HACCP Principles. Principle 1: Hazard Analysis. Purpose. Hazard Analysis Process. Hazard Analysis Form. HACCP Principle 1: Conduct a Hazard Analysis

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1 HACCP Principles 1. Conduct Hzrd Anlysis (HA) OFFICE OF THE TEXAS STATE CHEMIST Texs Feed nd Fertilizer Control Service Principle 1: Hzrd Anlysis Chpter 8 Hzrd Anlysis HACCP A Systemtic Approch to Food Sfety Agriculture Anlyticl Service 2. Identify Criticl Control Points (CCPs) 3. Estblish Criticl Limits (CLs) 4. Estblish CCP Monitoring Requirements 5. Estblish Corrective Actions (CA) 6. Estblish Verifiction Procedures 7. Estblish Record Keeping Procedures OFFICE OF THE TEXAS STATE CHEMIST 2 HACCP Principle 1: Conduct Hzrd Anlysis Purpose Definition of Hzrd Anlysis The process of collecting nd evluting informtion on hzrds ssocited with the product under considertion to decide which re significnt nd must be ddressed in the HACCP pln The purpose of the hzrd nlysis is to develop list of hzrds which re of such significnce tht they re resonbly likely to cuse injury or illness if not effectively. The HACCP tem conducts hzrd nlysis nd identifies pproprite control mesures NACMCF, 1998 OFFICE OF THE TEXAS STATE CHEMIST 3 OFFICE OF THE TEXAS STATE CHEMIST 4 Hzrd Anlysis Process 1) Hzrd identifiction 2) Hzrd evlution Biologicl Identify nd evlute know or resonbly foreseeble hzrds for ech type of niml food mnufctured, processed, pckged, or held t the fcility to determine whether there re hzrds tht re resonbly likely to occur including biologicl, chemicl, physicl, nd rdiologicl hzrds. OFFICE OF THE TEXAS STATE CHEMIST 5 OFFICE OF THE TEXAS STATE CHEMIST 6 1

2 Stge 1 Hzrd Identifiction Receive Bulk Ingredient Receiving Formultion of Feed Bgged Ingredient Receiving Liquid Receiving Resembles brin storming session in which the tem considers ech process (using the flow digrm) nd reviews informtion bout Rw mteril nd ingredients in the product Activities conducted t ech process The equipment used to mke the product The method of storge nd distribution The intended use nd consumers of the product Screen & Mgnet Storge Scle Processing Mgnet Bulk Storge Bins Bulk Scle Returned Product/ Rework Wrehouse Storge Micro Ingredient Minor Ing. Bin Bin Micro Scle Minor Scle Check Scle Mixer Holding Bin Automted Bgging Line Metl Detector Ing. Storge Continers Hnd Adds Screen Liquid Storge Mnul Plletizer Automted Plletizer Tote Filler OFFICE OF THE TEXAS STATE CHEMIST 7 Pckging Finished Prod. Storge & Storge Lodout OFFICE OF THE TEXAS STATE CHEMIST 8 Stge 1 Hzrd Identifiction Develop list of potentil biologicl, chemicl, physicl nd rdiologicl hzrds tht my be introduced, incresed or t ech of the production process Bulk Biologicl receiving Prohibited niml protein Use form to list potentil hzrds Slmonell grde Afltoxin ne identified t this OFFICE OF THE TEXAS STATE CHEMIST 9 OFFICE OF THE TEXAS STATE CHEMIST 10 Biologicl Hzrds Review the list of ingredients Are the hzrdous biologicl gents inherently ssocited with the ingredients? Are the ingredients or finished product cpble of supporting pthogens? Biologicl Hzrds Review the flow digrm Will procedure llow pthogens to multiply to hzrdous numbers? Will ingredients or the finished product become contminted with pthogens? OFFICE OF THE TEXAS STATE CHEMIST 11 OFFICE OF THE TEXAS STATE CHEMIST 12 2

3 Hzrds Review the list of rw mterils, ingredients nd pckging mterils: Are there hzrdous chemicls ssocited with growing, hrvesting or pckging of ny commodity or mteril? Are dditives pproved nd do they meet ingredient spec s? Do lbeling requirements pply nd is the product lbeled correctly? Hzrds Review the flow digrm: Are feed grde lubricnts used? Are slt nd ure levels being monitored in the process? Are clening nd snitizing chemicls pproved for use in feed mills nd used ppropritely? OFFICE OF THE TEXAS STATE CHEMIST 13 OFFICE OF THE TEXAS STATE CHEMIST 14 Hzrds Review the list of rw mterils, ingredients nd pckging mterils: Are foreign objects cpble of cusing injury ssocited with ny of the rw mterils or ingredients? Are there physicl hzrds ssocited with ny pckging mteril? Hzrds Refer to the flow digrm nd inspect the physicl fcilities t the plnt: Are there environmentl sources of physicl hzrds in nd round feed storge nd mnufcturing res? Is ny equipment cpble of generting physicl hzrds? Are there tools, utensils, nd other implements used on or ner the feed production lines tht my fll into the equipment or product? OFFICE OF THE TEXAS STATE CHEMIST 15 OFFICE OF THE TEXAS STATE CHEMIST 16 Stge 2 Hzrd Evlution HACCP tem decides which of the potentil hzrds listed during the hzrd identifiction stge present significnt risk to consumers using two fctors 1) severity (serious of the potentil illness or injury resulting from exposure to the hzrd) 2) likelihood of occurrence Stge 2 Hzrd Evlution Fctors tht my influence the likelihood of occurrence of the potentil hzrd in the finl product include: Effectiveness of prerequisite progrms Frequency of ssocition of the potentil hzrd with the food or n ingredient Method of preprtion in the estblishment Conditions during trnsporttion Expected storge conditions The likely preprtion s prior to consumption OFFICE OF THE TEXAS STATE CHEMIST 17 OFFICE OF THE TEXAS STATE CHEMIST 18 3

4 FSMA rule criteri for niml food (d) The hzrd evlution must consider the effect of the following on the sfety of the finished niml food for the intended niml 1. The formultion of the niml food; 2. The condition, function, nd design of the fcility nd equipment; 3. Rw mterils nd other ingredients; 4. Trnsporttion prctices; 5. Mnufcturing/processing procedures; 6. Pckging ctivities nd lbeling ctivities; 7. Storge nd distribution; 8. Intended or resonbly foreseeble use; 9. Snittion, including employee hygiene; 10. Any other relevnt fctors Bulk Biologicl receiving Prohibited niml protein Slmonell grde Afltoxin ne identified t this OFFICE OF THE TEXAS STATE CHEMIST 19 OFFICE OF THE TEXAS STATE CHEMIST 20 Severity Stge 2 Hzrd Evlution High H-R H-L H-M H-H Medium M-R M-L M-M M-H Low L-R L-L L-M L-H Remote Low Medium High Likelihood of Occurrence More likely to be ddressed in HACCP pln Stge 1: Hzrd ID Stge 2 Hzrd Evlution Justifiction for Determining Significnce Stge 2: Hzrd Evlution Assess severity of helth consequences if potentil hzrd is not properly Determine likelihood of occurrence of potentil hzrd if not properly Using this informtion, determine if this potentil hzrd is to be ddressed in the HACCP pln Prohibited niml protein fed to ruminnts Epidemiologicl evidence indictes tht the prion tht cuses BSE cn lso infect humns cusing vrint Creutzfeldt Jkob disese Firewlls (prohibiting imported beef or bovine from the EU, prohibiting feeding of mmmlin protein to ruminnts, nd inspections) hs lowered the likelihood of this disese becoming estblished in the U.S. HACCP tem decides tht prohibited mmmlin protein must be ddressed in the HACCP pln, since this is key to voiding the estblishment of BSE in the US FPI, HACCP: A Systemtic Approch to Food Sfety OFFICE OF THE TEXAS STATE CHEMIST 21 OFFICE OF THE TEXAS STATE CHEMIST 22 Stge 2 Hzrd Evlution Justifiction for Determining Significnce Stge 1: Hzrd ID Enteric pthogen E. coli 0157:H7 in incoming ingredients Ingredient or Processing Potentil hzrds introduced, incresed or significnt Severity:Likelihood Stge 2: Hzrd Evlution Assess severity of helth consequences if potentil hzrd is not properly Determine likelihood of occurrence of potentil hzrd if not properly Using this informtion, determine if this potentil hzrd is to be ddressed in the HACCP pln Epidemiologicl evidence indictes tht this pthogen cuses severe humn helth effects. The likelihood of E. coli 0157:H7 in the incoming ingredient is low nd there is little evidence tht demonstrtes tht feed is the source of this pthogen for nimls or humns. HACCP tem decides tht the enteric pthogen E. coli 0157:H7 is not hzrd for nimls or humns. Bulk receiving Biologicl Prohibited niml protein Slmonell grde Afltoxin Cross contmintion by prohibited niml protein (21 CFR:589:2000-1) is potentil source of bovine spongiform encephlopthy (BSE) Low likelihood in niml feed ingredients Moderte likelihood in ingredients, potentil source for Slmonellosis Potentil source of toxin to nimls Toxic to finishing cttle t concentrtions bove 300 ppb BSE in cttle cn cuse the humn disese vrint Creutzfeldt Jkob disese (vcjd) Low likelihood in humn food Low likelihood of it cusing humn food problem Low likelihood of trnsfer to humn food Hi likelihood of trnsfer to milk s M1 if fed to diry cttle if corn is >20 ppb ne identified t this OFFICE OF THE TEXAS STATE CHEMIST 23 OFFICE OF THE TEXAS STATE CHEMIST 24 4

5 Hzrd Anlysis Hzrds tht re resonbly likely to occur must be For humn food sfety hzrds, they re ddressed in the HACCP pln For niml helth hzrds, they re ddressed in the prerequisite progrm Control Mesures The HACCP tem must identify mesures to control hzrds tht re resonbly likely to occur Control mesure Any ction or ctivity tht cn be used to reduce significnt hzrd OFFICE OF THE TEXAS STATE CHEMIST 25 OFFICE OF THE TEXAS STATE CHEMIST 26 Control Mesures More thn one control mesure my be required for specific hzrd Bulk receiving Biologicl Cross contmintion by BSE in cttle cn cuse Prohibited niml protein prohibited niml protein the humn disese (21 CFR:589:2000-1) is vrint Creutzfeldt potentil source of Jkob disese (vcjd) bovine spongiform encephlopthy (BSE) Prohibited niml protein policy, pproved supplier, crrier inspection Assists with tsks for Principle 2 identifying CCP s Slmonell Low likelihood in niml feed ingredients Moderte likelihood in ingredients, potentil source for Slmonellosis Low likelihood in humn food Low likelihood of it cusing humn food problem Approved supplier, clening feed mnufcturing equipment grde Potentil source of toxin to nimls Low likelihood of trnsfer to humn food Approved supplier nd testing Afltoxin Toxic to finishing cttle t concentrtions bove 300 ppb Hi potentil of trnsfer to milk s M1 if fed to diry cttle if corn is >20 ppb Smpling nd testing incoming ingredients prone to fltoxin ne identified t this OFFICE OF THE TEXAS STATE CHEMIST 27 OFFICE OF THE TEXAS STATE CHEMIST 28 END Dr. Tim Herrmn Professor, Stte Chemist & Director Office of the Stte Chemist Texs A&M University (979) tjh@otsc.tmu.edu OFFICE OF THE TEXAS STATE CHEMIST Texs Feed nd Fertilizer Control Service Agriculture Anlyticl Service 5