FDA/CFSAN - Grade A Pasteurized Milk Ordinance 2001 Revision

U.S. Department of Health and Human Services
U.S. Food and Drug Administration
Center for Food Safety & Applied Nutrition
Grade "A" Pasteurized Milk Ordinance
2001 Revision
May 15, 2002

List of Previous Editions of PHS/FDA Milk Ordinance
Foreword
Preface
Introduction
Table of Contents
- Illustrations
- Tables
Grade "A" Pasteurized Milk Ordinance (PMO) - 2001 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(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-to-Milk Regenerative Heating
    - Item 16p(e). Pasteurization and Aseptic Processing Records, Equipment Tests and Examinations
    - Item 17p. Cooling of Milk
    - Item 18p. Bottling and Packaging
    - Item 19p. Capping
    - 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 Re-Construction
- 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
1. Milk Sampling and Hauling Procedures
2. Milk Tank Truck Permitting and Inspection
Appendix C. Dairy Farm Construction Standards and Milk Production
1. Toilet and Sewage Disposal Facilities
2. Guideline #45-Gravity Flow Gutters For Manure Removal in Milking Barns
3. Convalescent (Maternity) Pens in Milking Barns and Stables
4. Guidelines For Conventional Stall Barn With Gutter Grates Over Liquid Manure Storage
5. Dairy - Construction and Operation
  - Milking Barn, Stable or Parlor
  - Milkhouse or Milkroom
  - Milking Methods
  - Drug Residue Avoidance Control Measures
  - Insect and Rodent Control
Appendix D. Standards For Water Sources
1. Location of Water Sources
2. Construction
3. Disinfection of Water Sources
4. Continuous Water Disinfection
5. Water Reclaimed From the Condensing of Milk and Milk Products
6. Water Reclaimed From Heat Exchanger Processes
7. Drawings of Construction Details for Water Sources
Appendix E. Examples of 3-out-of-5 Compliance Enforcement Procedures
Appendix F. Sanitization
Appendix G. Chemical and Bacteriological Tests
1. Private Water Supplies and Recirculated Water - Bacteriological
2. Pasteurization Efficiency-Field Phosphatase Test
3. Phosphatase Reactivation in HTST Pasteurized Products
4. Detection of Pesticides in Milk
5. Detection of Drug Residues in Milk
6. Analysis of Milk and Milk Products for Vitamin A and D₃ Content
Appendix H. Pasteurization Equipment and Procedures
1. HTST Pasteurization
2. Air Under Pressure
3. Culinary Steam - Milk and Milk Products
4. Thermometer Specifications
5. Criteria For the Evaluation of Computerized Systems For Grade 'A' Public Health Controls
Appendix I. Pasteurization Equipment and Controls - Tests
1. Testing Apparatus Specifications
2. Test Procedures
Appendix J. Standards For the Fabrication of Single-Service Containers and Closures For Milk and Milk Products
Preface
1. Purpose and Scope
2. Definitions
3. Bacterial Standards and Examination of Single-Service Containers and Closures
4. Fabrication Plant Standards
  1. Floors
  2. Walls and Ceilings
  3. Doors and Windows
  4. Lighting and Ventilation
  5. Separate Rooms
  6. Toilet Facilities - Sewage Disposal
  7. Water Supply
  8. Handwashing Facilities
  9. Plant Cleanliness
  10. Locker and Lunch Rooms
  11. Disposal of Wastes
  12. Personal Cleanliness
  13. Protection From Contamination
  14. Storage of Finished Product and Material in Process
  15. Fabricating, Processing and Packaging Equipment
  16. Equipment/Materials For Construction of Containers and Closures
  17. Waxes, Adhesives, Sealants and Inks
  18. Handling of Containers and Equipment
  19. Wrapping and Shipping
  20. Identification and Records
  21. Surroundings
Appendix K. Reserved For Future Use
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
1. Industry Responsibilities
2. Regulatory Agency Responsibilities
3. Established Tolerances and/or Safe Levels of Drug Residues
Appendix O. Vitamin Fortification of Fluid Milk Products
Appendix P. Performance-Based Dairy Farm Inspection System
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 Adapter 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, 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 Well from Sources of Contamination
Table 11. Example of Enforcement Procedures for Pasteurized Milk Laboratory Examination
Table 12. Example of Enforcement Procedures for Raw Milk Laboratory Examination
Table 13. Holding Tube Length - HHST Pasteurizers - Indirect Heating
Table 14. Holding Tube Length, HHST Pasteurizers, Direct Heating

Milk Safety References

Table of Contents

Illustrations

Tables