Genetically modified food and international law - the biosafety protocol and regulations in Europe.

• Author: Nanda, Ved P.

1. INTRODUCTION

   Biotechnology has the potential to transform industry, including pharmaceuticals, and agriculture.(1) The Biosafety Protocol [hereinafter Protocol], adopted by over 130 states in Montreal, Canada, on January 30, 2000, defines modern biotechnology in the context of regulating the international trade of genetically modified organisms (GMOs). This regulation takes place through the application of "(a) In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or (b) Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection."(2) The Protocol defines a living organism as "any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids."(3) It defines a living modified organism as "any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology."(4) Thus, a GMO or transgenic product is created by inserting foreign genes from one organism into another, thereby crossing species barriers. Thus, genes from viruses, bacteria and animals may be planted in grains, fruits and vegetables.

   Genetic modification (GM) or manipulation in agriculture, undertaken by what is commonly known as genetic engineering, is aimed at increasing the quantity of world food supplies and improving their quality by enhancing beneficial traits, such as making crops resistant to insects or herbicides and reducing their dependence on pesticides. Two examples are insect-resistant corn and Roundup-Ready soybeans, which are impervious to Roundup herbicide, manufactured by the giant biotech firm Monsanto, the largest producer of GM seeds. Major substantive issues related to the creation and use of and trade in GMO products include the threat to biological diversity, economic considerations, intellectual property issues, ethical and religious concerns, risks to human and animal life or health, consumers' right to know, and food security.(5) The security interest, may be affected in several says, such as further consolidation of control over the methods of food production in the hands of a few large firms, excessive use of chemicals because of the increasing resistance of crops to herbicides, and reductions in crop diversity.(6)

   While all these issues are important, in this paper I will focus the discussion primarily on 1) the attempts internationally to regulate the trade in GMOs by the adoption of the Biosafety Protocol, and 2) regulation of GMOs in Europe. The first section will briefly describe the controversy. The second section will discuss the regulatory practice in the United States. The third and fourth sections will describe and analyze the Biosafety protocol and GMOs' regulation in Europe, respectively, before the final concluding section.

2. THE CONTROVERSY

   The use of biotechnology in agricultural practices has increased substantially in the United States and other major food exporting countries. These exporters are also the foremost proponents of the biotechnology industry and operate as the so-called "Miami Group"(7). To illustrate, 50 percent of soybean and one-third of corn crops in the United States in 1999 were grown from GM seed, and almost all canola oil in the US is made from genetically altered rape seeds.(8) Similarly, in Argentina, the world's largest soybean exporter, GM soybeans accounted for approximately 70 percent of the 1998-99 soybean crop.(9)

   The controversy surrounds the genetically modified crops because of the potential long-term risks to human health and the environment caused by the release of GMOs into the environment. Proponents claim that GM foods are beneficial because of their higher nutrient value and because of their capacity to substantially increase food production to feed the world's growing population. On the other hand, critics argue that the potential risks cannot be dismissed. Among unanticipated outcomes, the new genes might jump to other crops or species, or even to people. For example, unexpected toxins or allergens may be introduced into crops through genetic engineering, thus causing unforeseen allergic reactions in humans. In 1996, scientists genetically engineered soybeans to incorporate a gene from Brazil nuts that enhanced the soybeans' protein content. Subsequent testing showed that the protein introduced could trigger allergic reactions similar to those caused by Brazil nuts.(10) A plant with genes resistant to insects or herbicides could spread that gene through pollination, thus creating "super weeds."(11) Recent laboratory studies have shown that the pollen of genetically altered corn can kill caterpillars of the monarch butterfly, that the lives of ladybirds are shortened when they are fed aphids living on GM crops, and that lacewings, natural predators of insect pests, are killed when they are fed corn borer worms raised on genetically altered corn plants.(12)

   Consumer resistance to GM foods in Europe has been intense. United States exports to Europe of corn and soybeans, both genetically modified and conventional, have declined from nearly $3 billion in 1996, when American farms began shipping biotechnology crops to Europe, to about $1 billion in 1999.(13) While European regulators have not approved any new GM seed strains for nearly two years, "[p]lanting, importing or selling genetically altered seeds or foods has virtually stopped, because farmers will not plant the seeds, consumers will not buy the foods, and stores decline to stock them."(14)

   A major controversy was sparked when scientist Arpad Pusztai, at Rowett Research Institute in Aberdeen, Scotland, reported on British television that transgenic potatoes damaged the health of rats by stunting their growth and injuring their immune systems.(15) He was fired and silenced. Subsequently, however, the British medical journal, The Lancet, published a peer-reviewed paper co-authored by Pusztai in which he repeated the finding.(16) According to polls, only one percent of Britons think that there is any value in GM plants, and ingredients from these plants are called "Frankenstein food" by several British newspapers.(17) It is ironic that at a kitchen at Monsanto's Britain factory only GM-free meals are served.(18) Bowing to consumer concern, British Prime Minister Tony Blair wrote in late February 2000:

   There is no doubt that there is potential for harm, both in terms of human safety and in the diversity of our environment, from GM foods and crops. It's why the protection of the public and the environment is, and will remain the Government's over-riding priority. Testing [of GM food ingredients] has been tightened by this government even further. I can promise that no GM food will be put on the market here without going through the most rigorous safety assessments in the world. We also recognize the genuine fears over the impact of GM crops on our environment and wildlife. That is why no GM crops will be grown commercially in this country until we are satisfied there will be no unacceptable impact on the environment. We have insisted that products containing GM foods on shop shelves have to be labeled. And anyone eating in a restaurant has a legal right now to ask whether the food they serve contains GM ingredients. And we are leading the fight to have labeling extended in Europe.(19) The Minister for the Cabinet Office in Britain, Mo Mowlam, had earlier said in December 1999 that in 2000, the government would announce new rules on labeling of additives and flavorings as well.(20) In Wales, there has been a movement toward declaring that region of Britain a GM-free zone.(21) Because of the backlash against GM crops, the biotechnology industry is unable to find enough British farmers willing to grow GM crops even for a trial period.(22)

   The concern has now spread beyond Europe to many other countries. For example, the Washington Post reported in January 2000 that in Japan,

   [i]n the five months since the labeling requirement was announced, a major supermarket chain has started identifying its genetically modified products. The Asahi and Kirin Beer Companies said they will switch entirely to non-genetically modified ingredients. And Japanese soybean farmers, who do not use any genetically modified seeds, are enjoying a huge demand for their beans even at three to four times the price of imported American ones.(23) In Canada, McCain Foods, Ltd., a major potato producer and a leading supplier of French fries to Burger King, says that it will not use gene-altered potatoes.(24) Similar developments have occurred in several other countries, including Brazil,(25) Mexico(26) and South Korea.(27)

   A major controversial issue is whether genetically modified foods are "substantially equivalent" to their natural counterparts. The concept of "substantial equivalence" is the basis for US regulators not to treat such food differently from conventional food. Critics, however, argue that a GM food's being chemically similar to a conventional food "is not adequate evidence that it is safe for human consumption."(28) They contend that, while this "approach might seem plausible and attractively simple ... it is misguided, and should be abandoned in favor of one that includes biological, toxicological and immunological tests rather than merely chemical ones."(29)

   The concept of substantial equivalence has never been properly defined; the degree of difference between a natural food and its GM alternative before its "substance" ceases to be acceptably "equivalent" is not defined anywhere, nor has an exact definition been agreed by legislators. It is exactly this vagueness that makes the concept useful to industry but unacceptable to the consumer. Moreover, "the reliance by policymakers on the...