Dr. Tipvon Parinyasiri

Transcription

1 Dr. Tipvon Parinyasiri Director, Bureau of Food Thai Food and Drug Administration 28 January 2014, Faculty of Medicine

2 Guideline Content of Presentation Roles and Responsibility of Thai FDA From Research to Regulation for Food Safety: Case Studies 1

3 How do Thai FDA Work? Thai Food Act 1979 (Enforcement and Implementation) Use Food Law As the Tools Aim of Consumer Protection Safety Efficacy -Identity -Nutrition 3

4 Roles and Responsibility of Thai FDA 5. Surveillance 6. Support & Cooperate Technical Knowledge 1. Legislating of Notifications of Ministry of Public Health 2. Pre-Marketing Control 3. Post -Marketing Control 4. Importing Control 7. Disseminate Knowledge & Develop Consumer Behavior 2

5 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

6 Food Safety Driven Authority Management Law/ Regulation Evaluation Infrastructure Structure KPI/ Man Power Financial Contents Strategy/ Framework Best Practices Guidelines Knowledge Operation/Doing Action Enforcement Education

7 Thai FDA Food Safety Control System Pre-marketing Officers Raw Material Premise Product Advertisement Approval Notification of MOPH Specification Producer Produce/Import/Distribute Need to Follow the Notification and Specification of MOPH Post-marketing Officers Monitoring, Surveillance and Enforcement Raw Material Premise Product Advertisement Safety Efficacy Food Products Wholesomeness 4

8 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

9 The Legislative Process Problem of Illness/ Standard of International trade/public Concern Issue Research and development Sub Committee Risk assessment Risk management Risk communication Collect data, Analyze data and draft a Notification Considerate by Sub Committee Public Hearing and Circulation to WTO members Considerate by Food Committee Endorse by The Ministry Notify in the Government Gazette Working Team (FDA/ Univ./Consumer/ Industries) Risk Management Thai FDA Expert from University Consumer Group The Federation of Thai Industries 5

10 Food Regulations & Food Policy Based on Risk Analysis Principle Academic s Supporting 8

11 Guideline Content of Presentation Roles and Responsibility of Thai FDA From Research to Regulation for Food Safety: Case Studies 1

12 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

13 2 Microbial Contaminants in Drinking Water in Sealed Container 3 Revising Maximum Limits of microbial pathogen in Foods 4 Revising Maximum Level of Food Additives 1 Contamination of C. botulinum in Preserved Bamboo Shoots From Research to Regulation for Food Safety 5 Universal Salt Iodization Institute of Nutrition 10

14 1 Contamination of C. botulinum in Preserved Bamboo Shoots Incident of Botulinum Outbreak in Nan Province in B.E Lack of Appropriated Practices in OTOP/ Household (90%). 11

15 1 Contamination of C. botulinum in Preserved Bamboo Shoots How to Overcome the Problem Thai FDA/ Provincial Public Health Office Stakeholders in Province/ Local Institute of Nutrition Knowledge Appropriated Technology for SME (Acidified Products) Regulation and Education Guideline Inspection and Surveillance System Good Practices for SME Promote Compliances: Acidified Products Producers Household level Follow Regulation and guideline for Acidified Bamboo Shoots Products Wholesalers/ Retailers Sell Acidified Bamboo Shoots products and show all needed information on label Consumers Read Label and Buy Acidified Bamboo Shoot Products 12

16 2 Microbial Contaminants in Drinking Water in Sealed Container 3 Revising Maximum Limits of microbial pathogen in Foods 4 Revising Maximum Level of Food Additives 1 Contamination of C. botulinum in Preserved Bamboo Shoots From Research to Regulation for Food Safety 5 Universal Salt Iodization Institute of Nutrition 10

17 2 Contamination of Drinking Water in Sealed Container Contamination of drinking water in bottling plant Lacking of Knowledge Low technology 30% of Microbial Contamination Needs Research 14

18 2 Microbial Contaminants in Drinking Water in Sealed Container How to Overcome the Problem by Supporting from the Academic 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

19 2 Microbial Contaminants in Drinking Water in Sealed Container 3 Revising Maximum Limits of microbial pathogen in Foods 4 Revising Maximum Level of Food Additives 1 Contamination of C. botulinum in Preserved Bamboo Shoots From Research to Regulation for Food Safety 5 Universal Salt Iodization Institute of Nutrition 10

20 3 Revising Maximum Limits of Microbial 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

21 Research Result: Model to Estimate the Maximum Levels of Microbial Pathogens in Foods Growth Factors; ph, Aw, Generation time, Infective dose, Temp Y=X*2 n Y = Infective dose X = Maximum residue levels of microorganism in a portion size which no harmful to human health n = Generation time Related information - Food Properties - International Standards Propose; Notification of Ministry of Public Health on the Maximum Levels of Microbial Pathogen in Food Products 17

22 2 Microbial Contaminants in Drinking Water in Sealed Container 3 Revising Maximum Limits of microbial pathogen in Foods 4 Revising Maximum Level of Food Additives 1 Contamination of C. botulinum in Preserved Bamboo Shoots From Research to Regulation for Food Safety 5 Universal Salt Iodization Institute of Nutrition 10

23 3 Update Maximum Level of Food 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

24 3 Information Supporting to Update Maximum Level of Food Additives Review information for Toxicological Evaluation Toxicological data Epidemiological study others data National Survey A. Food consumption data B. Maximum Level(mg/kg of food) ADI Acceptable daily intake - mg/ kg bw Proposed quality and standard) Exposure Assessment Total Exposure of Food Additives in food = Food consumption data x Maximum Level ( A ) ( B ) Risk Characterization Risk = Risk < 1 Total Exposure of Food Additives in food ADI Therefore at the ML set forth, Thai populations are safe Proposed Regulation on Food additives: Maximum Use Levels in Food Products 19

25 2 Microbial Contaminants in Drinking Water in Sealed Container 3 Revising Maximum Limits of microbial pathogen in Foods 4 Revising Maximum Level of Food Additives 1 Contamination of C. botulinum in Preserved Bamboo Shoots From Research to Regulation for Food Safety 5 Universal Salt Iodization Institute of Nutrition 10

26 5 Universal Salt Iodization Situation; Iodine Deficiency is the Main Cause of Impaired Brain and 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

27 Study on the Awareness and Perception of all Stakeholders on Universal Salt Iodization College of Nursing (Boromarajonani) Technology (mixing machine) Development the mixing machine model Univ. (KMITL) Quality Control System Study on analytical method for I 2 Univ. (KMITL, INMU) Propose; - Regulation on universal Salt Iodization -Quality Control System Improvement the mixing machine and Development 3 Learning Centers Improvement salt producer s potential Result: Appropriated Technology Univ. (INMU) Univ. (INMU) Support 100 mixing machines for salt producers Guideline for Authority officer and salt producer -Production -QA & QC Univ. (INMU) Result QA & QC system 21

28 The academic institute is an essential stakeholders of Thai FDA includes; Research Generation: Knowledge Research Compilation: Develop Regulation and Guideline/ Recommendation Research Dissemination: Training and Consultation 22

29 Food Safety in Your Hand Government Private Sectors Consumers Academics