GENETIC DRIFT: THE SPREAD OF GMOS, WHY THEY MATTER, AND AN OUTLINE FOR LIABILITY ‘Eating is an agricultural act,’ as Wendell Berry famously said. It is also an ecological act, and a political act, too. Though much has been done to obscure this simple fact, how and what we eat determines to a great extent the use we make of the world - and what is to become of it. To eat with a fuller consciousness of all that is at stake might sound like a burden, but in practice few things in life can afford quite as much satisfaction. Michael Pollan, The Omnivore’s Dilemma The works of authors such as Michael Pollan (In Defense of Food, The Omnivore’s Dilemma, The Botany of Desire), Eric Schlosser (Fast Food Nation), Rachel Carson (Silent Spring), and Upton Sinclair (The Jungle) illustrate in very large-scale terms how what you do not know can, in fact, hurt you. The other approach these authors share is their unveiling of eating and foodways as complex issues informed not only by taste, but also by political preference, ecology, tradition, and health. In this paper, I will explore the world of GMOs and why they are a meaningful issue. I will not argue that GMOs are bad and should disappear, although I do think that they should give pause to decision-makers; rather, I propose that we be allowed to make informed choices about what we use to sustain our lives on a very basic level – the food we eat that fuels our biological processes and our health. Section One gives a history of why GMOs exist. Section Two will define what GMOs are and discuss their advantages and disadvantages. Section Three will review the domestic and international laws that govern GMOs and the interactions of those laws. Craven 1 Section Four will outline a theory of liability for GMO contamination based on trespass. I. History Humans have been cultivating seeds since societies transitioned from hunting and gathering to growing their own foods.1 Seed and plant diversity thrived as they traveled and had to adapt to an ever-changing environment of new pests, soil types, and weather conditions.2 Crop diversity has changed markedly in recent history, however. Throughout history up until the 1970s, plant genetic resources3 were considered “the common heritage of mankind” and were open and available to everyone.4 In fact, public policy for most of the 19th century was focused on ensuring open and unrestricted access to plant genetic resources.5 In the late 1800’s European countries took advantage of their colonial powers by transporting plant genetic resources to Europe.6 Tobacco, cocoa, quinine, sisal, rubber, bananas, tea, coffee, sugar, nutmeg clove, and indigo were all appropriated from their native countries by European powers.7 Some countries attempted to prevent the appropriation of their native plant KEITH AOKI, SEED WARS: CONTROVERSIES AND CASES ON PLANT GENETIC RESOURCES AND INTELLECTUAL PROPERTY 9 (2008) [hereinafter SEED WARS]. 2 SEED WARS, supra note 1, at 9. Even today, plant breeders still call upon this natural diversity to learn how to adapt a crop to a specific environment. Id. 3 Seeds, or PGRs. SEED WARS, supra note 1, at 9. 4 Id. 5 Id. at 10. 6 Id. at 11-12. 7 Id. at 11. 1 Craven 2 resources by prohibiting the export of plant germplasm, but they were unsuccessful.8 The author of Seed Wars points out the irony that, “nations once treated plant germplasm as a strategic resource waiting to be exploited freely by any party who managed to appropriate a sample of that resource, given that multinational corporations looking to national patent law today view their patented seeds as legally protected from free appropriation.”9 Today, corporations own patents on specific gene variations in plants and use the patent to profit off of the plants’ genetic expression. The building blocks of genetically modified plants are the plants (and their genetic makeup) honed by nature, indigenous populations, and subsistence farmers to exhibit certain characteristics that made the plants most viable in a specific environment.10 In the past, the free availability and exchange of seed were integral to this progress. The contradiction between the past custom of free exchange and time to develop plant genetics and the present one where profit can be made and the use of seeds restricted spurs the idea that companies seeking to build on the past successes of plant genetic development owe compensation to the subsistence farmers and indigenous populations for evolving commodity crops Id. at 12. Brazil, for example, held 95 percent of the world rubber trade in the late 1800s and prohibited the export of rubber germplasm, but the British smuggled it out anyway. Today, British and U.S. companies dominate the rubber market. Id. 9 Id. at 12. 10 See SEED WARS, supra note 1, at 40. 8 Craven 3 and creating the building blocks that today’s companies use to create resistant plants.11 In the early years of the United States, the importation of plants was necessary to the survival of the early Americans.12 Farmers saved the seeds of the best plants from one season to the next.13 The continuous influx of colonists brought more varieties and cross-pollination between varieties, over time, provided even more genetic diversity.14 At the time, seed collecting was the hobby of many upper class men, Thomas Jefferson included.15 They often belonged to seed exchange societies that traded and distributed seeds among geographic areas.16 The U.S. government soon became involved in seed collection. In 1819, the U.S. Treasury directed officials traveling abroad to collect plant germplasm and bring it back to the United States.17 By 1839, the U.S. Patent Office had established a plant repository for the samples and by 1857 had established a garden specifically to “propagate and multiply seeds for widespread public distribution.”18 In the 1840s, a government seed “[Ninety] percent of all plant breeding has been done by nature itself and 9.9 percent by subsistence farmers and our Neolithic ancestors. Should modern plant breeders doing 0.1 percent of the work reap all the credit and the rewards?” SEED WARS, supra note 1, at 40. 12 Id. at 12 (quoting JACK KLOPPENBURG, FIRST THE SEED (1988, 2d ed. 2004). 13 SEED WARS, supra note 1, at 13. 14 SEED WARS, supra note 1, at 13. 15 SEED WARS, supra note 1, at 13. 16 SEED WARS, supra note 1, at 13. 17 SEED WARS, supra note 1, at 13. 18 SEED WARS, supra note 1, at 13. 11 Craven 4 distribution program, aimed at establishing a broad and stable agricultural base, distributed seed packets from the Patent Office’s seed supplies to farmers free of charge.19 As such, American agriculture, “is the product of thousands of experiments by thousands of farmers committing millions of hours of labor in thousands of diverse ecological niches over a period of many decades. Introductions might or might not be successful, but in any case they had an opportunity to cross naturally with land races, so that, even when they failed, they might leave a legacy of genetic variability.”20 There was opposition, however, from the private seed industry. Private industry argued that the gratuitous distribution of seeds should cease because private industry could get new varieties to farmers faster than the government distribution program and that the program was “antagonistic to the seed as a commodity-form and in direct competition with the private seed trade.”21 In 1924, Congress bowed to industry pressure and discontinued the free seed distribution program.22 Private industry was hard at work creating hybrid varieties and convincing Congress to protect their interests. They were using the work of Gregor Mendel, an Augustinian monk in the mid-1800s who worked on pea plants,23 to create high-yielding hybrids of commodity crops.24 This work supplanted that of the USDA, which, since its creation in 1862 to take over SEED WARS, supra note 1, at 14. SEED WARS, supra note 1, at 14 (quoting Jack Kloppenburg, FIRST THE SEED 56-7 (1988)). 21 SEED WARS, supra note 1, at 16. 22 SEED WARS, supra note 1, at 18. 23 Mendel is widely considered to be the “father of genetics.” 24 SEED WARS, supra note 1, at 16-18. 19 20 Craven 5 the Patent Office’s Division of Agriculture, had been responsible for creating and distributing new varieties of plants.25 The USDA had, however, failed to make significant progress is developing higher-yielding varieties of commodity crops, in large part because the USDA would not distribute a new variety unless the variety was superior to existing varieties.26 High crop yields, though always a measure of agricultural success, were seen as an answer to world food shortages and a way to sustain population growth.27 The private sector changed the focus of plant breeding. Instead of focusing on the cultivation of exotic varieties and determining which were best suited to soil, pest, and weather conditions, they focused on creating hybrids that combined the desirable characteristics of current varieties with the desirable traits of exotic varieties.28 All private industry needed, after eliminating their public competitor (the USDA), was legal protection. II. What are GMOs? SEED WARS, supra note 1, at 15. The Hatch Act of 1887 established and funded a network of State Agricultural Experiment Stations (SAEs), which collected, propagated, evaluated, selected, introduced, and distributed new plant varieties. Id. 26 SEED WARS, supra note 1, at 16. 27 Greg Easterbrook, Forgotten Benefactor of Humanity, ATLANTIC MAGAZINE (Jan. 1997), available at http://www.theatlantic.com/magazine/archive/1997/01/forgotten-benefactorof-humanity/6101/. 28 SEED WARS, supra note 1, at 17. 25 Craven 6 GMO is an acronym for “genetically modified organism.”29 In the context of agriculture, a GMO is created when recombinant DNA technology alters a plant’s DNA by inserting a foreign30 section of DNA.31 Once the new gene has been inserted, the plant is called “transgenic” and the new genetic trait can be inherited through standard pollination.32 These genetic enhancements are desirable in agricultural for several reasons. One reason is the increase in genetic diversity this type of breeding facilitates.33 Genetic engineering allows a scientist to borrow beneficial traits from one species and add them to another species.34 Another reason is the ability to create a plant that has the beneficial characteristics without the risk of the plant also acquiring negative characteristics. Further, the modern process of DNA manipulation in a lab reduces the time it would otherwise take for nature to create new varieties of plants.35 GMO is most commonly used, but the terms “genetically engineered,” “transgenic”, and “bioengineered” are arguably more accurate descriptions of the process; in the context of this paper, I will use them interchangeably. 30 By “foreign” I mean that the inserted DNA sequence was not part of the plant’s own genetic makeup before human intervention. 31 Transgenic Crops: An Introduction and Resource Guide, http://cls.casa.colostae.edu/TransgenicCrops/faqpopup.html (last visited March 3, 2012) [hereinafter Transgenic Crops]. The new genes can come from the same or a different species of the same plant or a completely different organism, such as a bacterium or an animal. Id. 32 Id. 33 Id. 34 Id. Scientists can also turn the expression of certain genes on and off. Id. 35 Id. 29 Craven 7 In agriculture, GMOs were developed for the most widely36 used commodity crops.37 In 2011, biotechnology varieties accounted for eightyeight percent of the corn, ninety percent of the cotton, and ninety-four percent of the soybeans planted in the United States.38 These commodity crops go on to become human consumables: Corn and soybeans are processed into animal feed and food for human consumption, among other things; cotton is made into clothing and household goods.39 For perspective, consider this: You may not think you eat a lot of corn and soybeans, but you do: 75 percent of the vegetable oils in your diet come from soy (representing 20 percent of your daily calories) and more than half of the sweeteners you consume come from corn (representing around 10 percent of daily calories).40 In addition, other, less processed foods made from these commodity crops are also affected; whole corn, corn flour, whole soybeans, tofu, and soy protein are used extensively in the consumer food market. Though the use of GMOs in commodity crops may seem far removed from the average American’s From a pessimistic view, “widely-used” is interchangeable with “government-subsidized.” 37 “With the rise of industrial agriculture, vast monocultures of a tiny group of plants, most of them cereal grains, have replaced the diversified farms that used to feed us . . . . The simplification of the agricultural landscape leads directly to the simplification of the diet, which is now to a remarkable extent dominated by . . . corn and soybeans.” MICHAEL POLLAN, IN DEFENSE OF FOOD, 116 (2008). 38 National Agricultural Statistics Service, USDA, Acreage 25-7 (2011), http://usda01.library.cornell.edu/usda/current/Acre/Acre-06-30-2011.pdf (last visited March 3, 2012). 39 See generally, How Soybeans are Used, NORTH CAROLINA SOYBEAN PRODUCERS ASSOCIATION, INC. (Apr. 4, 2012), http://www.ncsoy.org/ABOUTSOYBEANS/Uses-of-Soybeans.aspx; Products Made From Corn, CORN REFINERS ASSOCIATION (Apr. 4, 2012), http://www.corn.org/products/. 40 MICHAEL POLLAN, IN DEFENSE OF FOOD 116-7 (2008). 36 Craven 8 everyday life, they are in fact, something the average American encounters several times on a daily basis. A. Why Use GMOs? GMOs are arguably the biggest agricultural innovation of the 20th century.41 Their development allows scientists to breed more plant varieties than nature would otherwise allow.42 The process of genetic engineering in a laboratory also expedites the process of plant breeding and trait expression; essentially, it speeds up the evolution process.43 GMOs were originally developed to feed the world. The goal was to increase crop yields to increase the food supply. GMOs accomplish this by making varieties of crops that are, most commonly, tolerant of herbicides, and insecticides and resistant to disease.44 When a crop is tolerant of an herbicide, the farmer can spray the specific herbicide to which the crop is tolerant indiscriminately on crops and weeds with the knowledge that the crop will be unaffected by the chemicals that will kill the undesirable Challenged only by mechanized farming. See Carolyn Dimitri, Anne Effland & Neilson Conklon, The 20th Century Transformation of U.S. Agriculture and Farm Policy, USDA Economic Information Bulletin 6 (June 2005). 42 Transgenic Crops, supra note 31. This is true largely due to the ability of a scientist to use species traits from outside the resource pool available to a plant in nature. See note 31. 43 Transgenic Crops, supra note 31. 44 Transgenic Crops, supra note 31. 41 Craven 9 weeds.45 A GMO plant thus stands a much better chance of survival than nature would otherwise give it, which increases crop yields.46 So important to our expanding world, work on GMO development has been highly lauded. Norman Borlaug received the Nobel Peace Prize in 1970 for his work on creating high-yielding, disease-resistant varieties of wheat.47 He genetically modified wheat seeds to yield more wheat per acre than nonGMO wheat. Borlaug’s goal was to “feed the hungry people of the world.”48 Indeed, the product of his work – high-yielding wheat – is planted and harvested all over the world.49 The advent of GMOs has also made mechanized farming possible. Genetically uniform crops were much more convenient for machines to harvest than genetically varied crops.50 A field of genetically diverse crops bore fruit at different places and ripened on different schedules.51 Genetically uniform crops, on the other hand, allowed for efficient mechanization of farming, which was also necessitated by the world’s growing population.52 B. What are the negative attributes of GMOs? Id. Up to four-fifths of cultivated crops succumb to crop viruses. SEED WARS, supra note 1, at 10 n.4. 47 Norman Borlaug Biography, The Nobel Foundation (1970), http://www.nobelprize.org/nobel_prizes/peace/laureates/1970/borlaug-bio.html. 48 Id. 49 Id. 50 SEED WARS, supra note 1, at 5 n.12. 51 Id. 52 Id. 45 46 Craven 10 Despite the advances in crop genetic engineering, GMOs have not been the curtailed world hunger on the scale Borlaug had hoped for. GMOs have environmental, health, and economic impacts that require consideration; as with any large-scale intervention in a core aspect of societal function, the issue is multi-faceted and the consequences far-reaching. Human interference with nature does not always have positive consequences. We have seen it happen again and again when, for example, a well-meaning government introduces a non-native species to its lands, resulting in unintended environmental consequences. We have seen this with the Asian Beetle, Zebra Mussels, and, most recently, Asian Carp. With no natural predators, these species have become problems that outweigh their intended benefits.53 GMOs are much like a non-native species – they have known benefits (or they would not have been developed or introduced), but their consequences are largely unknown. GMOs have human health implications. Beyond the fact that what we eat affects our health, modern science is still somewhat vague on the issue. We know, for instance, that we need to eat to live, but beyond that there is controversy. The Atkins Diet would have us believe that we don’t need many See generally, Invasive Species, EPA, http://water.epa.gov/type/oceb/habitat/invasive_species_index.cfm. See also, The Multicolored Asian Lady Beetle, USDA, http://www.ars.usda.gov/is/br/lbeetle/; Asian Carp, Asian Carp Regional Coordinating Committee, http://www.asiancarp.us/documents/AsianCarpTheProblem.pdf; Invasive Species – Great Lakes, EPA, http://www.epa.gov/glnpo/invasive/index.html#Animal_Species. 53 Craven 11 plant sources of food, while a vegan diet eschews all animal products and says humans survive best on plants alone. The mechanisms for how food works in our bodies are still largely unknown. We have identified three macronutrients (carbohydrates, protein, and fats), several micronutrients (such as iron, vitamin a, and iodine), and caloric values present in specific foods. There has been a concurrent emphasis on ideal proportions of these nutrients in the human diet and the isolation and addition of individual nutrients to foods: These additions attempt to make it easier for consumers to consume and receive the benefits of the specific nutrients. Yet, when specific nutrients are isolated and consumed, the vitamins fail to produce the same health effects as when nutrients are consumed as part of a whole food.54 In the development of GMOs, the nutrient value of the resulting food is not taken in to account – only disease and pest resistance, yields, and a seed’s ability to reproduce matter.55 The effect that GMOs have on the nutrient density of food does not concern their manufacturers, nor are GMO developers required to explore the issue to introduce their products in to the human food supply.56 Supplements: Nutrition in a Pill?, MayoClinic.com (last visited March 9, 2012), http://www.mayoclinic.com/health/supplements/NU00198. 55 Biotechnology, Sidebar: Biotechnology Facts, MONSANTO, http://www.monsanto.com/products/Pages/biotechnology.aspx (last visited March 9, 2012). Only traits that allow farmers to “increase their productivity and maximize profits” matter. Id. 56 See Alison Peck, Leveling the Playing Field in GMO Risk Assessment: Importers, Exporters and the Limits of Science, 28 B.U. INT’L L.J. 241, § 3 (2010). “Genetically engineered foods pose no special risk to consumers 54 Craven 12 A second concern is the environmental impact of GMOs. Again, their impact is largely unknown. As Monsanto acknowledges, GMOs have been available for consumer consumption for only ten years,57 making them a relatively recent addition to the ecosystem.58 As such, no knowledge of the long-term effects on the environment exists. Environmental experts express concern that GMOs will themselves become pests (akin to the non-native species mentioned infra) or could be toxic to insects or create resistant insects.59 A third concern is that of organic and conventional farmers and consumers. For those who wish to avoid eating GMOs for whatever the reason, the very nature of plants makes it difficult to know if one is truly avoiding GMOs in food. Plant pollen can drift several miles when carried by the wind.60 This cross-pollination that can occur when the pollen of GMO simply because they are produced by a new process.” Diahanna Lynch & David Vogel, The Regulation of GMOs in Europe and the United States, Council on Foreign Relations (April 5, 2001), available at http://www.cfr.org/genetically-modified-organisms/regulation-gmos-europeunited-states-case-study-contemporary-european-regulatory-politics/p8688. See also, infra § II. 57 MONSANTO, Biotechnology, supra note 55. 58 See infra § 1. 59 Stephanie E. Cox, Genetically Modified Organisms: Who Should Pay the Price for Pollen Drift Contamination?, 13 DRAKE J. AGRIC. L. 401, 404 (2008). A study from Cornell University found that pollen from corn that had been genetically modified to produce the Bacillus thuringiensis (Bt) toxin is fatal to monarch butterflies. Bryan Endres, “GMO:” Genetically Modified Organism or Gigantic Monetary Obligation? The Liability Schemes for GMO Damage in the United States and the European Union, 22 LOY. L.A. INT’L & COMP. L. REV. 453, 454 (2000). 60 Cox, supra note 59, at 405. Craven 13 crops mixes with conventional and organic crops affects the genetic purity of the conventional and organic crop genes.61 A fourth concern is a drop in plant genetic diversity. Conventional agriculture and plant genetic resources developed over centuries,62 resulting in a vast array of plant varieties with an almost infinite amount of attributes. The stronger GMO plants could eliminate native species (again, akin to the non-native species mentioned infra) and reduce genetic diversity.63 GMOs reduce genetic diversity by replacing the planting of many different crops (i.e., wheat, maize, millets, and oil seeds) with only wheat and rice from monocultures derived from a very narrow genetic base.64 History tells us that homogenous genetics are a large risk to take with a nation’s food supply.65 Id. See infra § I. 63 Cox, supra note 59, at 404. “Even single genes can diminish genetic diversity.” Id. See also, Pauline Askin, Alien Invasion a Threat to Antarctic Ecosystem, Reuters (March 6, 2012), available at http://news.yahoo.com/alien-invasion-threat-antarctic-ecosystem030858080.html (last visited March 11, 2012). 64 SEED WARS, supra note 1, n.81 at 23. Fewer crops are used because of market pressures – food company preferences, government marketing orders for specific kinds of fruits and vegetables, and the derivation of plants from similar strands. JACK DOYLE, ALTERED HARVEST: AGRICULTURE, GENETICS, AND THE FATE OF THE WORLD’S FOOD SUPPLY 15 (1985); SEED WARS, supra note 1, at 23. Seed companies started with the base of genes that produced plants with desirable characteristic (i.e., high-yielding) and developed new plants with enhanced characteristics (i.e., even higher yields). See CARY FOWLER & PAT R. MOONEY, SHATTERING: FOOD, POLITICS AND THE LOSS OF GENETIC DIVERSITY 56 (1990). 65 The Irish potato famine was caused by potato blight. FOWLER, supra note 64 at 45. All of the potatoes in Ireland were descended from one line that had no resistance to the blight. Id. In the United States in the 1970s the Southern Corn Leaf Blight was the result of a man-made change to corn 61 62 Craven 14 The increased chemical inputs required by GMOs also affect the ecosystem and is an environmental concern.66 There are many facets to the debate about GMOs. Next, we will look at the regulatory scheme that governs GMOs in two different societies: the United States and the European Union. III. Governing Law The safety and consumption of GMOs are by no means a settled issue in the United States or in the rest of the world. A conflict exists between the United States and the European Union about the use and regulation of GMOs.67 A. United States In the United States, the regulation of GMOs is split between the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the United States Department of Agriculture (USDA). The EPA plants that made the corn high yielding but vulnerable to fungus. DOYLE, supra note 64, at 13. One billion bushels of corn were lost. SEED WARS, supra note 1, at 24. “Whatever made one plant susceptible made them all susceptible.” Id. at 15 (quoting NATIONAL ACADEMY OF SCIENCES, GENETIC VULNERABILITY OF MAJOR CROPS (1972). 66 “High-input farming techniques . . . [brought] with them their expensive fertilizers, pesticides, herbicides, and other high-input chemical interventions. . . .[,] causing widespread environmental degradation due to extensive agrichemical runoff, with disastrous effects on the preservation of plant genetic diversity worldwide.” SEED WARS, supra note 1, at 23. “The increased use of pesticides specifically is significant. Of the 2.5 million tons of pesticides applied annually worldwide, only 0.3 percent reaches its intended target. All the remaining tonnage enters the environment as runoff, seepage into groundwater, volatilization into the air, intake by plants and soil organisms, or retention in the soil. Id. at n.81. 67 See Lynch, supra note 56. Craven 15 oversees pesticidal68 plants and genetically engineered microbial pesticides, the FDA regulates biotechnology-derived medical products, and the USDA is responsible for transgenic plants.69 The regulatory framework for GMOs is rooted in the assumption that biotechnology is not inherently risky and so can be adequately regulated under existing statutes and existing Federal agencies without need for legislation specific to GMOs.70 Within this framework of government agencies, there are several laws that regulate GMOs. The EPA’s authority for agricultural uses of GMOs derives from two federal regulations: The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)71 and the Federal Food, Drug, and Cosmetics Act (FFDCA).72 The FIFRA applies to pesticides and plants with pesticide-like properties,73 while the FFDCA applies to pesticide residues in food, which may include food made from plants with pesticide properties.74 The FIFRA requires pesticides Pesticidal plants have pesticide-like properties that make them harmful to bugs and insects. 69 Id. 70 MARK A. POLLACK & GREGORY C. SHAFFER, WHEN COOPERATION FAILS: THE INTERNATIONAL LAW AND POLITICS OF GENETICALLY MODIFIED FOODS 10 (2009). 71 Federal Insecticide, Fungicide, and Rodenticide Act § 6, 7 U.S.C. §§ 136– 136y (2006). 72 Federal Food, Drug, and Cosmetics Act § 9, 21 U.S.C. §§ 301–399d (2009). 73 7 U.S.C. § 136u (2006). See Endres, supra note 59, at 480. 74 21 U.S.C. § 342(a)(2)(B) (2006). See Endres, supra note 59, at 480. 68 Craven 16 to be registered with the EPA and requires that a permit be obtained prior to field testing.75 Under the FFDCA, the FDA must approve all ingredients added to food, unless the food additive is “generally recognized as safe” (GRAS) by experts.76 In 1992, the FDA began a policy that presumed most GM products to be GRAS, excluding most GM products from review as food additives.77 The presumption of GRAS status was novel – the FDA had never before issued a presumption of GRAS status for new hybrids or other new food products created using traditional breeding methods.78 In the past, the FDA had expressly warned food companies against assuming an ingredient was GRAS simply because it may be present in food in other forms or in other countries.79 The FDA’s authority is limited to the marketing aspects of GMOs, but there is currently no labeling requirement for GMOs.80 The USDA regulates GMOs in agricultural research under the Plant Protection Act (PPA) and the Animal and Plant Health Inspection Service 7 U.S.C. §§ 136a, 136c (2006). 21 U.S.C. § 342(a)(1) (2006). See Peck, Leveling the Playing Field, supra note 56, at 252. 77 Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. 22984(V)(C) (May 29, 1992). “When the substance present in the food is one that is already present at generally comparable or greater levels in currently consumed foods, there is unlikely to be a safety question sufficient to call into question the presumed GRAS status of such naturally occurring substances and thus warrant formal premarket review and approval by the FDA.” Id. 78 Id. 79 Emily Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture, 44 B.C. L. REV. 733, 749 (2003). 80 Endres, supra note 59, at 480. 75 76 Craven 17 (APHIS).81 The PPA is rooted in several Congressional findings, including that “the detection, control, eradication, suppression, prevention, or retardation of the spread of plant pests or noxious weeds is necessary for the protection of the agriculture, environment, and economy of the United States.”82 The PPA requires a permit for the import, export, or interstate movement of any plant pest, plant product, plant, biological control organism, or noxious weed.83 The PPA also allows for a person to petition to add or remove a covered plant or organism from regulation.84 APHIS is the agency of the USDA responsible for any regulating or de-regulating. In addition to oversight as a food product, GMOs are also subject to patent law. In contrast to food laws, patent law serves to protect GMOs instead of potentially limiting their use. The Supreme Court decision in Diamond v. Chakrabarty opened the door for the lawful patenting of genetic material.85 Earlier decisions had struck down the idea under the “products of nature” doctrine, which held that discoveries of natural phenomena were not patentable.86 Diamond distinguished “products of nature” by categorizing Plant Protection Act § 104, 7 U.S.C. § 7701-7786 (2000). See Endres, supra note 59, at 481. 82 7 USC § 7701(1). 83 7 USC § 7712(c)(1). 84 7 USC § 7712(f)(2), (g)(2). 85 Diamond v. Chakrabarty, 447 U.S. 303 (1980); Christopher J. Betti, Diagnostic Genetic Technologies Left Stranded on First Base: A Need to Unwind the Protection Afforded Gene Patents, 17 DCBA BRIEF 22 (Apr. 2005). 86 Along the same lines as the “common heritage of man” doctrine. Infra § I. 81 Craven 18 genetically modified organisms as “new manufacture or composition” under the Patent Act.87 Patent protections include the right to project against the unauthorized use of the patented material. As such, the owners of GMO patents license the use of their genetically modified seed to farmers for one growing season at a time.88 Furthermore, the patent-holder retains ownership of the gene material (the seed) and the right to sue infringers for unauthorized use.89 The laws in the United States that govern the use of GMOs do not differ greatly from those that regulate conventional foodstuffs. The United States’ view that GMOs do not warrant oversight beyond that required over nature-evolved food is unique in international law. B. European Union The European Union (EU) has taken a drastically different approach to regulating GMOs than has the United States. Instead of regulatory Betti, supra note 85, at 23. A “new manufacture or composition” is the creation of an organism with characteristics not found in nature. Id. 88 See, e.x., Monsanto Grower Agreement (2010), available at http://www.doeblers.com/08/2010%20Monsanto%20Technology%20Stewardsh ip%20Agreement%20-%20Downloadable%20version.pdf (last visited March 11, 2012). “Grower may not plant or transfer to others for planting any Seed that that the Grower has produced containing patented Monsanto Technologies for crop breeding, research, or generation of herbicide registration data.” Id. 89 Under the “Grower Receives from Monsanto Company” section: “Monsanto retains ownership of the Monsanto Technologies including the genes (for example, the Roundup Ready® gene) and the gene technologies. Grower receives the right to use the Monsanto Technologies subject to the conditions specified in this Agreement.” Id. 87 Craven 19 agencies, such as the United States’ FDA, oversight of biotechnology in the EU is through political avenues such as the European Parliament.90 The EU has taken a much stricter and more precautionary approach to GMO legislation.91 The EU approach embodies the idea that unless it’s proven safe, it’s not safe.92 All GM crops are subject to special authorization procedures and are then subject to strict labeling laws.93 The approval of new GM varieties in Europe is a much more involved process with more officials and more and stricter risk assessments.94 As a result, it takes much longer to approve new GM varieties in Europe than it does in the United States.95 Once approved on the EU level, GMOs are not in the clear. GMOs can still be banned by a member state of the EU and are subject to labeling laws that require consumer notification of the GMO status of food.96 The final hurdle for GMOs in the EU is public sentiment. Consumers in Europe are largely reluctant to consume GMOs and so retailers are less receptive to carrying products containing GMOs in their stores.97 POLLACK, supra note 70, at 10. Id. 92 In contrast to the U.S. approach that unless it’s proven unsafe it’s considered safe. 93 POLLACK, supra note 70, at 10-11. 94 Id. 95 Id. at 11. 96 Id. 97 Id. at 11, 13. 90 91 Craven 20 The Directorate General on the Environment, Consumer Protection, and Nuclear Safety (DG XI) is the applicable authority for GMO regulation.98 Based on the precautionary guidance offered by DG XI, the European Council passed Directive 90/220/EEC on the Deliberate Release of Genetically Modified Organisms.99 The directive required the applicant who wished to conduct GMO field tests to submit an environmental risk assessment to the country where the testing was to occur and then to apply to each member state separately for permission to market the products within their borders.100 The EU member states have the right to restrict or prohibit the sale or marketing of a product within their borders, even if approved on the EU level, if the member has a “justifiable reason” that the product poses “a risk to human or the environment.”101 The EU’s regulation of GMOs mirrors EU members’ qualms about GMOs. The objectives of the legislation, to protect health and the environment, represent the main consumer concerns about GMOs.102 An Lynch, supra note 56. Id. 100 Id. 101 Id. See also, Press Release, GMOs: Member States to be given full responsibility on cultivation in their territories, EUROPEAN COMMISSION, HEALTH AND CONSUMERS (July 13, 2010), http://europa.eu/rapid/pressReleasesAction.do?reference=IP/10/921&format= HTML&aged=0&language=EN&guiLanguage=en (last visited March 12, 2011). 102 Press Release, Questions and answers on the evaluation of the European Union's GMO legislation, EUROPEAN COMMISSION, HEALTH AND CONSUMERS (October 28, 2011), http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/11/742&for 98 99 Craven 21 evaluation of EU regulation of GMOs103 found that improved implementation is a growth area, but did not encourage changing the legislation.104 The EU has taken a much more precautionary, process-based approach to GMO legislation and approval; whereas the United States has adopted a GRAS policy for GMOs, the EU has maintained a strict approval process. The contrast between EU policy and United States policy is significant for the United States because EU policy limits EU imports of GM foods and crops. III. Liability A. Current Theories of GMO Liability As it stands now, liability for damage due to GMOs in the United States falls under one of several categories, depending on the identity of the damaged party. If you are a farmer who does not want GMOs growing in your field, you can sue your neighbor the GMO grower for a property-related claim grounded in nuisance, strict liability, or trespass.105 If you are a GMO manufacturer, you can file a claim against a farmer for using your patentprotected GMO without your permission. mat=HTML&aged=0&language=EN&guiLanguage=en (last visited Mar. 12, 2012). 103 Evaluation of the EU legislative framework in the field of food and feed (July 12, 2010), available at http://ec.europa.eu/food/food/biotechnology/evaluation/docs/evaluation_gm_re port_en.pdf (last visited Apr. 5, 2012); Evaluation of the EU legislative framework in the field of cultivation of GMOs (March 15, 2011), available at http://ec.europa.eu/food/food/biotechnology/evaluation/docs/gmo_cultivation_r eport_en.pdf (last visited Apr. 5, 2012). 104 Food and Feed, supra note 103. See Questions, supra note 102. 105 Cox, supra note 59, at 409. Craven 22 For the farmer plaintiff damaged by GMO presence in his fields, this is not a good arrangement. For a nuisance claim, the farmer generally would have to prove that the GMO invaded the farmer’s interest in the reasonable use and enjoyment of the farmer’s land.106 In Minnesota, however, as in many other states, agricultural operations are generally protected against nuisance claims as long as the agricultural operation complies with all applicable laws, has existed for at least a specific length of time, usually one or two years, and operates according to generally accepted agricultural practices.107 Strict liability is holds the producer of a product liable for any damage the product does regardless of intent. Strict liability is generally reserved for “abnormally dangerous activit[ies] . . . although [the actor] has exercised the utmost care to prevent the harm.”108 In order for an activity to be “abnormally dangerous,” there are several factors to consider, including the likelihood and degree of harm, the ability to eliminate the risk using reasonable care, and the extent to which the activity is commonly used.109 Id. MINN. STAT. 561.19 (2011). A significant alteration of the agricultural operation can reset the established date of operation, but the adoption of a new technology or a change in the crop product produced (i.e., GMOs) does not qualify as a significant alteration. Id. See, e.g., MISS. CODE ANN. § 95-329 (West 2011); IND. CODE ANN. § 32-30-6-9 (West 2011); N.C. GEN. STAT. ANN. § 106-701 (West 2011); CAL. CIVIL CODE § 3482.5 (West 2011); GA. CODE ANN. § 41-1-7 (West 2011); COLO. REV. STAT. ANN. § 35-3.5-102 (West 2011). 108 RESTATEMENT (SECOND) OF TORTS § 519 (2012). 109 RESTATEMENT (SECOND) OF TORTS § 520 (2012). There are six factors as follows: (a) existence of a high degree of risk of some harm to the person, land 106 107 Craven 23 The farmer would have to argue that the activity of planting GMOs is abnormally dangerous and the argument is likely to fail on the first two factors, degree of risk and likelihood of harm.110 The liability would fall to the person that engages in the dangerous activity, namely, the neighboring farmer. Trespass is the third liability theory for a farmer who has had GMO pollen drift onto his field. In Minnesota, trespass stands as a viable avenue for recovery. The recent case of Johnson v. Paynesville Farmers Union Cooperative Oil Company holds that pesticide drift can constitute a trespass.111 In differentiating pesticide drift from wafting odors, the court explained that, “while wafting odors will not affect the composition of the land, a liquid pesticide or herbicide being sprayed for agricultural purposes will; by design, it descends and clings to soil or plants, killing organisms.”112 While this issue awaits a final determination by the Minnesota Supreme Court, the Minnesota Court of Appeals held that damages could accrue from or chattels of others; (b) likelihood that the harm that results from it will be great; (c) inability to eliminate the risk by the exercise of reasonable care; (d) extent to which the activity is not a matter of common usage; (e) inappropriateness of the activity to the place where it is carried on; and (f) extent to which its value to the community is outweighed by its dangerous attributes. Id. 110 Roger A. McEowen, Legal Issues Related to the Use and Ownership of Genetically Modified Organisms, 43 WASHBURN L.J. 611, 624-5 (2004). 111 Johnson v. Paynesville Farmers Union Cooperative Oil Company, 802 N.W.2d 383 (Minn. 2011). 112 Id. at 388. Craven 24 pesticide drift.113 In Johnson, the Johnson farm’s organic certification was put at risk and the Johnson’s incurred costs to attempt to eliminate the offending presence of the pesticide, including affects on their crop rotation, removing some fields from production, and destruction of crops.114 The privileges the GMO patent holders enjoy due to patent protections are perhaps the biggest threat to the non-GMO farmer. The patent holder holds the right to enforce their exclusive right to control their proprietary product by suing anyone who uses the product without the patent-holder’s permission.115 The non-GMO farmer is usually only liable if the farmer grows the GMO crop, but the alternative to growing it (even when it’s presence is due to drift and it was not initially deliberately planted by the non-GMO farmer) is to dig up the field or take it out of production for a period of time sufficient to allow the patented plant to not intermingle with the non-GMO plants.116 Monsanto brought a successful suit against a conventional farmer in Canada for patent infringement.117 Percy Schmeiser harvested his crops and saved his seed, as he had always done, but his crops were contaminated with Id. at 391. Id. 115 See infra § III(A); Kanchana Kariyawasam, Legal Liability, Intellectual Property and Genetically Modified Crops: Their Impact on World Agriculture, 19 PAC. RIM L. & POL’Y J. 459 (2010). 116 See SEED WARS, supra note 1, at 39. 117 Schmeiser v. Monsanto, [2002] F.C. 309 (Can.), available at http://reports.fja.gc.ca/eng/2003/2002fca309.html (last visited Apr. 5, 2012); Kariyawasam, supra note 115. 113 114 Craven 25 pollen from a Monsanto-patented GMO canola.118 He re-planted his saved seed the next season, consistent with normal farming practice.119 Schmeiser grew suspicious of the presence of GMOs when he sprayed Roundup along the roadway and a large number of canola plants survived.120 Schmeiser’s canola crop subsequently tested positive for the “Monsanto gene” that made the canola resistant to glyphosate (Roundup).121 The court held that the farmer’s awareness of the presence of the GMO seed is irrelevant to the question of patent infringement – Schmeiser knew or ought to have known of the possibility that his crops were contaminated with GMO canola seed and Schmeiser was found guilty of patent infringement.122 Though Scheimser did not want Monsanto’s seed in his field, did not use Roundup on his canola crop,123 and did not benefit from the glyphosate resistance, the mere presence of the patented gene in his crop was enough for liability to attach.124 It is a lengthy and costly process for a farmer to remove GMO seed from a field; even more so in the case of an organic farmer. In order to Kariyawasam points out the disequilibrium of the broad patent protections Schmeiser, F.C. 309 (2002). Id. 120 Id. 121 Id. 122 Id. 123 He only used Roundup to kill plants and weeds along the roadway. Id. 124 In fact, the invasion of the patented seeds ruined Schmeiser’s work in developing his own strain of canola by saving his seeds every year. Stephanie M. Bernhardt, High Plains Drifting: Wind-Blown Seeds and the Intellectual Property Implications of the GMO Revolution, 4 NW. J. TECH. & INTELL. PROP. 1, ¶ 11 (2005). 118 119 Craven 26 extended to GMOs without the accompanying liability for the harms GMOs cause.125 B. Proposal for GMO Manufacturer Liability GMOs raise complicated and unsettled issues in the United States. Some sectors and people have embraced the new technology and point to short-term use and evidence of their suitability for continued use. Others take more of a cautionary approach and would like to see more evidence of safety or harm before jumping in with both feet. We should approach GMOs with caution. We need to be able to feed the world, but we also “need to reorient our regulation from a reactionary to a precautionary posture.”126 Our foodways would be much safer if “proof of safety” requirements were more common than “proof of harm” requirements.127 As such, we need more legislation limiting GMOs. GMOs need not be eliminated – they could be promising and have some distinct advantages – but the only or best hope for the future is not dependence on the large agricultural companies who hold the patents to GMOs. In Minnesota, the theory of trespass remains a means of legal redress for damages caused by GMOs.128 GMO damages parallel the damages the Johnson’s allege in Johnson, namely, crop loss, farm planning, removing Kariyawasam, supra note 115, at 471-2. Jeffrey A. Hank, Chemicals and Toxins in Consumer Goods, 89-SEP MICH. B.J. 33, 35 (Sept. 2010). 127 See id. at 35. 128 See infra § III(A); Johnson v. Paynesville Farmers Union Cooperative Oil Company, 802 N.W.2d 383 (Minn. 2011). 125 126 Craven 27 fields from production, and loss of price on crops.129 The Johnson’s, like many who would suffer damages from GMOs, are organic farmers and damages such as loss of price are specific to loss of the premium price organic food commands in the marketplace and potential loss of organic certification.130 Damages can also lie with conventional farms, not just with organic. If the farmer does not want GMO plants and has them in his field, he is harmed at least by the time and effort required to remove the GMOs from his fields and at the most by loss of value; he would not be able to export his crops to Europe or Japan, for example, nor sell them as non-GMO. In order to remove GMO seeds from a field, the soil has to be replaced, which an expensive undertaking.131 Limiting the spread of GMOs is also a challenge. It may be impossible, however, to eliminate contamination completely in areas where both conventional and GMO plants are grown in relatively close proximity. Buffer zones are a common way to help limit the spread of GMOs, but it is often the farmer who does not plant GMOs that bears the burden of maintaining the buffer; it is the non-GMO farmer, after all, who stands to be harmed by GMOs unintended presence in the non-GMO crops. A buffer of up to 800 meters may be required to isolate canola,132 other crops may require more or less of a buffer, but the responsibility for maintaining the buffer should be Johnson, 802 N.W.2d, at 391. See id., at 390-1. 131 Bernhardt, supra note 124, at ¶ 22. 132 Bernhardt, supra note 124, at ¶ 14. 129 130 Craven 28 shared proportionate to acreage.133 In addition to a buffer, planting GMO and non-GMO crops at different times will help reduce crosscontamination.134 This must be coordinated among neighbors in order to be effective. Isolation methods, however, should not be the only remedy for pollen drift – there should also be retroactive solutions to GMO contamination. When GMOs cross property lines unintentionally, as pollen, is wont to do, the non-GMO farmer is harmed by the invasion of his land. The party alleging harm must prove the two elements of trespass: (1) the claimant’s rightful possession of the land; and (2) defendant’s unlawful entry.135 Given that pesticide drift in Johnson could constitute a trespass, GMOs could, too, relying on the courts distinctions requiring “discernible deposits” on the claimant’s land136 and “affect[ing] the composition of the land.”137 Liability for trespass in the case of GMOs should not, however, rest with the neighboring farmer but with the manufacturer of the GMO. If the manufacturer holds the patent to a GMO, is allowed to license the GMO at its discretion, and can sue for damages if the GMO is discovered in a place the PETER THOMISON, OHIO ST. U. EXTENSION, MANAGING “POLLEN DRIFT” TO MINIMIZE CONTAMINATION OF NON-GMO CORN (2003). 134 Johnson, 802 N.W.2d, at 391. 135 Id. at 387. 136 Id. at 389. 137 Id. at 388. 133 Craven 29 GMO is not authorized to be138, the manufacturer should be liable if the owner of the land with the errant GMO does not want the GMO. Trespass liability for GMOs need not be determined by a traditional court of law, but by trustees of an Indemnity Fund. Legislation proposing a similar idea has been seen before.139 The Fund would be funded through a tax on GMO manufacturers or a fee on the sale of GMOs from the manufacturer to the grower. It is important that a farmer who has suffered damage not be required to bring action against his neighbor or against a multi-national corporation. Legal action in rural communities against neighbors can fracture those communities, the health of which is vital to the preservation of good will and perhaps the town or city itself. It is also unreasonable, as a practical matter, to presume that a farmer has the resources to sue a company such as Monsanto or Dow. Farming is not a glamorous profession for most and its practitioners work hard to supply their surrounding communities and the country with food. The Fund would not be intended to indemnify the farmers who use GMOs. GMO growers would need to document their compliance with reasonable measures to avoid pollen drift (i.e., wind direction, buffer zones, weight additives, coordination of planting schedules). The policy behind the Fund would be to allow those damaged by GMOs to be able to recover and to place the responsibility with the entity that wishes to protect the GMO – the 138 139 Bernhardt, supra note 124, at §§ V–VI. It was proposed in Iowa, but was not passed. Cox, supra note 59, at 414. Craven 30 patent-holder. The Fund would help to stop the spread of GMOs by providing the resources for the non-GMO farmer to reverse GMO contamination. By allocating financial resources from the entity that profits from the GMO to those who are actually harmed by the GMO’s presence, the quality of food and biodiversity have better protection, too. IV. Conclusion GMOs have become ubiquitous with the soybean, canola, and corn. While the potential advancements and improvements in agricultural yields should not be ignored, we should be more cautious in their widespread adoption. International sentiment in the European Union mirrors this precautionary approach. With the understanding that GMOs are not going away, we need a regulatory framework that both acknowledges that harm can come from GMOs and supports individual choice in whether or not to consume them. Food’s place as one of the human’s most basis survival requirements only underscores its supreme importance in our lives. The ability for an individual to make his or her own choices about food quality and food source is a basic freedom we in this country should continue enjoy. 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