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.

Harrison, Beth H. Shedding Light on Genetically Engineered Food: What You Don't Know about the Food You're Eating and What You Can Do to Protect Yourself. New York: IUniverse, 2007. Print.

"Introduction of Recombinant DNA-engineered Organisms Into the Environment." Google Books. Web. 4 May 2015. <http://books.google.com/books?id=IUErAAAAYAAJ&printsec=frontcover#v=onepage&q&f=false>.

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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.

"National-Academies.org | Where the Nation Turns for Independent, Expert Advice." National-Academies.org | Where the Nation Turns for Independent, Expert Advice. Web. 7 May 2015. "Presidents Bill Clinton and George W. Bush Address Global Issues and Biotechnology Applications at 2010 BIO International Convention Keynote." Presidents Bill Clinton and George W. Bush Address Global Issues and Biotechnology Applications at 2010 BIO International Convention Keynote. 4 May 2010. Web. 6 May 2015.

"Restrictions on Genetically Modified Organisms: United States. “Restrictions on Genetically Modified Organisms: United States. Web. 3 May 2015. <http://www.loc.gov/law/help/restrictions-on-gmos/usa.php>.

Robert, Falkner. "International Cooperation against the Hegemon: The Cartagena Protocol on Biosaftey." The International Politics of Genetically Modified Food: Diplomacy, Trade and Law (2007): 18. Print.

Rosenthal, Peter N., Harriet L. Robinson, William S. Robinson, Teruko Hanafusa, and Hidesaburo Hanafusa. "DNA in Uninfected and Virus-Infected Cells Complementary to Avian Tumor Virus RNA." Proc. Nat. Acad. Sci. USA 68.10 (1971): 2336-340. Dept. of Medicine, Stanford University. Web. <http://www.pnas.org/content/68/10/2336.full.pdf>.

"StarLink Corn: What Happened." StarLink Corn: What Happened. UC Davis. Web. 6 May 2015.

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