Makita, K.

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Application of food safety risk assessment in identifying effective control measures during the animal production phase  AIMS Project At Rakuno Gakuen University, 20 November, 2014 Kohei Makita Associate Professor of Veterinary Epidemiology at Rakuno Gakuen University, Japan (OIE Joint Collaborating Centre for Food Safety)  Joint Appointment Veterinary Epidemiologist at International Livestock Research Institute (ILRI)  Food safety risk assessment training in Vietnam Broad casted by ‘Voice of Vietnam’ on 2013 September 7 Objective of this talk • To share ideas for application of food safety risk assessment in improving food safety by controlling hygiene in the animal production phase Outline • Food safety risk assessment – Why important? – Risk assessment – Logic tree (event tree, fault tree) – Description of value chains – Field survey- importance of diagnostic tests – Construct and run a risk model • How food safety risk assessment can be applied to improve farm hygiene? Why food safety? • Every year, at least 2 billion cases of diarrhea occur and 1.5 million children under 5 yrs die worldwide  • Poor, young, elderly, pregnant women and immune-suppressed most affected  • Food borne diseases include non-diarrheal severe zoonoses Why animal source foods? • Two-thirds of human pathogens are zoonotic – many of these transmitted via animal source food  • Animal source food is a single most important cause of food-borne disease  • Many food-borne diseases cause few symptoms in animal host  • Many zoonotic diseases controlled most effectively in animal host/reservoir Formal marketing Informal marketing in sub-Saharan Africa (90-95%) Dominance of informal markets in developing countries “Absence of structured sanitary inspection”  8 Informal ≠ Illegal Outline • Food safety risk assessment – Why important? – Risk assessment – Logic tree (event tree, fault tree) – Description of value chains – Field survey- importance of diagnostic tests – Construct and run a risk model • How food safety risk assessment can be applied to improve farm hygiene? OIE Import Risk Analysis Release  assessment Exposure  assessment Consequence  assessment Risk  management Risk  assessment Hazard  identification                          Risk communication                       OIE Risk analysis for antimicrobial resistance Release  assessment Exposure  assessment Consequence  assessment Risk  management Risk  assessment Hazard  identification                          Risk communication                       Use of antimicrobials at farm and selection of resistant bacteria Food chain and consumption of the foods contaminated Weaker response of  antimicrobials in treatment Task 1. Assemble HACCP team Task 2. Describe product  Task 3. Identify intended use Task 4. Construct flow diagram Task 5. On-site confirmation of flow diagram Task 6. List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards (Principle 1) Task 7. Determine Critical Control Points (Principle 2) Task 8. Establish critical limits for each CCP (Principle 3) Task 9. Establish a monitoring system for each CCP (Principle 4) Task 10. Establish corrective actions (Principle 5) Task 11. Establish verification procedures (Principle 6) Task 12. Establish documentation and record keeping  (Principle 7) HACCP 12 step roadmap Food Chain Production stage Manufacturing, processing and distribution stages Consumption stage Supply of safe livestock products through integrated hygiene management from farms to consumers  In order to prevent health problems caused by livestock products, integrated risk-reduction hygiene management (food chain approach) is needed up to the point where food is served on the table through regional cooperation at each stage including the production stages.   Therefore, MAFF provides support for hygiene management at the production, manufacturing and processing stages. Dairy factories,  meat processing plants, etc. [Manufacturing, processing and distribution] Production farms Appropriate storage, cooking, etc. in accordance with the type of food  Consumers Support for introducing HACCP  Training on-site managers and leaders  Creation and dissemination of certification criteria  Training farm advisors  Support for facility development Production stage Manufacturing and processing stages Regulation and monitoring  Regulation and monitoring based on the Food Sanitation Act, etc.   Approval of the Comprehensive Sanitation Management and Production Process 1. Checking the general hygiene management program 2.  Conducting hazard analysis and creating hazard lists 3. Creating a hygiene management plan  4. Verifying the implementation situation for hygiene management Supporting the efforts to link HACCP (Hazard Analysis and Critical Control Points)  at different stages (production, processing and distribution stages) Information provision and risk communication through websites MAFF MHLW 1. Checking the general hygiene management program 2. Conducting hazard analysis and creating hazard lists 3. Creating a hygiene management plan  4. Verifying the implementation situation for hygiene management Strengthening cooperation Ensuring the Safety of Japanese Livestock Products MAFF, etc. 13  Advanced Hygiene Management based on HACCP approach at Production Stage “ Farm HACCP” • Advanced Hygiene Management Guidelines based on HACCP approach at Farm Level developed  (FY2002~) • HACCP approach at Farm Level shared and promoted among local stakeholders : livestock hygiene service centers, livestock producers, livestock industry organizations, veterinarians, etc.  • Certification criteria for being recognized as “HACCP Farm” established and a certification system developed (FY2009~）  • Training for “Farm HACCP advisors “(FY2008~） and pilot project involving whole food chain (production stage, the processing, distribution to consumption stages) started (FY2009~）  • Certification of HACCP Farms by certification organizations started (FY2011~) Creation of an implementation manual by each farmer • Hazard factor survey (Salmonella, E-coli O157, antibacterial agents, etc.) • Hazard analysis (HA) • Setting critical control points (CCP) • Creation of an implementation manual  Implementation Implementation of hygiene management based on the manual   Advice , Monitoring, Testing and Improvement Production of safer livestock products  which meet consumer  high demand Building trust of consumers in livestock products Feedback including abattoir inspections  Advanced Hygiene Management Guidelines Based on the HACCP approach, model requirements for controlling or reducing hazards are developed for each type of livestock.  Promotion of  “Farm HACCP “   Farm HACCP advisors Verification Appropriate revision of the manual      Certification organizations : 2 orgs approved  No. of farms  working on HACCP approach : 4,587  Certification as “HACCP Farm”  Valid for 3 years     No. of farms  certified  :   27 Dairy 3, Beef 2 Pig 16, Layer  6 (As of July ,2013) 14 15 Risk  Assessment Risk  Management  Risk  Communication Codex Alimentarius Commission Food safety risk analysis A tool for decision-making under uncertainty *Risk is a probability of occurrence of a scenario and its size of impact (Vose, 2008) Risk  Assessment Risk  Management  Risk  Communication Food safety risk analysis in informal marketing system Participatory methods What are participatory methods? • Participants discuss problems • Several formats: – Rapid rural appraisal – Participatory rural appraisal – Key-informants interview Codex Alimentarius Commission Risk assessment framework (CAC/GL-30 (1999)) Hazard  identification  Exposure  assessment  Hazard  characterization  Risk  characterization Statement of purpose of  risk assessment • Clear statement of the specific purpose of the particular risk assessment • Output form – Prevalence of illness – Annual incidence rate (eg. case/10,000)  • Preliminary investigation phase may be required Hazard  identification  Exposure  assessment  Hazard  characterization  Risk  characterization Hazard identification • The identification of biological, chemical, and physical agents –  • capable of causing adverse health effects –  • and which may be present in a particular food or group of foods Hazard  identification  Exposure  assessment  Hazard  characterization  Risk  characterization Exposure assessment • Assessment of the extent of actual or anticipated human exposure  • Based on potential extent of food contamination by a particular agent or its toxins, and on dietary information  Hazard  identification  Exposure  assessment  Hazard  characterization  Risk  characterization Hazard characterization • Qualitative or quantitative description of the severity and duration of adverse effects that may result from the ingestion of a microorganisms or its toxin in food • A dose-response assessment should be performed if the data are obtainable Hazard  identification  Exposure  assessment  Hazard  characterization  Risk  characterization Factors that need to be considered in hazard characterization • Factors related to the microorganism – Speed of replication – Virulence and infectivity – Delay of onset following exposure – Attributes altering pathogenicity, e.g., high fat content of a food vehicle • Factors related to the host – Genetic factors – Host susceptibility characteristics • Age, pregnancy, nutrition, immune status etc. – Population characteristics • Population immunity, access to and use of medical care etc.  Hazard  identification  Exposure  assessment  Hazard  characterization  Risk  characterization Dose-response Assessment • Determination of the relationship between the magnitude of exposure (dose) to a chemical, biological or physical agent and the severity and/or frequency of associated adverse health effects (response) Hazard  identification  Exposure  assessment  Hazard  characterization  Risk  characterization Risk characterization • Integration of previous three steps  • A qualitative or quantitative estimate of the likelihood and severity of the adverse effects which could occur in a given population • Degree of confidence: uncertainty and variability (stochastic model) • Influence of factors to the risk estimate: sensitivity analyses  Hazard  identification  Exposure  assessment  Hazard  characterization  Risk  characterization Types of risk assessment and  their outputs • Qualitative – Eg). high, middle, low, negligible   • Quantitative – Deterministic (point estimate) – Stochastic (probability distribution) Outline • Food safety risk assessment – Why important? – Risk assessment – Logic tree (event tree, fault tree) – Description of value chains – Field survey- importance of diagnostic tests – Construct and run a risk model • How food safety risk assessment can be applied to improve farm hygiene? 28 Event tree What is the implications of a cow harbouring EC O157:H7 on safety of informally marketed milk? Fault tree analysis in food safety • How the illness can occur Onset of  illness Preceded by Infection Ingestion Purchase Production Preceded by Preceded by Or Direction of identification and diagraming Value chain A producer A consumer Value chain Producers Consumers Middle men Actors in informal milk sales in Kampala, Uganda • Plus milk retail shop without refrigerator and dairy farmers selling at farms Shop with a bulk cooler Shop with a small refrigerator Boiling centre Trader with cans on a bicycle Roadside vendor Roadside vendor 33 Quantitative dairy value chain in Kampala, Uganda Source: Makita K. et al. (2010). How human brucellosis incidence in urban Kampala can be reduced most efficiently? A stochastic risk assessment of informally-marketed milk. PLoS ONE 5 (12): e14188. Field survey – Importance of diagnostic tests My bitter experience in Campylobacter risk assessment…  Nyama-choma in Tanzania <1st survey for prevalence> High prevalence using culture without rigorous identification <2nd survey for MPN> Low prevalence using PCR after culturing Constructing a risk model • Model value chains which include – Mixing – Separation – Growth – Inactivation  • In a stochastic model, computer simulation is used (I show you a demo briefly..)  Outline • Food safety risk assessment – Why important? – Risk assessment – Logic tree (event tree, fault tree) – Description of value chains – Field survey- importance of diagnostic tests – Construct and run a risk model • How food safety risk assessment can be applied to improve farm hygiene? How food safety risk assessment is applied to improve farm hygiene? (An example) Risk assessment of staphylococcal poisoning due to consumption of informally-marketed milk and home-made yoghurt in Debre Zeit,  Ethiopia  (Makita et al. (2012) Int. J. Food Microbiol. 153:  135-141.) Hazard identification • Hazard – Staphylococcus aureus enterotoxin – Produced by S. aureus when the concentration in milk exceeds 106.5 CFU/ml  • S. aureus is known to be prevalent in milk in Ethiopia by previous reports  Illness due to Staphylococcal poisoning due to milk consumption A consumer is susceptible to SAET SA multiply to reach enough cfu producing ET Milk contains SA Milk contains SA at production Milk contaminated with SA By traders/handlers Milk shed by SA Mastitis cow Milk contaminated by a farmer Infected cow Human source Human source AND OR Initiating event Fault tree: understanding the logic of illness 40 Dairy value chain- RRA and interviews Exposure assessment Contamination rate - a survey Isolation of  S aureus Boiling before sales Milk collection centre (n=25) 18 (70.4%) 0 Dairy farm (n=170) 74 (43.6%) 0 Example: Boil milk before consumption Percentage Dairy farming households (n=170) 116 68.2 Consumers (n=25) 16 64.0 Risk mitigation by consumers -participatory and interviews Exposure assessment Growth model: Cfu/ml Hour Stationary phase Exponential growth phase Lag phase Fujikawa and Morozumi (2006) modified logistic model Hazard characterization Risk mitigation by traditional milk fermentation- Modeling using reported data (Gonfa et al., 1999) Bacteria growth stops at pH 4.9 1/pH=0.002 t (h)+1.187 (df=3, r2=0.90, p=0.009) Source: Makita et al., 2012  Int. J. Food Microbiol. Hazard characterization Stop of growth of S. aureus in milk by low pH (h) Stop of bacterial growth due to milk fermentation Hazard characterization Risk characterization • Each of them are uncertainty distributions • The variety of uncertainty distributions shows variability • Variability in this case is the growth speed of S. aureus Sensitivity Tornado -0.5 00.5 11.5 22.5p / 1 to 2days G13Cont rate B24Boiling C24p / Day 0 F131960 / Cont rate B111960 / Cont rate B16p / 3 to 4 days H131960 / Boiling C161960 / Boiling C11109/291 (Arcuri 2010Temperature D10N0 D4Mean of Incidence rate46 Sensitivity analysis Prob. SA has SE genes Prob. farmers boil Prob. consumers boil Contamination, farm Store milk 3,4 days Contamination, centre Consume on day 0 Prob. centres boil Contamination, farm Store milk 1,2 days     Temperature Initial bacteria population *It provides efficient control options - Training for hygienic milking - Separation of cows with mastitis - Temperature control Risk characterization Conclusion • Food safety is important in public health  • Risk assessment is useful in identifying factors reducing the risk, including animal production phase  • Improvement of farm hygiene contributes food safety 

Application of food safety risk assessment in identifying effective control measures during the animal production phase

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Application of food safety risk assessment in identifying effective control measures during the animal production phase

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