RISTEK. Risk-Based Approach for Aflatoxin Control. Roy Sparringa. State Ministry of Research and Technology

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1 RISTEK Risk-Based Approach for Aflatoxin Control Roy Sparringa State Ministry of Research and Technology Presented at International Seminar Managing Aflatoxin - from Farm to Table IPB International Convention Center, Bogor, June 25, 2008 A-PDF Split DEMO : Purchase from to remove the watermark

2 Food standard for Risk assessment Aflatoxin control Recommendation How important is Conclusion & aflatoxin aflatoxin AGENDA O O O O O OCH 3

3 1 The beauty of Aspergillus flavus 2 Source: 1.ICRISAT 2.Iowa State University. 3.Queensland Govt. 3

4 How important is aflatoxin? Aflatoxin has received considerable attention due to their significance in agricultural loss and human health. Aflatoxin is epidemiologically implicated as carcinogen in humans and an environmental contaminant which is widespread in nature, therefore chronic toxicity is of greater concern than acute toxicity. How to control aflatoxin?

5 Food Watch 2007 Vol II Problems of aflatoxin What we have found in Indonesia? Post harvest technology to tackle the situation What we can do?

6 Target organs of some mycotoxins Mycotoxin Target Aflatoxin Ochratoxin A Trichothecenes Ergot alkaloids Zearalenone liver kidney mucosa peripheral vascular system uro-genital tract Aflatoxins and hepatitis B virus are cocarcinogens, with increased risk of liver cancer if both factors are present

7 HEPATITIS B IN INDONESIA 7.1% 19.5% 4% 10.5% 5.8% 4% 4% 5% 11.3% 9.2% 7.3% 20.3% Before 11.7% 11.3% Vaccination Population 222,192,000 people (2006) Moderately to highly endemic for Hepatitis B (WHO) HBsAg prevalence - 10% ( %) in healthy population % in liver cirrhosis % in hepatocellular carcinoma (HCC) 7

8 Top Ten for Consideration of Chemical Burden of Disease Estimates* 1. Methyl mercury 2. Lead 3. Cadmium 4. Pesticides 5. Fluoride 6. Cyanide 7. Aflatoxin 8. Dioxin 9. Arsenic 10. Barium * Herman Gibb, Sciences International. It is being discussed by WHO GEMS/Food (2007)

9 Food Standard for Aflatoxin Permitted maximum levels of aflatoxins vary greatly within Asia, often depending on whether the country imports or exports the affected commodities. Very strict regulation can be costly. The cost of aflatoxin-induced hepatocellular carcinoma can also be high, particularly where there is a high number of hepatitis B virus carriers

10 Regulatory limits for aflatoxins in some Asian and Pacific countries Country Australia/New Zealand China India Japan Malaysia Philippines Singapore Sri Lanka Thailand Indonesia *Limit of detection is around 10 µg/kg Limit (µg/kg) 15 (T) 5 (T) 20 (B 1 ) 30 (B 1 ) 10 (B 1 ) 5 (B 1) 35 (T) 20 (B 1 ) Absence (B 1 )* 30 (T) 20 (T) 30 (T) 20 (B 1 ) Commodity peanuts other foods maize, peanut all rice other grains all coconuts, peanut products (export) all all All Peanut and corn B 1 = Aflatoxin B 1 T = Total Aflatoxins

11 Regulatory limits for aflatoxins in EU, UK and USA European Mycotoxin Regulations Groundnuts, nut and dried for direct consumption shall not exceed 2 μg/kg of AFB1 and 4 μg/kg for total aflatoxins. Nut dried fruit, spices shall not exceed 5 μg/kg for AFB1 and 10 μg/kg for total aflatoxins. The UK Food Standards Agency and USFDA Legal limits levels of aflatoxin B1 and total aflatoxins in nuts and nut product of 2 and 4 μg/kg respectively.

12 Comply? Standard Negative list Positive list (Max level)) FOOD INSPECTOR Food inspector

13 How important is the standard? Exposure = Σ Food x Σ Concentration Body weight Risk characterization Exposure Toxicity reference? Exposure > Toxicity reference? Consumption data Toxicity reference FOOD INSPECTOR Comply? Max Limit ADI PTDI, PTWI ARfD etc Risk Assessor

14 Risk assessment is a decision-support tool for risk management EVALUATE RISK ASSESS RISK MANAGEMENT OPTION Risk Assessor Policy Regulation Standard etc RISK MANAGER IMPLEMENT RISK MANAGEMENT DECISION MONITOR AND REVIEW Assess the outcome Review the outcome

15 CHEMICAL RISK ASSESSMENT HAZARD INDENTIFICATION What is our concern HAZARD CHARACTERIZATION EXPOSURE ASSESSMENT TOXICOLOGICAL REFERENCE ARfD, NOEL, LOEL, ADI, PTDI, PTWI etc RISK CAHARACTERIZATION How much, how often, what is the level, who is the consumer Compare the daily intake (exposure) with the toxicological reference. Exceeding the reference is a risk for human health

16 Hazard characterization Hazard identification Exposure assessment RISK MANAGEMENT Risk management with identified issue Risk profile Risk characterization Decision on how to proceed RISK ASSESSMENT Perform risk assessment Consider results No risk assessment Select management options Fig. Risk management with risk assessment supports Final management decision

17 Risk assessment Risk management Risk estimate Risk management decision ALOP (Appropriate level of protection) GAPs / GHPs/ GMPs HACCP FSO PO PC PrC - MC

18 Appropriate level of protection (ALOP) Set by government / regulator Risk-based food safety management Food safety objective (FSO) Performance objective (PO) Performance criterion (PC) Process criterion (PrC) Microbiological criterion At the time of consumption The maximum frequency and/or concentration of a hazard in a food at the time of consumption At a specified step in the food chain The maximum frequency and/or concentration of a hazard in a food at a specified step in the food chain before the time of consumption (contribute to FSO and ALOP) Effect in of a control The effect in frequency and/or concentration of a hazard in a food that must be achieved by the application of one / more control measures to contribute to a PO or FSO Variable for process control To control parameter of a process or the combination of processes that can be applied to achieve the PO Sampling and testing To define and check compliance with microbiological requirements, e.g. absence/presence mo, number mo/lot etc

19 FOOD SAFETY ASSURANCE Parliament & Govt Government level Food Law, Other Laws related to food safety Government Regulation ALOP FSO PO PC PrC-MC Operational Level from farm to table (Industry) HACCP GAPs / GHPs/ GMPs Risk management decision

20 Primary Production Manufactures Performance objective Performance objective Performance criteria Transport Retail Performance objective Control measures Preparation Cooking Food safety objective Public health burden Exposure < ALOP Fig. Food safety practices throughout the food chain Consumption

Estimated cancers/year due to peanut and peanut sauce consumption*

Estimated cancers/year due to peanut and peanut sauce consumption* HBsAg prevalence in Indonesia 10% (3.4-20.3%) It assumes that 10% of the population carries the hepatitis B virus. Potency: 0.01 x 90% + 0.3 x 10% = 0.039 cancers per year/100 000 people per ng aflatoxin

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