ABSTRACT

Risk analysis can been defined as a means by which scientific, social, cultural, economic, and political issues that together form a consensus approach in public policy decisions in a particular discipline, such as agricultural biotechnology, can be addressed. In the case of science-based risk analysis, the potential risks must be assessed at each stage of the production process, from research and development to commercialization, and strategies must be developed to deal with them. These strategies can then be brought in front of political decision makers who must contend with the public perception of risk. With respect to plant-made biopharmaceuticals, the overall amount of risk is the measure used by the FDA to determine whether this approval should be granted (Shama and Peterson, 2004; Farrow, 2004).