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[[ GRADE "A" [[
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[[ Pasteurized [[
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[[ Milk [[
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[[ Ordinance [[
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[[ 1993 REVISION [[
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FOREWORD
The milk sanitation program of the United States Public Health
Service is one of its oldest and most respected activities. The
interest of the Public Health Service in milk sanitation stems from
two important public health considerations. First, of all foods,
none surpasses milk as a single source of those dietary elements
needed for the maintenance of proper health, especially in children
and older citizens. For this reason, the Service has for many
years promoted increased milk consumption. Second, milk has a
potential to serve as a vehicle of disease and has, in the past,
been associated with disease outbreaks of major proportions.
The incidence of milkborne illness in the United States has been
sharply reduced in recent years. In 1938, milkborne outbreaks
constituted 25 percent of all disease outbreaks due to infected
foods and contaminated water. Our most recent information reveals
that milk and fluid milk products continue to be associated with
less than 1 percent of such reported outbreaks. Many groups have
contributed to this commendable achievement, including Public
Health and Agricultural agencies, dairy and related industries,
several interested professional groups, educational institutions
and the consuming public. The Public Health Service is proud to
have contributed to the protection and improvement of the milk
supply of the nation through technical assistance, training,
research, standards development, evaluation and certification
activities.
Despite the progress that has been made, occasional milkborne
outbreaks still occur, emphasizing the need for continued vigilance
at every stage of production, processing, pasteurization and
distribution of milk and milk products. During the past decade,
problems associated with the sanitary control of milk and milk
products have become extremely complex because of new products, new
processes, new chemicals, new materials and new marketing patterns,
which must be evaluated in terms of their public health
significance. The Grade A Pasteurized Milk Ordinance--1993
Recommendations of the United States Public Health Service/Food and
Drug Administration translates this new knowledge and technology
into effective and practicable public health practices.
The responsibility for insuring the ready availability and safety
of milk and milk products is not confined to an individual
community or a State, or to the Federal Government, it is the
concern of the entire nation. With the continued cooperation of
all interested groups engaged in the sanitary control of milk and
milk products, including Government and industry, such
responsibility can be accepted with confidence.
PREFACE
Public Health Service activities in the area of milk sanitation
began at the turn of the century with studies on the role of milk
in the spread of disease. These studies led to the conclusion that
effective public health control of milkborne disease requires the
application of sanitation measures throughout the production,
handling, pasteurization, and distribution of milk. These early
studies were followed by research to identify and evaluate sanitary
measures which might be used to control disease, including studies
which led to improvement of the pasteurization process.
To assist States and municipalities in initiating and maintaining
effective programs for the prevention of milkborne disease, the
Public Health Service, in 1924, developed a model regulation, known
as the Standard Milk Ordinance for voluntary adoption by State and
local milk control agencies. To provide for the uniform
interpretation of this Ordinance, an accompanying Code was
published in 1927 which provided administrative and technical
details as to satisfactory compliance. This model milk regulation,
now titled the Grade A Pasteurized Milk Ordinance-- 1993
Recommendations of the United States Public Health Service/Food and
Drug Administration, represents the 15th revision since 1924 and
incorporates new knowledge into public health practice.
The Grade A Pasteurized Milk Ordinance was not produced by the
Public Health Service/Food and Drug Administration alone. As with
every preceding edition, it was developed with the assistance of
milk sanitation and regulatory agencies at every level of Federal,
State, and local government including both health and agriculture
departments; all segments of the dairy industry including
producers, plant operators, equipment manufacturers, and
associations; many educational and research institutions; and with
helpful comments from many individual sanitarians and others.
The Public Health Service/Food and Drug Administration recommended
Pasteurized Milk Ordinance is the basic standard used in the
voluntary Cooperative State-PHS Program for Certification of
Interstate Milk Shippers, a program participated in by all 50
States, the District of Columbia and U.S. Trust Territories. The
National Conference on Interstate Milk Shipments (NCIMS) in
accordance with the Memorandum of Understanding with the Food and
Drug Administration, has at its biennial conferences in 1979, 1981,
1983, 1985, 1987, 1989 and 1993 recommended changes and
modifications to the Pasteurized Milk Ordinance. These changes
have been incorporated into this 1993 revision. The counsel and
guidance rendered by the Conference in preparation of this edition
of the Pasteurized Milk Ordinance is deeply appreciated.
The Pasteurized Milk Ordinance is incorporated by reference in
Federal specifications for procurement of milk and milk products;
is used as the sanitary regulation for milk and milk products
served on interstate carriers; and is recognized by the public
health agencies, the milk industry, and many others as a national
standard for milk sanitation.
The Grade A Pasteurized Milk Ordinance--1993 Recommendations of the
United States Public Health Service/Food and Drug Administration,
adopted and uniformly applied, will continue to provide effective
public health protection without being unduly burdensome to either
regulatory agencies or the dairy industry. It represents a
"grass-roots" consensus of current knowledge and experiences and as
such represents a practical and equitable milk sanitation standard
for the nation.
INTRODUCTION
The following Pasteurized Milk Ordinance, with Appendixes, is
recommended for legal adoption by States, counties, and
municipalities, in order to encourage a greater uniformity and a
higher level of excellence of milk sanitation practice in the
United States. An important purpose of this recommended standard
is to facilitate the shipment and acceptance of milk and milk
products of high sanitary quality in interstate and intrastate
commerce.
This edition of the Ordinance contains sanitary standards for Grade
A pasteurized milk and milk products only. Outline of Contents.--As
shown by the table of contents, the publication consists of two
parts and the appendixes.
Part I is the unabridged form of the Ordinance, arranged and
presented in a form which can be adopted as an ordinance or as any
other legal instrument. Section 1 defines milk and those milk
products which are to be controlled under it. Communities
desiring to regulate cottage cheese, dry curd cottage cheese and
lowfat cottage cheese under the terms of this Ordinance can
optionally insert these products in this section as defined in
footnote 3. Section 1 also specifies those milk and milk products
which are not intended to be regulated under this Ordinance; such
as ice cream, evaporated milk, butter, etc. Section 7 establishes
the sanitation standards for Grade A milk and milk products and
specifies as well, the chemical, bacteriological and temperature
requirements thereof. Section 11 regulates milk and milk products
received from points beyond the limits of routine inspection and
supervision. Sections 8, 13, and 14 include requirements relating
to animal health and personal health, respectively. The other
sections are largely concerned with various phases of
administration and the enforcement of the Ordinance; e.g., permits,
labeling, inspection, laboratory examinations, future construction,
etc.
Part II contains the Ordinance, the public health reason for each
requirement, and administrative procedures that are designed to
unify the interpretation of the Ordinance and, particularly in the
case of the sanitation requirements, provide details as to methods
of satisfactory compliance. It will be noted that Section 15 of
the Pasteurized Milk Ordinance provides that enforcement of the
Ordinance shall be in accordance with the administrative procedures
contained in Part II.
The Appendixes are 14 in number, containing detailed, explanatory
material on various aspects of milk sanitation technology and
administration; e.g., individual water supply and sewage disposal
system standards, pasteurization equipment specifications and
tests, industry dairy farm inspector certification procedures and
milk production methods. Where mandatory compliance with specific
provisions of the appendixes is referenced in the Pasteurized Milk
Ordinance, such provisions shall be deemed a legal requirements of
the Ordinance.
Appendix K contains the adoption-by-reference form of the
recommended Pasteurized Milk Ordinance. The short form reduces the
cost of publishing and printing and helps to keep the Ordinance
up-to-date, since it is readily amendable. It is suggested for
adoption in those jurisdictions where adoption of ordinances by
reference to published standards is considered legal.
Legal Aspects.--Recommendations concerning legal aspects have been
suggested from time to time by the Office of the General Counsel
and have been incorporated into the Ordinance. Other changes have
also been incorporated on the advice of various State and local
legal counsel.
The Ordinance has been widely adopted and used for many years and
has been upheld by court actions. One of the most comprehensive
decisions upholding the various provisions of the Ordinance was
that of the District Court, Reno County, Kansas, in the case of
Billings et al. v. City of Hutchinson et al., decided May 1, 1934.
In this action, the plaintiffs unsuccessfully sought to enjoin the
enforcement of the Hutchinson ordinance on the grounds that (a) it
was unreasonable; (b) it conflicted with State statutes; (c) the
license fees provided in the local ordinance (but not in the
Ordinance recommended by the Public Health Service) were in excess
of expenses; and (d) the milk inspector was clothed with arbitrary
powers. (Reprint No. 1629 from Public Health Reports of June 8,
1934.)
The model ordinance discourages the use of public health
regulations to establish unwarned trade barriers against the
acceptance of high quality milk from other milksheds (section 11).
On repeated requests from the Association of State and Territorial
Health Officers and the National Conference on Interstate Milk
Shipments, the Public Health Service/Food and Drug Administration
is actively cooperating in the voluntary program for the
certification of interstate milk shippers. Such a program would be
impossible without widespread agreement on uniform standards, such
as those of the recommended Ordinance.
The value of these standards as a means of overcoming interstate
trade barriers was recognized by the U.S. Supreme Court in the case
of the Dean Milk Company v. City of Madison. (No. 258--October
term, 1950). The Court reversed the decision of the Wisconsin
Supreme Court which had sustained an ordinance requirement imposing
a 5-mile limit on the location of pasteurization plants selling
milk in Madison and pointed out that Madison consumers would be
adequately safeguarded if the city relied upon the provisions of
Section 11 of the Public Health Service's recommended Milk
Ordinance.
The Public Health Service has no legal jurisdiction in the
enforcement of milk sanitation standards, except on interstate
carriers and milk and milk products shipped in interstate commerce.
Elsewhere, it serves solely in an advisory and stimulative
capacity. Its program is designed primarily to assist State and
local regulatory agencies. Its aim is to promote the establishment
of effective and well-balanced milk sanitation programs in each
State; to stimulate the adoption of adequate and uniform State and
local milk control legislation; and to encourage the application of
uniform enforcement procedures through appropriate legal and
educational measures.
When this Ordinance is adopted locally, its enforcement becomes a
function of the local or State authorities. Consequently, the
Ordinance should be adopted only if adequate provisions can be made
for qualified personnel and for suitable laboratory facilities.
Small municipalities which cannot afford to provide these services
should arrange for supervision by the county or State health
department, or seek cooperation with neighboring municipalities in
organizing a milk-control district or area.
The charter and the legal counsel of the government unit involved
should be consulted for information or advice on proper legal
procedures, such as the recording and advertising of the Ordinance
after passage.
Adoption.--In the interest of national uniformity, it is
recommended that no changes be made in this Ordinance when adopted
by a State or local community, unless changes are necessary to
avoid conflict with State law. Modifications should be
contemplated with extreme caution so as not to render the Ordinance
unenforceable.
Amendment of Existing Regulations.--States and communities
that have adopted the 1989 or earlier editions of the Public Health
Service recommended milk sanitation ordinances are urged to bring
such Ordinance up-to-date in order to take advantage of the most
current developments in milk sanitation and administration. States
and communities whose milk sanitation law or regulations are not
based on past Public Health Service recommended milk sanitation
ordinances are urged to consider the attendant public health
benefits, as well as those economic in nature, which can accrue
upon adoption and implementation of the Pasteurized Milk Ordinance.
Acknowledgements.--The development, preparation and
publication of the Pasteurized Milk Ordinance is the responsibility
of the Milk Safety Branch (HFS-626), Division of Cooperative
Programs, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, in cooperation with the National Conference on
Interstate Milk Shipments in accordance with the principles of the
memorandum of understanding for the cooperative Federal/State
Program. The dedicated efforts of the agency's staff and
conference members, along with representatives of academia and the
milk industry, has made the publication of the 1993 ordinance
revision possible. Particular credit is due to the following for
their substantial contributions: Johnnie G. Nichols, Joseph M.
Smucker, Steven T. Sims, Robert N. Childers and Allen R. Sayler.
Acknowledgement should also be made to Daniel E. Rackley and the
members of the NCIMS drug residue committee for their contributions
in the addition of Appendix N., and to Donald George and the
Northeast Dairy Practices Council for their contributions in the
addition of Appendix O. to this edition. Special thanks are also
due to Robert Hennes, Mike Davis, Terry Musson, Charles Price and
Robert L. Sanders who all helped in the process of proof-reading
this document.
LIST OF PREVIOUS EDITIONS OF MILK ORDINANCE
RECOMMENDED
BY THE UNITED STATES PUBLIC HEALTH SERVICE/
FOOD AND DRUG ADMINISTRATION
__________
1924. Ordinance only. Reprint No. 971 from Public Health Reports
of November 7, 1924.
1926. Ordinance only. Reprint No. 1099 from Public Health
Reports of July 30, 1926.
1927. Ordinance and Code. Mimeographed tentative draft, November
1927.
1929. Ordinance and Code. Mimeographed, July 1929.
1929. Ordinance and Code. Mimeographed, September 1929.
1931. Ordinance and Code. Mimeographed, September 1931.
1933. Ordinance only. Mimeographed, July 1933.
1933. Ordinance and Code. Mimeographed, July 1933.
1933. Ordinance only. Rotoprinted, December 1933.
1933. Ordinance and Code. Rotoprinted, December 1933.
1934. Ordinance and Code. Rotoprinted, August 1934.
1934. Ordinance only. Rotoprinted, August 1934.
1935. Ordinance and Code. Printed as Public Health Bulletin No.
220, 1935 edition, July 1935.
1936. Ordinance only. Mimeographed, December 1936.
1936. Ordinance and Code. Printed as Public Health Bulletin No.
220, 1936 edition, January 1937.
1939. Ordinance and Code. Mimeographed, January 1939.
1939. Ordinance only. Mimeographed, February 1939.
1939. Ordinance only. Mimeographed, November 1939.
1939. Ordinance and Code. Printed as Public Health Bulletin No.
220, 1939 edition, February 1940.
1947. Ordinance only. Mimeographed tentative draft, August 1947.
1949. Ordinance only. Multilthed, April 1949.
1951. Ordinance only. Multilthed, November 1951.
1953. Ordinance and Code. Printed as Public Health Service
Publication No. 229.
1965. Pasteurized Milk Ordinance. Printed as Public Health
Service Publication No. 229.
1978. Pasteurized Milk Ordinance. Printed as Public Health
Service/Food and Drug Administration Publication No. 229.
1983. Pasteurized Milk Ordinance. Printed as Public Health
Service/Food and Drug Administration Publication No. 229.
1985. Pasteurized Milk Ordinance. Printed as Public Health
Service/Food and Drug Administration Publication No. 229.
1989. Pasteurized Milk Ordinance. Printed as Public Health
Service/Food and Drug Administration Publication No. 229.
1993. Pasteurized Milk Ordinance. Printed as Public Health
Service/Food and Drug Administration Publication No. 229.
__________________________________________________
PUBLIC HEALTH SERVICE/FOOD AND DRUG ADMINISTRATION
PUBLICATION NO. 229
__________________________________________________
CONTENTS
Part I. Grade A Pasteurized Milk Ordinance--1993 Recommendations
(unabridged form)
Part II. Grade A Pasteurized Milk Ordinance with Administrative
Procedures -- 1993 Recommendations
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 Milk and Milk Products
Chemical, Bacteriological and
Temperature Standards
Sanitation Requirements for Grade A Raw Milk for
Pasteurization, Ultra-Pasteurization or Aseptic
Processing
1r. Abnormal Milk
2r. Milking Barn, Stable or Parlor--Construction
3r. Milking Barn, Stable or Parlor--Cleanliness
4r. Cowyard
5r. Milkhouse or Room--Construction and Facilities
6r. Milkhouse or Room--Cleanliness
7r. Toilet
8r. Water Supply
9r. Utensils and Equipment--Construction
10r. Utensils and Equipment--Cleaning
11r. Utensils and Equipment--Sanitization
12r. Utensils and Equipment--Storage
13r. Utensils and Equipment--Handling
14r. Milking--Flanks, Udders, and Teats
15r. Milking--Surcingles, Milk stools and
Antikickers
16r. Protection from Contamination
17r. Personnel--Hand Washing Facilities
18r. Personnel--Cleanliness
19r. Cooling
20r. Vehicles
21r. Insect and Rodent Control
Sanitation Requirements for Grade A Pasteurized Milk,
Ultra-Pasteurized and Aseptically Processed Milk and
Milk Products
1p. Floors--Construction
2p. Walls and Ceilings--Construction
3p. Doors and Windows
4p. Lighting and Ventilation
5p. Separate Rooms
6p. Toilet-Sewage Disposal Facilities
7p. Water Supply
8p. Hand-Washing Facilities
9p. Milk Plant Cleanliness
10p. Sanitary Piping
11p. Construction and Repair of Containers and
Equipment
12p. Cleaning and Sanitizing of Containers and
Equipment
13p. Storage of Cleaned Containers and Equipment
14p. Storage of Single-Service Containers,
Utensils, and Materials
15p. Protection from Contamination
16p. Pasteurization--Aseptic Processing
16p. (A). Batch Pasteurization
16p. (B). High-Temperature, Short-Time, (HTST)
Continuous Flow Pasteurization
16p. (C). Aseptic Processing Systems
16p. (D). Pasteurizers and Aseptic Processing
Systems Employing Regenerative Heating
16p. (E). Temperature Recording Charts, Equipment
Tests and Examinations
17p. Cooling of Milk
18p. Bottling and Packaging
19p. Capping
20p. Personnel--Cleanliness
21p. Vehicles
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. Future Dairy Farms and Milk Plants
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
Appendixes
A. Animal Disease Control
B. Milk Production; Hauling; Industry Inspection
I.--Dairy--Construction and Operation
II.--Farm Bulk Milk Hauling
III.--Certification of Industry Dairy Farm Inspectors.
IV.--Guideline for Gravity Flow Gutters for Manure
Removal in Milking Barns
V.--Convalescent (Maternity) Pens in Milking Barns
and Stables
VI.--Guidelines for Conventional Stall Barn with
Gutter Grates Over Liquid Manure Storage
C. Construction Standards for Toilet and Sewage Disposal
Facilities
D. Standards for Water Sources
I.--Location of Water Sources
II.--Construction
III.--Disinfection of Water Sources
IV.--Continuous Water Disinfection
V.--Water Reclaimed from Condensing of Milk and Milk
Products
E. Examples of 3 out of 5 Compliance Enforcement
Procedures
F. Sanitization
I.--Methods of Sanitization
II.--Sanitization of Assembled Equipment
III.--Sanitizer Strength and Water Hardness Tests
G. Chemical and Bacteriological Tests
Bacillus stearothermophilus Disc Assay--Qualitative
Method
H. Pasteurization Equipment and Procedures
I.--HTST Pasteurization
II.--Air Under Pressure--Milk and Milk Product
Contact Surfaces
III.--Culinary Steam--Milk and Milk Products
IV.--Thermometer Specifications
I. Pasteurization Equipment and Controls--Tests
I.--Testing Apparatus Specifications
II.--Test Procedures
J. Standards for the Manufacture of Single-Service
Containers for Milk and Milk Products
K. Adoption-by-Reference Form of the Grade A Pasteurized
Milk Ordinance
L. Standards of Identity for Milk, Milk Products, and
Federal Food, Drug, and Cosmetic Act Definitions
M. Reports and Records
N. Drug Residue Monitoring and Farm Surveillance
I.--Industry Responsibilities
II.--Regulatory Agency Responsibilities
III.--Established Tolerances and/or Safe Levels of
Drug Residues
O. Vitamin Fortification of Fluid Milk Products
Index
ILLUSTRATIONS
Fig. 1. Side Cross Section of a Gravity Flow Gutter
2. Stepped Gravity Flow Gutter
3. Cross-Section of Typical Gutter and Grate
4. Manure Transfer to Storage
5. Side Cross Section of a Convalescent Pen
6. Schematic for Exhaust Fans in a Typical Stall Dairy
Barn with Gutter Grates Over Liquid Manure Storage
7. Schematic Pattern for Ventilation Air Movement,
Slot Inlet Design, and Fan House for Pit Fans
8. Bored Well with Driven Well Point
9. Drilled Well with Submersible Pump
10. Dug Well with Two-Pipe Jet Pump Installation
11. Pumphouse
12. Spring Protection
13. Pond
14. Schematic Diagram of a Pond Water-Treatment System
15. Cistern
16. Typical Concrete Reservoir
17. Pitless Adaptor with Submersible Pump Installation
for Basement Storage
18. Clamp-on Pitless Adaptor for Submersible Pump
Installation
19. Pitless Unit with Concentric External Piping for
Jet Pump Installation
20. Weld-on Pitless Adaptor with Concentric External
Piping for "Shallow Well" Pump Installation
21. Well Seal for Jet Pump Installation
22. Well Seal for Submersible Pump Installation
23. Typical Valve and Box, Manhole Covers, and Piping
Installation
24. Suction Feeder
25. Positive Displacement Chlorinator
26. Milk-to-Milk Regeneration--Homogenizer Upstream
from Holder
27. Milk-to-Milk Regeneration--Surface Cooler
28. Milk-to-Milk Regeneration--Booster Pump
29. Milk-to-Milk Regeneration--Homogenizer and Vacuum
Chambers Downstream from Flow-Diversion Device
30. Controls for Steam Injection Pasteurizer
31. HTST System with a Magnetic Flow Meter Using a
Constant Speed Centrifugal Pump and a Control Valve
32. HTST System with a Magnetic Flow Meter Using an A-C
Variable Speed Centrifugal Pump
33. Individual Compression-Type Air Supply
34. Central Compression-Type Air Supply
35. Individual Blower-Type Air Supply
36. Individual Fan-Type Air Supply
37. Rotating Mandrel Assembly
38. Culinary Steam Piping Assembly for Steam Infusion
or Injection
39. Culinary Steam Piping Assembly for Airspace Heating
or Defoaming
40. Pressure Switch Settings
41. Vitamin Fortification Using More than One Pump
TABLES
Table
1. Chemical, Bacteriological and Temperature Standards
2. Combination of Causticity, Time and Temperature, of Equal
Bactericidal Value, for Soaker-Type Bottle Washers
3. Equipment Tests--Batch, HTST, HHST, and AP Systems
4. Removal of Restrictions When Infection or High Risk of
Infection is Discovered
5. Work Water Volume of Various Sized Pipelines
6. Gravity Flow Gutter Depth vs. Length for Manure from Milking
Cows
7. Step Height vs. Length for Stepped Gravity Flow Gutters
8. Slot Size vs. Cattle Age--Gravity Flow Manure Systems
9. Minimum Acceptable Distance of Well from Sources of
Contamination
10. Example of 3-out-of-5 Compliance Enforcement Procedures for
Pasteurized Milk
11. Example of 3-out-of-5 Compliance Enforcement Procedures for
Raw Milk Abnormal Milk Tests
12. Holding Tube Length--HHST Pasteurizers--Indirect Heating
13. Centerline Distances of 3-A Fittings
14. Holding Tube Length--HHST Pasteurizers--Direct Heating
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