ABSTRACT

CONTENTS 16.1 Introduction ............................................................................................. 463 16.2 What Is Risk Assessment?..................................................................... 464 16.3 Brief Retrospective of Risk Assessment .............................................. 465 16.4 Chemical Risk Assessment.................................................................... 466 16.5 Risk Assessment for Replicating Organisms ..................................... 466 16.6 Foodborne Pathogens............................................................................. 467 16.7 Microbial Risk Assessment Issues ....................................................... 468

16.7.1 Is the Product Contaminated? ................................................ 468 16.7.2 At What Level Is the Product Contaminated?..................... 468 16.7.3 What Is the Public Health Impact from This Level

of Contamination? .................................................................... 469 16.7.4 How Do We Assess Equivalency for Trade Issues? ........... 469

16.8 Conclusions.............................................................................................. 470 References ........................................................................................................... 470

Various methods of risk assessment and analysis have been used by engineers, economists, and other scientists since at least the 1930s. In the 1950s and 1960s, risk assessment methods were applied to chemical contaminants that may be in the environment or our food and water.1 Later, the U.S. Food and Drug Administration (FDA) developed safety assessments, a variation of risk assessment, to evaluate food additives and chemical contaminants.

Application of formal risk assessment to biological (multiplying) organisms was not attempted until the 1980s and 1990s. At the time of the first edition of this book, biological risk assessment, including microbial contaminants of food, was literally in its infancy. The science of biological risk assessment has advanced greatly in the intervening years; risk assessments have become more complex and sophisticated. Government regulators have also become more familiar with the methods and have learned how to apply the methods to better inform food safety regulations. Risk assessments of microbial food contaminants and other sanitary and phytosanitary pathogens are routinely required to support any regulation that may restrict trade. USDA was the first government agency specifically required by statute to perform risk analysis and economic analysis for major regulations affecting human health, safety, or the environment.2