Pasteurized Milk Ordinance 2007

Grade "A" Pasteurized Milk Ordinance (2007 Revision)

Table of Contents

1. List of Previous Editions of USPHS/FDA Milk Ordinance
2. Foreword
3. Preface
4. Introduction
5. Table of Contents
   1. Illustrations
   2. Tables
6. Grade "A" Pasteurized Milk Ordinance (Grade "A" PMO) - 2007
   1. Section 1. Definitions
   2. Section 2. Adulterated or Misbranded Milk or Milk Products
   3. Section 3. Permits
   4. Section 4. Labeling
   5. Section 5. Inspection of Dairy Farms and Milk Plants
   6. Section 6. The Examination of Milk and Milk Products
   7. Section 7. Standards For Grade "A" Milk and Milk Products
7. Standards For Grade "A" Raw Milk for Pasteurization, Ultra-Pasteurization or Aseptic Processing
   1. Item 1r. Abnormal Milk
   2. Item 2r. Milking Barn, Stable or Parlor - Construction
   3. Item 3r. Milking Barn, Stable or Parlor - Cleanliness
   4. Item 4r. Cowyard
   5. Item 5r. Milkhouse - Construction and Facilities
   6. Item 6r. Milkhouse - Cleanliness
   7. Item 7r. Toilet
   8. Item 8r. Water Supply
   9. Item 9r. Utensils and Equipment - Construction
   10. Item 10r. Utensils and Equipment - Cleaning
   11. Item 11r. Utensils and Equipment - Sanitization
   12. Item 12r. Utensils and Equipment - Storage
   13. Item 13r. Milking - Flanks, Udders and Teats
   14. Item 14r. Protection from Contamination
   15. Item 15r. Drug and Chemical Control
   16. Item 16r. Personnel - Handwashing Facilities
   17. Item 17r. Personnel - Cleanliness
   18. Item 18r. Raw Milk Cooling
   19. Item 19r. Insect and Rodent Control
8. Standards for Grade "A" Pasteurized, Ultra-Pasteurized and Aseptically Processed Milk and Milk Products
   1. Item 1p. Floors - Construction
   2. Item 2p. Walls and Ceilings - Construction
   3. Item 3p. Doors and Windows
   4. Item 4p. Lighting and Ventilation
   5. Item 5p. Separate Rooms
   6. Item 6p. Toilet-Sewage Disposal Facilities
   7. Item 7p. Water Supply
   8. Item 8p. Handwashing Facilities
   9. Item 9p. Milk Plant Cleanliness
   10. Item 10p. Sanitary Piping
   11. Item 11p. Construction and Repair of Containers and Equipment
   12. Item 12p. Cleaning and Sanitizing of Containers and Equipment
   13. Item 13p. Storage of Cleaned Containers and Equipment
   14. Item 14p. Storage of Single-Service Containers, Utensils and Materials
   15. Item 15p. Protection from Contamination
   16. Item 16p. Pasteurization and Aseptic Processing
   17. Item 16p.(A) Batch Pasteurization
   18. Item 16p.(B) High-Temperature-Short-Time (HTST) Continuous-Flow Pasteurization
   19. Item 16p.(C) Aseptic Processing Systems
   20. Item 16p.(D) Pasteurizers and Aseptic Processing Systems Employing Regenerative Heating
       1. Milk or Milk Product-to-Milk or Milk Product Regenerative Heating
       2. Milk or Milk Product-to-Water to-Milk or Milk Product Regenerative Heating
   21. Item 16p.(E) Pasteurization and Aseptic Processing Records, Equipment Tests and Examinations
   22. Item 17p. Cooling of Milk and Milk Products
   23. Item 18p. Bottling, Packaging and Container Filling
   24. Item 19p. Capping, Container Closure and Sealing and Dry Milk Product Storage
   25. Item 20p. Personnel - Cleanliness
   26. Item 21p. Vehicles
   27. Item 22p. Surroundings
9. Section 8. Animal Health
10. Section 9. Milk and Milk Products Which May Be Sold
11. Section 10. Transferring; Delivery Containers; and Cooling
12. Section 11. Milk and Milk Products from Points Beyond the Limits of Routine Inspection
13. Section 12. Plans for Construction and Reconstruction
14. Section 13. Personnel Health
15. Section 14. Procedure When Infection or High Risk of Infection is Discovered
16. Section 15. Enforcement
17. Section 16. Penalty
18. Section 17. Repeal and Date of Effect
19. Section 18. Separability Clause
20. Footnotes
21. Appendix A. Animal Disease Control
22. Appendix B. Milk Sampling, Hauling and Transportation
    1. Milk Sampling and Hauling Procedures
    2. Requirements for Using an Approved In-Line Sampler
    3. Requirements for Using an Approved Aseptic Sampler for Milk Tank Trucks
    4. Milk Tank Truck Permitting and Inspection
23. 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
       1. Milking Barn, Stable or Parlor
       2. Milkhouse
       3. Milking Methods
       4. Reverse Flush Systems
       5. Drug Residue Avoidance Control Measures
       6. Insect and Rodent Control
24. 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 Milk and Milk Products and from Heat Exchangers or Compressors in Milk Plants
    6. Water Reclaimed from Heat Exchanger Processes or Compressors on Grade "A" Dairy Farms
    7. Tower Water Diagrams
    8. Drawings of Construction Details for Water Sources
25. Appendix E. Examples of 3-Out-of-5 Compliance Enforcement Procedures
26. Appendix F. Cleaning and Sanitization
    1. Methods of Sanitization
    2. Evaporating, Drying and Dry Product Equipment Cleaning
27. Appendix G. Chemical and Bacteriological Tests
    1. Private Water Supplies and Recirculated Water - Bacteriological
    2. Pasteurization Efficiency - Field Phosphate 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
28. Appendix H. Pasteurization Equipment and Procedures and other Equipment
    1. HTST Pasteurization
    2. Air for Drying Equipment and Air Under Pressure - Direct Contact with Milk and Milk Products and Milk Product Contact Surfaces
    3. Culinary Steam - Milk and Milk Products
    4. Thermometer Specifications
    5. Criteria for the Evaluation of Electronic Data Collection, Storage and Reporting
    6. Criteria for the Evaluation of Computerized Systems for Grade 'A' Public Health Controls
    7. Criteria for Steam-Block Type FDD Systems
    8. Milk and Milk Products HACCP CCP Models for Pasteurization Equipment
29. Appendix I. Pasteurization Equipment and Controls - Tests
    1. Testing Apparatus Specifications
    2. Test Procedures
31. Appendix J. Standards for the Fabrication of Single-Service Containers and Closures for Milk and Milk Products
    1. Preface
    2. Standards for the Fabrication of Single-Service Containers and Closures for Milk and Milk Products
    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 Lunchrooms
       11. Disposal of Wastes
       12. Personnel - Practices
       13. Protection from Contamination
       14. Storage of Materials and Finished Product
       15. Fabricating Equipment
       16. Materials for Construction of Containers and Closures
       17. Waxes, Adhesives, Sealants, Coatings and Inks
       18. Handling of Containers and Equipment
       19. Wrapping and Shipping
       20. Identification and Records
       21. Surroundings
    5. Criteria for Listing Certified Single-Service Manufacturers in the IMS List
32. Appendix K. HACCP Program
    1. The HACCP System Introduction
    2. Implementation of a HACCP System
    3. Employee Education and Training
    4. Training and Standardization
    5. HACCP Audits and Follow-Up Actions
33. Appendix L. Applicable Regulations, Standards of Identity for Milk and Milk Products and The Federal Food, Drug, and Cosmetic Act
34. Appendix M. Reports and Records
35. Appendix N. Drug Residue Testing and Farm Surveillance
    1. Industry Responsibilities
    2. Regulatory Agency Responsibilities
    3. Testing Program for Drug Residues Established
    4. Established Tolerances and/or Safe Levels of Drug Residues
    5. Approved Methods
36. Appendix O. Vitamin Fortification of Fluid Milk Products
37. Appendix P. Performance-Based Dairy Farm Inspection System
38. Appendix Q. Operation of Automatic Milk Installations for the Production of Grade "A" Raw Milk for Pasteurization
39. Appendix R. Determination of Time/Temperature Control for Safety of Milk and Milk Products

ILLUSTRATIONS

1. Figure 1. Side Cross Section of a Gravity Flow Gutter
2. Figure 2. Stepped Gravity Flow Gutter
3. Figure 3. Cross Section of a Typical Gutter and Grate
4. Figure 4. Manure Transfer to Storage
5. Figure 5. Side Cross Section of a Convalescent Pen
6. Figure 6. Schematic Diagram Showing Suggested Exhaust Fan Locations for a Typical Stall Dairy Barn with Gutter Grates Over Liquid Manure Storage
7. Figure 7. Schematic Diagram Showing General Pattern of Ventilation Air Movement, Slot Inlet Design and Fan House for Pit Fans
8. Figure 8. Tower Water Cooling Supplied Directly from a Tower Water Distribution Line without a Balance Tank
9. Figure 9. Tower Water Cooling Using a Balance Tank Overflow Higher than the Heat Exchanger with a Local Tower Water Supply Pump
10. Figure 10. Tower Water Cooling Using a Balance Tank Overflow Higher than the Heat Exchanger with a Bypass Line and a Local Tower Water Return Pump
11. Figure 11. Tower Water Cooling Using a Balance Tank Lower than the Heat Exchanger with a Local Tower Water Supply Pump
12. Figure 12. Tower Water Cooling Using a Balance Tank Lower than the Heat Exchanger with a Bypass Line and a Local Tower Water Return Pump
13. Figure 13. Bored Well with Driven Well Point
14. Figure 14. Drilled Well with Submersible Pump
15. Figure 15. Dug Well with Two-Pipe Jet Pump Installation
16. Figure 16. Pumphouse
17. Figure 17. Spring Protection
18. Figure 18. Pond
19. Figure 19. Schematic Diagram of a Pond Water-Treatment System
20. Figure 20. Cistern
21. Figure 21. Typical Concrete Reservoir
22. Figure 22. Pit-less Adapter with Submersible Pump Installation for Basement Storage
23. Figure 23. Clamp-on Pit-less Adapter with Concentric External Piping for "Shallow Well" Pump Installation
24. Figure 24. Pit-less Unit with Concentric External Piping for Jet Pump Installation
25. Figure 25. Weld-on Pit-less Adapter with Concentric External Piping for "Shallow Well" Pump Installation
26. Figure 26. Well Seal for Jet Pump Installation
27. Figure 27. Well Seal for Submersible Pump Installation
28. Figure 28. Typical Valve and Box, Manhole Covers, and Piping Installation
29. Figure 29. Suction Feeder
30. Figure 30. Positive Displacement Chlorinator
31. Figure 31. Milk-to-Milk Regeneration - Homogenizer Upstream from Holding Tube
32. Figure 32. Milk-to-Milk Regeneration - Booster Pump
33. Figure 33. Milk-to-Milk Regeneration - Homogenizer and Vacuum Chambers Downstream from Flow-Diversion Device
34. Figure 34. HTST System with a Magnetic Flow Meter Using a Constant Speed Centrifugal Pump and a Control Valve
35. Figure 35. HTST System with a Magnetic Flow Meter Using an A-C Variable Speed Centrifugal Pump
36. Figure 36. Controls for Steam Injection Pasteurizer
37. Figure 37. Individual Compression-Type Air Supply
38. Figure 38. Central Compression-Type Air Supply
39. Figure 39. Individual Blower-Type Air Supply
40. Figure 40. Individual Fan-Type Air Supply
41. Figure 41. Rotating Mandrel Assembly
42. Figure 42. Culinary Steam Piping Assembly for Steam Infusion or Injection
43. Figure 43. Culinary Steam Piping Assembly for Steam Infusion or Injection (Optional Configuration)
44. Figure 44. Culinary Steam Piping Assembly for Airspace Heating or Defoaming
45. Figure 45. Logic Diagram: HTST Flow-Diversion Device, Divert Valve Stem
46. Figure 46. Logic Diagram: HTST Flow-Diversion Device, Leak Detect Valve Stem
47. Figure 47. Logic Diagram: HTST Safety Limit Recorder-Controller
48. Figure 48. Logic Diagram: HTST Timing Pump
49. Figure 49. Logic Diagram: HTST Booster Pump
50. Figure 50. Pressure Switch Setting
51. Figure 51. Vitamin Fortification
52. Figure 52. Decision Tree for Using pH, a_w, or the Interaction of pH and a_w to Determine if a Milk or Milk Product Requires Time/Temperature for Safety

TABLES

1. Table A. Interaction of pH and a_w for Control of Spores in Milk and Milk Products Pasteurized to Destroy Pathogenic Vegetative Cells and Subsequently Packaged
2. Table B. Interaction of pH and a_w for Control of Pathogenic Vegetative Cells and Spores in Milk and Milk Products not Pasteurized or Pasteurized but not Packaged
3. Table 1. Chemical, Physical, Bacteriological, and Temperature Standards
4. Table 2. Combinations of Causticity, Time and Temperature, of Equal Bactericidal Value, for the Soaker Tank of Soaker Type Bottle Washers
5. Table 3. Pasteurization Temperature vs. Time
6. Table 4. Equipment Tests - Batch, HTST, HHST and Aseptic Processing Systems
7. Table 5. Removal of Restrictions when Infection or High Risk of Infection is Discovered
8. Table 6. Slot Size vs. Cattle Age
9. Table 7. Gravity Flow Gutter Depth vs. Length for Manure from Lactating Animals
10. Table 8. Step Height vs. Length for Stepped Gravity Flow Gutters
11. Table 9. Work Water Volume of Various Sized Pipelines
12. Table 10. Distance of a Well from Sources of Contamination
13. Table 11. Example of Enforcement Procedures for Pasteurized Milk Laboratory Examinations
14. Table 12. Example of Enforcement Procedures for Raw Milk Laboratory Examinations
15. Table 13. Sieve Sizes and Designations
16. Table 14. Holding Tube Length - HHST Pasteurizers - Indirect Heating
17. Table 15. Dimension for Standard Stainless Steel Sanitary Tubing
18. Table 16. Holding Tube Length, HHST Pasteurizers, Direct Heating