L6 Risk Management in Food Safety 2024 PDF

Lecture 6 Risk Management in Food Safety FNSC5430/LSCI6843 Food Toxicology and Safety Gordon Cheung B.Sc.(Hons.), Pg.D. Diet., M.Phil., Cert. Chi. Med., R.D.(UK)  Content Introduction of Food Safety Risk Analysis Framew...

Lecture 6 Risk Management in Food Safety FNSC5430/LSCI6843 Food Toxicology and Safety Gordon Cheung B.Sc.(Hons.), Pg.D. Diet., M.Phil., Cert. Chi. Med., R.D.(UK)  Content Introduction of Food Safety Risk Analysis Framework Risk Assessment Risk Management Introduction and General Principles General Frameworks Risk Communication Risk Analysis Framework Risk Risk Assessment Managment Science based Policy based Risk Communication Interactive exchange of information and opinions concerning tasks  Risk Analysis Risk analysis is used To develop an estimate of the risks to human health and safety To identify and implement appropriate measures to control the risks To communicate with stakeholders about the risks and measures applied It can be used to support and improve the development of standards, as well as to address food safety issues that result from emerging hazards or breakdowns in food control systems.  Risk Analysis ⚫ It provides food safety regulators with the information and evidence they need for ⚫ effective decision-making ⚫ contributing to better food safety outcomes ⚫ improvements in public health. ⚫ Regardless of the institutional context, the discipline of risk analysis offers a tool that all food safety authorities can use to make significant gains in food safety  Risk Analysis Risk analysis represents a structured decision-making process with three distinct but closely connected components: risk management risk assessment risk communication  Risk Analysis The three components are essential, complementary parts of the overall discipline in reality they are highly integrated In the course of a typical food safety risk analysis, almost constant interactions occur between risk managers and risk assessors within an environment characterized by risk communication. Risk analysis is most effective when all three components are successfully integrated by the risk managers directing the process.  The Three Main Components of Risk Analysis Defined by Codex Risk assessment: A scientifically based process consisting of the following steps: i) hazard identification; ii) hazard characterization; iii) exposure assessment; and iv) risk characterization. Risk management: 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  The Three Main Components of Risk Analysis Defined by Codex Risk communication: The interactive exchange of information and opinions throughout the risk analysis process concerning risk, 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.  Components of Risk Analysis ◼ Risk assessment is considered to be the “science-based” component of risk analysis, ◼ Risk management is the component in which scientific information and other factors, such as economic, social, cultural and ethical considerations, are integrated and weighed in choosing the preferred risk management options. ◼ In fact, risk assessment may also involve judgments and choices that are not entirely scientific, and risk managers need a sound understanding of scientific approaches used by risk assessors. ◼ The interactions and overlaps of science and nonscientific values at various stages in risk analysis will be explored in more detail in subsequent chapters concerned with risk management and risk assessment.  Carrying out Risk Analysis ◼ It normally begins with a risk management step, to define the problem, articulate the goals of the risk analysis and identify questions to be answered by the risk assessment, if and when one is required. ◼ The science-based tasks of “measuring” and “describing” the nature of the risk being analysed are performed during the risk assessment phase. ◼ Risk management and risk assessment are performed within an open and transparent environment involving extensive communication and dialogue, in which a variety of interested parties may participate at appropriate points ◼ The risk analysis process often culminates with the implementation of risk-reducing measures and continuous monitoring of their effectiveness by government, the private sector and other stakeholders. Risk Assessment  Risk Assessment A scientifically based process which consists of 4 steps: 1. Hazard Identification 2. Hazard Characterization 3. Exposure Assessment 4. Risk Characterization  Risk Assessment Framework Hazard Identification Is there a problem? What is the evidence? Hazard Characterization Identify & describe the chemical/microorganism s of concern in food and Exposure Assessment their adverse effects Risk Characterization 15  1. Hazard Identification - Chemical RA  Sources of information  Info Acquired in Hazard Identification ◦ Merck index ◦ dose-response relationship, ◦ Journals ◦ threshold, ◦ Internet ◦ route of exposure ◦ Regulatory agencies ◦ Expert Reports (IARC, JECFA)  Hazard Identification - MRA Toxicological/microbiological, clinical, and epidemiological studies Surveillance data Previous risk evaluations and assessments Epidemiological information such as outbreak investigations 17  Risk Assessment Framework Hazard Identification How much chemical will cause adverse health effects? / how many Hazard Characterization pathogens will make you sick? How severe is the adverse Exposure Assessment health effects / how sick will you be? Describe the severity and Risk Characterization duration of adverse effects 18  Process of Hazard Characterization Process initiation Data collection and evaluation (L/M detection, L/M count) Descriptive characterization Dose-response models Review Presentation of results 19  Hazard Characterization Important factors in relation to the host: Genetic Factors Individuals host susceptibility characteristics, e.g. age, pregnancy Population characteristics, e.g. population immunity, access to medical care, persistence of the organism in the population 20  Risk Assessment Framework Hazard Identification How much chemical would population exposed? / what Hazard Characterization is the probability of consuming a contaminated food? Exposure Assessment What are the likely numbers of a pathogen in the food at the time of consumption? Risk Characterization Assessment on the extent of actual or anticipated human exposure 21  3. Dietary Exposure Assessments  A dietary exposure assessment involves comparing the estimated exposure to a food chemical to a reference health standard in order to assess the risk to health of a population ◦ Simple concept ◦ Complex techniques ◦ Outcome depends on quality of data and assumption  Dietary modeling Dietary modeling is the process of combining food consumption data and food chemical data to estimate dietary exposure to food chemicals Food Dietary Food = x Chemical Exposure* Consumption Level  Risk Assessment Framework Hazard Identification Hazard Characterization Exposure Assessment Integration of the Risk Characterization previous 3 steps to obtain a risk estimate 24  Risk Characterization Risk Description – Event Risk Characterization – Evaluation of the health consequences of exposure Risk Estimate – Probability and magnitude 25  Risk Characterization Risk Description Description of the adverse health effect (illness) Risk Estimate (Level of risk) Description of the likelihood and severity of an adverse effect, through consumption of food (containing the hazard) by a specified population 26  Risk Ranking ▪ Based on a matrix which considers severity of adverse effects against likelihood of adverse effects Likelihood Low Medium High Moderate Low Low Medium Severity Serious Low Medium High Severe Medium High High 27 Risk Management  Introduction to Risk Management In the context of Risk Analysis When a food safety problem or issue is identified. Risk managers initiate a risk management process, which they then see through to completion. RM is best accomplished within a systematic, consistent and readily-understood framework Select and Implement Appropriate Control Measures requires: Scientific knowledge on risk and evaluations of other factors relevant to public health protection. The responsibilities of risk managers during this process also include –Commissioning a risk assessment when one is needed –Making sure that risk communication occurs wherever necessary.  General Principles Principle 1: Risk management should follow a structured approach The elements of a structured approach to risk management Risk Evaluation Risk Management Option Assessment Implementation of Management Decision Monitoring and Review In certain circumstances, not all of these elements will be included in risk management activities (e.g. standard setting by Codex, with implementation of control measures by national governments)  General Principles Principle 2: Protection of human health should be the primary consideration in risk management decisions Decisions on acceptable levels of risk should be determined primarily by human health considerations, and arbitrary or unjustified differences in the risk levels should be avoided. Consideration of other factors may be appropriate in some risk management contexts, particularly in the determination of measures to be taken economic costs Benefits technical feasibility societal preferences These considerations should not be arbitrary and should be made explicit.  General Principles Principle 3: Risk management decisions and practices should be transparent Risk management should include the identification and systematic documentation of all elements of the risk management process including decision-making, so that the rationale is transparent to all interested parties.  General Principles Principle 4: Determination of risk assessment policy should be included as a specific component of risk management Risk assessment policy sets the guidelines for value judgements and policy choices may need to be applied at specific decision points in the risk assessment process preferably should be determined in advance of risk assessment, in collaboration with risk assessors  General Principles Principle 5: Risk management should ensure the scientific integrity of the risk assessment process by maintaining the functional separation of risk management and risk assessment Functional separation of risk management and risk assessment serves to ensure the scientific integrity of the risk assessment process and reduce any conflict of interest between risk assessment and risk management However, it is recognised that risk analysis is an iterative process, and interactions between risk managers and risk assessors are essential for practical application  General Principles Principle 6: Risk management decisions should take into account the uncertainty in the output of the risk assessment The risk estimate should, wherever possible, include a numerical expression of uncertainty, and this must be conveyed to risk managers in a readily understandable form so that the full implications of the range of uncertainty can be included in decision-making. If the risk estimate is highly uncertain the risk management decision might be more conservative.  General Principles Principle 7: Risk management should include clear, interactive communication with consumers and other interested parties in all aspects of the process On-going reciprocal communication among all interested parties is an integral part of the risk management process. Risk communication is more than the dissemination of information, and a major function is the process by which information and opinion essential to effective risk management is incorporated into the decision  General Principles Principle 8: Risk management should be a continuing process that takes into account all newly generated data in the evaluation and review of risk management decisions Subsequent to the application of a risk management decision, periodic evaluation of the decision should be made to determine its effectiveness in meeting food safety objectives Monitoring and other activities will likely be necessary to carry out the review effectively  General Framework of Risk Management  Elements of Risk Management A. Preliminary RM Activities (Risk evaluation) · Identification of a food safety problem. · Establishment of a risk profile. · Ranking of the hazard for risk assessment and risk management priority. · Establishment of risk assessment policy for conduct of risk assessment. · Commissioning of risk assessment. · Consideration of risk assessment result.  Elements of Risk Management B. Risk management option assessment · Identification of available management options. · Selection of preferred management option, including consideration of an appropriate safety standard.* · Final management decision. C. Implementation of management decision D. Monitoring and review · Assessment of effectiveness of measures taken. · Review risk management and/or assessment as necessary.  Key Considerations of Reaching Risk Management Options Safety Standard refers to the level of acceptable risk, which is adopted by risk managers or is implicit in the chosen risk management option. Options of Safety Standards  “zero-risk” standards (such as are usually implicit in de minimis and ADI levels)  “threshold” standards (where a non-zero level of risk is stipulated as acceptable)  “balancing” standards (such as cost-benefit, cost effectiveness, and ALARA i.e. As Low As Reasonably Achievable)  “procedural” standards (where the acceptable risk level is determined by an agreed process, such as a negotiation or referendum)  Key Considerations of Reaching Risk Management Options Evaluation of available risk management options in order to reach a decision on management of the risk. ✓ Primary Consideration: Human health protection ✓ Other Consideration: ◦ Economic costs / benefits, ◦ Technical Feasibility, ◦ Risk Perceptions, etc.  Other Considerations of Reaching Risk Management Options—Consultative Process Involvement and Transparency: It is important that all interested parties/stakeholders who are likely to be affected by risk management decisions have an opportunity for input into the risk management process. Example of these groups ◦ consumer organizations, ◦ representatives of the food industry and trade, ◦ education and research institutions, ◦ and regulatory bodies ◦ any other interest groups Consultation process at all stages of Risk Management Policy Formulation: public meetings opportunities to comment on public documents.  How Safe is Enough If abating the risk costs nothing, obviously we want to get rid of the risk But risk abatement almost always does cost money and time When it is impossible to eliminate the risk completely with finite resources and time “How much risk abatement should we buy?”  How Safe is Enough Most common criteria to decide how much risk abatement to buy Acceptable risk Implies a threhold level below which risk will be tolerated Optimal risk Implies a trade-off that minimizes the sum of all undesirable consequence  Reduce Food Safety Risks For high risk food safety issues Especially those will impose significant adverse health impact Should adopt acceptable risk approach For relatively low risk issues May consider using optimal risk approach  Optimal risk For optimal risk approach Consider impact of new regulation Food cost Food availability / variety Economic activities Technical barrier to trade Closure of small business Public health status National medical expenses Productivity  Optimal Level of Risk Cost Total cost Cost of risk abatement Expected losses from risk Level of risk Optimal level of risk  Acceptable risk Adopt scientific approach to evaluate the specific food safety risk Food safety risk assessment It involves steps to study the hazards, possible health impact and population exposure to the risk The findings from the food safety risk assessment help the regulatory bodies to Set up new food laws Formulate public education  Implementation—Review Implementation of the management decision Monitor the actions for The effectiveness of the control measure its impact on the risk, and therefore the effect on the exposed consumer population, to ensure that the food safety objective is being met. Risk Communication  Risk Communication Effective communication of information and opinion on risks associated with real or perceived hazards in food is an essential and integral component of the risk analysis process Risk communication may originate from official sources at international, national or local levels The fundamental goals To provide meaningful, relevant and accurate information, in clear and understandable terms targeted to a specific audience To facilitate a higher degree of consensus and support by all interested parties for the proposed risk management option(s)  Risk Communication It may also be from other sources such as industry, trade, consumers and other interested parties Government agencies Industry representatives The media Scientists Professional societies Consumer organizations Other public interest groups and concerned individuals