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H(1 ,   V   -    + V.!"1#   / 0    $%&'(   * )`$b$Q:BiRHfj]*b$pBwew(TY]*$$$$2$;^ >el+e"6 0e0e A@A5%8c8c     ?1d0u0@Ty2 NP'p<'p@A)BCD|E? !3f@8,-Yʚ;ʚ;g4PdPdV 0(ppp@ <4!d!d$k 0X@,<4dddd$k 0X@, <4dddd$l 0X0___PPT10 pp___PPT9xzdL? -O =# General Principle & Application of Risk Analysis on Food Safety qSi'`RgvSRSvQ(WߘT [hQ-Nv^(uHyCF,a 9<Food safety  a global concern   Food ingredients and products sourced around the world ߘirSeTNTegnNNLuT0W Food control measures not the same everywhere T0WvߘT[hQc6Rce N T Food safety may be perceived differently in different parts of the world N T0WW[ߘT[hQvƋ N T Can obstruct international trade VE8fS;7ZZ.ZZIZZ!ZZ7.I!  h7  .  I  !  y0 CAC & WTO  HSPSTTBTOS/fWTObXT(WVE8f-N_{u_vYOS[ ^(ukSuN iirkSuceOS[, SPS Sanitary / Phytosanitary Measures Agreement 8fb/gXWOS, TBT The Agreement on Technical Barriers to Trade  ZBZZZ3Z -ff `  :  WHOBlTOXTV (WߘT[hQLRKN N ͑p6R[Tċ0OV[vc6Rbeu /ecSU\ċ0ONߘTvsQΘivyf[ SbRgNߘn'`uuvsQvؚqSV }g'YS)R(uSU\-NV[(Wߘn'`V }qSi'`ċ0OebvOo`N6R[VEhQ0d }}a} ,3&jBRisk analysis  why ? :NNHNۏLqSi'`Rg$" 33   Food safety of increasing concern ߘT[hQ^:NsQl Move towards a risk based approach TN[qSi'`vxvz Decision making based on sound science WNyf[W@x NvQV{"Z Z#Z ZZ'Z Z" #  '   N"   #   '   Risk Analysis - what is it?  A process consisting of 3 components: risk assessment qSi'`ċ0O risk management qSi'`{t risk communication qSi'`Oo`NAm 'N'"  "  "Z9       Risk Analysis Paradigm   BRisk Assessment (CAC, 1997) qSi'`ċ0O:" "  FA scientifically based process yf[ċ0Ov z^ The evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs. (WTO) ċ0OߘT0ne0re-NvmRBR0algir0k }buS̃[NbRir\o(WoR\O(uvyf[ z^0z,,   t       >    FRisk Management (CAC, 1997) qSi'`{tD$  "  The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options. (WqSi'`ċ0Ovyf[W@x N :NObm9eP^0OۏVEߘT8f ǑSv2Tc6Rce0 *N,N,"N * 4Risk Communication qSi'`Oo`NAm   The interactive exchange of information and opinions throughout the risk analysis process concerning hazards and risks, risk related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions (WqSi'`ċ0O qSi'`{t m9 ON f[/gVSOTvQN~~1\qS[0qSi'` NqSi'`vsQvV }TtI{ۏL^lvOo`Tal SbqSi'`ċ0Ov~TqSi'`{tQV{0 DsxsU"3&s U # .qSi'`ċ0O z^ Risk AssessmentJBbbb  *Hazard (CAC, 1997) qS[8 "  2A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. ߘT-NSX[(Wvq_TNSOeP^vuir0Sf[0irtV } brQ0B{{x  Hazards in Food2Microorganisms ~̃ Fungi and mycotoxins w̃Tw̃k } Viruses and parasites ukT[uk Toxic plants and animals gkR iir Potential environmental toxicants \o(WvsX gkSf[algirZZZZZZZZ"Z Z    " t " VHazard characterisation (CAC, 1997) qS[yr_vc., "$  The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with the hazard. For the purpose of Microbiological Risk Assessment the concerns relate to microorganisms and their toxins. _uirqS[v['`JS[ϑ 0[ϑċ0O.<    HExposure Assessment (CAC, 1997) f2ċ0O8% "   The qualitative and/or quantitative evaluation of the likely intake of biological, chemical and physical agents via food as well as exposures from other sources if relevant. NߘirbvsQegnDdeQuir0Sf[TirtVP[v['`0[ϑċ0O* PRisk Characterization(CAC,1997) qSi'`yr_vc8)  "   The process of determining the qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment. (WqS[vƋ+R0qS[vyr_cTf2ċ0OvW@x Nnx[NNfSvisT%N͑'` b[eP^Nu\o(W Noq_Tv['`T/[ϑċ0OvǏ z0*2?2?0/ 5 P Risk management qSi'`{t@)#  4 Elements Risk evaluation qSi'`ċN Risk management options assessment qSi'`{t yċ0O Implementation gbL Monitoring and review vKmTV~ n n #  #          #       "Implementation gbL,  Can be done by both government officials and the food industry S?e^[eTߘTONgbL Implementation will take different forms depending what decisions have been taken gbL\9hnc][vQǑS N Tb__ MRA may be useful in implementation information on product pathogen pathway in particular exposure assessment can be a valuable information source MRA(WgbL-Nv\O(u uS̃Nuv_ yr+R/ff2ċ0OS\O:N gNrFAO/WHO activities on risk analysis FAO/WHOS_vqSi'`RgN[TO<:+  1995 - Expert Consultation on Risk Analysis and Food Safety qSi'`RgNߘT[hQ 1997 - Expert Consultation on Risk Management and Food Safety qSi'`{tNߘT[hQ 1998 - Expert Consultation on the Application of Risk Communication to Food Standards and Safety Matters qSi'`Oo`NAm(WߘThQT[hQ-Nv^(u< A  A? A  Aj A A8 ; c  N<   @   j  ? 1999 - Expert Consultation on Risk Assessment of Microbiological Hazards in Foods ߘT-N_uirqS[vqSi'`ċ0O 2000 - Expert Consultation on Interaction between Risk assessors and risk managers of Microbiological Hazards in Food ߘT-N_uirqS[vqSi'`ċ0ON{tvvN\O(u 2001 - Expert Consultation on Exposure Assessment of Microbiological Hazards in foods ߘT-N_uirqS[vf2ċ0O 2002 - Expert Consultation on Incorporating Quantitative Risk Assessment in the Development of Microbiological Food Hygiene Standards Џ(u[ϑ_uirqSi'`ċ0O6RߘTkSuhQ:S A Av A AY A A A AJrU  " "T  v    2    h ~$CCFAC & JECFA Example: Aflatoxin B1L% 3   .    !1994, CCFAC asked JECFA: (26th Session) to provide estimates of the toxicological potency of aflatoxins and to derive estimates of the potential risks for different populations 1996, JECFA (46th meeting): Aflatoxins were considered 1997, JECFA (49th meeting): Aflatoxins were carried over "   %  )J] f -   Quantitative risk assessment at 49th JECFA Meeting in 1997 JECFA 49!kOv[ϑqSi'`ċNbP3" 3&D    Lv\O(u:_^ HBsAg( ) :0.3*NLv/t^/10NN/ ng AF/ kg bw/)Y HBsAg ( ) :0.01*NLv/t^/10NN/ng AF/kg bw/)Y NqSi^ = \O(u:_^ DdeQϑJQ3e                     @O1. HBsAg( ) 1%; 'k2malg4ls^/'k2mߘ~g  ! N       DdeQϑ NqSi^ (ng/N/)Y) (*NLv/t^/10NN) Pϑ20 g/kg 19 0.0041 (0.0006-0.01) Pϑ10 g/kg 18 0.0039 (0.0006-0.01) v] 2*NLv/t^/NNX33p53 C 1 2 *BO2. HBsAg( ) 25%; -NValg4ls^/܏Nߘ~g  "  N      ( DdeQϑ NqSi^ (ng/N/)Y) (*NLv/t^/10NN) Pϑ20 g/kg 125 0.17 (0.03-0.3) Pϑ10 g/kg 103 0.14 (0.02-0.3) v] 300*NLv/t^/NN *1990-92t^hQVLv{kNs20/10NZZ33hN3.C - . )jCCFH ACTIVITIES32nd CCFH 1999 Decided to proceed in MRA on the basis of pathogen/commodity combinationsElaborated and agreed on tentative priority list of pathogen / commodity combinations Q[[uSߘT~TۏL_uirqSi'`ċ0O v^cQf[OHQ~T r3 333Z  mFCCFH Drafting groups ߘTkSulxQYXTOwI]\O~$$   PL. monocytogenes in ready-to-eat food (Germany) sSߘߘT-NvUSXNgeyr̃ Salmonella spp. in poultry (Sweden) y-Nvll̃ Campylobacter spp. in poultry (Netherlands) y-Nvzz/_f̃ Vibrio spp. in seafood (United States) wmNT-NvoRn@'`'_̃ Enterohemorrhagic E. coli in meat (United States) ߘT-NvQ@'`'YFg̃0 2 3 ) 2   # !                   $     "           !   pRWhy RA is needed in China bV:NNHNۏLqSi'`Rg"* " qWTO CODEX / GB FOOD INDUSTRY FOOD SAFETY CONTROL Government Consumers HEALTH PROTECTION Life quality knowledge   VE8f ߘTlxQ / V[hQSO| ߘT]N ߘT[hQc6R ?e^ m9 Obm9eP^ u;m(ϑvcؚ [ߘT[hQwƋvBl  $ 6HCase in China The Control of the Deteriorated Sugarcane Food Poisoning$I !<Fresh sugarcane grown in southern area of China Shipped, stored and sold through the winter season in the northern parts of China Contaminated sugarcane could cause fatal food poisoning when sold in the next springSugarcane poisoningThe first outbreak of unknown causes sugarcane poisoning occurred in Henan Province in 1972 From 1972 to 1989: No. of outbreak: 217 No. of cases: 884 No. of deaths: 88 Average fatality: 10% Identified as a priority to assess and control by MOH<om6om6E Etiology and risk assessmentEtiology and causes study were been carried out by the Chinese Academy of Preventive Medicine in 1980 s Arthrinium spp. was the pathogenic fungus; 3-nitropropionic acid (3-NPA) produced by A. spp. was proved to be the causative compound Assessment was made according to case-based studies, epidemiological and laboratory studies^h^hF)^>h J)Decision making and management activities** Based on discovery and assessment, MOH promulgated: Diagnostic criteria and principles for the management of deteriorated sugarcane poisoning (WS/T10-1996); Methods for the isolation and identification of Arthrinium strains and analyzing 3-nitropropionic acid (GB47689.16) MOH issued a notification on the prevention and control of DSP to all provinces of China A national health campaign for prevention and control of the poisoning was launched<44  Good results As a result of these efforts, sugarcane poisoning has been satisfactory controlled No typical cases were reported in China in the last 10 years! 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Within this overall framework however, Commission meetings and meetings of the Codex Committees are open to international non-governmental organizations representing all interested parties, as official Observers. NGO Observers may participate in all Codex meetings except those of the Executive Committee; may submit papers and comments on matters under consideration; and may send comments in writing at the same time as draft standards are sent to Member governments for comment. Procedures for the admission of NGOs as Observers to meetings of the Executive Committee are being developed. Sessions of the Commission and all Codex Committees except the Executive Committee are also open to the public and media. Principles for the participation of international NGOs in the work of Codex were adopted by the 23rd Session of the Commission in 1999 and are published on our web-site together with a list of NGOs in formal  Observer status . Governments have been encouraged by the Commission to include consumer representatives on national delegations to Codex sessions and to ensure that consumer organizations are represented on national  Codex Alimentarius Committees and national food standards and food control structures.(DHbx      > H  0޽h ? ̙33p 0 0(<(  <^ <S    " <c $ @   1999t^12gWHOgbYO;`r^N(WsQN ߘT[hQ vbJT-NcQ ߘn'`uu/fN*N]'Yvv^ Neib'YvlQqQkSu0 BlOXTVR:_ߘT[hQvc6R /ecSU\ߘT[hQvqSi'`ċN 2000t^1g28ecN~53J\NLukSu'YOvbJT-N͑3u)R(uSU\-NV[vOo`6R[VEhQQH < 0޽h ? ̙33 0 TLL(  L^ LS    F Lc $C @   \I would like to use the remainder of my time today to talk about how WHO works with risk managers like Codex in a process called risk analysis. Risk analysis is a process composed of three parts: Risk management, risk assessment, and risk communication. Risk assessment is the scientific evaluation of known or potential adverse health effects resulting from human exposure to foodborne hazards. WHO together with FAO conduct scientific evaluations of known or potential adverse health effects resulting from human exposure to foodborne hazards. Risk communication is an interactive process of exchange of information and opinion on risk among risk assessors, risk managers, and other interested parties. Risk management is the process of weighting policy alternatives in the light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures. An international risk manager for the protection of public health from foodborne illness already exists. 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F2 *General Principle & Application of Risk .-@"Arial Black-. *2 "'Analysis on Food Safety.-κ-. .2 7ΣԷԭʳƷ .. .2 6ΣԷԭʳƷ .-κ-. 2 C8 ȫеӦ .. 2 B7 ȫеӦ .-՜.+,0(      Ļʾ MicrosoftB( 6Times New Roman Arial Black κTahoma WingdingsSymbol Helvetica _GB2312Monotype SortsArialHelvetica-NarrowBlendsMicrosoft Clip Gallery General Principle & Application of Risk Analysis on Food Safety ΣԷԭʳƷ ȫеӦ Food safety C a global concern CAC & WTO õƬ 4.Risk analysis C why ? ΪʲôҪΣԷRisk Analysis - what is it?Risk Analysis Paradigm'Risk Assessment (CAC, 1997) Σ)Risk Management (CAC, 1997) ΣԹ"Risk Communication ΣϢΣ Risk AssessmentHazard (CAC, 1997) Σ Hazards in Food3Hazard characterisation (CAC, 1997) Σ)Exposure Assessment (CAC, 1997) ¶1Risk Characterization(CAC,1997) Σ. Risk management ΣԹImplementation ִ!Monitoring and Review Risk Analysis-who uses itCAC õƬ 22pFAO/WHOרѯ֯CACйίԱϵ Relationship between expert consultation and Codex relevant committeesHFAO/WHO activities on risk analysis FAO/WHOٿΣԷרѯ õƬ 25 õƬ 26%CCFAC & JECFA Example: Aflatoxin B1[ Quantitative risk assessment at 49th JECFA Meeting in 1997 JECFA 49λĶΣ/1. HBsAg() 1%; ŷȾˮƽ/ŷʳṹ 02. 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