I have a Writing Assignment due 17 hrs

Raising Awareness and Discovering the Dirt

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RADD

What role can the FDA play in regulating GMO

products?

This brief is intended for the United States Food and Drug Administration (FDA) and is

presented on behalf of Raising Awareness and Discovering the Dirt (RADD). RADD is a non-profit

organization committed to promoting the wellness of the environment.

Since the earlier 1990s, commercialization of Genetic Modified Organisms (GMOs) has spread

throughout the U.S. The FDA has promoted a program of self-regulation among the biotech crop and

food developers (www.fda.gov). Many of the biotech food and crop developers’ primary interest is the

development of high-yielding products. For example, Monsanto, a biotech food and crop developer’s

director of corporate communications, Philip Angell was quoted saying; “Monsanto should not have to

vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its

safety is the FDA’s job,” (Antoniou, Robinson, & Fagan, 2012, p. 23).

Finally, research and Monsanto’s own feeding trials revealed health-effects and suggest that

more suitable options are needed to maintain the safety of consumers and the environment. Therefore,

RADD is committed to working with the FDA in creating programs that will ensure the safety of

environment and the use of GMOs.

Statement of Issue:

In order to promote awareness and ultimately protect the health of consumers, the FDA has the

ability to regulate GMOs by establishing new guidelines. There is a growing body of evidence that

connects GMOs with health problems, environmental damage, and violation of rights of farmers and

consumers. Studies show a correlation between GMOs and health problems such as production of new

allergens increased toxicity, decreased nutrition, and antibiotic resistance (Bernstein et al., 2003).

Additionally, since the emergence of GMO crops, there has been an increase in the amount of

agriculture changes. Such changes include the development of “massive weeds” and “super bugs,” both

requiring an increased dosage of toxins to rid of these unwanted, overgrown organisms. In return,

consumers are now ingesting these increased dosages of toxins.

Background:

Ultimately, the only beneficiaries of products containing GMOs are its producers, such as,

Monsanto, rather than consumers. Monsanto makes an abundant amount of profit on their GMO

products as they have scientifically modified crops, allowing them to have faster results. The “proposed”

purpose of GMOs was to increase yield and enhance nutritional value, while also lowering the use of

pesticides. (www.nongmoproject.org, 2013). Indeed, the use of GMOs increase yield, but studies show

that GMO products hold no nutritional value and rather, by decreasing the use of pesticides, there has

been an increase in the amount of food, and therefore calories, consumed by the average person

(www.nongmoproject.org, 2013).

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The process utilized to create GMOs is called,

“gene splicing.” In detail, gene splicing is

utilized to merge DNA’s from other species,

also known as crossbreeding (Genetically

Engineered Foods, 2013). For example, GMO

scientists take DNA from an Alaskan fish and

merge it with the DNA of that of a tomato

plant. The purpose of this is such that the

tomato crop will now have the ability to

withstand cold weather conditions, ultimately

increasing production. Although cross

breeding is typical amongst organism of the

same species, these types of cross breeds are

un-natural and as a result, reject each other when the DNA samples are merged. Therefore, in order to

get the two genes to properly merge, scientist, on top of gene splicing, also have to create viruses. These

viruses weaken the genes making them susceptible for the other gene to attack.

Monsanto, like other major food suppliers, utilizes mass amounts of pesticides and insecticides

to benefit their crop, while simultaneously contaminating our ecosystem with these toxins. As a result of

the use of GMOs, consumers either directly or indirectly ingest these toxins, causing unknown diseases

and making consumers susceptible to new and more intense illnesses.

Although the FDA has the authority and duty to establish regulations and to protect consumers of

potential hazards in our food supply, they have decided to allow the production of GMO crops. Despite

the fact that GMOs are either banned or regulated in 60 other countries, the U.S. is one of the only

countries without labeling regulations, leaving consumers today, un-informed of their food products

(www.nongmoproject.org, 2013).

Statement of Organization:

RADD has reviewed the FDA’s self-regulating policy and have concluded that GMO crop and

food developers are not capable of screening for GMO resistance to every potential pathogen, resulting

in environmental stress. The mutation process that occurs within the GMO process can sit like a silent

time bomb within the GMO, ready to “explode” at any time. RADD recognizes the need for the FDA to

move beyond the policy of self-regulation and promote

and develop a rigorous testing method that would

ensure the safety of the environment.

Pre-existing Policies:

GMO labeling policy for foods is under intense

development. Countries are choosing mandatory

labeling or adherence to voluntary labeling. Challenges

to mandatory labeling are unlikely to be successful

under current World Trade Organization (WTO) rules

(Caswell, 2000). Marketers and trade negotiators should

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recognize this and move toward living with diversity in labeling policy (Caswell, 2000).

The graph below is an illustration of GMO use at a global level and is a representation of policies

regarding the use or labeling of GMO’s worldwide. The graph also explains data regarding some

countries use of GMO crop farming (nature.com, 2013).

The five countries that regulate GMOs-Canada, USA, Mexico, Japan and the European Union

(EU)-have all considered the appropriate role of labels in signaling these new production methods to

consumers. Each of the five countries currently regulates the introduction of GMO products but only the

EU requires labels that specify the presence of GMOs. This potential "technical barrier to trade" poses

challenges to producers, consumers and governments alike (Phillips & Grant, 1998).

Policy Options:

The policy options are as follows:

Option 1: This policy option proposes the ban GMOs from the market

Option 2: This option calls for issuing a labeling policy on foods/by-products that contain/may contain

GMOs

Option 3: This policy option would allow for the construction and follow through with a 5-7 year study

that tests the effects of GMOs in products

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 Pros and Cons of banning GMOs from the market

Pros

 Revealed health effects such as: immune dysregulation, altered liver function, changes in the

pancreas, kidney and spleen, that were all present in animal testing involving GMOs, would be

no longer be health effects (Kantor, 2013)

 Diminishment of allergic reactions from consuming food with GMOs (Kantor, 2013)

 Increase to effectiveness of antibiotic medications that may be less effective with the

consumption of GMOs due to the resistance to bacteria (Kantor, 2013)

 The elimination of GMOs in farming eliminate the potential of the seeds spreading naturally and

causing cross-pollination to form an unknown, potentially dangerous breed (Kantor, 2013)

Cons

 Increased food supply due to the use of GMOs would decline

 Altered taste and appearance of foods would be reverted to their original state

 Pros and Cons of labeling foods/by-products that contain/may contain GMOs

Pros

 Develops an awareness of the contents of the consumed product

 Will assist in consumers making a proactive choice to avoid foods that have not been thoroughly

tested

 Not only serves as a visual aid to assist in calling for action in the future, but gives the consumer

their rights back to know what is in their food

Cons

 It may pose difficulties for companies to list what ingredients have GMOs because the usage is

so widespread

 An overwhelming amount of products include GMOs, and to label all of them may call for a rise

in prices (Byrne, 2010)

 Pros and Cons of constructing and following through with a 5-7 year study to test for

GMOs Pros

 An extensive study, such as this, has never been done with the intent of understanding what the

effects of GMOs are on humans

 This would enlighten scientists, farmers, corporations, and society as a whole by providing

information regarding GMOs

 With a lengthened amount of time, side effects may be discovered that were not previously

thought to be related to the consumption of GMOs

Cons

 The cost of the study may be a negligible amount that could be spent towards manufacturing

more products for consumption

Best Option:

RADD has concluded that the best option is a five to seven year study. This study will provide

consumers with information regarding potential side effects from the consumption of GMOs. This study

will allow the FDA to determine new information that will guide the outlining of potential next steps for

our food and agriculture industries and the use of GMOs. Most importantly, this study will give

consumers their right to know what is in their food.