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Seeds of hope: how new genetic technologies may increase value to farmers, seed companies, and the developing world.



1. INTRODUCTION

When Nobel Prize Nobel Prize, award given for outstanding achievement in physics, chemistry, physiology or medicine, peace, or literature. The awards were established by the will of Alfred Nobel, who left a fund to provide annual prizes in the five areas listed above.  winner Norman Borlaug Norman Ernest Borlaug (born March 25 1914) is an American agricultural scientist, humanitarian, Nobel laureate, and has been called the father of the Green Revolution.[1]  died in September 2009, a chorus of academics, scientists, and public policy experts sang his praises. (1) Borlaug was widely credited as the father of the "Green Revolution," the technological transformation of agriculture that has allowed food production to keep apace with explosive population growth since 1945. (2) Borlaug proclaimed that his work, by advancing the growth of more crops on less land, enabled countries such as India and Mexico, which historically faced difficulties feeding their expanding populations, to become largely self-sufficient. (3)

The Green Revolution has nonetheless sparked controversy. During Borlaug's lifetime, environmental advocate Vandana Shiva Vandana Shiva (b. November 5, 1952, Dehra Dun, Uttarakhand, India), is a physicist, ecofeminist, environmental activist and author. Shiva, currently based in New Delhi, is author of over 300 papers in leading scientific and technical journals.  contended that the ethnic violence that occurred in the Punjab region This article is about the geographical region. For other uses, see Punjab.
Punjab /span>]]?·i ਪੰਜਾਬ in Gurmukhi, Punjabi:
 of India in the mid-to-late 1980s could be traced directly to the influence of Borlaug's agricultural policies, which resulted in a scarcity of resources and the destruction of both the environment and a way of life. (4) Borlaug responded to such criticism by claiming that it was not the scientific development per se that had caused such problems, but the explosive population growth that made such developments necessary in the first place. (5)

This debate is symptomatic of a larger discussion about the role technology plays in food production. The development of new technologies (GM technologies) capable of altering the genetic makeup of plants has led to the production of genetically-modified organisms (GMOs), further intensifying the debate. (6) The commercialization of GMOs has allowed agriculture to move from a subsistence-based activity to a commercial operation and to the streamlining of seed production, as corporations compete to develop genetically-modified seeds with either the highest yields or the strongest resistance to pest or drought. (7)

Although the isolation of certain genetic traits in agriculture is nothing new, (8) the commercialization of the seed industry has significantly complicated the worldwide network of food production. Corporations, consumers, and farmers often work with competing objectives, advocating for or against different agricultural technologies in the pursuit of their respective interests. Mutual mistrust and an unwillingness to work together hinder the accomplishment of collective public goals, such as establishing sustainable agricultural systems and feeding the hungry.

One particular type of GM-technology which has generated enormous controversy is Genetic Use Restriction Technologies (GURTs). In their most common form, GURTs are a kind of anti-germinating, self-sterilizing seed, which are unable to reproduce after one growing season growing season, period during which plant growth takes place. In temperate climates the growing season is limited by seasonal changes in temperature and is defined as the period between the last killing frost of spring and the first killing frost of autumn, at which . (9) These seeds were developed by the biotechnology industry for the primary purpose of protecting biotech companies' intellectual property rights. (10) As is often the case with attempts to regulate technology, the rapid advancements in genetically modified genetically modified
Adjective

(of an organism) having DNA which has been altered for the purpose of improvement or correction of defects

genetically modified genetic adj [food etc] →
 organisms continue to outpace any attempts at administrative or statutory regulation. Although numerous jurisdictions have enacted laws that regulate GMOs or have enacted a legal framework for apportioning liability resultant harm from the use of GMOs, (11) few attempts have been made, specifically, to regulate GURTs.

This note provides a comprehensive discussion of the issues surrounding GMOs and GURTs, from the history of their development, to a discussion of their risks and benefits, and an analysis of how the law should address both the property rights in this technology and the resulting torts. Finally, following an analysis of the means by which farmers and biotechnology companies Top 100 Biotechnology Companies
The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies.
 inefficiently use litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 to pursue their goals, this note argues for the use of GURTs as a solution to the problem of social cost in a GMO GMO
abbr.
genetically modified organism
 context. In addition to increasing efficiency, GURTs can simultaneously assuage as·suage  
tr.v. as·suaged, as·suag·ing, as·suag·es
1. To make (something burdensome or painful) less intense or severe: assuage her grief. See Synonyms at relieve.

2.
 many concerns about GMOs, including the perception that GMOs threaten human health and the environment. If GURTs are brought to the marketplace, many of the concerns and controversies that surround GMOs would be alleviated, and farmers and biotechnology companies could better pursue their interests without the detraction de·trac·tion  
n.
1. The act of detracting or taking away.

2. A derogatory or damaging comment on a person's character or reputation; disparagement:
 of costly and inefficient litigation.

2. BACKGROUND OF GURTS

In March 1998, the U.S. Patent & Trademark Office granted a patent for the "[c]ontrol of plant gene expression" to researchers at the Delta and Pine Land Co. and the U.S. Department of Agriculture. (12) The patent covers "[p]lant cells, plant tissues, plant seed, and whole plants containing the above DNA DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
 sequences" (13) One application of this patented technology was a form of "self policing" seed that can sterilize sterilize /ster·i·lize/ (ster´i-liz)
1. to render sterile; to free from microorganisms.

2. to render incapable of reproduction.


ster·il·ize
v.
1.
 itself after one growing season. (14) Known as the "antigermination patent" by scientists and dubbed "terminator technology "Terminator gene" redirects here. For DNA transcription terminators, see terminator (genetics).

Terminator Technology is the colloquial name given to proposed methods for restricting the use of genetically modified plants by causing second generation seeds to be sterile.
" by critics, these seeds have not yet been made commercially available as of the writing of this note. (15)

Monsanto, the world's largest seed producer, (16) acquired the Delta and Pine Land Co. in 2007 and consequently acquired the antigermination patent. (17) Monsanto pledged in 1999 not to commercialize this technology and in 2006, the United Nations Convention on Biodiversity adopted a moratorium on the commercialization and field testing of these particular seeds. (18)

Canada, with support from Australia and New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. , recommended lifting the ban on field testing and suggested instead a case-by-case evaluation of the risks and benefits of this technology. (19) Under pressure from other major agricultural producers, such as Brazil, the ban remains in place. (20) Some activists continue to question Monsanto's promise not to commercialize the technology, arguing that unless governments impose a blanket ban on the technology, the threat of commercialization remains. (21) At this time, Monsanto maintains that it will neither develop nor sell the "terminator seeds." (22)

The term GURT n. 1. (Mining) A gutter or channel for water, hewn out of the bottom of a working drift.  was first proposed by molecular biologist Richard Jefferson and his colleagues in a study for the secretariat at the United Nations Convention on Biological Diversity The Convention on Biological Diversity, known informally as the Rio Treaty, is an international treaty that was adopted at the Earth Summit in Rio de Janeiro in 1992.  (CBD (Component Based Development) Building applications with components (objects). See component software.

CBD - component based development
). (23) Two types of technologies fall under the category of GURTs: TGURTs, which activate or deactivate a particular trait in an organism through a chemical inducer; and V-GURTs, which interfere with reproduction by yielding sterile seeds. (24) Additionally, there are three distinguishable varieties of VGURTs. (25) In the first category, fertile seeds can be made infertile in·fer·tile
adj.
Not capable of initiating, sustaining, or supporting reproduction.


infertile,
adj unable to produce offspring.
 through the activation of a chemically dormant lethal gene. (26) A second V-GURT can render a sterile seed fertile through the application of a chemical compound. (27) Finally, for vegetatively reproducing crops, a gene which represses growth during storage can be expressed through a chemical application. (28)

Another characteristic of this technology is that it provides an inherent biological means of enforcing the intellectual property rights of patent holders, which is especially useful to biotechnology companies operating in countries where patent and intellectual property rights are not strongly enforced. (29) For example, biotechnology companies selling patented, genetically modified seeds routinely require their customers to sign licenses that stipulate that the seeds will be planted for only one growing season and not hoarded for future use. (30) The yet un-commercialized terminator gene automatically sterilizes the crop after one growing season, thereby eliminating the need for biotechnology companies to investigate their customers' crops to ensure compliance with their contractual terms.

Activist groups such as Greenpeace, Friends of the Earth, and Organic Growers of the British Soil Association have continually criticized antigermination technology. (31) Greenpeace, for example, maintains that in addition to raising health and environmental concerns, the technology will lead to a consolidation of power in the seed industry that eventually will strangle Strangle

An options strategy where the investor holds a position in both a call and put with different strike prices but with the same maturity and underlying asset. This option strategy is profitable only if there are large movements in the price of the underlying asset.
 small farmers. (32) These organizations have been extraordinarily successful in arguing either for stronger regulation or an outright ban on many GMO products. (33) For example, anti-biotech forces successfully lobbied for and won a ban on the import of genetically modified crops into the European Union less than two years after the arrival of the first genetically modified soybeans on the continent. (34)

3. WHY SHOULD GMOS AND GURTS BE REGULATED?

Like all food and food additives, genetically modified food must be carefully evaluated by health and environmental agencies to ensure its safety for human or animal consumption. Yet, much of the concern generated over genetically modified foods--whether calling for stronger regulation, better labeling, or an outright ban--often stems less from scientific evidence of their harm than from deeply-rooted notions about the nature of human civilization. (35) This section first examines how the development of GURTs has led to increased regulation. Second, this section explores how a move into genetically modified products by companies and farmers can create unforeseen costs to them, a theme discussed later in greater detail. Finally, this section evaluates the perceived health, environmental, and sociological risks associated with GURTs and other GMOs.

3.1 Reasons for the Development of GURTs

Commentators have suggested three main reasons for the development of GURTs. (36) First, antigermination technology such as the terminator gene is designed to give biotechnology companies more control over the use of their products than legal recourse ever can. (37) In essence, GURTs have the potential to extend intellectual property protection beyond the length provided by statute. (38) Second, GURTs have the potential to contain transgenes in GMOs. (39) Third, they have the potential to act as a tool of "precision agriculture," i.e. as a switch that can be activated or deactivated to optimize growing conditions. (40) This discussion focuses on those GURTs which were developed to strengthen the proprietary rights of biotechnology companies, as these GURTs raise the most significant issues impacting policy.

3.2 Risks Associated with GURTs

The threats associated with GURTs specifically include many of the same risks posed by GMOs in general. Broadly speaking Adv. 1. broadly speaking - without regard to specific details or exceptions; "he interprets the law broadly"
broadly, generally, loosely
, these common dangers fall into three categories: perceived risks to human health, risks to the environment, and the sociological risks associated with a restructuring of the global food supply.

3.2.1 Perceived Risks to Human Health

The risks to human health posed by GMOs have been the subject of much public concern, due in part to media sensationalism sensationalism, in philosophy, the theory that there are no innate ideas and that knowledge is derived solely from the sense data of experience. The idea was discussed by Greek philosophers and is shown variously in the works of Thomas Hobbes, John Locke, George  that accompanies any news of illnesses possibly linked to GMO consumption. (41) Nevertheless, the Food and Drug Administration (FDA) has maintained its official position on these health risks, testifying to the U.S. Senate Committee on Agriculture, Nutrition and Forestry in June of 2005 that, consistent with the FDA's 1992 policy, the FDA remains "confident that the bioengineered foods on the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  market today are as safe as their conventional counterparts." (42) This testimony suggests that the FDA may evaluate genetically modified foods for health risks in the same way as conventionally grown Conventionally grown is an agriculture term referring to a method of growing edible plants (such as fruit and vegetables) and other products. It is opposite to organic growing methods which attempt to produce without synthetic chemicals (fertilisers, pesticides, antibiotics,  food. (43)

The World Health Organization, however, has set forth six categories of concern regarding genetically modified foods: "(a) direct health effects (toxicity); (b) tendencies to provoke allergic reaction allergic reaction
n.
A local or generalized reaction of an organism to internal or external contact with a specific allergen to which the organism has been previously sensitized.
 (allergenicity); (c) specific components thought to have nutritional or toxic properties; (d) the stability of the inserted gene; (e) nutritional effects associated with genetic modification; and (f) any unintended effects which could result from the gene insertion." (44) This section focuses on toxicity, allergenicity, and nutritional effects, using some of the more remarkable examples from recent years.

3.2.1.1 Allergenicity and Toxicity

A common refrain from biotechnology companies and their defenders is that genetic manipulation of plants is nothing more than what Gregor Mendel did 150 years ago: selective breeding
This article focuses on selective breeding in domesticated animals. For alternate uses, see artificial selection.


Selective breeding in domesticated animals is the process of developing a cultivated breed over time.
 to produce desired traits. (45) Some have even argued that genetically modified crops are safer for human consumption because of the precision with which the genetic changes are effected. (46)

The evidence suggests, however, that there are substantial differences between the crossbreeding that Mendel practiced and what the major biotechnology companies are doing today. Although genetic engineering is more precise than crossbreeding in some respects, it is also more random because scientists are isolating one of possibly a hundred thousand genes. (47) Once an isolated gene is inserted into a plant, the scientist has little control over where it ends up in the plant's chromosome. (48) The gene may likely produce the desired resulting trait, but it may also produce nothing; even worse, it may also produce an allergen allergen /al·ler·gen/ (al´er-jen) an antigenic substance capable of producing immediate hypersensitivity (allergy).allergen´ic

pollen allergen
 or a toxin. (49) While the vast majority of genetically modified crops have had no conclusively proven adverse effects on human health, two examples of unforeseen toxins possibly arising from genetic engineering serve to remind of the dangers in manipulating with plants at the genetic level.

3.2.1.1.1 L-trytophan

In late 1989, the diet supplement L-tryptophan, marketed by a Japanese firm in the form of tablets, capsules, and caplets, was linked to a rare blood disorder Noun 1. blood disorder - a disease or disorder of the blood
blood disease

cytopenia - a deficiency of some cellular element of the blood

acidemia - a blood disorder characterized by an increased concentration of hydrogen ions in the blood (which falls
 called eosinophilia-myalgia. (50) Ultimately the drug caused the deaths of twenty-four people and the illness of fifteen hundred others. (51) Because the company had used genetically engineered genetically engineered adjective Recombinant, see there  bacteria in producing the drug, opponents argued that this was an example of the unpredictable consequences of gene isolation. (52) How exactly the toxins got into the supplements is still not conclusive. (53)

3.2.1.1.2 StarLink Corn

Another example of concern over allergic reactions to GMOs is the StarLink corn controversy. Aventis CropScience patented transgenic maize, injected with a common bacterium, bacillus bacillus (bəsĭl`əs), any rod-shaped bacterium or, more particularly, a rod-shaped bacterium of the genus Bacillus. Some bacterium in the genus cause disease, for example B.  thuringiensis (Bt), that repels certain insects. (54) Although the FDA had approved the transgenic maize only for animal feed, the maize nevertheless made its way into tortilla shells sold in U.S. stores. (55) In the fall of 2000, fifty-one people who complained of sickness from eating tacos and corn tortillas later discovered that their tacos and tortillas contained StarLink corn. (56) Of those, twenty-eight appeared to have suffered a food allergy food allergy Allergy medicine A condition, the incidence of which–0.3-7.5%–is obscured by controversial data and differing disease definitions; food-induced reactions of immediate-hypersensitivity type are common and include anaphylaxis, angioedema, , and seventeen agreed to take a blood test for the CDC See Control Data, century date change and Back Orifice.

CDC - Control Data Corporation
. (57) The CDC found no evidence that the people who claimed an adverse reaction were allergic to the Bt protein. (58)

Nevertheless, the damage from negative publicity had been done. Foodstuffs foodstuffs nplcomestibles mpl

foodstuffs npldenrées fpl alimentaires

foodstuffs food npl
 containing StarLink corn sent as aid to Africa were rejected locally. (59) Aventis CropScience also agreed to pay millions to settle lawsuits filed by everyone from grain elevator grain elevator

Storage building for grain, usually a tall frame, metal, or concrete structure with a compartmented interior; also, the device for loading grain into a building.
 operators and farmers to grain exporters, despite the lack of conclusive evidence CONCLUSIVE EVIDENCE. That which cannot be contradicted by any other evidence,; for example, a record, unless impeached for fraud, is conclusive evidence between the parties. 3 Bouv. Inst. n. 3061-62.  that StarLink com had caused the allergy. (60)

3.2.2 Risks of GMOs to the Environment

Evidence that GMOs may pose risks to the environment is stronger and more substantial than evidence that they pose risks to human health. (61) The most common areas of environmental concern include threats to biodiversity, decline in yields, threats to animal species (especially insects), genetic drift genetic drift: see genetics.
genetic drift

Change in the pool of genes of a small population that takes place strictly by chance. Genetic drift can result in genetic traits being lost from a population or becoming widespread in a population without
, and the possibility of crossbreeding with hardy invasive species
See also: Introduced species


Invasive species is a phrase with many definitions. The first definition expresses the phrase in terms of non-indigenous species (e.g.
 to produce "superweeds."

3.2.2.1 Threats to Biodiversity

The terms "genetic erosion Genetic erosion is a process whereby an already limited gene pool of an endangered species of plant or animal diminishes even more when individuals from the surviving population die off without getting a chance to meet and breed with others in their endangered low population (see: " and "loss of biodiversity" are often associated with genetically modified plants. (62) Selective breeding and gene modification squeeze out traditional varieties of plants and tend to increase the genetic uniformity of crops. (63) The reliance on a single crop of one genetic makeup may make the same crop more vulnerable to disease. If a plague wipes out this single crop, it can devastate dev·as·tate  
tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates
1. To lay waste; destroy.

2. To overwhelm; confound; stun: was devastated by the rude remark.
 a society. This occurred during the Irish potato famine Irish Potato Famine

(1845–49) Famine that occurred in Ireland when the potato crop failed in successive years. By the early 1840s almost half the Irish population, particularly the rural poor, was depending almost entirely on the potato for nourishment.
 in 1845; more recently in the United States, blight hit many cornfields with certain hybrid varieties of corn producing only half of projected yields. (64) Accordingly, although loss of biodiversity is a very real concern, history shows that it is by no means solely the result of genetically modified farming techniques.

3.2.2.2 Decline in Yields

Coupled with threats to biodiversity are the declines in yields which may result from an increase in the planting of genetically similar crops. A heated debate continues to rage about whether planting genetically modified crops actually increases yields: for example, a 2008 article published in Britain's The Independent referenced an authoritative new study demonstrating that genetically modified soya in fact produced ten percent less food than the non-genetically modified variety. (65)

Eight days later, the study's author published a rebuttal rebuttal n. evidence introduced to counter, disprove or contradict the opposition's evidence or a presumption, or responsive legal argument. , criticizing the journalist's "gross misrepresentation misrepresentation

In law, any false or misleading expression of fact, usually with the intent to deceive or defraud. It most commonly occurs in insurance and real-estate contracts. False advertising may also constitute misrepresentation.
" of his research. (66) The author asserted that no such conclusions could be drawn from his work, and emphasized that "at times research findings can be exploited to inappropriate ends." (67)

In locations with suboptimal Suboptimal
A solution is called suboptimal if a part of the solution has been optimized without regards to the overall objective.
 growing conditions, such as those where plant nutrients and irrigation irrigation, in agriculture, artificial watering of the land. Although used chiefly in regions with annual rainfall of less than 20 in. (51 cm), it is also used in wetter areas to grow certain crops, e.g., rice.  are inadequate, evidence suggests that bioengineered seeds increase yields and reduce the need for pesticides. (68) At the same time, other studies show that the planting of insect-resistant crops in the United States and China has not significantly increased yields. (69)

Among the few conclusions that can be drawn about GMOs is that their ability to increase crop yield is location-specific. Farmers who plant newer varieties in poorer soil or who do not provide adequate nutrients or fertilizer to allow their crops to grow to their full potential will have less successful results. The danger of over-farming soil is always a problem. New genetic varieties may absorb more nutrients from the soil than their traditional counterparts.

3.2.2.3 Threats to Animal Species

Returning briefly to the StarLink corn controversy, researchers tested the Bt protein shortly after Aventis received its patent. (70) In 1999, a Cornell University Cornell University, mainly at Ithaca, N.Y.; with land-grant, state, and private support; coeducational; chartered 1865, opened 1868. It was named for Ezra Cornell, who donated $500,000 and a tract of land. With the help of state senator Andrew D.  study found that the Bt protein could also be toxic to non-target insects, such as monarch butterflies. (71) Anti-biotech activists seized on the Cornell report and called for an immediate ban on the planting of corn with the Bt protein. (72)

3.2.2.4 Genetic Drift and Gene Wandering

Genetic drift is a danger common to all GMOs: a gene from a transgenic plant migrates out of its location into another organism. (73) Genetic drift most commonly occurs through a process called outcrossing, in which "domesticated plants This is a list of plants that have been domesticated by humans.

The list includes species or larger formal and informal botanical categories that include at least some domesticated individuals.
 hybridize hy·brid·ize  
intr. & tr.v. hy·brid·ized, hy·brid·iz·ing, hy·brid·iz·es
1. To produce or cause to produce hybrids; crossbreed.

2.
 with wild relatives." (74)

Gene wandering is a similar concern. Organic farmers whose organic crops come into post-harvest contact with genetically modified crops risk losing their organic status. (75) In Canada, the system of shipping and handling grain is based on the commingling of fungibles. (76) Some farmers also fear that natural or accidental contamination of their farms through genetic drift or gene wandering will expose them to potential liability through no fault of their own. (77) The recent case of Percy Schmeiser Percy Schmeiser (born January 5 1931) is a farmer from Bruno, Saskatchewan, Canada. He specializes in breeding and growing canola. He became an international symbol and spokesperson for independent farmers' rights and the regulation of transgenic crops during his protracted legal , a Saskatchewan canola grower whose crop was found to contain Monsanto's patented Roundup Ready[R] canola seed, underscores this possibility. (78)

3.2.2.5 "Super-Weeds"

A final concern, similar in some ways to that of gene wandering, is that the pollen of a genetically modified crop could blow with the wind, mate with a wild plant, and result in a virtually indestructible in·de·struc·ti·ble  
adj.
Impossible to destroy: indestructible furniture; indestructible faith.



[Late Latin ind
 "super-weed." (79) Some scientists have posed an alternative hypothesis alternative hypothesis Epidemiology A hypothesis to be adopted if a null hypothesis proves implausible, where exposure is linked to disease. See Hypothesis testing. Cf Null hypothesis.  that the new genes might cause the extinction of the wild plant, which otherwise might have provided new and invigorating genes to keep the species alive. (80)

These concerns echo similar worries about genetically modified seeds leading to a decline in biodiversity. It is very difficult to keep ancient gene pools alive, and scientists rightfully worry that some genetically modified seeds may hasten the demise of older varieties. (81)

3.2.3 Perceived Sociological Risks of GMOs

Phrases such as "agricultural slavery" and "biopiracy bi·o·pi·ra·cy  
n.
The commercial development of naturally occurring biological materials, such as plant substances or genetic cell lines, by a technologically advanced country or organization without fair compensation to the peoples or nations in
" have become common parlance for many activist groups protesting biotechnology developments. (82) When Monsanto aggressively expanded its operations by buying up smaller competitors in the 1990s, many activists saw this as the consolidation of the international seed industry--and consequently the world food supply--into the hands of a corporate oligarchy Corporate oligarchy (Greek Ὀλιγαρχία, Oligarkhía) is a form of government where political power effectively rests with a small, elite segment of society (distinguished by wealthy Corporations, with the utmost contempt for their people, . (83) Monsanto thus has been accused of "corporate extortion," (84) whereas other biotechnology companies like Aventis have found themselves subjects of massive class action lawsuits when they did not adequately protect their interests in advance. (85)

The potential commercialization of GURTs--a type of GMO--has especially incensed those who feel that genetic engineering has a nefarious effect on the balance of power in the world's food supply. (86) Some activists estimate that as many as eighty percent of farmers in countries like Brazil and Pakistan save seeds from one season to the next; these farmers will undoubtedly be affected by self-policing seeds that prevent this possibility. (87) These same activists often claim that GMO production favors the rich over the poor by placing the control of the world's food supply in the hands of a powerful few. (88)

4. HOW SHOULD GMOs AND GURTs BE REGULATED?

No comprehensive proposals yet exist for the redress of liabilities and harms resulting from GURTs, most likely due to their lack of commercial availability. Because GURTs are a subset of GMOs, any proposal for the regulation of GURTs should be made within the context of the existing regulatory framework governing GMOs. The following section discusses various attempts at the regulation of GMOs, both in the United States and internationally.

4.1 Existing Regulatory Regimes

Regulation of GMOs has proceeded differently in the United States and Europe. This section reviews existing attempts to regulate GMOs in the United States at the federal, state, and local levels and compares these to some of the regulatory regimes in the European Union and the developing world.

4.1.1 Regulation of GMOs in the United States

The United States is the world's leading producer of genetically modified organisms. (89) Perhaps because of the significant U.S. business interests within this sector, regulation has consistently proceeded more slowly here than biotechnological advances, and more slowly than in other developed nations. (90)

4.1.1.1 Federal Regulation of GMOs in the United States

As use of genetic engineering expanded in the 1970s, the National Institutes of Health first took on the role of regulators by establishing research guidelines and initially prohibiting the release of any genetically modified organisms into the environment. (91) By 1978, standards had been relaxed, and in the mid-1980s, the Biotechnology Science Coordinating Committee (BSCC BSCC Bishop State Community College (Alabama)
BSCC Bedford Senior Citizens Center
BSCC Broadcast Stream Client Connector
) and the Office of Science and Technology Policy Congress established the White House Office of Science and Technology Policy (OSTP) in 1976 with a broad mandate to advise the President and others within the Executive Office of the President on the effects of science and technology on domestic and international affairs.  (OSTP OSTP Office of Science & Technology Policy
OSTP Onboard Short Term Plan
) established that oversight of GMOs would continue to be conducted based on existing laws rather than under any new statutory authority, and that oversight would be divided among existing regulatory agencies. (92) This fragmented system of regulation continues to this day, with supervision of GMOs divided among the Food and Drug Administration (FDA), the United States Department of Agriculture United States Department of Agriculture (USDA),
n.pr established in 1862, USDA is responsible for the safety of meat, poultry, and egg products. It conducts ongoing research in areas from human nutrition to new crop technologies and also helps ensure open
 (USDA USDA,
n.pr See United States Department of Agriculture.
), and the Environmental Protection Agency (EPA EPA eicosapentaenoic acid.

EPA
abbr.
eicosapentaenoic acid


EPA,
n.pr See acid, eicosapentaenoic.

EPA,
n.
). (93) For example, the FDA oversees food safety, the EPA evaluates plants which are genetically modified "to make their own pesticides," and the USDA is responsible for ensuring that the genes of transgenic plants do not escape into the environment. (94) As a result, some GMO issues are covered by multiple agencies while others are covered by none at all. (95)

To date, the United States has passed no federal legislation with respect to GMOs, instead relying entirely on court decisions and existing agency oversight as sources of law. (96)

4.1.1.2 State Regulation of GMOs in the United States

More regulatory activity has occurred at the state level than through federal channels. Almost a third of states, including California, Massachusetts, New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
, and Texas have introduced some form of legislation governing GMOs. (97) In some states, such as Massachusetts, these bills impose strict liability for harm caused by a person who genetically modifies organisms for use as food. (98) Other states, such as Illinois and Minnesota, have enacted permit and notification laws requiring either the issue of a permit or a notification accompanying any release of a GMO into the environment. (99) A liability bill in Vermont passed both chambers of the Vermont legislature in 2005 but was vetoed by the governor the following year. (100)

Thus far, Maine is the only state to have successfully enacted GMO liability legislation. (101) The Maine law is especially interesting because it assigns liability to manufacturers of genetically modified plants or seeds that create a risk of cross-contamination. (102) Names and addresses of those who purchase GM seeds or crops are kept on record with Maine officials, and manufacturers must provide growers with written instructions for planting and harvesting GMO crops. (103)

4.1.1.3 Local Regulation of GMOs in the United States

Efforts to regulate occurred earliest at the municipal level. (104) The first municipality in the United States to regulate genetic engineering was Cambridge, Massachusetts This article is about the city of Cambridge in Massachusetts. For the English university town, see Cambridge, England. For other places, see Cambridge (disambiguation).
Cambridge, Massachusetts is a city in the Greater Boston area of Massachusetts, United States.
, in 1977. (105) The Cambridge city council Cambridge City Council may refer to:
  • Cambridge City Council, England
  • Cambridge City Council, Ontario, Canada
 ordinance incorporated National Institutes of Health guidelines, but expanded them to cover all research facilities in the city. (106)

4.1.2 Regulation of GMOs in the European Union

The European Community (EC) has implemented a broad regulatory system governing the release of GMOs into the environment. The cornerstones of this system are EC Directive 90/219 on Contained Use and EC Directive 90/220 on Deliberate Release. (107)

The Contained Use Directive covers situations under which GMOs are "cultured, stored, used, transported, destroyed or disposed of and for which physical barriers ... are used to limit their contact with the general population and the environment." (108) Most situations involving contained use relate only to laboratory use and scientific studies. (109) The Directive is silent on the issue of liability, deferring either to the member countries' existing regimes (110) or to specific product legislation. (111)

The Deliberate Release Directive pertains to the intentional discharge of GMOs into the environment. The Directive defines "deliberate release" as "any intentional introduction into the environment of a GMO or a combination of GMOs without provisions for containment such as physical barriers or a combination of physical barriers together with chemical and/or biological barriers used to limit their contact with the general population and the environment." (112) The crux of the Deliberate Use Directive is a notification requirement: anyone intending to release a GMO into the environment must complete an environmental risk assessment and a technical dossier in order to obtain permission for the release. (113)

Both of these Directives were largely superseded when the Commission Regulation on genetically modified food and feed came into effect in 2003. (114) Most significantly, this Regulation established the EC's "one door--one key" policy, providing a single authorization procedure for all food containing GMOs. (115) Provided that the Environmental Risk Assessment determines the GMO does not pose undue environmental risk, an individual is entitled to use the GMO in human food and animal feed, to cultivate the organism, and to release it deliberately into the environment. (116)

These directives focus primarily on the procedures for obtaining permission to use or cultivate a GMO in the European Union, not on establishing a liability structure for harms resulting from such use. When considering issues of liability, the member states defer instead to the Council Directive on Products Liability of 1985, which establishes the provisions governing liability for defective products among the Member States. (117) Initially, this products liability directive was not easily applicable to GMO harm cases because it did not cover "primary agricultural products," many of which could be subject to commercial genetic modification. (118) However, a 1999 amendment removed the exception for primary agricultural products. (119) Accordingly, a product is now defective
   when it does not provide the safety which a person is entitled to
   expect, taking all circumstances into account, including: (a) the
   presentation of the product; (b) the use to which it could
   reasonably be expected that the product would be put; [and] (c) the
   time when the product was put into circulation. (120)


Similar to the establishment of a prima facie [Latin, On the first appearance.] A fact presumed to be true unless it is disproved.

In common parlance the term prima facie is used to describe the apparent nature of something upon initial observation.
 tort case, the injured person must prove the existence of a defect, the occurrence of an injury, and a causal relationship between the defect and the injury. (121)

Despite the protections afforded by the Products Liability Directive, it would be difficult to bring a cause of action for harms resulting from a GMO. One commentator has cited five reasons for this. (122) First, the manufacturer of the GMO is only held liable for the damages resulting from a defect in the product, therefore the injured party Noun 1. injured party - someone injured or killed in an accident
casualty

victim - an unfortunate person who suffers from some adverse circumstance
 would have to show that the GMO was somehow defective within the meaning of the Directive. (123) The harms which could result from GMOs would not be due to a defect in the product itself, but rather to unforeseen consequences such as gene transfer. (124)

Second, GMOs which have been shown to cause environmental damage, such as genetically modified maize, have not been placed in circulation. (125) Third, the Directive limits harms caused by a defective product to "damage caused by death or by personal injuries" and "damage to, or destruction of, any item of property other than the defective product itself." (126) Fourth, the biotechnology producer could respond to the charges with the so-called "state of the art" affirmative defense A new fact or set of facts that operates to defeat a claim even if the facts supporting that claim are true.

A plaintiff sets forth a claim in a civil action by making statements in the document called the complaint.
 by claiming that "the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered." (127) Fifth and finally, the product liability Directive allows a court to consider all factors that may have led to increased risk, and may limit compensation to damages that stem directly from the defective product. (128)

4.1.3 International Agreements Covering the Regulation of GMOs

Several international agreements offer liability regimes for harms resulting from GMOs, most notably the 1992 United Nations Convention on Biological Diversity, which includes the 2000 Cartagena Biosafety Protocol (129) and the 1993 Lugano Convention. (130)

4.1.3.1 The 1992 U.N. Convention on Biological Diversity

The U.N. Convention on Biological Diversity was part of the Rio de Janeiro conference of 1992. (131) Entering into force in December 1993, it was approved by the European Union that same year and became part of EC law. (132) The parties to the Convention are required to "regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology, which are likely to have adverse environmental impacts" and to "prevent the introduction of, control or eradicate those alien species which threaten ecosystems, habitats or species." (133) The Convention does not provide specific rules for the signatories' handling of GMOs, but instead requires that each Convention Party provide detailed rules to the Convention about how it will handle such organisms and their potential adverse impacts. (134)

4.1.3.2 Cartagena Protocol on Biosafety The Cartagena Protocol on Biosafety is an international agreement on biosafety, as a supplement to the Convention on Biological Diversity.
Overview of the Biosafety Protocol
 to the Convention on Biological Diversity

The most important legacy of the Biodiversity Convention is the Cartagena Biosafety Protocol, which provides the legal basis for safe handling of biological specimens. (135) This protocol, adopted in 2000, lays out procedures on "the safe transfer, handling and use of any living modified organisms resulting from biotechnology that may have adverse effects on the conservation and sustainable use Sustainable use is the use of resources at a rate which will meet the needs of the present without impairing the ability of future generations to meet their needs. The concept was notably put forth by the Brundtland Commission in 1987. See also
  • http://www.iucn.
 of biological diversity." (136)

Article 27 of the Cartagena Protocol deals with liability and redress, calling for the "Parties to this Protocol" to "adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damages resulting from transboundary movements of living modified organisms." (137) Because the parties could not agree at the time of the Convention, the Protocol called for the Parties to "endeavor to complete this process within four years." (138) The failure of the Convention to implement liability rules specific to biotechnology raises questions about the adequacy of existing regimes in the signatory countries, and whether specific environmental or other circumstances necessitate a biotechnology-specific liability regime. (139)

4.1.3.3 Lugano Convention

The goal of the Lugano Convention, in its own language, was to ensure "adequate compensation for damage resulting from activities dangerous to the environment and [to] provide[] for means of prevention and reinstatement." (140) The Member States of the Council of Europe Council of Europe, international organization founded in 1949 to promote greater unity within Europe and to safeguard its political and cultural heritage by promoting human rights and democracy. The council is headquartered in Strasbourg, France.  adopted the Lugano Convention in 1993. (141)

Under the terms of the Lugano Convention, the "operator" (142) of a dangerous activity is held strictly liable for damages resulting from any "incident," defined as "any sudden occurrence or continuous occurrence or any series of occurrences having the same origin, which causes damage or creates a grave and imminent threat Imminent threat is a standard criterion in international law, developed by Daniel Webster, for when the need for action is "instant, overwhelming, and leaving no choice of means, and no moment for deliberation.  of causing damage." (143)

Among the "dangerous activities" considered by the Convention are
   the production, culturing, handling, storage, use, destruction,
   disposal, release or any other operation dealing with one or more
   ... genetically modified organisms which as a result of the
   properties of the organism, the genetic modification and the
   conditions under which the operation is exercised, pose a
   significant risk for man, the environment or property. (144)


Joint and several liability may apply to situations where "damage results from incidents which have occurred in several installations or on several sites where dangerous activities are conducted." (145) Comparative negligence comparative negligence n. a rule of law applied in accident cases to determine responsibility and damages based on the negligence of every party directly involved in the accident.  principles also apply, reducing or disallowing damages for those who have contributed to their own injury. (146)

The Lugano Convention does allow for a few limited affirmative defenses. If the operator can prove that the damage was caused by an "act of war" or a "natural phenomenon of an exceptional, inevitable and irresistible character," or "by pollution at tolerable levels under local relevant circumstances," then the operator will not be held liable under the terms of the Convention. (147)

It is important to note that under the Lugano Convention, only the operator can be held liable for any damages. (148) This means that the producer of the GMO, the biotechnology company, or other parties associated with the dangerous or defective product cannot be charged. (149) This presents a difficulty since the "operator," under the definition provided by the Convention, may be a local farmer of limited resources. (150)

4.2 Possible Liability Regimes

As the survey of comparative liability regimes above demonstrates, governments and international organizations have faced difficulties agreeing to and implementing a single regime for harms resulting from GMOs. Nonetheless, liability lawsuits for GMO harms have proceeded apace, with injured parties filing their claims either under strict liability or under the common law claims of nuisance and trespass.

4.2.1 Strict Liability

Some might argue that the application of strict liability to harm resulting from genetically modified organisms is appropriate, since patent law, under which most GMO cases currently are litigated, is itself a form of strict liability. (151) In other words Adv. 1. in other words - otherwise stated; "in other words, we are broke"
put differently
, one who infringes on a patent is held liable regardless of whether her violation was the result of negligence, recklessness, or any other fault-based principle.

In practice, however, strict liability can place undue burdens on the livelihoods of farmers. They may find themselves subjected to massive monetary obligations as a result of "blow-by," in which genetically modified seeds they planted on their property migrate to a neighbor's property by natural means. (152) Under the Lugano Convention's liability regime, for example, the "operator" of the dangerous substance is deemed liable for the resulting damage, and this operator may be another small farmer who simply purchased his GM seed through a large seed company. (153)

The concept of strict liability traces its origin to the 1868 English case Rylands v. Fletcher Rylands v. Fletcher was the 1868 English case (L.R. 3 H.L. 330) that was the progenitor of the doctrine of Strict Liability for abnormally dangerous conditions and activities. . (154) The House of Lords House of Lords: see Parliament.  held that a landowner owes an absolute duty when he lawfully brings something onto his land which, although harmless while it remains there, will naturally cause damage if it escapes. (155) Further, a party is considered liable for damage caused by an "activity unduly dangerous and inappropriate to the place where it is maintained, in the light of the character of that place and its surroundings." (156)

The modern doctrine of strict liability, as embodied in the Restatement (Second) of Torts, states that:

(1) One who carries on an abnormally dangerous activity is subject to liability for harm to the person, land or chattels of another resulting from the activity, although he has exercised the utmost care to prevent the harm.

(2) This strict liability is limited to the kind of harm, the possibility of which makes the activity abnormally dangerous. (157)

The application of this doctrine to genetically modified organisms has hinged repeatedly on whether their use constitutes abnormally dangerous activity, and what form the redress should take.

To assist in the determination of which activities fall under the classification of "abnormally dangerous," the Restatement suggests the following six factors for guidance:

(a) existence of a high degree of risk of some harm to the person, land 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. (158)

In one prominent case, Langan v. Valicopters, Inc., the Washington State Supreme Court applied these six factors to a dispute over contamination damages to an organic farm from a crop duster's aerial spraying of agricultural pesticides. (159) The Langan court applied the strict liability standard while adjudicating the financial losses the Langans suffered when their crops were decertified as organic. (160) Although this case illustrates that strict liability may be applied to GMOs, it can more likely be considered an outlier. Very few other cases involving pesticide drift have involved the application of a strict liability standard. (161)

Just as courts have found that pesticide application is not an abnormally dangerous activity, judges are also unlikely to find that the planting of GM crops is an abnormally hazardous per se, or that the risks posed to society outweigh the benefits. (162) The Restatement's sixth factor, the balance of risks and benefits, is a plaintiff's key obstacle, as biotechnology companies repeatedly emphasize the potential benefits of increased sustainability and efficiency that GMOs offer farmers, consumers, and the environment. (163)

4.2.2 Strict Products Liability

Another possible liability regime, closely connected to strict liability, is strict products liability. Strict products liability is distinguished from strict liability in the assignment of liability to the manufacturers, distributors, suppliers, and retailers of the dangerous item, rather than to those who use it for its intended purpose. (164) Strict products liability requires the plaintiff to establish that a defect which made the product unreasonably dangerous existed when the product was released "into the stream of commerce." (165) Defects may involve design, manufacturing, or marketing. (166)

In general, producers and manufacturers have a duty to "exercise due care in the design of products; to research, make and sell the product safely; and to warn of defects and dangers to consumers or users." (167) The difficulty in proving product defects in GMO or GURT cases may make it difficult for some plaintiffs to bring cases under strict products liability. (168)

4.2.3 The Common Law Torts: Nuisance and Trespass

Many farmers have sought refuge in the common law tort theories of nuisance and trespass. Although some scholars believe that these theories fail to encompass the uniqueness of biotech situations and therefore may not provide adequate remedies, (169) these are often the easiest laws under which to bring GMO claims because of the large body of analogous case law, especially in situations of pollution or invasive plants.

4.2.3.1 Nuisance

Nuisance was famously described by Prosser as an "impenetrable jungle" because of the uncertainty, vagueness, and confusion which have surrounded its application. (170) In the context of harms resulting from genetic drift, two kinds of remedy in nuisance are available to aggrieved parties: private nuisance private nuisance n. the interference with an individual's peaceful enjoyment of one's property, which can be the basis for a lawsuit both for damages caused by the nuisance and an order (injunction) against continuing the noxious (offensive) activity or condition.  and public nuisance public nuisance n. a nuisance which affects numerous members of the public or the public at large, as distinguished from a nuisance which only does harm to a neighbor or a few private individuals. .

4.2.3.1.1 Private Nuisance

At its core, private nuisance amounts to "an interference with the use and enjoyment of one's land." (171) Courts have found the existence of private nuisance in two circumstances which could be analogous to GMOs: the destruction of crops, trees or plants, (172) and the pollution of streams. (173)

An organic farmer whose crop is damaged as a result of contamination by GMO pollen may not even need to demonstrate that the GMO farmer intended to allow the cross-pollination to occur. (174) Sometimes, courts will balance the magnitude of the plaintiff's injury against the utility of the defendant's conduct. (175) However, anecdotal evidence anecdotal evidence,
n information obtained from personal accounts, examples, and observations. Usually not considered scientifically valid but may indicate areas for further investigation and research.
 suggests that courts increasingly are willing to side with aggrieved farmers in nuisance cases without engaging in a balancing test A balancing test is any judicial test in which the jurists weigh the importance of multiple factors in a legal case. Proponents of such tests argue that they allow a deeper consideration of complex issues than a bright-line rule can allow. . (176)

4.2.3.1.2 Public Nuisance

Public nuisance is a broader term than private nuisance, encompassing a more extensive range of activities. (177) Public nuisance laws allow local governments to enjoin To direct, require, command, or admonish.

Enjoin connotes a degree of urgency, as when a court enjoins one party in a lawsuit by ordering the person to do, or refrain from doing, something to prevent permanent loss to the other party or parties.
 activities which unreasonably interfere "with a right common to the general public," provided that state or federal laws do not preempt pre·empt or pre-empt  
v. pre·empt·ed, pre·empt·ing, pre·empts

v.tr.
1. To appropriate, seize, or take for oneself before others. See Synonyms at appropriate.

2.
a.
 such action. (178) For example, if a GMO field cross-pollinates with local common resources, and this cross-pollination interferes with the safety, health, comfort, or peace of the general public, then the local government may seek an injunction under public nuisance laws. (179) More often than not, however, individual farmers suffer from the effects of cross-pollination, not the public as a whole. (180) For this reason, private nuisance is more likely to be the remedy under which aggrieved farmers seek compensation for GMO crosspollination.

4.2.3.2 Trespass

The tort of trespass can broadly be defined as an interference with the fight of a property owner to "use" his exclusive possessory interest possessory interest n. in real estate, the intent and right of a person to occupy and/or exercise control over a particular plot of land. A possessory interest is distinguished from an interest in the title to property, which may not include the right to immediately , even if the invasion caused no harm or was not the defendant's fault. (181)

The difficulty of arguing that genes have "trespassed" onto a neighboring property is in satisfying the traditional "dimensional test," which requires a showing that the invasion of the land is immediate or direct and in the form of a tangible, physical object. (182) If courts find that the GMO is an intangible object, the farmer is barred from recovery. (183)

Under the "modified dimensional test," which some states have adopted instead, the court focuses on the interference with possession, and the farmer must show resulting physical damage. (184) Jurisdictions with this test appear to blend the concepts of trespass and nuisance, as the traditional tort of trespass does not require the plaintiff to establish that physical damage occurred. (185)

5. EVALUATING A LIABILITY REGIME

Any proposal for a liability regime addressing harm resulting from GURTs must include an analysis of marginal benefits and costs. Effective regulation of the biotechnology industry must account for the large number of parties potentially affected by such regulation and the social cost of implementation and enforcement. (186)

5.1 Social Cost in the Context of GMOs

Prosser acknowledged the right of a person to make use of his property "at the expense of some harm to his neighbors.... It is only when his conduct is unreasonable, in light of its utility and the harm which results that it becomes a nuisance." (187)

Ronald Coase Ronald Harry Coase (b. December 29, 1910) is a British economist and the Clifton R. Musser Professor Emeritus of Economics at the University of Chicago Law School. After studying with the University of London External Programme in 1927-29, Coase entered the London School of , however, in his prominent 1960 article, The Problem of Social Cost, advanced the analysis of externalities a step further, posing the question as one of reciprocity: "[s]hould A be allowed to harm B or should B be allowed to harm A?" (188) Coase offers the examples of a confectioner, whose machinery disturbs a physician in an adjacent office; and of straying cattle, which while grazing on a neighbor's land, destroys its crops. (189) To avoid doing harm to one harms the other, and the challenge is to identify the more serious harm. (190) Thus the problem, writes Coase, "is one of choosing the appropriate social arrangement for dealing with harmful effects." (191)

5.1.1 Applying Coasean Analysis to Manufacturer-Farmer Conflicts

In a recent article, Paul J. Heald n. 1. A heddle.  and James Charles James Charles was one of the founding members of the Richmond Football Club.

He was Richmond's inaugural Club Secretary, serving in 1885 and 1886, at the same time as being the Club's delegate to the Victorian Football Association.
 Smith apply Coase's framework to a farmer whose crop's value is diminished as the result of blow-by or pollen drift. (192) The authors begin by envisioning a conflict between two farmers, one organic and one GMO. (193) They continue this analysis with an example more relevant to this discussion--that of a conflict between two farmers and a manufacturer of patented seeds, to whom the two farmers must make royalty payments. (194)

Based on an arithmetical analysis, the authors conclude that the value of joint production will fall if farmers do not use genetically modified seed, or if the seed company does not receive patent royalty payments as compensation for its research and development costs. (195) Because of this, the authors argue in favor of strict liability (patent law) in the GMO context, provided that patent law provides efficient incentives to invent. (196) When transaction costs (197) and switching costs (198) are taken into account, a strong possibility exists that patent law does not provide such incentives. (199) The conclusion may be drawn that generally speaking, strict liability regimes do not provide the economically optimal arrangement of legal rights for the parties involved in such conflicts.

5.2 The Protection of R&D in Agribusiness: Example Monsanto

Investments in research and development are often among the largest expenses at biotechnology companies, (200) These companies invest not only in the research and development of their products, but also in the protection and enforcement of their patents.

A well-documented example of such aggressive enforcement can be found in Monsanto, the largest company of its kind. (201) Monsanto's dominance in the world of agribusiness allows one to view the legal actions it pursues to protect its patents as a proxy for the most common conflicts that develop between farmers and GMO manufacturers. Both sides in these conflicts face substantial costs.

5.2.1 Costs to Monsanto

As of the year ending August 31, 2008, Monsanto had spent over $980 million on research and development, (202) more than any of its competitors in the market. (203) According to according to
prep.
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

3.
 Monsanto spokesman Darren Wallis: "One tool in protecting this investment is patenting our discoveries and, if necessary, legally defending those patents against those who might choose to infringe upon them." (204)

Monsanto has indeed patented its discoveries: with 674 biotechnology patents, the company holds more than any other agricultural company. (205) Its means of enforcing these patents have generated much controversy. A team of investigators, dubbed by critics as the "seed police," scour scour, scours

1. the chemical and physical cleaning of fleece wool.

2. diarrhea.


dietetic scour
see dietary diarrhea.

peat scour
see secondary nutritional copper deficiency.
 farms around the United States, collecting crop samples to test for the presence of Monsanto's patented genes. (206) Incidents of these investigators intimidating local farmers and threatening them with lawsuits have been recorded. (207) Monsanto devotes ten million dollars per year and a staff of seventy-five to the sole task of "investigating and prosecuting farmers." (208) To facilitate this process, Monsanto maintains a toll-free number where farmers can anonymously report other farmers whom they suspect of engaging in "seed piracy." (209)

5.2.2 Costs to Local Farmers

According to a report published by the Center for Food Safety, Monsanto investigates roughly 500 farmers per year. (210) As of October 26, 2007, the company had filed 112 lawsuits against 372 farmers and 49 small farm businesses in 27 different states for alleged licensing agreement violations or patent infringements. (211) Of the 57 judgments against farmers that Monsanto had won as of October, 2007, the total payout to Monsanto amounted to $21,583,431.99. (212) Some farmers have been forced into bankruptcy as a result of legal costs. (213)

Some farmers allege that Monsanto monopolizes the seed industry, leaving them no choice except to purchase their seeds through the company, thus compelling them to sign the company's licensing agreement. (214) By some estimates, Monsanto's seeds account for 80 percent of cotton (215) and 90 percent of soybeans (216) grown in the United States. In recent years, Monsanto has acquired a number of its smaller competitors, strengthening its control over the seed market. (217)

Finally, some farmers have complained about being forced into litigation because their crops contained Monsanto's seeds without their knowledge. (218)

5.3 A lose-lose situation

Monsanto seeks to protect its investments in research and development through proactive litigation. Biotechnology companies themselves are not immune from lawsuits and often choose to sue proactively lest they find themselves caught up in massive class action suits, as the case was with Aventis CropScience. (219) Biotechnology litigation has included class action suits against Monsanto alleging anti-trust violations; lawsuits against Monsanto with respect to its enforcement of technology use agreements; genetic drift cases; a suit filed by Greenpeace against the EPA for approving Bt genes in corn; and a lawsuit against the FDA for approving GMOs without adequately testing them. (220)

Biotechnology companies face the constant threat of lawsuits by farmers, activists groups, and government agencies. Farmers face the same threats from biotechnology companies, and government agencies also face these threats from different sides. Case-by-case evaluations of liability may alleviate some of the pain of this proliferation of litigation, but the liability regimes currently used by all sides in pursuit of their interests show no signs of moving in a more cost-efficient or less wasteful direction on their own.

6. SEEDS OF HOPE: GURTs AS AN ALTERNATIVE TO A LIABILITY REGIME

GURTs would provide a solution to both farmers and biotech companies, reducing the need for litigation and reducing the chances of environmental damage from blow-by, genetic drift, or gene wandering. Additionally, GURTs could provide a substantial benefit to farmers in the developing world, allowing for increased crop yields and a decline in poverty.

6.1 GURTs and Reduced Litigation

The most immediate benefit GURTs would provide to both farmers and seed companies is a reduction in the costs of litigation. Biotech companies would no longer need to worry about farmers who save their seeds, because the seeds would be worthless by the next growing season. A firm like Monsanto could also expend fewer resources on investigating farmers whom it suspects of saving seeds or violating the contract. Most importantly Adv. 1. most importantly - above and beyond all other consideration; "above all, you must be independent"
above all, most especially
, the firm's intellectual property investment is ensured; it does not need to pursue claims of patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. , since they are not possible.

Farmers, in turn, would not have to deal with harassment and intimidation by their seed suppliers, because they do not have the option of violating these terms of the contract. Although some have argued that antigermination technology would increase costs to farmers, (221) these arguments do not take into account the increased yield and efficiency that GMOs offer, which, assuming crops are planted and rotated properly, are likely to result in a net value increase to farmers.

6.2 GURTs and Environmental Advantages

Many of the concerns about super-weeds and gene transfer are rendered moot when one deals with non-germinating seeds. Scientists hope that antigermination seeds would prevent a bacteria combined with a plant in the laboratory from mating with wild grass in a field. (222) If the seeds were to blow into a neighboring farm, they would not last more than a season, and the neighboring farmer would not be held liable for patent infringement.

The dangers of GURTs with respect to super-weeds seem negligible in comparison to most GMOs. Some scientists have even argued that had GURTs been available, they could have helped to prevent some GMO environmental disasters, such as the ProdiGene incident, in which unwanted and experimental second-generation maize plants containing an animal protein contaminated a field of soy, resulting in the destruction of about fourteen million kilograms of soybeans. (223)

Some concerns have been expressed about what has been called the ninety percent problem: if the GURTs are only ninety percent effective at not reproducing, they could still germinate with a hardy seed to become potentially indestructible. (224) A final concern about GURTs in the environment is that they could spread a "generalized infertility" through the ecosystem if they cross with wild plants. Supporters argue that this is impossible, since sterile plants cannot pass on their genetic traits. (225)

6.3 GURTs and the Developing World

GURTs potentially could provide developing countries with increased yields and hardier plants that can withstand pests or drought. There is also a possibility that GURTs could "switch on" certain genes, such as a gene which requires less water for the plant if there were a drought. Another possibility is a gene that could be resistant to an invasive insect but would not be activated unless the insect actually poses a problem.

In many cases, American biotechnology companies are unwilling to market their products in developing countries, where an unfavorable legal system and limited enforcement of intellectual property rights means that their investment may not be protected. With GURTs, they no longer need to rely on the foreign country's legal system, since the seeds are self-policing. This would encourage investment by major biotech companies in the developing world and potentially increase food supply in countries that currently rely on lower-yield, non-GM crops.

CONCLUSIONS

The controversies surrounding GURTs and GMOs are often more interesting than the agricultural products themselves. A number of prominent scientists and agricultural experts from around the world have argued that at least the testing and research into GURTs should continue, and that an outright ban on a technology which has not been fully investigated is irresponsible.

Practical concerns must be acknowledged. The chances of winning approval in the face of massive protest from activist groups are slim at best. These same groups fought for and won a ban on European imports of GM foods. It is estimated that over a billion farmers a year save their seeds, and they are not likely to accept a new system with ease.

At the same time, however, many farmers, even in the developing world, are aware of the advantages biotechnology can offer them. (226) Farmers who remain adamantly opposed to GURTs are likely to recognize the value these products can offer them once supplied with scientific information independent of activist propaganda.

The agricultural revolution Agricultural Revolution

Gradual transformation of the traditional agricultural system that began in Britain in the 18th century. Aspects of this complex transformation, which was not completed until the 19th century, included the reallocation of land ownership to make farms
 produced the changes in technology and genetic science that have allowed farmers to produce more from less, and to save time and money in the process. The transformations that occurred in the United States in the twentieth century did not come easily. This does not mean that they were not worth undertaking.

"The greatest service which can be rendered to any country is to add a useful plant to its culture," wrote Thomas Jefferson. (227) This is especially true when the plant can improve efficiency without changing a population's diet or the ecosystem in which it lives. This is what GURTs offer. The strength of the opposition to these seeds must be overcome through patience, education, and science. This effort will serve not only the interest of seed companies, but also of farmers, governments, and the millions of people who lack access to nutritious food every year.

(1.) See, e.g., Justin Gillis, Norman Borlaug, Plant Scientist Who Fought Famine, Dies at 95, N.Y. TIMES, Sept. 14, 2009, at A1.

(2.) Id.

(3.) See Norman Borlaug, The Green Revolution Revisited and the Road Ahead, Special 30th Anniversary Lecture Delivered to the Norwegian Nobel Institute The Norwegian Nobel Institute was established in 1904 in Oslo (Kristiania), Norway. The institute is situated in the center of the city, just by the Royal Palace. The building was built in the 1800s as Oslo Vestbanestasjon (Oslo V) station, but it closed in 1987 and its services  (Sept. 8, 2000), available at http://nobelprize.org/nobel_prizes/peace /articles/borlaug/borlaug-lecture.pd f.

(4.) VANDANA SHIVA, THE VIOLENCE OF THE GREEN REVOLUTION 19-23 (1991).

(5.) See Gillis, supra A relational DBMS from Cincom Systems, Inc., Cincinnati, OH (www.cincom.com) that runs on IBM mainframes and VAXs. It includes a query language and a program that automates the database design process.  note 1 (indicating that Borlaug was frustrated that governments took insufficient steps to tackle the larger problem of growing populations).

(6.) U.S. Department of Energy, Office of Science, Human Genome Project Information." Genetically Modified Foods and Organisms, http://www.ornl.gov/s ci/techresources/Human_Genome/elsi/gmfood.shtml).

(7.) Derek Eaton, Frank van Tongeren, Niels Louwaars, Bert Visser & Ingrid van der Meer Van der Meer is a Dutch surname that simply means the phrase 'from the lake' in English. Many years ago, descendants would have lived from a lake in the Netherlands which is how the name first originated. , Economic and Policy Aspects of 'Terminator' Technology, 49 BIOTECHNOLOGY & DEV. MONITOR 19, 19 (2002).

(8.) Gregor Mendel, for example, successfully isolated traits in pea plants between 1856 and 1863. See infra [Latin, Below, under, beneath, underneath.] A term employed in legal writing to indicate that the matter designated will appear beneath or in the pages following the reference.


infra prep.
 note 39 and text accompanying note 41.

(9.) Dan L. Burk, Lex See yacc.

1. (tool) Lex - A lexical analyser generator for Unix and its input language. There is a GNU version called flex and a version written in, and outputting, SML/NJ called ML-lex.
 Genetica: The Law and Ethics of Programming Biological Code, 4 ETHICS AND INFO. TECH. 190 (2002).

(10.) See infra note 14 and accompanying text for a discussion of GURTs as a "self-policing" technology.

(11.) See discussion infra [section] 4-4.1.3.3.

(12.) Bert Visser, Ingrid van der Meer, Niels Louwaars, Jules Beekwilder & Derek Eaton, The Impact of 'Terminator' Technology, 48 BIOTECHNOLOGY & DEV. MONITOR 9 (2001); see also U.S. Patent No. 5,723,765 (filed June 7, 1995).

(13.) u.s. Patent No. 5,723,765 at [57].

(14.) Burk, supra note 9.

(15.) Haider Rizvi, Don't Sell "Suicide Seeds," Activists Warn, INTER PRESS SERVICE Inter Press Service (abbreviated: IPS) is a global news agency. Its main focus is the production of independent news and analysis about events and processes affecting economic, social and political development. , Mar. 21, 2006, http://ipsnews.net/print.asp?idnews=32582.

(16.) Doug Cameron, Monsanto to Restructure Herbicide herbicide (hr`bəsīd'), chemical compound that kills plants or inhibits their normal growth. A herbicide in a particular formulation and application can be described as selective or nonselective.  Unit as Profit Drops 14%, WALL ST. J., June 25, 2009, at B3; see also Monsanto Company Description, HOOVERS, http://hoovers.com/monsanto- company/--ID_100932--/free-coprofile.xhtml (last visited Feb. 16, 2010) ("Monsanto estimates that more than 70% of the world's herbicide-resistant crops bear its stamp.").

(17.) Press Release, Monsanto, Monsanto Company Completes Acquisition of Delta and Pine Land Company, Seeks Approval of Related Divestitures (Jun. 1, 2007), http://monsanto.mediaroom.com/index.php?s=43&item=494.

(18.) Rizvi, supra note 15.

(19.) Id.

(20.) Id.

(21.) See Organic Consumers Association, Monsanto Breaks Promise to Abandon Terminator Technology, Apr. 23, 2003, http://www.organicconsumers.o rg/monsanto/promise042403.cfm; see also Rizvi, supra note 15.

(22.) Monsanto.com, News & Media, Is Monsanto Going to Develop or Sell "Terminator" Seeds?, http://www.monsanto.com/monsanto_today/for the record/ monsanto_terminator_seeds.asp (last visited Nov. 24, 2009).

(23.) Visser et al., supra note 12.

(24.) Id. at 10.

(25.) Id

(26.) Id.

(27.) Id.

(28.) Id. at 11.

(29.) See Haider Rizvi, Putting the Gene Back in the Bottle, INTER PRESS SERVICE, Mar. 29, 2006, http://ipsnews.net/print.asp?idnews=32696 (last visited Nov. 20, 2009).

(30.) See, e.g., Monsanto Canada v. Schmeiser, [2004] 1 S.C.R. 902 (Can.) (describing Monsanto's "Technology Use Agreement" as requiring that the purchasing farmer "undertake to use the seed for planting a single crop").

(31.) See, e.g., PETER PRINGLE, FOOD, INC.: MENDEL TO MONSANTO--THE PROMISES AND PERILS OF THE BIOTECH HARVEST 101-07 (2003).

(32.) GREENPEACE, THE SOCIAL AND ECONOMIC IMPACTS OF GMOS (2008), available at http://www.greenpeace.org/raw/ content/eu-unit/press-centre/policy-papers-briefings/social-and-economic- impacts-of-GMOs.pdf.

(33.) PRINGLE, supra note 31, at 101-07.

(34.) Id. at 101.

(35.) The Prince of Wales Prince of Wales

switches places with his double, poor boy Tom Canty. [Am. Lit.: The Prince and the Pauper]

See : Doubles
, a vocal opponent of genetically modified foods, told the BBC BBC
 in full British Broadcasting Corp.

Publicly financed broadcasting system in Britain. A private company at its founding in 1922, it was replaced by a public corporation under royal charter in 1927.
 that "an instinctive, heart-felt awareness ... [is] the most reliable guide as to whether or not our actions are really in the long term interests of our planet and all the life it supports." Charles, The Prince of Wales, Respect for the Earth, on REITH LECTURES 2000, pt. 6 (BBC Radio 4 broadcast May 17, 2000), available at http://news.bbc.co.uk/hi/english/ static/events/reith_2000/lecture6.stm.

(36.) See, e.g., Eaton et al., supra note 7, at 19.

(37.) Id.

(38.) Clemens Kerle, International IP Protection for GMO--A Biotech Odyssey, 8 COLUM. SCI (Scalable Coherent Interface) An IEEE standard for a high-speed bus that uses wire or fiber-optic cable. It can transfer data up to 1GBytes/sec.

(hardware) SCI - 1. Scalable Coherent Interface.

2. UART.
. & TECH. L. REV. 147, 159 (2007).

(39.) Eaton et al., supra note 7, at 19

(40.) Id.

(41.) Charles A. Deacon & Emilie K. Paterson, Emerging Trends in Biotechnology Litigation, 20 REV. LITIG. 589, 599 (2001).

(42.) Bioengineered Foods: Testimony Before the S. Comm. on Agriculture, Nutrition and Forestry, 109th Cong. (2005) (statement of Robert E. Brackett, Director, FDA Center for Food Safety and Applied Nutrition The Center for Food Safety and Applied Nutrition (CFSAN, pronounced sif'-san) is the branch of the Food and Drug Administration (FDA) which regulates food, dietary supplements, and cosmetics.

"Food" within the context of FDA is a very broad term with some limitations.
) (referring to Foods Derived From New Plant Varieties, 57 Fed. Reg. 22984, 22984 (May 29, 1992), which announced that FDA was "not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or material way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding").

(43.) 57 Fed. Reg. at 22984.

(44.) World Health Organization, 20 Questions on Genetically Modified Foods, Q4, http://www.who.int/foodsafety/ publications/biotech/20questions/en/(last visited Nov. 17, 2008).

(45.) Deacon & Paterson, supra note 41, at 590.

(46.) Press Release, Center for Global Food Issues This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. : 'New Report' on Genetically Modified Crops is Neither Independent nor Scientific (June 17, 2003), http://www.cgfi.org/2003/06/17/ new-report-on-genetically_modified_crops/ (last visited Feb. 11, 2010).

(47.) PRINGLE, supra note 31, at 59-61

(48.) Id.

(49.) Id.

(50.) See Diet Additive Blamed in Additional Illnesses, N.Y. TIMES, Dec. 7, 1989, at B28.

(51.) PRINGLE, supra note 31, at 70-71.

(52.) Id. at 71.

(53.) Id.

(54.) Linda Beebe, In re Starlink Corn: The Link Between Genetically Damaged Crops and Inadequate Regulatory Framework for Biotechnology, 28 WM. & MARY ENVTL. L. & POL'Y REV. 511, 511-12 (2004).

(55.) Deacon & Paterson, supra note 41, at 593.

(56.) CDC Finds No Evidence That StarLink Corn Protein Causes Allergic Reactions, BNET BNET Battle.net (Blizzard Entertainment)
bnet Bungie.net
BNET Bentley Intranet
BNET Billy Noguera Entertainment Group Inc.
BNET Britain-Nigeria Educational Trust
: Food & Beverage Industry, Jun. 18, 2001, http://findarticles.com/p/ articles/mi_m0EUY/is_/ai_75762122 (last visited Oct. 26, 2009).

(57.) Id.

(58.) Id.

(59.) PRINGLE, supra note 31, at 184.

(60.) Deacon & Paterson, supra note 41, at 593.

(61.) See generally PRINGLE, supra note 31, at 121-40.

(62.) Id. at 43.

(63.) Id

(64.) Id. at 22.

(65.) Geoffrey Lean, Exposed: The Great GM Crops Myth, THE INDEPENDENT, Apr. 20, 2008, http://www.independent.co.uk/environment/green-living/ exposedthe-great-gm-crops-myth-812179.html (citing Barney Gordon, Manganese Nutrition of Glyphosate-Resistant and Conventional Soybeans, 91 BETTER CROPS 12, 12-13 (2007), available at http://www.ipni.net/ppiweb/bcrops.nsf/ $webindex/ 70ABDB50A75463F085257394001B157F/$file/07-4p12.pdf (asserting that GM crops produced less yields than non-GM crops, due to two possible factors: the lag time it takes to modify a plant; or, the productivity-lowering process of modification itself)).

(66.) Barney Gordon, Fact Sheet/Rebuttal Statement: Manganese Nutrition of Glyphosate-Resistant and Conventional Soybeans ... Setting the Record Straight, BETTER CROPS WITH PLANT FOOD, Apr. 28, 2008, http://www.ipni.net/ppiweb/FILEL1B.NSF/0/3FCACF5C93 CFA9A 18525743A00 6C7630/$file/Gordon_Fact_Sheet.pdf.

(67.) Id.

(68.) Sarah Yang, Genetically Modified Crops in India Produced Greater Yields, Reduced Pesticide Use, New Study Finds, EUREKALERT!, Feb. 6, 2003, http://www.eurekalert.org/pub_releases/2003-02/uoc--gmc020303.php.

(69.) Id.

(70.) A. Bryan Endres, "GMO:" Genetically Modified Organism ge·net·i·cal·ly modified organism
n. Abbr. GMO
An organism whose genetic characteristics have been altered by the insertion of a modified gene or a gene from another organism using the techniques of genetic engineering.
 or Gigantic Monetary Obligation? The Liability Schemes for GMO Damage in the United States and the European Union, 22 LOY n. 1. A long, narrow spade for stony lands. . L.A. INT'L & COMP. L. REV. 453, 454 (2000) (citation omitted).

(71.) Id.

(72.) PRINGLE, supra note 31, at 124-125.

(73.) Holly Saigo, Note, Agricultural Biotechnology and the Negotiation of the Biosafety Protocol, 12 GEO. INT'L ENVTL. L. REV. 779, 787 (2000).

(74.) Id

(75.) Jane Matthews Glenn, Footloose foot·loose  
adj.
Having no attachments or ties; free to do as one pleases.


footloose
Adjective

free to go or do as one wishes

Adj. 1.
: Civil Responsibility for GMO Wandering in Canada, 43 WASHBURN L.J. 547, 548 (2004).

(76.) Id at 547.

(77.) See Paul Elias, Small Farmer's Fight Becomes Anti-Biotech Crusade, USA TODAY, Jan. 19, 2004, http://www.usatoday.com/tech/news/techpolicy/2004_ 01-19-schmeiser_x.htm. Monsanto sued a farmer for failing to pay technology fees when its Roundup canola was found growing in the farmer's fields. The farmer insisted that the seed had migrated from his neighbor's farm without his knowledge, and that in fact Monsanto was liable for contaminating the canola crop he had spent a lifetime improving. Id.

(78.) Monsanto Canada v. Schmeiser, [2004] 1 S.C.R.902 (Can.) (holding that the growing of genetically modified crops constitutes "use" of the patented invention of genetically-modified seeds).

(79.) Scott Canon, Sterile Seed is the Focus of the Current Biotech Brouhaha, KAN. CITY STAR, Nov. 8, 1999, at A1.

(80.) PRINGLE, supra note 31, at 172.

(81.) See supra [section] 3.2.2.1.

(82.) See, e.g., Rizvi, supra note 15; Rizvi, supra note 29.

(83.) See U.S. DEPT dept department . OF AGRIC AGRIC Agricultural/Agriculture ., BULL. NO. AIB762, ECONOMIC ISSUES 1N AGRICULTURAL BIOTECHNOLOGY 3 (2001), available at http://www.ers.usda.gov/publications/aib762/aib762.pdf; Steve Stecklow & Matt Moffett, Brazil's Farmers Dispute Ban on Genetically Modified Food, GENETICALLY MANIPULATED FOOD NEWS, Dec. 28, 1999, at 16, http://home.intekom.com/tm_info/rw91231.htm.

(84.) Stephen Leahy, World Social Forum: Monsanto "Seed Police" Scrutinize Farmers, INTER PRESS SERVICE, Jan. 14, 2005, at 1, http://ipsnews.net/print.asp ?idnews=27041.

(85.) See Deacon & Paterson, supra note 41 and text accompanying note 60.

(86.) See, e.g., Rizvi, supra note 15.

(87.) Id.

(88.) See id.

(89.) This statistic is valid as of the year 2008. CLIVE JAMES, INT'L SERV SERV Service
SERV Society of Ethical and Religious Vegetarians
SERV Sociaal-Economische Raad Van Vlaanderen
. FOR THE ACQUISITION OF AGRI-BIOTECH APPS., GLOBAL STATUS OF COMMERCIALIZED BIOTECH/GM CROPS: 2008, BRIEF 39-2008 (2008), http://www.isaaa.org/resources /publications/briefs/39/pptslides/Global-Status-Map-2008.pdf.

(90.) See Jesse Male, Note, The State of Genetically Engineered Crops in the European Union Following Monsanto v. Italy and the Adoption of a New Regulatory Framework for Genetically Modified Food and Feed, 9 DRAKE J. AGRIC. L. 439, 441-43 (2004) (explaining the lack of United States regulation specifically geared toward GMOs and the administrative processes that seek to deal with them instead).

(91.) See Endres, supra note 70, at 479.

(92.) David J. Earp, The Regulation of Genetically Engineered Plants: Is Peter Rabbit Safe in Mr. McGregor's Transgenic Vegetable Patch? 24 ENVTL. L. 1633, 1640-41 (1994).

(93.) See, e.g., William Allen, The Current Federal Regulatory Framework for Release of Genetically Altered Organisms into the Environment, 42 FLA. L. REV. 531, 550 (1990) (illustrating inadequate coverage of the current administrative framework with examples of loopholes in the review process for GMOs).

(94.) PRINGLE, supra note 31, at 67.

(95.) See Allen, supra note 93, at 550-53.

(96.) See Oregon State University Oregon State University, at Corvallis; land-grant and state supported; coeducational; chartered 1858 as Corvallis College, opened 1865. In 1868 it was designated Oregon's land-grant agricultural college and was taken over completely by the state in 1885. , Outreach in Biotechnology, Regulation, http://agsci.oregonstate.edu/orb/gm#us (last visited Feb. 18, 2010).

(97.) CHRISTINA GRIIVIM, NEW HAMPSHIRE New Hampshire, one of the New England states of the NE United States. It is bordered by Massachusetts (S), Vermont, with the Connecticut R. forming the boundary (W), the Canadian province of Quebec (NW), and Maine and a short strip of the Atlantic Ocean (E).  HEALTH FREEDOM COALITION, CURRENT (FEBRUARY-MARCH 2001) STATE GMO LEGISLATION IN THE UNITED STATES, http://www.biotech-info.net/current_state_legislation.html. The following states have also passed legislation governing GMOs: Colorado, Hawaii, Iowa, Maine, Maryland, Michigan, Mississippi, Minnesota, Nebraska, New Hampshire, Oklahoma, Pennsylvania, South Dakota, Vermont, and West Virginia. Id.

(98.) See Margaret Rosso Grossman, Biotechnology, Property Rights and the Environment, 50 AM. J. COMP. L. SUPP SUPP Support
SUPP Supplement
SUPP Supplementary (geometry)
SUPP suppository
SUPP Sarawak United People's Party (Malaysia) 
. 215, 241 & n.159 (2002) (citing S.B. 1789 (Mass. 2001)).

(99.) See id. at 240 and nn. 150 & 153 (citing MINN MINN Minnesota (old style) . SWAT. [section] 18F (2010); 430 ILL. COMP. SWAT. 95/1-11 (2009)).

(100.) Andrew Barker, Vermont Plows Ahead on GE Seed Liability Law, available at http://www.ruralvermont.org/archives/2005/03/vermont_plows_ ahead_on_ge_seed_liability_law.html (last visited Feb. 4, 2010); Biotech Bullying: Vermont Governor Vetoes Bill to Protect Farmers from Genetic Contamination, available at http://www.organicconsumers.org/articles/article_480.cfm (last visited Nov. 24, 2009).

(101.) See ME. REV. STAT. ANN. tit. 7, [section][section] 530-A, 1051-52 (2002).

(102.) Grossman, supra note 98, at 240-41.

(103.) Id. at 241.

(104.) See id. at 243-44.

(105.) Id. at 244.

(106.) Id. See also Maureen Bessette, Genetic Engineering: The Alternative of Self-Regulation for Local Governments, 22 SUFFOLK U. L. REV. 1121, 1142 (1988).

(107.) Lucas Bergkamp, Allocating Unknown Risk: Liability for Environmental Damages Caused by Deliberately Released Genetically Modified Organisms, 61 ENVTL. LIAB. L. REV., Pt. II 104, 110-11 (2000).

(108.) Council Directive 90/219, art. 2, 1990 O.J. (L 117) 227, 229 (EC).

(109.) Id.

(110.) See id. art. 11.

(111.) Bergkamp, supra note 107, at 104.

(112.) Council Directive 90/220, art. 2(3), 1990 O.J. (L 117) 15, 17 (EC).

(113.) Bergkamp, supra note 107, at 106-07.

(114.) Commission Regulation (EC) 1829/2003, 2003 O.J. (L 268) 1 (amended in 2006 by Commission Regulation (EC) 1981/2006, 2006 O.J. (L 368)).

(115.) Id art. 3-14; see also Europa, Summaries of EU Legislation, GM Food and Feed, http://europa.eu/legislation_summaries/agriculture/food/ 121154_en.htm.

(116.) Commission Regulation 1829/2003, supra note 114.

(117.) Council Directive 85/374, 1985 O.J. (L 210) 29-33 (EC).

(118.) Council Directive 1999/34, 1999 O.J. (L 141) 20 (EC) (amending Directive 85/374, 1985 O.J. (L 210) 29-33 (EC)) ("Primary agricultural products" are "the products of the soil, of stock-farming and of fisheries, excluding products which have undergone initial processing.").

(119.) Id.

(120.) Council Directive 85/374, supra note 117, art. 6.

(121.) Id. art. 4.

(122.) Bergkamp, supra note 107, at 104-05.

(123.) Id.

(124.) See discussion infra [section] 4.2-4.2.3.2 for a review of potential harms which could result from GMOs and GURTs.

(125.) Bergkamp, supra note 107, at 105.

(126.) Id. at 17 (quoting Directive 85/374 art. 9).

(127.) Id. (discussing Directive 85/374 art. 7).

(128.) Id.

(129.) United Nations Conference on Environment and Development United Nations Conference on Environment and Development (UNCED) or Earth Summit, an 11-day meeting held in June, 1992, in Rio de Janeiro, Brazil, to discuss the global conflict between economic development and environmental protection. : Convention on Biological Diversity, June 5, 1992, 31 I.L.M. 818 (1992), 1992 WL 672430 [hereinafter Biodiversity Convention]; Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Jan. 29, 2000, 39 I.L.M. 1027 (2000), [hereinafter Cartagena Protocol].

(130.) Convention on Civil Liability for Damage Resulting from Activities Dangerous to the Environment, June 21, 1993, 32 I.L.M. 1228 (1993), 1993 WL 720529 (1.L.M.)[hereinafter Lugano Convention].

(131.) United Nations Conference on Environment and Development: Rio Declaration on Environment and Development The Rio Declaration on Environment and Development, often shortened to Rio Declaration, was a short document produced at the 1992 United Nations Conference on Environment and Development (UNCED), informally known as the Earth Summit. , June 14, 1992, 31 I.L.M. 874 (1992), 1992 WL 672434 (I.L.M.).

(132.) Council Decision 93/626 Concerning the Conclusion of the Convention on Biological Diversity, 1993 O.J. (L 309) art. 1 (EC).

(133.) Biodiversity Convention, supra note 129, art. 8 (g)-(h).

(134.) Id. art. 19 (4).

(135.) Cartagena Protocol, supra note 129, art. 1

(136.) Id.

(137.) Id. art. 27.

(138.) Id.

(139.) Bergkamp, supra note 107, at 112.

(140.) Lugano Convention, supra note 130, art. 1.

(141.) Bergkamp, supra note 107, at 112.

(142.) Lugano Convention, supra note 130, art. 2(5). The Convention defines "operator" as "the person who exercises the control of a dangerous activity." Id.

(143.) Id. art. 2(11).

(144.) Id. art. 2(1)(b).

(145.) Id art. 11.

(146.) Id. art. 9.

(147.) Id. art. 8.

(148.) Id.

(149.) Id.

(150.) See, e.g., supra note 78 and accompanying text.

(151.) Paul J. Heald & James Charles Smith, The Problem of Social Cost in a Genetically Modified Age, 58 HASTINGS L.J. 87, 89 & n. 13 (2006).

(152.) Id. at 91-108.

(153.) See Lugano Cenvention, supra note 130, art. 2(5) and note 142 for the definition of "operator" and art. 6(1) imposing liability.

(154.) (1868) L.R. 3 H.L. 330.

(155.) Id. at 340.

(156.) W. PAGE KEETON ET AL., PROSSER & KEETON ON THE LAW OF TORTS [section] 78, at 547-48 (5th ed. 1984).

(157.) RESTATEMENT (SECOND) OF TORTS [section] 519 (1977).

(158.) Id. [section] 520.

(159.) 567 P.2d 218, 220-23 (Wash. 1977).

(160.) Id. at 223.

(161.) See Grossman, supra note 98, at 215, at 237-39 (explaining that most courts refuse to find operators strictly liable for harm caused by GMOs, preferring instead to apply the negligence theory); Gulf, Colo. & Santa Fe Ry. Co. v. Oakes, 58 S.W. 999, 1001 (Tex. 1900) (holding that a bystander-farmer must bring her claim under the nuisance balancing test rather than under strict liability or per se nuisance). See also Bennett v. Larsen, 348 N.W.2d 540, 553 (Wisc. 1984) (holding that "pesticide application is not an ultrahazardous activity ultrahazardous activity n. an action or process which is so inherently dangerous that the person or entity conducting the activity is "strictly liable" for any injury caused by the activity. ").

(162.) Grossman, supra note 98, at 238.

(163.) See, e.g., Monsanto.com, For the Record, http://www.monsanto.com/ mon santo_today/for the record/default.asp (last visited Nov. 23, 2009) (describing Monsanto's technology as helping "farmers grow food more efficiently and in a more sustainable manner").

(164.) See KEETON ET AL., supra note 156, [section] 95, at 677-679.

(165.) See, e.g., McLennan v. American Eurocopter Corp., Inc., 245 F.3d 403, 431 (5th Cir. 2001) (holding that a helicopter manufacturer was not strictly liable for a pilot's injuries caused by post-sale modifications of which the company was unaware).

(166.) Deacon 8: Paterson, supra note 41, at 602-03; RESTATEMENT (THIRD) OF TORTS: PROD. LIAB. [section][section] 1-2 (Proposed Final Draft, 1997).

(167.) Brady L. Montalbano, It's Not Easy Being Green. Holding Manufacturers Of Genetically Modified Bentgrass Liable Under Strict Products Liability, 14 PENN ST. ENVTL. L. REV. 111, 120 & n.58 (2005).

(168.) Grossman, supra note 98, at 238-39.

(169.) See Deacon & Paterson, supra note 41, at 608.

(170.) KEETON ET AL., supra note 156, [section] 86, at 616-19.

(171.) Id. [section] 87, at 619.

(172.) See, e.g., United Verde Extension Mining Co. v. Ralston, 296 P. 262, 265 (Ariz. 1931) (smoke from a smelter prevented owner of property from farming land); Andrews v. Andrews, 88 S.E.2d 88, 92 (N.C. 1955) (geese lured to pond by defendant destroyed plaintiffs crops); Campbell v. Seaman, 63 N.Y. 568, 582 (1876) (defendant's brick kiln produced gas which killed plaintiffs trees); Stevens v. Moon, 202 P. 961, 963 (Cal. Dist. Ct. App. 1921) (root system of defendant's trees extending under plaintiff's property may have detroyed plaintiffs trees).

(173.) See, e.g., Beach v. Sterling Iron & Zinc Co., 33 A. 286, 290 (N.J. Ch. 1895) (mine's discharge of muddy water into river was a nuisance), aff'd, 41 A. 1117 (N.J. 1896); Johnson v. City of Fairmont, 247 N.W. 572, 572-73 (Minn. 1933) (both sewage dumped into river by city and waste dumped into river by canning factory created nuisances); Farley v. Crystal Coal & Coke Co., 102 S.E. 265 (W. Va. 1920) (mining runoff created nuisance); Rose v. Standard Oil Co. of N.Y., 185 A. 251, 254 (R.I. 1936) (waste from oil refinery may be considered nuisance).

(174.) Endres, supra note 70, at 492-93.

(175.) RESTATEMENT (SECOND) OF TORTS [section] 826 (1977).

(176.) See, e.g., Jost v. Dairyland Power Cooperative, 172 N.W. 2d 647, 653 (Wisc. 1969) (holding that a coal-burning plant is liable for damaging neighboring crops, without balancing the damage caused by the power plant against the social utility it provided).

(177.) KEETON ET AL., supra note 156, [section] 90, at 643-46.

(178.) RESTATEMENT (SECOND) OF TORTS [section] 821b (1977).

(179.) See Endres, supra note 70, at 491-92.

(180.) Id. at 492.

(181.) KEETON ET AL., supra note 156, [section] 13.

(182.) Stephen M. Scanlon, Comment, Should Missouri Farmers of Genetically Modified Crops be Held Liable for Genetic Drift and Cross-Pollination?, 10 Mo. ENVTL. L. & POL'Y REV. 1, 7 (2002).

(183.) Id.

(184.) Id. at 8.

(185.) KEETON ET AL., supra note 156, [section] 13, at 67-84.

(186.) See George Van Cleve, Regulating Environmental and Safety Hazards of Agricultural Biotechnology for a Sustainable World, 9 WASH. U. J.L. & POL'Y 245, 259 (2002).

(187.) WILLIAM L. PROSSER, LAW OF TORTS [section] 70, at 398 (2nd ed. 1955).

(188.) Ronald H. Coase, The Problem of Social Cost, 3 J.L. & ECON ECON Economics (course)
ECON Economy (minimum cost speed schedule)
ECON Centre for Economic Analysis
ECON Eastern Coalition of Nations (Star Trek) 
. 1, 2 (1960).

(189.) Id.

(190.) Id.

(191.) Id. at 18.

(192.) Heald & Smith, supra note 151, at 91-108.

(193.) Id at 92-103.

(194.) Id. at 103-08.

(195.) Id. at 105.

(196.) Id. at 106.

(197.) Coase summarizes some examples of costly market transactions:
   In order to carry out a market transaction it is necessary to
   discover who it is that one wishes to deal with, to inform people
   that one wishes to deal and on what terms, to conduct negotiations
   leading up to a bargain, to draw up the contract, to undertake the
   inspection needed to make sure that the terms of the contract are
   being observed, and so on. Coase, supra note 188, at 15. See also
   Heald & Smith, supra note 151, at 97-101 (outlining transaction
   costs with respect to the pollen drift example).


(198.) See Coase, supra note 188, at 15-19 (discussing how the increased value of production effected by the rearrangement must be greater than the costs involved in bringing it about when the cost of market transactions is taken into account in a rearrangement of legal rights).

(199.) See, e.g., Paul J. Heald, A Transaction Costs Theory of Patent Law, 66 OHIO Ohio, state, United States
Ohio, midwestern state in the Great Lakes region of the United States. It is bordered by Pennsylvania (NE) West Virginia (SE), Kentucky (S), Indiana (W), and Michigan and Lake Erie (N).
 ST. L.J. 473,499-506 (2005) (remarking on the inverse relationship between increases in patent law protection and instances of invention).

(200.) Biotechnology Industry Organization Biotechnology Industry Organization or BIO was founded 1993 in Washington, DC. James C. Greenwood is BIO's current President. External links
  • BIO Website
, Biotechnology Industry Facts, http://www.bio.org/speeches/pubs/er/statistics.asp (last visited Feb. 12, 2010).

(201.) Carey Gillam, Monsanto's Monopoly of Biotech Sector Spurs Lawsuit, Organic Consumers Ass'n, Aug. 25 2004, http://www.organicconsumers.org /monsanto/monopoly.cfm.

(202.) Monsanto Co., Annual Report (Form 10-K), at 41 (Aug. 31, 2008). The $980 million figure is a conservative estimate, as it does not include the expenses for research and development already in progress at companies Monsanto acquired during the fiscal year, which amount at least to an additional $164 million. Id.

(203.) Andy Meek, Down and Out in Covington, MEMPHIS Memphis, city, ancient Egypt
Memphis (mĕm`fĭs), ancient city of Egypt, capital of the Old Kingdom (c.3100–c.2258 B.C.), at the apex of the Nile delta and 12 mi (18 km) from Cairo.
 DAILY NEWS, June 22, 2006, http://www.memphisdailynews.com/editorial/Article.aspx?id=30496.

(204.) Donald L. Barlett & James B. Steele, Monsanto's Harvest of Fear, VANITY FAIR, May 2008, at 158.

(205.) Id.

(206.) Id.

(207.) Id. at 160-61.

(208.) This statistic is valid as of 2005. CTR See click-through rate. . FOR FOOD SAFETY, MONSANTO VS. U.S. FARMERS 23 (2005), available at http://www.percyschmeiser.com/Monsanto vsFarmerReport1.13.05.pdf.

(209.) Barlett & Steele, supra note 204, at 160.

(210.) CTR. FOR FOOD SAFETY, MONSANTO VS. U.S. FARMERS: NOVEMBER 2007 UPDATE, (2007), available at http://truefoodnow.files.wordpress.com/2009/12/m onsanto20november20200720update.pdf.

(211.) Id.

(212.) Id.

(213.) See, e.g., Meek, supra note 203.

(214.) See Matt Pressman, Q & A: dames Steele on the Seed Police, VANITY FAIR ONLINE DAILY, Apr. 7, 2008, http://www.vanityfair.com/online/daily/2008/04/qajames-steele.html.

(215.) Meek, supra note 203.

(216.) Barlett & Steele, supra note 204, at 160.

(217.) Id.

(218.) See id. A seed dealer in Kansas was wrongly accused of planting Monsanto's seeds in violation of its patent; he was threatened to settle with Monsanto or face the consequences. Id.

(219.) See supra note 60 and accompanying text.

(220.) Neil D. Hamilton, Legal Issues Shaping Society's Acceptance of Biotechnology and Genetically Modified Organisms, 6 DRAKE J. AGRIC. L. 81, 113-14 (2001).

(221.) The environmental activist group ETC ETC - ExTendible Compiler. Fortran-like, macro extendible. "ETC - An Extendible Macro-Based Compiler", B.N. Dickman, Proc SJCC 38 (1971).  estimates that if GURTs were used, soybean soybean, soya bean, or soy pea, leguminous plant (Glycine max, G. soja, or Soja max) of the family Leguminosae (pulse family), native to tropical and warm temperate regions of Asia, where it has been  production in Argentina would cost an additional $276 million annually, and wheat production in Pakistan would cost $191 million more. Mario Osava, Biodiversity." Ban on Terminator Seed Field Trials Continues, INTER PRESS SERVICE, March 24, 2006, available at http://www.globalexchange .org/countries/brazil/3838.html.

(222.) Canon, supra note 79.

(223.) Stephen Leahy, 'Pharma Crops' Threaten Food Safety, INTER PRESS SERVICE, Dec. 30, 2004, available at http://www.commondreams.org/headlines04 /1230-08.htm.

(224.) See Canon, supra note 79.

(225.) See id.

(226.) See, e.g., Samantha M. Ohlgart, Note, The Terminator Gene: Intellectual Property Rights vs. the Farmers' Common Law Right to Save Seed, 7 DRAKE J. AGRIC. L. 473, 475 (2002).

(227.) THOMAS JEFFERSON, Summary of Public Service, [after 2 Sep. 1800], in 32 THE PAPERS OF THOMAS JEFFERSON 122, 124 (Barbara B. Oberg et al. eds., 1950).

David Daniel *

* David Daniel is a 2011 candidate for the degree of J.D./M.B.A. at the Law and Business Schools of Rutgers University in Newark, N.J. He wishes to thank Prof. Sabrina Safrin of Rutgers School of Law--Newark for her help in formulating a research plan.
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