ABSTRACT

Safety refers to a “reasonable certainty of no harm” according to Title 21 of the United States Code (Section §348). Safety is an intellectual concept and not an inherent property of a substance. Safety assessment is a continual ongoing process, not an absolute determination based on a single point in time. The relationship between biology and safety is mediated through concepts of harm, benefit, and risk. Risk analysis forms the basis on which food safety policy is based. The three components of risk analysis involve risk assessment (scientific advice and information analysis), risk management (regulation and control), and risk communication. As such, the concepts of safety, safety assessment, and risk analysis are influenced by many different individuals, organizations, and regulatory authorities, and encompass several intellectual disciplines.