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.

1.1 Risk analysis in plain language

Risks from microbiological and chemical hazards are of serious concern to human health. As the discipline of risk analysis matures, it is developing its own tools and language, and this paper explains what those tools can do, in simple language. To begin, the definitions and terms used in risk analysis are set out in the CAC Principles and guidelines for the conduct of microbiological risk assessment (CAC/GL-30, 1999). The Codex words are in italics and some explanatory words are in normal type.


A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.

Two Sides of Risk


A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

There are two very useful books that give information on seafood hazards:

  • Assessment and management of seafood safety and other quality aspects (FAO, 2004).
  • Fish and fisheries products hazards and controls guide (FDA, 2001).
Risk analysis

A process consisting of three components:

  • risk assessment
  • risk management
  • risk communication

A common question is "Which of the three elements do I do first?" In most cases, the risk managers identify the need for a risk assessment and select an assessment team. Ideally, they should also begin the risk communication process as early as possible so that all interested and affected groups know what is happening from the first day. Tactically, it is a mistake to keep people uninformed - even if they agree with the assessment they will be displeased to have been excluded from the process.

Risk assessment

A scientifically based process consisting of the following steps:

  • hazard identification
  • hazard characterization
  • exposure assessment
  • risk characterization

The aim of risk assessment is to estimate the level of illness that may be expected in our target population from a product or group of products.

The information flow for the four components in a risk assessment is shown below:

Risk Management Flow Chart

Hazard identification

The identification of biological, chemical and physical agents capable of causing adverse health effects and that may be present in a particular food or group of foods.

This is the first stage in risk assessment and is a screening process to make certain that the hazard really does exist in this particular product. For example, Clostridium botulinum is readily identified as a hazard in canned, smoked and vacuum-packed seafoods, but is unlikely to be a hazard for any other seafood product. So hazard identification is a primary screen that allows risk managers to eliminate product: pathogen pairs that are of no concern.

You will find material on hazard identification for all of the hazards associated with seafoods in the Resources Bank.

Hazard characterization

The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents that may be present in food. For the purpose of microbiological risk assessment the concerns relate to micro-organisms and/or their toxins.

There are two parts to hazard characterization:

  • a description of the effects of the hazard (micro-organism or toxin);
  • the dose-response relationship (if it exists).


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