|Agenda Item 4.4 b||GF 01/14|
FAO/WHO Global Forum of Food Safety Regulators
Ensuring efficient communication and interaction between food safety risk assessors and risk managers
Discussion-Paper prepared by Germany
The experts of the WHO Expert Consultation submitted the following principal comments:
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.
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:
The following steps of the procedure are within the mandate of risk assessors and risk managers:
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.
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.
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.
The following recommendations of the Expert Consultation held in Kiel 2000 should be discussed: