A Comprehensive Feed SafetyA Comprehensive Feed SafetyApproach for Rendered Products Approach for Rendered Products

FDA Public MeetingFDA Public MeetingDiscussion of Animal Feed Safety SystemDiscussion of Animal Feed Safety System

September 23, 2003September 23, 2003

David HarlanTaylor Packing Co., Inc An Excel Food Solutions Company

Food Animal Production

Pet Foods

RenderedCo-Products

Animal FeedManufacture

Meat Processing

Feed Ingredients

ConsumerFoods

Rendering Cycle Plays a Critical Role

Dressing Floor

Fabrication

Further Process

Edible Beef Products

Inedible Rendering

Beef ProcessingBeef Processing Typical Fed-Cattle PlantTypical Fed-Cattle Plant

Blood Drying

EdibleRendering

Feed & Technical

USDA Ante mortem

Dressing Floor

Fabrication

Edible Beef Products

Inedible Rendering

Beef ProcessingBeef ProcessingTaylor PackingTaylor Packing

Blood Drying

Feed & Technical

USDA Ante mortem

Further Process

CENTRIFUGE

Dressing Offal

COOKER

Taylor Rendering ProcessTaylor Rendering Process

MIX & GRIND

Fab Bone & Fat

PRESS (3)SCREENSolidLiquid

COOLER

STORAGE

GRIND/SCREEN

LOADOUT/BLENDING

TANK

FILTER

BEEF TALLOWTANKS

Comprehensive ProgramComprehensive Program

Philosophy & CommitmentPhilosophy & Commitment Raw Material Source, Specifications & AssurancesRaw Material Source, Specifications & Assurances Hazard Analysis & Critical Control Point programHazard Analysis & Critical Control Point program Good Manufacturing PracticesGood Manufacturing Practices Employee Training ProgramsEmployee Training Programs Transportation PolicyTransportation Policy Third Party Audits Third Party Audits

Philosophy & CommitmentPhilosophy & Commitment

Preventative MindsetPreventative Mindset Proactive vs. ReactiveProactive vs. Reactive Continuous ImprovementContinuous Improvement Commitment from Entire TeamCommitment from Entire Team

– LeadershipLeadership– ManagementManagement– ProductionProduction

Raw Material SpecificationsRaw Material Specifications

In-House Packer Source – 100% Bovine with mixed In-House Packer Source – 100% Bovine with mixed supply from 70% mature cows and 30% fed-cattle supply from 70% mature cows and 30% fed-cattle

100% from Cattle Passing Ante Mortem Inspection 100% from Cattle Passing Ante Mortem Inspection Conducted by USDA:FSIS VeterinarianConducted by USDA:FSIS Veterinarian

Packinghouse Training & Awareness Relative to Packinghouse Training & Awareness Relative to Potential Physical & Chemical ContaminantsPotential Physical & Chemical Contaminants

CNS Tissue Removed in PackinghouseCNS Tissue Removed in Packinghouse

Hazard Analysis and Critical Hazard Analysis and Critical Control Point (HACCP) Control Point (HACCP)

7 Principles7 Principles

1.1. Assess Hazards Assess Hazards

2.2. Determine Critical Control Points – CCPDetermine Critical Control Points – CCP

3.3. Establish Critical Limits for CCP’s – CCPCLEstablish Critical Limits for CCP’s – CCPCL

4.4. Procedures to Monitor CCP’sProcedures to Monitor CCP’s

5.5. Develop Corrective Action PlansDevelop Corrective Action Plans

6.6. RecordkeepingRecordkeeping

7.7. Verification Verification

Potential HazardsPotential Hazards3 Classes3 Classes

BiologicalBiological– MicrobiologicalMicrobiological

– Insect InfestationInsect Infestation

– TSE’sTSE’s

ChemicalChemical– Pesticides & PCB’sPesticides & PCB’s

– Lubricants, oils, etc.Lubricants, oils, etc.

PhysicalPhysical– MetalMetal

– Plastic Plastic

HACCP Example HACCP Example Microbiological - PasteurizationMicrobiological - Pasteurization

1.1. Assess HazardAssess Hazard• Raw material contains potential pathogensRaw material contains potential pathogens

2.2. Determine Critical Control Points – CCPDetermine Critical Control Points – CCPa.a. Cooker discharge temperature - Cooker discharge temperature - TEMPTEMPb.b. Raw material grind - Raw material grind - GRINDGRINDc.c. Processing rate - Processing rate - RATERATE

3.3. Establish Critical Limits for CCP’s – CCPCLEstablish Critical Limits for CCP’s – CCPCLa.a. TEMPTEMP - Minimum 270 - Minimum 270oo F based on validation study F based on validation study b.b. GRINDGRIND - Maximum 30 mm anvil gap on pre-breaker - Maximum 30 mm anvil gap on pre-breakerc.c. RATERATE - Maximum 36,000 pounds/hour feed rate - Maximum 36,000 pounds/hour feed rate

HACCP – MicrobiologicalHACCP – MicrobiologicalContinuedContinued

4.4. Procedures to Monitor CCP’sProcedures to Monitor CCP’sa.a. TEMPTEMP - Continuous monitoring by certified - Continuous monitoring by certified

thermocouplethermocouple

b.b. GRINDGRIND - Inspection, Weekly measurement of anvil gap - Inspection, Weekly measurement of anvil gap

c.c. RATERATE - Computer tracking of cooker feed auger - Computer tracking of cooker feed auger

5.5. Develop Corrective Action PlansDevelop Corrective Action Plansa.a. TEMPTEMP - Alarm notification, automated discharge shutoff - Alarm notification, automated discharge shutoff

b.b. GRINDGRIND - Repair, Rebuild when gap reaches 30 mm - Repair, Rebuild when gap reaches 30 mm

c.c. RATERATE - Reduce feed rate if over 36,000 pounds/hour - Reduce feed rate if over 36,000 pounds/hour

HACCP – MicrobiologicalHACCP – MicrobiologicalContinuedContinued

6.6. RecordkeepingRecordkeepinga.a. TEMPTEMP - Computer tracking of CCP and alarm log - Computer tracking of CCP and alarm log

b.b. GRINDGRIND - Operations & maintenance logs - Operations & maintenance logs

c.c. RATERATE - Computer tracking of CCP and alarm log - Computer tracking of CCP and alarm log

7.7. Verification Verification • Clostridium perfringens testing – indicator organismClostridium perfringens testing – indicator organism

• 15 day intervals 15 day intervals

• Rotate shift and time within shiftRotate shift and time within shift

Plant Operator Screen

RecordkeepingCooker TemperatureTrending and Statistical Analysis

Good Manufacturing Practices Good Manufacturing Practices (GMP)(GMP)

Housekeeping IssuesHousekeeping Issues RecordkeepingRecordkeeping Pest Control ProgramPest Control Program Facility Design & RepairFacility Design & Repair Sanitation ProgramSanitation Program Startup & Shutdown Procedures Startup & Shutdown Procedures

GMP ExampleGMP Example Prevent Salmonella RecontaminationPrevent Salmonella Recontamination

APPI model adopted by +99% of industryAPPI model adopted by +99% of industry Process zones in facilityProcess zones in facility Work habits & policiesWork habits & policies Startup procedures Startup procedures Reprocessing of product spillsReprocessing of product spills Dry cleaning of finished product areasDry cleaning of finished product areas Sanitation practices that target “hot spots”Sanitation practices that target “hot spots” Facility design & equipment maintenanceFacility design & equipment maintenance Effectiveness verified by finished product testingEffectiveness verified by finished product testing

No CCP available except formaldehyde additionNo CCP available except formaldehyde addition

Employee TrainingEmployee Training Specific Modules on HACCP, GMP’s and SOP’sSpecific Modules on HACCP, GMP’s and SOP’s New Hires New Hires

– Entry at Trainee positionEntry at Trainee position– Individualized training over several monthsIndividualized training over several months

Career Advancement Career Advancement – Training program for each positionTraining program for each position– Certified by written & verbal testing Certified by written & verbal testing

All Employee’s All Employee’s – Quarterly quality trainingQuarterly quality training– Immediate team review of feed safety issuesImmediate team review of feed safety issues

Transportation PolicyTransportation Policy Certification of regulatory compliance by carriersCertification of regulatory compliance by carriers Trucks are only to haul agricultural commoditiesTrucks are only to haul agricultural commodities Trucks are to be clean Trucks are to be clean priorprior to arrival to arrival Visual inspection of empty trucks upon arrivalVisual inspection of empty trucks upon arrival

– No visible carryover regardless of past ingredient hauledNo visible carryover regardless of past ingredient hauled– Will the integrity of our product be maintained?Will the integrity of our product be maintained?

Assurance of cleanout after delivery Assurance of cleanout after delivery – Included in policy signed by carriers & driversIncluded in policy signed by carriers & drivers– Prominent reminder to driver attached to Bill of LadingProminent reminder to driver attached to Bill of Lading

Clean Conveyances and Inspection Prior to LoadingIs the Responsibility of Every Ingredient Supplier!!

Third Party AuditsThird Party Audits21 CFR 589.200021 CFR 589.2000

APPI Certification via Cook & ThurberAPPI Certification via Cook & Thurber– Found high compliance in Rendering IndustryFound high compliance in Rendering Industry– Confirmed by FDA Inspections Confirmed by FDA Inspections – Discontinued because of high complianceDiscontinued because of high compliance

Facility Certification Institute - FCIFacility Certification Institute - FCI– Requirements are based upon FDA ruleRequirements are based upon FDA rule– Must prove compliance with FCI programMust prove compliance with FCI program– Ingredient supplier and transport certificationsIngredient supplier and transport certifications– Must demonstrate adequacy of flushing when co-Must demonstrate adequacy of flushing when co-

mingling restricted use productsmingling restricted use products– Annual audits to maintain status in programAnnual audits to maintain status in program

Thank YouThank You

Special Thanks To:Special Thanks To:Debby Capela, Taylor Packing Debby Capela, Taylor Packing

The Taylor & Excel Rendering TeamThe Taylor & Excel Rendering Team