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CFSAN/Office of Compliance
March 2, 2004
Grade "A" Pasteurized Milk Ordinance
2003 Revision
(This document is also available in
PDF, 3.5 MB)
TABLE OF CONTENTS
- List of Previous Editions of USPHS/FDA Milk Ordinance
- Foreword
- Preface
- Introduction
-
Table of Contents
-
Grade "A" Pasteurized Milk Ordinance (Grade "A" PMO)--2003 Revision
- Section 1. Definitions
- Section 2. Adulterated or Misbranded Milk or Milk Products
- Section 3. Permits
- Section 4. Labeling
- Section 5. Inspection of Dairy Farms and Milk Plants
- Section 6. The Examination of Milk and Milk Products
- Section 7. Standards For Grade "A" Milk and Milk Products
- Standards For Grade "A" Raw Milk For Pasteurization, Ultra-Pasteurization or Aseptic Processing
- Item 1r. Abnormal Milk
- Item 2r. Milking Barn, Stable or Parlor - Construction
- Item 3r. Milking Barn, Stable or Parlor - Cleanliness
- Item 4r. Cowyard
- Item 5r. Milkhouse - Construction and Facilities
- Item 6r. Milkhouse - Cleanliness
- Item 7r. Toilet
- Item 8r. Water Supply
- Item 9r. Utensils and Equipment - Construction
- Item 10r. Utensils and Equipment - Cleaning
- Item 11r. Utensils and Equipment - Sanitization
- Item 12r. Utensils and Equipment - Storage
- Item 13r. Milking - Flanks, Udders and Teats
- Item 14r. Protection From Contamination
- Item 15r. Drug and Chemical Control
- Item 16r. Personnel - Handwashing Facilities
- Item 17r. Personnel - Cleanliness
- Item 18r. Raw Milk Cooling
- Item 19r. Insect and Rodent Control
- Standards For Grade "A" Pasteurized, Ultra-Pasteurized and Aseptically Processed Milk and Milk Products
- Item 1p. Floors - Construction
- Item 2p. Walls and Ceilings - Construction
- Item 3p. Doors and Windows
- Item 4p. Lighting and Ventilation
- Item 5p. Separate Rooms
- Item 6p. Toilet-Sewage Disposal Facilities
- Item 7p. Water Supply
- Item 8p. Handwashing Facilities
- Item 9p. Milk Plant Cleanliness
- Item 10p. Sanitary Piping
- Item 11p. Construction and Repair of Containers and Equipment
- Item 12p. Cleaning and Sanitizing of Containers and Equipment
- Item 13p. Storage of Cleaned Containers and Equipment
- Item 14p. Storage of Single-Service Containers, Utensils and Materials
- Item 15p. Protection From Contamination
- Item 16p. Pasteurization and Aseptic Processing
- Item 16p.(A) Batch Pasteurization
- Item 16p.(B) High-Temperature-Short-Time (HTST) Continuous-Flow Pasteurization
- Item 16p.(C) Aseptic Processing Systems
- Item 16p.(D) Pasteurizers and Aseptic Processing Systems Employing Regenerative Heating
- Milk or Milk Product-To-Milk or Milk Product Regenerative Heating
- Milk or Milk Product-To-Water To-Milk or Milk Product Regenerative Heating
- Item 16p.(E) Pasteurization and Aseptic Processing Records, Equipment Tests and Examinations
- Item 17p. Cooling of Milk and Milk Products
- Item 18p. Bottling, Packaging and Container Filling
- Item 19p. Capping, Container Closure and Sealing and Dry Milk Product Storage
- Item 20p. Personnel - Cleanliness
- Item 21p. Vehicles
- Item 22p. Surroundings
- Section 8. Animal Health
- Section 9. Milk and Milk Products Which May Be Sold
- Section 10. Transferring; Delivery Containers;
Cooling
- Section 11. Milk and Milk Products From Points Beyond the
Limits of Routine Inspection
- Section 12. Plans For Construction and
Reconstruction
- Section 13. Personnel Health
- Section 14. Procedure When Infection or High Risk of
Infection is Discovered
- Section 15. Enforcement
- Section 16. Penalty
- Section 17. Repeal and Date of Effect
- Section 18. Separability Clause
-
Footnotes
-
Appendix A. Animal Disease Control
- Appendix B. Milk Sampling, Hauling and Transportation
- Milk Sampling and Hauling Procedures
- Milk Tank Truck Permitting and Inspection
- Appendix C. Dairy Farm Construction Standards and Milk Production
- Toilet and Sewage Disposal Facilities
- Guideline #45 - Gravity Flow Gutters For Manure Removal In Milking Barns
- Convalescent (Maternity) Pens In Milking Barns and Stables
- Guidelines For Conventional Stall Barn With Gutter Grates Over Liquid Manure Storage
- Dairy - Construction and Operation
- Milking Barn, Stable or Parlor
- Milkhouse
- Milking Methods
- Reverse Flush Systems
- Drug Residue Avoidance Control Measures
- Insect and Rodent Control
-
Appendix D. Standards For Water Sources
- Location of Water Sources
- Construction
- Disinfection of Water Sources
- Continuous Water Disinfection
- Water Reclaimed From Milk and Milk Products
- Water Reclaimed From Heat Exchanger Processes
- Drawings of Construction Details For Water Sources
-
Appendix E. Examples of 3-Out-of-5 Compliance Enforcement Procedures
- Appendix F. Sanitization
- Methods of Sanitization
- Evaporating, Drying and Dry Product Equipment Cleaning
- Appendix G. Chemical and Bacteriological Tests
- Private Water Supplies and Recirculated Water - Bacteriological
- Pasteurization Efficiency - Field Phosphate Test
- Phosphatase Reactivation In HTST Pasteurized Products
- Detection of Pesticides In Milk
- Detection of Drug Residues In Milk
- Analysis of Milk and Milk Products For Vitamin A and D3 Content
- Appendix H. Pasteurization Equipment and Procedures
- HTST Pasteurization
- Air For Drying Equipment and Air Under Pressure - Direct Contact With Milk and Milk Products and Milk Product - Contact Surfaces
- Culinary Steam - Milk and Milk Products
- Thermometer Specifications
- Criteria For The Evaluation of Computerized Systems For Grade 'A' Public Health Controls
- Criteria For Steam-Block Type FDD Systems
- Milk and Milk Products HACCP CCP Models For Pasteurization Equipment
- Appendix I. Pasteurization Equipment and Controls - Tests
- Testing Apparatus Specifications
- Test Procedures
- Appendix J. Standards For The Fabrication of Single-Service Containers and Closures For Milk and Milk Products
- Preface
- Purpose and Scope
- Definitions
- Bacterial Standards and Examination of Single-Service Containers and Closures
- Fabrication Plant Standards
- Floors
- Walls and Ceilings
- Doors and Windows
- Lighting and Ventilation
- Separate Rooms
- Toilet Facilities - Sewage Disposal
- Water Supply
- Handwashing Facilities
- Plant Cleanliness
- Locker and Lunchrooms
- Disposal of Wastes
- Personnel - Practices
- Protection From Contamination
- Storage of Materials and Finished Product
- Fabricating Equipment
- Materials For Construction of Containers and Closures
- Waxes, Adhesives, Sealants, Coatings and Inks
- Handling of Containers and Equipment
- Wrapping and Shipping
- Identification and Records
- Surroundings
- Criteria For Listing Certified Single-Service Manufacturers In The IMS List
- Appendix K. HACCP Program
- The HACCP System Introduction
- Implementation of A HACCP System
- Training and Standardization
- HACCP Audits and Follow-Up Actions
-
Appendix L. Applicable Regulations, Standards of Identity For Milk and Milk Products and The Federal Food, Drug, and Cosmetic Act
-
Appendix M. Reports and Records
- Appendix N. Drug Residue Testing and Farm Surveillance
- Industry Responsibilities
- Regulatory Agency Responsibilities
- Testing Program For Drug Residues Established
- Established Tolerances and/or Safe Levels of Drug Residues
- Approved Methods
-
Appendix O. Vitamin Fortification of Fluid Milk Products
-
Appendix P. Performance-Based Dairy Farm Inspection System
- Appendix Q. Operation of Automatic Milking Installations For The Production of Grade "A" Raw Milk For Pasteurization
-
Index
ILLUSTRATIONS
- Figure 1. Side Cross Section of a Gravity Flow Gutter
- Figure 2. Stepped Gravity Flow Gutter
- Figure 3. Cross Section of a Typical Gutter and Grate
- Figure 4. Manure Transfer to Storage
- Figure 5. Side Cross Section of a Convalescent Pen
- Figure 6. Schematic Diagram Showing Suggested Exhaust Fan Locations for a Typical Stall Dairy Barn with Gutter Grates Over Liquid Manure Storage
- Figure 7. Schematic Diagram Showing General Pattern of Ventilation Air Movement, Slot Inlet Design and Fan House for Pit Fans
- Figure 8. Bored Well with Driven Well Point
- Figure 9. Drilled Well with Submersible Pump
- Figure 10. Dug Well with Two-Pipe Jet Pump Installation
- Figure 11. Pumphouse
- Figure 12. Spring Protection
- Figure 13. Pond
- Figure 14. Schematic Diagram of a Pond Water-Treatment System
- Figure 15. Cistern
- Figure 16. Typical Concrete Reservoir
- Figure 17. Pit-less Adapter with Submersible Pump Installation for Basement Storage
- Figure 18. Clamp-on Pit-less Adaptor with Concentric External Piping for "Shallow Well" Pump Installation
- Figure 19. Pit-less Unit with Concentric External Piping for Jet Pump Installation
- Figure 20. Weld-on Pit-less Adapter with Concentric External Piping for "Shallow Well" Pump Installation
- Figure 21. Well Seal for Jet Pump Installation
- Figure 22. Well Seal for Submersible Pump Installation
- Figure 23. Typical Valve and Box, Manhole Covers, and Piping Installation
- Figure 24. Suction Feeder
- Figure 25. Positive Displacement Chlorinator
- Figure 26. Milk-to-Milk Regeneration - Homogenizer Upstream from Holding Tube
- Figure 27. Milk-to-Milk Regeneration - Booster Pump
- Figure 28. Milk-to-Milk Regeneration - Homogenizer and Vacuum Chambers Downstream from Flow-Diversion Device
- Figure 29. HTST System with a Magnetic Flow Meter Using a Constant Speed Centrifugal Pump and a Control Valve
- Figure 30. HTST System with a Magnetic Flow Meter Using an A-C Variable Speed Centrifugal Pump
- Figure 31. Controls for Steam Injection Pasteurizer
- Figure 32. Individual Compression-Type Air Supply
- Figure 33. Central Compression-Type Air Supply
- Figure 34. Individual Blower-Type Air Supply
- Figure 35. Individual Fan-Type Air Supply
- Figure 36. Rotating Mandrel Assembly
- Figure 37. Culinary Steam Piping Assembly for Steam Infusion or Injection
- Figure 38. Culinary Steam Piping Assembly for Airspace Heating or Defoaming
- Figure 39. Logic Diagram: Flow-Diversion Device, Divert Valve Stem
- Figure 40. Logic Diagram: Flow-Diversion Device, Leak-Detect Valve Stem
- Figure 41. Logic Diagram: Safety Thermal Limit Recorder-Controller
- Figure 42. Logic Diagram: Timing Pump
- Figure 43. Logic Diagram: Booster Pump
- Figure 44. Pressure Switch Setting
- Figure 45. Vitamin Fortification
TABLES
- Table 1. Chemical, Physical, Bacteriological, and Temperature Standards
- Table 2. Combinations of Causticity, Time and Temperature, of Equal Bactericidal Value, for the Soaker Tank of Soaker-Type Bottle Washers
- Table 3. Pasteurization Temperature vs. Time
- Table 4. Equipment Tests - Batch, HTST, HHST and Aseptic Processing Systems
- Table 5. Removal of Restrictions when Infection or High Risk of Infection is Discovered
- Table 6. Slot Size vs. Cattle Age
- Table 7. Gravity Flow Gutter Depth vs. Length for Manure from Lactating Animals
- Table 8. Step Height vs. Length for Stepped Gravity Flow Gutters
- Table 9. Work Water Volume of Various Sized Pipelines
- Table 10. Distance of a Well from Sources of Contamination
- Table 11. Example of Enforcement Procedures for Pasteurized Milk Laboratory Examinations
- Table 12. Example of Enforcement Procedures for Raw Milk Laboratory Examinations
- Table 13. Sieve Sizes and Designations
- Table 14. Holding Tube Length - HHST Pasteurizers - Indirect Heating
- Table 15. Holding Tube Length - HHST Pasteurizers - Direct Heating