by patenting their seeds and
creating terminator seeds such that the smaller businesses could not use the seeds. It was
the 1980 Supreme Court Decision ruling in favor of a General Electric microbiologist
who had previously, in 1971, challenged the laws against patenting life in the U.S. by
applying to the Patent and Trademark Office (PTO) to a patent transgenic
microorganisms that would consume oil spills in the sea (Harrison 4), that lead to the
acceptance of patents on life. The PTO further opened this to all genetically engineered
living organisms in 1987. Businesses soon began to reap the benefits of even greater
control through corporate funded science.
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The Funding Effect- Science and Corporation
Before 1980, there was limited collaboration between the public and private
sectors due to the restrictions on the private sector regarding not being able to claim
ownership of inventions or patents that resulted from federally funded research (Harrison
30). Then, in 1980, the Bayh-Dole Act granted institutions “certainty of title” for
inventions or patents resulting from federally funded research. And in 1986, the
Technology Transfer Act was passed which allowed government agencies to convert
funded scientific findings into profitable private-sector products (Harrison 30). For the
biotechnology industry, these two acts translated into allowing members of the public
sector, such as universities who conduct a majority of the scientific research, to
collaborate with members of the private sector, such as dominating biotech corporations.
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Dr. Sheldon Krimsky, professor of urban and environmental policy and planning,
School of Arts and Sciences at Tufts University and adjunct professor in the Department
of Public Health and Family Medicine at the Tufts School of Medicine, coins the term
“funding effect” to describe the relationship between the private and public sectors which
he explains in the context of science as being when research benefits the financial
interests of those that sponsor the research rather than the well being of those that are
affected by the research results. In his book Science in Private Interest, Krimsky
explains that in the context of universities collaborating with large corporations, the result
is that sources of reliable, objective information no longer exist. Many scientists have
conflicts of interest with the large corporations. Krimsky explains two rules that guide
how the federal advisory committees are designed. He explains how “rule number one is
that no scientist with a substantial conflict of interest should be permitted to serve on an
advisory committee and rule number two is that rule number one can be waived. And the
number of waivers is extraordinary” (Harrison 32). Corporate funded science leads to
minimal little transparency with the public given that the biotech corporations get to
make the final decision on what becomes publically available. If a study does not address
something in a favorable light, the study will simply not be made available as public
knowledge. There are some specific examples that shed light on this problem.
In 1998, Novartis (now Syngenta) gave University of California Berkeley $25
million for research in agricultural biotechnology with an agreement that allowed
Syngenta to gain access to DNA databases and proprietary technology. The University
owns the patents and earns royalties from any discoveries made during the contract, and
in return, Syngenta has the first rights to license about 30-40% of any biotech
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“inventions”. The influence these corporations have over the research providers becomes
completely controlling. For instance, Professor Dr. Ignacio Chapela from the University
of California Berkeley published a scientific report in the British scientific journal Nature
in March 2001 on a study he conducted with a graduate student that revealed there was
contamination from native Mexican corn produced through genetic engineering.
Chapela’s publication resulted in him being fired from the university. It is of little
wonder that there was a conflict of interest with Syngenta, which was currently funding
research at the university (Harrison 33). Another example from March of 2005 is when
the University of Nebraska at Lincoln partnered with Monsanto and made a deal such that
the researchers would receive up to $2.5 million from Monsanto for the following five
years to assist in developing soybean seeds that can withstand the spraying of a particular
weed killer. These examples illustrate how the dominating biotech corporations have far
reaching control over this industry (Harrison 31).
Biotechnology Corporations are King
These dominating corporations are at the crux of the problem with biotechnology
regulation. As the corporations collude with the research providers and choose which
information they want revealed, they provide an incomplete and typically not entirely
truthful picture of the scientific reality of the genetically engineered products. These
businesses are able to claim the science as “confidential business information” if they
would prefer it to be kept away from public knowledge (Harrison 37).
Dr. David Schubert, cell biologist and medical researcher at California’s Salk
Institute, and William Freese, research analyst with Friends of the Earth U.S., report in a
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peer-reviewed scientific study, Safety Testing and Regulation of Genetically Engineered
Foods, which was published in 2004 in Biotechnology and Genetic Engineering Reviews,
that there were many flaws in the studies that the biotech corporations were funding.
Some of these flaws included the tests being done with substitute GE proteins rather than
the GE plant-produced proteins that are consumed by the public; the unintended effects
of the unpredictable GE process was not tested for, and the biotech companies
manipulated tests to get desired results. Schubert and Freese explain that, “the picture
that emerges from our study of U.S. regulation of GM foods is a rubber-stamp approval
process designed to increase public confidence in, but not ensure the safety of,
genetically engineered foods” (Freese and Schubert).
During the 1980s, Reagan Administration policies on biotechnology were focused
on industrial profit rather than public safety (Harris 54). George W. Bush and Clinton
spoke at the Biotechnology Industry Organization’s (BIO) annual conference in 2010.
The BIO represents more than 1,100 biotechnology corporations and Bush he put forward
that “we need to incent research and aggressively encourage investment [in biotech],”
(BIO). With backing from the presidencies, it is of little wonder that there exists a
corrupt system of lobbying between the biotech companies and government.
The “Revolving Door”
This is the name given to the main form of collusion between the biotech
corporations and the government, which accurately describes the exchange of employees
of the corporations and the agencies going back and forth working in both arenas. A
study by the Center for Public Integrity found that, between 1998 and 2004, more than
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2,200 former federal government employees registered as federal lobbyists. The biotech
corporations are strong proponents for this lobbying.
A perfect example of this effect can be displayed through the sequence of divisive
decisions made by one of Monsanto’s researchers in order to play the system to benefit
Monsanto. Monsanto was required to submit a safety report on Posilac to the FDA, so in
turn the researcher who made the report strategically left Monsanto soon before having to
submit the report. The FDA subsequently hired her as deputy director of the Office of
New Animal Drugs. In this position, she then had the power to decide whether or not to
approve the report she had prepared on Posilac on behalf of Monsanto (Harris 53). This
type of strategic transition between the private and public sector, specifically between the
large biotech corporations and the regulatory agencies over the industry is common.
With this form of colluding taking place, the question to ask is who the public is left to
rely on? If the regulatory agencies aren’t working for the public’s best interest, but rather
the corporations’ bottom lines, then how do we have assurance in the health of the
products we consume and are exposed to, as well as the environmental consequences that
can result?
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New Regulation
A Call for New Regulation
With the commercialization of GMOs hampering existing regulatory measures
over biotechnology, new measures were necessary. The corporate funded research that
became popular made the NIH become somewhat obsolete given that these regulations
governed only government-funded work. The U.S. federal government faced two critical
issues in regard to genetic engineering. One issue was whether the government already
had adequate authority to regulate biotechnology or whether biotechnology was a unique
enough form of agriculture such that new legislation would be required. The second
issue was whether the regulations in place over GMOs should control the process by
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which genetically engineered products are produced, or rather, should they just oversee
and regulate the products of biotechnology.
In 1984, the White House proposed that the Cabinet Council on Economic Affairs
be in charge of biotechnology. This was a strategic decision because, in having a
working group internally under the White House, the White House could bypass public
opposition. This biotechnology-working group issued the document that remains the key
U.S. government document on biotechnology titled the Coordinated Framework for the
Regulation of Biotechnology (Lynch and Vogel).
Coordinated Framework for the Regulation of Biotechnology
Part of the framework established a Biotechnology Science Coordinating
Committee that handled the two issues of concern. The first issue handling whether new
legislation was necessary was concluded that rather than address GMOs with a new form
of federal legislation, GMOs could be regulated under the statutory authority of the
USDA, FDA and EPA. Their view on this matter was that there already existed the
expertise in risk assessment, analysis and management needed to regulate GMOs within
the three agencies. The FDA became responsible for GMO products that are food related
for both humans and animals; the USDA for transgenic plants; and the EPA for pesticidal
plants and genetically engineered microbial pesticides (Lynch and Vogel). With three
regulatory bodies responsible for different GMO products, there can be loopholes in the
regulatory process, which lends the risk of GMO products inevitably being left without
proper regulation if any oversight at all. The second issue regarding how to treat GMOs
was whether regulating the process in which they are created, or as final products, was
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needed. The decision was certified within the National Academy of Science (NAS)
White Paper 1987. Biotechnology” (Executive Office of the President, Office of Science
and Technology Policy).
Product vs. Product
This White Paper was the first of a number of studies that came to the same
conclusion that regulation should focus on GMOs as their end product not in the process
of genetically engineering the products. This assertion put forth that there was nothing
unique about genetic engineering that made the process worthy of scrutiny. The NAS
White Paper 1987, as well as a subsequent study done by NAS in 1988 and numerous
follow up studies on the same topic of how best to regulate GMOs, came to three
overarching conclusions. These included that (i) all methods of genetic modification,
including traditional breeding, can give rise to potentially hazardous products; (ii)
biotechnology is no more likely to result in a hazardous product than traditional methods
of breeding; and (iii) the regulatory trigger for risk assessment should be based on the
physical features of the product rather than on the process by which the product was
generated (McHughen and Smyth). Following the established conclusions, each
regulatory agency developed their form of risk assessment from which to regulate GMOs.
FDA
In their role as regulatory authority over biotechnology, the FDA is responsible
for the regulation of all food products for both humans and animals. In 1997, the FDA
established a voluntary consultation process that can be used by the GMO crop
developers as a means to determine the “substantial equivalence” of the product before it
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is marketed. The crop and the specific genetic traits are assessed for such measures as
toxicity and allergenicity. If the FDA deems the results are satisfactory, which the FDA
has termed under the Federal, Food, Drug and Cosmetic Act (FFDCA) as meaning that
the GMO food additive is “generally recognized as safe”, then the product is permitted to
go to market (FAS “U.S. Regulation of Genetically Modified Crops”). If the food
additives are deemed as being significantly different in structure, function, or
composition from substances in food that is currently on the market, then they must
receive mandatory pre-market approval (Library of Congress, “Restrictions on
Genetically Modified Organisms: United States”).
There are two main concerns with this system. Given that it is voluntary is the
first point to note. This lends the question of whether the FDA is exerting enough
oversight among the GMO crop developers. The second concern is the loopholes that
exist between what does versus what does not fall under the FDA’s direct responsibilities
for regulation. An example is with pharmaceuticals that use the genes from food crops.
Given that the end product was not a food product, the FDA, originally, did not claim
responsibility to regulate the genetic traits being used for the pharmaceuticals. In 2004,
Senator Dick Durbin put forward legislation to require any product grown in a food crop,
whether or not this product was intended as part of the human food supply, to receive
pre-market approval under the FDA (FAS “U.S. Regulation of Genetically Modified
Crops”).
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EPA
The EPA’s responsibilities in the realm of biotechnology regulation include
evaluating GMO pesticides and microorganisms in terms of their safety on the
environment and in food. The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) mandates that pesticides must not cause “unreasonable adverse effects on the
environment,” which entails the safety of the environment as well as safety of food for
consumption (EPA). FIFRA also requires all pesticides to be registered before being
commercially distributed and to include a safety analysis with registration, which
includes such details as the testing process, the identity of the product, and information
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on the tolerance of residues. The EPA also regulates plants that are genetically modified
to produce substances intended to control pests, referred to as plant-incorporated
protectants (PIPs). PIPs must comply with the pesticide registration procedures, unless
they meet the criteria for exemption from these procedures (FAS “U.S. Regulation of
Genetically Modified Crops”). The EPA regulates microorganisms through the Toxic
Substances Control Act (TSCA) which requires that those looking to commercialize the
microorganisms submit a Microbial Commercial Activity Notice (MCAN) (Library of
Congress, “Restrictions on Genetically Modified Organisms: United States”).
Despite the regulatory framework in place, there are cases in which the EPA has
lacked proper regulatory oversight given inadequate data from which they backed their
conclusions. One example is in the case of Bayer CropScience, a subsidiary of Bayer
AG, who produced the genetically engineered Star Link corn. The EPA had approved the
corn for animal feed only, but it was infiltrated into the human food supply. The EPA
Scientific Advisory panel had determined that the protein Cry9C, which is a protein
isolated from the soil bacteria Bacillus thuringiensis (Bt), was only a medium risk human
allergen, but this was determined on limited data (UC Davis, “Star Link Corn: What
Really Happened”). The public questioned the EPA’s original approval of StarLink corn
solely for animal use, given the fact that the market infrastructure was not designed to
keep the production of the corn solely for animal feed (Taylor and Tick).
On April 5, 2000, the National Academy of Sciences (NAS) published a report
initiated by The National Research Council, which addressed the health, environmental,
and regulatory issues posed by genetically modified “pest-protected” plants (PIPs) which
would be injected with such toxins as Cry9C and other Bt toxins. The report states
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“Cry9C raises concerns of allergenicity because of the protein’s relative stability in a
simulated gastric environment” (NAS 2005). The report further advises the EPA to
improve testing for the human and environmental impacts of Bt crops and to make the
results of these tests, rather than just the agency’s evaluation, more available to the public
(Taylor and Tick).
Another example is in the case of DuPont’s Benomyl, the chemical ingredient in
the fungicide Benlate. In 2003, a family was awarded $7million in damages from
charges against DuPont for giving birth to a son with empty eye sockets. It was
concluded that this tragedy was the result of the mother being sprayed with Benlate when
she was only seven weeks pregnant while walking by a farm. The EPA was the
regulatory agency responsible and since 1972 they had recommended that DuPont should
include labels on Benlate to explain that exposure during pregnancy should be avoided.
DuPont lobbied with the EPA to accept the corporation’s position that a label would be
misleading and unnecessary and the EPA obliged (Barnett). This is where the flaw lies in
the U.S. as the regulatory agencies will allow the biotech corporations to have the final
say.
USDA
The USDA, specifically through their Animal and Plant Health Inspection
Services (APHIS), is responsible for regulating genetically modified plants under the
Plant Protection Act of 2000. The genetically modified plants are regulated if they were
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created through gene transfer with the plant pest Agrobacterium tumefaciens or if they
incorporate DNA from a plant pest.
The GM plants are regulated by a notification process, permit, or determination of
non-regulated status. The notification process allows a company growing the GM plants
to submit notice of their test on the crops in which they adhere to pre-established rules
laid out by APHIS, and given that the tests are disclosed properly with all rules being
followed, approval will be granted. The permit is required for the GM crops that are
riskier, meaning they could be highly outcrossing or they take much time to grow beneath
the soil, in either case the risk is in the potential for genes to spread.
Permits are required for GM crops that are used for pharmaceuticals or industrial
chemicals. Under the permitting process, the requirement by the APHIS is either an
environmental assessment, which is the less rigorous review, or an environmental impact
statement. The environmental impact statement details the test done, provides an analysis
of alternatives that could be used in place of the product as well as analyzes the potential
impacts of the alternatives, and demonstrates compliance with other applicable
environmental laws and executive orders (FHWA “NEPA Documentation").
If GM plants have been tested and proven not to have a risk on the safety of the
environment then the plant may be qualified for a nonregulated status. The APHIS
requires detailed biological information about the genetically modified product and the
plant in which the gene has been injected in, published and unpublished scientific studies,
data from field tests, as well as any other information APHIS deems useful to certify
whether the plant is safe and eligible to be under nonregulated status. The APHIS allows
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the public to voice their opinion on whether the plant should be granted nonregulated
status by posting the petitions on the Federal Registrar for 60 days (Library of Congress,
“Restrictions on Genetically Modified Organisms: United States”).
The USDA has flaws in their regulatory procedures, similar to the EPA and the
FDA. Beth Harrison, Ph. D. explains how “in a report released in December 2005, the
inspector general of the USDA criticized many aspects of the oversight of GE crops and
charged that the branch of the USDA that oversees biotechnology regulatory functions
was not complying with regulations it was supposed to be following regarding field-trial
monitoring of biotech crops” (Harrison 24). Furthermore, in February, 2007, a federal
judge ruled that the USDA violated the law by neglecting to assess possible
environmental impacts before approving Monsanto’s GE alfalfa.” And alfalfa is the
fourth most widely planted crop in the United States, meaning it is a huge market for
Monsanto to penetrate (Harrison 24-25).
Recommendations
Full Disclosure of Corporate Funded Research
Corporate funded scientific research needs to be publically available in its
entirety. The biotech corporations should not have the right to be selective in what
information they release. The public has a right to know the truth in what they consume
and what they are exposed to in the environment. The information disclosed by the
biotech corporations becomes in essence a form of propaganda when the corporations do
not reveal the entire truth. The corporations do not treat the public in equal standing as
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they feel the right to put greater concern in their business’s bottom line rather than the
public’s health.
Minimum Leave Period for Transitioning Between Public and Private Sector
To prevent the “revolving door” there should be a minimum period of time from
when an employee of a regulatory agency can be hired by a biotech corporation and form
when an employee of a corporation can join a regulatory agency. Currently there are a
large number of corrupt job transitions between the government and biotech corporations
to assist in bringing GMO products to market. This form of colluding is unethical as it
gives the corporations an upper hand when they become part of the regulatory process or
when regulatory agents lobby for them, in either case, helping the corporations reap
greater profits. Here again, the profit motive dominates the concern over public health
and therefore this form of public and private sector colluding needs to be terminated.
Regulate the Process, not just the End Product
The current regulation of GMOs in their end product not in the process of
genetically engineering them, as put forward in the NAS 1987 White Paper and the
Coordinated Framework for the Regulation of Biotechnology, has not lead to adequate
regulation. The FDA allows for voluntary participation in the consultation process under
the notion that genetic engineering does not pose any greater risk. In reality, it has been
found that that there are inadequate studies being performed due to a variety of reasons
including the use of the incorrect gene in a study, by simply deciding not to disclose all
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information, and by conducting too few studies to obtain conclusive results. Therefore
there is just reason for the process rather than the product to be regulated.
Put GMOs to Better Use
There are a number of ways in which GMOs could be of great benefit to society.
Two examples of beneficial uses of GMOs include through clean fuel producer and bio-
degrader or to produce recombinant vaccines (Harrison 70). In using the science of
biotechnology for the betterment of society at large through a focus on public health, not
just the biotech corporations’ bottom line.
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"Coordinated Framework for Regulation of Biotechnology." Office of Science and Technology Policy (1986): 1-123. Executive Office of the President, Office of Science and Technology Policy. Web. 3 May 2015. <http://www.epa.gov/biotech_rule/pubs/pdf/coordinated-framework-1986.pdf>.
"Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)." EPA. Environmental Protection Agency. Web. 7 May 2015.
"Genetics and Genomics Timeline." GNN – Genomes News Network. Web. 7 May 2015.
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McHughen, Alan, and Stuart Smyth. "US Regulatory System for Genetically Modified [genetically Modified Organism (GMO), RDNA or Transgenic] Crop Cultivars." Wiley Online Library. John Wiley & Sons, Inc. Web. 7 May 2015.
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