Assessing the Risks Associated with Biotechnology: The Regulatory Problem

Abstract

In examining the regulatory problem posed by biotechnology, three areas must be considered: 1) the potential benefits to mankind, 2) the generation of profits to industry, and 3) the mitigation of risk presented to human health and the environment. Environmental risk assessments involving exposure and effects assessments must consider the potential for establishment in the environment, the potential for altering ecosystem processes and the potential for unexpected events as they relate to biotechnology applications. Predictive and analytical tools must be developed and used by regulators to ensure that the rewards of genetic engineering to both mankind and industry are realized with minimal consequence.