BANANA VACCINES – EAT UP YOUR VACCINES
by
Group I
Brett Eaker, Deepa Thamodaran, Kevin George, Mamud Mansaray & Theresa Hoang
A group project submitted for BIOT 640 9020 Societal Issues in Biotechnology (2155)
UNIVERSITY OF MARYLAND UNIVERSITY COLLEGE
Adelphi, MD 20783
Summer 2015
BANANA VACCINES – EAT UP YOUR VACCINES
(Introduction)
Risk Assessment and Testing
Risk assessment is a process to identify potential hazardous components, analyze dose-response relationship, evaluating the possibility for human exposure, and estimating the frequency of contrary effects under various conditions. The production of edible vaccines in transgenic plants was first proposed in 1990. As technology matures, production of these vaccines is more focused on the regulatory framework that controls and approves the products (Straub et al., 2012). There is no inclusive federal legislation specifically addressing GMOs. GMOs are regulated under the general statutory authority of environmental, health, and safety laws. The three main agencies involved in regulating GMOs are
1. The US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS)
2. The Food and Drug Administration (FDA)
3. The Environmental Protection Agency (EPA)
Risk Assessment Logical Flow
The process of risk assessment flows in a logical stepwise fashion that includes the following five steps: (1) problem formulation; (2) hazard identification; (3) dose-response relationships; (4)
GM foods are in the middle of many controversial issues; primarily these are addressed by conflicts over the relative pros and cons of GM foods. Major biotech companies like ‘Monsanto ' and ‘Cargill ' are promoting GM foods by focusing only on their beneficial aspects, giving least importance to their negative effects on safety, environment and biodiversity. On the other hand, governmental regulators and nongovernmental organizations, along with some scientists, are strictly opposing this type of blind promotion of GM food by enlightening the people on their negative effects The controversies associated with GM foods include issues such as safety, environmental benefits and risks, biodiversity, and ethical and social considerations.GM foods are implicated for adverse human health risks like people being allergic to it, environmental hazards such as development of super weeds, and pesticide and antibiotic resistance in disease causing organisms. On the other
Health and Safety Executive (n.d.2) explain five steps of risk assessment that are ‘identify the hazards, decide who might be harmed and how, evaluate the risks and decide on precautions, record your significant findings, and review your assessment and update if necessary’.
Whether or not to require labeling of GM foods is a major issue in the persistent debate over the risks and benefits of foods crops that are produced using biotechnology. Bills requiring compulsory labeling have been introduced and proposed in different levels, but not evenly implemented. Some of the common genetically engineered crops include soya beans, canola, corn and cotton. The US Food and Drug Administration policy on the labeling of GM food requires labeling is the food has significantly distinct nutritional property (US FDA par 2). Further, labeling is required if the GM food product includes an allergen that consumers may not expect to find in such a product, or if the product contains a toxicant that is beyond acceptable limits (US FDA par 3).
According to the regulations established by the FDA in 1992, “Under this policy, foods, such as fruits, vegetables, grains, and their byproducts, derived from plant varieties developed by the new methods of genetic modification are regulated within the existing framework of the act” (FDA). In other words, instead of creating new regulations that are specific to these completely unique food products, they are put within the umbrella of other “natural” products. As time passes it appears to be harder to establish strict regulations to manage genetically modified food. According to the Center for Food Safety the most current propose of the Food and Drug Administration establishes that agricultural biotech companies should notify the FDA within a period of 120 before the companies proceed to introduce the product to the market. Regrettably, there is not mention of any regulation that requires assessment for health and environmental safety. This leave the companies with the freedom decide the kind of test that they want to perform if they decide to do so. But most important if this proposal is successful approve it will mean that the companies will have the right to freely even control what they want to include on their labels, which it will most likely exclude the mentioning of genetically modified food.
After conducting some research I found that “The United States does not have any federal legislation that is specific to genetically modified organisms (GMOs)” . Along with this I discovered that, “The US approach to regulating GMOs is premised on the assumption that regulation should focus on the nature of the products, rather than the process in which they were produced” . I found this to be alarming. After finding this information I decided to investigate further, specifically, into the regulation of genetically modified foods. All things related to food must go through the Food and Dug Administration (FDA). Essentially the FDA regulates if foods are safe or not for a consumer. After searching high and low for any information regarding the FDA regulations for genetically modified foods, I found nothing. I found no information about what is allowed and what is not with genetically modified foods and nothing about labeling genetically modified foods, besides when allergens are present in a food. The only information I found was that “The FDA encourages developers of new plant varieties intended for food use, including GMOs, to engage in a consultation procedure with the FDA, in order ‘to ensure that human food and animal feed safety issues or other regulatory issues (e.g. labeling) are resolved prior to commercial
While the production of GMO foods have increased the FDA refuse to regulate it because in 1993 the FDA declared GMOs as “not inherently dangerous” so they therefore do not need special regulations (). Unlike the United
Generally Modified Organism better known as GMOs are becoming a popular topic of argument around the world. The question on everyone’s mind is whether GMOs are safe to consume and what effects they may possibly have. GMOS while becoming a topic today have been around for years now. Scientists have been genetically altering crops for years now and this idea has been around for some time. Nonetheless, GMOs are becoming the new wave of discussion among many. GMOs are needed today to help the food shortage but first studies need to be done to show are GMOs safe, the impact they have on the environment, and to show what are the pros and cons are.
The Food and Drug Administration, Environmental Protection Agency, and the US Department of Agriculture's Animal and Plant Health Inspection Services are all different entry points for the approval of GM crops or GMOs. The EPA largely deals with the regulation of bio-pesticides. For the EPA approval of a GM crop, there must be sufficient proof from the developer that the crop is environmentally safe and the protein does not cause food allergy. The FDA regulates the safety of GMOs consumed by humans and animals. A 1992 policy by the FDA established that most GM crops are "Substantially equivalent" to non-GM crops. This means that crops that are "Generally Recognized as Safe" do not require approval before being sold at market. APHIS regulates GM crops under a permit of notification
It is argued that genetically amended produce can cause a decrease in antibiotic efficacy, and an increase in allergic reactions; further, some are alarmed with the complexity of gene transfer, and there is a belief that scientists are tampering too much with nature. However, the truth of the matter is that antibiotic properties are only sparingly used in severe cases where no other options are present, such as the Hawaiian Papaya, a fruit that owes its existence solely to genetic modification, and its new antiviral genetic code (“Advantages & Disadvantages…” 2). As for allergic reactions, there has been no documented link able to connect the prevalence of GMOs to the rise in allergies in the youth population ( “Commonly Asked Questions…” 4). Further in contrast, each additional gene added to a plant is carefully testes and researched to ensure complete safety for consumption. Lastly, gene transfer is only used with specific beneficial characteristics of plants, so there are no accidental crossings of unintended genes (“Advantages & Disadvantages…” 3). As for tampering with nature, there are still a multitude of options in the market today, including alternatives such as organic or non-GMO certified foods. It is almost as highly regulated as experimental
The first position of the federal government on GM crops, is the department of the EPA, FDA, USDA biochemist scientists to experiment and record GMO foods are safe for the consumer to eat without any severe risk. The government department American Association for the Advancement of Science (AAAS) approves that consuming foods from modified genetic ingredients obtained from GM crops pose no greater danger than consuming from Non-GMO foods. Therefore, the different characteristic of GM foods was altered will stay fresh for an extended amount of time, significantly delaying its expiration, for a longer period of freshens in the local grocery store. The FDA has approved that GMO is safe to consume, and there is no need to test or labeling supplements containing material made from genetically modified organisms. However, the federal government departments of the EPA, USDA, FDA does not inform the customer of the harmful ingredient injected into a seed that may cause unfavorable proteins. (Food and Drug Administration. 2013). Secondly, the government agencies and biotech company are keeping the public in the dark about the hazardous proteins in GMO foods. The federal government has assigned specific departments to safeguard the public, from the dangerous ingredients that generated from GM crops. Even though, the public is unaware about how the biotech industries have concealed the adverse results from the pubic though threatening genetic
GMO, or Genetically Modified Organism, is a modern problem today because of its abundance in foods, and lack of labels. GMO’s are used to modify the DNA of our consumable food to protect them from herbicides, pests, and any other disease that can destroy a crop. Unfortunately, these methods are not considered safe in most countries, with the notable exception of America. The European Union has outright bans on using anything that has even the effect of a GMO on foods that will be sent to be eaten by consumers, however, most Genetically Modified foods in America are not even labelled. 80% of foods contain some sort of genetic modification; the most common of these are soy, corn, beets, canola, yellow squash, and zucchini. GMO product first became an ethical issue when they were introduced to the produce sent to grocery stores to be consumed. Because of their many benefits and disadvantages, the use of GMO’s became an ethical and debatable issue with room to move either way. Some people argue that GMO’s are the cause of illness, and cancer, while others believe that they are paving the way for the produce of the future. Still others are completely unaware of the contents of the food they are buying. Either way, Genetically Modified Foods will always be around to surprise you, even when you least expect it.
The 4 Steps of Risk Assessment Step 1 – Hazard Identification – this step examines if the agent has the potential to cause harm to human or the ecosystem Step 2 – Dose-Response Assessment – this step examines the numerical relationship between exposure and harm caused Step 3 – Exposure Assessment – this step examines what is known about the levels of exposure to the agent Step 4 – Risk Characterization - this step examines how well the data reflects the amount of risk that the agent presents to humans or the ecosystem
Genetically modified organisms, GMOs for short, are becoming more popular in food around the world. Scientists take genes from some different organisms to add different qualities to specific crops, like corn. With that, however, comes many unfaced challenges like the cross fertilization of natural and modified organisms, resistence to pesticides, and health complications, to name a few. As GMOs are becoming more widespread, it is also becoming more evident that their presence is hazardous and they should be phased out of our food system.
Researchers utilizing the transgenic plants to produce vaccine for us humans are the main purpose of molecular farming. Numerous transgenic plant vaccines are being created and field tested each and every day. Several test of the hepatitis B vaccine in the potato were hampered by the low levels of antigen produced in the plant, and by the safety requirement that only individuals previously immunized with injected vaccine should be exposed to the plant vaccine (Cummins, 2011). In this case, the oral vaccine preparations will induce "immune tolerance", thereby making the individual susceptible to the hepatitis B virus (Cummins, 2011).
In light recent technological advancements, the agricultural field has seen a huge shift in the way food is produced, manufactured and regulated. Standing on the frontier of molecular biology is the introduction of Genetically Modified Organisms or GMO’s into the food industry as a means of creating better crops. Since the initial merging of GMO and the food industry there has been a growing use of genetically modified crops, an increase in the creation of new strains, and expansion in the use, manufacturing and distribution of these products. In the past 20 years alone Canada has seen a visible rise of GMO foods available in grocery stores, specifically as a part of basic ingredients that make up a diversity of food products (David Suziki). Thus, the GMO revolution has unapologetically established itself in the food industry and has become a large feature of food production today. Nevertheless, the creation and implementation of these practices is not without its share of concern and controversy. Despite its steady expansion, there is still much to be said about the safety of these products and the procedures by which they are formed under, the potential health risks they pose, the damage it causes to the agricultural business and the effect it has on the environment. Altogether, evidence points to several issues associated with GMO and its integration with food safety, health, the industry and the environment.