FAO-WHO Global Forum of Food Safety Regulators

Agenda Item 4.4 b GF 01/14

FAO/WHO Global Forum of Food Safety Regulators
Marrakesh, Morocco, 28-30 January 2002

Ensuring efficient communication and interaction between food safety risk assessors and risk managers

Discussion-Paper prepared by Germany
on the basis of the report of the WHO Expert Consultation
"The Interaction between Assessors and Managers of Microbiological Hazards in Food",
21-23 March 2000, Kiel, Germany

1. Introduction
2. Risk Analysis
3. Functional separation of risk assessment and risk management
4. Interaction between Risk Assessors and Risk Managers
5. Transparency
6. Recommendations

1. Introduction

The experts of the WHO Expert Consultation submitted the following principal comments:

Food Safety Authorities in Member Countries should structure their food safety system(s) on a risk-based approach that includes appropriate communication and interaction between risk assessors, risk managers, and stakeholders.

The functional separation of risk assessment and risk management is essential to the conduct of risk analysis activities.

Independence, transparency, and robustness of the scientific analyses and advice are essential determinants of their credibility. Nonetheless, effective dialogue among risk assessors, risk managers, and other stakeholders is essential to maximize the utility of the assessment findings and to ensure that both scientific and societal goals are met.

Concerning the interactions between risk managers and risk assessors, the terminology adopted or under discussion of the FAO/WHO Codex Alimentarius Commission is used. The same applies to the description of risk analysis.

2. Risk Analysis

Risk analysis is composed of three components, i.e. risk assessment, risk communication and risk management. The definitions for those three components are described in Codex terminology as follows:

Risk Assessment is defined in the Codex "Principles and Guidelines for the Conduct of Microbiological Risk Assessment" as a scientifically based process consisting of the following steps: i) hazard identification, ii) hazard characterization, iii) exposure assessment, and iv) risk characterization.

Risk communication is defined in the Codex as: the interactive exchange of information and opinions throughout the risk analysis process concerning risk-related factors and risk perceptions, among 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.

Risk management is defined in the Codex as: the process, distinct from risk assessment, of weighing policy alternative 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.

The following steps of the procedure are within the mandate of risk assessors and risk managers:

Risk assessors:

hazard identification,

hazard characterization,

assessment of the exposure,

risk characterization

risk communication with regard to the aforementioned tasks.

Risk managers:

identification of the problem,

definition of a risk profile,

goal description,

identification and definition of the tolerable risk,

risk communication with regard to the aforementioned tasks.

3. Functional separation of risk assessment and risk management

The draft Working Principles of Risk Analysis and the Principles and Guidelines for the Conduct of Microbiological Risk Assessment refer to the functional separation of Risk Assessment and Risk Management. Individual(s) who prepare the risk assessment should not normally be the same individual(s) who are responsible for the management of the risk. The tasks of risk assessment and risk management are best performed by different people or functional groups. However, it is recognized that in many countries an individual may act as both a risk manager and an assessor. In all cases it is paramount that the activities of the risk analysis process are transparent and appropriately documented. This applies to all interactions between risk assessors and risk managers, or to the separation of the activities by an individual.

Functional separation is essential for the conduct of risk analysis activities in order to maintain the scientific integrity of the risk assessment process and to avoid political pressures that would undermine the objectivity and the credibility of the conclusions. Separation of risk management and risk assessment helps to ensure that assessments are not biased by pre-conceived opinions related to management solutions. However, there is a need for frequent interaction between risk managers and risk assessors in order to arrive at effective risk management decisions. Active interaction is necessary to ensure that the assessment will meet the needs and answer the concerns of the risk manager. The assessors must understand the manager's questions and both parties must acknowledge any constraints, which may impact on the risk assessment. The strengths and limitations of the assessment must be properly communicated so that people using the risk assessments can properly understand the results. Interactions between assessors and managers do not end with the completion of the risk assessment. There will often be exchanges of information and input from assessors during subsequent risk management activities, for example, during the option assessment stage and in communication of results to interested parties.

The nature of the interaction between risk assessors and risk managers may differ according to the way national or international organizations are structured. For example, organizational as well as functional separation between risk managers and risk assessors is currently envisaged in the Codex system for microbiological food safety. Nevertheless, interaction and communication are essential for effective risk management, while maintaining the scientific integrity of risk assessment, and should include active steps such as open review.

There are constraints, and inefficiencies in the risk management procedures as carried out by the Codex Committee on Food Hygiene, and improved interaction between risk assessors and risk managers is needed. With this in mind, it is suggested that FAO and WHO give strong consideration on how experts in risk management procedures can feed into the work of the ad hoc FAO/WHO risk assessment consultations, while at all times clearly maintaining risk assessment and risk management as separate functions.

4. Interaction between Risk Assessors and Risk Managers

Risk assessment and risk management interactions may be subject to time constraints, especially in situations where a food safety problem requires rapid deployment of interim or emergency measures. Effective risk management in emergency situations depends on an urgent dialogue between assessors and managers. However, even in such situations managers should strive for open communications in order that the need for transparency is satisfied to the greatest possible extent.

The interaction between managers and assessors depends on the scope of the risk assessment. Often the risk assessment is designed to identify the stage in the food chain where interventions will most effectively reduce the public health burden attributable to the specific food and pathogen in question. A risk assessment may also be initiated to examine the cost effectiveness of current controls or to evaluate a new technology for control. In this case a list of options for consideration will be included in the scope. In an emergency situation with an emerging pathogen where the etiology of disease is not well understood the options comparison will be abbreviated.

5. Transparency

Transparency is a key objective of the risk analysis approach and its importance cannot be overemphasized. This is reflected in the Codex Statement of Principles relating to Food Safety Risk Assessment, the Codex Committee on Food Hygiene (CCFH) Guidelines for Microbiological Risk Assessment, and the CCFH draft Guidelines for Microbiological Risk Management. Transparency in risk assessment means that all assumptions, data, inferences, and conclusions are explicitly documented and made available for open review and discussion. Transparency in risk management means that the process is open and available for scrutiny by interested parties including stakeholders and consumers who may be affected by the outcome of the risk analysis and risk management activity.

6. Recommendations

The following recommendations of the Expert Consultation held in Kiel 2000 should be discussed:

Food Safety Authorities in Member Countries should structure their food safety system(s) on a risk-based approach that includes appropriate communication and interaction between risk assessors, risk managers, and stakeholders.

FAO and WHO should actively seek opportunities to promote collaborative international risk assessment and risk management activities among Member Countries.

FAO and WHO should encourage the implementation of relevant studies to obtain new and needed information required to support international risk assessment and risk management activities in the area of food safety. This may be best achieved through the FAO and/or WHO collaborative centres, and would involve establishing protocols, providing training, and design of appropriate sampling plans for investigating food-borne risks to human health.

FAO and WHO should emphasize that communication has to occur frequently and iteratively while striving to ensure scientific integrity and achieve freedom from bias in risk assessments.

FAO and WHO should invite the CCFH to take account of the output from this consultation in its work to develop "Principles and Guidelines for the Conduct of Microbiological Risk Management".

FAO and WHO should give strong consideration to how experts in risk management procedures can interact with risk assessors involved in the ad hoc FAO/WHO Consultation on Microbiological Risk Assessment. This interaction is particularly important when deciding on the scope of a particular risk assessment, developing risk assessment policy appropriate to that risk assessment, and ensuring the results of the risk assessment are of maximum utility for risk management.

FAO/WHO and national authorities should consider carefully the training needs of risk assessors and managers so that they are able to undertake the full range of their responsibilities efficiently and effectively.

FAO and WHO should facilitate discussions of the nature and value of food safety objectives especially in the microbiological field. In the light of the report of the Director General of the WHO (EB 105/10 para 10), WHO is requested to expedite consideration of this matter in coordination with FAO.

National governments should acknowledge the importance of functional separation between risk assessment and risk management while ensuring transparent and appropriate interaction between them.



Agenda Item 4.4 b	GF 01/14
FAO/WHO Global Forum of Food Safety Regulators Marrakesh, Morocco, 28-30 January 2002 Ensuring efficient communication and interaction between food safety risk assessors and risk managers Discussion-Paper prepared by Germany on the basis of the report of the WHO Expert Consultation "The Interaction between Assessors and Managers of Microbiological Hazards in Food", 21-23 March 2000, Kiel, Germany 1. Introduction 2. Risk Analysis 3. Functional separation of risk assessment and risk management 4. Interaction between Risk Assessors and Risk Managers 5. Transparency 6. Recommendations 1. Introduction The experts of the WHO Expert Consultation submitted the following principal comments: Food Safety Authorities in Member Countries should structure their food safety system(s) on a risk-based approach that includes appropriate communication and interaction between risk assessors, risk managers, and stakeholders. The functional separation of risk assessment and risk management is essential to the conduct of risk analysis activities. Independence, transparency, and robustness of the scientific analyses and advice are essential determinants of their credibility. Nonetheless, effective dialogue among risk assessors, risk managers, and other stakeholders is essential to maximize the utility of the assessment findings and to ensure that both scientific and societal goals are met. Concerning the interactions between risk managers and risk assessors, the terminology adopted or under discussion of the FAO/WHO Codex Alimentarius Commission is used. The same applies to the description of risk analysis. 2. Risk Analysis Risk analysis is composed of three components, i.e. risk assessment, risk communication and risk management. The definitions for those three components are described in Codex terminology as follows: Risk Assessment is defined in the Codex "Principles and Guidelines for the Conduct of Microbiological Risk Assessment" as a scientifically based process consisting of the following steps: i) hazard identification, ii) hazard characterization, iii) exposure assessment, and iv) risk characterization. Risk communication is defined in the Codex as: the interactive exchange of information and opinions throughout the risk analysis process concerning risk-related factors and risk perceptions, among 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. Risk management is defined in the Codex as: the process, distinct from risk assessment, of weighing policy alternative 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. The following steps of the procedure are within the mandate of risk assessors and risk managers: Risk assessors: hazard identification, hazard characterization, assessment of the exposure, risk characterization risk communication with regard to the aforementioned tasks. Risk managers: identification of the problem, definition of a risk profile, goal description, identification and definition of the tolerable risk, risk communication with regard to the aforementioned tasks. 3. Functional separation of risk assessment and risk management The draft Working Principles of Risk Analysis and the Principles and Guidelines for the Conduct of Microbiological Risk Assessment refer to the functional separation of Risk Assessment and Risk Management. Individual(s) who prepare the risk assessment should not normally be the same individual(s) who are responsible for the management of the risk. The tasks of risk assessment and risk management are best performed by different people or functional groups. However, it is recognized that in many countries an individual may act as both a risk manager and an assessor. In all cases it is paramount that the activities of the risk analysis process are transparent and appropriately documented. This applies to all interactions between risk assessors and risk managers, or to the separation of the activities by an individual. Functional separation is essential for the conduct of risk analysis activities in order to maintain the scientific integrity of the risk assessment process and to avoid political pressures that would undermine the objectivity and the credibility of the conclusions. Separation of risk management and risk assessment helps to ensure that assessments are not biased by pre-conceived opinions related to management solutions. However, there is a need for frequent interaction between risk managers and risk assessors in order to arrive at effective risk management decisions. Active interaction is necessary to ensure that the assessment will meet the needs and answer the concerns of the risk manager. The assessors must understand the manager's questions and both parties must acknowledge any constraints, which may impact on the risk assessment. The strengths and limitations of the assessment must be properly communicated so that people using the risk assessments can properly understand the results. Interactions between assessors and managers do not end with the completion of the risk assessment. There will often be exchanges of information and input from assessors during subsequent risk management activities, for example, during the option assessment stage and in communication of results to interested parties. The nature of the interaction between risk assessors and risk managers may differ according to the way national or international organizations are structured. For example, organizational as well as functional separation between risk managers and risk assessors is currently envisaged in the Codex system for microbiological food safety. Nevertheless, interaction and communication are essential for effective risk management, while maintaining the scientific integrity of risk assessment, and should include active steps such as open review. There are constraints, and inefficiencies in the risk management procedures as carried out by the Codex Committee on Food Hygiene, and improved interaction between risk assessors and risk managers is needed. With this in mind, it is suggested that FAO and WHO give strong consideration on how experts in risk management procedures can feed into the work of the ad hoc FAO/WHO risk assessment consultations, while at all times clearly maintaining risk assessment and risk management as separate functions. 4. Interaction between Risk Assessors and Risk Managers Risk assessment and risk management interactions may be subject to time constraints, especially in situations where a food safety problem requires rapid deployment of interim or emergency measures. Effective risk management in emergency situations depends on an urgent dialogue between assessors and managers. However, even in such situations managers should strive for open communications in order that the need for transparency is satisfied to the greatest possible extent. The interaction between managers and assessors depends on the scope of the risk assessment. Often the risk assessment is designed to identify the stage in the food chain where interventions will most effectively reduce the public health burden attributable to the specific food and pathogen in question. A risk assessment may also be initiated to examine the cost effectiveness of current controls or to evaluate a new technology for control. In this case a list of options for consideration will be included in the scope. In an emergency situation with an emerging pathogen where the etiology of disease is not well understood the options comparison will be abbreviated. 5. Transparency Transparency is a key objective of the risk analysis approach and its importance cannot be overemphasized. This is reflected in the Codex Statement of Principles relating to Food Safety Risk Assessment, the Codex Committee on Food Hygiene (CCFH) Guidelines for Microbiological Risk Assessment, and the CCFH draft Guidelines for Microbiological Risk Management. Transparency in risk assessment means that all assumptions, data, inferences, and conclusions are explicitly documented and made available for open review and discussion. Transparency in risk management means that the process is open and available for scrutiny by interested parties including stakeholders and consumers who may be affected by the outcome of the risk analysis and risk management activity. 6. Recommendations The following recommendations of the Expert Consultation held in Kiel 2000 should be discussed: Food Safety Authorities in Member Countries should structure their food safety system(s) on a risk-based approach that includes appropriate communication and interaction between risk assessors, risk managers, and stakeholders. FAO and WHO should actively seek opportunities to promote collaborative international risk assessment and risk management activities among Member Countries. FAO and WHO should encourage the implementation of relevant studies to obtain new and needed information required to support international risk assessment and risk management activities in the area of food safety. This may be best achieved through the FAO and/or WHO collaborative centres, and would involve establishing protocols, providing training, and design of appropriate sampling plans for investigating food-borne risks to human health. FAO and WHO should emphasize that communication has to occur frequently and iteratively while striving to ensure scientific integrity and achieve freedom from bias in risk assessments. FAO and WHO should invite the CCFH to take account of the output from this consultation in its work to develop "Principles and Guidelines for the Conduct of Microbiological Risk Management". FAO and WHO should give strong consideration to how experts in risk management procedures can interact with risk assessors involved in the ad hoc FAO/WHO Consultation on Microbiological Risk Assessment. This interaction is particularly important when deciding on the scope of a particular risk assessment, developing risk assessment policy appropriate to that risk assessment, and ensuring the results of the risk assessment are of maximum utility for risk management. FAO/WHO and national authorities should consider carefully the training needs of risk assessors and managers so that they are able to undertake the full range of their responsibilities efficiently and effectively. FAO and WHO should facilitate discussions of the nature and value of food safety objectives especially in the microbiological field. In the light of the report of the Director General of the WHO (EB 105/10 para 10), WHO is requested to expedite consideration of this matter in coordination with FAO. National governments should acknowledge the importance of functional separation between risk assessment and risk management while ensuring transparent and appropriate interaction between them.