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A Comprehensive Feed Safety Approach for Rendered Products FDA Public Meeting Discussion of Animal Feed Safety System September 23, 2003: 

A Comprehensive Feed Safety Approach for Rendered Products FDA Public Meeting Discussion of Animal Feed Safety System September 23, 2003 David Harlan Taylor Packing Co., Inc An Excel Food Solutions Company

Slide2: 

Food Animal Production Pet Foods Rendered Co-Products Animal Feed Manufacture Meat Processing Feed Ingredients Consumer Foods Rendering Cycle Plays a Critical Role

Beef Processing Typical Fed-Cattle Plant: 

Dressing Floor Fabrication Further Process Edible Beef Products Inedible Rendering Beef Processing Typical Fed-Cattle Plant Blood Drying Edible Rendering Feed & Technical USDA Ante mortem

Beef Processing Taylor Packing : 

Dressing Floor Fabrication Edible Beef Products Inedible Rendering Beef Processing Taylor Packing Blood Drying Feed & Technical USDA Ante mortem Further Process

Taylor Rendering Process: 

CENTRIFUGE Dressing Offal C O O K E R Taylor Rendering Process MIX & GRIND Fab Bone & Fat PRESS (3) SCREEN Solid Liquid COOLER STORAGE GRIND/SCREEN LOADOUT/ BLENDING TANK FILTER BEEF TALLOW TANKS

Comprehensive Program: 

Comprehensive Program Philosophy & Commitment Raw Material Source, Specifications & Assurances Hazard Analysis & Critical Control Point program Good Manufacturing Practices Employee Training Programs Transportation Policy Third Party Audits

Philosophy & Commitment: 

Philosophy & Commitment Preventative Mindset Proactive vs. Reactive Continuous Improvement Commitment from Entire Team Leadership Management Production

Raw Material Specifications: 

Raw Material Specifications In-House Packer Source – 100% Bovine with mixed supply from 70% mature cows and 30% fed-cattle 100% from Cattle Passing Ante Mortem Inspection Conducted by USDA:FSIS Veterinarian Packinghouse Training & Awareness Relative to Potential Physical & Chemical Contaminants CNS Tissue Removed in Packinghouse

Hazard Analysis and Critical Control Point (HACCP) 7 Principles: 

Hazard Analysis and Critical Control Point (HACCP) 7 Principles Assess Hazards Determine Critical Control Points – CCP Establish Critical Limits for CCP’s – CCPCL Procedures to Monitor CCP’s Develop Corrective Action Plans Recordkeeping Verification

Potential Hazards 3 Classes: 

Potential Hazards 3 Classes Biological Microbiological Insect Infestation TSE’s Chemical Pesticides & PCB’s Lubricants, oils, etc. Physical Metal Plastic

HACCP Example Microbiological - Pasteurization: 

HACCP Example Microbiological - Pasteurization Assess Hazard Raw material contains potential pathogens Determine Critical Control Points – CCP Cooker discharge temperature - TEMP Raw material grind - GRIND Processing rate - RATE Establish Critical Limits for CCP’s – CCPCL TEMP - Minimum 270o F based on validation study GRIND - Maximum 30 mm anvil gap on pre-breaker RATE - Maximum 36,000 pounds/hour feed rate

HACCP – Microbiological Continued: 

HACCP – Microbiological Continued Procedures to Monitor CCP’s TEMP - Continuous monitoring by certified thermocouple GRIND - Inspection, Weekly measurement of anvil gap RATE - Computer tracking of cooker feed auger Develop Corrective Action Plans TEMP - Alarm notification, automated discharge shutoff GRIND - Repair, Rebuild when gap reaches 30 mm RATE - Reduce feed rate if over 36,000 pounds/hour

HACCP – Microbiological Continued: 

HACCP – Microbiological Continued Recordkeeping TEMP - Computer tracking of CCP and alarm log GRIND - Operations & maintenance logs RATE - Computer tracking of CCP and alarm log Verification Clostridium perfringens testing – indicator organism 15 day intervals Rotate shift and time within shift

Slide14: 

Plant Operator Screen

Slide15: 

Recordkeeping Cooker Temperature Trending and Statistical Analysis

Good Manufacturing Practices (GMP): 

Good Manufacturing Practices (GMP) Housekeeping Issues Recordkeeping Pest Control Program Facility Design & Repair Sanitation Program Startup & Shutdown Procedures

GMP Example Prevent Salmonella Recontamination: 

GMP Example Prevent Salmonella Recontamination APPI model adopted by +99% of industry Process zones in facility Work habits & policies Startup procedures Reprocessing of product spills Dry cleaning of finished product areas Sanitation practices that target “hot spots” Facility design & equipment maintenance Effectiveness verified by finished product testing No CCP available except formaldehyde addition

Employee Training: 

Employee Training Specific Modules on HACCP, GMP’s and SOP’s New Hires Entry at Trainee position Individualized training over several months Career Advancement Training program for each position Certified by written & verbal testing All Employee’s Quarterly quality training Immediate team review of feed safety issues

Transportation Policy: 

Transportation Policy Certification of regulatory compliance by carriers Trucks are only to haul agricultural commodities Trucks are to be clean prior to arrival Visual inspection of empty trucks upon arrival No visible carryover regardless of past ingredient hauled Will the integrity of our product be maintained? Assurance of cleanout after delivery Included in policy signed by carriers & drivers Prominent reminder to driver attached to Bill of Lading Clean Conveyances and Inspection Prior to Loading Is the Responsibility of Every Ingredient Supplier!!

Third Party Audits 21 CFR 589.2000: 

Third Party Audits 21 CFR 589.2000 APPI Certification via Cook & Thurber Found high compliance in Rendering Industry Confirmed by FDA Inspections Discontinued because of high compliance Facility Certification Institute - FCI Requirements are based upon FDA rule Must prove compliance with FCI program Ingredient supplier and transport certifications Must demonstrate adequacy of flushing when co-mingling restricted use products Annual audits to maintain status in program

Thank You Special Thanks To: Debby Capela, Taylor Packing The Taylor & Excel Rendering Team : 

Thank You Special Thanks To: Debby Capela, Taylor Packing The Taylor & Excel Rendering Team