Outline. Ensuring Food Safety and Fair Trade in ASEAN : Case Study of Risk-Based Aflatoxin Standard

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4th Asia-Pacific International Food Safety Conference & 7th Asian Conference on Food and Nutrition Safety, October 11-13, 2016, Penang, Malaysia Ensuring Food Safety and Fair Trade in ASEAN : Case Study of Risk-Based Aflatoxin Standard Pisan Pongsapitch National Bureau of Agricultural Commodity and Food Standards (ACFS), Ministry of Agriculture and Cooperatives, Thailand 4th Asia-Pacific International Food Safety Conference & 7th Asian Conference on Food and Nutrition Safety, 11 October 2016, Penang, Malaysia Outline ASEAN food safety standard harmonization Food safety standard : Aflatoxin case study Aflatoxin risk assessment Aflatoxin risk management Risk-based standard : Aflatoxin in Thai peanuts Conclusion

POLITICAL-SECURITY Blueprint Rules based, shared norms and values Cohesive, peaceful, stable, resilient with shared responsibility Dynamic and Outward looking ASEAN COMMUNITY ECONOMIC Blueprint Single Market and production base Competitive economic region Equitable Economic development Integration into global economy Free flow of goods Intra- & Inter- regional trade facilitation Standard harmonization SOCIO-CULTURAL Blueprint Human Development Social Welfare and Protection Social justice and rights Environmental Sustainability ASEAN Identity ASEAN Food Safety Standard Harmonization Approach Filling FSS Harmonization template Evaluation of FSS Similarities & Differences Time given to AMS to review their FSS Evaluation of FSS Similarities & Differences FSS unharmonized Stop Continue bilateral Similarities FSS harmonized among AMS and with Codex FSS harmonized among AMS Choice: FSS Risk Assessment (exposure assessment) at National Level by AMS FSS Risk Assessment at ASEAN level Risk Analysis Risk assessment policy -Risk evaluation -Option assessment -Implementation -Monitoring/review Risk Assessor - hazard ID - hazard characterization - exposure assessment - risk characterization - scientific based result - uncertainties Risk Manager consumer benefits impacts on economy and society stakeholder input * Risk communication at all steps Aflatoxin Standard

4th Asia-Pacific International Food Safety Conference & 7th Asian Conference on Food and Nutrition Safety, October 11-13, 2016, Penang, Malaysia 5DSLG 5DSLG G $OHUW $OHUW 6\VWHP IRU )RRG 6\VWHP P IR RU )RRG DQG )HHG 5$6)) Questions from risk management Notification on mycotoxins in food and feed (2013) 1000 800 Is there any significant risks from mycotoxin in food commodities? How high the risk? What mycotoxin? What food commodities involve? Which risk management needed to reduce consumer risk from aflatoxin? Is standard/regulation needed? 600 400 200 0 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Deoxynivalenol Fumonisins Ochratoxin A Patulin Zearalenone 0\FRWR[LQ $IODWR[LQV 'HR[\QLYDOHQ RO &RGH[ &RGH[ [ &RPP &RPPLWWHH RQ PLWWH HH RQ &RQWDPLQDQWV V LQ )RRG 2FKUDWR[LQ $ =HDUDOHQRQH 10 )XPRQLVLQV 3DWXOLQ Aflatoxins 7RWDO Monitoring o off Aflatoxin Af xin nm M1 1 Contamination in Milk k - 2007 CODEX STAN 193-1995: General Standard for Contaminants and Toxins in Food and Feed Mycotoxin Aflatoxin, Total Product Level (µg/kg) Peanut intended for further processing 15 Almonds, Brazil nuts, Hazelnuts, Pistachios for further processing 15 Almonds, Brazil nuts, Hazelnuts, Pistachios ready-toeat Dried figs ready-to-eat 10 Aflatoxin M1 Milk 0.5 Ochratoxin A Raw wheat, Barley, Rye Fumonisins (B1 + B2) Raw maize grain 4,000 Maize flour and maize meal 2,000 Patulin Apple juice 10 5 50 Type of Milk No. of Samples UHT milk 75 Pasteurized milk 125 Total 200

Monitoring of Aflatoxin (B1 & Total) in 2011 Foods/Feeds No. of Samples Raw/roasted peanut 216 Ground roasted peanut 104 Fried peanut & other products 38 Maize 40 White/Brown rice 50 Dried chili 40 Jobs tear 40 Cashew nut 20 Total 548 % of Milk Sample detected ected Aflatoxin M1 at specified ranges (µg/kg) Average aflatoxin contaminated in various foods in 2011 Aflatoxin in Peanuts 120.00 100.00 80.00 60.00 40.00 20.00 0.00 115.34 99.20 43.88 38.30 36.81 32.97 3.87 1.89 1.02 1.48 0.04 0.60 0.03 0.60 Thai ML 20 Codex ML 15 aflatoxin B1 (ug/kg) total aflatoxin (ug/kg) Mouldy kernel Good kernel

4th Asia-Pacific International Food Safety Conference & 7th Asian Conference on Food and Nutrition Safety, October 11-13, 2016, Penang, Malaysia Hazard Identification onn--aflatoxin n B1 Human epidemiological studies: - Correlation between human liver cancer and aflatoxin exposure (synergism with hepatitis B) - IARC - Group 1 Carcinogenic to humans Hazard Characterization (JECFA, 1998) - Quantitative assessment of genotoxic carcinogen (JECFA, 1998) - No threshold level no NOEL - Risk affected by presence of hepatitis B surface antigen - Potency estimates from epidemiological data: Animal studies: - LD50 in male rat: 7200 µg/kg (oral) - Hepatotoxicity - Hepatocarcinogenicity Exposure Assessment of Aflatoxin Dietary Exposure = Aflatoxinlevel in a Food x Consumption of a Food HBsAg+: 0.3 cancers/year per 100 000 population per ng AFB1/kg b.w. per day HBsAg-: 0.01 cancers/year per 100 000 population per ng AFB1/kg b.w. per day http://consumption.acfs.go.th/index.php

Comparison of total intake between average peanuts consumption and high peanuts consumption of Thai population in 2011 250 200 150 100 50 47 56.8 184.8 216.9 aflatoxin B1 intake (ng/person/day) total aflatoxin intake (ng/person/day) Ratio of Aflatoxin B1 (%) intake from various foods for average peanut consumption consumers 14.70 5.10 7.40 4.50 2.60 28.10 raw peanut ground peanut fried peanut rice dried chilli egg viscera 0 average consumption high peanut consumption others 10.10 Aflatoxin B1 from various foods 27.40 65.7% of aflatoxin intake comes from peanuts Ratio of Aflatoxin B1 (%) intake from various foods for high peanut (raw) consumption consumers Estimated risk of liver cancer in Thai consumers from Aflatoxin B1 7.00 2.60 3.70 3.10 1.90 raw peanut roasted peanut Estimated potency of liver cancer using JECFA model (1997) 81.70 fried peanuts rice dried chili Potency (cancer/year/100,000 people) = 0.01 x Aflatoxin B1 intake (ng/kgbw/day) for population without Hepatitis B surface antigen Aflatoxin B1 from various foods others 91.3% of aflatoxin intake comes from peanuts = 0.30 x Aflatoxin B1 intake (ng/kgbw/day) for population with Hepatitis B surface antigen

Estimated Potency of Liver Cancer in 2011 (cancer/year/100,000 people) Estimated Potency of Liver Cancer caused by Aflatoxin B1(cancer/year/Thai population) 0.14 0.135 0.12 25 0.1 20 0.08 0.06 0.04 0.034 15 10 22 0.02 0 average consumption high peanut consumption 5 0 2011 Cancer risk How to manage risk from aflatoxin in peanuts? Establishment of standards for entire food chain Establish standards for the whole food chain Promote standards to farmers, shellers, manufacturers, etc. Certify producers Certify products Educate consumers Anything else??? Farm Peanut shelling plant 20-30% Raw peanuts Processing plant Peanut products Import peanuts 70-80%

Establishment of standards for entire food chain GAP Farm Peanut shelling plant Raw peanuts Processing plant Peanut products Import peanuts GMP Setting up standards on peanut Produce Std GMP/HA CCP Product Std 1. Establishment of voluntary standards for entire food chain Thai Agricultural Standard on Good Agricultural Practices for Peanut (TAS 4900-2010) covers all steps in the primary production practiced by farmers especially the steps affecting the contamination of aflatoxin e.g. drying, pod sorting, storage, etc. Main regulations on contaminants Notification under MOPH (No. 98) B.E. 2529 (1986) entitled Contaminants in Foods Tin, Zinc, Copper, Lead, Arsenic, Mercury, Aflatoxin ML of aflatoxins in food in general is 20 µg/kg Notification under MOAC B.E. 2537 (1994) entitled Property of deteriorated feed ML of aflatoxin in feed (30-200 µg/kg) and feed raw material (50-500 µg/kg) Setting up standards on peanut (cont.) Thai Agricultural Standard on Good Manufacturing Practices for Peanut Shelling Plant covers all steps affecting the contamination of aflatoxin in the shelling plant e.g. raw material storage, shelling, sorting, etc. Thai Agricultural Standard on Dried Peanut (TAS4700-2011) covers minimum requirements/quality criteria including specification of moisture content and total aflatoxin, sampling and analysis of aflatoxin, etc.

Setting up standards on peanut (cont.) 2. Development of mandatory standard (Regulation) on Peanut kernel : Aflatoxin requirement ML = [15 or 20] µg/kg (ppb) focusing on peanut shelling plant, peanut distributor, importer & exporter Estimated Potency of Liver Cancer (cancer/year/thai population) Comparison between present situation and removal from market 50% peanut contaminated with Aflatoxin (total) at level higher than 15 and 20 ppb 25 20 15 10 5 22 17 17 0 present situation remove 50% peanut>15ppb remove 50% peanut>20ppb Estimated Potency of Liver Cancer (cancer/year/thai population) Regulation Comparison between present situation and removal from market 90% peanut contaminated with Aflatoxin (total) at level higher than 15 and 20 ppb 25 20 15 10 5 22 10 10 PEANUT KERNEL : MAXIMUM LEVEL OF AFLATOXIN (TAS 4702 2014) To be effective on January 2017 for peanut kernels sold/imported into Thailand 0 present situation remove 90% peanut>15ppb remove 90% peanut>20ppb

4th Asia-Pacific International Food Safety Conference & 7th Asian Conference on Food and Nutrition Safety, October 11-13, 2016, Penang, Malaysia TAS : Pea Peanut nut Kernel Kerne : Maximum Level of Aflatoxin Maximum level of total aflatoxins in peanut kernel shall not exceed 20 ppb (microgram/kilogram) Control measures for peanut kernel producers (shelling plant, collector, packer, and warehouse operator) Sorting Testing for aflatoxins before selling Control measures for importer and exporter Control of moisture content/sorting of peanuts & aflatoxin testing Implement at producer level Control mea measure for peanut ut kernel producer Mouldy kernel, broken kernel, damaged kernel and foreign matters shall be sorted out before distribution and record be kept Such defective kernel shall be separated in clearly labelled container, and shall not be marketed for human consumption or processed into food products. Peanut sorting

4th Asia-Pacific International Food Safety Conference & 7th Asian Conference on Food and Nutrition Safety, October 11-13, 2016, Penang, Malaysia Study of Aflatoxin Afflatoxin n re reduction ed by sorting Mouldy kernel Aflatoxin level in peanut kernel passing normal/routine sorting at 16 81 µg/kg Good kernel Re-sorting Aflatoxin reduced to 0-50 µg/kg 17-100% reduction : Average 82% Control mea measures for peanut ut kernel producer To ensure tthat peanut kernel is in compliance with the specified maximum level : A shelling manufacturer shall be required to test aflatoxin level of each lot of peanut kernel prior to distribution. A collector, packer, or warehouse operator shall be randomly tested aflatoxin level during storage Test result shall be kept for inspection by competent authority or certification body inspector as requested. Exporter Peanut kernel exporter shall have Evidence showing that exported peanut kernel is produced by the licensed and certified peanut kernel producer in accordance with this standard Test result by recognized competent authority or private laboratory showing that aflatoxin level does not exceed the maximum level or limit as required by trading-partner countries.

Importer Peanut kernel importer shall have Evidence showing that imported peanut kernel is produced from peanut kernel producer who has control measure in place Test result issued by the recognized competent authority or private laboratory showing that aflatoxin level does not exceed the maximum level specified. Importation of peanut into Thailand Implement of Std. by producer & exporter Register & certify producer /exporter by CA/CB Export of peanut kernel to Thailand Information/training Testing by lab / Use of Test kit Audit/certify producer/exporter List of approved producer /exporter prepared & submit to ACFS Recognition of CA/CB by ACFS Recognised Lab with Std. methods CoA for Aflatoxin each shipment Information provided to importer Border control by Thai MOAC Risk Communication Risk manager vs Risk assessor Risk manager vs Policy maker Risk manager vs Stakeholders Peanut kernel producers, importers/exporters Peanut farmers Peanut processors Certification bodies, Laboratories Consumers, Public Summary Risk-based standards can be achieved by the application of risk analysis principles including risk assessment, risk management & risk communication Adequate data and knowledge are needed in conducting risk assessment Farm-to-Table risk management to ensure consumer safety Standard harmonization taking into account international standards and risk analysis principles is a key success in ensuring food safety and fair trade in ASEAN

Questions or Comments?? Thank you Pisan Pongsapitch pisan@acfs.go.th www.acfs.go.th