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GENETIC ENGINEERING AND INTERNATIONAL LAW DEVELOPMANT - AN INTROSPECTION

SHANTANU JUGTAWAT INTRODUCTION
Genes are the fundamental chemical codes that determine the physical nature of all living things, from the tiniest single-celled organism to human beings. Genes make up DNA, the cell-level master plan, which determines how the organism is going to develop in all ways that are not environmentally influenced. Genes are the substance within the nucleus of a cell that transmits genetic codes. In human beings and other bio-species, the synthesis of protein and the reproduction of cells and tissue take place according to the genetic blueprint contained in the genes. There are approximately 7,000 to 10,000 kinds of genes of differing sizes and properties in the human body1. It is in this light this paper seeks to examine the different aspects involved in Genetic Engineering (GE). In the course of my discussion I will also be analyzing the international law developments with respect to Genetic Engineering, the critical examination of the same and the discrepancies, which flow along with it. Since the birth of the duplicated sheep "Dolly," genetic engineering (GE) has attracted attention from all levels of society. GE raises questions of religion, ethics, and ecology that are of great concern to many people. What is Genetic engineering? Genetic engineering aims to re-arrange the sequence of DNA in gene using artificial methods. To determine the DNA sequence on such a long chain, a high-speed, low-cost method is needed. Unfortunately, the currently available method (gel-electrophoresis) does not satisfy these requirements. Genetic engineering is sometimes also called bioengineering or biotechnology (biotech for short). All these terms refer to making artificial changes in the genes of the DNA of a living thing. Its nature and characteristics are then changed, often in ways that could never occur naturally. Some of the effects of genetic engineering are known, but most are not. The effects we may have information about are all short term, specific and physical. The effects that remain unknown are long term, general, and mental. Genetic engineering of foods involves the insertion of genes from plants, bacteria, insects, fish, animals or humans into the DNA of another plant, fish, or animal to create a new variety. In the case of plants this is usually done either to enhance herbicide resistance, reduce susceptibility to cold or frost damage, or increase

5TH YEAR STUDENT, NATIONAL LAW INSTITUTE UNIVERSITY, BHOPAL

After several decades of research, people have gained a preliminary understanding of the

structure and properties of about 1,500 small genes. However, knowledge of large genes, especially chromosomes, is very limited. The larger the gene, the more difficult it is to determine its structure and properties.

2 rates of growth. Human growth genes have been introduced into food plants, fish and animals to enhance growth rates. Rationale behind Genetic Engineering What benefit could GE bring to humankind? Some scientists believe that, since genetic codes determine the appearance, personality, health, and aging process of human beings, if that genetic information in the chromosomes could be decoded and the genetic mechanism were understood, we could potentially control and improve our health, quality of life, and the biochemical processes in our bodies. In other words, we could control our own fate. Also, wed be able to improve the genes of other animals and vegetables so that they could serve humankind better. At first sight, these ideas seem reasonable and attractive. However, careful analysis reveals that they are based upon an incorrect theory--the theory of gene determinism. Various issues for our consideration: Whether GE is just an extension of conventional breeding or GE and conventional breeding are radically different? Conventional breeding works only within the same or closely related species (e.g., bacteria to bacteria, corn with corn, pigs with pigs, etc.) In contrast, GE involves mixing genes from very distantly related species that in nature will never breed with each other (e.g., bacteria to corn, or pig to human beings). Actually GE is a new, experimental, very dangerous, AND radical technology. The process causes unnatural mutation and combination of the DNA in our food in a manner, which excludes nature out of the process.2 The preferred approach of the industry has been to use compositional comparisons between GM and non-GM crops. When they are not significantly different the two are regarded as "substantially equivalent", and therefore the GM food crop is regarded as safe as its conventional counterpart. This ensures that GM crops can be patented without animal testing. However, substantial equivalence is an unscientific concept that has never been properly defined and there are no legally binding rules on how to establish it. GM tomatoes: The first and only safety evaluation of a GM crop, the FLAVR SAVRTM tomato. This GM tomato was produced by inserting kanr genes into a tomato by an 'antisense' GM method. The test has not been peer-reviewed or published but is on the Internet. The results claim there were no significant alterations in total protein, vitamins and mineral contents and in toxic glycoalkaloids. Therefore, the GM and parent tomatoes were deemed to be "substantially equivalent." Some rats died within a few weeks after eating GM tomatoes. Whether the genetically engineered food plants and animals are compatible as well as well suited to the eco system ecosystems which are the products of billions of years of evolution?

Whoever argues that GE is no different from conventional breeding is probably laying the groundwork for the concept of "substantial equivalence", that the products of genetic engineering are as safe as the products of conventional breeding. This dubious concept is often used as excuse to avoid thorough and rigorous testing.

3 The main environmental problem with genetically engineered food plants and animals is that, when they escape into the wild, they permanently disrupt the environment. For example, the most recent conservative scientific estimates indicate that genetically engineered plants will probably cross-pollinate with wild relatives, thereby escaping into the wild and permanently disrupting ecosystems at about one percent a year. That means they will probably cause major environmental problems in about ten years. Another potential problem area is viruses. By their very nature, viruses invade the genetic material of their hosts and often break apart and recombine using part of the host's genetic material to create new viruses. When this happens with genetically engineered plants and animals outside of the laboratory, new viruses will be created that incorporate genetically engineered genetic material. The viruses will then spread and, because they could not have been naturally produced, there may be no natural defenses against them. Depending upon the kind of virus, they may then cause widespread death of certain plants or animals, or even of humans. Whether the genetic engineering techniques aims at long-term profits or they outweigh them? Genetic engineering is a totally new kind of science. Previously science concerned itself with understanding how Nature works. For the first time in human history, through genetic engineering techniques, science is changing Nature on the most fundamental level. Rather than considering whether it should be done at all or what kind of wisdom should govern the process, most of the efforts in the field are fueled not by concern for the short or long term benefits for human beings or the planet, but in most cases by corporate pressures for short term profits at almost any cost. Certainly some short-term and rather spectacular benefits will probably occur, particularly in the medical field; however, the long-term problems may far outweigh them. Whether Labeling Should Be made mandatory on the genetically engineered foods? Current regulations against the labeling of genetically engineered foods blatantly abridge the rights of citizens in a free society to choose what they want to eat and what they do not. You usually cannot rely on looking, tasting or feeling to identify genetically engineered food. Labeling is necessary for its clear identification. Therefore, because labeling is not now required, citizens are effectively denied their fundamental right of free choice. Labeling genetically engineered foods would in no way restrict the rights of those people who do wish to purchase and consume them. Whether the results of genetic engineered products are extremely precise? Often described as extremely precise, the results of genetic engineering are only partly predictable. Position effects create secondary effects (dependent on the mostly uncontrolled integration of the new genetic material into the genome of the host organism) that affect the physiology of the organism in question and consequently the food produced from it. In the complicated network of an organism's physiology, effects of a newly introduced gene can result in unintentional changes in the contents or modifications of specific ingredients (toxic, allergenic or influencing the nutritional value) or in the synthesis of products not previously present3.
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A Swiss study, which reviewed the allergenic potential of transgenic plants, came to the

conclusion that these increase the probability of an unwanted allergenic reaction. In essence these

4 Ethical Problems Genetically engineered foods create specific ethical problems for those of various faiths. Religious vegetarians, such as Hindus and Buddhists, want to be able to avoid fruits and vegetables with insect, animal or humans genes in them. Jews and Muslims, who have special religious dietary laws, want to be able to make sure that genetically engineered foods do not violate their restrictions; for instance, they won't want pig genes in their carrots. Religious leaders from a broad spectrum of faiths, in this country and throughout the world, object to genetically engineered food because they have serious doctrinal objections to the kind of tampering with the basic patterns of life that occur in most genetic engineering. Many others who are not formally religious wish to avoid genetically engineered foods because they also have serious ethical objections. Under our current laws, meats, vegetables, and fruits can even contain human genes without our knowing it. This kind of cannibalism is repulsive to most people.

authors argued that while molecular breeding can use the totality of all organisms as generesources, traditional breeding was restricted to cross-hybridizing relatives with similar allergenic potential. The directed alteration of the expression levels of the species own genes is also only possible by genetic engineering. The risk of unwanted and unprecedented allergies is therefore higher in transgenic plants than in traditionally bred plants.

INTERNATIONAL DEVELOPMENTS WITH RESPECT TO GGENETIC ENGINEERING: Under the Convention on Biological Diversity, a global treaty was adopted on genetically modified organisms at Montreal on 29 January 2000. After five years of talks, ministers and senior officials from over 130 governments finalized a legally binding agreement for protecting the environment from risks posed by the transboundary transport of living modified organisms (LMOs [also called GMOs]) created by modern biotechnology. The United Nations Environment Programme (UNEP): UNEP is developing International Technical Guidelines on Safety in Biotechnology. Following a global consultation at Cairo in 1995, UNEP adopted a consolidated text on risk assessment and risk management of GMOs. United Nations Environment Programme International Register on Biosafety web site offers information from many sources on biosafety. It focuses on information useful in establishing a regulatory framework for the safe development, transfer, and application of biotechnology. Organization for Economic Cooperation and Development (OECD): Biotrack Online BioTrack Online is part of OECD's Programme on the Harmonization of Regulatory Oversight in Biotechnology. The main aim of this Programme is to produce documents for use by national authorities for the regulatory assessment of GMOs or release to the environment. The focus is on GM plants and microorganisms. Home of BIOTRACK, a database of environmental releases from OECD member countries. Biosafety Information Network and Advisory Service: BINAS is a service of the United Nations Industrial Development Organization (UNIDO). BINAS monitors global developments in regulatory issues in biotechnology. BINAS tracks regulatory developments from many countries, including the full text of regulations and guidelines.

Human Applications
United Nations Education Science and Culture Organisation's (UNESCO) Universal Declaration on the Human Genome and Human Rights was drafted by the International Bioethics Committee and adopted by 186 member states on 11 November 1997. It covers things such as genetic discrimination; genetic reductionism; informed consent; confidentiality; non-peaceful use of genomic data; equitable access to treatment and it encourages research into 'genetically-based and genetically-influenced diseases'. The only biological procedure it expressly does not permit is reproductive cloning. The Declaration is not binding. Its principles therefore cannot take shape unless the States assume their role. It is for them to specify the means to be used to reach the goals set out by the document, by drafting legislation, setting up ethics committees and establishing programmes of education in bioethics.

Legal Instruments
USA Coordinated Framework for Regulation of Biotechnology Agricultural, Environmental and Food Applications of Genetic Engineering United States Regulatory Oversight in Biotechnology Presents an overview of the activities of agencies primarily responsible for regulating biotechnology in the United States: the US Department of Agriculture (USDA), Environmental Protection Agency

6 (EPA), and the Food and Drug Administration (FDA). Before commercialization, genetically engineered plants/organisms must conform with standards set by State and Federal marketing statutes such as State seed certification laws, the Federal Food, Drug, and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), and the Federal Plant Pest Act. This is the most comprehensive gateway into this aspect of USA regulatory agencies.

Human Aspects
'The Council of Europe Convention for the Protection of Human Rights and the Dignity of the Human Being with Regard to the Application of Biology and Medicine' specifically rules out human cloning; human genetic modification which is not for preventive, diagnostic or therapeutic purposes; germ-line genetic modification (i.e. which passes on to descendents). The use of techniques of medically assisted procreation shall not be allowed for the purpose of choosing a future child's sex, except where serious hereditary sex-related disease is to be avoided. Additional protocol on the Convention for the Protection of Human Rights and the Dignity of the Human Being with Regard to the Application of Biology and Medicine, ON THE PROHIBITION OF CLONING HUMAN BEINGS. (Signed Paris, January 1998, Treaty number 168) European Group on Ethics in Science and New Technologies (EGE): Which advises the European Commission has published a report titled Ethical Aspects of Human Stem Cell Research and Use. Biological and Toxin Weapons Convention The Biological and Toxin Weapons Convention, which is 30 years old and which has 144 States Parties, prohibit biological weapons. Under the Convention, the development, stockpiling, acquisition, and transfer of biological weapons are illegal. On paper, the Biological Weapons Convention is strong. Genetic engineering has presented the Biological Weapons Convention with serious problems4. Point of distinction: -There are important commonalities between the Biosafety Protocol and the Biological Weapons Convention. There are strong parallels between the Precautionary Approach and the Biological Weapons Convention's "general purpose criterion", which prohibits any development of agents for hostile use. Like the Precautionary Approach, the Biological Weapons Convention does not prohibit specific agents, but instead applies a key principle of caution to all scientific research with agents that can be used in a hostile manner. The import and export supervision

These have been recognized in interventions and written submissions by States Parties, including

strong apprehensions expressed by Northern, even NATO, countries. Discussions at the Biological Weapons Convention are drawing increasing attention to what the Biosafety Protocol can do to help prevent abuse of genetic engineering.

7 responsibilities of the Competent Authority directly relate to States Parties nonproliferation commitments under the Biological Weapons Convention. Many governments, including cooperation proposed by Mexico, Peru, France, Italy, and other countries, have recognized this Protocols relationship to the Biological Weapons Convention and the role that this agreement can play in assisting implementation of the Biological Weapons Convention. The Non-Aligned Movement, at the Biological Weapons Convention, has proposed capacity building and technology transfer in cooperation with the Convention on Biological Diversity. Overall it the important proposals from Latin American countries to develop the means to implement the Biological Weapons Convention and the Biosafety Protocol together.

Cartagena Protocol on Biosafety.

Introduction On 29 January 2000, the Conference of the Parties to the Convention on Biological Diversity adopted a supplementary agreement to the Convention known as the Cartagena Protocol on Biosafety. The Protocol seeks to protect biological diversity from the potential risks posed by living modified organisms resulting from modern biotechnology. It establishes an advance informed agreement (AIA) procedure for ensuring that countries are provided with the information necessary to make informed decisions before agreeing to the import of such organisms into their territory5. History Pursuant to Article 19, paragraph 3, of the Convention on Biological Diversity, the Conference of the Parties, by its decision, established an Open-ended Ad Hoc Working Group on Biosafety to develop a draft protocol on biosafety, specifically focusing on transboundary movement of any living modified organism resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity. The Open-ended Ad Hoc Working Group on Biosafety held six meetings between July 1996 and February 1999. At its conclusion, the Working Group submitted a draft text of the Protocol, as well as the outstanding concerns of the Parties, for consideration by Conference of the Parties at its first extraordinary meeting, convened for the purpose of adopting a protocol on biosafety to the Convention on Biological Diversity6.
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The Protocol contains reference to a precautionary approach and reaffirms the precaution

language in Principle 15 of the Rio Declaration on Environment and Development. The Protocol also establishes a Biosafety Clearing-House to facilitate the exchange of information on living modified organisms and to assist countries in the implementation of the Protocol.
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In accordance with decision the first extraordinary meeting of the Conference of the Parties was

opened on 22 February 1999, in Cartagena, Colombia. The Conference of the Parties was not able to finalize its work in the time available. As a result, the Conference of the Parties suspended its

8 The resumed session took place in Montreal from 24 to 29 January 2000 and was preceded by regional and interregional informal consultations from 20 to 23 January 2000 at the same venue. On 29 January 2000, the Conference of the Parties, by its decision adopted the Cartagena Protocol on Biosafety to the Convention on Biological Diversity and approved interim arrangements pending its entry into force. It established an openended ad hoc Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP) with a mandate to undertake the preparations necessary for the first meeting of the Parties to the Protocol. Now that the required number of 50 countries has ratified it, this protocol had come into force on 11 September 2003. Fifty was the minimum number of ratifying countries needed to trigger the 90-day countdown that ushers this treaty into law7. The ICCP Process Following its establishment, the Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP) convened organizational meetings on 29 January 2000, chaired by Ambassador Yang, and endorsed the nominations of regional representatives to its Bureau. These included Cameroon (Chair), Denmark, India, Islamic Republic of Iran, Peru, Poland, Saint Kitts and Nevis, South Africa, Switzerland and Ukraine. At the first meeting of ICCP, Denmark was replaced by France. The ICCP Bureau held more than 10 oversight meetings over a period of four years of its existence. The first task of the Bureau was to develop a work plan for the ICCP, which was submitted, to and endorsed by, the fifth meeting of the Conference of the Parties8.

first extraordinary meeting and agreed that it should be reconvened as soon as possible and in any event no later than the fifth meeting of the Conference of the Parties.
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The Cartagena Protocol on Biosafety to the Convention on Biological Diversity Protocol takes

the first part of its cumbersome name from Cartagena, Colombia, the venue where the international treaty's formal language was hammered out in 1999. Concern over international trade in GMO seedswhich are the edible product of many cropsproved the big issue during that meeting, and most final terms of the treaty were settled at a follow-up meeting the next year in Canada

The ICCP held three meetings during the course of its existence. The first meeting was held in

Montpellier, France, from 11 to 15 December 2000; the second in Nairobi, Kenya, 1 to 5 October 2001; and the third in The Hague, The Netherlands, 22 to 26 April 2002 back-to-back with the sixth meeting of the Conference of the Parties.

9 Objective: 1. In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer. 2. Handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity. 3. Taking also into account risks to human health, and specifically focusing on Tran boundary movements. 4. This Protocol shall apply to the Tran boundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

European Union: GMOs in Food

The use of GMOs in food is dealt with under the regulation for Novel Foods and Food Ingredients. This Regulation, which came into force on 15 May 1997, established an EU wide system, which requires that a novel food is assessed for safety before it can be released onto the market. A novel food is a food, which has not been consumed by humans to any wide extent in the EU before. This includes any food containing, or produced from, a GMO9. European Network on Genetically Modified (GM) Food Crops: "ENTRANSFOOD". An European Network on genetically modified (GM) food crops has been installed which will deal with the problems related to food safety and market introduction of GM-food crops.

Human Applications of Genetic Engineering

Human Fertilisation and Embryology Authority: The HFEA administers the Human Fertilisation and Embryology Act 1990, the key statute covering human embryo creation and manipulation, which would also cover transmissible human genetic modification and cloning (e.g. creation and cloning of human embryonic stem cells for transplantation purposes) because such procedures would require licensing by the authority. But the Act currently authorises experimentation on embryos less than 14 days old for research into infertility, congenital disease, miscarriage, contraception and pre-implantation genetic diagnosis. Parliament is expected to consider extending the purposes to include "therapeutic cloning" in 2007 Specific primary legislation to outlaw reproductive cloning or the mixing of adult (somatic) cells with live animal eggs is still lacking.
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In September 1998 provision was made for the labeling of foods made from GM soya and

maize and subsequently a minimis threshold for a maximum of 1% adventitious contamination was added as an amendment. The use of food additives and flavourings containing GMO protein or DNA is regulated amending the organic regulation , prohibits the use of GMOs or their derivatives in organic foods.

10 Human Genetics Advisory Commission -- established in December 1996 as a nonstatutory advisory body to UK health and industry ministers on issues arising from developments in human genetics and cloning that have social, ethical and/or economic consequences. Gene Therapy Advisory Committee (GTAC) -- established 1993, non-statutory, advising on clinical protocols and more general issues; gives advice to UK health ministers on developments in the field and their implications. Advisory Committee on Genetic Testing (ACGT) -- established 1996, non-statutory, advises Ministers on developments in testing for genetic disorders, advises on testing individuals for genetic disorders taking into account ethical, social and scientific aspects and sets quality standards for commercial tests. Office of Science and Technology -- consults public on developments in biotechnology. Medicines and Healthcare products Regulatory Agency -- approvals of new drugs including those made by recombinant DNA technology. (No apparent search facility)

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Critical analysis: A. Cartagena Protocol

1. While the definition of genetic engineering and genetically modified organisms has hitherto varied from one state to another, the Cartagena Protocol provides a general definition. The term "modern biotechnology" is defined in the text of the protocol as the "application of ... techniques ... that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection". GMOs, or "living modified organisms" as they are termed in the protocol, are defined as "any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology". "Living organisms" are in turn defined as "any biological entity capable of transferring or replicating genetic material". 2. One important element of the protocol is the anchoring of the precautionary principle according to which Member States are permitted to ban imports even if there is no conclusive evidence of possible dangers. 3. Although most of negotiations over the Cartagena Protocol have focused on possible risks associated with genetically modified seeds, the treaty will, in fact, govern international trade in everything from engineered tomatoes to cattle to fruit trees. 4. The Trans boundary movement of agricultural raw materials containing genetically modified organisms is to be regulated in future through the Biosafety Clearing-House (BCH), an internet-based information system. All genetically modified organisms that have been approved at national level as food or feed, and which are registered with the BCH, may be exported to other Member States, provided the importing country does not have sent in any restrictions. Stricter approval procedures apply to genetically modified organisms that are to be introduced into the environment, for instance in the form of seed. The importing countries must be informed prior to the first import, and under the "advance informed agreement" system Member States of the protocol may, after a risk analysis, permit imports, impose conditions, or refuse imports. 5. GMOs, in this treaty, are plants and animals into which scientists have inserted foreign genes for specific, desired traitssuch as cold tolerance, insect resistance, drug production, or immunity to common pesticides. This high-tech approach is different from conventional plant or animal breeding for desired traits, in which individuals of a species are repeatedly crossed to bring out what the breeder is looking for in a domestic animal or crop plant. 6. The new treaty required that documentation accompany all shipments of GMOs to and through nations that ratified the treaty, which so far doesn't include the United States. The treaty will also limit the terms under which signatory nations can discriminate against imports of GMOs. Essentially, it will prevent nations from banning imports of them as long as exporting nations can demonstrate that the novel goods pose no risk of environmental harm. B. Biological and Toxin Weapons Convention: -

12 1. Recent years have seen a disturbing trend, particularly in the United States, towards narrower interpretations of Article I. This includes an ever-more permissive US definition of acceptable biodefense activities, including the wellpublicized production of anthrax spores, genetic engineering of anthrax, and testing of biological bombs. Another well-known case are US claims that forcible eradication of narcotic crops a form of agricultural biological warfare would not violate the BTWC. 2. The US generation of ambiguity surrounding the BTWC extends to the poorly defined area of so-called 'non-lethal' biological weapons. These potentially include a number of weapons, such as anti-material agents, riot control agents, and even human disease. A high level US endorsement of this view was made at United Nations in October 2001, where US Assistant Secretary of State articulated a new interpretation of Article I by suggesting biological weapons are "biological agents used with lethal intent". Avis distinction implies that so-called non-lethal biological weapons, including anti-material agents, may be acceptable to the US. 3. If such an interpretation of BTWC Article I10 were to be widely accepted, it would amount to a major reduction of the scope of the BTWC, potentially relaxing controls on all biological weapons except those used with the specific goal of killing humans (as opposed to sickening them, or harming animals, plants, or materials). Some US supporters of anti-material biological weapons have called on the US to simply ignore a "doomed" BTWC. 4. The BTWC needs to address a lack of foresight in language used in its Final Declaration at the BTWC Third and Fourth Review Conferences. At those meeting, in decisions on Article I, the Conference stated: "The Conference reaffirms that the Convention prohibits the development, production, stockpiling, other acquisition or retention of microbial or other biological agents or toxins harmful to plants and animals, as well as humans..." 5. Article I ban all agents for non-peaceful purposes and have zero exemptions, much less a huge gap for anti-material agents that would subject the entire human-built environment to legal biological attack. In this sense, the Review Conferences adopted text that poorly re-articulates the treatys prohibition with respect to materials. By the same token, BTWC States Parties cannot reasonably be asked to predict the future, and the decisions of Review Conferences predate any serious technological possibility of effective GAMAs, which have only recently become feasible due to genetic engineering. Nevertheless, the potential ambiguity in the Review Conference decisions should be cleared up without delay.

The Biological and Toxin Weapons Convention (BTWC) is a landmark in international law in large part because of its Article I, which bans an entire class of arms by prohibiting the development, acquisition, and stockpiling of all biological weapons. The BTWC was intended and designed to prohibit all biological weaponry, contains no exemptions for any class of biological warfare, and has been broadly understood as such since its beginning.

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13 C. Probable dangers: 1. The dangers of genetically engineered biological weapons are not science fiction; but a deadly reality. Last year in Australia, researchers created a genetically engineered poxvirus that provides a blueprint for extraordinarily dangerous genetically engineered viruses. The United States government recently announced it will create genetically engineered anthrax, and its military scientists are building genetically engineered superbugs to attack materials. In preparation for field use, they are putting terminator technology into these material munching LMOs. The US has also created genetically engineered pathogens in its campaign to use biological weapons to eradicate illicit crops worldwide11. 2. Worries over the safety of some seeds arose from studies demonstrating that foreign genes in crop plants don't always stay put. Pollen from such plants might carry inserted genes from modified soybeans, for instance, into a field of wild soybean plants or an unmodified crop. The unintentionally broadcast genes could come to dominate in future generations of the wild or supposedly normal crop plants and thus reduce genetic diversity in the species. 3. Despite some people's fear of that scenario, developed nations including the United States, Canada, and Australia have embraced GMOs. In the United States at present, up to one-third of all corn and 75 percent of all planted soybeans are GMOs. Harvested seeds from those plants usually aren't even segregated from the yields of unmodified plants in shipments headed to market within the United States. Trying to label all GMOs seeds and keep them separate from unmodified products in international shipments could prove costly.

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Recently in the United Kingdom, researchers built and almost accidentally released a

genetically engineered hybrid of the organisms that cause Hepatitis C and Dengue Fever. The effects and treatment regime of this GM disease are unknown; but British officials called it "more lethal than HIV". Also here in Europe, the German Army is working with biological weapons agents genetically engineered to resist antibiotics.

14 4. In most cases, genetically modified products pose no risk to nations through and to which they're shipped because the seeds are destined for eating, not planting, as the US negotiators assert it, but there are always probabilities that in some poor nations, people might divert some modified seeds for planting rather than consumption. Also, some GMOs might be unintentionally sown in the wilds of such countries, the critics assert. 5. To avoid that risk, some developers of genetically modified crops have patented sterile, so-called "terminator" seeds for their products, eliminating the chance of unintended germination of plants and spread of foreign genes. To date, the U.S. State Department notes, this terminator-seed technology "has not been fully developed or implemented anywhere in the world." Nevertheless, it's already controversial in its own right. That's because it would limit the use of genetically modified cropsoften, the highest yielding onesto growers who can afford high licensing fees. 6. Even terminator genes won't stop foreign genes from spreading beyond modified crops if the route is via pollen, some environmental scientists point out. It is quite possible that unusual genes in pollen may poison wildlife12. 7. Indeed, scientists have recently reported getting bananas and potatoes to make certain vaccines. The idea is that these pharmaceutical foods could be harvested at low cost in developing countries and fed to people as a way to immunize them against disease. However, some ecologists have argued that if vaccine genes in these plants were to spread to wild plants and unmodified crops, many people's food might eventually end up inappropriately, and potentially dangerously, laced with drugs.

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For example it is point out the documented poisoning of monarch butterflies by the

windblown pollen of genetically modified corn that produces its own pesticide.

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CONCLUSION: This paper being one, which sought to summarize the positions of the law relating to genetic engineering and the various provisions, treaties, conventions in the world, does not have much to state for the conclusion. However, there are a few observations that can be made at this juncture. One has to agree with this view that there are many opinions but scarce data on the potential health risks of GM food crops, even though these should have been tested for and eliminated before their introduction. Our present database is woefully inadequate. Moreover, the scientific quality of what has been published is, in most instances not up to expected standards. If, as claimed, our future is dependent on the success of the promise of genetic modification delivering wholesome, plentiful, more nutritious and safe GM foods, the inescapable conclusion of this review is that the present crude method of genetic modification has so far not delivered these benefits and the promise of a superior second generation is still in the future. Although it is argued that small differences between GM and non-GM crops have little biological meaning, it is clear that most GM and parental line crops fall short of the definition of "substantial equivalence." In any case, this crude, poorly defined and unscientific concept outlived its possible previous usefulness and we need novel methods and concepts to probe into the compositional, nutritional/toxicological and metabolic differences between GM and conventional crops and into the safety of the genetic techniques used in developing GM crops if we want to put this technology on a proper scientific foundation and allay the fears of the general public. We need clear and strict labeling so that any organism can be traced throughout the production and trade line and each consumer can decide individually. It will not be possible to give a hundred percent safety because of remaining scientific uncertainty and open questions which can be answered only on an empirical basis and the growing evidence on different possibilities of long-term negative health impacts. Genetic engineering of food and fiber products is inherently unpredictable and dangerous for humans, for animals, the environment, and for the future of sustainable and organic agriculture. The hazards of GE foods and crops fall basically into three categories: human health hazards, environmental hazards, and socioeconomic hazards. A brief look at the already-proven and likely hazards of GE products provides a convincing argument for why we need a global moratorium on all GE foods and crops. Traditional breeding is based on sexual reproduction between like organisms. The transferred genes are similar to genes in the cell they join. They are conveyed in complete groups and in a fixed sequence that harmonizes with the sequence of genes in the partner cell. In contrast, bioengineers isolate a gene from one type of organism and splice it haphazardly into the DNA of a dissimilar species, disrupting its natural sequence. Further, because the transplanted gene is foreign to its new surroundings, it cannot adequately function without a big artificial boost.

16 We have limited or no predictive power for the fate of recombinant genes. In the case of an antibiotic resistance, we may be able to say that its known functions pose no additional threats. But we cannot be sure that its known functions are all of its potential functions either or its own or in conjunction with the many novel genomic contexts in which it might be found should it be transferred horizontally. Therefore, as a qualitatively different technology, genetic engineering should be commercialized with extreme caution until the appropriate scientific experiments can be conducted" From the opinion of experts and polls conducted in various countries prima facie presumption has been created which is not in favour of Genetically engineered food. (Annexure1 and annexure 2 enclosed in the end) Action required in international perspective Translation of international resolutions and regulations on biosafety into national legislation and policymaking. Further development of the subject matter of the Protocol and its instruments. Designation of national bodies with the power and competency to ensure the functions called for are performed (risk-assessment, precautionary principle, public participation, etc.) Establishment of an international Biosafety Clearing-House (BCH) with national headquarters in the individual signatory states Provide information worldwide through the BCH Capacity building in the fields of Policy advice/ legislation Establishing biosafety authorities Promoting state bodies and NGOs Individual capacity building in the fields of risk assessment and management, and socioeconomic impacts PR work and awareness raising Development of mechanisms to enable civil society to participate in political decision-making processes

In the context of Biological and Toxin Weapons Convention the Biosafety Protocol's relationship to arms control should be addressed by: Exchanging observer status between the Protocol and the Biological Weapons Convention. The undertaking of a Biosafety Protocol study of its relationship to biological weapons control and how it can avert hostile use of genetic engineering. Development of a cooperative Program of Work with the Biological Weapons Convention to prevent the hostile use of GMOs, and.

17 Capacity building for the Biosafety Protocol that includes components dedicated to the relationship between biosafety and biological weapons control. In the context of Cartegna Protocol following appraisals are suggested: It is time to move into action, and for ICCP to embrace its cooperative role with arms control to prevent abuse of genetic engineering. No legal framework on risks of genetically modified organisms is complete or will be effective without addressing some of their most serious potential consequences, their hostile use against biodiversity, agriculture, animals, people, and even the infrastructure necessary for modern life. To begin this vital process, there should be a meeting of the ICCP to request the Secretariat to prepare a study of the Biosafety Protocols relationship to biological weapons control, and for the ICCP to direct the Secretariat to apply for observer status and to send representation to the next meeting of the Biological Weapons Convention in Geneva this November. This ICCP should lay the groundwork for a cooperative program of work with the Biological Weapons Convention to prevent hostile use of genetically engineered organisms.

To put my self in a prcised manner I admit that our knowledge about the safety and digestibility of traditional food is mainly based on the history of safe use and experience. This history of safe use cannot be transferred to genetically engineered food.

18

Proposed Treaty
Alternative Biosafety Protocol To Prevent Harm To Human Health, Biodiversity and the Environment THE PARTIES TO THIS PROTOCOL Recalling That at the United Nations Conference on Environment and Development (1992), the member states of the United Nations made a commitment to prevent the transfer to other states of substances or activities that are harmful to human health or the environment (principle 14, Rio Declaration); Recognizing the serious issues raised by genetic engineering in terms of health and safety, the environment, ethical considerations and social justice; considering the worldwide support for: A global ban on genetically engineered processes, foods, crops and animals A global ban on the patenting of life forms as being contrary to the "ordre public" (public interest) Criminalizing biopiracy and theft of the genetic material and knowledge of farmers, peasants, and indigenous peoples; Noting that the precautionary principle affirms that, where there is a threat to human health or to the environment, the lack of full scientific certainty shall not be used as a reason for postponing measures to prevent the threat. The precautionary principle has long been a tenet of international customary law and, as such, is required to be integrated into state law13. (a) Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. (b) Where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat. Aware Of the evidence of hazards arising from genetically engineering foods and crops reported in the World Scientists' Statement presented at Cartegena, Columbia, February 1999: Herbicide resistant transgenes have spread to wild relatives by cross-pollination in both oilseed rape and sugar beet creating many species of potential superweeds. Herbicide-resistant transgenic plants may lead to increased use of herbicides, contrary to what is being claimed. The transgenic plants themselves are already turning up as volunteer plants after the harvest and have to be controlled by additional sprays of other herbicides.

13

This principle is present in documents in differing forms such as the Rio Declaration

19 Bt-toxins engineered into a wide range of transgenic plants already released into the environment may build up in the soil and have devastating impacts on pollinators and other beneficial insects Genetic engineering of organisms is hit-or-miss and not at all precise, contrary to misleading accounts intended for the public, as it depends on the random insertion of the artificial vector carrying the foreign genes into the genome. This random insertion is well known to have many unexpected and unintended effects, including cancer, in the case of mammalian cells (Walden R, 1991). Serious doubts over the safety of transgenic foods are raised by new revelations on the results of animal feeding experiments. Potatoes engineered with snowdrop lectin fed to rats caused highly significant reduction in both dry and wet weights of many essential organs: small intestine, liver, spleen, thymus, pancreas and brain. In addition, it resulted in impairment of immunological responsiveness and signs suggestive of viral infection (Leake, C ,1999). Hazards may come from new genes and gene products. New genes and gene products are introduced into food, often from bacteria and viruses and other nonfood species that have never been eaten before and certainly not in the quantities produced in the genetically engineered crops, where they are typically expressed at high levels. The long term impacts of these genes and gene products on human health will be impossible to predict Genetically engineered agriculture not only obstructs the implementation of real solutions to the problems of food security for all, but also poses unprecedented risks to health and biodiversity. Far from feeding the world, it will intensify corporate control on food production and distribution, which created poverty and hunger in the first place. It will also reinforce existing social structures and intensive agricultural practices that have led to widespread environmental destruction and falling yields since the 1980s14

Recognizing That the global community has made a commitment to the international principle of customary law -- the precautionary principle. This principle states that where there is a threat to human health or the environment, the lack of full scientific certainty shall not be used as a reason to postpone measures to prevent the threat. There is sufficient scientific evidence of the harmful health and environmental consequences of GE foods and crops to justify the banning of GE foods and crops, the end to export of GE foods and crops and the immediate removal of GE foods from grocery shelves in accordance with the precautionary principle; Recalling That an exception to the patenting of inventions arises when the invention is contrary to "ordre public" or morality; this explicitly includes inventions dangerous to human, animal or plant life or health or seriously prejudicial to the environment and applies where the commercial exploitation of the invention must also be prevented and this prevention is necessary for the protection of order public or morality; Concurring With The World Scientists Statement That, "Genetic engineering is a new departure from conventional breeding and introduces significant differences. Conventional breeding involves crossing related species, and plants with the desired
14

Excerpts from the World Scientists' Statement}

20 characteristics selected from among the progeny for reproducing, and the selection is repeated over many generations. Genetic engineering bypasses reproduction altogether. It transfers genes horizontally from one individual to another (as opposed to vertically from parent to offspring), often making use of infectious agents as vectors or carriers of genes so that genes can be transferred between distant species that would never interbreed in nature. For example human genes are transferred into pig, sheep, fish and bacteria. Toad genes are transferred into tomatoes. Completely new exotic genes are being introduces into food crops." (World Scientists Statement, 1999); Noting That The current practices of genetic engineering are creating unpredictable and irreversible combinations of transgenic organisms with one another and with natural varieties and, as such, are defeating the purpose of the Convention on Biological Diversity; Noting That under the Vienna Law of Treaties, the signatories to the Convention must not create a situation that would make it impossible for them to discharge their obligations under the treaty and that the creation of unpredictable and irreversible combinations of transgenic organisms with one another with natural varieties would defeat the purpose of the Convention to "conserve biodiversity"; Recognizing That genetic engineering in the area of medical research raises serious questions of ethics and social justice; Recalling That Under the UN Convention on Women, Equality, Development and Peace (1995) and Habitat II (1996), the member states of the United Nations made a commitment to ensure that corporations (including transnational corporations comply with international law, including international environmental law; Mindful That member states of the United Nations have failed to sign and ratify the Convention on Biological Diversity along with other relevant treaties, covenants and conventions, and that under the Vienna Law of Treaty states are bound not to do anything in the interim between the signing and the coming into force of the treaty to defeat the purpose of the convention; Have Agreed To The Following: To invoke the precautionary principle and institute an immediate ban on all genetically engineered processes, foods, crops and animals; To embark upon the immediate removal of GE foods from grocery shelves; To invoke the "order public" principle and ban the patenting of living organisms and their parts; To criminalize biopiracy and theft of genetic material and knowledge of farmers, peasants, and indigenous peoples; To place a moratorium on genetically engineered medical research into uses of genetic engineering until ethical standards can be put in place; To urge the full ratification of the Convention on Biological Diversity and the enactment of domestic legislation to ensure compliance. SIGN-0N: ----------------------------NAME: --------------------------------A DDRESS---------------------------COUNTRY----------------------------E-MAIL-------------------------------

21

References: Treaty is imminent for genetically engineered foods by Janet Ralogg

Jain, H.K., Biodiversity Convention, More Losers than Winners, Biotechnology and Development Monitor, No.21, Dec. 1994.

De Kathen, Andre, The Impact of Transgenic Crop Releases in Developing Countries, Biotechnology and Development Monitor, No.21, Sep., 1996.

Genetic engineering and the production of food stuffs by Beatrix Tappeser, presented at Discovery 98, international conference , Kulmbach, Germany

Health risks of genetically modified foods: Many opinions but few data. by Domingo, J.L. (2000) Science 288, 1748-1749.

Doyle, J., Potential Food Safety Problems Relating to New Uses of Biotechnology, (National Academy Press, Washington DC, 1986).

Beyond substantial equivalence by Millstone and Mayer, S. (1999) Nature 401, 525-526.

Lauroesh, Mark W., Genetic Engineering Innovation Minimization, 57, George Washington Law Review, 100 (1988).

and

Risk

Mac-Wanlto, Genetic Engineering, Hope or Hoax?, Third World Resurgence, No.53/54.

22

Bijman, Jos. Biosafety Regulation, Biotechnology and Development Monitor, No.18, (1994).

Genetically Modified Foods: Are They a Risk to Human/Animal Health? By Arpad Pusztai

The Genetic Engineering debate complied by Roberto Verzola

Milius, S. 2001. Bt corn risk to monarchs is "negligible." Science News 160(Sept. 15): 164

Paarlberg, R. 2000. Promise or peril? Genetically modified crops in developing countries. Environment 42(January/February)

Perkins, S. 1997. Transgenic plants provoke petition. Science News 152(Sept. 27): 199.

2003. Treaty on international trade in GMOs to become law. United Nations Environment Programme press release. June 13. Available at http://www.grida.no/news/index.cfm?requestedItemId=750.

U.N. Convention on Biological Diversity. 2003. Cartagena Protocol on Biosafety. Available at http://www.biodiv.org/biosafety/.

23

Websites: http://www.foodsafetynow.org/page4.cfm http://www.truefoodnow.org/ http://www.btinternet.com/~nlpwessex/Documents/gmocarto.htm http://www.bioworld.com/ http://www.plab.ku.dk/tcbh/Pusztaitcbh.htm http://www.colostate.edu/programs/lifesciences/TransgenicCrops/current.html http://www.colostate.edu/programs/lifesciences/TransgenicCrops/index.html http://www.biointegrity.org/health-risks/health-risks-ge-foods.htm The Convention on Biological Diversity's secretariat's web site is at http://www.biodiv.org/. http://www.chem.unep.ch/biodiv/default.html http://www.oecd.org/topic/0,2686,en_2649_34385_1_1_1_1_37437,00.html http://binas.unido.org/binas/binas.html http://www.oecd.org/dataoecd/8/3/2375496.pdf http://unesdoc.unesco.org/images/0010/001096/109687eb.pdf. http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm

24 ANNEXURE 1

Opinion of experts
Name of the scientist 1. Dr. John S. Hagelin Professor of Physics, Maharishi University of Management Presidential Candidate, The Natural Law Party Opinion The fact is, it is virtually impossible to even conceive of a testing procedure to assess the health effects of genetically engineered foods when introduced into the food chain, nor is there any valid nutritional or public interest reason for their introduction.

Genetic engineering bypasses Leeds conventional breeding by using artificially constructed parasitic genetic elements, including viruses, as vectors to carry and smuggle genes into cells. Once inside cells, these vectors slot themselves into the host genome. The insertion of foreign genes into the host genome has long been known to have many harmful and fatal effects including cancer of the organism. In 1983, hundreds of people in Spain died 3. Professor Mae Wan-Ho Department of Biology, Open University, after consuming adulterated rapeseed oil. UK This adulterated rapeseed oil was not toxic to rats. Genes encode proteins involved in the 4. Professor Dennis Parke School of Biological Sciences, University control of virtually all biological processes. of Surrey, UK By transferring genes across species barriers, which have existed for aeons between species like humans and sheep, we risk breaching natural thresholds against unexpected biological processes. For example, an incorrectly folded form of an ordinary cellular protein can under certain circumstances be replicative and give rise to infectious neurological disease. Probably the greatest threat from 5. Dr. Peter Wills Auckland University, New Zealand genetically altered crops is the insertion of modified virus and insect virus genes into crops. It has been shown in the laboratory that genetic recombination will create highly virulent new viruses from such 2. Dr. Richard Lacey Professor of Food Safety, University, UK

25 constructions. Certainly the widely used cauliflower mosaic virus is a potentially dangerous gene. It is a pararetrovirus meaning that it multiplies by making DNA from RNA messages. It is very similar to the Hepatitis B virus and related to HIV. Modified viruses could cause famine by destroying crops or cause human and animal diseases of tremendous power. We see this as a multi-million dollar 6. Dr. Joseph Cummins Professor Emeritus of Genetics, University problem. In Europe, there is already a big of Western Ontario problem with gene flow between wild beet and cultivated beet. Oil-seed rape (canola) also has close relatives and is going to cause problems in the future. One would expect that the kind of genes that are now being engineered are going to be the ones that have a higher potentiality for causing trouble. 7. Dr. Norman Ellstrand Professor of Genetics, University California The generation of genetically engineered of plants and animals involves the random integration of artificial combinations of genetic material from unrelated species into the DNA of the host organism. This procedure results in disruption of the genetic blueprint of the organism with totally unpredictable consequences. The unexpected production of toxic substances has now been observed in genetically engineered bacteria, yeast, plants, and animals with the problem remaining undetected until a major health hazard has arisen. Moreover, genetically engineered food or enzymatic food processing agents may produce an immediate effect or it could take years for full toxicity to come to light.

Recombinant DNA technology [genetic 8. Dr. Michael Antoniou Senior Lecturer in Molecpar Pathology, engineering] faces our society with London, UK problems unprecedented not only in the history of science, but of life on the Earth. It places in human hands the capacity to redesign living organisms, the products of

26 some three billion years of evolution.

9.Dr. George Wald Nobel Laureate in Medicine, 1967 Higgins Professor of Biology, Harvard University. From The Case Against Genetic Engineering by George Wald in The Recombinant DNA Debate, Jackson and Stich, eds. P. 127-128 (Reprinted from The Sciences, Sept./Oct. 1976 issue)

It is all too big and is happening too fast. So this, the central problem, remains almost unconsidered. It presents probably the largest ethical problem that science has ever had to face. Our morality up to now has been to go ahead without restriction to learn all that we can about nature. Restructuring nature was not part of the bargain. For going ahead in this direction may be not only unwise, but also dangerous. Potentially, it could breed new animal and plant diseases, new sources of cancer, novel epidemics.

Current testing procedures for genetically Dr. Parke Professor of Genetics, University of South altered foods including rodent tests do not Carolina. prove safety for humans. He has suggested a moratorium on the release of genetically engineered organisms, foods, and medicines.

27

ANNEXURE 2 Results of the poll conducted in various countries with respect to genetically engineered food: -

Name of the country

Results of the poll

Commissioned by Gene Watch, the MORI poll of June, 1998, finds that 75% of the British public feel there should be a ban on the growing of GE crops here until there has been further assessment of the implications; 73 % are concerned about genetic pollution; 61% (up 8% since December 1996) do not want to eat GE foods and 58% (up 7% since December 1996) do not welcome the use of GE in foods.

Britain

Canada

In a poll conducted by the Toronto Star, the vast majority wanted genetically engineered foods to be labeled. In Canada, genetically engineered food must be labeled only when it changes the nutritional value or could pose a health risk to some people. Should all genetically engineered foods be labeled? Of those polled, 98% said yes, while 2% said no. A French opinion poll found that 76% of the French public do not want to eat genetically manipulated food.

France

28 A 1998 survey undertaken in Japan on people's attitude to genetically altered food found that 91% of respondents desired safety information on such food products. The survey, performed by the Society for Techno-innovation of Agriculture, Forestry and Fisheries, also showed that 72% want information on environmental impact, and 55% would like details of how the genetically engineered product differs from ordinary food.

Japan

Austria

In spring 1997, the most successful referendum in Austrian history took place and was signed by 1.2 million people, which is about 22% of the Austrian population. The result: No genetically engineered food in Austria and a very critical public debate on genetic engineering.

USA

A poll by biotech and pharmaceutical giant Novartis released in February 1997 found 54% of American consumers stating that they would prefer to see chemical-intensive agriculture move toward organic production. In the same poll 93% said that genetically engineered foods should be labeled, with 73% indicating that they felt "strongly" about this. A Time Magazine poll of January 1999 found that 81% of Americans wanted genetically engineered food labeled15.

15

In November, 1999, Congressman Kucinich introduced bill H.R.3377 which would require a

label that says United States government notice: This product contains genetically engineered material, or was produced with a genetically engineered material. In February 2000, Senator Barbara Boxer (D-California) introduced a similar bill S.2080 in the U.S. Senate. In March 2000, Congressman Kucinich introduced bill H.R.3883 on safety testing of genetically engineered foods.

29

Australia

An Australian National University, International Social Science Survey, conducted by Jonathon Kelley in 1993, found that 67% of Australians would try genetically engineered foods, however, 89% expected such foods to be labeled and would reject them if they were unlabeled.

Germany

Consumers across Germany are signaling that they do not wish to eat GM foods, because of potential risks to their health. A Gallup poll on Foods shows that the vast majority of consumers who have heard about them have reservations about GM foods. Only 4% of consumers in the poll indicated that they were "very likely" to buy genetically modified food.