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U.S. Department of Health and Human Services

Food

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Pasteurized Milk Ordinance 2005: Section 1 through Section 7


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An Ordinance defining "milk" and certain "milk products", "milk producer", "pasteurization", etc.; prohibiting the sale of adulterated and misbranded milk and milk products; requiring permits for the sale of milk and milk products; regulating the inspection of dairy farms and milk plants; the examination, labeling, pasteurization, aseptic processing and packaging and distribution and sale of milk and milk products; providing for the construction of future dairy farms and milk plants; the enforcement of this Ordinance; and the fixing of penalties.

Be it ordained by the ... of ...1 as follows: 
 

SECTION 1. DEFINITIONS

Terms used in this document, not specifically defined herein, are those within Title 21, Code of Federal Regulations (CFR) and/or the Federal Food, Drug, and Cosmetic Act (FFD&CA) as amended.

The following additional definitions shall apply in the interpretation and the enforcement of this Ordinance:

  1. ABNORMALITIES OF MILK:
    1. A-1. Abnormal Milk: Milk that is visibly changed in color, odor and/or texture.
    2. A-2. Undesirable Milk: Milk that, prior to the milking of the animal, is known to be unsuitable for sale, such as colostrum.
    3. A-3. Contaminated Milk: Milk that is un-saleable or unfit for human consumption following treatment of the animal with veterinary products, i.e. antibiotics, which have withhold requirements, or treatment with medicines or insecticides not approved for use on dairy animals by FDA or the Environmental Protection Agency (EPA).
       
  2. ASEPTIC PROCESSING: The term "Aseptic Processing", when used to describe a milk product, means that the product has been subjected to sufficient heat processing and packaged in a hermetically sealed container, to conform to the applicable requirements of 21 CFR 113 (Refer to the Reference in Appendix L.) and the provisions of Section 7, Item 16p of this Ordinance, and to maintain the commercial sterility of the product under normal non-refrigerated conditions.
     
  3. AUTOMATIC MILKING INSTALLATION (AMI): The term automatic milking installation covers the entire installation of one (1) or more automatic milking units, including the hardware and software utilized in the operation of individual automatic milking units, the animal selection system, the automatic milking machine, the milk cooling system, the system for cleaning and sanitizing the automatic milking unit, the teat cleaning system, and the alarm systems associated with the process of milking, cooling, cleaning and sanitation.
     
  4. BULK MILK HAULER/SAMPLER: A bulk milk hauler/sampler is any person who collects official samples and may transport raw milk from a farm and/or raw milk products to or from a milk plant, receiving station or transfer station and has in their possession a permit from any State to sample such products.
     
  5. BULK MILK PICKUP TANKER: A bulk milk pickup tanker is a vehicle, including the truck, tank and those appurtenances necessary for its use, used by a bulk milk hauler/sampler to transport bulk raw milk for pasteurization from a dairy farm to a milk plant, receiving station, or transfer station.
     
  6. BUTTERMILK: Buttermilk is a fluid product resulting from the manufacture of butter from milk or cream. It contains not less than 8¼ percent of milk solids not fat.
    1. F-1. Grade "A" Dry Buttermilk: Grade "A" dry buttermilk means dry buttermilk, which complies with the applicable provisions of this Ordinance.
    2. F-2. Grade "A" Dry Buttermilk Products: Grade "A" dry buttermilk products means dry buttermilk products, which complies with the applicable provisions of this Ordinance.
    3. F-3. Concentrated (Condensed) Buttermilk: Concentrated (condensed) buttermilk is the product resulting from the removal of a considerable portion of water from buttermilk.
    4. F-4. Grade "A" Concentrated (Condensed) and Dry Buttermilk and Buttermilk Products: Grade "A" concentrated (condensed) and dry buttermilk and buttermilk products means concentrated (condensed) or dry buttermilk and buttermilk products, which comply with the applicable provisions of this Ordinance. The words "concentrated (condensed) and dry milk products" shall be interpreted to include concentrated (condensed) and dry buttermilk and buttermilk products.
       
  7. CLEAN: Direct product contact surfaces that have had the effective and thorough removal of product and/or contaminants.
     
  8. COMMON NAME: The generic term commonly used for domestic animals, i.e., cattle, goats, sheep, horses, water buffalo, etc. (Refer to the last NOTE: in Section 6.)
     
  9. CONCENTRATED (CONDENSED) MILK: Concentrated (condensed) milk is a fluid product, unsterilized and unsweetened, resulting from the removal of a considerable portion of the water from the milk, which when combined with potable water in accordance with instructions printed on the container label, results in a product conforming with the milkfat and milk solids not fat levels of milk as defined in this Section.
    1. I-1. Concentrated (Condensed) Milk Products: Concentrated (condensed) milk products shall be taken to mean and to include homogenized concentrated (condensed) milk, concentrated (condensed) skim milk, concentrated (condensed) reduced fat or low fat milk, and similar concentrated (condensed) products made from concentrated (condensed) milk or concentrated (condensed) skim milk, which when combined with potable water in accordance with instructions printed on the container label, conform with the definitions of the corresponding milk products in this Section.
    2. I-2. Grade "A" Concentrated (Condensed) Skim Milk: Grade "A" concentrated (condensed) skim milk means concentrated (condensed) skim milk, which complies with the applicable provisions of this Ordinance.
       
  10. COOLING POND: A cooling pond is a man-made structure designed for the specific purpose of cooling cows.
     
  11. DAIRY FARM: A dairy farm is any place or premises where one (1) or more lactating animals (cows, goats, sheep, water buffalo, or other hooved mammal) are kept for milking purposes, and from which a part or all of the milk or milk product(s) is provided, sold or offered for sale to a milk plant, receiving station or transfer station. (Refer to the last NOTE: in Section 6.)
     
  12. DAIRY PLANT SAMPLER: A person responsible for the collection of official samples for regulatory purposes outlined in Section 6 of this Ordinance. This person is an employee of the Regulatory Agency and is evaluated at least once every two (2)-year period by a State Sampling Surveillance Officer or a properly delegated Sampling Surveillance Regulatory Official.
     
  13. EGGNOG OR BOILED CUSTARD: Eggnog or boiled custard is the product defined in 21 CFR 131.170.
     
  14. FOOD ALLERGENS: Are proteins in foods that are capable of inducing an allergic reaction or response in some individuals.

    Reference: Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108-282) and Information about Food Allergens.

  15. FROZEN MILK CONCENTRATE: Frozen milk concentrate is a frozen milk product with a composition of milk fat and milk solids not fat in such proportions that when a given volume of concentrate is mixed with a given volume of water the reconstituted product conforms to the milk fat and milk solids not fat requirements of whole milk. In the manufacturing process, water may be used to adjust the primary concentrate to the final desired concentration. The adjusted primary concentrate is pasteurized, packaged, and immediately frozen. This product is stored, transported and sold in the frozen state.
     
  16. GOAT MILK: Goat milk is the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one (1) or more healthy goats. Goat milk sold in retail packages shall contain not less than 2½ percent milk fat and not less than 7½ percent milk solids not fat. Goat milk shall be produced according to the sanitary standards of this Ordinance. The word "milk" shall be interpreted to include goat milk.
     

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  17. HACCP DEFINITIONS: (For use in conjunction with Appendix K.)
    1. Q-1. AUDIT: An evaluation of the entire milk plant, receiving station or transfer station facility and NCIMS HACCP System to ensure compliance with the NCIMS HACCP System and other NCIMS regulatory requirements.
       
    2. Q-2. CENTRALIZED DEVIATION LOG: A centralized log or file identifying data detailing any deviation of critical limits and the corrective actions taken as required in Appendix K.
       
    3. Q-3. CONTROL:
      1. To manage the conditions of an operation to maintain compliance with established criteria.
         
      2. The state where correct procedures are being followed and criteria are being met.
         
    4. Q-4. CONTROL MEASURE: Any action or activity that can be used to prevent, eliminate, or reduce a significant hazard that is managed at a Critical Control Point.
       
    5. Q-5. CORRECTIVE ACTION: Procedures followed when a deviation occurs.
       
    6. Q-6. CRITICAL CONTROL POINT (CCP): A step at which control can be applied and is essential to prevent or eliminate a milk or milk product safety hazard or reduce it to an acceptable level.
       
    7. Q-7. CRITICAL LIMIT (CL): A maximum and/or minimum value to which a biological, chemical, or physical parameter must be controlled at a CCP to prevent, eliminate, or reduce to an acceptable level the occurrence of a milk or milk product safety hazard.
       
    8. Q-8. CRITICAL LISTING ELEMENT (CLE): An item on the MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT identified with a double star (**).The marking of a CLE by a State Rating Officer or FDA auditor, indicates a condition that constitutes a major dysfunction likely to result in a potential compromise to milk or milk product safety, or that violate NCIMS requirements regarding drug residue testing and traceback or raw milk sources, whereby a listing may be denied or withdrawn.
       
    9. Q-9. DAIRY HACCP CORE CURRICULUM: The core curriculum consists of:
      1. Basic HACCP training; plus
      2. An orientation to the requirements of the NCIMS HACCP Program.
         
    10. Q-10. DEFICIENCY: An element inadequate or missing from the requirements of the HACCP System or Appendix K.
       
    11. Q-11. DEVIATION: A failure to meet a CL.
       
    12. Q-12. HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP): A systematic approach to the identification, evaluation, and control of significant milk or milk product safety hazards.
       
    13. Q-13. HACCP PLAN: The written document, which is based upon the principles of HACCP and delineates the procedures to be followed.
       
    14. Q-14. HACCP SYSTEM: The implemented HACCP Plan and Prerequisite Program, including other applicable NCIMS requirements.
       
    15. Q-15. HACCP TEAM: The group of people who are responsible for developing, implementing, and maintaining the HACCP System.
       
    16. Q-16. HAZARD: A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.
       
    17. Q-17. HAZARD ANALYSIS: The process of collecting and evaluating information on hazards associated with the milk under consideration, to decide which are reasonably likely to occur and must be addressed in the HACCP Plan.
       
    18. Q-18. MONITOR: To conduct a planned sequence of observations or measurements to assess whether a CCP is under control or to assess the conditions and practices of all required Prerequisite Programs.
       
    19. Q-19. NON-CONFORMITY: A failure to meet specified requirements of the HACCP System as described in Appendix K.
       
    20. Q-20. POTENTIAL HAZARD: Any hazard to be evaluated by the hazard analysis.
       
    21. Q-21. PREREQUISITE PROGRAMS (PPs): Procedures, including Good Manufacturing Practices (GMPs), which address operational conditions that provide the foundation for the HACCP System. The required PPs specified in Appendix K. are sometimes called Sanitary Standard Operating Procedures (SSOPs) in other HACCP Systems.
       
    22. Q-22. VALIDATION: The element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP Plan, when properly implemented, will effectively control the hazards.
       
    23. Q-23. VERIFICATION: Those activities, other than monitoring, that determine the validity of the HACCP Plan and that the HACCP System is operating according to the plan.
       
  18. HOOVED MAMMALS MILK: Hooved mammals milk is the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one (1) or more healthy hooved mammals. This product shall be produced according to the sanitary standards of this Ordinance. (Refer to the last NOTE: in Section 6.)
     
  19. INDUSTRY PLANT SAMPLER: A person responsible for the collection of official samples for regulatory purposes at a milk plant, receiving station or transfer station as outlined in Appendix N. This person is an employee of the milk plant, receiving station or transfer station and is evaluated at least once every two (2) year period by a State Sampling Surveillance Officer or a properly delegated Sampling Surveillance Regulatory Official.
     
  20. MILK DISTRIBUTOR: A milk distributor is any person who offers for sale or sells to another any milk or milk products.
     
  21. MILK PLANT: A milk plant is any place, premises; or establishment where milk or milk products are collected, handled, processed, stored, pasteurized, ultra-pasteurized, aseptically processed, condensed, dried, packaged, or prepared for distribution.
     
  22. MILK PRODUCER: A milk producer is any person who operates a dairy farm and provides, sells or offers milk for sale to a milk plant, receiving station or transfer station.
     
  23. MILK PRODUCTS: Milk products include cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated (condensed) milk, concentrated (condensed) milk products, concentrated (condensed) and dry milk products, nonfat (skim) milk, reduced fat or low fat milk, frozen milk concentrate, eggnog, buttermilk, buttermilk products, whey, whey products, cultured milk, cultured reduced fat or low fat milk, cultured nonfat (skim) milk, yogurt, low fat yogurt, nonfat yogurt, acidified milk, acidified reduced fat or low fat milk, acidified nonfat (skim) milk, low-sodium milk, low-sodium reduced fat or low fat milk, low-sodium nonfat (skim) milk, lactose-reduced milk, lactose-reduced reduced fat or low fat milk, lactose-reduced nonfat (skim) milk, aseptically processed and packaged milk and milk products as defined in this Section, milk, reduced fat, low fat milk or nonfat (skim) milk with added safe and suitable microbial organisms and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin or mineral fortification of milk products defined herein.2, 3

    Milk products also include those dairy foods made by modifying the federally standardized products listed in this Section in accordance with 21 CFR 130.10-Requirements for foods named by use of a nutrient content claim and a standardized term.

    This Definition shall include those milk and milk products, as defined herein, which have been aseptically processed and then packaged.

    Milk and milk products which have been retort processed after packaging or which have been concentrated (condensed) or dried are included in this Definition only if they are used as an ingredient to produce any milk or milk product defined herein or if they are labeled as Grade "A" as described in Section 4.

    Powdered dairy blends may be labeled Grade "A" and used as ingredients in Grade "A" dairy products, such as cottage cheese dressing mixes or starter media for cultures used to produce various Grade "A" cultured products, if they meet the requirements of this Ordinance. If used as an ingredient in Grade "A" products, such as those listed above, blends of dairy powders must be blended under conditions, which meet all applicable Grade "A" requirements. Grade "A" powder blends must be made from Grade "A" powdered dairy products, except that small amounts of functional ingredients, (total of all such ingredients shall not exceed 5% by weight of the finished blend) which are not Grade "A" are allowed in Grade "A" blends when the finished ingredient is not available in Grade "A" form, i.e., sodium caseinate. This is similar to the existing FDA position that such dairy ingredient in small cans of freeze-dried starter culture need not be Grade "A".

    This definition is not intended to include dietary products (except as defined herein), infant formula, ice cream or other frozen desserts, butter or cheese.

    1. W-1. Dry Milk Products: Dry milk products mean products resulting from the drying of milk or milk products and any product resulting from the combination of dry milk products with other wholesome dry ingredients.
       
    2. W-2. Grade "A" Dry Milk Products: Grade "A" dry milk products mean dry milk products, which comply with the applicable provisions of this Ordinance.
       

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  24. MILK TANK TRUCK: A milk tank truck is the term used to describe both a bulk milk pickup tanker and a milk transport tank.
     
  25. MILK TANK TRUCK CLEANING FACILITY: Any place, premises, or establishment, separate from a milk plant, receiving station or transfer station, where a milk tank truck is cleaned and sanitized.
     
  26. MILK TANK TRUCK DRIVER: A milk tank truck driver is any person who transports raw or pasteurized milk or milk products to or from a milk plant, receiving station or transfer station. Any transportation of a direct farm pickup requires the milk tank truck driver to have responsibility for accompanying official samples.
     
  1. MILK TRANSPORT TANK: A milk transport tank is a vehicle, including the truck and tank, used by a bulk milk hauler/sampler to transport bulk shipments of milk and milk products, from a milk plant, receiving station or transfer station to another milk plant, receiving station or transfer station.
     
  2. MILK TRANSPORTATION COMPANY: A milk transportation company is the person responsible for a milk tank truck (s).
     
  3. OFFICIAL LABORATORY: An official laboratory is a biological, chemical or physical laboratory, which is under the direct supervision of the Regulatory Agency.
     
  4. OFFICIALLY DESIGNATED LABORATORY: An officially designated laboratory is a commercial laboratory authorized to do official work by the Regulatory Agency, or a milk industry laboratory officially designated by the Regulatory Agency for the examination of producer samples of Grade "A" raw milk for pasteurization and commingled milk tank truck samples of raw milk for drug residues and bacterial limits.
     
  5. PASTEURIZATION: The terms "pasteurization", "pasteurized" and similar terms shall mean the process of heating every particle of milk or milk product, in properly designed and operated equipment, to one (1) of the temperatures given in the following chart and held continuously at or above that temperature for at least the corresponding specified time:
     
    TemperatureTime
    63°C (145°F)*30 minutes
    72°C (161°F)*15 seconds
    89°C (191°F)1.0 second
    90°C (194°F)0.5 seconds
    94°C (201°F)0.1 seconds
    96°C (204°F)0.05 seconds
    100°C (212°F)0.01 seconds

    *If the fat content of the milk product is ten percent (10%) or greater, or a total solids of 18% or greater, or if it contains added sweeteners, or if it is concentrated (condensed), the specified temperature shall be increased by 3°C (5°F).

    Provided, that eggnog shall be heated to at least the following temperature and time specifications:

    TemperatureTime
    69°C (155°F)30 minutes
    80°C (175°F)25 seconds
    83°C (180°F)15 seconds
    Provided further, that nothing shall be construed as barring any other pasteurization process, which has been recognized by FDA to be equally efficient and which is approved by the Regulatory Agency.
     
  6. PERSON: The word "person" shall include any individual, milk plant operator, partnership, corporation, company, firm, trustee, association or institution.
     
  7. RECEIVING STATION: A receiving station is any place, premises, or establishment where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting.
     
  8. RECONSTITUTED OR RECOMBINED MILK AND/OR MILK PRODUCTS: Reconstituted or recombined milk and/or milk products shall mean milk or milk products defined in this Section which result from reconstituting or recombining of milk constituents with potable water when appropriate.4
     
  9. REGULATORY AGENCY: The Regulatory Agency shall mean the ... of the ...1 or their authorized representative. The term, "Regulatory Agency", whenever it appears in the Ordinance shall mean the appropriate agency having jurisdiction and control over the matters embraced within this Ordinance.
     
  10. SANITIZATION: Is the application of any effective method or substance to properly cleaned surfaces for the destruction of pathogens, and other microorganisms, as far as is practicable. Such treatment shall not adversely affect the equipment, the milk and/or milk product, or the health of consumers, and shall be acceptable to the Regulatory Agency.
     
  11. SHEEP MILK: Sheep milk is the normal lacteal secretion practically free of colostrum, obtained by the complete milking of one (1) or more healthy sheep. Sheep milk shall be produced according to the sanitary standards of this Ordinance. The word "milk" shall be interpreted to include sheep milk.
     
  12.  TIME/TEMPERATURE CONTROL FOR SAFETY OF MILK AND MILK PRODUCTS: Milk and milk products that require time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation includes:
     
    1. Milk or milk products that are raw, heat-treated, pasteurized, or ultra-pasteurized; or
       
    2. Except as specified in 3. below of this definition, a milk or milk product that because of the interaction of it's aw and pH values is designated as Product Assessment (PA) as required in either Table A or B as follows:
       
      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*
      Aw valuespH values
      4.6 or less> 4.6 - 5.6> 5.6
      0.92 or lessNon-TCS**Non-TCSNon-TCS
      >0.92 - .95Non-TCSNon-TCSPA***
      > 0.95Non-TCSPAPA
       
      • *Refer to Appendix R. for instruction in how to use Table A.
      • ** TCS means TIME/TEMPERATURE CONTROL FOR SAFETY MILK AND MILK PRODUCTS.
      • *** PA means either that the product needs time and temperature control or further PRODUCT ASSESSMENT is required to determine if the milk or milk product is Non-TCS.
         
      Table B. Interaction of pH and aw for Control of Pathogenic Vegetative Cells and Spores in Milk and Milk Products not Pasteurized or Pasteurized but not Packaged*
      Aw valuespH values
      < 4.24.2 - 4.6> 4.6 - 5.0> 5.0
      < 0.88Non-TCSNon-TCSNon-TCSNon-TCS
      0.88 - 0.90Non-TCSNon-TCSNon-TCSPA
      > 0.90 - 0.92Non-TCSNon-TCSPAPA
      > 0.92Non-TCSPAPAPA

      * Refer to Appendix R. for instruction in how to use Table B

      This definition does not include:

      1. A milk or milk product that because of it's pH or aw value, or interaction of aw and pH values, is designated as Non-TCS in Table A or B as specified in 2. above of this definition;
      2. A milk or milk products, in an unopened hermetically sealed container, that is commercially processed to achieve and maintain commercial sterility under conditions of non-refrigerated storage and distribution;
      3. A milk or milk product for which evidence (acceptable to FDA) demonstrates that time/ temperature control for safety is not required as specified under this definition (such as, a product containing a preservative known to inhibit pathogenic microorganisms, or other barriers to the growth of pathogenic microorganisms, or a combination of barriers that inhibit the growth of pathogenic microorganisms); or
      4. A milk or milk product that does not support the growth of pathogenic microorganisms as specified under this definition even though the milk or milk product may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.<
         

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  13. TRANSFER STATION: A transfer station is any place, premises, or establishment where milk or milk products are transferred directly from one (1) milk tank truck to another.
     
  14. ULTRA-PASTEURIZATION (UP): The term "Ultra-Pasteurization", when used to describe a dairy product, means that such product shall have been thermally processed at or above 138°C (280°F) for at least two (2) seconds, either before or after packaging, so as to produce a product, which has an extended shelf-life under refrigerated conditions. (Refer to 21 CFR 131.3)
     
  15. WATER BUFFALO MILK: Water buffalo milk is the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one (1) or more healthy water buffalo. Water buffalo milk shall be produced according to the sanitary standards of this Ordinance. The word "milk" shall be interpreted to include water buffalo milk. (Refer to the last NOTE: in Section 6.)
     
  16. WHEY PRODUCTS: Whey products mean any fluid product removed from whey; or made by the removal of any constituent from whey; or by the addition of any wholesome substance to whey or parts thereof.
     
    1. PP-1. Grade "A" Whey Products: Grade "A" whey products means any fluid product removed from whey; or made by the removal of any constituent from whey; or by the addition of any wholesome substance to whey or parts thereof which have been manufactured under the provisions of this Ordinance.
       
    2. PP-2. Dry Whey Products: Dry whey products mean products resulting from the drying of whey or whey products and any product resulting from the combination of dry whey products with other wholesome dry ingredients.
       
    3. PP-3. Grade "A" Concentrated (Condensed) and Dry Whey and Whey Products: Grade "A" concentrated (condensed) and dry whey and whey products means concentrated (condensed) or dry whey and whey products, which complies with the applicable provisions of this Ordinance. The words "concentrated (condensed) and dry milk products" shall be interpreted to include concentrated (condensed) and dry whey and whey products.
       

 

SECTION 2. ADULTERATED OR MISBRANDED MILK OR MILK PRODUCTS

No person shall, within the ... of ...1, or its jurisdiction, produce, provide, sell, offer, or expose for sale or have in possession with intent to sell any milk or milk product, which is adulterated or misbranded. Provided, that in an emergency, the sale of pasteurized milk and milk products, which do not fully meet the requirements of this Ordinance, may be authorized by the Regulatory Agency.

Any adulterated or misbranded milk or milk products, may be impounded by the Regulatory Agency and disposed of in accordance with applicable laws or regulations.
 

ADMINISTRATIVE PROCEDURES

This Section of the Ordinance shall be used in impounding the milk or milk products of, or preferring charges against, persons who adulterate or misbrand their milk or milk products; or label them with any grade designation not authorized by the Regulatory Agency under the terms of this Ordinance; or who sell or deliver ungraded milk or milk products, except as may be permitted under this Section in an emergency. An emergency is defined as a general and acute shortage in the milk shed, not simply one (1) distributor's shortage.
 


 

SECTION 3. PERMITS

It shall be unlawful for any person who does not possess a permit from the Regulatory Agency of the ... of ... 1 to manufacture, bring into, send into or receive into the ... of ... 1 or its jurisdiction, for sale, or to sell, or offer for sale therein or to have in storage any milk or milk products, defined in this Ordinance. Provided, that grocery stores, restaurants, soda fountains and similar establishments where milk or milk products are served or sold at retail, but not processed may be exempt from the requirements of this Section. Provided further, that brokers, agents, and distributors representing, buying from, and/or selling condensed and dry milk products from or to a milk plant having a valid permit are not required to have a permit.

Only a person who complies with the requirements of this Ordinance shall be entitled to receive and retain such a permit. Milk plants, receiving stations and transfer stations permitted under the NCIMS HACCP Program shall meet the applicable provisions of this Ordinance, includin Appendix K. Permits shall not be transferable with respect to persons and/or locations.

Provided, that the manufacture of condensed and dry milk products, which do not meet the requirements of this Ordinance for Grade "A" condensed or dry milk products and which are intended for other uses, shall not be construed to violate the terms of this Ordinance, if such products are processed, packaged and stored separately and are plainly identified.

It shall be unlawful for any person to manufacture in a milk plant under a permit for Grade "A" condensed or dry milk products in the...of...1 or its jurisdiction any condensed and dry milk products which do not meet the requirements of this Ordinance for Grade "A" condensed or dry milk products without a permit from the Regulatory Authority who shall require that such condensed and dry milk products be processed, packaged and stored separately from Grade "A" condensed or dry milk products and that each container of such products be plainly marked in such a manner as to prevent confusion of the product with Grade "A" condensed or dry milk products.

The Regulatory Agency shall suspend such permit, whenever it has reason to believe that a public health hazard exists; or whenever the permit holder has violated any of the requirements of this Ordinance; or whenever the permit holder has interfered with the Regulatory Agency in the performance of its duties. Provided, that the Regulatory Agency shall, in all cases, except where the milk or milk product involved creates, or appears to create, an imminent hazard to the public health; or in any case of a willful refusal to permit authorized inspection/audit, serve upon the holder a written notice of intent to suspend permit, which notice shall specify with particularity the violation(s) in question and afford the holder such reasonable opportunity to correct such violation as may be agreed to by the parties, or in the absence of agreement, fixed by the Regulatory Agency, before making any order of suspension effective. A suspension of permit shall remain in effect until the violation(s) has been corrected to the satisfaction of the Regulatory Agency.

Upon notification, acceptable to the Regulatory Agency, by any person whose permit has been suspended, or upon application within forty-eight (48) hours of any person who has been served with a notice of intention to suspend, and in the latter case before suspension, the Regulatory Agency shall within seventy-two (72) hours proceed to a hearing to ascertain the facts of such violation(s) or interference and upon evidence presented at such hearing shall affirm, modify or rescind the suspension or intention to suspend.

Upon repeated violation(s), the Regulatory Agency may revoke such permit following reasonable notice to the permit holder and an opportunity for a hearing. This Section is not intended to preclude the institution of court action as provided in Sections 5 and 6.
 

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ADMINISTRATIVE PROCEDURES

ISSUANCE OF PERMITS: Every milk producer, milk distributor, bulk milk hauler/sampler, milk tank truck5, milk transportation company and each milk plant, receiving station, transfer station, milk tank truck cleaning facility operator shall hold a valid permit. The permit for a milk tank truck(s) may be issued to the milk transportation company. Milk producers who transport milk or milk products only from their own dairy farms; employees of a milk distributor or milk plant operator who possesses a valid permit; and employees of a milk transportation company that possesses a valid permit and transports milk or milk products from a milk plant, receiving station or transfer station shall not be required to possess a bulk milk hauler/sampler's permit. Grocery stores, restaurants, soda fountains and similar establishments where milk and milk products are served or sold at retail, but not processed, may be exempt from the requirements of this Section.

While compliance with the requirements for Grade "A" condensed and dry milk products is necessary to receive and retain a permit for these products, it is not the intent of this Ordinance to limit the production of a milk plant that condenses and/or dries milk or milk products, to Grade "A" products.

The manufacture of ungraded products for other uses in milk plants operating under a permit for the manufacture of Grade "A" condensed and dry milk products is allowed under conditions specified in Section 7 of this Ordinance and whereby such products are processed, packaged, and stored separately. In such cases, a second permit is required, which is issued with the understanding that ungraded products will be handled in such a manner so as to avoid confusion with the Grade "A" production.

Either or both permits may be temporarily suspended for the violation of any applicable provision of this Ordinance, or revoked for a serious or repeated violation. Suspension of permits for violation of sanitation Items of Section 7 is provided for in Section 5. In addition, the Regulatory Agency may, at any time, institute court action under the provisions of Section 6. There is no specific frequency for the issuance of permits. This should be in accordance with the policies of the Regulatory Agency and in agreement with those employed for the issuance of permits under this Ordinance.

SUSPENSION OF PERMIT: When any requirement(s) of this Ordinance is violated, the permit holder is subject to the suspension of their permit.

The Regulatory Agency may forego suspension of the permit, provided the milk or milk product in violation is not sold or offered for sale as Grade "A" milk or milk product. A Regulatory Agency may allow the imposition of a monetary penalty in lieu of a permit suspension, provided the milk or milk product in violation is not sold or offered for sale as Grade "A" milk or milk product. Except, that a milk producer may be assessed a monetary penalty in lieu of permit suspension for violative counts provided:

  1. If the monetary penalty is due to a violation of the bacterial or cooling temperature standards, the Regulatory Agency shall conduct an inspection of the facility and operating methods and make the determination that the conditions responsible for the violation have been corrected. Samples shall then be taken at the rate of not more than two (2) per week on separate days within a three (3) week period in order to determine compliance with the appropriate standard as determined in accordance with Section 6 of this Ordinance.
  2. If the monetary penalty is due to a violation of the somatic cell count standard, the Regulatory Agency shall verify that the milk supply is within acceptable limits as prescribed in Section 7 of this Ordinance. Samples shall then be taken at the rate of not more than two (2) per week on separate days within a three (3) week period in order to determine compliance with the appropriate standard as determined in accordance with Section 6 of this Ordinance.

HEARINGS: If a State Administrative Procedure Act (APA), which provides procedures for administrative hearings and judicial review of administrative determinations, is available, the APA shall be made applicable by reference to the hearings provided for in the Ordinance. If such APA is not available, appropriate procedures, including provision for notice, hearing officer, their authority, record of hearing, rules of evidence and court review shall be established by the appropriate authority.

REINSTATEMENT OF PERMITS: Any permit holder whose permit has been suspended may make written application for the reinstatement of their permit.

When the permit suspension has been due to a violation of any of the bacterial, coliform or cooling temperature standards, the Regulatory Agency, within one (1) week after the receipt of notification for reinstatement of permit, shall issue a temporary permit after determining by an inspection of the facilities and operating methods that the conditions responsible for the violation have been corrected. When a permit suspension has been due to a violation of the somatic cell count standard, the Regulatory Agency may issue a temporary permit whenever a resampling of the herd's milk supply indicates the milk supply to be within acceptable limits as prescribed in Section 7. Samples shall then be taken at the rate of not more than two (2) per week on separate days within a three (3) week period and the Regulatory Agency shall reinstate the permit upon compliance with the appropriate standard as determined in accordance with Section 6 of this Ordinance.

Whenever the permit suspension has been due to a violation of a requirement other than bacteriological, coliform, somatic cell count, drug residue test or cooling-temperature standards, the notification shall indicate that the violation(s) has been corrected. Within one (1) week of the receipt of such notification, the Regulatory Agency shall make an inspection/audit of the applicant's facility, and as many additional inspections/audits thereafter as are deemed necessary, to determine that the applicant's facility is complying with the requirements. When the findings justify, the permit shall be reinstated.

When a permit suspension has been due to a positive drug residue, the permit shall be reinstated in accordance with the provisions of Appendix N.
 


 

SECTION 4. LABELING

All bottles, containers and packages containing milk or milk products defined in Section 1 of this Ordinance shall be labeled in accordance with the applicable requirements of the FFD&CA, the Nutrition Labeling and Education Act (NLEA) of 1990, and regulations developed there under, the CFR, and in addition, shall comply with applicable requirements of this Section as follows:

All bottles, containers and packages containing milk or milk products, except milk tank trucks, storage tanks and cans of raw milk from individual dairy farms, shall be conspicuously marked with:

  1. The identity of the milk plant where pasteurized, ultra-pasteurized, aseptically processed, condensed and/or dried.
  2. The words "keep refrigerated after opening" in the case of aseptically processed milk and milk products.
  3. The common name of the hooved mammal producing the milk shall precede the name of the milk or milk product when the product is or is made from other than cattle's milk. As an example, "Goat", "Sheep", "Water Buffalo", or "Other Hooved Mammal" milk or milk products respectively. (Refer to the last NOTE: in Section 6.)
  4. The words "Grade "A"" on the exterior surface. Acceptable locations shall include the principal display panel, the secondary or informational panel, or the cap/cover.
  5. The word "reconstituted" or "recombined" if the product is made by reconstitution or recombination.
  6. In the case of condensed or dry milk products the following shall also apply:
    1. The identity of the Regulatory Agency issuing such permit; and if distributed by another party, the name and address of the distributor shall be shown by a statement, such as "Distributed by".
    2. A code or lot number identifying the contents with a specific date, run, or batch of the product, and the quantity of the contents of the container.

All vehicles and milk tank trucks containing milk or milk products shall be legibly marked with the name and address of the milk plant or hauler in possession of the contents.

Milk tank trucks transporting raw, heat-treated or pasteurized milk and milk products to a milk plant from another milk plant, receiving station or transfer station are required to be marked with the name and address of the milk plant or hauler and shall be sealed; in addition, for each such shipment, a shipping statement shall be prepared containing at least the following information:

  1. Shipper's name, address and permit number. Each milk tank truck containing milk shall include the IMS Bulk Tank Unit (BTU) identification number(s) or the IMS Listed Milk Plant Number, for farm groups listed with a milk plant, on the weight ticket or manifest.
  2. Permit identification of hauler, if not an employee of the shipper.
  3. Point of origin of shipment.
  4. Tanker identification number.
  5. Name of product.
  6. Weight of product.
  7. Temperature of product when loaded.
  8. Date of shipment.
  9. Name of supervising Regulatory Agency at the point of origin of shipment.
  10. Whether the contents are raw, pasteurized, or in the case of cream, low fat or skim milk, whether it has been heat-treated.
  11. Seal number on inlet, outlet, wash connections and vents.
  12. Grade of product.

All cans of raw milk from individual dairy farms shall be identified by the name or number of the individual milk producer.

Each milk tank truck containing milk shall be accompanied by documentation, weigh ticket or manifest, which shall include the IMS BTU Identification Number(s) or the IMS Listed Milk Plant Number, for farm groups listed with a milk plant.
 

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ADMINISTRATIVE PROCEDURES

The purpose of this Section is to require labeling that will permit easy identification of the milk and milk product and its origin. It is required that the milk or milk product be designated by its common or usual name.

LABELING OF EMERGENCY SUPPLIES: When the sale of ungraded milk or milk products is authorized during emergencies, under the terms of Section 2, the label must bear the designation "ungraded". When such labeling is not available, the Regulatory Agency shall take immediate steps to inform the public that the particular supply is "ungraded" and that the supply will be properly labeled as soon as the distributor can obtain the required labels.

IDENTITY LABELING: "Identity", as used in this Section, is defined as the name and address or permit number of the milk plant at which the pasteurization, ultra-pasteurization, aseptic processing, condensing and/or drying takes place. It is recommended that the voluntary national uniform coding system for the identification of milk plants, at which milk and milk products are packaged, be adopted in order to provide a uniform system of codes throughout the country.

In cases where several milk plants are operated by one firm, the common firm name may be utilized on milk bottles, containers and packages. Provided, that the location of the milk plant at which the contents were pasteurized, ultra-pasteurized, aseptically processed, condensed and/or dried is also shown, either directly or by a code. This requirement is necessary in order to enable the Regulatory Agency to identify the source of the pasteurized, ultra-pasteurized, aseptically processed, condensed and/or dried milk or milk products. The street address of the milk plant need not be shown when only one (1) milk plant of a given name is located within the municipality.

The identity labeling requirement may be interpreted as permitting milk plants and persons to purchase and distribute, under their own label, milk and milk products processed and packaged at another milk plant, provided, that the label reads, "Processed at ... (name and address)", or that the processing and packaging milk plant is identified by a proper code.

MISLEADING LABELS: The Regulatory Agency shall not permit the use of any misleading marks, words or endorsements upon the label. They may permit the use of registered trade designs or similar terms on the bottle cap or label, when in their opinion, they are not misleading and are not so used as to obscure the labeling required by this Ordinance. For dry milk products, the outer bag must be preprinted "Grade "A" before filling. The use of super grade designations shall not be permitted. However, this should not be construed as prohibiting the use of official grade designations awarded to dry milk products by the United States Department of Agriculture (USDA). Grade designations such as "Grade "AA" Pasteurized", "Selected Grade "A" Pasteurized", "Special Grade "A" Pasteurized", etc., give the consumer the impression that such a grade is significantly safer than Grade "A". Such an implication is false, because the Ordinance requirements for Grade "A" pasteurized, ultra-pasteurized, or aseptically processed milk when properly enforced, will ensure that this grade of milk will be as safe as milk can practically be made. Descriptive labeling terms must not be used in conjunction with the Grade "A" designation or name of the milk or milk product and must not be false or misleading.
 


 

SECTION 5. INSPECTION OF DAIRY FARMS AND MILK PLANTS

Each dairy farm, milk plant, receiving station, transfer station, milk tank truck cleaning facility whose milk or milk products are intended for consumption within ...of...1 or it's jurisdiction, and each bulk milk hauler/sampler who collects samples of raw milk for pasteurization, for bacterial, chemical or temperature standards and hauls milk from a dairy farm to a milk plant, receiving station or transfer station and each milk tank truck and its appurtenances shall be inspected/audited by the Regulatory Agency prior to the issuance of a permit. Following the issuance of a permit, the Regulatory Agency shall:

  1. Inspect each milk tank truck and its appurtenances used by a bulk milk hauler/sampler who collects samples of raw milk for pasteurization for bacterial, chemical or temperature standards and hauls milk from a dairy farm to a milk plant, receiving station or transfer station, at least once every twelve (12) months.
  2. Inspect each bulk milk hauler/sampler's, dairy plant sampler's and industry plant sampler's pickup and sampling procedures at least once every twenty-four (24) months.
  3. Inspect each milk plant and receiving station at least once every three (3) months, except that, for those milk plants and receiving stations that have HACCP Systems, which are regulated under the NCIMS HACCP Program, regulatory audits shall replace the regulatory inspections described in this Section. The requirements and minimum frequencies for these regulatory audits are specified in Appendix K.
  4. Inspect each milk tank truck cleaning facility and transfer station at least once every six (6) months, except that, for those transfer stations that have HACCP Systems, which are regulated under the NCIMS HACCP Program, regulatory audits shall replace the regulatory inspections described in this Section. The requirements and minimum frequencies for these regulatory audits are specified in Appendix K.
  5. Inspect each dairy farm at least once every six (6) months.6

Should the violation of any requirement set forth in Section 7, or in the case of a bulk milk hauler/sampler, industry plant sampler or milk tank truck also Section 6 and Appendix B, be found to exist on an inspection/audit, a second inspection/audit shall be required after the time deemed necessary to remedy the violation, but not before three (3) days. This second inspection/audit shall be used to determine compliance with the requirements of Section 7 or in the case of a bulk milk hauler/sampler, industry plant sampler or milk tank truck also Section 6 and Appendix B. Any violation of the same requirement of Section 7, or in the case of a bulk milk hauler/sampler or milk tank truck also Section 6 and Appendix B, on such second inspection/audit, shall call for permit suspension in accordance with Section 3 and/or court action or in the case of an industry plant sampler, shall cease the collection of official regulatory samples until successfully re-trained and re-evaluated by the Regulatory Agency. Provided, that when the Regulatory Agency finds that a critical processing element violation involving:

  1. Proper pasteurization, whereby every particle of milk or milk product may not have been heated to the proper temperature and held for the required time in properly designed and operated equipment;
  2. A cross-connection exists whereby direct contamination of pasteurized milk or milk product is occurring; or
  3. Conditions exist whereby direct contamination of pasteurized milk or milk product is occurring.

The Regulatory Agency shall take immediate action to prevent further movement of such milk or milk product until such violations of critical processing element(s) have been corrected. Should correction of such critical processing element(s) not be accomplished immediately, the Regulatory Agency shall take prompt action to suspend the permit as provided for in Section 3 of this Ordinance. Provided, that in the case of milk plants producing aseptically processed milk and milk products, when an inspection of the milk plant and its records reveal that the process used has been less than the required scheduled process, it shall be considered an imminent hazard to public health and the Regulatory Agency shall take immediate action to suspend the permit of the milk plant for the sale of aseptically processed milk and milk products in conformance with Section 3 of this Ordinance.

One (1) copy of the inspection/audit report shall be handed to the operator, or other responsible person or be posted in a conspicuous place on an inside wall of the establishment. Said inspection/audit report shall not be defaced and shall be made available to the Regulatory Agency upon request. An identical copy of the inspection/audit report shall be filed with the records of the Regulatory Agency.

The Regulatory Agency shall also make such other inspections and investigations as are necessary for the enforcement of this Ordinance.

Every permit holder shall, upon the request of the Regulatory Agency, permit access of officially designated persons to all parts of their establishment or facilities to determine compliance with the provisions of this Ordinance. A distributor or milk plant operator shall furnish the Regulatory Agency, upon request, for official use only, a true statement of the actual quantities of milk and milk products of each grade purchased and sold, a list of all sources of such milk and milk products, records of inspections, tests and pasteurization time and temperature records.

It shall be unlawful for any person who, in an official capacity, obtains any information under the provisions of this Ordinance, which is entitled to protection as a trade secret, including information as to the quantity, quality, source or disposition of milk or milk products or results of inspections/audits or tests thereof, to use such information to their own advantage or to reveal it to any unauthorized person.
 

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ADMINISTRATIVE PROCEDURES

INSPECTION FREQUENCY: For the purposes of determining the inspection frequency for dairy farms and transfer stations the interval shall include the designated six (6) month period plus the remaining days of the month in which the inspection is due.

For the purposes of determining the inspection frequency for milk plants and receiving stations the interval shall include the designated three (3) month period plus the remaining days of the month in which the inspection is due.

One (1) milk tank truck inspection every twelve (12) months, or bulk milk hauler/sampler's or industry plant sampler's pickup and sampling procedures inspection each twenty-four (24) months, or one (1) producer, transfer station, or milk tank truck cleaning facility inspection every six (6) months, or one (1) milk plant or receiving station inspection every three (3) months is not a desirable frequency, it is instead a legal minimum. Bulk milk hauler/samplers, industry plant samplers, milk tank trucks, milk tank truck cleaning facilities, dairy farms, milk plants, receiving stations and transfer stations experiencing difficulty meeting requirements should be visited more frequently. Milk plants that condense and/or dry milk or milk products and which operate for a short duration of time or intermittent periods of time should also be inspected more frequently. Inspections of dairy farms shall be made at milking time as often as possible and of milk plants at different times of the day in order to ascertain if the processes of equipment assembly, sanitizing, pasteurization, cleaning and other procedures comply with the requirements of this Ordinance.

For the purpose of determining the minimum audit frequency for milk plants, receiving stations and transfer stations regulated under the NCIMS HACCP Program the interval shall include the remaining days of the month in which the audit is due.

ENFORCEMENT PROCEDURES: This Section provides that a dairy farm, bulk milk hauler/sampler, milk tank truck, milk tank truck cleaning facility, milk plant, receiving station, transfer station or distributor, except those processing aseptically processed milk and milk products, shall be subject to suspension of permit and/or court action if two (2) successive inspections disclose a violation of the same requirement.

Experience has demonstrated that strict enforcement of the Ordinance leads to a better and friendlier relationship between the Regulatory Agency and the milk industry than does a policy of enforcement which seeks to excuse violations and to defer penalty thereof. The sanitarian's criterion of satisfactory compliance should be neither too lenient nor unreasonably stringent. When a violation is discovered, the sanitarian should point out to the milk producer, bulk milk hauler/sampler, industry plant sampler, responsible person for the milk tank truck, milk tank truck cleaning facility, milk plant, receiving station, transfer station or distributor the requirement that has been violated, discuss a method for correction and set a time for correcting the violated requirement.

The penalties of suspension or revocation of permit and/or court action are provided to prevent continued violation of the provisions of this Ordinance but are worded to protect the dairy industry against unreasonable or arbitrary action. When a condition is found which constitutes an imminent health hazard, prompt action is necessary to protect the public health; therefore, the Regulatory Agency is authorized in Section 3, to suspend the permit immediately. However, except for such emergencies, no penalty is imposed on the milk producer, bulk milk hauler/sampler, responsible person for the milk tank truck, milk tank truck cleaning facility, milk plant, receiving station, transfer station or distributor upon the first violation of any of the sanitation requirements listed in Section 7. A milk producer, bulk milk hauler/sampler, responsible person for the milk tank truck, milk tank truck cleaning facility, milk plant, receiving station, transfer station or distributor found violating any requirement must be notified in writing and given a reasonable time to correct the violation(s) before a second inspection is made, but not before three (3) days. The requirement of giving written notice shall be deemed to have been satisfied by the handing to the operator or by the posting of an inspection report, as required by this Section. After receipt of a notice of violation, but before the allotted time has elapsed, the milk producer, bulk milk hauler/sampler, responsible person for the milk tank truck, milk tank truck cleaning facility, milk plant, receiving station, transfer station or distributor shall have an opportunity to appeal the sanitarian's interpretation to the Regulatory Agency or request an extension of the time allowed for correction.

ENFORCEMENT PROCEDURES - ASEPTIC PROCESSING MILK PLANTS: Because aseptically processed milk and milk products are stored at room temperature and are not refrigerated after processing they must be considered an imminent hazard to public health whenever it is revealed by an inspection or a review of the processing records that the process is less than the required scheduled process and the products produced have not maintained their commercial sterility. Prompt action by the Regulatory Agency to suspend the permit must be initiated in order to protect the public health. The Regulatory Agency shall stop the sale of all under-processed milk or milk product and follow at least the minimum requirements of 21 CFR 113.89 before releasing any product. (Refer to Appendix L.)

CERTIFIED INDUSTRY INSPECTION: The Regulatory Agency may certify industry personnel, with their consent, to carry out cooperatively the provisions of this Ordinance with respect to the supervision of dairy farms, bulk milk haul/sampler's pickup and sampling procedures, and/or milk tank trucks. States utilizing certified industry inspections shall have on file and available for review, a written program that describes how the requirements of this Ordinance and related documents shall be implemented. Delegation of the inspection and evaluation of bulk milk hauler/sampler's pickup and sampling procedures shall be done by the Sampling Surveillance Officer (SSO) in accordance with the Evaluation of Milk Laboratories (EML).

Reports of all inspections conducted by such personnel to determine compliance with the provisions of this Ordinance shall be maintained by the industry at a location acceptable to the Regulatory Agency. The Certified Industry Inspector may perform all punitive actions and all inspections for the issuance or reinstatement of permits. Initial inspections and change of market inspections are required and shall be conducted by the Regulatory Agency in conjunction with the Certified Industry Inspector.

When a producer changes market, the producer records for the preceding twenty-four (24) months shall be transferred with the producer, through the Regulatory Agency, and will continue to be a part of the producer's record.

Industry personnel shall be certified every three (3) years by the Regulatory Agency.

At least annually, the Certified Industry Inspector shall attend an educational seminar provided by the Regulatory Agency, or equivalent training acceptable to the Regulatory Agency.

At least once in each six (6) month period, the Regulatory Agency shall inspect the records maintained by the Industry for the Certified Industry Inspection Program and conduct farm field work to assure the program meets the provisions of the Regulatory Agency's written plan and requirements of this Ordinance and related documents.

Initial certification by the Regulatory Agency shall not be made during the course of an official inspection. Re-certification by the Regulatory Agency may be conducted during the course of an official inspection.

Purpose of Certification: The purpose of certification is to have the applicant formally demonstrate their inspection ability to apply proper interpretations of this Ordinance, related documents, and the Regulatory Agency's procedures.

Designation of Individuals to Be Certified: Candidates shall submit requests for certification to the Regulatory Agency. The applicant for certification shall have had experience in the field of milk sanitation, and shall be an employee of a milk plant, a producer association, officially designated laboratory or shall be employed on a consulting basis.

Recording of Qualification Data: Prior to conducting the certification procedure, background information shall be secured on the applicant. This shall include academic training, experience in milk sanitation and related fields, in-service courses attended, etc. This information is to be retained by the Regulatory Agency as part of the applicant's file, along with appropriate records of the applicant's performance during the certification examination.

Field Procedure: Only one (1) applicant shall be certified at a time. The certification is to be conducted without prompting from the Regulatory Agency or comparison of inspection results in any way until the entire procedure is completed. Initial certification shall not be made during the course of an official inspection by the Regulatory Agency.

At least twenty-five (25) randomly selected dairy farms and/or five (5) milk tank trucks shall be visited. After the necessary inspections have been completed, the Regulatory Agency shall compare their results with those of the candidate. The percentage agreement for each Item of sanitation shall be determined by dividing the number of agreements by the total number of dairy farms and/or milk tank trucks inspected.

Criteria for Certification: In order to be certified, an industry inspector shall agree with the Regulatory Agency eighty percent (80%) of the time on individual Items of sanitation and shall further agree to comply with the administrative procedures established by the Regulatory Agency for the program of dairy farm and/or milk tank truck supervision. The Regulatory Agency should allow sufficient time to discuss the findings with the applicant.

Duration of Certification: Certification of industry inspection personnel shall be for a period not exceeding three (3) years from the date of formal certification or re-certification, unless revoked.

Re-Certification: The Regulatory Agency shall notify the certified industry inspector of the need for certification renewal at least sixty (60) days prior to its expiration. If re-certification is desired, the inspector will make appropriate arrangements for the renewal procedure. Re-certification can be made for the succeeding three (3) year period, by following the procedures outlined above. Provided, that re-certification may be conducted during the course of an official inspection by the Regulatory Agency.

Reports and Records: Upon satisfactory completion of certification or re-certification, the certified industry inspector shall be issued a certificate. The milk plant(s) or officially designated laboratory(ies) employing the inspector shall be formally notified by letter of the certification. The letter shall outline the purpose of the certification and the conditions under which the certification may be retained. A copy of the notification letter, together with a copy of the qualification data above and a resume of the percentage agreement on individual items, shall be retained by the Regulatory Agency.

Revocation of Certification: The certification of an industry inspector may be revoked by the Regulatory Agency upon a finding that the inspector is:

  1. Not in agreement with the Regulatory Agency at least eighty percent (80%) of the time on Items of sanitation in a field examination conducted as described in the Field Procedure outlined above; or
  2. Not complying with the established administrative procedures of the Regulatory Agency for the program; or
  3. Failing to carry out the provisions of this Ordinance in the course of the inspector's work.

INSPECTION/AUDIT REPORTS: A copy of the inspection/audit report shall be filed as directed by the Regulatory Agency and retained for at least twenty-four (24) months. The results shall be entered on appropriate ledger forms. The use of a computer or other information retrieval system may be used. Examples of field inspection/audit forms are identified in Appendix M.
 

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SECTION 6. THE EXAMINATION OF MILK AND MILK PRODUCTS

It shall be the responsibility of the bulk milk hauler/sampler to collect a representative sample of milk from each farm bulk tank or from a properly installed and operated in-line-sampler, that is approved for use by the Regulatory Agency and FDA to collect representative samples, prior to transferring milk from a farm bulk tank, truck or other container. All samples shall be collected and delivered to a milk plant, receiving station, transfer station or other location approved by the Regulatory Agency.
 

  1. During any consecutive six (6) months, at least four (4) samples of raw milk for pasteurization shall be collected from each producer, in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days. These samples shall be obtained under the direction of the Regulatory Agency or shall be taken from each producer under the direction of the Regulatory Agency and delivered in accordance with this Section.
  2. During any consecutive six (6) months, at least four (4) samples of raw milk for pasteurization, ultra-pasteurization or aseptic processing, shall be collected in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days. These samples shall be obtained by the Regulatory Agency, from each milk plant after receipt of the milk by the milk plant and prior to pasteurization, ultra-pasteurization or aseptic processing.
  3. During any consecutive six (6) months, at least four (4) samples of heat-treated milk products, from milk plants offering such products for sale, shall be collected by the Regulatory Agency in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days.
  4. During any consecutive six (6) months, at least four (4) samples of pasteurized milk, flavored milk, flavored reduced fat or low fat milk, flavored nonfat (skim) milk, each fat level of reduced fat or low fat milk and each milk product defined in this Ordinance, shall be collected by the Regulatory Agency in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days from every milk plant. All pasteurized (including Aseptically Processed and Ultra-Pasteurized) milk and milk products required sampling and testing is to be done only when there are test methods available that are validated by FDA and accepted by the NCIMS. Products with no validated and accepted methods are not required to be tested.
     

NOTE: If the production of any Grade "A" condensed or dry milk product as defined in this Ordinance is not on a yearly basis, at least five (5) samples shall be taken within a continuous production period.

Samples of milk and milk products shall be taken while in the possession of the producer, milk plant or distributor at any time prior to delivery to the store or consumer. Samples of milk and milk products from dairy retail stores, food service establishments, grocery stores and other places where milk and milk products are sold shall be examined periodically as determined by the Regulatory Agency and the results of such examination shall be used to determine compliance with Sections 2, 4 and 10. Proprietors of such establishments shall furnish the Regulatory Agency, upon request, with the names of all distributors from whom milk or milk products are obtained.

Required bacterial counts somatic cell counts and cooling temperature checks shall be performed on raw milk for pasteurization. In addition, drug tests on each producer's milk shall be conducted at least four (4) times during any consecutive six (6) months.

All pasteurized (including Aseptically Processed and Ultra-Pasteurized) milk and milk products required sampling and testing to be done only when there are test methods available that are validated by FDA and accepted by the NCIMS, otherwise there would be no requirement for sampling. Required bacterial counts, coliform counts, phosphatase and cooling temperature determinations shall be performed on Grade "A" pasteurized milk and milk products defined in this Ordinance only when there are validated and accepted test methodology.

NOTE: When multiple samples of the same milk or milk products, except for aseptically processed milk and milk products, are collected from the same producer or processor from multiple tanks or silos on the same day, the laboratory results are averaged arithmetically by the Regulatory Agency and recorded as the official results for that day. This is applicable for bacterial (standard plate count and coliform), somatic cell count and temperature determinations only.

Whenever two (2) of the last four (4) consecutive bacterial counts (except those for aseptically processed milk and milk products), somatic cell count, coliform determinations, or cooling temperatures, taken on separate days, exceed the standard for the milk and/or milk products as defined in this Ordinance, the Regulatory Agency shall send a written notice thereof to the person concerned. This notice shall be in effect as long as two (2) of the last four (4) consecutive samples exceed the standard. An additional sample shall be taken within twenty-one (21) days of the sending of such notice, but not before the lapse of three (3) days. Immediate suspension of permit, in accordance with Section 3, and/or court action shall be instituted whenever the standard is violated by three (3) of the last five (5) bacterial counts (except those for aseptically processed milk and milk products), somatic cell counts, coliform determinations or cooling temperatures.

Whenever a phosphatase test is positive, the cause shall be determined. Where the cause is improper pasteurization, it shall be corrected and any milk or milk product involved shall not be offered for sale.

Whenever a pesticide residue test is positive, an investigation shall be made to determine the cause and the cause shall be corrected. An additional sample shall be taken and tested for pesticide residues and no milk or milk products as defined in this Ordinance shall be offered for sale until it is shown by a subsequent sample to be free of pesticide residues or below the actionable levels established for such residues.

Whenever a drug residue test is confirmed positive, an investigation shall be made to determine the cause, and the cause shall be corrected in accordance with the provisions of Appendix N.

Whenever a container or containers of aseptically processed milk or milk product is found to be non-sterile, due to under-processing, the Regulatory Agency shall consider this to be an imminent hazard to public health and shall suspend the permit of the milk plant for the sale of aseptically processed milk and milk products. No aseptically processed milk and milk product shall be sold until it can be shown that the processes, equipment and procedures used are suitable for consistent production of a sterile product. All products from the lot that were found to contain one (1) or more non-sterile units shall be recalled and disposed of as directed by the Regulatory Agency.

Samples shall be analyzed at an appropriate official or officially designated laboratory. All sampling procedures, including the use of approved in-line samplers, and required laboratory examinations shall be in substantial compliance with the most current edition of Standard Methods for the Examination of Dairy Products (SMEDP) of the American Public Health Association, and the most current edition of Official Methods of Analysis of AOAC INTERNATIONAL (OMA). Such procedures, including the certification of sample collectors and examinations shall be evaluated in accordance with the EML. Aseptically processed milk and milk products packaged in hermetically sealed containers shall be tested in accordance with FDA's Bacteriological Analytical Manual (BAM).

Each milk plant regulated under the NCIMS HACCP Program shall adequately document its response to each regulatory sample test result that exceeds any maximum level specified in Section 7 of this Ordinance. The Regulatory Agency will monitor and verify that appropriate action(s) was taken by the milk plant.

Examinations and tests to detect adulterants, including pesticides, shall be conducted, as the Regulatory Agency requires. When the Commissioner of the FDA determines that a potential problem exists with animal drug residues or other contaminants in the milk supply, samples shall be analyzed for the contaminant by a method(s) determined by FDA to be effective in determining compliance with actionable levels or established tolerances. This testing will continue until such time that the Commissioner of the FDA is reasonably assured that the problem has been corrected. The determination of a problem is to be based upon:
 

  1. Sample survey results;
  2. USDA tissue residue data from cull and veal dairy animals;
  3. Animal drug disappearance and sales data;
  4. State feed back; and
  5. Other relevant information.
     

Assays of milk and milk products as defined in this Ordinance, to which vitamin (s) A and/or D have been added, shall be made at least annually in a laboratory, which has been accredited by FDA and which is acceptable to the Regulatory Agency, using test methods acceptable to FDA or other official methodologies, which gives statistically equivalent results to the FDA methods.

Vitamin testing laboratories are accredited if they have one (1) or more certified analysts and meet the quality control requirements of the program established by FDA. Laboratory accreditation and analyst certification parameters are specified in the EML manual.

In addition, all facilities fortifying milk or milk products with vitamins must keep volume control records. These volume control records must cross reference the form and amount of vitamin D, vitamin A and/or vitamins A and D used with the amount of products produced and indicate a percent of expected use, plus or minus.
 

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ADMINISTRATIVE PROCEDURES

ENFORCEMENT PROCEDURES: All violations of bacteria, coliform, confirmed somatic cell counts and cooling temperature standards should be followed promptly by inspection to determine and correct the cause. (Refer to Appendix E. Examples of Three (3)-out-of-Five (5) Compliance Enforcement Procedures)

Aseptically processed milk and milk products packaged in hermetically sealed containers are exempt from the refrigerated storage requirements of this Ordinance. Therefore, whenever a breakdown in the processing or packaging of these products occurs an imminent hazard to public health exists. Prompt action is needed by the Regulatory Agency. Milk plants aseptically processing milk and milk products in hermetically sealed containers should be encouraged to perform bacterial and other quality tests on each lot of aseptically processed milk and milk product produced in order to ascertain that these products have been properly processed and have not been rendered non-sterile after aseptic processing and packaging. The Regulatory Agency may utilize industry records, of each lot of aseptically processed milk and milk products, to determine when lots can be released for sale after a violation of the bacterial standards has existed.

LABORATORY TECHNIQUES: Procedures for the collection, including the use of approved in-line samplers, and holding of samples; the selection and preparation of apparatus, media and reagents; and the analytical procedures, incubation, reading and reporting of results, shall be in substantial compliance with the FDA 2400 series forms, SMEDP and OMA. The procedures shall be those specified therein for:

  1. Standard plate count at 32°C (agar or Petrifilm method).
     
  2. Alternate methods, for bacterial counts at 32°C (89.6°F), including the Plate Loop Count, Spiral Plate Count and the BactoScan FC for raw milk.
     
  3. Coliform test with solid media or Petrifilm method at 32°C for all milk and milk products, and the Petrifilm High Sensitivity Coliform Count method for all milk and milk products, except unflavored whole, reduced or low fat and nonfat (skim) milk.
     
  4. A viable bacterial count of nonfat dry milk shall be made in accordance with the procedures in SMEDP for the Standard Plate Count of Dry Milk, except agar plates shall be incubated for 72 hours.
     
  5. Beta lactam methods which have been independently evaluated or evaluated by FDA and have been found acceptable by FDA for detecting drug residues in raw milk, or pasteurized milk, or that particular type of pasteurized milk product at current safe or tolerance levels, shall be used for each drug of concern, except those products for which there are not any approved drug test kits available. Regulatory action shall be taken on all confirmed positive results. (Refer to Appendix N.) A result shall be considered positive if it has been obtained by using a method, which has been evaluated and deemed acceptable by FDA and accepted by the NCIMS at levels established in memoranda transmitted periodically by FDA as required by Section IV of Appendix N.
     
  6. Screening and Confirmatory Methods for the Detection of Abnormal Milk: The results of the screening test or confirmatory test shall be recorded on the official records of the dairy farm and a copy of the results sent to the milk producer.

    When a warning letter has been sent, because of excessively high somatic cell counts, an official inspection of the dairy should be made by regulatory personnel or certified industry personnel. This inspection should be made during milking time.

    1. 6a. Milk (Non-Goat): Any of the following confirmatory or screening test procedures shall be used: Single Strip Direct Microscopic Somatic Cell Count or Electronic Somatic Cell Count.
       
    2. 6b. Goat Milk: Direct Microscopic Somatic Cell Count or Electronic Somatic Cell Count may be used for screening raw goat milk samples, to indicate a range of somatic cell levels, as long as the somatic cell standard for goat milk remains 1,000,000/mL. Screening for official purposes must be conducted by an analyst (s) certified for that procedure. Only the Pyronine Y-Methyl Green stain or "New York modification" Single Strip Direct Microscopic Somatic Cell Count test procedures shall be used to confirm the level of somatic cells in goat milk by certified analysts.
       

    Any of the following confirmatory or screening tests shall be used: Direct Microscopic Somatic Cell Counting Single Strip Procedure, Electronic Somatic Cell Counting or Flow Cytometry/Opto-Electronic Somatic Cell Counting. Pyronine Y-Methyl green stain or "New York modification" shall be used in the confirmatory test for Direct Microscopic Somatic Cell Counts in goat milk.

  7. Electronic Phosphatase Tests: The phosphatase test is an index of the efficiency of the pasteurization process. In the event an accredited laboratory finds that a sample confirms positive for phosphatase, the pasteurization process shall be investigated and corrected. When a laboratory phosphatase test is confirmed positive, or if any doubt should arise as to the compliance of the equipment, standards or methods outlined in Section 7, Item 16p, the Regulatory Agency should immediately conduct field phosphatase testing at the milk plant. (Refer to Appendix G.)
     
  8. Vitamin testing shall be performed using test methods acceptable to FDA or other official methodologies, which give statistically equivalent results to the FDA methods.
     
  9. Any other tests, which have been approved by FDA to be equally accurate, precise and practical.
     
  10. All standards used in the development and use of drug residue detection methods designed for Grade "A" PMO monitoring programs will be referenced to a United States Pharmacopeia (USP) standard when available. When a USP standard is not available, then the original method must define the standard to be used.
     
  11. Procedural or reagent changes for official tests must be submitted to FDA for acceptance prior to being used by certified NCIMS milk laboratories.
     

SAMPLING PROCEDURES: SMEDP contains guidance for sampling of milk and milk products. (Refer to Appendix G. for a reference to drug residues in milk and the conditions under which a positive phosphatase reaction may be encountered in properly pasteurized milk or cream. Refer to Appendix B. for reference to farm bulk milk hauling programs regarding training, licensing/permitting, routine inspection and the evaluation of sampling procedures.)

When samples of raw milk for pasteurization are taken at a milk plant prior to pasteurization, they shall be drawn following adequate agitation from randomly selected storage tanks. All counts and temperatures should be recorded on a milk-ledger form as soon as reported by the laboratory. A computer or other information retrieval system may be used.

 NOTE: Milk from animals not currently in the Grade "A" PMO may be labeled as Grade "A" and IMS listed upon FDA's acceptance of validated Grade "A" PMO, Section 6 and Appendix N. test methods for the animal to be added.
 

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SECTION 7. STANDARDS FOR GRADE "A" MILK AND MILK PRODUCTS

All Grade "A" raw milk or milk products for pasteurization, ultra-pasteurization, or aseptic processing and all Grade "A" pasteurized, ultra-pasteurized or aseptically processed milk and milk products, shall be produced, processed, manufactured and pasteurized, ultra-pasteurized, or aseptically processed to conform to the following chemical, physical, bacteriological and temperature standards and the sanitation requirements of this Section.

No process or manipulation other than pasteurization, ultra-pasteurization or aseptic processing; processing methods integral therewith; and appropriate refrigeration shall be applied to milk and milk products for the purpose of removing or deactivating microorganisms. Provided, that in the bulk shipment of cream, nonfat (skim) milk or reduced fat or low fat milk, the heating of the raw milk, one time, to temperatures greater than 52°C (125°F) but less than 72°C (161°F), for separation purposes, is permitted when the resulting bulk shipment(s) of cream, nonfat (skim) milk or reduced fat or low fat milk are labeled heat-treated. In the case of heat-treated cream, the cream may be further heated to less than 75°C (166°F) in a continuing heating process and immediately cooled to 7°C (45°F) or less when necessary for enzyme deactivation (such as lipase reduction) for a functional reason.

Milk plants, receiving stations and transfer stations participating in the NCIMS HACCP Program, shall also comply with the requirements of Appendix K of this Ordinance.

Whey shall be from cheese made from Grade "A" raw milk for pasteurization as provided in this Ordinance.

Buttermilk shall be from butter made from Grade "A" cream, which has been pasteurized prior to use in accordance with Item 16p of this Ordinance. Provided, that this requirement shall not be construed as barring any other heat treatment process which has been recognized by the FDA to be equally efficient in the destruction of staphylococcal organisms and which is approved by the Regulatory Agency.

Buttermilk and whey used in the manufacture of Grade "A" milk and milk products shall be produced in a milk/cheese plant that complies with Items 1p, 2p, 3p, 4p, 5p 6p, 7p 8p, 9p, 10p, 11p, 12p, 13p, 14p, 15p, 17p, 20p, 21p and 22p as provided in this Ordinance.

Whey shall be from:

  1. Cheese made from Grade "A" raw milk for pasteurization, which has been pasteurized prior to use, in accordance with Item 16p of this Ordinance, or
  2. Cheese made from Grade "A" raw milk for pasteurization, which has been heat-treated to a temperature of at least 64°C (147°F) and held continuously at that temperature for at least twenty one (21) seconds or to at least 68°C (153°F) and held continuously at that temperature for at least fifteen (15) seconds, in equipment meeting the pasteurization requirements provided for in this Ordinance. Provided, that this requirement shall not be construed as barring any other heat treatment process which has been recognized by the FDA to be equally efficient in the destruction of staphylococcal organisms and which is approved by the Regulatory Agency.
     
Table 1. Chemical, Physical, Bacteriological, and Temperature Standards
ProductConditionsRequirement
GRADE "A" RAW MILK AND MILK PRODUCTS FOR PASTEURIZATION, ULTRA-PASTEURIZATION OR ASEPTIC PROCESSINGTemperature................Cooled to 10°C (50°F) or less within four (4) hours or less, of the commencement of the first milking, and to 7°C (45°F) or less within two (2) hours after the completion of milking. Provided, that the blend temperature after the first milking and subsequent milkings does not exceed 10°C (50°F). NOTE: Milk sample submitted for testing cooled and maintained at 0°C (32°F) to 4.4°C (40°F), where sample temperature is >4.4°C (40°F), but ≤7.0°C (45oF) and less than three (3) hours after collection has not increased in temperature.
Bacterial Limits...........Individual producer milk not to exceed 100,000 per mL prior to commingling with other producer milk. Not to exceed 300,000 per mL as commingled milk prior to pasteurization. NOTE: Tested in conjunction with the drug residue/inhibitory substance test.
Drugs.......................No positive results on drug residue detection methods as referenced in Section 6 - Laboratory Techniques
Somatic Cell Count*...Individual producer milk not to exceed 750,000 per mL.
GRADE "A" PASTEURIZED MILK AND MILK PRODUCTS AND BULK SHIPPED HEAT-TREATED MILK PRODUCTSTemperature................Cooled to 7°C (45°F) or less and maintained thereat. NOTE: Milk sample submitted for testing cooled and maintained at 0°C (32°F) to 4.4°C (40°F), where sample temperature is >4.4°C (40°F), but ≤7.0°C (45°F) and less than three (3) hours after collection has not increased in temperature.
Bacterial Limits**......20,000 per mL, or gm.*** NOTE: Tested in conjunction with the drug residue/inhibitory substance test.
Coliform****..............Not to exceed 10 per mL. Provided, that in the case of bulk milk transport tank shipments, shall not exceed 100 per mL. NOTE: Tested in conjunction with the drug residue/inhibitory substance test.
Phosphatase*****.........Phosphatase testing of Ultra-Pasteurized milks is not required.
Drugs**......................There are no validated and accepted drug residue tests for Ultra-Pasteurized Milk and Milk Products
GRADE "A" PASTEURIZED CONCENTRATED (CONDENSED) MILK AND MILK PRODUCTSTemperature............Cooled to 7°C (45°F) or less and maintained thereat unless drying is commenced immediately after condensing.
Coliform...............Not to exceed 10 per gram. Provided, that in the case of bulk milk transport tank shipments shall not exceed 100 per ml.
GRADE "A" ASEPTICALLY PROCESSED MILK AND MILK PRODUCTSTemperature................Cooled to 7:C (45:F) or less and maintained thereat
Bacterial Limits...........Refer to 21 CFR 113. 3(e)(1)******
Drugs**.......................There are no validated and accepted drug residue tests for Aseptically Processed Milk and Milk Products.
GRADE "A" NONFAT DRY MILK
Butterfat..................No More Than: 1.25%
Moisture..................No More Than: 4.00%
Titratable Acidity........No More Than: 0.15%
Solubility Index.........No More Than: 1.25 mL.
Bacterial Estimate.......No More Than: 30,000 per gram
Coliform..................No More Than: 10 per gram
Scorched Particles
disc B.....................
No More Than: 15.0 per gram
GRADE "A" WHEY FOR CONDENSING AND/OR DRYINGTemperature.............Maintained at a temperature of 45°F (7°C) or less, or 57°C (135°F) or greater, except for acid-type whey with a titratable acidity of 0.40% or above, or a pH of 4.6 or below.
GRADE "A" PASTEURIZED CONDENSED WHEY AND WHEY PRODUCTSTemperature..............Cooled to 10°C (50°F) or less during crystallization, within 48 hours of condensing.
Coliform Limit...........Not to exceed 10 per gram
GRADE "A" DRY WHEY, GRADE "A" DRY WHEY PRODUCTS, GRADE "A" DRY BUTTERMILK, AND GRADE "A" DRY BUTTERMILK PRODUCTSColiform Limit...........Not to exceed 10 per gram

* Goat Milk 1,000,000 per mL
** Not applicable to acidified or cultured products, eggnog and flavored (non-chocolate) milk and milk products.
*** Results of the analysis of dairy products which are weighed in order to be analyzed will be reported in # per gm. (Refer to the current edition of the SMEDP)
**** Not applicable to bulk shipped heat-treated milk products.
***** Not applicable to bulk shipped heat-treated milk products; UP products that have been thermally processed at or above 138°C (280°F) for at least two (2) seconds to produce a product which has an extended shelf life (ESL) under refrigerated conditions; and condensed products.
****** 21 CFR 113.3(e)(1) contains the definition of "COMMERCIAL STERILITY".

 

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