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GM Development and Applications Humans have been discovering new methods of farming to improve crop production for centuries. Farmers have used techniques such as controlling the pollination of plants through selective breeding and hybridization to create new varieties of plants that express more desirable traits than the original plants. Traditional plant breeding involves the random crossing of hundreds of thousands of genes from similar organisms that can transfer both wanted and unwanted traits to the new plant. More recently though, plant biotechnology through genetic modification has become the favored method for producing more commercially viable plant varieties. Unlike traditional plant breeding, biotechnology allows for the transfer of only one or a few of the specific genes that are desired in the new plant. Plant genetic engineering also allows for the transfer of genetic information from a certain species to a completely unrelated plant, which makes its possible applications very broad (http://www.epa.gov/oppbppd1/biopesticides/regtools/biotech-reg-prod.htm#I). The most prevalent uses of agricultural biotechnology at this time are products that are engineered to tolerate herbicides and resist pests. GM products such as these that are modified to improve productive quality are known as input-based technologies. Crops that carry herbicide tolerant genes (Ht) allow farmers to spray a specific type of herbicide on their fields to kill weeds, but leave the crop undamaged. Pest-resistant crops, on the other hand, contain a gene for the protein, Bacillus thurigiensis (Bt), which is a toxin to common crop pests such as the European Corn Borer. Those crops that have both pest and herbicide resistant input traits are known as “stacked” organisms. Scientific Background – What are Genetically Modified Foods? DNA is the basic building block of life. It contains and carries the genetic information of the cell and expresses itself through the formation of proteins. Genes are specific lengths of DNA, which are copied and translated into functional purposes. DNA is in the shape of a double helix where the bases (adenine – A, thymine – T, cytosine – C, and guanine – G) form centrally located pairs: A always faces T, and C always faces G through hydrogen bonds. In order for the proteins to be created successfully, the information in the DNA is copied to an RNA molecule. The sequence of base pairs on this molecule determines where each amino acid is placed in the sequence of the formation of a protein. The correct placement of amino acids is essential for the proper functioning of proteins, which drive a cell’s activities. Genetic modification involves the modification of certain parts of the DNA (certain genes), which will in turn influence the phenotype of an organism—or outward expression of the genotype (CCFRA, 1999; Witherly, 2001; Watson, 2003). How Genetic Modification is Carried Out – Briefly, restriction enzymes cut DNA at specific recognizable sequences of bases to create “sticky ends” – named for their persistence in sticking to other ends (with their complementary base pairs) generated by the same enzyme (See Figure 1). In genetic modification, plasmids (naturally occurring short loops of DNA in bacteria) are cut open with restriction enzymes and mixed with the target gene which has been similarly cut from the desired species’ genome. DNA ligase, an enzyme, is then used to add the gene to the plasmid, now known as a “recombinant” plasmid. This recombinant plasmid is mixed with bacteria, which take up the plasmid. The bacteria can then be cultured, and many copies of the plasmid with the gene inside are created (CCFRA, 1999). The cloned gene is then removed from the bacteria and introduced to individual plant or animal cells. This can be done in one of two ways. First, and most common, the gene is linked to a plasmid of the bacterium Agrobacterium, and the plasmid is transferred into the plant when the plant is exposed to and infected by the bacterium (See Figure 2). The DNA is integrated into the plant DNA, and cells are then grown to produce roots and shoots. A second method of transfer is a gene gun. Gene coated gold pellets are fired through the plant or animal cell. The pellet passes through, while the gene is left behind to be incorporated into the cell’s DNA. Genetic modification is much more precise, direct, and controlled than conventional breeding techniques, however, the insertion of the gene into the host cell’s DNA leaves some uncertainty. Scientists have little control over the location of the gene insertion (Parekh, 2004; CCFRA, 1999, Cummins and Lilliston, 2000). Figure 1. The roles of restriction enzymes And DNA ligase in genetic modification (Jones, 1999). Figure 2. Insertion of cloned gene through bacterial vector (Jones, 1999). Plants can be genetically modified for many purposes, but the two most popular forms of genetic modification are herbicide tolerant crops (HT) and pesticide resistant crops containing the bacterium Bacillus thuringiensis (Bt). HT crops carry genes that allow them to survive herbicide use of certain varieties. Bt crops are registered as a pesticide under the Food and Drug Administration, and contain a bacterium that produces a protein toxic to many species of insects (Adam – source?; Pollan 2001). The adoption of biotechnology in the United States has increased rapidly since the introduction of GM crops for commercial use in 1996. At that time, there were 4.2 million acres of GM crops worldwide. Since then, the rate of farmers adopting GM technology has jumped dramatically. It is estimated by the USDA that about 167 million acres of GM crops were cultivated worldwide in 2003. Biotech crop plantings increased by 20% from 2003-2004, making it the ninth straight year of double-digit increases (www.whybiotech.com). The United States now accounts for about 90% of the global share of GM crop production (From issue 2483 of New Scientist magazine, 22 January 2005, page 5). The three major GM crops in America are corn, soybeans and cotton. From 2001- 2004, the amount of GM corn produced as a percentage of total production rose from 26% to 45%, soybeans increased from 68% to 85% and GM cotton grew from 69%-76%. Other significant GM crops grown in the United States include canola, squash and papaya. http://pewagbiotech.org/resources/factsheets/display.php3?FactsheetID=1 The adoption of GM technologies in agriculture to this point has largely been concentrated in a small number of heavy agriculture producing states in the Midwest. The USDA showed in 2004 that, while farmers in every state in the continental US did plant some GM corn, 11 states were responsible for 81% of the country’s GM corn production. The same trend is true for soybean production. Of the 31 states that reported planting GM soybeans in 2004, the top producing 14 states grew 89% of the national total. Cotton too has the top seven producing states accounting for 81% of the total GM cotton production in the US. (http://www.ers.usda.gov/Publications/aer810/) The agriculture industry in Virginia represents 11.2% of the State’s economy. There are 47,600 individual farms, covering 8.5 million acres in the state. The market value of farm production in 2003 was $2.3 Billion, with 718 million coming from crops with the remaining 1.6 billion coming from livestock. Of the three major GM commodity crops in Virginia, soybeans bring in $81 million in cash receipts, corn amounts to $62 million and cotton brings in $30 million. (USDA, NASS 2002 Census of Agriculture) The state of Virginia, specifically, is also looking into further adopting GM technologies. Currently, it is estimated that less than 1% of the crops grown in the state are genetically modified. Rather than focusing the input-based applications that were discussed earlier, Bill Scruggs, Project Manager of Agribusiness Development at the Virginia Department of Agriculture says that there is a greater potential for output-based products. Output-based genetic modifications are used to effectively change the final product of what is being produced from the original organism. This includes crops that are nutritionally enhanced with desired traits, such as fruits and vegetables with modified oil and protein contents or crops that are grown with specific modifications for biopharmaceutical research. The adoption of value-added technology rather than production enhancement biotechnology by Virginia’s farmers seems to have more potential because it is a small-market agricultural state. It is difficult for Virginia farmers to compete with Midwestern states in the major commodity crop markets of corn and soybeans. A major purchaser of GM products is the livestock industry, which has a very small market in VA because most of the feeds that are used for livestock are already being imported from the major producing states. This makes it difficult for VA farmers to scale up production and find a suitable market in the major food commodity industry. It is more of a desire that VA farmers will develop a product niche for specialized GM crops that will allow the farming industry to sustainably prosper into the future. (Bill Scruggs) No matter how many GM products your state grows, it is important to understand that biotechnology significantly affects people in all states. Most notably, the end products of GM farming are the foods that are distributed by major companies across the nation. It is estimated that 75% of foods that are processed in the United States contain some genetically modified ingredients. Nearly every product that has corn or soy ingredients, and some that have canola and cottonseed oil, has a GM element in it. (Grocery Manufacturers of America) The Pros of Genetic Modification – Who Benefits and How? The extreme increase from virtually no genetically modified foods in supermarkets in 1995 to excessive GM food production has come with much controversy. There has been a constant debate on whether GM foods are safe, or as safe as traditional foods. However, through this controversy many known benefits and potential benefits have been recognized. Genetic engineering has increasingly become a major industry in the world over the past decade, allowing many sectors of society to benefit. Internationally, GM foods have been argued to provide vast benefits, especially to developing countries. Firstly, GM foods will be able to be grown in areas that traditionally are not suitable for agriculture, thus providing jobs and food to deprived parts of the world. Producing sturdier, healthier, faster growing crops, the world will also be more prepared for the oncoming effects of the population explosion, and food security will be less of a concern. The biotechnology business has been very successful in the United States. The top five agriculturally-related biotech companies in the United States, Syngenta, Monsanto, Dupont/Pioneer, Bayer CropScience, BASF and Dow had total sales of over $27 Billion in 2003 (Company Annual Reports). Beyond agricultural biotech, there is also a growing market demand for GM biopharmaceuticals. Plant-grown pharmaceuticals utilize the cellular machinery of certain types of plants to produce therapeutic proteins. Using plants to produce medicines enables the production of more complex therapeutic proteins in higher volume than traditional pharmaceutical methods. The biopharmaceutical industry continues to grow as global demand for medicine at a low cost increases. (http://www.dow.com/plantbio/grow/index.htm) Nationally, genetic engineering has provided millions of people with employment, from research to sales. In 2003 there was an estimated $1.9 billion in net economic benefits to United States producers of GM crops (James, 2004). This lends itself many potential benefits for the economy, human health, and the environment. For the economy, it has been shown in many incidences that GM crops increase yields for farmers, thus leading to lower production costs, and lower supermarket prices for consumers. Regarding human health, foods have been genetically engineered to be enriched with vitamins and nutrients, for example “Golden Rice.” This “Golden Rice” has been genetically altered with a daffodil gene to contain beta-carotene, which the body converts to Vitamin A. Although surrounded with much debate, this “Golden Rice” supposedly will benefit countless people in poorer countries who have a deficiency in Vitamin A, perhaps sparing them of blindness (Rockefeller Foundation Website). Food taste and quality can be enhanced through genetic modification as well. Also, lower pesticide and herbicide (potential cancer-causing agents) use will supposedly be reduced as sturdier crops are developed, thus reducing contamination to food and water supplies. Environmentally, lower pesticide and herbicide use is advantageous as well. Pesticides and herbicides are not only degrading to human health, but other wildlife as well. Overuse of pesticides and herbicides will also increase resistance of crops as well as wild organisms, thus increasing necessity to spray. “Bt” crops incorporate a pesticide inside the genome of the crop, so no further spraying is necessary for the crop itself (Parekh, 2004). It is further argued that as GM crops increase yields, natural ecosystems will be protected from further demand for farming land. Specifically in Virginia, agricultural growth is impossible due to lack of space. The bottom line is extremely tight on many small farms, so they have been rescued temporarily by GM crops (Neale, Personal Communication, 2005). Some GM crops have been specifically designed to reduce pesticide use, therefore reducing machinery use and fuel consumption as well. Any savings, whether it be temporary or permanent, are welcomed by Virginia farmers. Andy Hankins, of the Virginia Association of Biological Farmers, agrees that Roundup® Ready soybeans—which are resistant to Roundup® herbicide—certainly increase yields and therefore provide monetary benefits to farmers (Personal Communication, 2005). Although Virginia is not one of the top GM food producers, research has been going into cotton, peanuts, and soybeans, all of which are important in Virginia (Neale, Personal Communication, 2005). Spencer Neale of the Virginia Farm Bureau argues that there must be a reasonable difference in GM crops versus traditional crops for such rapid integration and growth of the industry over the past ten years; the farmers must be getting economic benefits (Personal Communication, 2005). Furthermore, Virginia contains around 180 bioscience and pharmaceutical companies, including bioscience research universities, research parks, centers, and incubators (Adam – source?). Because of the high number of potential stakeholders in the Virginia area, genetic modification could be a crucial element of Virginia politics. Furthermore, employment opportunities in the biotech and pharmaceutical fields are massive. Finally, GM foods provide environmental benefits as pesticide and herbicide use is reduced, thus decreasing contamination of the Chesapeake Bay (Chesapeake Bay Foundation Website). Genetic engineering of crops has undergone much progress over the past decade, and modern techniques now allow manipulation of genes for natural toxicants, antinutrients, and allergens. Additionally, preservation of fruits and vegetables is potentially going to be controlled through modification of the “spoilage” gene rather than the use of chemical preservatives. Furthermore, upcoming technology is assessing genetic engineering methods to be used for renewable sources of vaccines and drugs (Parekh, 2004). Advocates of GM technology argue that foods containing genetically modified contents have not caused any proven damages to human health as of date, and that they are just as safe as non-GM foods as they are tested with more rigor. With the speed at which GM technology is growing, there are sure to be many benefits in the future. Hopeful future applications of biotechnology include (Adam – source?): Disease resistant sweet potatoes Drought resistant rice Flood resistant corn and rice Canker resistant citrus fruit Blight beating bananas Virus resistant papayas Hardier citrus trees Cancer fighting tomatoes Fresher fruit and vegetables Tastier tomatoes Vitamin E enriched corn and canola oil Vitamin A enriched mustard Non-allergenic soybeans Healthier potatoes Healthier fish food and safer fish Heart healthier soybean oil Decaffeinated coffee bean plants Enriched mustard seed oil The Cons of Genetic Modification – What’s to Fear? With the many suggested benefits come questions of potential harms on the environment, human health, and the economy. Probably the greatest fear of all is fear of the unknown. Genetic engineering technology is even now surrounded by much uncertainty. Those arguing against genetic modification argue that not enough is known currently to continue integration into society at the existing pace. The precautionary principle must come into effect until safety is assured. To begin with, the technology itself is very uncertain. Most of the structure of DNA is so little understood, that 97% of human DNA material is regarded as “junk” and ignored (Molecular biology and biotechnology). Scientists do not know what these “junk” elements do, much less what will happen if these are modified through genetic engineering. Furthermore, a cell’s DNA is constantly changing. Stretches of DNA can be rearranged, inserted, deleted or replicated, and genes can jump from one site in the DNA to another naturally. This leads to unpredictability of what could happen if a foreign gene is inserted into the DNA in an unknown location. The task to predict the exact effects of adding a gene to a foreign cell’s DNA involves knowledge of what is currently unknown. There is also much uncertainty surrounding the impacts to human health and the environment. Regarding humans, allergies are a major concern. Genes selectively transferred to GM foods may contain common allergens. This occurred when a gene from the Brazil nut was inserted into soybeans to increase nutrition. The allergy-causing agent transferred as well, and thus was not marketed (New Zealand Ministry of Agriculture and Forestry). There are other unpredictable health risks—ingesting combinations of genes that have never been a part of the human diet could cause unknown responses. One such concern is that the antibiotic-resistant genes could possibly transfer to stomach bacteria, making some antibiotics ineffective. In one study, six out of the seven patients given a meal containing GM soy products had measurable traces of the antibiotic-resistance marker gene present after the meal. With overuse of antibiotics as it is in the United States, this would considerably increase the scale of the problem (Pusztai, 2001; New Zealand Ministry of Agriculture and Forestry; Jones, 1999). Both environmentally and in regards to humans there are several issues concerning the use of herbicide and pesticide resistant genes. First, some studies have shown that instead of reducing pesticide and herbicide use, farmers spray the pesticide and herbicide tolerant crops more liberally without fear of damage. One study through the Northwest Science and Environmental Policy Center in Idaho concluded that the GM crops planted since 1996 have increased pesticide and herbicide use by approximately 50 million pounds (Institute of Science in Society website). Now, Monsanto, the corporation in control of almost half of the GM seed supply to farmers, is producing “Roundup Ready” products, such as canola, corn, and soybeans. These seeds are sold in packages with Roundup, an herbicide, which must be purchased with the purchase of the GM seeds (Union of Concerned Scientists website; Monstanto website; VanDeVeer, 2003). Susan Swales, an organic meat farmer, said that the Roundup ready seeds need Roundup to grow, rather than can simply tolerate it (Personal Communication, 2005). Several other concerns involve the use of herbicide and pesticide resistant genes. First, there is the concern of “superpests” and “superweeds”. Superpests are those organisms that develop a tolerance to the liberal application of pesticides or through the pest-resistant qualities of the crop. The same is a threat from weeds. Weeds can develop resistance from excessive applications of herbicides, such as Roundup, or through transfer of genetic traits into the soil or to weedy relatives. Furthermore, there is the fear that cross-contamination or cross-pollination of GM crops to non-GM crops or wild relatives could decrease biodiversity (New Zealand Ministry of Agriculture and Forestry website; Sooby). There is a “terminator” gene attached to all GM crops, prohibiting the plant to re-grow. Seeds must be purchased each year from the GM seed supplier company. This “terminator” gene could escape or contaminate wild relatives and cause massive plant extinctions (Andy Hankins, Personal Communication, 2005). Hankins also expressed the importance of soil in this equation. He describes that in a given handful of soil, about 3 million different organisms can be found. His concern is now that Bt corn is planted, this Bacillus thuringiensis bacterium now has a much larger presence in the delicate soil profile: “The Bt organism used to be trace, and now eight tons every year are added to soils (Personal Communication, 2005).” Although these potential devastating harms are very real, GM food industry continues to grow at an alarming rate. Further harms include those to farmers. Patenting genes and species by corporations has allowed a small corporate elite to own and control these patents on seeds sold to farmers. Farmers are no longer in control of their products, and are relying more and more on these large corporations. Damage can also be visible to non-GM farmers who, through cross-contamination, can and have had their GM-free status and their trade destroyed without compensation (VanDeVeer, 2003; Pollan, 2001; the Human Genome Project website). Finally, many ethical concerns surround this issue, about which many citizens feel strongly. Permanent alteration of genetic codes and creation of new species can be argued to be immoral. Furthermore, the idea of “owning” a species with a patent seems over the top to some. Finally, we are irreversibly tinkering with the evolutionary process, and unknown damages may well occur to both humans and the environment (Mills, 1985; VanDeVeer, 2003; Pollan, 2001). We are at the “tip of the iceberg here…biotechnology has increased fast, and this is just the beginning (Andy Hankins, Personal Communication, 2005).” These harms apply to Virginia as well as the rest of the United States. However, due to the lack of ability to expand farms in Virginia and the tight bottom line on many farms as discussed previously, something needs to assist these farmers. Hankins does not believe that genetically modified crops are the answer. According to Hankins, genetically modified foods are not returning the profitability in Virginia. There is no evidence that it has had a substantial impact on Virginia agriculture, and the number of farms is reducing significantly despite what this new technology has to offer. Neale and Hankins both expressed concerns over the fact that farmers are prohibited to save GM seeds and must purchase more year after year for both economic and environmental concerns (decreased control over product and decreasing biodiversity). Because there are both perceived benefits and perceived harms, significant and heated debate over genetic modification exists. The Government and Biotechnology The science of biotechnology is continually evolving, and so must the regulations that protect humans and the environment from the potential harms that biotechnology may cause. The federal government recognized the potential effects of biotechnology in 1984 by stating that that it must be able to respond quickly to the rapid growth and potential changes in the biotechnology industry. As more and more biotech products were moving from the laboratory to the market, the need for organizing regulatory oversight was realized in order to ensure that these new products would not negatively affect public health and the environment. An interagency working group was developed by White House Cabinet Council on Natural Resources in 1984 in order to clarify regulatory jurisdiction of biotechnology products. The goal of this interagency group is not only to establish regulatory procedures that adequately evaluate health and environmental safety, but also to emphasize the importance of not inhibiting innovation and competitiveness of the biotechnology industry as it develops. (http://usbiotechreg.nbii.gov/index.asp) In 1986, the Federal Government dedicated the efforts of three agencies, the U.S. Department of Agriculture's Animal and Plant Health Inspection Service (USDAAPHIS), the U.S. Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA) to coordinating domestic regulation and policy regarding GE organisms. The Coordinated Framework for the Regulation of Biotechnology concluded that products of biotechnology are not fundamentally different than conventional products, and that it is the product, not the development process, that should be regulated. Simply stated, reviews of new genetically modified products are done on a case-by-case basis with respect to their specific uses, and not by their methods of development. These agencies are responsible for the oversight and approval of newly developed agricultural biotechnology products for public trade and consumption. When a new bioengineered product is developed, it is subject to review by any or all of these agencies, depending on its modified characteristics. (http://www.epa.gov/oppbppd1/biopesticides/regtools/biotech-reg-prod.htm) The USDA-APHIS is primarily responsible for regulating the practices that are used to protect domestic agriculture from pests and diseases. As a result of the Plant Protection Act of 2000, APHIS has oversight over genetically modified products that are engineered to improve plant resistance to various biological blights. A new product that is developed through genetic modifications is introduced as a “regulated article” until it passes a testing stage. Regulated articles are reviewed by the agency to ensure that the ways in which the product is used, handled and disposed of do not present a risk to New Trait/Organism Regulatory Review Conducted by: Viral Resistance in food crop USDA EPA FDA Herbicide Tolerance in food crop USDA EPA FDA Reviewed for: Safe to grow Safe for the environment Safe to eat Safe to grow New use of companion herbicide Safe to eat Herbicide Safe to grow USDA New use of companion Tolerance EPA herbicide in ornamental crop Modified Oil USDA Safe to grow content FDA Safe to eat in food crop Modified flower USDA Safe to grow color ornamental crop Modified soil bacteria Safe for the EPA environment degrades pollutants agriculture or the environment. Specifically, APHIS evaluates new products on their potential for gene transfer to other organisms, disease and pest susceptibilities, new enzymes, changes to plant metabolism and their effect on non-target organisms. APHIS is usually the first regulatory agency that producers of new products turn to for approval for introduction into the marketplace. Once the product assessment by the USDA is complete it will either be reviewed by another agency or be given a deregulated status and be freely sold and distributed. (http://www.aphis.usda.gov/brs/compliance.html) The EPA is responsible for evaluating the risks to the environment and the public health of all pesticides, including biopesticides. It draws its regulatory framework from three major Acts; the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Federal Food, Drug, and Cosmetic Act (FFDCA), and the Toxic Substances Control Act (TSCA). Similar to APHIS, the EPA issues Experimental Use Permits for field testing of new products to see if a substance poses a risk to humans or the environment based on how toxic it is and how much exposure other organisms have to it. These risks are assessed and then the EPA establishes the pesticide’s conditions for safe use. These regulations pertain to the substance’s manufacturing, labeling, distribution and disposal rules, as well as setting tolerance limits for pesticide residue in food and animal feed. Products that are deemed safe for the environment and human health are granted a license that permits their sale and use according to the established regulatory guidelines. It is important to note that the EPA evaluates GM products by balancing the risks with the benefits of biopesticides use to develop appropriate regulations. Approvals of pesticide products are then reviewed every 15 years to continually monitor the effects of the substances. The FDA assesses the food safety and nutritional aspects of new varieties of bioengineered foods. The FDA’s policy towards Genetically Modified foods is to simply hold them to the same standards that are applied to traditional food products under the 1992 policy interpretation, "Statement of Policy: Foods Derived from New Plant Varieties," under the Federal Food, Drug and Cosmetic Act. Under the Act. It is the responsibility of the food and feed manufacturers to ensure that the foods that they produce meet safety health standards and are properly labeled. The evaluation procedure is similar to the other two agency’s process. A developer who intends to commercialize a bioengineered food meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food. The developer then submits a summary of its scientific and regulatory assessment of the food and the FDA evaluates the submission and approves it or declines it. The FDA is also responsible for establishing labeling standards for all food products and the enforcement of the tolerances of allowable pesticide residue laws that the EPA establishes. (http://www.cfsan.fda.gov/~lrd/biotechm.html) Statements on post-market monitoring and regulation modifications. Government involvement at the State level in Virginia is a lot less active than at the Federal level. The State primarily acts as an information resource for the federal agencies. In Virginia, the Department of Environmental Quality and the Department of Agriculture aid the federal agencies in monitoring biotechnology products and testing for relevant environmental and health effects. The Virginia Biotechnology Research Act is the major piece of state legislation that affects Virginia state agencies. The Act simply says that the state will follow the guidelines that are set by the federal agencies As Virginia is not currently a major producer of GM crops, the state agencies have not been appropriated sufficient funds to take a proactive role in developing policies and regulating biotechnology products. The Virginia Dept. of Agriculture also works with biotechnology companies and farmers to help assist in the safe transition from traditional crops to bioengineered crop production. They also help federal agencies monitor experimental test plots and test for reproductive carry-over and the unwanted field overlap of modified genetic traits. The DEQ focuses its efforts on the waste management side of GM organism production. They enforce the laws concerning the composting and disposal of regulated GM waste products. Policies concerning biotechnology are driven by federal guidelines, but the states and individuals are asked to get involved by providing comments and information on current policies and GM products in their region (Bill Scruggs, DOA). States working with Federal agencies Outside of Virginia, state legislatures are becoming more active in addressing a wide range of issues associated with both the opportunities and challenges presented by agricultural biotechnology. In 2003, 130 pieces of state legislation were introduced on the issue of biotechnology in agriculture. Most of these proposed bills are in support of biotechnology as a means of regional economic development. These bills include additional funding for biotechnology research and education, providing loans for biotech investment and providing tax incentives to biotechnology farmers and businesses. At the same time, some legislatures are pushing for increases in regulation of GM products in their states. These state-level changes that may add to federal requirements include changing the state regulatory system for planting and using GM crops, developing standards for labeling foods that either have or do not have GM ingredients, addressing liability issues raised by agricultural biotechnology, developing standards for agricultural contracts or banning certain GM crops or animals. It is important to note that all 130 pieces of proposed legislation came from only 32 states, and only 27 pieces were actually passed in 2003. The majority of the passed bills are in support of increasing biotechnology in their state, or at least in support of increasing research funding. A very small number of bills in favor of restricting the industry passed in 2003. (http://pewagbiotech.org/resources/factsheets/legislation/factsheet.php) The interagency coordination of federal regulatory oversight in biotechnology between the USDA, the EPA and the FDA works to ensure that all newly developed products meet the standards that are established in the Federal Food, Drug, and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), and the Federal Plant Pest Act. Congress has granted these agencies the regulatory jurisdiction to develop whatever policies are needed to ensure that all new products are tested with regards to their risks to human and environmental health before they are released to the market. (http://www.epa.gov/pesticides/regulating/laws.htm) The government coordinates its efforts to make sure that all new GM products are safe to the public and the environment before they are deregulated. The adoption of policies that demand pre-market evaluation and approval of new GM products is a way to ensure that the public is not exposed to unknown and undocumented products. Once the product is approved, it becomes relatively unmonitored and unregulated by the government. The government makes it the responsibility of the technology producers and the growers to use the products within their approved guidelines. This pre-market oriented review process means that the government has very little influence on how biotechnologies are received and used once they are introduced into the market. The government is discouraged from implementing policies that interfere with the growth of the biotech industry, and as a result, genetically modified organisms may be present in many of the products that we use without ever knowing about them. Analysis of Stakeholders There are many stakeholders involved in the debate over genetically modified organisms in Virginia, including research institutions and schools, the biotechnology industry, farmers and other producers, retailers, consumers, and advocacy groups. In this examination, it is important to not only investigate the position and influence these stakeholders have, but to also understand how they are interrelated. (figure 1… something like this, but more professional looking!) The first step in the GM process takes place in research institutions – usually schools that are exploring new possibilities in biotechnology. In the state of Virginia, there are a numerous schools that can fall under this category, including Virginia Polytechnic Institute (“Virginia Tech”), Virginia Commonwealth University, and the University of Virginia, among others. Of these, Virginia Tech has perhaps been the most active on the biotechnology front, and is involved in the Virginia Cooperative Extension with Virginia State University, which provides research-based educational resources through a network of on-campus and local Extension offices and educators (Virginia Cooperative Extension, 2005). Schools such as Virginia Tech are often provided with funding, both public and private, to further explore different GM options and the positive and negative effects of new strains and combinations (Hankins, pers. comm., 2005; Neale, pers. comm., 2005). As a result, most of the literature and sentiment coming out of these institutions is probiotechnology (Hankins, pers. comm., 2005). For example, on the “Biotechnology and the Environment” page of the Virginia Cooperative Extension Web site, the introduction states: “Biotechnology has the potential to reduce the application of agricultural chemicals for pest control and fertilization through the utilization of genetically modified microorganisms, plants, and animals” (Virginia Cooperative Extension, 2005). There is minimal mention of any of the potential harmful effects of transition to GM organisms on the environment, and those effects are usually refuted or downplayed when they are mentioned. In the Frequently Asked Questions page on the site, the following question and answer are shown: Question: Does biotechnology put DNA in our food? Is that safe? Answer: DNA is present in all living things. So, humans eat DNA every day! The carrots, potatoes, fish and chicken on the dinner table contain miles of DNA. Consequently, food products that contain new pieces of DNA are not inherently dangerous (Virginia Cooperative Extension, 2005). Clearly, there is an agenda at work here. This is not unexpected, but it should be taken into account when examining the research institutions’ place in the debate. The funds coming into these institutions is often directly from the biotechnology companies themselves, and so the need to keep a positive biotechnology outlook is apparent. Hankins, who also works in the Virginia Cooperative Extension but is admittedly against GM foods, said that nearly all of the research going on involves biotechnology (2005). He said he’s sure other disciplines are suffering, both in terms of money and in terms of bright young minds (Hankins, pers. comm., 2005). And he said what scares him is that many of these young researchers may be looking for a “hot new organism” and forgetting the precautionary principle because they want to get the discoveries out and make money off of them (Hankins, pers. comm., 2005). Still, the importance of these research institutions cannot be overstated. The Virginia Agricultural Experiment Station at Virginia Tech, for example, includes about 320 scientists in five colleges at Virginia Tech: Agriculture and Life Sciences; Natural Resources; Liberal Arts & Human Sciences; College of Science; and Veterinary Medicine (Virginia Agricultural Experiment Station, 2005). If GMOs are going to continue to be used in society, it is important to have the research to support and inquire about them, and the fact that significant research is taking place in Virginia can be considered beneficial for the state. According to its Web site, The mission of VAES is to perform basic and applied research on agricultural, environmental, and natural and community resource issues related to the future needs of Virginia, the region, the nation, and the world. Research is designed to provide knowledge that will enhance the quality of individual and family life and the social and economic vigor of Virginia (Virginia Agricultural Experiment Station, 2005). These research institutions have a reciprocal relationship with the next step, the biotechnology industry. While industry often provides the funding for much of the research that takes place involving GMOs, it also depends on that research in order to produce and sell new products. Some people, such as Susan Swales, an organic livestock breeder in Virginia, believe that the biotechnology industry has the most power of all of the stakeholders (2005). In addition to supporting much of the research, the industry directly influences farmers and farm equipment retailers (Swales, pers. comm., 2005). Swales said that seed and chemical companies heavily promote new technologies to farmers and to seed and chemical retailers. She said that farmers are looking toward these companies to tell them what to switch to and when (Swales, pers. comm., 2005). Spencer Neale, of the Virginia Farm Bureau, takes the stance that this is, in many ways, a good thing (2005). According to the VAFB Web site, one of the initiatives that the group is advocating is for excellence in research, education, and outreach, and the site says: “Virginia needs Virginia Tech and Virginia State University to be in a position to provide fundamental and innovative research, aggressive new market opportunities, and dynamic instructional programs to support the competitiveness and profitability of agriculture and forestry” (Virginia Farm Bureau, 2005). The seed and chemical companies are the farmers’ liaison between this research and their own practices. The biotechnology industry has been looked upon with extreme appreciation as well as extreme disdain. Neale pointed out that the bottom line for farmers is so tight that anything helps, and in a state that is losing agriculture at such a rapid pace as Virginia, these improvements are essential (2005). In this sense, the biotechnology enterprise is bringing much-needed support to a struggling industry. Some are more skeptical. Hankins points to two occurrences that bring about his own suspicious view. First, he said that a number of authors recently suggested that there is a conflict of interest in terms of government regulation and the biotechnology corporation Monsanto, citing that many of the higher ups in the FDA, USDA and EPA are also on the Board of Directors for Monsanto (Hankins, pers. comm., 2005). This could partially be explained, however, by the idea that perhaps the most knowledgeable on the subject of GM foods are so few and far between that it is inevitable that some may make it to leadership roles in both the government and in corporations. Nonetheless, it is of concern and should be addressed at some point. Additionally, Hankins said the “terminator gene” deeply concerns him, as farmers can no longer harvest their own seeds from the best plants (Hankins, pers. comm., 2005). While some, such as Hankins, see this as too much control, large corporations like Monsanto argue that without patent protection, they can't afford to do the research needed to provide further advances in biotechnology (Cunningham and Cunningham, 2003). Regardless of the control these companies have over seed distribution, more and more farmers are switching to GM crops, such as Roundup® Ready soybeans. In fact, these soybeans were introduced in 1999, and by 2004 they accounted for more than 90 percent of the soybeans grown in the United States (Hankins, pers. comm., 2005). Those farmers who choose not to use GM crops are creating their own niche market. Swales, who has made this market work for her, said that many farmers are switching to non-conventional agriculture, which often includes organic methods (2005). Hankins also said that the increase in GM foods has been a “beautiful marketing opportunity” for those who farm organically, because consumers who don’t want to eat foods with any trace of GMOs are forced to purchase 100 percent certified organic foods (2005). Farmers and other producers also have a direct relationship with food retailers, with the farmers depending on the retailers to sell their products and the retailers depending on farmers to produce the right amount at the right price. The role that retailers specifically play here is one that connects to the producer to the consumer of crops, both GM and non-GM. (more about retailers…i.e. Ellwood and Thompson’s and Ukrops growing natural foods section) Consumers are the major stakeholder group that, it seems, can either be the most consequential or the least consequential to the growth of biotechnology and GM crops in the state of Virginia. In Europe, consumers have been the catalyst for change in the GM industry. Further explanation will continue later in this paper, but it is important to note that consumers do have the capacity to be the major driving force in the direction of GM crops. As Swales predicts, however, this is unlikely to happen in the U.S. unless there is some kind of disaster similar to the Mad Cow epidemic in Europe that turns people away from GM crops (2005). Currently, consumers seem to have a minimal effect on the industry. Many don’t know much about GM crops or have concrete feelings about them. And Swales points out that, at the current time, much of the interaction that goes on between the farmers, retailers, and biotechnology companies have little to do with consumer attitudes (2005). She said there is very little contact between farmers and consumers right now, and with minimal public push in one way or the other in regards to GM crops, farmers are simply focusing on their bottom-lines (Swales, pers. comm., 2005). Consumers, she said, are not the first priority (Swales, pers. comm., 2005). (CONSUMER SURVEY INFORMATION!!!!) Advocacy groups emerge from all of these other stakeholder groups as a stakeholder themselves. Some of these advocacy groups represent the Virginia Farm Bureau and other pro-GM organizations, and these seem to have been the most active in Virginia as of late. The Virginia Farm Bureau Web site boasts of the strides it has made, and explains an aspect of its effectiveness: “Virginia AgPAC, a non-partisan, political action committee, was set up to further Farm Bureau's legislative effectiveness in state races by supporting political candidates and issues collectively” (Virginia Farm Bureau, 2005). It further explains its activities by saying that the AgPAC participates in the selection of qualified candidates whose beliefs and actions are consistent with Farm Bureau policies, educates candidates about Farm Bureau policy positions, and encourages more political involvement of its membership” (Virginia Farm Bureau, 2005). Non-partisan groups, such as the Pew Initiative on Food and Biotechnology, serve a more independent role, as an informative source about the issue. On its Web site the group writes: As often occurs with the introduction of transformative technologies, the development of genetically modified foods and other products of agricultural biotechnology has generated significant public debate. The Pew Initiative on Food and Biotechnology was established in 2001 to be an independent and objective source of credible information on agricultural biotechnology for the public, media and policymakers (Pew Initiative on Food and Biotechnology, 2005). For the time being, groups such as the Pew Institute are effective at informing those who come searching for information about GM foods, but they aren’t a pro-active group that lobbies for legislation in states or federally, and so their impact is limited. A third category of advocacy groups is that which fights against the spread of GM crops, and often these groups also argue for stricter labeling laws. Nationally, these groups are making some waves, and in states such as Oregon, major battles have been fought. But in Virginia, local chapters of groups such as the Sierra Club, PIRG, and Greenpeace have done little in state government on the issue of GM foods and labeling. According to Neale and Hankins, there was some activity on the GM front a few years ago, but they speculate that public attention was shifted after the events of September 11, 2001, took place. Today, GM foods are not on the agenda of any of these local chapters. European debate- Is our way the best way, or is theirs smarter? Although this study is focusing on the impact of GM crops and foods in the state of Virginia, it is important to understand the global framework involved in the debate and how the situation is handled elsewhere. Specifically, the citizens of Europe have had a strikingly different reaction – a strong negative one – to the use of GM foods, in comparison to the relatively accepting view of U.S. citizens. The same stakeholders are involved in the GM debate in Europe as are involved in the United States. Below is a basic timeline that will serve as a foundation to explain the role that each of these groups plays: 1987: Potato becomes first GM plant introduced to UK. (The Independent, 2005) 1994: Flavr Savr tomato is approved by US Food and Drug Administration, paving way for more GM products. (The Independent, 2005) 1997: Public finds Monsanto GM soy is used, unlabelled, in processed UK food. April 1998: The European Union sets a de facto moratorium on the approval of any new GM foods. (Rousu and Huffman, 2001) June 1998: Prince Charles stokes debate by saying he will neither eat GM produce nor serve it to his family or friends. (The Independent, 2005) July 1998: English Nature, the Government's wildlife advisory body, calls for a moratorium on planting of GM crops while trials are conducted into effects on wildlife of their weedkillers. (The Independent, 2005) February 1999: Michael Meacher, the UK environment minister, persuades GM companies to agree to a moratorium until farm-scale weedkiller trials are done. (The Independent, 2005) Spring 2000: Farm-scale trials of GM crops begin. (The Independent, 2005) May 2003: The United States, Canada, Argentina, and Egypt file a complaint with the World Trade Organization over European countries’ moratorium on GM foods. (The Economist, 2003) June 2003: U.S. President George W. Bush accuses the European Union of being indirectly responsible for Africa’s hunger plight with its obstructionist stance. (Deutsche Welle, 2003) July 2003: Laws to end a European Union-wide ban on new genetically modified foods are passed by the European Parliament. The laws allow new GM foods to be sold in Europe for the first time in five years, but only if they are clearly labeled. Under the new law, all foods with more than 0.9% genetically modified content will have to be labeled (BBC News, 2003). October 2003: Preliminary results find that two of three GM crops are believed to damage the environment. (The Independent, 2005) March 2004: Cabinet members approve qualified planting of first UK GM crop. (The Independent, 2005) May 2004: A six-year moratorium on genetically modified food is lifted by the European Commission; commissioners backed a bid by Swiss-based Syngenta to sell Bt-11 sweet corn for human consumption. (BBC News, 2004) Of the group of stakeholders, the consumers seem to have driven most of the change that has taken place throughout Europe and specifically in the United Kingdom. In 1998, Science Magazine reported on a poll that determined that 77 percent of citizens in the United Kingdom wanted genetically modified crops banned and 61 percent do not want to eat any genetically modified foods (Williams, 1998). As The Economist reported in 1999, “Official rejection in much of Europe is matched by unofficial resistance on the part of consumers. Their objections rest on three main claims. The first is that genetic manipulation is unnatural and so inherently nasty. The second is that the food it produces is dangerous. And the third is that it is bad for the environment.” Gaskell, et al. (1999) conducted research comparing U.S. and European reaction to GM foods in 1999 and published their findings in Science. They found that “people in the United States were significantly more supportive of GM crops and GM foods than were people in Europe” (Gaskell, et al., 1999). The researchers attributed these differences to three factors. First, increasing amounts of press coverage in Europe correlates with greater public concern. Second, the group found that trust in the regulatory authorities is higher in the United States than in Europe. Third, there is a greater prevalence of menacing food images – most notably surrounding the BSE scare – in Europe, which has sensitized large sections of the European public to potential dangers in farming practices (Gaskell, 1999). This negative reaction among consumers has driven much of the activity within two of the other stakeholders: the retailers and the government. Supermarkets have responded quickly to such public concerns about genetically modified foods (Williams, 1998). Even in 1998 in the United Kingdom, most of the major retailers introduced plans to label products containing genetically modified ingredients before there was any EU regulation, directly as a result of consumer pressure (Williams, 1998). Pascal Lamy, the European Union’s trade commissioner, told Newsweek in 2003 that: Scientists everywhere in the world acknowledge that foods may be toxic, provoke allergies or create environmental problems, be they GM or non-GM. On the human-health front, the U.S. approach is to allow marketing without prior testing of GM foods that are deemed to be "substantially equivalent" to the non-GM variety. Many scientists question whether this is a sufficient basis for regulatory approval. In Europe, we do more thorough testing on every GM variety. Our objective is to rebuild consumer confidence, which has been badly shaken by food scares in recent years. (Newsweek, 2003) The government has also reacted to public concern, declaring a moratorium on GM food in 1998 and painstakingly going through legislation regarding these foods. Not only has there been a lag in producing GM crops, but European governments have enacted strict labeling laws to accompany those that do make it to grocery shelves. In 2003, European Consumer Affairs Commissioner David Byrne told the European Parliament: "We have now come to the stage where we must lift the de facto moratorium. I believe we have got in place legislation... to enable consumers to make the choice for themselves whether to consume GM foods or not” (BBC News, 2003). The consumer has remained the center of the GM debate in Europe. The producers of GM foods – most often coming from the United States – are another major stakeholder in this debate in Europe. “U.S. and multinational biotechnology companies are increasingly alarmed and surprised at the level of resistance in Europe to what they see as safe and innocuous technologies” (Williams, 1998). As the proportion of GM crops has increased drastically in the United States over the past decade, European countries have been increasingly skeptical about the technologies. Their caution has been met by U.S. protest, and the United States, along with a coalition of other countries, filed such a protest with the World Trade Organization in May 2003. This protest states that such a moratorium can only be legal if there is scientific data to prove that GM foods are somehow dangerous (The Economist, 2003). Afterward, the European Union lifted the moratorium, but put in place rigorous labeling laws, so that foods that have at least 0.9 percent GM ingredients must be marked as such. This is an example of how, overall, there has been a limited degree of industry influence on policy in Europe (Rosendal, 2005). Ultimately, it seems that, in European society there is a much stronger skepticism to both GM foods and the agricultural industry in general for a variety of reasons. The most important reflection to come away from a study of the situation in Europe involves the role of the consumer. The majority of regulations and changes that have taken place in Europe in regards to GM foods have come directly from consumer influence, not that of the biotechnology industry. Whether something could occur in the United States, and specifically Virginia, to cause a change in consumer attitudes toward GM foods is unknown. It is imperative to note, however, that if some event should occur, using the European model it seems clear that the consumer will likely play a substantial role in the future of GM foods in Virginia and the greater United States. 9. Recommendations/Evaluation – Is this the right thing at the right time for VA? 7. Conclusion - Who is leading the charge? Who has the greatest influence on how much GM impacts our lives?