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Introduction to Risk Analysis

Food law is not intended to guarantee that all food is safe. Achieving that goal would be too expensive at this time. Instead, food safety law is intended to reduce the risk of unsafe food. This page introduces the three components of risk analysis as it relates to food safety: risk assessment, risk management and risk communication.

 

Food law is not intended to guarantee that all food is safe; achieving that goal would be too expensive. Instead, food safety law is intended to reduce the risk of unsafe food. To reduce the risk of unsafe food, food businesses are urged to pursue the practice of risk analysis and its three components as it relates to food safety: 1) risk assessment, 2) risk management and 3) risk communication.

The following statements are drawn from "Introductions to Food Safety Risk Analysis" at http://foodrisk.org/overviewriskanalysis/.  Even though some of the quotes or excerpts are several years old, the fundamental concepts have not changed, but they have been refined.

 

Risk analysis is defined … as "A process consisting of three components: risk assessment, risk management and risk communication."  The first component of risk analysis is to identify risks associated with the safety of food, that is, conduct a risk assessment.  The second component is to develop and implement strategies that manage or reduce the identified risks of unsafe food.  The final component of risk analysis is to inform others of risks and management practices associated with food safety, that is, risk communication.

 

  • Risk assessment is defined … as "A scientifically based process consisting of  ... (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization."
    • Hazard identification is "The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods."
      • Congress, in enacting the Food Safety Modernization Act, extended this list of hazards to include "(A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; (B) hazards that occur naturally or may be unintentionally introduced; and (C) hazards that may be intentionally introduced, including hazards intentionally introduced by acts of terrorism."  Persons identifying food hazards may want to consider this extended list.
    • Hazard characterization is "The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable."
      • Again, these thoughts should be broadened as the description of hazards is refined and expanded.
    • Exposure assessment is "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."
    • Risk characterization is "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.
      • The idea of risk analysis and its three components is perhaps 20 years old; recognition of intentional attacks on food has received increasing attention in the past decade.  Accordingly as one reads and considers the point of "risk characterizations", it may be helpful to refine the brief description presented above to include the probability of an intentional attack on a food product.

 

  • Risk management is defined … as "The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.
    • This description is written at a relatively high level; it mentions policy and trade practices.  This web page encourages readers to consider these ideas on a more micro or business level; that is, how would managers of food businesses incorporate risk management into their thought process and business practices.

The World Health Organization (WHO) includes the following statements about risk management (at http://www.who.int/foodsafety/risk-analysis/risk-management/en/).

"The four components of risk management frameworks can be summarized as follows:

  • Preliminary risk management activities comprise the initial process. It includes the establishment of a risk profile to facilitate consideration of the issue within a particular context, and provides as much information as possible to guide further action. As a result of this process, the risk manager may commission a risk assessment as an independent scientific process to inform decision-making.
  • Evaluation of risk management options is the weighing of available options for managing a food safety issue in light of scientific information on risks and other factors, and may include reaching a decision on an appropriate level of consumer protection. Optimization of food control measures in terms of their efficiency, effectiveness, technological feasibility and practicality at selected points throughout the food-chain is an important goal. A cost-benefit analysis could be performed at this stage. [emphasis added]
    • In a cost-benefit analysis, the cost of adopting a practice to lower the risk of experiencing a problem is weighed against the benefit of avoiding a loss that would result from a problem if nothing was done to reduce the likelihood of the problem. 
    • Quantifying the benefit of managing a risk considers both a) the probability of a problem occurring or arising if the risk is not managed and b) the magnitude or size of loss if the problem that occurs or arises if the risk is not managed.
    • The cost of adopting a risk management practice or strategy is considered to be known or determinable with some degree of certainty.
    • It is the benefit component of a cost-benefit analysis that is uncertain because the frequency and magnitude of a problem occurring is not known with certainty.
  • Implementation of the risk management decision will usually involve regulatory food safety measures, which may include the use of HACCP. Flexibility in the choice of individual measures applied by industry is a desirable element, as long as the overall programme can be objectively shown to achieve the stated goals. Ongoing verification of the application of food safety measures is essential.
  • Monitoring and review is the gathering and analyzing of data so as to give an overview of food safety and consumer health. Monitoring of contaminants in food and foodborne disease surveillance should identify new food safety problems as they emerge. Where there is evidence that required public health goals are not being achieved, redesign of food safety measures will be needed. "

Heads up:  the several components of risk management introduced above are similar to the principles which underpin HACCP and Food Safety Plans (as discussed on subsequent pages).  Look for these similarities as we study these materials.  Recognize that HACCP and Food Safety Plans are implementations of risk analysis, risk assessment, risk management and risk communication.

 

  • Risk communication is defined … as "The interactive exchange of information and opinions throughout the risk analysis process concerning hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions. Excerpts from “Risk Communication" at http://foodrisk.org/rc/ ; citing Codex.
    • Again, these thoughts are written at a relatively high (policy?) level.  What do business managers need to do to apply these ideas to their food products?

Consumers require access to adequate information about potential hazards and appropriate precautions to be taken in the final preparation and serving of food. In addition, consumers need to be aware of and to understand food safety control measures implemented by their government in the interest of consumers' health.

Communication provides the public with the results of expert scientific review of food hazard identification and assessment of the risks to the general population or to specific target groups such as infants or the elderly. Certain people, such as those who are immunodeficient, allergic or nutritionally deficient, require particular information. Communication provides the private and public sectors with the information necessary for preventing, reducing or minimizing food risks to acceptably safe levels through systems of food quality and safety management by either mandatory or voluntary means. It also provides sufficient information to permit the populations with the greatest level of risk from any particular hazard to exercise their own options for achieving even greater levels of protection.”  Excerpt from http://www.fao.org/docrep/w8088e/w8088e07.htm

 

Some resources to learn more about risk analysis:

 

 

These excerpts introduced the three concepts of risk assessment, risk management and risk communication, but the discussion is at a relatively high level that may not have much practical application for food businesses.  For example, risk management for a food business would not likely focus on public policy, but instead would address “business strategies and practices that minimize the likelihood that a food product is rendered unsafe as a result of the business’ activity.”  Risk communication, at a business level, may focus on consumer information about the product and its safe handling, as well as public explanation and reassurance when a food safety problem has arisen.  Risk assessment at the firm level may focus on studying the firm's current production practices to determine whether they may lead to an unsafe food product.  Like the definitions presented above, risk assessment at the firm level likely has several components.  The firm also needs to assess the benefits and cost of various risk management practices. Thus the components of risk analysis introduced above may be appropriate for food businesses, but the concepts may have different meanings at the firm level.

The following statement seems to address risk management more at the firm level, rather than the policy level, but even this statement may require some revision to clearly state the application of risk management at the firm level.

“The goal of the risk management process is to establish the significance of the estimated risk, to compare the costs of reducing this risk to the benefits gained, to compare the estimated risks to the societal benefits derived from incurring the risk and to carry out the political and institutional process of reducing the risk.”  Excerpt from http://www.fao.org/docrep/w8088e/w8088e07.htm

 

My attempt at describing the application of risk analysis at the firm level.

  • Risk Analysis – the idea that risk of unsafe food will never be eliminated so businesses will focus on the hazards that pose the greatest risks, and strategies or practices that provide the greatest reduction in risk (i.e., benefit).
  • Risk Assessment – careful study of the firm's current production practices to determine whether the practices  may lead to an unsafe food product or a food-related health problem.
  • Hazard Identification – process of assessing risk of chemical, physical, biological or any other form of attack that may render food unsafe.
  • CARVER + Shock – process of assessing the risk of intentional attack on the food business
  • Risk Management – business strategies and practices that minimize the likelihood that a food product is rendered unsafe as a result of the business’ activity; some of these practices may be mandated; others may be adopted by the firm after a benefit/cost analysis.
  • Cost-Benefit analysis – a numeric analysis to identify hazards that pose the greatest risk of unsafe food and the business practices that result in the greatest reduction of the risk of producing an unsafe food or creating a food-related health problem.
    • The business practice that is used reduce the risk of unsafe food is the "cost" in a cost-benefit analysis; the value of reducing the risk is the "benefit." The food business would be expected to direct its limited resources to the business practices that produce the greatest value of reduced risk. Restated, the firm would direct its resources to the activities that offer the lowest cost-benefit ratio.
  • Risk Communication – may likely involve 1) consumer information (education) about the product and its safe handling, and 2) public explanation and reassurance when a problem arises. It may be better to refer to point 2 of risk communication as crisis communication.

 

Summary

It is too expensive to guarantee that all food is safe.  The alternative is to identify the risk of unsafe food, pursue management strategies to reduce the risk, and to discuss and interact to assure the food industry, food regulators and consumers appreciate (understand) the risks and strategies to reduce the risk of unsafe food.

The goal is to reduce the risk of unsafe food!!

 

 

Email David.Saxowsky@ndsu.edu

This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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