The safety and economics of transgenic organisms in agriculture are critically important issues for both consumers and agricultural producers (Herdt, 2001). In spite of the impressive amount of evidence that transgenic organisms, commonly referred to as genetically modified organisms (GMO), are as safe as any of the other varieties of crop plants that have been introduced in the history of agriculture (Thomas and Fuchs, 2002; National Research Council, 2000, 2002a, 2002b), there is still a great deal of undue political pressure to regulate them increasingly stringently, that are costly and do not add any appreciable value to the safety concerns warranted by any reasonable risk assessment. Scientifically sound risk assessment can allay most of the concerns of the public and instil confidence, but the public has been confused by a campaign of fear and misinformation that is turning out to be detrimental to scientific progress. Transgenic crops, and the biotechnology that produces them, have enormous potential to solve many of the intransigent problems of modern agriculture, conserve natural resources and protect the environment, yet in many countries, the whole technology has been bogged down in a regulatory quagmire.Ever since Rachel Carson's Silent Spring (1962), citizens of the industrialised world have become extremely concerned about hazards of technology and have created new sets of institutionalised mechanisms to control technology. This has seriously affected the way technologies are designed and developed (Kates, 1986). Irrespective of the ideological differences between the various stakeholders in biotechnology, it is now generally accepted that biotechnology will be regulated and that society will have to bear the costs of such regulation. To a large extent, the public interest groups and activists will influence the development of biotechnological regulation, and this is already seen in Europe, Africa and Asia. An important goal of risk assessment is the minimisation of surprises and plan for risk management. It has to be acknowledged, of course, that ‘surprises’ will persist, but adequate risk assessment should help us manage those surprises and mitigate them.
It is just over a decade and a half since the first transgenic tobacco plants were field tested in the United States in 1986, and the basic principles of assessing the environmental and biosafety risks of transgenic plants have not changed very much since then. The basic question addressed has always been the variety of interactions that a given organism might have with the environment into which it is introduced over a finite period of time. The essential problems addressed are the nature, characteristics and identity of the organism being introduced, together with its persistence and likely impact on non-target organisms. These questions are basically addressed by using the formula:
Risk: Exposure x Time
This formula is derived mostly from chemical and radiation technologies. Risk assessment of transgenic plants continues to evolve. However, it is getting more and more influenced by societal and economic concerns rather than real-world biosafety considerations. As a result, it is not only becoming unduly burdensome but is also hindering biotechnological development and transfer. The standards' bars for biosafety and environmental safety are now being raised on the basis of perceptions of risks rather than real risks, and this is making transgenic crops one of the most expensive technologies. A conservative calculation by one of us (S.S.) estimates that the regulatory review process is costing US $8–10 million for a single transgenic variety to be brought to the market place in the United States, and about $15 million in the European Union. Additional costs for maintaining full regulatory compliance in different countries of the world will also accrue, and these cannot be reasonably estimated at the present time. These enormous precautionary expenditures are undertaken by the developers of transgenics in order to avoid huge penalty costs, to the tune of millions of dollars, such as those that resulted from the StarLink episode (2001) and the ProdiGene Affair (2002). Biotech industry is now engaged in a laborious regulatory compliance process that is going to add to the cost of product development to the tune of millions of dollars.
Most risk assessments proceed from known to the unknown, starting with an excellent scientific background of the crops in question. There is copious information available on the basic biology, reproductive habits and agricultural requirements and husbandry of the majority of the food crops in the world. This background information provides workers with the confidence to take the deliberate and carefully considered steps necessary to introduce transgenic crops into modern agriculture. Yet, there is now such a widening gulf of misunderstanding between the practitioners of modern biotechnology and agriculture and non-scientific people that there no longer seems to be any chance of reaching a consensus. The basic concern of the opponents of transgenic crop technology is that no one can understand the long-term effects of these transgenic crops, and that, if something terrible were to happen, no one would be able to recall them from nature again, and, further, they have the potential to destroy valuable biodiversity, thereby causing untold environmental damage to the planet (National Research Council,2002a, 2002b). Some of the other issues that surround the risk-assessment process are threat to biodiversity, gene transfer into wild and weedy relatives of cultivated plants, increased weediness or evolutionary ‘fitness’, the compromising of plant defence systems, increased resistance by pest species, human health-risk issues, such as the use of antibiotic marker genes, allergenicity and toxicity, and contamination of human and animal food-chain by plants producing biologically active pharmaceuticals, drugs, vaccines and industrial compounds (Gaff and Newcomb, 2003). People are also concerned about the use of genetic user restriction technologies (GURTS), which in the opinion of some will rob poor farmers of the ability to save seed for future planting.
Risk communication has therefore become a central aspect in gaining public confidence about agricultural biotechnology. This critical challenge needs to be addressed by the scientific community in order to overcome public apprehensions about transgenics. In this context, it needs to be emphasised that, whatever scientific risk assessment is carried out on transgenic organisms, the results of this research must be communicated in a simple and easy-to-understand form while remaining accurate. A risk-assessment document is primarily aimed at the general public who may or may not have the necessary scientific background, but is nevertheless concerned about the issues at hand.
Another critical aspect of the risk assessment of transgenic crops is the policy imperative that triggers the development of rules and regulations and lays down the basic principles upon which transgenic organisms are evaluated. A sound scientific policy is the only instrument that can promote the development of standardised risk-assessment procedures based on existing knowledge on a case-by-case basis. When the pathway of regulatory-policy development in most parts of the world is examined, it is usually found that it has been driven by the politics of compromise, which has resulted in a plethora of non-harmonised rules and regulations, executive decrees and guidelines, devised by committees with people who may have had little or no understanding of agriculture, biotechnology or environment and safety issues. The process is thus driven by political expediency and compromise, with science taking a back seat. This has resulted in highly expensive, poor-quality risk assessments that cannot assuage the feelings of the public about biotechnology. It seems likely, therefore, that transgenic organisms will be caught in this type of regulatory quagmire for some time to come, unless science-based risk assessments and risk management procedures are used to provide
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