Risk Management Basics

Risk Management BasicsThis is a general discussion on risk assessment and is not specific to the EPA or the Libby Superfund Site.  The information contained herein is for learning about Risk Assessment and will help you understand LATAG and the EPA's approach to Risk Management. This is a lengthy document and is divided into 5 parts so the document is easier to read.

Dose-response assessment

The determination of the relationship between the magnitude of exposure (dose) to a chemical, biological or physical agent and the severity and/or frequency of associated adverse health effects (response).

For any particular individual, dose-response links the amount of the hazard you ingest (dose) with the chance of your becoming infected and the scale of the illness if you do. For example, most healthy individuals can consume large numbers of Listeria monocytogenes (maybe as many as 100 million cells) without becoming seriously ill. By contrast, in susceptible people (foetuses, the aged or individuals with impaired immune systems) a much smaller dose (maybe as few as 10 000 cells) can cause serious illness and, in around 30 percent of cases, death. In the Resources Bank you will find a list of dose-responses for several micro-organisms and their toxins.

Exposure assessment

The qualitative and/or quantitative evaluation of the likely intake of biological, chemical and physical agents via food as well as exposures from other sources if relevant.

To carry out an exposure assessment you need data in two areas:

  • number of servings of potentially dangerous food eaten;
  • level of contamination with the micro-organism or toxin at the time of consumption.

To arrive at these types of data you will probably follow the micro-organism or toxin through the processing-food preparation chain and estimate changes that occur to the hazard throughout the chain.

Risk characterization

The process of determining the qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment.

When you do the risk characterization, you integrate hazard identification, exposure assessment and hazard characterization to provide an estimate of the risk.

Risk estimate

Output of risk characterization

This may vary from a qualitative estimate (high, low, medium) to a quantitative estimate where you predict the number of people you expect will become ill from the particular product:hazard pairing. Alternately, your risk characterization may be semi-quantitative and you make a risk ranking that is a number in a specific range, 0-100, for example.

Risk management

The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant to the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.

Risk managers have a difficult responsibility because they must take into account the views of various groups. Trying to find compromises between the views of scientists, industry, consumer groups, politicians and lawyers is almost impossible, but it is what risk managers are required to do.

Risk communication

The interactive exchange of information and opinions throughout the risk analysis process concerning hazards and risk, risk-related factors and risk perceptions among risk assessors, risk managers, consumers, industry, the academic community and other interested groups, including the explanation of risk assessment findings and the basis of risk management decisions.

Communicating risk is a very difficult task because it involves the full range of stakeholders. A major problem is informing consumers that no food product is risk-free and, as a consequence, they must be prepared for X deaths and Y illnesses each year from this particular product. Risk communication includes changing perceptions of stakeholders so they all move towards some central positions that are not far removed from each other.

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