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CFSAN/Office of Compliance
March 2, 2004
The milk sanitation program of the United States Public Health Service (USPHS) is one of its oldest and most respected activities. The interest of the USPHS 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 USPHS has for many years promoted increased milk consumption. Second, milk has a potential to serve as a vehicle of disease transmission 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 1938, milkborne outbreaks constituted twenty-five percent (25%) 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 one percent (<1%) 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 United States Public Health Service/Food and Drug Administration (USPHS/FDA) 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. Problems associated with assuring the safety of milk and milk products have become extremely complex because of new products, new processes, new materials and new marketing patterns, which must be evaluated in terms of their public health significance. The Grade "A" Pasteurized Milk Ordinance (Grade "A" PMO), 2003 Revision translates this new knowledge and technology into effective and practicable public health practices and incorporates the provisions of the Grade "A" Condensed and Dry Milk Ordinance--Supplement I to the Grade "A" Pasteurized Milk Ordinance--1995 Recommendations of the United States Public Health Service/Food and Drug Administration.
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 engaged in assuring the safety of milk and milk products, including Government and industry, this responsibility can be accepted with confidence.
USPHS 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 and milk products. These early studies were followed by research to identify and evaluate sanitary measures, which might be used to control disease, including studies that 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 USPHS, 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 (Grade "A" PMO), 2003 Revision, incorporates the provisions governing the processing, packaging, and sale of Grade "A" milk and milk products, including buttermilk and buttermilk products, whey and whey products, and condensed and dry milk products and represents the 25th revision and incorporates new knowledge into public health practice.
The USPHS/FDA alone did not produce the Grade "A" PMO. As with preceding editions, it was developed with the assistance of Milk Regulatory and Rating Agencies at every level of Federal, State, and Local Government, including both Health and Agriculture Departments; all segments of the dairy industry, including producers, milk plant operators, equipment manufacturers, and associations; many educational and research institutions; and with helpful comments from many individual sanitarians and others.
The USPHS/FDA's recommended Grade "A" PMO is the basic standard used in the voluntary Cooperative State-USPHS/FDA Program for the Certification of Interstate Milk Shippers, a program participated in by all fifty (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 (FDA) has at its biennial conferences recommended changes and modifications to the Grade "A" PMO. These changes have been incorporated into this 2003 revision. The counsel and guidance rendered by the Conference in preparation of this edition of the Grade "A" PMO is deeply appreciated.
The Grade "A" PMO 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 the national standard for milk sanitation. The Grade "A" PMO 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.
Within the 2003 Grade "A" PMO, the administrative and technical requirements for the manufacture of condensed and dry milk products and condensed and dry whey included in the Grade "A" Condensed and Dry Milk Ordinance--Supplement I to the Grade "A" Pasteurized Milk Ordinance--1995 Recommendations of the United States Public Health Service/Food and Drug Administration have been incorporated as directed by the 2001 NCIMS.
The following Grade "A" PMO, with Appendices, 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 only Grade "A" raw milk for pasteurization and Grade "A" milk and milk products defined in Section 1.
The following form is suggested for adoption by States, Counties, and Municipalities subject to the approval of the appropriate legal authority. Adoption of this form will reduce the cost of publishing and printing, and will enable the Grade "A" PMO to be easily kept current. The adoption of this form is considered legal in many States and has been so adopted. The Council of State Governments has prepared a model State law, Milk and Food Codes Adoption-by-Reference Act (1), which is recommended for enactment by States to enable communities to adopt milk and food ordinances by reference.
An ordinance to regulate the production, transportation, processing, handling, sampling, examination, labeling, and sale of Grade "A" milk and milk products; the inspection of dairy farms, milk plants, receiving stations, transfer stations, milk tank truck cleaning facilities, milk tank trucks and bulk milk hauler/samplers; the issuing and revocation of permits to milk producers, bulk milk hauler/samplers, milk tank trucks, milk transportation companies, milk plants, receiving stations, transfer stations, milk tank truck cleaning facilities, haulers, and distributors; and the fixing of penalties.
The.....of.....(2) ordains:
SECTION 1. The production, transportation, processing, handling, sampling, examination, labeling and sale of all Grade "A" milk and milk products sold for the ultimate consumption within the ..... of ..... (2) or its jurisdiction; the inspection of dairy farms, milk plants, receiving stations, transfer stations, milk tank truck cleaning facilities, milk tank trucks and bulk milk hauler/samplers; and the issuing and revocation of permits to milk producers, bulk milk hauler/samplers, milk tank trucks, milk transportation companies, milk plants, receiving stations, transfer stations, milk tank truck cleaning facilities, haulers, and distributors shall be regulated in accordance with the provisions of the current edition of the Grade "A" PMO, a certified copy (3) of which is filed in the office of the appropriate governing official. Provided, that Sections 15 and 16 of this Ordinance shall be replaced, respectively by Sections 2 and 3 below.
SECTION 2. Any person who shall violate any of the provisions of this Ordinance shall be guilty of a misdemeanor and, upon conviction thereof, shall be punished by a fine of not more than $....., and/or such persons may be enjoined from continuing such violations. Each day upon which such a violation occurs shall constitute a separate violation.
SECTION 3. All ordinances and parts of ordinances in conflict with this Ordinance, shall be repealed 12 months after the adoption of this Ordinance, at which time this Ordinance shall be in full force and effect, as provided by law.
Legal Aspects: Recommendations concerning legal aspects have been suggested from time to time by the Office of the Chief 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 USPHS) 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 unwarranted trade barriers against the acceptance of high quality milk from other milk sheds. (Refer to Section 11) On repeated requests from the Association of State and Territorial Health Officers and the NCIMS, the USPHS/FDA 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 this 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 USPHS's recommended Milk Ordinance.
The USPHS/FDA does not have legal jurisdiction in the enforcement of milk sanitation standards, except on interstate carriers and milk and milk products shipped in interstate commerce. It serves solely in an advisory and stimulative capacity and 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. In order to promote uniformity, it is recommended that all of the Administrative Procedures be adopted as well.
Amendment of Existing Regulations: States and Communities that have adopted the 2001 or earlier editions of the USPHS/FDA recommended Grade "A" PMO 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 a previous USPHS/FDA recommended Grade "A" PMO are urged to consider the attendant public health benefits, as well as those economic in nature, which can accrue upon the adoption and implementation of the Grade "A" PMO.
FOOTNOTES:
(1) A copy of the model act is included in Suggested State Legislation Programs for 1950, developed by the Council of State Governments, Box 11910, Iron Works Pike, Lexington, KY 40578.
(2)Substitute proper legal jurisdiction here and in all similar places throughout the Ordinance.
(3)A certified copy may be secured from the Department of Health and Human Services, Public Health Service, Food and Drug Administration, Milk Safety Branch (HFS-626), 5100 Paint Branch Parkway, College Park, MD 20740-3835.
