theme throughout the report. This chapter ends with a discussion of two important points of international cooperation: the use of risk and hazard analysis in food safety and the regulation of active pharmaceutical ingredients (APIs).


The first step in understanding the core elements of food and medical product regulatory systems is identifying the underlying attributes of successful systems. The committee identified five main characteristics of good systems: they should be responsive, outcome-oriented, predictable, risk-proportionate, and independent. These attributes are consistent with those outlined in the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS), especially in their emphasis on the protection of human, plant, and animal health without the application of regulations that would “arbitrarily or unjustifiably discriminate between countries where identical or similar conditions prevail” (WTO, 1998). Similarly, the WTO relies on a scientific evidence base for decision making. Its preference is to use international standards whenever possible, but does allow countries to set their own standards so long as their standards comply with the basic tenets of the WTO rules.

The major attributes the committee identified are common to all highly functioning regulatory systems. These attributes are not the system’s main duties, which will be discussed later, but are scientific and philosophical underpinnings of a robust system.


The responsiveness of a regulatory system involves two related functions. The first is the ability to respond rapidly to a crisis. The regulatory system should be able to contain and correct any product safety lapse that has occurred, minimizing the health effects. Responsiveness also includes the ability of the system to promptly modify its policies. Responsive regulation keeps pace with the emergence of new hazards, changes in technology, expanding evidence base, and evolving consumer expectations. This attribute also includes the ability of the system to stay up-to-date and knowledgeable about new science. Responsiveness refers to the ability of the regulatory agency to continually expand its knowledge base, to be a learning organization that has internal scientific depth and effective collaboration with academics, and to draw on the technical and business expertise of regulated industry.

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