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RISTEK
Risk-Based Approach for Aflatoxin ControlRisk-Based Approach for Aflatoxin Control
Roy SparringaRoy 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
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How important is
aflatoxin
Food standard for
aflatoxin
Risk assessment
Aflatoxin control
Conclusion &
Recommendation
AGENDAAGENDA
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Source:1.ICRISAT2.Iowa State University.3.Queensland Govt.
The beauty of
Aspergillus flavus
The beauty of
Aspergillus flavus
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22
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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?
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?
Target organs of some Target organs of some mycotoxinsmycotoxins
Mycotoxin Target
Aflatoxin liver
Ochratoxin A kidney
Trichothecenes mucosa
Ergot alkaloids peripheral vascularsystem
Zearalenone uro-genital tract
Aflatoxins and hepatitis B virus are cocarcinogens, with increased risk of liver cancer if both factors are present
7
Before Vaccination
19.5%
5.8%4% 5%
11.3%20.3% 11.7% 11.3%
9.2%7.3%
7.1%
4%
4%
10.5%
Population 222,192,000 people (2006)Moderately to highly endemic for Hepatitis B (WHO)HBsAg prevalence
- 10% (3.4-20.3%) in healthy population- 37-76% in liver cirrhosis- 37-68% in hepatocellular carcinoma (HCC)
HEPATITIS B IN INDONESIAHEPATITIS B IN INDONESIA
Top Ten for Consideration of Chemical Burden of Disease Estimates*
1. Methyl mercury2. Lead3. Cadmium4. Pesticides5. Fluoride6. Cyanide7. Aflatoxin 8. Dioxin9. Arsenic10. Barium
* Herman Gibb, Sciences International. It is being discussed by WHO GEMS/Food (2007)
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
Regulatory limits for aflatoxins Regulatory limits for aflatoxins in some Asian and Pacific countriesin some Asian and Pacific countries
CountryAustralia/New Zealand
China
IndiaJapan
MalaysiaPhilippines
SingaporeSri LankaThailandIndonesia
15 (T)5 (T)
20 (B1)30 (B1)10 (B1)5 (B1)
35 (T)20 (B1)
Absence (B1)*30 (T)20 (T)30 (T)20 (B1)
peanutsother foods maize, peanutallriceother grainsallcoconuts, peanut products (export)
allallAllPeanut and corn
Limit (µg/kg) Commodity
BB11 = Aflatoxin B= Aflatoxin B11T = Total AflatoxinsT = Total Aflatoxins*Limit of detection is around 10 µg/kg
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.
Regulatory limits for aflatoxins Regulatory limits for aflatoxins in EU, UK and USAin EU, UK and USA
Exposure ‹ Toxicity reference?Exposure > Toxicity reference?
How important is the standard?
Consumption data
Exposure
Risk characterization
Toxicity reference
Risk AssessorADIPTDI, PTWIARfD etc
FOOD INSPECTOR
Max Limit
Σ Food x Σ Concentration
Body weight=
Comply?
RISK MANAGER
Risk assessment is a decision-support toolfor risk management
IMPLEMENT RISK MANAGEMENT
DECISION
IMPLEMENT RISK MANAGEMENT
DECISION • Assess the outcome • Review the outcome• Assess the outcome • Review the outcome
MONITOR AND REVIEWMONITOR AND REVIEW
• Policy• Regulation• Standard etc
• Policy• Regulation• Standard etc
Risk Assessor
EVALUATE RISKEVALUATE RISK
ASSESS RISK MANAGEMENT OPTION
ASSESS RISK MANAGEMENT OPTION
HAZARD INDENTIFICATION
HAZARD INDENTIFICATION
HAZARD CHARACTERIZATION
HAZARD CHARACTERIZATION
EXPOSURE ASSESSMENT
EXPOSURE ASSESSMENT
RISK CAHARACTERIZATION
RISK CAHARACTERIZATION
What is our concern
TOXICOLOGICAL REFERENCE
ARfD, NOEL, LOEL, ADI, PTDI, PTWI
etc
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
CHEMICAL RISK ASSESSMENT
Final management decisionFinal management decision
Risk management withidentified issue
Risk management withidentified issue
Risk profileRisk profile
Decision onhow to proceed
Decision onhow to proceed
No risk assessmentNo risk assessment
Consider resultsConsider results
Select managementoptions
Select managementoptions
Hazard characterization
Exposure assessment
Hazard identification
Riskcharacterization
RISK MANAGEMENTRISK MANAGEMENT
RISK ASSESSMENT
RISK ASSESSMENT
Perform risk assessmentPerform risk assessment
Fig. Risk management with risk assessment supports
Risk assessment Risk management
Risk estimate Risk management decision
ALOP (Appropriate level of
protection)
ALOP (Appropriate level of
protection)
FSO – PO – PC – PrC - MCFSO – PO – PC – PrC - MCHACCPGAPs / GHPs/ GMPs
Appropriate level of protection (ALOP)
Appropriate level of protection (ALOP)
Food safety objective (FSO)
Food safety objective (FSO)
Performance objective (PO)Performance
objective (PO)
Performance criterion
(PC)
Performance criterion
(PC)
Risk-based food safety management
Risk-based food safety management
Microbiological criterion
Microbiological criterion
Set by government / regulator
At the time of consumptionThe maximum frequency and/or concentration of a hazard in a food at the time of consumption
At a specified step in the food chainThe 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 controlThe 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
Process criterion
(PrC)
Process criterion
(PrC)
Variable for process controlTo control parameter of a process or the combination of processes that can be applied to achieve the PO
Sampling and testingTo define and check compliance with microbiological requirements, e.g. absence/presence mo, number mo/lot etc
FOOD SAFETY ASSURANCE
FOOD SAFETY ASSURANCE
Food Law, Other Laws related to food safety
Government Regulation
HACCP
GAPs / GHPs/ GMPs
ALOP – FSO – PO – PC – PrC - MC
Government levelGovernment level
Operational Level from farm to table (Industry)
Operational Level from farm to table (Industry)
Risk management decision
Parliament & Govt Parliament & Govt
Primary Production
Primary Production
ManufacturesManufactures
TransportTransport
RetailRetail
PreparationPreparation
CookingCooking
ConsumptionConsumption
Performance criteria
Control measures
Performance objective
Performance objective
Food safety objective
ExposurePublic health burden< ALOP
Fig. Food safety practices throughout the food chain
Performance objective
Performance objective