AnelichPresentation-Revised 11-28-05-FINAL [Read-Only] · Presentation • Introduction • FSOs in...

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Applicability of Food Safety ObjectiveApplicability of Food Safety Objective--derived Microbiological Criteria in derived Microbiological Criteria in

Developing CountriesDeveloping Countries

Lucia Anelich Dept Biotechnology and Food Technology, Faculty of Natural Sciences, South Africa

ICMSF Symposium - Washington DC 31 October-1November2005

PresentationPresentation

•• IntroductionIntroduction•• FSOs FSOs in International Tradein International Trade•• Developing Countries and Developing Countries and

Microbiological CriteriaMicrobiological Criteria•• Indonesia*, Brazil*, South Indonesia*, Brazil*, South

Africa & MCsAfrica & MCs•• ConclusionsConclusions

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IntroductionIntroduction

Food safety objective (FSO):Food safety objective (FSO): maximum maximum frequency and/or concentration of a frequency and/or concentration of a microbiological hazard in a food at time of microbiological hazard in a food at time of consumption that provides appropriate level consumption that provides appropriate level of protection (ALOP) (ICMSF, 2002)of protection (ALOP) (ICMSF, 2002)

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IntroductionIntroduction……

•• FSO translates public health goal to FSO translates public health goal to measurable level of control measurable level of control

•• Creates link between ALOP and Creates link between ALOP and performance / process performance / process criteracritera for for manufacture of specific foodsmanufacture of specific foods


Microbiological Criteria (MCs):Microbiological Criteria (MCs): define define acceptability of a product or food lot, based acceptability of a product or food lot, based on absence/presence/number on absence/presence/number microorganisms, including parasites &/or microorganisms, including parasites &/or quantity of their toxins/metabolites, per quantity of their toxins/metabolites, per unit(s) / mass / volume / area / lot (CAC, unit(s) / mass / volume / area / lot (CAC, 2002).2002).

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•• MCs may include testing for safety MCs may include testing for safety and and qualityquality

•• FSOsFSOs basis for setting MCsbasis for setting MCs•• MCs applied to provide evidence that MCs applied to provide evidence that

FSO is met FSO is met reducing reducing foodbornefoodborneillnessillness

•• MCs contribute to achieving ALOPMCs contribute to achieving ALOP



•• MC should consist of:MC should consist of:•• Statement of m.o. of concern &/or Statement of m.o. of concern &/or

toxins/metabolites + reason for concerntoxins/metabolites + reason for concern•• Analytical methods for detection / Analytical methods for detection /

quantificationquantification•• Sampling plan Sampling plan no. field samples + size of no. field samples + size of

analytical unitanalytical unit•• Micro limits at specified point of food chainMicro limits at specified point of food chain•• No. analytical units to conform to limitsNo. analytical units to conform to limits

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•• MC should also include:MC should also include:•• Food to which criterion appliesFood to which criterion applies•• Point(s) in food chain where criterion Point(s) in food chain where criterion

appliesapplies•• Actions taken when criterion not metActions taken when criterion not met

FSOsFSOs in International Tradein International Trade

•• GovtsGovts have right to ensure have right to ensure food safety, animal & plant food safety, animal & plant health protection in particular health protection in particular countriescountries

•• Imported foods may be Imported foods may be rejectedrejected

WTO/SPSWTO/SPS

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FSOsFSOs in International Tradein International Trade……

•• NB: criteria used to determine NB: criteria used to determine safe/unsafe foods must be safe/unsafe foods must be communicated clearly to exporting communicated clearly to exporting country country (transparency)(transparency)

•• Criteria may not be more restrictive Criteria may not be more restrictive than those implemented for than those implemented for domesticallydomestically--produced food produced food artificial barrier to tradeartificial barrier to trade

WTO/SPSWTO/SPS

FSOsFSOs in International Tradein International Trade……

•• FSOsFSOs provide means of provide means of implementing concept of implementing concept of equivalenceequivalence

•• Countries may use different Countries may use different control measures to ensure control measures to ensure FSO is met FSO is met

WTO/SPSWTO/SPS

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•• Food control systems in developing Food control systems in developing countries (DC) differ widelycountries (DC) differ widely

•• Some more sophisticated than othersSome more sophisticated than others•• Least developed countries (Least developed countries (LDCsLDCs) have ) have

rudimentary food control or nonerudimentary food control or none•• LDCsLDCs rely on more developed countries rely on more developed countries

in region for support / testing imported in region for support / testing imported foods / foods for exportfoods / foods for export

Developing Countries & MCsDeveloping Countries & MCs

•• Example: Namibia Example: Namibia –– has no has no system for inspection of system for inspection of fresh / frozen fish / canned fresh / frozen fish / canned fish for exportfish for export

•• SA Bureau of Standards SA Bureau of Standards (SABS) fulfills function(SABS) fulfills function

Developing Countries & MCsDeveloping Countries & MCs……

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•• All inspected fish taken to SA by All inspected fish taken to SA by refrigerated truck (approx 2000 km) and refrigerated truck (approx 2000 km) and exported from Johannesburg exported from Johannesburg International Airport to EUInternational Airport to EU

•• MCs set by EUMCs set by EU•• Refined procedures developed by SABS Refined procedures developed by SABS

to ensure micro limits met (including to ensure micro limits met (including parasites on fresh fish)parasites on fresh fish)


•• Many Many DCsDCs have food control system have food control system spread out over:spread out over:•• Several government agenciesSeveral government agencies•• ParastatalParastatal bodiesbodies•• Private organizations (NGOs)Private organizations (NGOs)

•• FragmentationFragmentation•• Duplication of scarce resources Duplication of scarce resources •• Lack of capacity on all levels e.g. Lack of capacity on all levels e.g.

provincial and localprovincial and local

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•• Overlapping of functionsOverlapping of functions•• Multiple decisionMultiple decision--makingmaking•• Lack of communication between food Lack of communication between food

control agenciescontrol agencies•• Weak import control Weak import control dumping grounddumping ground•• No clear responsibility re food safetyNo clear responsibility re food safety•• Difficulty in harmonizing regulations with Difficulty in harmonizing regulations with

stdsstds and related texts of CACand related texts of CAC


•• Many socioMany socio--economic problems too:economic problems too:•• High unemployment ratesHigh unemployment rates•• Lack of adequate sanitation & drinking waterLack of adequate sanitation & drinking water•• UnderUnder--nutritionnutrition•• HIV/AIDS (subHIV/AIDS (sub--Saharan Africa)Saharan Africa)•• IlliteracyIlliteracy•• Civil wars (Africa)Civil wars (Africa)•• Human rights violationsHuman rights violations•• Lack of good governanceLack of good governance

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•• 44thth largest population in worldlargest population in world 220 220 million over thousands of islandsmillion over thousands of islands

•• Food product standards developed by Food product standards developed by National Standardization Agency National Standardization Agency –– based based on consensus amongst all stakeholderson consensus amongst all stakeholders

•• StdsStds developed with reference to:developed with reference to:•• ANZFA (New ZealandANZFA (New Zealand--Australia)Australia)•• CFR (USA)CFR (USA)•• CACCAC

Indonesia and MCsIndonesia and MCs

•• Some standards old Some standards old –– need updatingneed updating•• StdsStds do not cover many components of do not cover many components of

MCs e.g. sampling plansMCs e.g. sampling plans•• Most cases, Most cases, military standardsmilitary standards usedused

•• Do not include sampling plans / stringency Do not include sampling plans / stringency categories as per ICMSF (2002)categories as per ICMSF (2002)

•• Are sampling methods for general purposes Are sampling methods for general purposes of analysis of analysis

•• Based mainly on random samplingBased mainly on random sampling

Indonesia and MCsIndonesia and MCs……

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•• GovtGovt participates in Codex activities participates in Codex activities •• Only those involved + academics / Only those involved + academics /

scientists understand terminologyscientists understand terminology•• Initiatives exist attempting to improve Initiatives exist attempting to improve

food safety focusfood safety focus•• 1998: team of Indonesian and Australian 1998: team of Indonesian and Australian

specialists developed national Integrated specialists developed national Integrated Food Safety System (IFSS)Food Safety System (IFSS)


•• Model implements risk analysis principles Model implements risk analysis principles on national level through three on national level through three networks:networks:•• Food Intelligence Network Food Intelligence Network –– Risk Risk

AssessmentAssessment•• Food Control Food Control –– Risk ManagementRisk Management•• Food Promotion Network Food Promotion Network –– Risk Risk

CommunicationCommunication


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•• IFSS provides national framework for IFSS provides national framework for food safety food safety –– transcends transcends govtgovt deptsdepts, , academia, industry and consumers academia, industry and consumers

•• Enables them to work together to Enables them to work together to maximisemaximise resources and improve food resources and improve food safety safety


•• 2001: Population of 172 2001: Population of 172 million; 24 % below million; 24 % below international poverty lineinternational poverty line

Brazil and MCsBrazil and MCs

•• VERY NB: VERY NB: Poultry exportPoultry export•• Third largest poultry meat Third largest poultry meat

producer in worldproducer in world

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Brazil and MCsBrazil and MCs……

•• 1994: National 1994: National ProgrammeProgramme on Poultry on Poultry HealthHealth

•• Main goal is control of following in Main goal is control of following in poultry and eggs:poultry and eggs:•• New Castle diseaseNew Castle disease•• SalmonellaSalmonella•• Mycoplasma Mycoplasma

•• All aspects related to control of above All aspects related to control of above coveredcovered


•• 2003: National Pathogen Reduction 2003: National Pathogen Reduction ProgrammeProgramme (Ministry of Agriculture)(Ministry of Agriculture)

•• Phase 1 (2003Phase 1 (2003--2006): Focused on 2006): Focused on SalmonellaSalmonella in broilers and turkeysin broilers and turkeys

•• Directed to processing plants for both Directed to processing plants for both export and domestic productionexport and domestic production

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•• Objectives:Objectives:•• Evaluate occurrence of Evaluate occurrence of SalmonellaSalmonella in in

products products •• Build databaseBuild database•• Establish quantitative standardsEstablish quantitative standards•• Monitor degree of contamination in plantsMonitor degree of contamination in plants•• Increase ultimately, safety of productsIncrease ultimately, safety of products

•• Micro testing in accredited labs Micro testing in accredited labs includedincluded


•• Sampling plan also established:Sampling plan also established:•• Every 30 000 chicken carcasses or every Every 30 000 chicken carcasses or every

1000 turkey carcasses / day: one tested for 1000 turkey carcasses / day: one tested for SalmonellaSalmonella

•• 51 samples = one cycle (n)51 samples = one cycle (n)•• c= 12c= 12

•• When no. + samples > 12, When no. + samples > 12, GMPsGMPs, , SSOPsSSOPs, HACCP re, HACCP re--evaluatedevaluated

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•• When 2 consecutive cycles out of spec, When 2 consecutive cycles out of spec, can no longer export till 2 consecutive can no longer export till 2 consecutive cycles fall back within spec.cycles fall back within spec.

•• Here, plant comes up with contingency Here, plant comes up with contingency plan within 5 days, otherwise shut plan within 5 days, otherwise shut downdown


RetailRetail

•• 2000: National 2000: National ProgrammeProgramme for for Monitoring Sanitary Quality of Foods Monitoring Sanitary Quality of Foods (Ministry of Health)(Ministry of Health)

•• Focused on Focused on physicophysico--chemical & chemical & microbiological parameters, microbiological parameters, labellinglabelling

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RetailRetail……

•• Appropriate only to selected productsAppropriate only to selected products•• Selection based on level of Selection based on level of

consumption, higher risk, availability on consumption, higher risk, availability on market, previous involvement in market, previous involvement in outbreaks, possibility of collection of outbreaks, possibility of collection of samples, possibility of lab analysissamples, possibility of lab analysis


•• 2001: Ministry of Health established 2001: Ministry of Health established micro limits for 28 types of food micro limits for 28 types of food through Resolutionthrough Resolution

•• Resolution established 2 types samples:Resolution established 2 types samples:•• Indicative Indicative -- only one sample tested (2only one sample tested (2--class class

sampling plan)sampling plan)•• Representative Representative –– five units of same product five units of same product

(3(3--class sampling plan): n = 5; c = 0class sampling plan): n = 5; c = 0--3 3 according to according to RISKRISK

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•• Brazil also Brazil also recognisesrecognises need to reneed to re--evaluate food control system evaluate food control system

•• Paper presented at Second FAO/WHO Paper presented at Second FAO/WHO Global Forum of Food Safety Regulators Global Forum of Food Safety Regulators held in Bangkok, Thailand in 2004, held in Bangkok, Thailand in 2004, outlined new policy approachoutlined new policy approach

South Africa & MCsSouth Africa & MCs

•• Population:46.6 Population:46.6 million million

•• 48.4% have < 48.4% have < 38US$/month to 38US$/month to spendspend

•• OneOne--fifth to onefifth to one--quarter: HIV/AIDS quarter: HIV/AIDS i.e. 9i.e. 9--11 million11 million

•• MalariaMalaria•• TBTB•• UnderUnder--nutritionnutrition•• Lack of sanitation Lack of sanitation

(rural)(rural)•• Lack of drinking Lack of drinking

water (rural)water (rural)

Scenario 1Scenario 1

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South Africa & MCsSouth Africa & MCs……

•• WellWell--developed food & developed food & bevbev industryindustry•• Generates 90 billion Rand (+/Generates 90 billion Rand (+/-- 14 billion 14 billion

US$) per annumUS$) per annum•• 21% of total manufacturing sector = 21% of total manufacturing sector =

biggestbiggest•• 2238 companies 2238 companies –– most multinationalsmost multinationals

Scenario 2Scenario 2


•• Economy:Economy:•• MarketMarket--drivendriven•• ExportExport--orientedoriented•• DTI 1994: trade reforms to > regional DTI 1994: trade reforms to > regional

(SADC) & international trade (SADC) & international trade

•• Policy shift to Policy shift to valuevalue--added productsadded productsfrom from primary productsprimary products (pre 1994)(pre 1994)

Scenario 2Scenario 2……

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•• 2001: SA one of 6 net exporting nations2001: SA one of 6 net exporting nations•• Exports = 30% total value of annual Exports = 30% total value of annual

agric productionagric production•• Food & Food & bevbev exports from Africa: 65% exports from Africa: 65%

from SA (10% from Gauteng)from SA (10% from Gauteng)•• Free trade with 15 (25) EU countriesFree trade with 15 (25) EU countries•• Exports to USA via AGOA ActExports to USA via AGOA Act

Scenario 2Scenario 2……


•• Changes necessitated revision of food Changes necessitated revision of food control systemcontrol system

•• 19971997--2003: three projects FAO, World 2003: three projects FAO, World BankBank

•• No progressNo progress•• Consumer Goods Council of SA (CGCSA) Consumer Goods Council of SA (CGCSA)

Food Safety Authority (Feb 2006)Food Safety Authority (Feb 2006)

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•• Food control very fragmented Food control very fragmented •• Dept HealthDept Health•• Dept AgricultureDept Agriculture•• Dept Trade & Industry (SABS)Dept Trade & Industry (SABS)•• Private Orgs (NGOs)Private Orgs (NGOs)

•• MCs understood, developed, used MCs understood, developed, used differentlydifferently

•• MCs in MCs in govt govt = = micro limits & methodsmicro limits & methods

••


•• Most cases, no Most cases, no sampling plan, no. sampling plan, no. analytical units, analytical units, size of analytical size of analytical units units

PeanutsPeanuts

Fish & fish productsFish & fish productsExceptionsExceptions

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SA & MCsSA & MCs……

•• Hazardous to health Hazardous to health aflatoxins aflatoxins (B1)(B1)•• SA (rest of Africa): high hepatitis BSA (rest of Africa): high hepatitis B•• Risk for liver cancer higherRisk for liver cancer higher•• Peanut butter in school feeding Peanut butter in school feeding

schemesschemes•• AllAll consignments taken as hazardous consignments taken as hazardous

regardless of exporting countryregardless of exporting country

Peanuts Peanuts –– domestic & domestic & importedimported

•• 2003: 2003: DoHDoH: Regulation on : Regulation on ““tolerances tolerances for fungusfor fungus--produced toxins in produced toxins in foodstuffsfoodstuffs””; Annexure A: Sampling ; Annexure A: Sampling plan for total plan for total aflatoxins aflatoxins in peanuts in peanuts intended for further processingintended for further processing

•• WellWell--described MC included:described MC included:

SA & MCsSA & MCs…… Peanuts Peanuts –– domestic & domestic & importedimported

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••Material to be sampledMaterial to be sampled••No. incremental samples for lots < 15 No. incremental samples for lots < 15 tonnestonnes••Incremental sample collectionIncremental sample collection••Sampling static lotsSampling static lots••Sampling dynamic lotsSampling dynamic lots••Weight of incremental sampleWeight of incremental sample••Packaging & transmission of samplesPackaging & transmission of samples


••Sealing and Sealing and labelling labelling of samplesof samples••Precautions with sample preparationPrecautions with sample preparation••Homogenization of sampleHomogenization of sample••Size of test portion Size of test portion ••Selection of appropriate method of analysisSelection of appropriate method of analysis••Toxin limit of 15Toxin limit of 15 g/kg total g/kg total aflatoxinsaflatoxins


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•• Most other foods under Most other foods under DoH DoH –– few MCsfew MCs•• Not specified which pathogens NBNot specified which pathogens NB•• Testing left to discretion of Testing left to discretion of Env Env Health Health

OfficerOfficer


•• Food safety low on list of priorities of Food safety low on list of priorities of govt govt food securityfood security

•• Function of ensuring imported foodstuffs Function of ensuring imported foodstuffs safe left to importers (retailers) & safe left to importers (retailers) & standards agencies standards agencies

•• Here, MCs better understood and Here, MCs better understood and implementedimplemented

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SA & MCsSA & MCs…… Fish & fish products: Fish & fish products: domestic, import, exportdomestic, import, export

ExportExport•• Competent authority for EUCompetent authority for EU•• MCs set according to EU MCs set according to EU

requirementsrequirements•• MCs further refined to ensure MCs further refined to ensure

achieving EU requirementsachieving EU requirements

SABS (DTI)SABS (DTI)


Imports and domesticImports and domestic•• Compulsory standard specsCompulsory standard specs•• Specify:Specify:

•• Pathogens + other m.o.Pathogens + other m.o.•• Micro limitsMicro limits•• Micro proceduresMicro procedures


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Imports and domesticImports and domestic•• Based on Based on stdsstds, SABS develops , SABS develops

sampling plans etc to fulfill sampling plans etc to fulfill elements of MCselements of MCs


•• Food control systems need to be Food control systems need to be restructured in restructured in DCs DCs with respect to food with respect to food safetysafety

•• Need political willNeed political will•• FSOs FSOs and MCs not clearly understood in and MCs not clearly understood in

govtgovt•• LDCs LDCs still grappling with still grappling with GHPsGHPs, , GMPsGMPs•• MCs developed where there are MCs developed where there are ““hot spotshot spots””

+ exports+ exports

ConclusionsConclusions

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•• Most MCs for domestic foods not well Most MCs for domestic foods not well developeddeveloped

•• Most are antiquated and origin not knownMost are antiquated and origin not known•• Definitely place for FSODefinitely place for FSO--derived MCs in derived MCs in

DCsDCs::•• More scientifically basedMore scientifically based•• Derived from recent info on risk assessmentsDerived from recent info on risk assessments•• More relevant More relevant

ConclusionsConclusions……

•• Such MCs transparent + provide for Such MCs transparent + provide for equivalence equivalence NB re WTO/SPSNB re WTO/SPS


••ALOPs ALOPs need to be set need to be set esp esp re re immunoimmuno--compromised populationcompromised population

••Training, awarenessTraining, awareness

••VERY NB: participation in international VERY NB: participation in international discussions and decisiondiscussions and decision--makingmaking

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••Intensive process: wellIntensive process: well--planned strategyplanned strategy

••Matter of urgencyMatter of urgency

••Already perception that Already perception that FSOs FSOs are designed by are designed by developed world as artificial barrier to developed world as artificial barrier to trade with respect to developing countriestrade with respect to developing countries

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