Fundamental Concepts of Safety Regulations

A hazard generally refers to some substance or combination of substances (organic or inorganic, or in some cases psychological) that may, under some circumstances or for some individuals, produce undesired health-related outcomes. Nearly any substance can have the potential to produce an undesired health outcome to some individual under some circumstance. Exposure to a hazard, however, does not guarantee that an undesired outcome will occur. 

The likelihood that such an outcome will occur given exposure to a hazard is what is referred to as the risk of that hazard. The risk of a hazard is not a general (main effect) property of the substance, but rather it is an interaction between the nature of the hazard, the circumstances of the exposure (e.g., the magnitude, the timing, and the specific features of the individual, such as health status, age, and susceptibility), and other such conditions that moderate the actual health impact of the hazard. 

Harm refers to the nature of the undesired outcome (usually a health outcome) associ- 

Opposite harms are the benefits of the addition of substances. The ratio of costs to benefits is a critical unit in some safety assessment systems. Cost-benefit ratios may apply to individuals or groups. For example, an individual may benefit from a treatment but may experience side effects. Another example is the case of iron supplementation to reduce infant risk of anemia. Some or all of the infants within a group may benefit from receiving additional iron, while some may be harmed (e.g., experience constipation) on average, however, the population that benefits from iron fortification will be larger than the population that experiences harm. 

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