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Food Safety risk analysis
What Is Risk Analysis?

Risk analysis encompasses three target areas:

Risk assessment - a process that involves identifying a potential hazard that can cause a negative impact.
Risk management - a process that involves identifying, evaluating, selecting, and implementing specific management measures to mitigate risk.
Risk communication - a process that includes the exchange of information about the risk.



What Is the Origin of Risk Analysis?

Risk analysis got its start from the original model used to determine the source of anthropogenic pollution. The concept of "risk" arose from Rachel Carson's book, Silent Spring. Carson, a marine biologist, primarily focused on the effects of polychlorinated biphenyls on the environment. Carson's book made a powerful plea for less harmful methods of insect control. Two main themes were the initial sparks that ignited the environmental movement and established the formative definition of risk:
  • A technology (such as pesticide to control insect pests) that seems harmless may have long-term environmental effects.

  • The actions of human beings have become a primary influence on the health of the earth.
Industry spoke out strongly against Carson's book, claiming that the book was based on feeling and not hard scientific evidence. This perceived lack of scientific evidence prompted the President of the United States to convene a scientific committee to investigate the long-term environmental effects of the application of DDT. The initial study demonstrated no threat to human health. A later study, of course, found that not only was DDT bio-accumulative, but that is was also causing a decline in the raptor population because it affected reproductive ability, mainly by making the egg shells too thin to survive incubation.

The environmental health and public health movements converged in the 1970s. Most people were concerned about their risk of cancer from exposure to certain man-made pollutants. The combination of this popular movement and politics resulted in the testing of chemicals, usually via animal testing, to determine if the chemical was carcinogenic. Because it was difficult, and in some cases impossible in the short term, to determine the effect of exposure on humans of many chemicals, the birth of the concept of risk assessment resulted.

The approach to assessing human health risk from chemical exposure differs substantially from the approach for assessing microbiological risks.


Feature Chemical Risk Assessment Microbiological Risk Assessment
Pollutant Concentration Assumed to be lowered over time through dilution. Pathogen concentration may increase or decrease or change in virulence.
Hazard Identification Compiling a list of pollutants and potential sources which contribute to increased loading of the environment. Requires experimental trials to determine and prove causal association. Compiling a list of bacteria associated with the source of food or the method of production or processing.
Exposure Characterization  

Single-cell pathogen may be undetectable at slaughter but can reproduce to pose a later problem.

Pathogens may be introduced at any point.

Risk may change at any point in food processing and distribution.

Impact of Exposure Cumulative for long-term exposure. May be acute or chronic.
Estimation of Risk Risk based on pollutant concentration, body weight, and other factors. Difficult to estimate risk of human infections because of multiple factors involved in individual susceptibility.

Risk assessment is the science of identifying and evaluating potential hazards and potential exposures. The two basic factors associated with risk assessment are

  • The likelihood of an event, and
  • The consequences if it occurs.

Risk assessment provides an analytical framework to support decisions related to food safety. Food safety risk assessment involves the development of either quantitative or qualitative models. A model is basically a mathematical framework of components that are used to assess the risk for any given commodity or process.

The first step in the risk assessment framework is to identify the potential microbiological hazard. The goal of microbiological hazard identification is to identify the organism and determine its potential effect on people. There are many tools for assisting in identifying foodborne pathogens. Some are the "Bad Bug Book" of the FDA, the CDC's Mortality and Morbidity Reports and guidelines for clinicians, as well as the government's Food Safety Information Center, USDA/FDA Foodborne Illness Education Information Center, and the Department of Commerce's Seafood Inspection Service. In the private sector, the Center for Science in the Public Interest, the National Food Processors Association, and the International Food Information Council are three of many hundreds worldwide.


Microbiological hazard identification is accomplished by observing and defining the types of adverse health effects associated with exposure to foodborne agents. These health effects are evaluated through measures such as morbidity ratios, disease severity as determined by the ratio of hospitalized cases to the total number of cases in an outbreak, mortality ratio, and attack rates. Hazard identification also involves specific routes of transmission. Hazard identification may also involve statistical analyses and literature reviews for existing information/studies regarding the pathogen of concern.

Risk characterization, the next step in risk analysis, is one of the most important steps. Risk characterization takes information from microbiological hazard identification and uses qualitative or quantitative tools to assess and predict the exposure for people. Risk characterization serves to bridge risk assessment and risk communication, allowing for the discussion of confidence and uncertainties in analysis. The foundations of risk characterization are embodied in:

  • Exposure assessment - determining the routes of exposure and the likelihood of being exposed

  • Dose-response assessment - determining the variation in impact following exposures to differing levels of foodborne pathogens.
Exposure assessments may be either qualitative or quantitative. Qualitative exposure assessments are generally used when there is insufficient quantitative information about the bacteria. Many qualitative exposure assessment models focus on identifying the point of entry of the pathogen. At a minimum, they should identify and rank the microbes' entry potential and identify and rank the potential of the microbes to spread. An example of a qualitative exposure assessment tool has been developed by the Ontario Ministry of Agriculture.

Quantitative exposure assessments often involve more elaborate mathematical or predictive models. These models are used to:

  • Predict the effect of changes in food processing or food storage on microbial growth, and

  • Model food handling procedures to obtain optimal reduction in microbial growth.

Two quantitative exposure assessment models that are readily accessible are those of the USDA's Agricultural Research Service, and the AMIF.

Dose-response risk assessment also may be either qualitative or quantitative. Qualitative dose-response risk assessments, in many cases, are limited by available data. Some times, because of the paucity of data, they are based on anecdotal information. In this case, it is difficult to determine the minimum exposure necessary to cause a negative effect - the so-called Lowest Observed Effect Level (LOEL).

Quantitative dose-response risk assessments attempt to determine the number of vegetative cells - or spores - that will result in morbidity. Animal studies are often employed, with the results being extrapolated to humans. As any toxicologist knows, this method is not nearly as reliable as actually observing infection and resulting morbidity in humans.  The acute nature of foodborne illness, as well as its extensive underreporting by clinicians, who many times fail to identify either the agent of the disease, militate against quantitative dose-response risk assessments.

 

 

 

An independent study project for Environmental Health 511,
summer quarter 2000, taught by Dr. Bill Daniell

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© 2000 Department of Environmental Health
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