Ethical Dilemma Analysis Paper Genetically Modified Organism (GMO) Thomas J. Shaw Jr Northeastern University March 26, 2017

Transcription

1 Ethical Dilemma Analysis Paper Genetically Modified Organism (GMO) Thomas J. Shaw Jr Northeastern University March 26, 2017 Author s notes: This paper was prepared for RFA 6100-Introduction to Regulatory Affairs of Food Taught by Professor Dr. Darin Detwiler The purpose of this Case Study is to show that even if there isn't a direct connects to GMO products and health concerns to the human body the consumer has the right to know what's in their food so they are able to make an educated decision on if they should buy and consume products of GMO. Anything less should be considered as Food Fraud.

2 Ethical Dilemma Analysis For the last two decades Genetically Modified Organisms (GMO) have been produced and sold as normal products in and out of stores. GMO products were not required in the US to be reported on labels until recently when the federal government mandated that all GMO products be provided on labels by year In July of 2016 President Obama signed into law "The GMO Labeling Bill" (Charles, 2016) which explains that all GMO products are required to have some sort of label showing that the products contains GMO. The White House does fear that requiring the labels will make people think that GMO foods are not safe for consumption. Many studies have been presented over the years showing that GMO foods are safe for human consumption and recently the Nations Academies of Science, Engineering and Medicine conducted a study with concluding results again that GMO foods are safe for human consumption. The scientists wrote in the study that they found no substantiated evidence that foods from GE crops were less safe than foods from non-ge crops (Lynas, 2016) which means that science believes that there is no connection between GMO's and any major health concerns from the consumption of GMO. Not labeling GMO for some is considered a form of food fraud. A survey conducted by Rutgers University back in 2013, found that more than half (53%) of the people surveyed said that they knew very little or nothing at all about GMO foods and one out of four (25%) said that they have never heard of GMOs (2013). This means that purchases are made daily of products where consumers believed to be purchasing goods that are normal. They have not been given the information behind GMOs and allowed the chance to make the choice to purchase something that has been altered or purchase something that has not been genetically altered. While science tells us that GMOs are completely safe for food consumption, could not requiring labeling of GMO products be considered food fraud? By not providing GMO information on labels be classified as Food Fraud? By definition food fraud is the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, food ingredients, or food packaging; or false or misleading statements made about a product, for economic gain. An author from the National Geographic s states that with 85% of all foods consumed in the United States being made up of GMOs, GMOs are the biggest fraud in the history of science and not the answer to feeding the world (Worrall, 2015). When food is presented in any other fashion than what is natural and then is not explained to be anything different for reason of financial gain then this is called Food Fraud. Until the law was changed with the GMO Labeling Bill making it mandatory for all food to carry labels by 2018 listing GMOs as part of the ingredients. Before the GMO Labeling Bill, labels were not required because science concluded and believed that the idea of having the required labels might suggest that GMO products were inferior or unsafe (Charles, 2016). With supporting details from the Food and Drug Administration (FDA) and other agencies the US government supported the advancement of GMOs. Underdeveloped third world countries and even places in the United States have concerns with food safety. As the world becomes even more populated the food safety concerns grows even bigger than ever. During the Ronald Reagan administration biotechnology was going to play a big role in the advancement of the United States and policies were adopted to promote the biotech industry. The FDA was charged by the government to conduct studies on GMO progress. Later it was determined that the studies performed by the FDA were not science based studies but framed up studies for economic and political gain (Worrall, 2015). It was believed that the FDA had presented false information concerning GMOs

3 to get these products in markets which would allow for some to profit from a large economic financial gain. This study is meant to highlight three different topics. First focus should be placed on bringing awareness to the fact that labels for GMO products have not always been required here in the United States. If examined further you can understand that while food safety is being created food fraud by definition is also being created. Altering food or the ingredients, which go into the foods where there is a financial gain, is considered food fraud but there seems to have been a double standard when it comes to those who have been charged with food fraud and those who produce GMO altered foods. Next awareness should focus on facts that there has not been enough time passed or studies concluded on people looking for the evidence that consuming GMO foods might have some long-term issues associated with it. Then lastly the focus should be that consumers should be allowed to make an educated decision to purchase product which contain GMOs or purchase products that are non-gmos. The first modern day GMO discovery took places in 1973's when Herbert Boyer and Stanley Cohen worked together to engineer the first successful genetically engineered (GE) organism (Maurer, 2015). Since then the idea of GMO and the production of GMO has grown and developed into something larger than anyone would have ever dreamed of. Science has created a new way to ensure food safety and this done by taking out unwanted traits and then inserting in its place a favorable trait which would allow crops to grow to desired perfection. GMO crops are grown the exact same way that any non-gmo crops would be grown. GMO crops ensures that we get the exact same result each time a plant or animal's weak organism is replaced with a stronger more favorable organism. In 1994 GMO crops were introduced to grocery stores in the United States after the U.S. Food and Drug Administration approved the Flavr Savr tomato for sale on grocery store shelves (Woolsey, 2012). The Flavr Savr tomato had been genetically modified so that it could sit on the shelves in the stores for longer times. The organism which causes it to ripening quickly was removed and a new organism which would slow down its ripening was put in its place. Food Concern The concern is that there has not been enough evidence collected to know if GMOs cause any health concerns when consumed over an extended period of time. With the United States government backing the FDA studies and allowing GMO to be a part to become a major part of food resources no one ever tracked the long-term affects that GMO problems could have one people's health. During a doctor s visit no one is asked how often they consume GMO products to take in consideration if their illness might have come from the consumption of GMO products. Questions were not asked about GMO consumption because no one knew that they were consuming food from GMO crops. In 1992 the FDA issued a policy called "Foods Derived from New Plant Varieties: Policy Statement 22984". The purpose of this policy was to prevent consumer deception by clarifying that a food labeled is misleading if it omits significant material information. The FDA later determined that genetically modified foods were equivalent to conventionally produced foods, so there was no material difference and therefore no labeling would be required on any food were GMO had taken place. The speculations which surfaced during the Reagan administration paint the picture that the FDA was not telling the truth about the studies that it had conducted. The speculations claim that the

4 FDA's study was not science based but was based for economic and political gains (Worral, 2015). If the speculations were true that would mean that when GMOs were introduced in the United States there was no real proof that GMO were safe for human consumption. No real studies or evidence was available to show proof that it was safe to consume GMO products. With no allergic reactions to GMO food by consumers have been confirmed, in vitro evidence suggesting that some GMO products could cause an allergic reaction has motivated biotechnology companies to discontinue their development (Bakshi, 2003). One the largest GMO altered foods that s consumed is that of a plant. Without being altered plants currently do produce a small amount of harmful side effects to human. Because the side effect is so small most people will never have a clue that the side effect is even there. Once plants are altered the amount of side effects that a plant produces increases which should cause concern when consuming GMO products. This has been a growing concern since the mid 1990's when GMO products were introduce in grocery stores across the country. A study conducted by the Center for Disease, Control and Prevention shows that from 1997 to 2007 the prevalence of reported food allergy increased 18% among children under age 18 years (Branum, 2008). Can GMO products be to blame for the increase of allergies in Children and adults seeing that almost a year after the introduction of GMO products in society allergies in children increased? If this is the case the introduction of GMO products into mainstream society could be a questionable action on the part of the government. Another concern is that GMO foods may be less nutritious than non-gmo foods. They might contain lower amounts of phytoestrogens, which protect against heart disease and cancer (Bakshi, 2003). When eating beans for fiber a average human would have to eat double the amount of GMO beans then it would non-gmo beans to ensure they are getting the level of fiber that needed for human body. Consumers should be aware that they are purchasing and consuming products that have been altered because if you examine the bean example the consumer is having to purchase twice as many beans when purchasing GMO products in order to get the same results as the non-gmo bean. Not requiring GMO foods to be labeled as GMO products is a major dilemma for all involved. From the government who have given its blessings that GMO products are safe for human consumption, the farmers who knowingly purchase and produce GMO altered crops and down to the consumer who might not know or understand exactly what GMO products are or that they are because until recently it was not a requirement for GMO products to labeled on food products in the United States. The government plays a role in trying to provide food security for its people but at the same time many are questioning if they are in fact allowing the crime of food fraud to take place. The farmers are focused on producing their crops to turn a profit and many stand by the government that GMO foods are safe for consumer consumption. Lastly there are the consumers who shop without knowing that they are buying products, which have been altered in order to bring them the best-looking products possible. Dilemma Not requiring GMO foods to be labeled as GMO products is a major dilemma for all involved. From the government who have given its blessings that GMO products are safe for human consumption, the farmers who knowingly produce and produce GMO altered crops down to the consumer who might not know or understand exactly what GMO products or that they are actually purchasing GMO products because until recently it was not a requirement for GMO products to labeled on food products in the United States. The government plays a role in trying to provide food security for its people but at the same time many are questioning if they are in

5 fact allowing the crime of food fraud to take place. The farmers are focused on producing their crops to turn a profit and many stand by the government that GMO foods are safe for consumer consumption. Lastly there are the consumers who shop without knowing that they are buying products, which have been altered in order to bring them the best-looking products possible. By not requiring food GMO products to be labeled as such has many people questioning the government's actions. The major dilemma involves everyone from the government, the farmer and the consumers of the GMO products. Since the birth of GMO by Herbert Boyer and Stanley Cohen in 1973 over the last two decades GMO products have taken over in the food industry. In 2015 it was reported the around 85 percent of all food consumed in the United States contains GMO (Worrall, 2015). The United States government has time and time again given its approval that GMOs will not cause any health concerns from consumption. The farmer communities have given into supply and demand and purchase products in order to produce their crops in order to make a living. Many consumers have no clue that they are buying GMO altered products and in some cases have no clue exactly what GMOs are. With the introduction of GMO products fully into society only two short decades ago when was testing on the product concluded? Is there a true answer that GMO consumption provides no long-term health concerns? The government gave GMOs the stamp of approval without any real facts supporting the claim that there is no difference between GMOs and non-gmos? Methodology In order for the government to regain the trust of the people concerning not requiring labeling on GMO food products a campaign needs to be started which will go into detail showing current testing results that there are no health concerns from GMO consumption. The government should also provide education on GMO and the process that the United States has taken to lead to the current status of GMOs in this country. The Government needs to show evidence as to why they believed that GMOs were safe for human consumption as well as explain going forward what the plan is for GMOs in the US. Grocery stores should be required to carry either all GMO products or either non-gmo products. Once consumers are educated on what GMO products are they will be able to make their decision on what they want to purchase and consume. This gives those who believe that GMO products are safe a place to shop for food and it would also give those who are against GMO foods places to safely shop knowing that they are not consuming GMO products. When enrolling in health care people will have to declare which products they've elected to purchase, GMO products or non-gmo products and when the health care providers track any health concern from their patience they can note if there are any solid differences in people who elect to purchase and consume GMO products against those who elect to purchase and consume non-gmo products. This provides a way to properly track and monitor any health issues which might be connected with GMO or connected with non-gmo products. If GMO are safe for human consumption and they cause no long-term health issues then the world would have a chance to battle world hungry around the globe. Advancements in GMOs across the globe would allow for perfect crops and crops that could grow year around in many different climates as the favorable organisms are selected for. GMO crops alone will not solve the hungry problem in this world but they can be an important component in a broader food security strategy (Alvarez, 2013). A step closer to global food security is needed and if GMO crops can assist in taking steps in the right direction then this can be seen as a bonus.

6 Ethical consideration(s) Because foods which contained GMO organisms were not required to be printed on food labels containing GMO products because the FDA thought that by printing this information on the labels it would suggest that GMO products are inferior or unsafe (Charles, 2016) and people would not purchase or consume food which they believed could cause them harm. By definition food fraud is the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, food ingredients, or food packaging; or false or misleading statements made about a product, for economic gain. Because ethical values and trust were broken during this situation there will also be people who go against the government and their support for GMO products. Top commercial seed markets like Monsanto, DuPont, Syngenta and Groupe Limagrain who produce genetically modified organisms stand to make a large profit as they are able to drown out smaller seed markets. When no competition and no innovation to be found in the seed market place farmers have no choice but to buy and raise one company to the top. Top tier seed companies like Monsanto climb to the top then raise seed prices by 35% (2009). Farmers are able to see that GMO crops increase their farming efficiency: higher yields, reduced pesticide use, increased profits and reduced farm labor (Ruishalme, 2015). With almost near perfect crops, farmers have taken their focus off of growing the traditional crops but are more so focused on growing the best crops for the return on their profits. While making a profit for the hard work of farming there is a line between making a living and giving up your ethics to gain economic gains from an industry which might have connections with causing harm to human life GMOs are not safe for consumption. In any job that connects your results to the general public the top concern should always be focused towards the health and wellness of the people. Options Educate the consumer on GMO products Because many people have no clue what GMO is there is a need to educate. Education is the key in understanding exactly what GMO's are how they can or cannot affect our health from consumption. Consumers need to be educated to know that there are options when it comes to the consumption of GMO's as well as they have a right to be educated on the history and process of GMO's. Pros - The pros behind the education option is that people will have a clear understanding of GMO's and will be able to make an educated decision on if they want to purchase and consume a product that might not be the exact quality that they'd hope for. Cons - The cons in educating the people on GMOs are that people might be fearful to purchase or consume foods which contain GMOs. The consumer might become confused while purchasing food will go out the way to sure that their family is consuming product that contains no GMOs. Separate Showing estimates for GMO foods and non-gmo foods Shopping store should be divided between store who carry the GMO products and stores who carry non-gmo foods. This should be done so those who have no issues with GMO products can shop at a certain store and those who have issues with the consumption of GMO products will have a place to shop knowing that the products are GMO free. This also allows for a way of tracking who eats which type of food and if they have any health concerns this can be shared with their health care provider for tracking purposes.

7 Pros - The pros of having individual places to shop to for GMO and non-gmo products gives the convenience to the consumer as well as allows GMO foods to track. Allowing GMO foods to be tracked will help with studying the long time effects of GMO products on human consumption. Cons - The cons of having individual places to shop for GMO and non-gmo products is that the consumer will always have to know their surroundings to figure out where their correct places to shop are. This will also cause problems for the government in terms of the store reporting. Individual stores across the country would create a lot of feedback which will have to be tracked for the government. This will call for more government man power. Medical/health care systems collect data - Once the consumer has identified if they are going to consume GMO products or non-gmo products they will have to report this decision to their health care provider. Health care concerns should be tracked and followed per patients according to which food situation they have made the choice to consume. When enough data has been collected the information could be used to backup and support the government's claims that GMO foods do not cause any long-term health issues after human consumption. The data could also be used to show results on the opposite side of the claim which is that long-term consumption of GMO products does cause health concerns. Pros - The pros on the medical/health care system collecting data on patients who consume GMO products and patients who have made the choice to consume non-gmo products to receive real life evidence that consumption of GMO foods does or does not cause any long-term health concerns. Cons - The cons on the medical/health care system collecting data on patients who consume GMO products and patients who have made the choice to consume non-gmo products is that there is room for consumer to consume the wrong foods at some points during the course of life. This would not be a favorable condition for the data and would cause the evidence to have some inaccurate details.

8 Recommendation My recommendation for the government to prove that not requiring GMO information to be printed on labels was not food fraud and to prove that GMO products do not cause any health concerns after long-term consumption is continue requiring that GMO products be provided on all food labels. Consumers need to know what they are buying and should be able to make the choice to purchase GMO foods or non-gmo foods. Education on GMO and health concerns should be provided for those who might not understand what GMO is and the history behind how GMO came into existence over the course of the last years. In order for the United States government to regain the trust of the people they will need to charge the FDA to conduct current testing showing results that GMOs are safe for human consumption or that GMOs are not safe for human consumption. Education should also be provided on GMO, its history and the process it has taken for 85 percent of food found in grocery stores containing GMO products. To make things simple and convenient, Grocery stores should be required to carry either GMO products or non-gmo products. Once consumers are educated on what GMO products are they will be able to make their decision on what they want to produce and consume. When enrolling in health care people will have to declare which products they've elected to purchase, GMO products or non-gmo products and the health care providers can track any health concerns. The health concerns can be used to judge if there are any differences in people who elect to consume GMO products against those who elected to consume non-gmo products. This would give those who believe that GMO products are safe a place to shop for food and it would also give those who are against GMO foods places to safely shop knowing that they are not consuming GMO products.

9 Memo To: Food and Drug Administration (FDA), The White House, Anti GMO Groups in the United States, GMO Supporters in the United States, Consumers in the United States From: Thomas Shaw (Northeastern University Student) SUBJECT: GMO Standards - Improvement Evidence shows that there is concern centered on the truth with GMOs. Issues have surfaced ranging from The American Academy of Environmental Medicine (AAEM) urges doctors to prescribe non-gmo diets for all patients citing that animal studies are showing organ damage, gastrointestinal and immune system disorders, accelerated aging, and infertility (Smith, 2011) to issues with GMO foods not having the same nutritional values as non-gmo foods. This is a major concern as we move forward with GMO crops and other advancements which might contain GMO concepts. The United States as a World Super Power owes itself and all others who model themselves after the United States, to know the true facts concerning GMOs. Are GMOs safe for consumption or did the Food and Drug Administration (FDA) conduct false investigations leading the United States to believe that GMOs are safe for consumption and cause no health concerns for humans? If this is the case actions need to be taken as soon as possible to correct the FDA's findings in order to set the record straight. The first step is to educate the consumers on exactly what GMOs are and allow them the options of consuming GMO products or consuming non-gmo products. Consumers have a right to be educated on GMOs so they can make educated decisions about issues which could possibly affect human health if the government has withheld or provided false information since the introduction of GMOs in to society. The next approach would be to take on testing to determine if GMO products are safe for human consumption. The testing policy should be designed around the consumer and their choice to either consume GMO foods or non-gmo foods. *Example of Real Life Testing: Once the consumer is educated on the current facts they will be required to make the choice to consume GMO products or non-gmo products. They will also be required to report to their primary caregivers their choice between the GMO products and non-gmo products. The care provider will track any long-term health concerns from both sets of consumers and note anything that seems unusual or anything that seems to be a pattern within the group or any kind of differences between the two groups. If there are no difference between the two groups this might conclude that GMOs are no different than non-gmos and are completely safe for human consumption. The results could be shared with those against GMO to show that the government was not acting out for economic gain but acting in favor of providing stable means of producing food. The White House should be required to make formal statements along the course of the study showing the progress and findings concerning GMO itself as well any health concerns which might or might not appear. The White House should also create policies that govern the commercial seed companies to create methods to ensure that cross pollination does not occur between the GMO crops and the non-gmo crops. This will be a key component in the process as it will ensure that consumers who have chosen to consume GMO only consume GMO foods and those who have chosen to consume non-gmo foods only consume non-gmo foods. Thomas Shaw

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