S E C O N D E D I T I O N F o o d P l a n t SANITATION Design, Maintenance, and Good Manufacturing Practices S E C O N D E D I T I O N F o o d P l a n t SANITATION Design, Maintenance, and Good Manufacturing Practices MICHAEL M. CRAMER Boca Raton London New York CRC Press is an imprint of the Taylor & Francis Group, an informa business CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2013 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Version Date: 20130404 International Standard Book Number-13: 978-1-4665-1174-3 (eBook - PDF) This book contains information obtained from authentic and highly regarded sources. Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use. 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Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com Contents Preface ............................................................................................................xi The Author ..................................................................................................xiii 1 Sanitation Regulatory Requirements .....................................................1 FDA .............................................................................................................2 Food Safety Modernization Act of 2011 ....................................................16 USDA ...............................................................................................17 Sanitation Standard Operating Procedures (SSOPs) .........................17 Sanitation Performance Standards (SPSs) ................................24 European Food Safety Authority ..............................................................34 References ..................................................................................................35 2 Regulatory Inspection and Control Action ..........................................37 Inspection ..................................................................................................37 Regulatory Control Action .......................................................................46 Recall .........................................................................................................48 Recall Policy .....................................................................................49 Recall Procedure ...............................................................................50 Practice Recovery ..............................................................................57 References ..................................................................................................60 3 Microorganisms of Food Manufacturing Concern ..............................61 Microorganisms .........................................................................................61 Bacterial Requirements ..............................................................................62 Moisture ...........................................................................................63 Temperature .....................................................................................63 Oxygen ............................................................................................64 Differentiation .................................................................................64 Bacteria Shapes ........................................................................65 Gram Staining .........................................................................65 Spore Formation ......................................................................65 Nutrient Metabolism ...............................................................65 v vi  ◾  Contents Nonpathogenic Microorganisms .......................................................65 Spoilage Organisms .........................................................................66 Pathogens .........................................................................................67 Listeria monocytogenes ..............................................................67 Salmonella................................................................................68 Escherichia coli O157:H7 ..........................................................68 Staphylococcus aureus ................................................................69 Campylobacter ..........................................................................69 Bacillus cereus ...........................................................................69 Yersinia enterocolitica ................................................................69 Clostridium ..............................................................................70 Viruses .....................................................................................70 Parasites ...................................................................................71 Foodborne Illness.......................................................................................71 Microbiological Control Methods ..............................................................71 Incoming Ingredients .......................................................................73 Sanitary Design and Materials .........................................................77 Sanitation .........................................................................................78 Microbiological Testing and Validation ............................................78 Good Manufacturing Practices .........................................................78 Pest Control ......................................................................................78 Employee Education .........................................................................79 References ..................................................................................................79 4 Control of Listeria in Food Manufacturing .........................................81 Listeria .......................................................................................................81 Requirements .............................................................................................82 Listeriosis ....................................................................................................83 Listeria Harborage and Contamination ...........................................84 Listeria Management and Control Methods..............................................84 Ingredients ........................................................................................89 Sanitary Design and Materials ..........................................................91 Sanitation .........................................................................................93 Product .............................................................................................94 Microbiological Testing and Validation ............................................94 Personnel ..........................................................................................95 Pest Control ......................................................................................95 Construction ....................................................................................95 Employee Education .........................................................................99 References ..................................................................................................99 5 Biofilms ..............................................................................................101 Formation ................................................................................................101 Contents  ◾  vii Evidence of Biofilm ..................................................................................103 Biofilm Removal ......................................................................................105 Current Research .....................................................................................106 References ................................................................................................107 6 Sanitary Facility Design .....................................................................109 The AMI 11 Principles of Sanitary Facility Design [10,12].......................111 Principle 1: Distinct Hygienic Zones Established in the Facility .....111 Principle 2: Personnel and Material Flows Controlled to Reduce Hazards ..............................................................................112 Principle 3: Water Accumulation Controlled in the Facility ...........113 Principle 4: Room Temperature and Humidity Controlled ............113 Principle 5: Room Airflow and Room Air Quality Controlled .......115 Principle 6: Site Elements Facilitate Sanitary Conditions ................116 Principle 7: Building Envelope Facilitates Sanitary Conditions .......116 Principle 8: Interior Spatial Design Promotes Sanitation ................118 Principle 9: Building Components and Construction Facilitate Sanitary Conditions ........................................................................118 Principle 10: Utility Systems Designed to Prevent Contamination ...............................................................................121 Principle 11: Sanitation Integrated into Facility Design ..................122 Other Considerations for Facility Sanitary Design ..................................122 Equipment ...............................................................................................124 The 10 Principles of Sanitary Design .......................................................124 Principle 1: Cleanable to a Microbiological Level (Contact and Noncontact Surfaces) ......................................................................124 Principle 2: Made of Compatible Materials .....................................125 Principle 3: Accessible for Inspection, Maintenance, Cleaning, and Sanitation ................................................................................126 Principle 4: Self-Draining—No Product or Liquid Collection ........126 Principle 5: Hollow Areas Hermetically Sealed (No Penetration of Hollow Areas) .............................................................................126 Principle 6: No Niches (Pits, Cracks, Recesses, Poor Welds, Corrosion) ......................................................................................127 Principle 7: Sanitary Operational Performance (No Contribution to Insanitary Conditions During Operations) ...........128 Principle 8: Hygienic Design of Maintenance Enclosures (Junction Boxes, etc.) ......................................................................129 Principle 9: Hygienic Compatibility with Other Plant Systems (Electric, Air, Water) .......................................................................129 Principle 10: Validate Cleaning and Sanitary Protocols (Encourage Equipment Designers to Demonstrate Effective Cleaning of the Equipment) ...........................................................129 viii  ◾  Contents Other Considerations for Sanitary Equipment Design .............................130 Repairs ............................................................................................131 References ................................................................................................132 7 Sanitation Best Practices ....................................................................135 Who Is Responsible for Sanitation? ..........................................................136 Sanitarians ......................................................................................137 Written Cleaning Procedures ...................................................................142 Considerations for Effective Cleaning ......................................................143 Soils ................................................................................................144 Chemical Functions ........................................................................144 Water ..............................................................................................145 Cleaning Chemicals ........................................................................146 Cleaning Systems and Equipment ..................................................147 The Cleaning Process .............................................................148 Specialized Cleaning Procedures and Equipment ...........................153 Equipment Baking ................................................................154 Deep Cleaning ......................................................................155 Floors and Floor Drain Cleaning ...........................................155 Sanitizing ..............................................................................157 Ozone ....................................................................................161 Operational Sanitation ..........................................................162 Mid-Shift Cleanup .........................................................................163 Inspections ............................................................................164 References ................................................................................................165 8 Verification of Sanitation ...................................................................167 Verification ..............................................................................................167 Organoleptic ...................................................................................168 ATP Bioluminescence .....................................................................170 Microbiological ...............................................................................173 Validation .......................................................................................178 Environmental Listeria Monitoring ..........................................................178 Alternatives .....................................................................................181 Prerequisite Monitoring Program ...................................................183 Identification of Swab Sites .............................................................184 Commando Swabs ..........................................................................184 Swab Frequency and Selection of Sites ............................................186 Collection of Swabs ........................................................................186 Analysis ..........................................................................................191 Data Tracking.................................................................................192 Positive Swab Investigation .............................................................193 Corrective Actions ..........................................................................195 Contents  ◾  ix Test and Hold ........................................................................197 Special Event Sampling .........................................................198 FSIS Testing ..........................................................................198 Intensified Verification Testing and Routine L. monocytogenes Monitoring .................................................199 Product Testing for L. monocytogenes ....................................200 References ................................................................................................201 9 Employee Good Manufacturing Practices ..........................................205 Rationale for Good Manufacturing Practices (GMPs) .............................205 Basic Good Manufacturing Practices ......................................................206 Hands and Hand Washing ............................................................206 Employee Welfare Rooms ...............................................................213 Locker Storage and Sanitation ........................................................215 Gloves .............................................................................................216 Hair and Beard Covers ...................................................................217 Clothing and Footwear ...................................................................218 Jewelry ...................................................................................221 Disease Control .............................................................................222 Food and Tobacco .........................................................................222 Raw and Cooked Separation...........................................................223 Visitors and Contractors .................................................................223 Maintenance GMPs ........................................................................224 Training and Implementation .........................................................227 Monitoring and Enforcement ........................................................228 Operational Sanitation ..................................................................228 References ................................................................................................232 10 Pest Control and Sanitation ...............................................................233 Pests of Food Plant Concern ...................................................................234 Insects............................................................................................234 Rodents ..........................................................................................237 Birds ...............................................................................................238 Pest Control Measures .............................................................................238 Pest Control Program .....................................................................238 Habitat Elimination........................................................................242 Exclusion ...............................................................................245 Sanitation .......................................................................................247 Externally ..............................................................................247 Internally ...............................................................................248 Warehousing ...................................................................................248 Extermination .................................................................................248 Bird Control ...................................................................................252 x  ◾  Contents Chemical Interventions ............................................................................253 Insecticides and Alternatives ...........................................................253 Residuals and Nonresidual Insecticides ..........................................253 Insecticide Application ...................................................................254 Alternatives to Chemical Insecticides ..............................................255 Rodenticides ...................................................................................255 Avicides...........................................................................................256 What Do You Do if a Bird Gets in the Plant? .................................256 References ................................................................................................256 11 Chemical and Physical Hazard Control .............................................259 Chemical Hazards ...................................................................................259 True Food Allergy ...................................................................................260 Food Intolerance .....................................................................................260 Regulatory Requirements .........................................................................262 Allergen Management ..............................................................................265 Ingredients ..............................................................................................268 Production ...............................................................................................271 Packaging and Labeling ...........................................................................273 Sanitation and Allergen Control ..............................................................274 Consumer Feedback ................................................................................275 Disposition/Liability ................................................................................275 Physical Hazards ......................................................................................277 Sanitation Role in Physical Hazard Prevention ........................................279 References ...............................................................................................280 Index ...........................................................................................................281