GUIDELINES FOR THE SAFE HANDLING OF ENZYMES IN DETERGENT MANUFACTURING Version 2.1 – June 2015 Complete report Enzymes Occupational Exposure Working Group LIST OF CONTRIBUTORS ................................................................................................... 3 LIST OF ABREVIATIONS .................................................................................................... 4 CHAPTER 1 - INTRODUCTION ........................................................................................... 5 CHAPTER 2 - HEALTH HAZARDS ...................................................................................... 7 2.1. ALLERGY ...................................................................................................................................... 7 2.2. IRRITATION ................................................................................................................................... 8 CHAPTER 2, REFERENCES.................................................................................................................... 9 CHAPTER 3 - SETTING OF OCCUPATIONAL EXPOSURE GUIDELINES FOR ENZYMES WITHIN THE DETERGENT INDUSTRY ............................................................................. 10 3.1. OEGS OF CURRENTLY USED ENZYMES IN DETERGENT MANUFACTURING ............................ 10 3.2. DETERMINATION OF OEGS FOR NEW ENZYMES .................................................................... 11 3.3. VERIFICATION OF OEGS ....................................................................................................... 11 CHAPTER 3 - APPENDIX 1: EXAMPLES OF SUBTILISIN EXPOSURE REGULATORY LIMITS (2011 VERSION). .......................................................................................................................................... 12 CHAPTER 3, REFERENCES.................................................................................................................. 13 CHAPTER 4 - MANAGEMENT AND SUPERVISION ......................................................... 14 4.1. RISK ASSESSMENT ...................................................................................................................... 16 4.2. RISK MANAGEMENT ................................................................................................................... 19 4.3. MANAGEMENT OF CHANGE ........................................................................................................ 20 4.4. RISK COMMUNICATION .............................................................................................................. 20 4.5. MONITORING .............................................................................................................................. 20 4.6. TRAINING ................................................................................................................................... 21 4.7. AUDIT ......................................................................................................................................... 22 CHAPTER 5 - CONTROL OF EXPOSURE DURING THE HANDLING OF ENZYMES AND THE MANUFACTURE OF ENZYMATIC DETERGENTS ................................................... 23 5.1. ENZYMES QUALITY AND FORM .................................................................................................. 24 5.2. SUPPLY UNITS ............................................................................................................................ 27 5.3. STORAGE OF SUPPLY UNITS ....................................................................................................... 27 5.4. DISPOSAL OF EMPTY SUPPLY UNITS .......................................................................................... 28 5.5. BUILDING AND PLANT DESIGN CONSIDERATIONS ..................................................................... 29 5.6. DISCHARGE OF SUPPLY UNITS ................................................................................................... 33 5.7. ENZYME TRANSFER AND DOSING .............................................................................................. 39 5.8. MIXING / BLENDING / FLUIDISING.............................................................................................. 43 5.9. BULK OR INTERMEDIATE STORAGE ........................................................................................... 44 5.10. PACKING OF FINISHED PRODUCT ............................................................................................. 49 5.11. TABLETTING ............................................................................................................................. 54 5.12. PRODUCT RECLAIM, REWORK AND TRADE RETURNS ............................................................. 55 5.13. FILTRATION OF EXTRACT AIR FROM VENTILATION CONTROL SYSTEMS................................ 58 5.14. DEALING WITH SPILLAGES, AND CLEANING OF PLANT AND EQUIPMENT ............................... 59 5.15. RESPIRATORY PROTECTIVE EQUIPMENT (RPE) ....................................................................... 62 5.16. PERSONAL PROTECTIVE EQUIPMENT (PPE) ............................................................................. 63 CHAPTER 5 - APPENDIX 1: THE DOWNFLOW BOOTH ....................................................................... 65 CHAPTER 5 - APPENDIX 2: EXAMPLE OF A SIZE ................................................................................ 66 CHAPTER 6 - PERFORMANCE ASSESSMENT OF EQUIPMENT AND BEHAVIOUR ..... 68 6.1. SEMI QUANTITATIVE ASSESSMENT OF CONTAINMENT ............................................................... 68 6.2. ASSESSMENT OF EQUIPMENT PERFORMANCE AND MAINTENANCE ............................................ 69 6.3. DETECTING AND RANKING PEAK EXPOSURE SOURCES ............................................................... 70 6.4. BEHAVIOUR OBSERVATION SYSTEM (BOS) ............................................................................... 72 1 CHAPTER 6 - APPENDIX 1: SITE ENZYME PROGRAM OPERATIONAL GUIDELINES MONITORING SURVEY ............................................................................................................................................. 75 CHAPTER 6 - APPENDIX 2: EXAMPLE OF A RANKING SYSTEM FOR A SEMI-QUANTITATIVE ASSESSMENT OF CONTAINMENT ........................................................................................................ 76 CHAPTER 6 - APPENDIX 3: CRITICALITY INDEX RATING GUIDELINES ............................................... 77 CHAPTER 6 - APPENDIX 4: OBSERVATION CYCLE ............................................................................ 78 CHAPTER 6- APPENDIX 5: BOS SURVEY ............................................................................................ 79 CHAPTER 6, REFERENCES.................................................................................................................. 80 CHAPTER 7- ROUTINE AIR MONITORING PROGRAMME .............................................. 81 7.1. APPROACH .................................................................................................................................. 81 7.2. COMPONENTS OF AN AIR MONITORING PROGRAMME ................................................................ 81 CHAPTER 8 - HEALTH SURVEILLANCE ............................................................................... 87 8.1. DEFINITION ................................................................................................................................. 87 8.2. OBJECTIVES ................................................................................................................................ 87 8.3. PRE-PLACEMENT TESTING .......................................................................................................... 88 8.4. TEMPORARY WORKERS .............................................................................................................. 88 8.5. EMPLOYEES WORKING WITH ENZYMES ...................................................................................... 88 8.6. RECORD KEEPING ....................................................................................................................... 89 8.7. DATA INTERPRETATION AND FOLLOW-UP .................................................................................. 89 CHAPTER 8 - APPENDIX 1: THE RESPIRATORY QUESTIONNAIRE ....................................................... 90 CHAPTER 8 - APPENDIX 2: LUNG FUNCTION TESTING USING A SPIROMETER .................................... 93 CHAPTER 8 - APPENDIX 3: IMMUNOLOGICAL TESTS ......................................................................... 95 CHAPTER 8, REFERENCES.................................................................................................................. 99 CHAPTER 9 – MONITORING AND PERFORMANCE ASSESSMENT FOLLOW-UP ...... 101 9.1. APPROACH ................................................................................................................................ 101 9.2. PROCESS ................................................................................................................................... 101 CHAPTER 9 - APPENDIX 1 : MULTI-CAUSE ANALYSIS..................................................................... 103 CHAPTER 9 - APPENDIX 2: MULTIPLE CAUSE-ANALYSIS APPLIED TO AIR SAMPLING ..................... 104 CHAPTER 9 - APPENDIX 3: PROBLEM INVESTIGATION REPORT ....................................................... 105 CHAPTER 9, REFERENCES...............................................................................................................