Dr. Tipvon Parinyasiri Director, Bureau of Food Thai Food and Drug Administration 28 January 2014, Faculty of Medicine
Guideline Content of Presentation Roles and Responsibility of Thai FDA From Research to Regulation for Food Safety: Case Studies 1
How do Thai FDA Work ? Thai Food Act 1979 Aim of Consumer Protection (Enforcement and Implementation) • Safety • Efficacy - Identity - Nutrition Use Food Law As the Tools 3
Roles and Responsibility of Thai FDA 1. Legislating of Notifications of 5. Surveillance Ministry of Public Health 2. Pre-Marketing Control 6. Support & 3. Post -Marketing Control Cooperate Technical Knowledge 4. Importing Control 7. Disseminate Knowledge & Develop Consumer Behavior 2
Food Control System (FAO) Law / Regulation/ Std/ Guideline/ Recommendation Promote Compliance, Enforcement & Communication Food Control Management (Organization, Structure, Functions) Inspection and Certification Laboratories / Facilities Monitoring & Evaluation 5
Food Safety Driven Authority Infrastructure Management Structure Law/ Regulation KPI/ Man Power Evaluation Financial Contents Operation/Doing Strategy/ Framework Action Best Practices Enforcement Guidelines Education Knowledge
Thai FDA Food Safety Control System • Notification of MOPH • Specification Pre-marketing Officers Post-marketing Officers Monitoring, Approval Surveillance and Enforcement Raw Material Producer Raw Material Produce/Import/Distribute Premise Premise Need to Follow the Notification and Product Product Specification of MOPH Advertisement Advertisement Food Products Safety Efficacy Wholesomeness 4
Legislation Principle under SPS measures 1. Safety and Health Protection based on Risk Analysis and Accurate Scientific Data. 2. No Barrier to Trade 3. Justified Measures 4. Transparency 7
The Legislative Process Problem of Illness/ Standard of International trade/Public Concern Issue Collect data, Analyze data Working Team (FDA/ Research and development Univ./Consumer/ and draft a Notification Industries) Sub Committee Considerate by Sub Committee Risk Management Risk Risk Public Hearing and assessment management Circulation to WTO members Thai FDA Expert from Risk communication Considerate by Food Committee University Consumer Group The Federation of Endorse by The Ministry Thai Industries Notify in the Government Gazette 5
Food Regulations & Food Policy Based on Risk Analysis Principle Academic’s Supporting 8
Guideline Content of Presentation Roles and Responsibility of Thai FDA From Research to Regulation for Food Safety: Case Studies 1
Food Safety Problems and Challenges in Thailand Burden and Emerging of Food-Related Illness Harmonization on Food Safety and Quality Standards of International Food Trade. Lack of Knowledge and Appropriated Practices in SME/ OTOP cause Microbial Contamination. Changing in Lifestyles, including Rapid Urbanization Food Innovation and health claim. 10
Revising Maximum Limits 3 of microbial pathogen in Foods Revising Microbial Maximum Level Contaminants in 2 4 Drinking Water in of Food Sealed Container Additives Contamination of From Research to Regulation Universal Salt C. botulinum in 1 5 for Food Safety Iodization Preserved Bamboo Shoots 10 Institute of Nutrition
Contamination of C. botulinum in Preserved Bamboo Shoots 1 Incident of Botulinum Outbreak in Nan Province in B.E. 2549 Lack of Appropriated Practices in OTOP/ Household (90%). 11
Contamination of C. botulinum in How to Overcome the Problem 1 Preserved Bamboo Shoots Thai FDA/ Stakeholders in Provincial Public Province/ Local Health Office Knowledge Institute of Nutrition Guideline Regulation and Education Appropriated Technology for SME Inspection and (Acidified Products) Surveillance System Good Practices for SME Producers Wholesalers/ Retailers Consumers Promote Household level Compliances: Read Label and Acidified Follow Regulation and Sell Acidified Bamboo Shoots Buy Acidified guideline for Acidified Products products and show all needed Bamboo Shoot Bamboo Shoots information on label 12 Products Products
Revising Maximum Limits 3 of microbial pathogen in Foods Revising Microbial Maximum Level Contaminants in 2 4 Drinking Water in of Food Sealed Container Additives Contamination of From Research to Regulation Universal Salt C. botulinum in 1 5 for Food Safety Iodization Preserved Bamboo Shoots 10 Institute of Nutrition
Contamination of Drinking Water in Sealed Container 2 Contamination of Lacking of Knowledge drinking water in 30% of Microbial Contamination Low technology bottling plant Needs Research 14
How to Overcome the Problem by Microbial Contaminants in Drinking 2 Supporting from the Academic Water in Sealed Container o Research in Appropriated Process Control and Sanitation Measure (De-fluoridation). o Design and Develop Appropriate Technology for SME. o Training Center for Small Businesses to do a Good Practice. o Publish Printed Media and Materials to Producers and all Stakeholders. 15
Revising Maximum Limits 3 of microbial pathogen in Foods Revising Microbial Maximum Level Contaminants in 2 4 Drinking Water in of Food Sealed Container Additives Contamination of From Research to Regulation Universal Salt C. botulinum in 1 5 for Food Safety Iodization Preserved Bamboo Shoots 10 Institute of Nutrition
Revising Maximum Limits of Microbial 3 Pathogen in Foods (Old Version) Notification of Ministry of Public Health on Maximum Levels of some Microorganisms in Food Products กฎกระทรวง There was only the Standard for Sanitary Indicator Bacteria such as; Coliform, E.coli, Yeast and Mold In Food Products shall not Detect Pathogen such as; Bacillus cereus, Clostridium perfringens, Salmonella spp., and Staphylococcus aureus Requiring the Limit Levels of Pathogen to Comply with International Standards. 20
Research Result: Model to Estimate the Maximum Levels of Microbial Pathogens in Foods Growth Factors ; Y=X*2 n pH, Aw, Generation time, Infective dose, Temp Y = Infective dose X = Maximum residue levels of microorganism in a portion size which no harmful to human health n = Generation time Related information Propose; - Food Properties - International Standards Notification of Ministry of Public Health on the Maximum Levels of Microbial Pathogen in Food Products 17
Revising Maximum Limits 3 of microbial pathogen in Foods Revising Microbial Maximum Level Contaminants in 2 4 Drinking Water in of Food Sealed Container Additives Contamination of From Research to Regulation Universal Salt C. botulinum in 1 5 for Food Safety Iodization Preserved Bamboo Shoots 10 Institute of Nutrition
Update Maximum Level of Food 3 Additives Notification of Ministry of Public Health on Food Additives Provided the Maximum Use Levels of Food Additives Codex has Reviewed and published the GENERAL STANDARD FOR FOOD ADDITIVES (GSFA) Needs to adapt the guideline to reduce international trade disruption. 23
Information Supporting to Update Maximum Level of Food Additives 3 Review information for Toxicological Evaluation ADI • Toxicological data Acceptable daily intake - mg/ kg bw • Epidemiological study Proposed quality and standard ) • others data Exposure Assessment National Survey A. Food consumption data Total Exposure of Food Additives in food B. Maximum Level(mg/kg of food) = Food consumption data x Maximum Level ( A ) ( B ) Risk Characterization Proposed Regulation on Food additives: Total Exposure of Food Additives in food � Risk = Maximum Use Levels in Food Products ADI Therefore at the ML set forth, Risk < 1 � Thai populations are safe 19
Revising Maximum Limits 3 of microbial pathogen in Foods Revising Microbial Maximum Level Contaminants in 2 4 Drinking Water in of Food Sealed Container Additives Contamination of From Research to Regulation Universal Salt C. botulinum in 1 5 for Food Safety Iodization Preserved Bamboo Shoots 10 Institute of Nutrition
Universal Salt Iodization 5 Iodine Deficiency is the Main Cause of Impaired Brain and Situation; Cognitive Development among people at all age. Iodine Deficiency Disorders (IDD) have been Recognized as a Serious Public Health Problem in Thailand in the Past Decade Problem Solving Techniques; Awareness and Perception on Iodized Salts among Stakeholders : Gov., Processers, Academics Appropriated Technology and QA/QC Inspection and Surveillance system 26
Study on the College of Awareness and Nursing Technology Quality Control Perception of (Boromarajonani) (mixing machine) System all Stakeholders Development the Univ. Study on Univ. on Universal (KMITL) (KMITL, Salt Iodization mixing machine analytical INMU) model method for I 2 Improvement the Univ. Guideline for Univ. (INMU) (INMU) mixing machine Authority and Development officer and Propose; 3 Learning Centers salt producer - Regulation on universal Salt - Production Improvement salt Univ. Iodization - QA & QC (INMU) producer’s - Quality Control System potential Result Result: Appropriated Technology QA & QC system Support 100 mixing machines for salt producers 21 21
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