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

FOOD INSPECTOR

Comply?

Food inspector

Standard• Negative list• Positive list (Max level))

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