Microbiological risk management: Principles, process and preliminary activities PDF

Microbiological Risk Management: Principles, process and preliminary activities Chantal ABOU JAOUDEH – REEF (Ph.D) Dr. Ch AJ RIF 1  Purpose of Lectu...

Microbiological Risk Management: Principles, process and preliminary activities Chantal ABOU JAOUDEH – REEF (Ph.D) Dr. Ch AJ RIF 1  Purpose of Lecture Explain the concept of MRM Explain MRM principles Introduce concept of food safety as a public health goal Describe MRM process and how MRA fits into it Describe preliminary MRM activities Dr. Ch AJ RIF 2  Risk Analysis Framework – Codex Risk Assessment Risk Management Examining the Defining and science implementing the policies Risk Communication The exchange of information Dr. Ch AJ RIF 3  Risk Analysis Framework – Codex 1. Preliminary risk management activities Risk 2. Options 4. Monitoring and review Management identification, evaluation & Framework selection 3. Implementation Dr. Ch AJ RIF 4  Risk Management Framework – Codex Dr. Ch AJ RIF 5  Risk Management: Definition 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 Codex Alimentarius Dr. Ch AJ RIF 6  Some food safety issue Dr. Ch AJ RIF 7  Fitting MRA in the MRM structure Preliminary MRM activities (chap 7) MRA Identification and selection of MRM options Implementation of MRM options Monitoring and review Dr. Ch AJ RIF 8  The 8 MRM principles (abbreviated) 1. Protection of human health 2. The whole food-chain 3. Structured process 4. Transparent, consistent, documented 5. Consultation with interested parties 6. Interaction with risk assessors 7. Regional differences 8. Monitoring and review Codex Alimentarius, MRM document (based on) Dr. Ch AJ RIF 9  MRM principles 1 & 2 1. Protection of human health is the primary objective in MRM 2. MRM should take into account the whole food- chain Dr. Ch AJ RIF 10  MRM principle 3 3. MRM should follow a structured approach: ▪ Preliminary MRM activities ▪ Identification, evaluation and selection of MRM options ▪ Implementation of MRM decisions ▪ Monitoring and review of MRM decisions Topic 2 - Microbiological Risk Management: Dr. Ch AJ RIF Principles, process and preliminary activities 11  MRM principle 4, 5 & 6 4. MRM should be transparent, consistent and fully documented 5. Risk managers should ensure effective consultation with relevant interested parties 6. Risk managers should ensure effective interaction with risk assessors Dr. Ch AJ RIF 12  MRM principle 7 & 8 7. Risk managers should take account of risks resulting from regional differences in hazards in the food-chain and regional differences in available risk management options 8. MRM decisions should be subject to review and revision Dr. Ch AJ RIF 13  MRM process Risk manager with identified issue Risk management can Risk profile be complex It can follow many pathways Decision on how to proceed It requires many decisions to be taken Perform risk assessment No risk assessment A structured approach needs to be taken Consider results This facilitates interaction with risk assessors and Select management use of MRA outcomes options Final management decisions Dr. Ch AJ RIF 14  Risk manager’s responsibilities (1) Drive the risk analysis process Set public health goals and priorities Determine whether a risk assessment is required Establish the risk assessment profile Establish the risk assessment policy Dr. Ch AJ RIF 15  Risk manager’s responsibilities (2) Select the most effective control options, based on scientific advice and/or MRA Seek the views of stakeholders (social values, perception, feasibility, costs etc.) with regard to the various options Decide and communicate control measures Dr. Ch AJ RIF 16  Public health goals for food safety “Zero" incidence of food-borne illness is an ideal public health goal Realistically, it is not possible to achieve this Therefore, there is a need to set public health goals for food safety considered to be appropriate / acceptable / tolerable Appropriate level of protection (ALOP) is an expression of the current public health status Dr. Ch AJ RIF 17  ALOP in the SPS context ALOP is defined in the WTO/SPS Agreement as: “The level of protection deemed appropriate by the member [country] establishing a sanitary or phytosanitary measure to protect human, animal or plant life or health within a territory Note: Many members otherwise refer to this concept as the ‘acceptable level of risk’” SPS Agreement Dr. Ch AJ RIF 18  Appropriate level of protection (ALOP) One interpretation: An expression of the achieved, health status of a country’s population regarding a pathogen or pathogen/food combination Dr. Ch AJ RIF 19  Expressions of ALOP Reflect the current public health status or current level of risk in a country It is something that is currently being achieved Not a future target Example: The yearly incidence of food-borne listeriosis should not exceed 2.5 cases per 1 000 000 of population, and of these not more than 0.5 cases may be caused by smoked fish Dr. Ch AJ RIF 20  Different expressions of Public Health Goals Country examples: United States of America Reduce infections caused by key food-borne pathogens, e.g. Campylobacter species, from 24.6 cases per 100 000 (baseline 1987) to 12.3 (in 2010) Reduce number of outbreaks per year caused by Salmonella serotype Enteritidis from 44 (baseline 1987) to 22 (in 2010) United Kingdom Reduce the incidence of food-borne disease by 20% by April 2006 (from situation in 2000) Dr. Ch AJ RIF 21  Microbiological risk management (MRM) components 1. Preliminary risk management activities Risk 2. Options 4. Monitoring and review Management identification, evaluation & Framework selection 3. Implementation Dr. Ch AJ RIF 22  1. Preliminary MRM activities Identify problem Elaborate risk profile Consideration of risk profile and decision on next steps Formulate risk assessment policy, scope and purpose of the MRA and range of products Risk manager: person or organization responsible for MRM Dr. Ch AJ RIF 23  Identidying a food safety issue Dr. Ch AJ RIF 24  Risk profile A description of the food safety problem and its context, the current state of knowledge, and potential control options ▪ Purpose: to enable decision on what is to be done next, i.e. is a risk assessment possible? feasible? required? ▪ Responsibility of the risk managers, but can involve communication with scientists and other interested parties Dr. Ch AJ RIF 25  Risk profile elements Pathogen/food combination of concern Description of the public health problem Food production, processing, distribution and consumption characteristics Other risk profile elements (e.g. consumer perception, economic issues) Risk assessment needs and questions for the risk assessors Available information and major knowledge gaps Identification of existing and potential control measures Dr. Ch AJ RIF 26  Risk profile Dr. Ch AJ RIF 27  Evaluating result of risk profile Establish risk management goals Implement control measures when risk profile contains adequate information Implement interim control measures if problem is a serious public health concern Commission a risk assessment to improve or support interim measures or provide more information on more complex issues Do nothing, e.g. if information indicates there is NO public health concern Dr. Ch AJ RIF 28  Deciding whether a risk assessment is needed Dr. Ch AJ RIF 29  Risk management goals Desired reduction in the current level of risk within a given period of time An MRA can then be used to examine potential risk management options that could be used to achieve that goal Goals may influence the nature of questions posed to risk assessors Dr. Ch AJ RIF 30  Risk management goals Dr. Ch AJ RIF 31  Risk assessment policy If a risk assessment is needed, a risk assessment policy should be established: ▪ It includes guidelines for scientific judgements and policy choices applied at appropriate decision points during the risk assessment process ▪ Guidelines should be elaborated by risk managers in consultation with all interested parties and applied by risk assessors Codex, 1998 Dr. Ch AJ RIF 32  Example of MRA policy Including considerations relevant to developing countries Key scientific judgements when high degree of uncertainty in existing data or data gaps exists Risk estimate for the most susceptible population or defined subpopulation Sources of data to be considered Dr. Ch AJ RIF 33  Reasons for undertaking MRA Assist managers to make decisions on the appropriate measures to protect consumer health Compare management interventions Improve existing food control systems Take measures based on sound science Comply with international standards, regulations Assure safe food for international trade and maintenance of market access Dr. Ch AJ RIF 34  Commissioning of the MRA Assemble MRA team Give clear mandate Define roles and responsibilities of team members Document how outcomes should be formatted and used Set criteria for assessing whether the risk assessment is reasonable and adequate Appoint coordinator / project manager and risk communicator Dr. Ch AJ RIF 35  Interaction with managers during conduct of MRA Helps to ensure important issues are addressed Provides opportunity to refocus and refine risk management questions and MRA if needed Enhances understanding of MRA amongst all parties Dr. Ch AJ RIF 36  Outcomes of MRA Outcomes include: 1. Risk of illness by consumption of specific product/pathogen combination 2. Estimated number of illnesses (e.g. per year in a country) due to consumption of specific food-hazard combination 3. Risk estimates for different processing, distribution and consumer-use scenarios 4. Efficiency of control measures Dr. Ch AJ RIF 37  2. Identification, evaluation and selection of MRM options* 1. Identification of available MRM options 2. Selection of preferred option(s) or combinations thereof 3. Decision-making * Previously referred to as “evaluation of risk management options” Dr. Ch AJ RIF 38  Risk management options ▪ Enforcement of existing control measures ▪ Code of practice ▪ Food safety objectives / performance objectives ▪ Microbiological criteria ▪ Labelling ▪ Public inspection, certification and approval ▪ Import certification ▪ New technology ▪ Temperature/time control ▪ Education of consumers or subgroups Dr. Ch AJ RIF 39  3. MRM option implementation Some control measures are executed by regulators, many are in the hands of industry along the food-chain The safety of food is the responsibility of risk managers (i.e. government) and food safety managers (i.e. industry), but consumers also have a role to play according to the Codex Alimentarius Dr. Ch AJ RIF 40  4. Monitoring and review Assessment of effectiveness of measures taken Review risk management and / or assessment as necessary (new option, new information) Dr. Ch AJ RIF 41  Key points MRM is a structured process with well-defined principles Setting a public health goal is an important aspect of MRM MRA is a science-based process that supports decision-making Precise briefing of risk assessors and continuing communication between managers and assessors is a key element of MRM Dr. Ch AJ RIF 42  Questions / Clarifications Dr. Ch AJ RIF 43  Food risk and assessment (NTR 642) Chantal ABOU JAOUDEH – RIF (Ph.D) Dr. Ch AJ RIF 1  OVERVIEW Libnor was established by a law dated 23/7/1962 as a Public Institution attached to the Ministry of Industry Decree no 4517 dated 13/12/1972 Decree no 9444 “Establishment and Operation of Public Defining the structure and Institutions in the Lebanese organization of LIBNOR. Republic” where the relation Roles and Responsibilities between LIBNOR and the Tutelage authority is defined Dr. Ch AJ RIF 2  LIBNOR’s Main Missions Issuing, publishing, and amending National Standards for all products and services Granting the Lebanese Conformity Mark (NL Mark) – Voluntary scheme Representing Lebanon Internationally in the field of standardization Delivering Trainings for the public and private sectors. Operating an Information Center and WTO/TBT Enquiry Point Dr. Ch AJ RIF 3  STANDARDIZATION Definitions 1. Technical regulation Document which lays down product characteristics or their related processes and production methods, with which compliance is mandatory 2. Standard Document approved by a recognized body that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is voluntary Dr. Ch AJ RIF 4  STANDARDIZATION Lebanese national standards are VOLUNTARY. However; For reasons of public safety, public health, and/or national interest, and upon approval by LIBNOR’s Board of Directors A standard may be given a MANDATORY Status by a decree upon the proposal of the Minister of Industry Dr. Ch AJ RIF 5  TECHNICAL COMMITTEES Technical Committee Members: Experts from: Ministries Manufacturers Importers Laboratories Universities LIBNOR Others Dr. Ch AJ RIF 6  STANDARDS SECTORS Sector Number of standards Chemical 158 Construction 850 More than 3000 Lebanese Standards Domestic equipments 25 Published Electrical 414 Rubber and plastic 30 Paper technology 17 More than 75% of Lebanese standards Food Technology 600 are harmonized with European and Mechanical 145 International Standards Petroleum 60 Health care technology 87 Textile 15 Other (packaging/ energy/ 117 management etc…) Dr. Ch AJ RIF 7  STANDARD’S TYPES Dr. Ch AJ RIF 8  STANDARDIZATION PROCESS Establish Committee Prepare Discuss Agree on Draft Draft Draft Receive Finalize Approve comments Draft Draft Announce Publish Issue of and sell Standard Lebanese Standards Technical Committees Dr. Ch AJ RIF 9  IMPORTANCE OF FOOD STANDARDS Industry Regulators Consumers Standards ensure the Standards make Industry safety and quality of more competitive and products to protect promote global trade. Regulators can rely on Consumers worldwide. trusted internationally They disseminate best harmonized solutions, They address issues of practice and innovations which are continually concern to consumers so that industry does not reviewed and improved, such as nutritional value, need to reinvent the as a technical basis for labeling and declaration, wheel, while at the same regulations that meet the taste, hygiene, genetically time facilitating market expectations of citizens modified organisms, access to the latest limits on additives, technologies pesticides, contaminants, and so on. Dr. Ch AJ RIF Ch AJ RIF 10 10  STANDARDS FROM FARM TO FORK RETAIL FARM CONSUMERS Fertilizers Pesticides DISTRIBUTION Labeling GAP PROCESSING - STORAGE Nutrition Food Claims additives Packaging Processing ------- Hygiene Transportation ------ Storage Refrigeration ------ Dr. Ch AJ RIF Ch AJ RIF 11 11  SYLLABUS Dr. Ch AJ RIF 12  Purpose of lecture Risk analysis in context: Problem of food borne illness Food trade in the context of WTO Food control and food safety – role of government, industry, consumer Present the concept of risk analysis Introduce the components: Microbiological risk management Microbiological risk assessment Risk communication Dr. Ch AJ RIF 13  DEFINITIONS Acceptable daily intake (ADI): The estimate of the amount of a substance in food or drinking-water, expressed on a body weight basis, which can be ingested daily over a life-time without appreciable health risk to the consumer. The ADI is expressed in milligrams of the chemical per kilogram of body weight (a standard adult person weighs 60 kg). Acceptable/Tolerable risk: The level of risk that is agreed to be borne after risk management is applied Exposure assessment: The qualitative and/or quantitative evaluation of the magnitude, frequency and duration of exposure to biological, chemical, and physical agents via food as well as exposures from other sources if relevant. It is the third step in the risk assessment process. Dr. Ch AJ RIF 14  DEFINITIONS Food additive : Any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, the intentional addition of which to food is for a technological purpose. Good agricultural practice (GAP) : Good Agricultural Practices (GAP), as defined by FAO, are a “collection of principles to apply for on-farm production and postproduction processes, resulting in safe and healthy food and non-food agriculture products, while taking into account economic, social and environmental sustainability”. Good manufacturing practice (GMP): is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Dr. Ch AJ RIF 15  DEFINITIONS Hazard : chemical (including nutrient), microbiological or physical agent in food with the potential to cause an adverse health effect. Hazard assessment: The combined hazard identification and hazard characterization steps of the risk assessment process. Hazard characterization: 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. It includes a dose-response assessment. It is the second stage of the hazard assessment process, and the second step in the risk assessment process. Hazard identification: A process used to clearly describe the biological, chemical or physical hazard being assessed and to identify the type and nature of the adverse effects that could occur as a result of exposure to the agent. It is the first stage of the hazard assessment process, and the first step in the risk assessment process. Dr. Ch AJ RIF 16  DEFINITIONS Maximum residue limit (MRL): The maximum level of a residue of a chemical which is permitted to be present in a food. Risk : The likelihood and severity of an adverse effect from exposure to a hazard. Risk analysis : A structured process to identify, assess, communicate and manage risks consisting of three inter-related components: risk assessment, risk management and risk communication. Dr. Ch AJ RIF 17 Dr. Ch AJ RIF 18  DEFINITIONS Risk assessment: A process of identifying, analyzing and characterizing risk consisting of four steps: hazard identification, hazard characterization, exposure assessment and risk characterization. Risk characterization: The qualitative and/or quantitative estimation, including attendant uncertainties, of the likelihood of occurrence and severity of known or potential adverse health effects in a given population. It is the fourth step in the risk assessment process and integrates information from the hazard and exposure assessments. Risk communication: Interactive exchange of information about risk between risk assessors and risk managers, news media, interested groups and the general public. Risk management: A consultative and decision-making process that identifies the problem; considers the risk assessment, social, economic and other factors; and develops, weighs and selects the option of greatest net benefit to the community. The process may also evaluate the implemented decision. Dr. Ch AJ RIF 19  Food-borne illnesses, a major public health problem Worldwide, an estimated 2.2 million children < 5 years die annually of diarrhoeal diseases (WHO) A large proportion of these diseases originate from contaminated food and drinking water Up to 30% of people in industrialized countries are estimated to suffer from food- borne illness each year (WHO) Everyone is at risk from food-borne illness Dr. Ch AJ RIF 20  Some examples of outbreaks Causal agent Year Food item Country of People ill origin S. Enteritidis 1994 Ice-cream USA 224 000 * V. cholerae 1994 Street food El Salvador 541 E. coli O157 1996 Sprouts Japan > 10 000 C. botulinum 1996 Mascarpone Italy 8 Cyclospora 1996 Raspberries USA/Canada 1 465 Staph. aureus 1996 Cooked meat Germany 21 Y. pseudotuberculosis 1998 Iceberg lettuce Finland 47 C. botulinum 1998 Fermented bamboo shoot Thailand 11 V. parahaemolyticus 1999 Raw oysters Spain 64 L. monocytogenes 2002 Turkey deli meat USA 43 B. cereus 2002 Rice Australia 37 S. Typhimurium 2002 Caesar salad Australia 78 S. Bareilly 2003 Egg and mayonnaise UK 186 S. Enteritidis 2004 Almonds USA 7 C. botulinum 2006 Canned Bamboo Thailand 163 S Montevideo 2006 Chocolate UK 53 E. coli O157 2006 Fresh Spinach USA 199 * Estimated number. Dr. Ch AJ RIF 21  Example of incidence of intestinal infections Number of laboratory-reported cases in England and Wales 70,000 60,000 50,000 Salmonella Shigella 40,000 Campylobacter 30,000 Rotavirus 20,000 Cryptosporidium 10,000 0 86 88 90 92 94 96 98 00 02 04 19 19 19 19 19 19 19 20 20 20 Dr. Ch AJ RIF 22  Food borne illness in Asia Extensive statistics not readily available Malaysia – 10.7 – 17.9 cases of Salmonella per 100,000 people annually Viet Nam – July 2006 – 22 large scale food poisoning events, 534 cases, 14 deaths China - recent outbreak - 200 students with Shigella illness Topic 1 – Risk Analysis in Public Health and International Trade in food: Dr. Ch AJ RIF Introducing the risk analysis concept 23  Examples of outbreaks related to imported food Country Year Agent Food implicated No. cases Outbreak Source 1989 Staph. aureus Canned mushroom USA China 99 1994 Shigella sonnei Iceberg lettuce Norway Spain 276 1995 S. Stanley Alfalfa sprouts USA, Finland The Netherlands 114 1996 S. Anatum Infant formula UK, France Belgium 17 1997 Hepatitis A Prawn Australia Myanmar 17 1999 S. Newport Mango USA Brazil 78 2000 Cyclospora Mixed salad Germany France, Italy 34 2003 S. Typhimurium Kebab meat Sweden Denmark 112 2004 Hepatitis A Green onions USA Mexico 555 2009 Salmonella Peppers USA Mexico 1 400 Topic 1 – Risk Analysis in Public Health and International Trade Dr. Ch AJ RIF in food: Introducing the risk analysis concept 24  World Trade Organization agreements International trade in food is regulated by the World Trade Organization (WTO) Relevant agreements for food safety and quality: Agreement on the Application of Sanitary and Phytosanitary measures (SPS) Agreement on Technical Barriers to Trade (TBT) Topic 1 – Risk Analysis in Public Health and International Trade Dr. Ch AJ RIF in food: Introducing the risk analysis concept 25  WTO Agreement on the Application of Sanitary and Phytosanitary (SPS) measures Members have the right to take SPS measures necessary for the protection of human, animal or plant life or health, provided that such measures are not inconsistent with the provisions of this Agreement…….…. shall ensure that any SPS measure is applied only to the extent necessary ………, is based on scientific principles and is not maintained without sufficient scientific evidence………....... their SPS measures do not arbitrarily or unjustifiably discriminate between Members, …... shall not be applied in a manner which would constitute a disguised restriction on international trade. The World Trade Organization (WTO) is an international body Dr. Ch AJ RIF 26  SPS Agreement Restricts the use of unjustified SPS measures for trade protection Encourages consistent decision-making and use of systematic risk assessment Encourages “harmonization”, i.e. national SPS measures consistent with international standards Recognizes acceptable level of risk can often be achieved using different measures Increases transparency – notification of SPS measures Dr. Ch AJ RIF 27  Sanitary measure Sanitary measure: Any measure applied to protect human or animal life or health, within the territory of a member, from risks arising from additives, contaminants, toxins or disease-causing organisms in food, beverages or foodstuffs Annex 1 WTO/SPS Agreement (based on) Dr. Ch AJ RIF 28  ALOP in the SPS Context Appropriate Level Of Protection (ALOP) is a specific notion of the SPS Agreement It is the current level of health protection that is achieved in a country It should not be endangered by imported foods Dr. Ch AJ RIF 29  SPS and Codex SPS Agreement refers to the Codex Alimentarius as: Providing the standards, guidelines and recommendations for food safety Benchmark standards under SPS Dr. Ch AJ RIF 30  International standards Codex Alimentarius is the reference for food in international trade Basis for national measures Presumption of conformance with SPS Right to deviate from international standard provided there is scientific justification Dr. Ch AJ RIF 31  Codex Alimentarius Joint FAO/WHO Food Standards Programme Objectives: Protect the health of consumers Ensure fair trade practices in the food trade Promote coordination of all food standards work undertaken by international governmental and non-governmental organizations Dr. Ch AJ RIF 32  Codex Alimentarius Standards, Codes, Guidelines Important documents dealing with microbiological food safety General principles of food hygiene HACCP Establishment of microbiological criteria Principles of microbiological risk assessment Principles of microbiological risk management Validation of food hygiene control measures Guidelines on the Application of General Principles of Food Hygiene to the Control of Listeria monocytogenes in Ready-to-Eat Foods Guidelines on the Application of General Principles of Food Hygiene to the Control of Pathogenic Vibrio Species in Seafood Dr. Ch AJ RIF 33  Role of governments Protect consumers adequately from illness or injury caused by food Provide assurance that food is safe and suitable for normal human consumption Maintain confidence in internationally traded foods Provide health education programmes which effectively communicate the principles of food hygiene to industry and consumers Codex Alimentarius, General Principles of Food Hygiene Dr. Ch AJ RIF 34  Food control systems* All governmental activities undertaken to provide consumers with the assurance that foods meet with national and/or international regulations * Control is used here in the broad sense described in the FAO/WHO guidelines (FNP 76) (not only in terms of testing and monitoring) Dr. Ch AJ RIF 35  RISK ANALYSIS Elements of food safety systems at the national level Activities include: Food laws, policies, regulations and standards. Institutions with clearly defined responsibilities for food control management and public health. Scientific capacity. Integrated management approach. Inspection and certification. Diagnostic and analytical laboratories. Standard-setting Infrastructure and equipment. Monitoring structures and capabilities. Surveillance of human health problems related to food intake. Capacity for emergency response. Training. Public information, education and communication. Dr. Ch AJ RIF 36  Food control systems: basic considerations How safe should food be? Who decides and how? How are consistency, objectivity, acceptability and efficiency assured? How are stakeholders’ views taken into account? How are decisions implemented? How is food safety controlled in the global market? Dr. Ch AJ RIF 37  Role of food industry Provide food which is safe and suitable for consumption Ensure that consumers have clear and easily understood information (regarding hygienic food handling) Maintain confidence in internationally traded foods Codex Alimentarius, General principles of food hygiene Dr. Ch AJ RIF 38  Food safety Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use Codex Alimentarius, General principles of food hygiene Dr. Ch AJ RIF 39  Food safety assurance This expression is used in this course to describe industrial activities intended to provide consumers with safe foods that meet national and/or international regulations “Industry” means all businesses in the food-chain “from farm to fork” Dr. Ch AJ RIF 40  Role of consumers They should recognize their role by following relevant instructions and appropriate food hygiene measures Codex Alimentarius, General principles of food hygiene Dr. Ch AJ RIF 41  Factors driving changes in food control systems Dr. Ch AJ RIF 42  Response – Risk Analysis Risk analysis - a tool that all governments/food safety authorities can use to make significant gains in food safety It can be used to: develop an estimate of the risks to human health and safety, identify and implement appropriate measures to control the risks communicate the risks and measures applied to stakeholders. support and improve the development of standards, address food emergencies that result from emerging hazards or breakdowns in food control systems. Dr. Ch AJ RIF 43  Risk Analysis It provides risk managers / food safety regulators with information and evidence needed for effective decision-making better food safety outcomes improvements in public health. Recommended by the Codex Alimentarius Commission Dr. Ch AJ RIF 44  Safety and risk Safety means “no harm” 100% safety does not exist There is always a chance that a certain harm is caused by Safety a specific pathogen/food combination (i.e. no zero risk) Risk Risk assessment estimates this chance (probability + severity) Risk analysis provides a framework for managing the risk Dr. Ch AJ RIF 45  Risk analysis attributes (1) Structured and objective approach to decision-making in food safety Delineation of responsibilities of different sectors and governmental authorities Separation of risk assessment from risk management Interaction (in process) of risk assessors and risk managers Dr. Ch AJ RIF 46  Risk analysis attributes (2) Integration of science and objectivity in decision-making Identification of efficient control measures Prioritization of actions Dr. Ch AJ RIF 47  Risk analysis attributes (3) Transparency in decision-making Understanding uncertainties in science and their communication Consideration of other factors, such as cost, feasibility, socio- cultural values and consumer opinion, in decision-making Ensuring stakeholders’ participation Dr. Ch AJ RIF 48  Risk analysis framework - Codex Risk Assessment Risk Management Defining and implementing the Examining the policies science Risk Communication The exchange of information Dr. Ch AJ RIF 49  Microbiological Risk Assessment (MRA) A scientific process which consists of determining the likelihood and severity of an adverse health effect in a population exposed to a certain pathogen/food combination Dr. Ch AJ RIF 50  Purpose of MRA Facilitate and support decision-making by risk managers This may be achieved by providing: Estimates of the risk of illness from the consumption of a certain pathogen/food combination Estimates of risk reduction that may be obtained by certain control measures Dr. Ch AJ RIF 51  is not expressed in MRAAcceptability of risk A risk estimate does not provide information on whether the risk associated with the level (prevalence and/or concentration) of a microbe in a food is acceptable or not This is a decision that society (stakeholders: politicians, consumers, industry) needs to make ! Topic 1 – Risk Analysis in Public Health and International Trade in food: Dr. Ch AJ RIF Introducing the risk analysis concept 52  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 measures: European parliament:Regarding the spread of transmissible spongiform encephalopathies (TSEs), such as BSE, there is an EU ban on the use of processed animal proteins (PAPs), including MBM, in feed for food-producing animals (Regulation 999/2001) Codex Alimentarius Dr. Ch AJ RIF 53  Tasks of risk management Setting public health goals Achieving public health goals Implementing, monitoring and review Dr. Ch AJ RIF 54  Risk communication 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 Codex Alimentarius Dr. Ch AJ RIF 55  Communication during risk assessment and management Interaction between managers and assessors is necessary, even when functionally they need to be separated Interaction between managers and stakeholders (consumers, industry, regulators etc.) is essential to assure acceptability and feasibility of planned control measures Dr. Ch AJ RIF 56  HAZARD ANALYSIS vs. RISK ANALYSIS Distinction between the terms "hazard analysis" and " risk analysis " We can see that the risk analysis and HACCP (Hazard Analysis Critical Control Points) are often cited at the same time and involved in the same discussions, which inevitably leads to confusion in the terminology. Although the two approaches have something in common. Dr. Ch AJ RIF 57  HAZARD ANALYSIS vs. RISK ANALYSIS Dr. Ch AJ RIF 58  HAZARD ANALYSIS vs. RISK ANALYSIS Risk Assessment The first step in risk analysis is risk assessment. This helps the facility to decide on the level of risk for each hazard. Risk assessment should provide complete information to allow the risk management team to make the best possible decisions. Begin the risk assessment by answering three basic questions: 1. What could go wrong? 2. How likely is the event to happen? 3. What would be the outcome or impact if this event happened? A risk assessment is never exact. The results of the risk assessment point toward probable outcomes that describe the population risk (e.g. look into density, distribution, disease and/or death). Dr. Ch AJ RIF 59  HAZARD ANALYSIS vs. RISK ANALYSIS Risk analysis (international context See CODEX): A risk analysis is generally carried out by national or international bodies in consultation with all interested parties. The analysis is generally limited to one type of food in combination with a specific danger (eg Salmonella Enteritidis in eggs, E. coli O157: H7 in burgers, etc.). Risk analysis is a complex activity that consists of assessing, managing and communicating the risks. The results of a risk assessment allow, on the one hand, risk managers to determine priorities and set the most appropriate control measures to ensure the safety of the food chain, but they can, on the other hand, be used to perform the hazard analysis (see figure below) according to the HACCP methodology. Dr. Ch AJ RIF 60  HAZARD ANALYSIS vs. RISK ANALYSIS Dr. Ch AJ RIF 61  Pre-Requisite Program (PRP) Pre-Requisite Program (PRP) or Good Practices : - GMP - GLP - GHP - GAP - GKP Good Manufacturing Practices (GMP) are the basic operational and environmental conditions required to safe foods. They address hazards associated with personnel and environment during food production. They provide a foundation for any food safety system GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Dr. Ch AJ RIF 62  Pre-Requisite Program (PRP) 63 Dr. Ch AJ RIF 63  HACCP Principles HACCP includes Seven Principles HACCP System should be supported by PRP, it identifies specific hazards and measures for their control to ensure the safety of food Dr. Ch AJ RIF 64  HAZARD ANALYSIS vs. RISK ANALYSIS Hazard analysis (HACCP and ISO 22000 context): A hazard analysis as one of the 7 basic principles of the HACCP system is carried out at industry level by a HACCP team. Dr. Ch AJ RIF 65  HAZARD ANALYSIS Dr. Ch AJ RIF 66  Hazard analysis (exemple) 9/4/2024 67 Dr. Ch AJ RIF 67  Key points Food-borne diseases are a major concern and need to be addressed The safety of nationally and internationally traded foods needs to be regulated Codex and the WTO-SPS Agreement are the basis for achieving this Risk analysis is a tool used in a food control system to address these items The provision of safe food is a shared responsibility of government, industry and consumers Risk analysis has three well-defined components; RA, RM, RC Dr. Ch AJ RIF 68  References Source: © AFNOR – Module de soutien – n°8 version 2 – Créé le 13/09/2016 – olb ftp.fao.org/es/esn/food/Risk_Analysis.pdf. Federal Register. 2013. “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.” 78(11):3646–3824. Oscar, TP. 2012. “Food Risk Analysis.” In Microbial Food Safety: An Introduction, edited by OA Oyarzabal and S Backert, New York: Springer Verlag. Dr. Ch AJ RIF 69  Microbiological Risk Assessment: Principles and concept Dr. Ch AJ RIF 1  Purpose of lecture ▪ Understand Microbiological Risk Assessment (MRA) principles ▪ Explain the purpose of MRA ▪ Illustrate various outcomes of MRA Dr. Ch AJ RIF 2  Codex Risk Analysis Framework Science Policy based Risk Assessment Risk Management based Hazard Identification Hazard Characterization Exposure Assessment Risk Characterization Risk Communication Dr. Ch AJ RIF 3  What is MRA? Microbiological Risk Assessment is a science based process driven by governments to assess the severity of illness and its probability of occurrence as a consequence of the exposure to a certain food/pathogen combination Dr. Ch AJ RIF 4  Purposes of MRA in MRM Provide support to governments to evaluate the acceptability of a certain food to design food safety improvement programmes to ensure acceptance of product for exportation Dr. Ch AJ RIF 5  Fitting MRA in the MRM structure ▪ Preliminary MRM activities MRA ▪ Evaluation of MRM options ▪ Implementation of MRM decisions ▪ Monitoring and review Dr. Ch AJ RIF 6  MRA attributes In order to answer a management question, the data should be: ▪ structured to clearly tell what we know ▪ descriptive to characterize how well we know it ▪ transparent to reveal any bias Dr. Ch AJ RIF 7  MRA TERMS ▪ Hazard Agent causing an adverse effect ▪ Exposure Estimation of likely intake ▪ Severity The extent of the adverse health effect ▪ Risk A Combination of the probability of an adverse effect and its severity Dr. Ch AJ RIF 8  Risk and hazard Exposure Hazard Hazard Hit likely ? Effect serious ? Risk Dr. Ch AJ RIF 9  Major Risk Assessment Models Food Additive Safety Microbial Risk Pesticide Residue Genetically Modified Assessment Assessment Risk Assessment Foods of Plant Origin Chemical Microbial Pesticide Bio- Risk Risk Residue technology Assessment Assessment Risk Risk Assessment Assessment Sensitivity Dose Expert Animal Monte Carlo Knowledge Analysis Response Opinion Studies Decision Ranking Probability Statistics Economics Tree Models PSAs Theory Methods Biology Chemistry Epidemiology Toxicology Medicine Genetics Cytology Other Dr. Ch AJ RIF 10  Chemical hazards Most effects are not acute Many hazards can be effectively controlled at the farm level Manufacturing has little effect on many chemical hazards Acceptable levels have been defined for many chemical hazards Dr. Ch AJ RIF 11  Chemical hazards: process steps Hazard identification Identify food additive, chemical reactive or contaminant of interest Hazard characterization Undertake toxicity studies of substance if needed Determine the “No Observed Adverse Effect Level” (NOAEL) Select a safety factor or uncertainty factor to extrapolate results from animals to humans Calculate the acceptable daily intake (ADI) Exposure assessment Calculate the exposure to the substance Risk characterization Compare the exposure and the ADI If exposure exceeds ADI some sort of risk mitigation is in order Dr. Ch AJ RIF 12  Safety factor in chemical RA Dose Rat NOAEL ? Man 100(0) Safe level Effect A safety factor is applied to deal with uncertainty Dr. Ch AJ RIF 13  Chemical hazards: process steps Advise on acceptable levels is given by The Joint FAO-WHO Expert Committee on Food Additives (JECFA) The Joint FAO/WHO Meeting on Pesticide Residues (JMPR) Dr. Ch AJ RIF 14  Microbiological hazards ▪ Most effects are acute ▪ Many hazards cannot be effectively controlled at the farm level ▪ Manufacturing, commercialisation, preparation and use have a large effect on many microbiological hazards ▪ Acceptable levels have not been defined for most microbial hazards ▪ In risk characterisation, no safety factors are applied Dr. Ch AJ RIF 15  Acceptable level? A MRA does not provide information whether the risk associated with the level (prevalence and/or concentration) of a microbe in a food is acceptable or not This is a decision that Risk Managers need to make, with input from stakeholders (regulators, consumers, industry) Dr. Ch AJ RIF 16  Microbiological risk assessment Salmonella Escherichia coli O157 Vibrio parahaemolyticus Listeria monocytogenes Microbiological risk assessment is performed for pathogen/food combinations that are associated with food-borne illness (single pathogen, one product type, whole chain) Campylobacter Dr. Ch AJ RIF 17  Inputs to MRA ▪ Science (multidisciplinary) ▪ Infrastructure Data Epidemiology Knowledge Food consumption Experts Outbreak investigation Consumer behaviour ▪ Tools ▪ Framework Statistics Risk analysis Ranking Simulation (e.g. Monte Carlo) Knowledge elicitation Dr. Ch AJ RIF 18  An Iterative process Receive Charge from Risk Managers Receive Assumptions from RM Refine Assumptions for modeling Assemble data/model inputs Verify data/model inputs New data Develop model Audit model Run scenarios/iterations Conduct sensitivity analysis Review results Draft Report Dr. Ch AJ RIF 19  Last MRA process steps ▪ Integrate the quantitative results with the qualitative knowledge also available ▪ Interpret the results in light of the questions asked and if it makes sense scientifically ▪ Interpretation is likely to require input of risk managers ▪ Drafting of report will require scientific writers skilled in “plain language” Dr. Ch AJ RIF 20  Types of MRAs Product Pathogen Pathway risk assessment One pathogen/one food - absolute risk estimate Risk ranking One pathogen/multiple foods - relative risk estimate Geographical risk estimate Risk of introduction into a region (e.g. BSE / TSE) Risk/Risk trade-off Nitrites versus C. botulinum in sausages Dr. Ch AJ RIF 21  Outcomes of MRAs 1. The chance for a person of falling ill by consuming a food 2. The estimated number of illnesses (e.g. per 100.000/year in a country) due to consumption of a specific food/pathogen combination 3. The relative risk posed by a pathogen in different food products or uses 4. Risk estimates for different processing, distribution and consumer use conditions and risk reduction scenarios Dr. Ch AJ RIF 22  Example of outcome (1) The estimated chance that a person in the USA would get Salmonellosis by eating a serving of shell eggs is 3.3 x 10-6 (Attendant uncertainties not mentioned) USA MRA Dr. Ch AJ RIF 23  Example of outcome (2) It is estimated that circa 30 cases of listeriosis per year in the USA (280 Mio inhabitants) are caused by eating cold frankfurters USA MRA Dr. Ch AJ RIF 24  Example of outcome (3) Predicted relative risks associated with food categories for the USA population based on the median predicted cases of listeriosis per 100 million Servings. P = Pátê and Meat Spreads SS = Smoked Seafood; FS = Fresh Soft Cheese DM =Deli Meat PF = Preserved Fish DS = Deli Salads SC = Soft Mold-Ripened Cheese PM = Pasteurized Fluid Milk UM =Unpasteurized Fluid Milk; MD =Miscellaneous Dairy Products RS = Raw Seafood; PC = Heat-Treated Natural Cheese V = Vegetable F = Fruits AC = Aged Chees IC = Ice Cream (CFSAN, FDA, USDHHS, FSIS, USDA, 2001) Dr. Ch AJ RIF 25  Example of outcome (4a) Probability of illness per serving of shell eggs Salmonellosis cases 3.5 3 2.5 x 10-6 2 1.5 1 0.5 0 Baseline Shelf-life Shelf-life Cooling 14 days 7 days 7°C FAO/WHO Dr. Ch AJ RIF 26  Example of outcome (4b) Probability of salmonellosis before and after changing cooking practices of chicken FAO/WHO Dr. Ch AJ RIF 27  Codex principles of microbiological risk assessment ▪ The Codex Commission has published The principles and guidelines for the conduct of MRA [CAC/GL-30 (1999)] ▪ The principles are described in the following slides Dr. Ch AJ RIF 28  Codex principles for MRA (1) 1. MRA should be soundly based on science 2. There should be a functional separation between risk assessment and risk management 3. MRA should be conducted according to a structured approach that includes hazard identification, hazard characterization, exposure assessment and risk characterization Dr. Ch AJ RIF 29  Codex principles for MRA (2) 4. An MRA should clearly state the purpose of the exercise, including the form of risk estimate that will be the output 5. The conduct of an MRA should be transparent 6. Any constraints that impact on the MRA, such as cost, resources or time, should be identified and their possible consequences described Dr. Ch AJ RIF 30  Codex principles for MRA (3) 7. The risk estimate should contain a description of uncertainty and where the uncertainty arose during the MRA process 8. Data should be such that uncertainty in the risk estimate can be determined; data and data collection systems should, as far as possible, be of sufficient quality and precision that uncertainty in the risk estimate is minimized Dr. Ch AJ RIF 31  uncertaintiescurves Dose response for salmonellosis with attendant 1.0 Probability of salmonellosis 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 0 1 2 3 4 5 6 7 8 9 10 Log dose Dr. Ch AJ RIF FAO/WHO32  Codex principles for MRA (4) 9. An MRA should explicitly consider the dynamics of microbiological growth, survival and death in food and the complexity of the interaction (including sequelae) between human and agent following consumption as well as the potential for further spread 10. Wherever possible, risk estimates should be reassessed over time by comparison with independent human illness data 11. An MRA may need re-evaluation, as new relevant information becomes available Dr. Ch AJ RIF 33  MRA in MRM A governmental MRA considers all foods consumed in a specific country, whether produced locally or imported Dr. Ch AJ RIF 34  Examples of MRAs FAO/WHO Canada Salmonella Enteritidis in eggs Campylobacter jejuni in fresh poultry Salmonella spp. in broilers Salmonella spp. in cracked eggs L. monocytogenes in ready-to-eat foods L. monocytogenes in raw milk cheese Vibrio spp. in seafood E. coli O157:H7 in ground beef Campylobacter spp. in broilers Toxoplasma gondii in pork USA Netherlands Salmonella in shell eggs Bacillus cereus in pasteurised milk Vibrio parahaemolyticus in raw oysters Campylobacter spp. in broiler chicken Listeria in ready-to-eat retail foods E. coli in steak tartare E. coli O175:H7 in ground beef B. cereus in vegetable puree Dr. Ch AJ RIF 35  MRAs must report Key assumptions Inconclusive or controversial scientific information Estimates of risks with attendant uncertainties An indication of the degree of variability and scientific uncertainty Possible undertakings to complete the data so that the MRA may be improved, if necessary Dr. Ch AJ RIF 36  FAO/WHO Expert Committees Risk Assessment is done and advise on acceptable levels for chemical hazards is given by The Joint FAO-WHO Expert Committee on Food Additives (JECFA) The Joint FAO/WHO Meeting on Pesticide Residues (JMPR) Risk Assessment is done but no advise on acceptable levels for microbial hazards is given by The Joint FAO-WHO Expert Meeting on Microbiological Risk Assessment (JEMRA) Dr. Ch AJ RIF 37 JEMRA output CCFH use Dr. Ch AJ RIF 38  Some players in today’s MRA Health Canada Dr. Ch AJ RIF 39  Key Points ▪ MRA is a well defined process ▪ MRA is done to answer questions formulated by Microbiological Risk Managers ▪ These questions can be very different in nature, thus also the outcomes of MRA may be presented in many forms Dr. Ch AJ RIF 40