Biotechnology and International Law

Sean D. Murphy

I. INTRODUCTION

II. THE SCIENCE OF BIOTECHNOLOGY, ITS APPLICATIONS, AND ITS CRITICS

The Science

The Applications General Criticisms

III. PROBLEMS OF BIOTECHNOLOGY IN THE TRANSNATIONAL SPHERE

Equitable Concerns Regarding the Patenting of Genetically Modified Organisms

Transparency Regarding Exports of Genetically Modified Products Import Bans on Genetically Modified Products

Liability for Damage by Genetically Modified Imports

Liability for Extraterritorial Damage by Genetically Modified Products Long-term Decline in Global Biological Diversity

IV. THE JURISGENERATIVE NATURE OF INTERNATIONAL LA W

International Law as Driven by the Self-Interest of Transnational Actors International Law as Driven by Social Interaction Among

Transnational Actors

International Law as Grounded in National Law and Society

V. TOWARD AN EPISTEMIC COMMUNITY

Developing an Epistemic Community

The Structure of a Transnational Forum

The Goals of a Transnational Forum

Potential Crystallization of a Coherent Legal Regime

VI. CONCLUSION

*George Washington University Law School. My thanks to Patrick Abbot, John Knox, Michael Reisman, Sabrina Safrin, and the author’s colleagues at the law school for their thoughtful comments on an earlier draft of this article, and to Dean Michael K. Young for financial support and Matthew Haws (’02) for outstanding research assistance.

I. INTRODUCTION

If one were to forecast the areas involving the greatest technological breakthroughs for the new millennium, the genetic engineering made possible by biotechnology1 would be at or near the top of the list. It is entirely possible that over the next fifty years thousands of novel, genetically modified bacteria, viruses, plants and animals could be developed and released into the global environment for

pharmaceutical, agricultural, medical, environmental remediation, alternative fuel, and other purposes. For some internationalists, this is extremely good news, especially for the developing world. For instance, recent estimates indicate that around 790 million people in developing states are chronically undernourished (meaning their food intake is insufficient to meet basic energy requirements on a continuing basis) and millions more experience under nutrition (meaning they lack essential vitamins and minerals in their diet) leaving them underweight and stunted.2 Absent biotechnology developments, one might doubt that current plant-breeding techniques could increase the world’s food supply enough to

1 “Biotechnology” encompasses a variety of techniques, such as selecting natural strains of organisms that carry desirable traits, making hybrids by fusing cells from different parental sources, using chemicals and radiation to create mutant strains, or genetically engineering plants, animals, and micro-organisms to contain specific phenotypic characteristics. At its most general level, biotechnology concerns techniques for using the properties of living things to make products or services. The principal focus of this article is on recent, controversial developments in biotechnology relating to genetic engineering.

2 U.N. FOOD AND AGRIC. ORG., THE STATE OF FOOD INSECURITY IN THE WORLD 1999 at 1 0

11 (1999).

feed an estimated 9.4 billion people by the year 2050.3

Yet the dawn of the biotechnology world is generating serious transnational concerns that pose an enormous challenge for the international law and structures of our new century. Concerns arise over whether the genetic resources of the world, once manipulated, should be reducible to property rights, allowing a few companies of technologically-rich states to control access to food, medical, and other resources essential to the health and welfare of billions of people. Concerns arise over whether states should be notified first before any genetically modified products are exported to them, and once informed, on what grounds they may refuse to permit the export to occur. Already a trade impasse has developed between the United States and the European Union over genetically modified food, fueled by consumer demands for labeling schemes or even outright bans. To the extent that widespread bans on exports among developed states emerge, they may inhibit the ability of developing states to obtain the fruits of biotechnology for their own urgent needs, and close off markets for exports of genetically modified products from developing states to the developed world. Further concerns arise if genetic engineering causes transnational catastrophic harm. Although no such harm has occurred to date (such as by destabilizing a state’s biosphere through “genetic pollution”), such an outcome is feared, and raises questions as to responsibility if such an event occurs. Finally, there are long-term concerns about the decline in global biological diversity, which may be accelerated by the widespread use of genetically modified products.

The purpose of this article, broadly stated, is to assess the strengths and limits of existing

international law and structures designed to address these concerns, and to suggest a means for augmenting current structures to make them more effective. Part II begins with a discussion of the science of biotechnology, which is useful background for understanding its promises and perils, and then proceeds to briefly relate recent applications of the science and some general concerns about those applications. Part III clarifies and analyzes six specific concerns about biotechnology in the transnational sphere and associated international law and structures. As will be seen, there is no single treaty regime addressing these concerns but, rather, a segmented and at times conflicting network of intellectual property, trade, and environment treaties, accompanied by ambiguous customary law or principles. The few legal studies to date in this area tend to focus on just one of these several concerns, which results in an inability to see connections among them that suggest cross-sectoral opportunities for bargaining and cooperation among relevant state and non-state actors.

Prior scholarly studies in this area also tend to focus on state-to-state negotiations as the means for addressing transnational biotechnology. Yet, as discussed in Part IV, international law develops and regulates transnational behavior in a manner that goes well beyond the development treaty regimes. International law is driven in large part by the self-interest of states, but they also arise from the social interaction of states and non-state actors, and they ultimately must become grounded in national laws and society in order to become effective. While Part III emphasizes the need for coordination across different treaty regimes, Part IV emphasizes the need for coordination at different levels of state and non-state behavior as the law develops over time. While states should continue to grapple with concerns in the area of biotechnology through incremental tinkering of existing treaty regimes -seen most recently in the adoption of a Biosafety Protocol to the Convention on Biological Diversity-this

article argues that the principal emphasis of the global community on episodic and segmented intergovernmental negotiations as a means for addressing these concerns is misplaced, especially since the science in this area is changing rapidly, the behavior to be regulated is highly commercial and private in nature, and transnational regulation affects a wide variety of state and non-state actors who have complex motivations that change over time.

Rather, as advanced in Part V, there is value in coordinating and augmenting traditional treaty regimes by the coalescence of an “epistemic community” of scientists, environmentalists, multinational businesses, trade organizations, development experts, academic groups, and others that transcend sectors. The many issues raised by biotechnology in the transnational sphere need to be addressed by international society as a whole, rather than left to the vagaries of the market, to governments alone, or to the initiatives of a few well-financed interest groups, such as biotechnology companies and environmentalists. One approach would be to establish a transnational forum on biotechnology, which could serve as a relatively informal and non-binding means for the transnational “bargaining” of views among a wide range of relevant non-state actors. Such a forum ultimately may be instrumental in achieving consensus on a coherent and effective legal regime to address concerns with transnational biotechnology, one that balances the tremendous opportunities of biotechnology against its potentially severe and adverse transnational effects.

Moreover, if successful, such a forum might provide a template for resolving the recurrent problem seen in reconciling other problems in the field of trade and environment, as well as clashes among other fields of international law. The structure of international society grows ever deeper in the ways in which non-governmental actors operate and cooperate across borders. Traditional methods of

developing international law affecting private behavior must give way to newer approaches, ones that

recognize the indispensability of cooperation among non-governmental actors in advance of the formation of new international legal regimes and in advance of major reforms of existing regimes. Otherwise, the development of international law in such areas will prove increasingly ineffective and unsatisfactory in responding to the demands of international society.

II. THE SCIENCE OF BIOTECHNOLOGY, ITS APPLICATIONS, AND ITS CRITICS

The Science4

The term “biotechnology” can be applied to pre-twentieth century methods of producing dairy products, bread, or wine, as well as selective breeding of animals or cloning of plants by grafting. As such, the field has been around for centuries without creating any significant problems for national regulation, let alone international regulation. However, the genetic engineering of modern biotechnology -whereby a firefly can be crossed with a tobacco plant to produce a glowing

4 The information contained in this section may be found in a variety of standard works on biotechnology. Non-scientists seeking more information may find accessible SUSAN ALDRIDGE, THE

THREAD OF LIFE:THE STORY OF GENES AND GENETIC ENGINEERING (1996)

CENTURY (Frederick B. Rudolph & Larry V. McIntire, eds. 1996). For standard scientific textbooks on genetics and biotechnology, see BERNARD R. GLICK & JACK J. PASTERNAK, MOLECULAR BIOLOGY (2d ed. 1998)

1996).

plant-moves well beyond anything previously seen. Traditional cross-breeding involves selectively breeding for desired genetic traits, usually within a single species or species complex, while the genetic engineering that began in the 1970’s allows genes to be transferred between distant species that would never interbreed in nature, raising new issues, questions, and problems in both the national and transnational sphere.

How is genetic engineering done? Each cell of an organism typically has a nucleus containing threadlike bodies known as chromosomes. Each chromosome contains tightly packed sequences of nucleotides, a compound consisting of a base, a phosphate group, and a sugar. These nucleotides arrange themselves structurally as two complementary chains wound in a helix, to form deoxyribonucleic acid (DNA). A sequence of nucleotides on a chromosome contains within it a particular piece of information about the organism’s parent: that sequence is known as a gene. Different sequences of nucleotides provide codes for the creation of specific amino acids, which in turn dictate what cells are created. Why do the cells of a firefly egg develop so as to create a new firefly instead of, for example, a tobacco plant? The sequences of nucleotides in the chromosomes of the parent fireflies, when combined to create the off-spring firefly, dictate the arrangement of specific macromolecules, which results ultimately in the creation of a new firefly.5

By combining genes from the DNA of one species with that of another, is it possible to create a tobacco plant with leaves that glow like a firefly? There are various techniques for transferring genes

most cells is found on chromosomes located within a cell nucleus, bacteria do not have nuclei

When attacked by a virus, however, bacteria will also counterattack by generating a group of enzymes, known as restriction endonucleases or restriction enzymes, that try to chop up the invading DNA. Different restriction enzymes recognize specific sequences of nucleotides and chop up the invading DNA at these points. Researchers have identified hundreds of restriction enzymes possessing unique recognition sites and therefore can use them as cutting tools. Because of the structure of DNA, any two fragments of DNA-from any biological source-cut by the same restriction enzyme can be joined together.7 So, if the relevant genes whose product emits light were chopped off from the DNA of a firefly and joined to relevant genes of a tobacco plant seed, the result would be a tobacco plant that

6 See generally GRACE, supra note 4, ch. 1

grows.

The Applications

Using such techniques, scientists are capable of joining DNA fragments from different sources to create novel DNA (known as recombinant DNA or rDNA) so as to take a valued quality of one organism and join it with the valued quality of a second organism. Although today’s science is not advanced enough to know what fragments of DNA to combine in order to cross complex organisms without seriously disrupting the normal development of the embryo,9 there already exist many less complex applications of this new biotechnology.

In the medical field, scientists are developing plants genetically engineered to contain drugs that can then be extracted (or delivered by simply eating the plant), a process called molecular farming or “biopharming” that is far less costly process than current laboratory techniques.10 Scientists also envisage treating (and perhaps even curing) diseases through “gene therapy,” by infusing a patient who

8 The feat was accomplished in 1986. See JEREMY RIFKIN, THE BIOTECH CENTURY at 14

(1998).

9 The control of genes in multi-celled organisms is highly complex. Scientists do not yet understand how undifferentiated cells within an embryo express different genes to produce different body tissues and organs. It is not enough to transfer genes that create the structure of an organ

10 See Andrew Pollack, New Ventures Aim to Put Farms In Vanguard of Drug Production, N.Y. TIMES, May 14, 2000, at 1.

has missing or defective genes with corrective doses of DNA.11 Genetic diseases such as cystic fibrosis

ultimately may be cured through such applications, as well as more complex conditions involving the interactions of various genes that lead to heart disease, cancer, and Alzheimer’s disease. Ultimately, gene therapy might result in longer living, more intelligent humans.12

To date, however, success with gene therapy has been minimal.13 Greater success exists in use of genetic engineering for the mass production of therapeutic proteins that would otherwise be difficult

11 See generally ANDREW KIMBALL, THE HUMAN BODY SHOP:THE ENGINEERING AND MARKETING OF LIFE (1993)

THE RETOOLING OF HUMAN LIFE (1995). Scientists currently mapping the multi-billion-unit human DNA sequence hope that it will lead to an ability to identify and manipulate human genes responsible for aging and disorders, leading to treatments for cancer, heart disease, and other maladies. See Karl Lenhard Rudolph et al., Longevity, Stress Response, and Cancer in Aging Telomerase-Deficient Mice, 96 CELL 701 (1999). As of July 2000, two entities-a private company named Celera Genomics Corporation and a multi-national consortium of educational centers named the Human Genome Project-are on the verge of completing a total sequencing of genes of a human cell. See Rick Weiss & Justin Gillis, DNA-Mapping Heralded, WASH. POST, June 27, 2000, at A1. As each gene sequence is uncovered by the Human Genome Project, there is complete and continuous public disclosure, which has the effect of blocking private patents on the uncovered gene sequence. For the consortium’s Internet site, maintained by the U.S. National Center for Biotechnology, see <http://www.ncbi.nlm.nih.gov/genome/seq>. Although public and private ventures are already seeking patents for various segments of the human genome, in all but a handful of these instances, the applicant does not yet understand the function, usefulness or commercial value of the genetic material.

12 Scientists have already manipulated the DNA sequence of mouse genes so as to make a smarter mouse. See Ya-Ping Tang et al., Genetic Enhancement of Learning and Memory in Mice, 401 NATURE 63 (Sept. 2, 1999).

13 See, e.g., Sheryl Gay Stolberg, The Biotech Death of Jesse Gelsinger, N.Y. TIMES, Nov. 28, 1999, §6 (Magazine), at 136 (describing the unsuccessful seven-week University of Pennsylvania gene therapy experiment on a teenager suffering from a rare metabolic disorder)

or costly to produce, or even unavailable by conventional means.14 Animals are being engineered with

special genetic traits from human genes, so that the animals can produce human proteins for making drugs to combat disease.15 In the future, engineered animals might even produce entire organs useable by humans by xenotransplants.16 Moreover, once engineered, such animals can be duplicated ad infinitum through cloning (i.e., using a gene from an ancestor to produce a genetically identical organism).17 Current U.S. policy, however, disfavors use of biotechnology to clone humans, largely out of ethical, moral, religious and legal concerns.18

14 For instance, antibodies (proteins created by certain white blood cells to fight infection) have been very difficult to create in the laboratory using traditional methods, since white blood cells do not survive easily outside the body. Using techniques of biotechnology, however, the antibody-producing qualities of white blood cells have been fused with cancer cells, which have the property of unstoppable growth, so as to turn out a continuous supply of antibodies. Other therapeutic proteins replicated using genetic manipulation include insulin, alpha interferon, and human growth hormones, some of which have purely animal applications. One advantage of using human genes to produce the drugs for humans is that they are less likely to generate adverse side-effects.

15 See Justin Gillis, Down on the High-Tech Pharm, WASH. POST, Jan. 17, 2000, at A1

16 See, e.g., Sheryl Gay Stolberg, Could This Pig Save Your Life? N.Y. TIMES, Oct. 3, 1999, §6 (Magazine), at 46 (describing efforts to insert human genes into pig embryos, so that the organs of the grown pig, when transplanted into the physiologically similar humans, will not be rejected

by the human immune system)

17 In 1996, Scottish scientists successfully cloned a lamb from an adult sheep, by taking the nucleus of an adult sheep’s cell and transferring it into another sheep’s unfertilized egg. The “reconstructed” embryo was placed in the womb of a foster mother and brought to term. Thus, was born Dolly. See I. Wilmut et al., Viable Ofspring Derived from Fetal and Adult Mammalian Cells, 385 NATURE 810 (1997).

18 See Remarks Announcing the Prohibition on Federal Funding for Cloning of Human Beings and an Exchange with Reporters, Mar. 4, 1997, 1997 PUB. PAPERS:WILLIAM J. CLINTON 230-32 (President Clinton urging “the entire scientific and medical community, every foundation, every

The transnational implications of these biotechnology applications are significant

available, such pharmaceuticals and medical treatments can potentially improve the health and wellbeing of millions of people worldwide afflicted with treatable diseases and conditions. Moreover,

certain applications could be targeted to the needs of the developing world. For instance, scientists may be within striking distance of plants that would produce edible vaccines and insulin, a highly practical means of distribution to developing states that would obviate the cost of transportation, the need for refrigeration, and the dangers of using needles.19 Separately, scientists are trying to reengineer insects so that they cannot spread major diseases, such as malaria, yellow fever, trypanosomiasis and dengue, which afflict millions of people each year, particularly in developing states. Insects harmful to the agricultural economies of Argentina, Chile, Guatemala, Japan, Mexico, Tanzania, and the United States are already breed in captivity to be sterile, so that when released they diminish the overall population

university, every industry that supports work in this area to heed the Federal Government’s example” and to undertake a voluntary moratorium on the cloning of human beings “until our Bioethics Advisory Commission and our entire Nation have had a real chance to understand and debate the profound ethical implications of the latest advances”). The National Bioethics Advisory Commission was established by Exec. Order No. 12,975, 3 C.F.R. 409 (1995), reprinted in 42 U.S.C. §6601 (Supp. II 1996).

In January 1998, the FDA asserted that it had January 1998 that it had statutory authority to regulate human cloning. See Gregory J. Rokosz, Human Cloning: Is the Reach of FDA Authority Too Far a Stretch? 30 SETON HALL L. REV. 464 (2000). Meanwhile, some U.S. states have banned human cloning. See, e.g., CAL. HEALTH & SAFETY CODE §24185 (West Supp. 2000).

On ethical, social, religious, and legal concerns regarding cloning of humans, see generally THE

GENETIC REVOLUTION AND HUMAN RIGHTS (Justine Barley ed., 1999)

BIOETHICS ADVISORY COMMISSION (1997) (concluding that the inefficiency and risk of known cloning techniques made research on human cloning inappropriate)

CODE OF CODES:SCIENTIFIC AND SOCIAL ISSUES IN THE HUMAN GENOME PROJECT (1992).

19 See Anne Simon Moffat, Toting Up the Early Harvest of Transgenic Plants, 282 SCI. 2176 (1998).

with biotechnology this process may become simpler and more effective.20

Next to applications of biotechnology in the medical field rank those in the field of agriculture.21 Genetically modified microorganisms might be developed that, when released into the environment, may help control soil acidity/alkalinity or salinity, thereby increasing the geographic range of crops. Already, “transgenic crops” can be genetically modified to do better at surviving drought or frost,22 to stay

20 See David A. O’Brochta & Peter W. Atkinson, Building the Better Bug, SCI. AM., Dec. 1998, at 90.

21 See generally Maurizio G. Paoletti & David Pimentel, Genetic Engineering in Agriculture and the Environment, 46 BIOSCIENCE 665 (1996). For an analysis of ethical and social issues that reaches conclusions favorable to continued development of biotechnology, see NUFFIELD COUNCIL ON

BIOETHICS, GENETICALLY MODIFIED CROPS:THE ETHICAL AND SOCIAL ISSUES (1999),

<http://www.nuffieldfoundation.org>.

22 The first genetically engineered micro-organism for use in agriculture authorized by the U.S. Government to be field-tested concerned a frost-inhibiting bacteria, known as “ice minus.” Ice minus was developed by taking bacteria that promoted ice formation (formally called pseudomonas syringae), isolating the ice-promoting protein within it and, through use of recombinant DNA techniques and restriction enzymes, creating a new bacterium lacking in the protein (other methods of creating the mutant strain were also used). Once sprayed on crops, it was hoped that the engineered strain of bacteria would delay frost formation at least until the temperature dropped below -10B C. The field tests on ice minus that began in 1987, however, ultimately revealed that some naturally occurring strains of pseudomonas syringae were just as effective as ice minus, leading to the abandonment of further research, testing and development of ice minus. See SHELDON KRIMSKY & ROGER P. WRUBEL,

AGRICULTURAL BIOTECHNOLOGY AND THE ENVIRONMENT 1 54-65 (1996).

fresher longer,23 to resist insect pests and diseases (viruses),24 and to tolerate herbicides, which allow

farmers to spray weedkiller on fields without damaging crops.25 The same biotechnology tools can be applied to livestock, so as to improve the quality and quantity of milk, eggs, meat, and wool, and to produce healthier, faster-growing animals.26

23 The first genetically modified product for food use to receive U.S. Government approval was the Flavr-Savr tomato, developed by Calgene. Approved in May 1994, the tomato had been genetically engineered so that it could stay on the vine until fully ripe, picked, but then delay ripening (and hence rotting) further. See Calgene, Inc., Availability of Letter Concluding Consultation, 59 Fed. Reg. 26,647 (Dep’t Health & Human Services 1994). The Flavr-Savr tomato proved less successful than hoped, as it cost more and did not taste as good as competing tomatoes.

24 The first genetically modified, insect-resistant crop to receive U.S. Government approval for commercial sale was the Monsanto’s NewLeaf potato. Approved in 1995, the genetic structure of the potato was modified to contain genes from a natural soil bacterium (Bacillus thuringiensis, or Bt) which emits organic toxins that, when ingested, kill certain insects. The same bacterium, however, is quickly

broken down into harmless chemicals when ingested by humans due to the highly acidic conditions of human stomachs. Ironically, Bt is the principle insect-controlling spray used by organic farmers, since it is an organic insecticide. Many genetically modified, insect-resistant crops currently used contain the Bt gene. See Michael Pollan, Playing God in the Garden, N.Y. TIMES, Oct. 25, 1998, §6 (Magazine), at 44.

25 The first herbicide-tolerant transgenic plant approved for commercial use was a type of cotton that could tolerate the herbicide bromoxynil. One of the most extensively used herbicidetolerant, genetically modified crops in the United States are Monsanto’s “Roundup Ready” canola, corn, cotton, and soybeans. “Roundup” is a Monsanto herbicide that has been used commercially for more than twenty years. It contains glyphosate, which kills weeds by interfering with an enzyme in their growth mechanism (a mechanism not found in animals). Through biotechnology, tolerance to “Roundup” has been transferred to desirable crops, allowing farmers to spray fields with “Roundup” to eliminate weeds without harming their crops. See Rick Weiss, Seeds of Discord, WASH. POST, Feb. 3, 1999, at A1. Monsanto argues that farmers can spray “Roundup Ready” crops less often than normal crops. See Monsanto Press Release on Environmental Benefits Of Crops Developed Through Biotechnology (July, 1997),

http://www.monsanto.com/monsanto/mediacenter./background/97jul_EnvBenefits.html>.

26 For example, in February 1994, the U.S. Food and Drug Administration approved for use in the United States a bovine growth hormone to increase a cow’s milk yield by up to twenty percent. The hormone, known as bovine somatotropin (BST), occurs naturally in cows, but can also be produced

16

All told, the U.S. Department of Agriculture (USDA) has approved some 50 varieties of

genetically modified crops. In 2000 in the United States, 52 percent of approximately 75 million acres of soybeans, 56 percent of approximately 15.5 million acres of cotton, and 25 percent of approximately 78 million acres of corn are planted with genetically modified crops.27 Those crops are used to produce a wide range of products consumed worldwide. For example, soy is present in an estimated 60 percent of all processed foods (mostly in the form of flour, oil and lecithin), including breads, baby foods, salad dressings, and ice cream.28

Again, the transnational implications of these agricultural biotechnology applications are significant

cheaply by inserting genes associated with the pituitary gland of cattle into bacteria, which then manufacture the hormone. Once produced, the hormone can be either injected in the cow or added to the cow’s feedstock. See KRIMSKY & WRUBEL, supra note 22, at 167-90

27 See NATIONAL AGRIC. STATISTICS SERV., U.S. DEP’T OF AGRIC., PROSPECTIVE PLANTINGS

4, 12, 18, 23-24 (2000), <http://jan.mannlib.cornell.edu/reports/nassr/field/pcp-bbp>. Most of the transgenic plants currently being developed in the United States are to tolerate chemical herbicides or

weedkillers. See JANE RISSLER AND MARGARET MELLON, THE ECOLOGICAL RISKS OF ENGINEERED

CROPS 14-15 (1996).

28 See Seeds of Change, CONSUMER REP., Sept. 1999, at 41.

29 See Robert B. Horsch, Biotechnology and Sustainable Development, in BIOTECHNOLOGY AND BIOSAFETY 25 (Ismail Serageldin & Wanda Collins eds., 1999). A study by the U.S. Department of Agriculture found that the farm-level impacts of genetically crops on pesticide use, yields, and net returns vary with the crop and technology examined. For instance, adoption of herbicide-tolerant cotton led to significant increases in yields and net returns, but was not associated with significant changes in herbicide use, while increases in adoption of herbicide-tolerant soybeans led to small but significant

possibility is of particular interest to the lesser developed states: China and India, for example, can only

feed their growing populations through continuous improvements in crop yields .30 By using crops genetically modified to have beneficial characteristics, developing states may find that they can meet increasing demand, while practicing even more environmentally benign agricultural methods. Not only might the supply be increased, but foods could be engineered to have a higher nutritive value,

possessing more vitamins, healthy fats and oils, or could be engineered to stay fresh longer in tropical states.31

Although there are concerns about the adverse environmental effects of manipulating nature

increases in yields, no changes in net returns, but significant decreases in herbicide use. See JORGE

FERNANDEZ-CORNEJO & WILLIAM D. MCBRIDE, U.S. DEP’T OF AGRIC., AGRIC. ECON. REP. NO. 786, GENETICALLY ENGINEERED CROPS FOR PEST MANAGEMENT IN U.S. AGRICULTURE (2000),

<http://www.ers.usda.gov/epubs/pdf/aer786/>.

30 See Anne Kathrine Hvoslef-Eide & Odd Arne Rognli, Environmental Issues for Plant Biotechnology Transfer: A Norwegian Perspective, in PLANT BIOTECHNOLOGY TRANSFER TO DEVELOPING COUNTRIES 37, 38-39 (David W. Altman & Kazuo N. Watanabe eds., 1995) (arguing that biotechnology “will probably provide the key for producing more food and other agricultural commodities from less land and water in the twenty-first century, without the adverse ecological implications associated with the expression of the full yield potential of high-yielding crop varieties through high-input agriculture”).

31 See generally AGRICULTURAL BIOTECHNOLOGY IN INTERNATIONAL DEVELOPMENT

(Catherine L. Ives & Bruce M. Bedford eds., 1998). For example, scientists have now created a strain of genetically altered rice carrying beta-carotene, a compound that is converted into vitamin A within the human body. Vitamin A deficiency is the world’s leading cause of blindness, creates susceptibility to a host of diseases, and is the source of a malaise that affects as many as 250 million children. Millions of those suffering the deficiency cannot be reached through distribution of pills, leaving genetically modified crops a low-cost yet effective option. See Xudong Ye et al., Engineering the Provitamin A (ß-Carotene) Biosynthetic Pathway into (Carotenoid-Free) Rice Endosperm, 287 SCI. 303 (2000). It is estimated that every year some 500,000 children become blind or partially blind from vitamin A

deficiency. See TRANSGENIC PLANTS AND WORLD AGRICULTURE 10 (July 2000),

<http://bob.nap.edu/html/transgenic> (collaborative report of eight national academies of science, including the U.S. National Academy of Sciences).

through biotechnology, it is important to note that there are several potentially positive uses of biotechnology, such as through genetically engineering crops to require less inputs (land, water, pesticides). One potential benefit relates to environmental clean-up. For decades tiny bacteria (or microbes) have been used to treat domestic sewage, industrial waste water, or other environmental pollutants, by essentially feeding upon large, complex, harmful molecules, and thereby breaking them down into smaller, harmless ones. After the 1990 oil spill by the Exxon Valdez off the coast of Alaska, Exxon used microbe-enhanced fertilizers to help clean beaches and shorelines of the oil debris.32 This process, referred to as bio-remediation, has one principle drawback: unpredictability. At any given waste site, various factors (such as climate and soil) can effect the speed and effectiveness of the bioremediation. For that reason, scientists are currently studying how such bacteria can be genetically engineered for greater reliability and to expand the number of pollutants that can be treated.33

General Criticisms

With the advent of genetic engineering has come a host of concerns both nationally and transnationally. While U.S. biotechnology companies, their trade associations, U.S. government officials, and others interested in using biotechnology (such as farmers, doctors, and industrial waste managers) assert that current U. S. regulation is sufficient to protect human health and the environment, many U.S. consumer and environmental groups believe that genetically modified products are inherently

32 See Janet Raloff, An Alaskan Feast for Oil-Eating Microbes, 143 SCI. NEWS 253 (1993).

33 See GRACE, supra note 4, at 138-39

dangerous and should not be developed further absent extensive long-term testing, if at all. In particular, critics note that unlike hazardous chemicals or wastes, genetically modified organisms are potential hazards “with legs,” capable not just of spreading but of proliferating.34 Reviewing the scientific literature shows that scientists can be found to support both positions, with molecular biologists tending to see little risk in genetically modified organisms, and ecologists tending to see more. The widespread introduction in the United States of bioengineered products, from food to fabric, initially provoked little reaction from the public at large, but that now may be changing, and may result in greater attention by politicians to the means by which biotechnology is regulated.

Fears have arisen over various potential aspects of the new biotechnology: unknown toxins, antibiotic resistance, religious infringements, allergic reactions, counterfeit freshness, “genetic pollution,” and other adverse effects from the introduction of exotic organisms into ecosystems. For instance, with respect to medical applications of biotechnology, critics note that xenotransplants may allow for a plentiful supply of engineered organs for thousands of needy human recipients, but they also may create the potential for the contamination of humans with viruses or retroviruses (viruses that integrate their genetic code into the cells they infect) .35 With respect to the agricultural field, critics detected in taco

34 See generally M. CHIARA MANTEGAZZINI, THE ENVIRONMENTAL RISKS FROM BIOTECHNOLOGY (1986)

35 Some critics fear that the genetically modified pig organ transplanted into a human could carry with it the porcine endogenous retrovirus (PERV). See, e.g., Stolberg, supra note 16, at 49. As for the consequences of infecting humans with such retroviruses, most AIDS researchers now believe that the HIV retroviruses are really primate viruses that somehow jumped into humans, with one theory focusing on polio vaccines grown from monkey kidneys that were fed to Africans in Burundi, the

Congo, and Rwanda in 1957-60. See EDWARD HOOPER, THE RIVER:A JOURNEY TO THE SOURCE OF HIV AND AIDS (1999)

shells sold in grocery stores a form of genetically modified corn approved as an animal feed, but not for

human consumption because of allergy concerns, prompting a voluntary recall by a major U.S. food

36

company.

Critics of bio-engineering argue that genetically modified products destined for human or animal consumption are inadequately regulated by national authorities,37 including the U.S. Government.38 In the United States, there is no comprehensive statute addressing the testing and monitoring of genetically

14. On the likely acquisition by humans throughout history of viruses from domesticated animals, see

JARED M. DIAMOND, GUNS, GERMS & STEEL:THE FATES OF HUMAN SOCIETIES 196-97, 207-09

(1997).

36 See Marc Kaufman, Biotech Critics Cite Unapproved Corn in Taco Shells, WASH. POST, Sept. 18, 2000, at A2

source material. See ORGANIZATION FOR ECON. COOPERATION AND DEV., INTELLECTUAL PROPERTY, TECHNOLOGY TRANSFER AND GENETIC RESOURCES 28-29 (1996) [hereinafter OECD REPORT].

37 For an analysis of regulations in various states relevant to emergent biotechnology applications, see OECD, Compendium of National Food Safety Systems and Activities, OECD Doc. SG/ADHOC/FS(2000)5/ANN/FINAL (June 8, 2000)

38 For criticisms of U.S. regulation, see generally Mary Jane Angelo, Genetically Engineered Plant Pesticides: Recent Developments in the EPA ‘s Regulation of Biotechnology, 7 U. FLA . J.L. & PUB. POL’Y 257 (1996)

altered products

Rather, genetically altered products are regulated under existing statutes relating to food, drugs, agriculture, or the environment principally39 by the Food and Drug Administration (FDA),40 the

USDA,41 and the Environmental Protection Agency (EPA) .42 Although as yet there is no scientific

39 Other federal entities, such as the National Institutes of Health, the National Science Foundation, and the Department of Energy also play a role in federal regulation of the biotechnology industry. In fact, the earliest U.S. regulations concerning biotechnology arose with NIH’s effort to address contained testing in laboratories and greenhouses that developed during the 1970s. See Guidelines for Research Involving Recombinant DNA Molecules, 45 Fed. Reg. 77,384 (1980). For the White House’s interagency coordinating guidelines, see Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302 (1986). Those guidelines make clear that existing laws will regulate biotechnology, that the products of biotechnology (rather than the process) will be regulated, and that the safety of a biotechnology product will be decided on a case-by-case basis.

40 The FDA regulates biotechnology products under statutes relating to food (except for meat, poultry, and egg products), feed, drugs, and medical devices. See Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. §§301-95 (1994)

41 The USDA considers biotechnology applications as part of its mandate for ensuring the purity, potency, efficiency, and safety of agricultural products. Relevant statutes include the Virus-Serum-Toxin Act, 21 U.S.C. §§151-59 (1994), the Federal Meat Inspection Act, 21 U.S.C. §606 (1994), the Poultry Products Inspection Act, 21 U.S.C. §§451-70 (1994), the Plant Quarantine Act, 7 U.S.C. §§151-67 (1994), and the Federal Plant Pest Act, 7 U.S.C. §§150aa-150jj (1994)

42 The EPA regulates genetically modified organisms primarily under statutes relating to toxics and pesticides. See Toxic Substances Control Act (TSCA), 15 U.S.C. §§2601-2629 (1994) (regulating toxic substances)

evidence of any harm to humans from eating genetically modified food,43 critics charge that more

extensive studies should be conducted by independent scientists regarding the risks to human and animal health from consumption of genetically modified food.

Further, critics worry about the environmental effects of genetically modified crops.44 Critics doubt industry claims that use of genetically modified crops will decrease the use of conventional pesticides, since crops engineered to be resistant to herbicides arguably will result in far greater use of herbicides by farmers (since there is no concern with hurting the crop itself). Moreover, critics fear that

§§136-136y (1994) (regulating pesticides). The EPA also has responsibilities under the FFDCA, 21 U.S.C. §§346a(a)-(o) (1994) (regulating tolerances or exemptions for the requirement of a tolerance for pesticide residues in foods). Relevant regulations may be found at C.F.R. §§152.1-152.500, 172.1-172.59, 180.1-180.1206, & 725.1-725.1000 (2000). For the EPA’s Internet sites on biotechnology, see <http://www.epa.gov/opptintr/biotech/index.html> (for bio-toxics)

43 See COMMITTEE ON GENETICALLY MODIFIED PEST-PROTECTED PLANTS, NATIONAL RESEARCH COUNCIL, GENETICALLY MODIFIED PEST-PROTECTED PLANTS:SCIENCE AND

REGULATION (2000), <http://books.nap.edu/catalog/9795.html>. One controversial study, however, has found that rats fed with genetically modified potatoes experienced a thickening of their intestines. See Stanley W.B. Ewen & Arpad Pusztai, Efect of Diets Containing Genetically Modified Potatoes Expressing Galanthus Nivalis Lectin on rat Small Intestine, 354 LANCET 1353 (1999). Various scientists charged that this study was severely flawed. See Richard Horton, Genetically Modified Foods: “Absurd” Concern or Welcome Dialogue? 354 LANCET 1314 (1999)

44 See generally Miguel A. Altieri, The Environmental Risks of Transgenic Crops: An Agroecological Assessment, in BIOTECHNOLOGY AND BIOSAFETY, supra note 29, at 31

transgenic plants will alter the balance of an eco-system in ways that cannot be predicted and, in the long-term, can be very harmful to the environment. For instance, genetic engineering might inadvertently generate new, more virulent strains of virus or pathogenic bacteria harmful to the environment or, at a minimum, might threaten genetic diversity by promoting uniform crop systems. Herbicide-resistant traits of a transgenic plant could transfer by pollination to weeds, creating uncontrollable “superweeds.”45 Increased use of insecticides made possible by insecticide-resistant plants could lead insects to mutate into insecticide-resistant “superbugs.” Further, by genetically manipulating crops so as to poison insects, it may be inevitable that harmless insects or beneficial insects (i.e., insects that feed on pests) are poisoned, thus actually increasing the pest population and decreasing biological diversity among insects .46 For that reason, the U.S. Government encourages (but does not legally require) growers of most genetically modified crops to maintain a certain amount of acreage planted with non-genetically modified crops, for the purpose of allowing some non-mutated insects to survive and, by breeding with any mutating insects, decrease the likelihood (or at least the speed) of mutation.47

45 For a recent example, see Carol Kaesuk Yoon, Squash With Altered Genes Raises Fears of “Superweeds,” N.Y. TIMES, Nov. 3, 1999, at A1.

46 See, e.g., Allison A. Snow & Pedro Morán Palma, Commercialization of Transgenic Plants: Potential Ecological Risks, 47 BIOSCIENCE 86, 93 (1997).

47 See Rick Weiss, Corn Seed Producers Move to Avert Pesticide Resistance, WASH. POST, Jan. 9, 1999, at A4. Even though the soil bacterium Bt is already used to spray crops, see supra note 24, critics charge that crops genetically modified to contain Bt add much more of the toxin to the environment and are less apt to degrade, thus threatening insects far more with extinction, and in turn prompting greater mutation.

III. PROBLEMS OF BIOTECHNOLOGY IN THE TRANSNATIONAL SPHERE

The advent of modern biotechnology is already generating various concerns in the transnational sphere which the global community is struggling to address through disparate and largely uncoordinated treaty regimes .48 Although some success has been achieved, the rapid development of biotechnology applications will place increasing stress on traditional regulatory regimes. For instance, as xenotransplants become more common, national regulations may be developed in some states to prevent animal viruses from jumping into humans, but what if comparable regulations do not exist in other states, leading to the risk of such viruses originating elsewhere and then traveling to the highly regulated states? Even if cloning of humans is banned by some states, how should international law-including human rights law-handle humans that are cloned or hybrid mammals (part human, part non-human) created in other states?49 Suppose the United States genetically engineers a microbe

48 For Internet sites dealing with biotechnology in the transnational sphere, see listings that appear at the Internet site operated jointly by the Organization for Economic Cooperation and Development (OECD) and the U.N. Industrial Development Organization (UNIDO),<http://www.oecd.org/ehs/biobin>. The U.S. Information Agency also maintains an Internet site on global biotechnology issues at <http://usinfo.state.gov/topical/global/biotech>.

49 See Rochelle Cooper Dreyfuss & Dorothy Nelkin, The Jurisprudence of Genetics, 45 VAND. L. REV. 313 (1992)

As a first step toward addressing ethically questionable applications of biotechnology in the field of medicine, twenty-three European states have signed the Convention for the Protection of Human Rights and Dignity of the Human Being With Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, done Apr. 4, 1997, Eur. T.S. 164, reprinted in 36 I.L.M. 817 (1997), which addresses issues such as gene therapy, genetic discrimination, and organ or

capable of destroying all coca plants in Columbia as a means of eliminating drug trafficking

those governments alone to decide on its deployment, or do other groups or governments have a legal entitlement to speak to the issue?50 Indeed, if biotechnology succeeds in generating new, revolutionary capabilities, the global community will have to confront the degree of transnational cooperation that is desirable (whether for economic, political or moral reasons) either to regulate those capabilities or to help finance those capabilities so as to make them available to those in need.51

Concerns with potential biotechnology applications in the transnational sphere are too numerous to address fully within the scope of this article. Consequently, this section focuses on concerns that have

tissue transplantation. See also Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being With Regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings, Jan. 12, 1998, Eur. T.S. No. 168, reprinted in 36 I.L.M. 1415 (1997).

The U.N. Educational, Scientific, and Cultural Organization (UNESCO) has adopted a nonlegally binding declaration stating that human cloning is “contrary to human dignity” and “shall not be permitted”. UNESCO, Universal Declaration on the Human Genome and Human Rights (1997), <http://www.unesco.org/ibc/uk/genome/projet/index.html>. Similarly, the World Health Organization (WHO) has adopted a resolution affirming “that the use of cloning for replication of human individuals is ethically unacceptable and contrary to human integrity and morality.” WHO Doc. WHA50.37 (May 14, 1997). No doubt further steps will need to be considered on a global level.

50 One can imagine a host of other potential problems of the future. In the field of immigration and refugee law, if the use of biotechnology for medical treatments in one group of states vastly outpaces in development in other states, there may emerge a new category of persons known as “medical refugees.” Or, if scientists can some day screen individuals genetically for their disposition to engage in criminal behavior, legislators may be tempted to use the information to deny the admission of refugees on grounds of national security or safety. U. S. law currently calls for refusal of asylum or for removal when an alien is shown to have engaged in a “serious nonpolitical crime” prior to the alien’s arrival in the United States, see, e.g., INS v. Aguirre-Aguirre, 526 U.S. 415 (1999), regardless of whether the alien has completed his or her sentence, presumably on grounds that the prior act is predictive of future behavior.

51 See Michael J. Malinowski, Globalization of Biotechnology and the Public Health Challenges Accompanying It, 60 ALB. L. REV. 119 (1996).

arisen with existing biotechnology applications in the field of pharmaceuticals and agriculture, in the

hope that the ensuing analysis will prove useful in addressing concerns about potential applications in the future. The principal contemporary concerns may be placed in six general categories: (1) equitable concerns regarding the patenting of genetically modified products

Equitable Concerns Regarding the Patenting of Genetically Modified Products

Particularly in the area of pharmaceuticals and agriculture, there are important concerns that arise in the patenting of genetically modified products. Those concerns largely play upon two themes. First, developed states argue that intellectual property in genetically modified products must be protected so as to promote the costly research and development of such products, while developing states counter that such protection will make access to the products very expensive if not prohibitive for

developing states, and in any event is inappropriate for life forms. Second, developed states desire relatively unrestricted access to the rich genetic diversity found in developing states as source material for genetic engineering, while developing states argue that the fruits of genetic resources uncovered in developing states should be equitably shared with them.52 Each theme is addressed in turn.

With respect to the first theme-concerning whether to grant and protect intellectual property rights in genetically modified products-U. S. intellectual property law generally does not acknowledge ownership or use of naturally occurring or socially maintained materials or information in the public domain, such as genetic resources. Consequently, access to such genetic resources is generally unrestricted. However, once novel products or processes are developed from genetic resources, then U.S. law may provide intellectual property protection. Thus, a naturally occurring substance, whether living or inanimate, in principle can be patented if it is isolated from its surroundings, identified and made available for the first time, and has a useful purpose. Further, patents may be issued for chemical compounds corresponding to genes or nucleotide sequences when isolated and made available for a useful purpose.

52 Developing states can try to dedicate resources to develop biotechnology applications themselves, but the costs and expertise required make widespread biotechnology research and development prohibitive. For instance, of thirty-four states conducting field trials of transgenic crops from 1986 through 1995, more than half (eighteen) were developed states, while only three were states that were formerly centrally planned and thirteen were developing states. Of the 3,647 tests conducted during that period, more than half (1,952) were in the United States and more than a fourth in Belgium, Canada, France, the Netherlands, and the United Kingdom (1,082). In Africa, only twenty-five field tests were conducted in three African states: Egypt, South Africa, and Zimbabwe. See CLIVE JAMES &

ANATOLE F. KRATTIGER, GLOBAL REVIEW OF THE FIELD TESTING AND COMMERCIALIZATION OF TRANSGENIC PLANTS, 1986 TO 1995: THE FIRST DECADE OF CROP BIOTECHNOLOGY 4-5 (Int’l Serv.

for the Acquisition of Agri-biotech Applications Briefs No. 1, 1996).

Under this rationale, U. S. intellectual property protection has been extended to include micro

organisms, as well as genetically modified plant and animal breeds. Although the U.S. Patent and Trademark Office initially had doubts about the ability to patent micro-organisms, the U.S. Supreme Court decided in 1980 that it is possible to issue a patent for such a product under U.S. law53 so long as it could be said that someone had invented or discovered a new and useful “manufacture” or “composition” of matter having a distinctive name, character, and use.54 Similarly, new plant and animal breeds traditionally have been protected in the United States under intellectual property laws, and this protection extends to genetically modified plants and animals.55

53 35 U.S.C. §101 (1994).

54 Diamond v. Chakrabarty, 447 U.S. 303 (1980) (finding that a genetically engineered bacterium capable of breaking down crude oil could be patented). See generally John M. Czarnetzky, Note, Altering Nature ‘s Blueprints for Profit: Patenting Multicellular Animals, 74 VA. L. REV. 1327 (1988). Interestingly, the oil eating bacterium at stake in Chakrabarty was never commercialized. See KRIMSKY & WRUBEL, supra note 22, at 158. On the generally favorable disposition of U.S. courts and of the policy decisions of the U.S. Patent and Trademark Office toward genetic innovation, see Timothy Caulfield et al., Patent Law and Human DNA: Current Practice, in LEGAL RIGHTS AND HUMAN GENETIC MATERIAL 117 (Bartha Maria Knoppers et al. eds., 1996).

55 See, e.g., Ex parte Allen, 2 U.S.P.Q.2d (BNA) 1425 (Bd. Pat. App. 1987), af’d, 846 F.2d 77 (Fed. Cir. 1988) (allowing patent of an oyster egg with a genetically altered number of chromosomes)

In 1987, the U.S. Patent and Trademark Office promulgated a rule that permitted the patenting of higher organisms. 1077 OFFICIAL GAZETTE PAT. & TRADEMARK OFF. 24 (1987). In 1988, the first genetically modified animal patent was issued to Harvard University for a mouse engineered with a gene that made it susceptible to cancer and therefore useful in testing for carcinogens. See Malcolm

Gladwell, Harvard Scientists Win Patent for Genetically Altered Mouse

The case of agricultural seeds helps illustrate the significant transnational consequences that can flow from the recognition of such patents on genetically engineered products. At one time, farmers retained seeds from prior harvests to sow new ones, as well as purchased or shared seeds locally. In recent decades, farmers began purchasing seeds nationally and transnationally from large companies but, even then, the fact that plants grown from the seeds produced a second generation of seeds largely left the various strains of seeds available to all farmers for use and experimentation. With the advent of modern biotechnology, however, the control of agricultural seeds may shift from farmers worldwide to just a few multinational biotechnology companies.56 When seeds for genetically modified plants are exported by a U. S. company, 57 the foreign importer must enter into a license agreement, whereby the importer is licensed to grow a crop for a single generation. That crop, once produced, is the property of the licensee. The genes of the crop, however, remain the property of the U.S. company and are protected under U. S. patents. If the importer attempts to produce a second generation of the crop, the importer violates the license agreement and U.S. patent law. The asserted reason for the patent protection is to recoup developmental costs.58

56 Principal companies holding patents on newly engineered agricultural products and services include AgrEvo, Agrigenetics, Cargill Seed, Dupont, Hoechst-Roussel, Monsanto, Novartis Agribusiness Biotechnology, and Pioneer Hi-bred International. As an example of the scale of these companies, Monsanto maintains the largest biotechnology research center in the world