Introduction Genetic Engineering (GE) is one branch of biotechnology and can be applied to animals, fish, trees and plants and other main techniques include plant genomics and cloning. 1 Biotechnology uses series of biological processes or enabling technologies involving the practical applications of living organisms or their subcellular components to make or modify commercially important products, to improve plants and animals or to develop microorganisms for specific uses and services. Scientists today are applying GE to alter the salient traits of living organisms, by relocating the basic building blocks of life to create new varieties of living organisms. The architects of genetically modified organisms (GMOs) or living modified organisms (LMOs) argue that the potential of GE would benefit society by, for example, increasing crop yields or improving food quality. Many scientists, however, warn that GMOs could pose a threat to human health and the environment and many have voiced concern about the ethical and social implications of GE.2 Humans, for ages, have taken advantage of naturally occurring genetic variation within a species to selectively breed organisms with desirable traits. GE, as such, is not the first effort to influence the characteristics of living organisms. Many of the characteristics of domestic animals and agricultural crops have been developed through such selective breeding. Humans have also influenced the reproductive behaviours or opportunities of closely related species that did not cross breed in the wild because of reproductive or geographic barriers. Cross breeding between distinct species, either naturally or through human influence, is 1 2 Genomics is the study of gene sequences in living organisms and being able to read and interpret them. The study of genomics originated in the 1930s and essentially involves the investigation of structures and functions of various genomes from humans, animals and plants. Incidentally, DNA was not identified as the genetic material of all living organisms until 1944. A total of 449 scientists from 56 countries issued an open letter in September 1999 expressing concerns about GMOs and urging governments to take actions on it. For details see Annex 1. known as hybridisation. Humans, for example, have bred two different species of the grass family, wheat and rye, resulting in hybrid offspring that have the ruggedness of rye and the high yield of wheat. Because breeding can only take place between individuals of the same or closely related species, such breeding programs confront limits in the genetic combinations they can make and, therefore, the results they can achieve. A GMO is created when the DNA (deoxyribonucleic acid) from one species is taken and merged into the DNA of another life form. This is completely different from the age-old cycle of plant breeding where farmers save seed from plants that exhibit desired traits. Genetic information programmed in DNA determines an organism's biochemical, anatomical, physiological and, to some extent, behavioural traits. DNA forms a hereditary code that is carried in each cell of an organism. The process of genetic modification involves identifying the portions of DNA that are responsible for a particular trait in one organism, extracting or copying these DNA sequences, and then introducing them into a different organism.3 The aim is to change the traits or functions of the recipient organism, and the result is a GMO. Scientists have placed genetic information from humans into mice, and scorpion genes into corn. This genetic mixing is possible because the genetic information of all organisms is carried in the same DNA codes. If a DNA sequence in a pig is responsible for the production of a particular animal protein, that sequence can be introduced into a plant cell's DNA, and the plant cell will produce the same protein. There are around 100,000 genes in a mammal. GE can involve moving genes both within and between species. It is the movement of genes between species which is of the greatest concern. GMO technology thus gives the ability to add, subtract, alter or exchange an individual gene or a group of genes known to influence an individual characteristic. 4 3 4 Either directly or using vectors such as parts of a bacteria or viruses. The first genetically modified food was approved by the FDA to go to market in 1994. Calgene, a biotechnology company, modified Flavr Savr, the tomato, using antisense technology resulting in altered ripening. Traditional tomatoes must be picked from the GE has produced some successful results in medical and agricultural applications.5 Human DNA sequences have been transplanted into mice, causing the mice to produce components for human blood needed in medicine. Crop plant strains that have been developed carry genetic information from bacteria making plants resistant to herbicides. But these techniques also pose great ethical and biological dangers, risks, and uncertainties. For instance, in Mexico GM maize found its way into farms growing traditional varieties, despite the fact that since 1999, it has been illegal to plant GM maize. Starlink, a variety of maize not approved for human consumption in the United States, contaminated the food products and maize seeds three years ago. It is still found in 1 percent of maize samples tested by the US government. Two cases of crops contaminated with maize engineered to produce pig vaccine were reported by the US Department of Agriculture in December 2002. In one case, 500,000 bushels of soybeans worth US$2 million had to be destroyed. In the other incident, 63 hectares of contaminated maize field had to be burned. 5 vine while still green in order to maintain their firmness during transport to the supermarket. The tomatoes are then sprayed with ethylene, their natural ripening agent, in order to turn the tomatoes red. Flavr Savr tomatoes are designed so they can ripen on the vine longer while maintaining firmer skin, thus producing a fuller flavoured tomato on the supermarket shelves. Public concern surrounded Flavr Savr’s introduction to the market. Debate raged across North America. How would this change the tomato? Question raised, had Calgene created a “Frankenfood”? In 1997, the tomato was pulled from the market. Supporters of the tomato claimed that the company required specialized transportation equipment, which was not economically feasible for Calgene. Those opposed to genetically modified foods hailed it as a victory. Data compiled by the Pharmaceutical Research and Manufacturers of America show that of the 371 biotech medicines now undergoing commercial tests, 116 have reached Phase III clinical trials -- the last step before the U.S. Food and Drug Administration decides whether they are safe and effective enough to sell to consumers. A record number of biotech medicines has reached the final stage of clinical trials, positioning the industry to produce as many products in the next few years as it has during the past 20.