Inspection

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Introduction

Introduction

                The following material is excerpted from “Dairy Farm Sanitation and Inspection”, FD375, 2009 Revision which was originally prepared by the Food and Drug Administration Division of Human Resource Development University (ORAU). Additional material comes directly from the Grade “A” Pasteurized Milk Ordinance, 2011 Revision.

It is illegal to sell, offer for sale, or have in storage any milk product without possession of a valid permit. To receive and retain a permit the person must comply with the requirements of the Ordinance.

In general, the PMO stipulates that when a public health hazard exists; or when the permit holder has violated any of the Ordinance requirements; or when the permit holder has interfered with the Regulatory Agency (RA) in the performance of its duties, the RA shall suspend the permit.  Except in the case of an imminent public health hazard or in any case of a willful refusal to allow an authorized inspection/audit, a written notice of intent to suspend the permit, specifying the particular violation(s) is sent to the permit holder. This affords the holder reasonable opportunity to correct the violation before making any order of suspension effective. The dairy farm is subject to permit suspension if two succes­sive inspec­tions disclose a violation of the same requirement.  The suspension remains in effect until the violation(s) has been corrected to the satisfaction of the RA.  Frequent violations/suspension may result in a revocation of the permit.

A few brief examples of how a permit suspension might be reinstated follow:

            1. Sanitation violations - Within one (1) week of receipt of notifi­ca­tion from the milk producer that the violations have been corrected an inspec­tion of the facility shall be made to determine that the establishment is in compliance.  If in compliance, the permit is reinstat­ed.

            2. Violation of bacterial or cooling stan­dards - Within one (1) week after the receipt of notification for reinstatement of permit, the RA 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.

            3. Violation of the somatic cell count (SCC) stan­dard - A temporary permit may be issued following acceptable re-sampling of the herd's milk supply. Full reinstatement of the permit shall be made following an acceler­ated sampling program. (Sam­ples to be taken no more than twice per week on separate days within a three week period).

            4. Drug residues - In accordance with the provisions of Appendix N of the PMO. More detailed information on drug residues and Appendix N will be covered in later sections.

                 During a dairy farm inspection, every part of the operation is to be evaluated and inspected for compliance with the current state and federal regulations.  This makes the inspector a potentially valuable resource to the dairy operation, since a fresh set of eyes may identify areas where improvements could lead to improved milk quality. Therefore, the dairy inspector must be a true milk production specialist, and will have the potential to offer practical solutions to problems identified. The dairy inspector and the producer have the same objectives in mind – production of safe, wholesome milk that meets state and federal requirements.

                Milk is one of the most tightly regulated and inspected food supplies in the nation. Producer dairies are inspected a minimum of twice a year, with many agencies inspecting on a quarterly or monthly schedule. Interstate listed shippers are surveyed at least once every 24 months. Raw milk is sampled at the farm bulk milk tank, from the milk tanker, and at the plant from the storage silo tanks. Individual farm supplies are tested for compliance with bacteria, temperature, somatic cell and antibiotic standards. Periodic testing is also done for pesticide residues.

 


Inspection

Inspection of Dairy Farms

Background

                Inspection of dairy farms is required prior to issuance of a permit. Each dairy farm is required to be inspected at least once every 6 months, with a copy of the report provided to the producer, and a copy kept on file at the regulatory authority.

                The inspection of a Grade “A” dairy farm includes the milkhouse, milking barn, stable and parlor, adjacent storage areas, cow yard and cattle housing areas, surroundings, waste disposal areas and the water supply and its distribution system. These areas may include dairy animal maternity areas, animal treatment areas or hospital barns, replacement heifer areas, offices, utility rooms, tool sheds, (drug cabinets, refrigerators, etc.) or other areas where drugs used to treat dairy animals may be used or stored. In terms of drug storage and labeling, the dairy farm includes any area reasonably expected to contain drugs used to treat animals that are currently or intended for milk production. Private residences or vehicles are not included without permission of the owner or authorized agent.

                It is important for inspections to include some “down time” from milking to allow for inspection of milk contact surfaces of equipment for construction and cleanliness. Occasional inspections should occur during milking as well, to determine compliance with milking procedures.

                Except for imminent health hazards, no penalty is imposed on the producer upon the first violation of any requirement of the Ordinance; however, issuance of the inspection report is considered as sufficient notice to the producer to correct any item not in compliance. Permit suspension may occur if two successive inspections disclose violations of the same equipment.

Sampling of milk

                The Universal Sampling Program refers to the responsibility of the milk hauler to collect a representative sample from each farm bulk tank before transferring it. These samples, if collected by a licensed milk hauler, may be used as official samples by the regulatory agency. During any consecutive six month period, at least four samples of raw milk shall be collected from each Grade “A” dairy farm.  These official samples can be used for determination of compliance with established standards. The samples are tested for bacterial counts, somatic cell counts, drug residues, and cooling temperatures.

                Violations of bacteria, somatic cell count and temperatures will be promptly followed up by inspection to determine and correct the cause. Notices may be sent by the regulatory agency, or permits suspended, depending on the number and frequency of repeat violations. Re-sampling may be required to reinstate the dairy.

                A positive drug residue test results in immediate action so that the milk is not offered for sale or consumption until subsequent samples prove the milk to be free of residues. An investigation is initiated to determine the cause, and then correct the cause. The producer must receive a drug residue prevention education program and farm procedure changes to prevent future residues. Permits may be reinstated after a representative sample is no longer positive for drug residues.

                All sampling procedures and required laboratory examinations must be in compliance with the most current edition of Standard Methods for the Examination of Dairy Products and Official Methods of Analysis of the Association of Official Analytical Chemists. Official farm bulk milk samples must be collected by a regulatory agency certified sampler or by a milk tanker hauler/sampler under the Universal Sampling Program.

                The "Dairy Sampling video" produced by the University of Tennessee at the end of this app describes the correct method of obtaining sterile milk samples:

               

Standards for Grade “A” raw milk and milk products (PMO)

Temperature

Cooled to 10ºC (50ºF) or less within four (4) hours or less, of the commencement of the first milking, and to 7°C (45ºF) 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 10ºC (50ºF). NOTE: Milk sample submitted for testing cooled and maintained at 0ºC (32ºF) to 4.4ºC (40ºF), where sample temperature is >4.4ºC (40ºF), but =7.0ºC (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.

Somatic Cell Count*

Individual producer milk not to exceed 750,000 per mL.

*Goat milk – 1,500,000 per mL

 


Sanitation

Sanitation requirements of dairy farms

Detailed information related to the requirements can be found in the PMO. Material in italics is taken directly from the PMO as well as the public health reasoning for the requirements, while other information considered to be special areas of concern or inspection emphasis that should be considered during regulatory dairy farm inspections is also included. When inspecting a farm, keep in mind the Dairy Farm Inspection Report (FDA Form 2359a) and ensure that all areas of the form are considered.


ITEM 1r. ABNORMAL MILK

1.    Abnormal milk

     Lactating animals which show evidence of the secretion of milk with abnormalities in one (1) or more quarters, based upon bacteriological, chemical or physical examination, shall be milked last or with separate equipment and the milk shall be discarded. Lactating animals producing contaminated milk, that is, lactating animals which have been treated with, have consumed chemical, medicinal or radioactive agents, which are capable of being secreted in the milk and which, in the judgment of the Regulatory Agency, may be deleterious to human health, shall be milked last or with separate equipment and the milk disposed of as the Regulatory Agency may direct.

A California Mastitis Test paddle is often used to detect mastitis.

Public Health Reason:

     The health of lactating animals is a very important consideration because a number of diseases of lactating animals, including salmonellosis, staphylococcal infection and streptococcal infection, may be transmitted to man through the medium of milk. The organisms of most of these diseases may get into the milk either directly from the udder or indirectly through infected body discharges which may drop, splash or be blown into the milk. Bovine mastitis is an inflammatory and, generally, highly communicable disease of the bovine udder. Usually, the inciting organism is a streptococcus of bovine origin (type B), but a staphylococcus or other infectious agent often causes the disease. Occasionally lactating animal's udders become infected with hemolytic streptococci of human origin, which may result in milkborne epidemics of scarlet fever or septic sore throat. The toxins of staphylococci and possibly other organisms in milk may cause severe gastroenteritis. Some of these toxins are not destroyed by pasteurization. Residues of drugs and other chemicals in milk and milk products can also have serious consequences if consumed by sensitive individuals.

Cows treated with intramammary antibiotic infusions would produce "abnormal milk", and the milk must be separated.

The 1999 National Conference on Interstate Milk Shipments (NCIMS) placed unclean abnormal milking equipment under this item.  Thus any equipment found unclean and not properly stored will be debited under Item 1r.  This is a 5 point violation on the milk rating summary form.  The purpose of this change was to place more emphasis on reducing the possibility of re-infecting or cross infection of dairy animals.

                Some practices which can lead to contamination of milk supplies include:

1.       Using common milking equipment to milk treated animals within the normal milking string.

2.       Not adhering to recommended milk withholding times on treated cows.

3.       Milking treated cows into a vessel located in the milkroom may lead to possible contamination through splash, incidental contamination or direct spillage into the bulk tank, single service filters, cleaning brushes, etc.

4.       Using insecticides such as back rub bags containing an insecticide that is not U.S. EPA approved for use on dairy animals.

5.       Using unapproved drugs on lactating animals or failure to follow drug treatment directions on the drug labeling.

6.       Using animal feeds which contain unsafe levels of animal drugs or other chemicals.

7.       Feeding grains contaminated with naturally occurring toxins.

8.       Feeding protein animal feed to dairy animals or other ruminants that are composed wholly or partially of rendered tissue.

9.       Feeding unprocessed poultry litter and unprocessed recycled animal body discharges.


ITEM 2r. MILKING BARN, STABLE OR PARLOR - CONSTRUCTION

2.    Milking barn, stable, or parlor - construction

     A milking barn, stable, or parlor shall be provided on all dairy farms in which the milking herd shall be housed during milking time operations. The areas used for milking purposes shall:

1.       Have floors, gutters, and feed troughs constructed of concrete or equally impervious materials. Provided, convalescent (maternity) pens located in milking areas of stanchion-type barns may be used when they comply with the guidelines specified in Appendix C., III.

2.       Have walls and ceilings which are smooth, painted, or finished in an approved manner, in good repair. The ceiling must be dust tight.

3.       Have separate stalls or pens for horses, calves, and bulls, and not be overcrowded.

4.       Be provided with natural and/or artificial light, well distributed, for day and/or night milking.

5.       Provide sufficient air space and air circulation to prevent condensation and excessive odors.

Public Health Reason:

     When milking is done elsewhere than in a suitable place provided for this purpose, the milk may become contaminated. Floors constructed of concrete or other impervious materials can be kept clean more easily than floors constructed of wood, earth or similar materials and are; therefore, more apt to be kept clean. Painted or properly finished walls and ceilings encourage cleanliness. Tight ceilings reduce the likelihood of dust and extraneous material getting into the milk. Adequate lighting makes it more probable that the barn will be clean and that the lactating animals will be milked in a sanitary manner.


Usually the milking area is maintained as well as the milk room area. However, sometimes complacency prevails and the floors, walls, and other con­struction requirements in the milking parlor or barn may be ignored or put-off until time allows. Dairy Farm Inspectors should make note of the following possible problem areas.

 1. Wooden stanchions may become worn or rotten and need replacing or painting; pipe railing stanchions, feed­ers, or door/gates may become excessively corroded making them difficult or impossible to to clean adequately.

 2.  Floor areas where cows stand may become excessively worn, building structures may settle exposing large cracks in the walls or floor junctures. 

 3.  Inadequate ventilation usually results in rusty metal partitions peeling paint, excessive odors, and electrical problems.  Adequate ventilation is especially needed during the winter months, when moisture levels are high, and windows are kept closed.  Adequate heaters are necessary to reduce condensation and ventilation is necessary to remove odors from the milking area.  

 4.  All walking surfaces must be constructed of concrete or equally impervious material.  Wood sometimes is used for steps. Gutter cross walks, splash guards that are not impervious quickly be­comes rough and become water and manure soaked, making them impossible to clean.

 5.  Animals (calves, heifers, dry cows, bulls,) and other livestock may be found housed in the milking barn, causing overcrowding and often unsanitary conditions.

 6. Hay loft door(s) opening into the milking area are re­quired to remain closed during milking times.  Doors to feed rooms or silos that open into the milking area must be kept closed, except when in use.  Open feed dollies may be used for feed distribution, but not for storage in the milking area.

 7.  Bull pens, calving areas, and horse stalls must be completely partitioned from the milking area.  If not, then they must meet all the requirements of the milking area.       


ITEM 3r. MILKING BARN, STABLE OR PARLOR - CLEANLINESS

3.    Milking barn, stable, or parlor - cleanliness

     The interior shall be kept clean. Floors, walls, ceilings, windows, pipelines and equipment shall be free of filth and/or litter and shall be clean. Swine and fowl shall be kept out of the milking area. Feed shall be stored in a manner that will not increase the dust content of the air or interfere with the cleaning of the floor. (For applicability to AMIs, refer to Appendix Q.) Surcingles, or belly straps, milk stools and antikickers shall be kept clean and stored above the floor.

Public Health Reason:

     A clean interior reduces the chances of contamination of the milk or milk pails during milking. The presence of other animals increases the potential for the spread of disease. Clean milk stools and surcingles reduce the likelihood of contamination of the milker's hands between the milking of one (1) lactating animal and the milking of another.

A clean milking area reduces the chances of milk or milk equipment contamination during milking times. The interior, including the floor, walls, ceilings, windows, pipelines, and equipment, shall be kept free of filth and/or litter and shall be clean. Feed needs to be stored such that there will not be increased dust in the air or interfere with cleaning of the floor. This helps provide a suitable place provided for the purpose of milking, minimizing the potential for contamination of the milk.

     Problem areas may include a) excessive manure build-up on stanchions, floors, walls, underneath floor mats, tail (splash) plates, partitions, etc. b) excessive cobwebs, fly specks, feed dust on ceilings, milk/CIP lines, and stanchions, c) litter and trash in the breezeway (defined as the open area between the milkroom and milking parlor, with no close-able doors), d) birds nesting in the milking barn, e) soggy, left over feed in the feeders or mangers, f) swine in the milking area, g) ineffective try cleaning methods used when water under pressure is available in the milking area, h) milk stools or other similar type stools or chairs, surcingles, and antikickers that are not clean and stored appropriately.


ITEM 4r. COWYARD

4.    Cow yard

     The cowyard shall be graded and drained and shall have no standing pools of water or accumulations of organic wastes. Provided, that in loafing or lactating animal-housing areas, lactating animal droppings and soiled bedding shall be removed, or clean bedding added, at sufficiently frequent intervals to prevent the soiling of the lactating animal's udder and flanks. Cooling ponds shall be allowed provided they are constructed and maintained in a manner that does not result in the visible soiling of flanks, udders, bellies and tails of lactating animals exiting the pond. Waste feed shall not be allowed to accumulate. Manure packs shall be properly drained and shall provide a reasonably firm footing. Swine shall be kept out of the cowyard.

Public Health Reason:    

     The cowyard is interpreted to be that enclosed or unenclosed area in which the lactating animals are apt to congregate, approximately adjacent to the barn, including animal-housing areas. This area is; therefore, particularly apt to become filthy with manure droppings, which may result in the soiling of the lactating animal's udders and flanks. The grading and drainage of the cowyard, as far as is practicable, is required because wet conditions are conducive to fly breeding and make it difficult to keep manure removed and the lactating animals clean. If manure and barn sweepings are allowed to accumulate in the cowyard, fly breeding will be promoted, and the lactating animals, because of their habit of lying down, will be more apt to have manure-soiled udders. Lactating animals should not have access to piles of manure, in order to avoid the soiling of udders and the spread of diseases among dairy animals.

     Things to watch for when inspecting the cow yard include:

  1. Large piles of manure accessible to the milking herd in the cow yard.
  2. Low, poorly drained areas in the milking herd cow yard in which pools of surface drainage and liquid waste accumulate.
  3. Soggy, muddy low areas around and adjacent to water troughs.
  4. Buildup of manure underneath and along side of the corral fences.
  5. Accumulation of waste feed in the cattle housing areas.
  6. Barn or milk house waste runs into the cow yard and creates pools of waste liquids.
  7. Free-stalls have heavy accumulation of manure in stall areas and alleyways.
  8. Approaches to the milking barn are soggy, with depressed areas which may cause injury to the udder.
  9. Uneven step-downs or excessively steep or tall steps for the cow entrances or exits to the milking area conducive to animal injury.
  10. Improperly maintained manure packs.

ITEM 5r. MILKHOUSE - CONSTRUCTION AND FACILITIES

5.    Milkhouse or room – construction and facilities

A milkhouse of sufficient size shall be provided, in which the cooling, handling and storing of
milk and the washing, sanitizing and storing of milk containers and utensils shall be conducted,
except as provided for in Item 12r of this Section.
The milkhouse shall be provided with a smooth floor constructed of concrete or equally
impervious material; graded to drain; and maintained in good repair. Liquid waste shall be
disposed of in a sanitary manner. Floor drains shall be accessible and shall be trapped if
connected to a sanitary sewer system.
The walls and ceilings shall be constructed of smooth material; be in good repair; and be well
painted, or finished in an equally suitable manner.
The milkhouse shall have adequate natural and/or artificial light and be well ventilated.

The milkhouse shall be used for no other purpose than milkhouse operations. There shall be no direct opening into any barn, stable or parlor or into a room used for domestic purposes. Provided, that a direct opening between the milkhouse and milking barn, stable or parlor is permitted when a tight-fitting, self-closing, solid door(s) hinged to be single or double acting is provided. Screened vents in the wall between the milkhouse and a breezeway, which separates the milkhouse from the milking parlor, are permitted, provided animals are not housed within the milking facility. Water under pressure shall be piped into the milkhouse. The milkhouse shall be equipped with a two (2) compartment wash vat and adequate hot water heating facilities. A transportation tank may be used for the cooling and/or storage of milk on the dairy farm. Such tank shall be provided with a suitable shelter for the receipt of milk. Such shelter shall be adjacent to, but not a part of, the milkhouse and shall comply with the requirements of the milkhouse with respect to construction items; lighting; drainage; insect and rodent control; and general maintenance. In addition, the following minimum criteria shall be met:
1. An accurate, accessible temperature-recording device shall be installed in the milk line downstream from an effective cooling device, which cools the milk to 7°C (45°F) or less. Electronic records that comply with the applicable provisions of Appendix H., IV and V, with or without hard copy, may be used in place of temperature-recording records. An indicating thermometer shall be installed as close as possible to the recording device for verification of recording temperatures. This indicating thermometer shall comply with all applicable requirements in Appendix H. This thermometer shall be used to check the temperature-recording device during the regulatory inspection and the results recorded on the recording record or into the electronic data collection, storage and reporting system.
2. Temperature-recording charts shall be maintained on the premises for a period of a minimum of six (6) months and are available for review by the Regulatory Agency. Except that, the electronic storage of required temperature records, with or without hard copy, shall be acceptable, provided the computer and computer generated temperature records are readily available for review by the Regulatory Agency.
3. The milk shall be sampled at the direction of the Regulatory Agency in a manner so as to preclude contaminating the milk tank truck or sample, by a permitted milk sample collector.
4. The milk tank truck shall be effectively agitated in order to collect a representative sample.

When the Regulatory Agency determines conditions exist whereby the direct loading of a milk tank truck (through by-passing the use of a farm bulk milk tank(s) and/or silo(s)) can be adequately protected and sampled without contamination, a shelter need not be provided if the following minimum criteria are met:
1. The milk hose connection is accessible to, and made from within, the milkhouse. The milk hose connection to the milk tank truck is completely protected from the outside environment at all times. Provided, based on Regulatory Agency acceptance, the direct loading of milk from the milkhouse to the milk tank truck may be conducted through a properly designed hose port that adequately protects the milkhouse opening or by stubbing the milk transfer and associated CIP cleaned lines outside the milkhouse wall in accordance with Item 5r, ADMINISTRATIVE PROCEDURES#15.                                                                                                                                                                          2. To assure continued protection of the milk, the milk tank truck manhole must be sealed after the truck has been cleaned and sanitized.
3. The milk tank truck shall be washed and sanitized at the permitted milk plant, receiving station, or transfer station receiving the milk, or at a permitted milk tank truck cleaning facility.
4. An accurate, accessible temperature-recording device shall be installed in the milk line downstream from an effective cooling device, which cools the milk to 7ºC (45ºF) or less. Electronic records that comply with the applicable provisions of Appendix H., IV and V, with or without hard copy, may be used in place of temperature-recording records. An indicating thermometer shall be installed as close as possible to the recording device for verification of recording temperatures. This indicating thermometer shall comply with all applicable requirements in Appendix H. This thermometer shall be used to check the temperature-recording device during the regulatory inspection and the results recorded on the recording record or into the electronic data collection, storage and reporting system.
5. Temperature-recording records shall be maintained on the premises for a period of a minimum of six (6) months and are available for review by the Regulatory Agency. Except that, the electronic storage of required temperature records, with or without hard copy, shall be acceptable, provided the computer and computer generated temperature records are readily available for review by the Regulatory Agency.
6. The milk shall be sampled at the direction of the Regulatory Agency, in a manner so as to preclude contaminating the milk tank truck or sample, by a permitted milk sample collector. The milk in the milk tank truck shall be effectively agitated in order to collect a representative sample.
7. The milk tank truck shall be parked on a self-draining concrete or equally impervious surface during filling and storage.
8. When direct loading of a milk tank truck using either a hose port, as addressed above, or stubbing the milk transfer and associated CIP cleaned lines outside the milkhouse wall in accordance with Item 5r, ADMINISTRATIVE PROCEDURES #15, overhead protection of the milk hose connection to the milk tank truck shall be provided.

Public Health Reason:

     Unless a suitable, separate place is provided for the cooling, handling and storing of milk and for the washing, sanitizing and storage of milk utensils, the milk or the utensils may become contaminated. Construction, which permits easy cleaning, promotes cleanliness. A well-drained floor of concrete or other impervious material promotes cleanliness. Ample light promotes cleanliness, and proper ventilation reduces the likelihood of odors and condensation. A milkhouse that is separated from the barn, stable or parlor and the living quarters provides a safeguard against the exposure of milk and milk equipment and utensils to contamination.

Following the actual milking operation, the milk must be cooled, stored and then protected from contamination until it is picked up and delivered to the milk processing plant. Therefore, the dairy farm must have a suitable milk house where facilities for cooling, handling, and storing of milk can occur and where milk containers, utensils and equipment can be washed, stored, and sanitized. In the absence of such a facility, the milk or the milk containers, utensils and equipment may become contaminated.  The initial design and construction of the milk house is important to insure the proper construction materials are used.  The major criteria being that the milk house construction shall result in a facility that permits easy cleaning by the operator.  

If something is easy to clean, it is more likely to be cleaned and be cleaned correctly. Requirements for the milkhouse include:


Special attention in terms of milkhouse construction includes:

1.       Large cracks or holes in the milkhouse floor, or standing pools of water on the floor.

2.       Walls in need of repair or repainting.

3.       Window sills and/or door jambs that are rotten and in poor repair.

4.       Excessive odors and condensation dripping from the walls and ceilings.

5.       Excessive peeling paint on the walls and ceilings.

6.       The hoseport may be in poor repair, and /or the milkhouse windows are broken.

7.       The outside slab underneath the hoseport may be cracked or too small to protect the hose, and/or covered with dirt/mud or weeds.

8.       Light fixtures directly over the bulk tank lid.

9.       The door leading from the milkhouse into the milking area is not tight or self-closing.

10.   Milkhouse being used for purposes other than milkhouse operations.

11.   A CIP vat for recirculation of milk pipelines and appurtenances may be accepted as one part of the two compartment vat if acceptable to the State Regulatory Authority.

The milk house shall be used for no other purpose than normal milk house operations.  Again, the intended purpose of the milk house provide a facility where the cooling, handling, and storing of milk can occur and where milk containers, utensils and equipment can be washed, stored, and sanitized. If other activities are conducted in the milk house then the milk or the milk containers, equipment or utensils could become contaminated. Therefore, the Dairy Farm Inspector should note the following specific problems that would violate the restricted use of the milk house.

     Ani­mals can not be housed in the milking facility or in the milk house or milk room.

    No direct opening from the milk house/room into any barn, stable or into a room used for domestic purposes is permitted.  Except, that a direct open­ing between the milk house and milking area is permit­ted when a tight-fitting self-closing solid door(s), hinged to be single or double acting, is provid­ed.  



ITEM 6r. MILKHOUSE - CLEANLINESS

6.    Milkhouse or room – cleanliness

The floors, walls, ceilings, windows, tables, shelves, cabinets, wash vats, non-product-contact surfaces of milk containers, utensils and equipment and other milkhouse equipment shall be clean. Only articles directly related to milkhouse activities shall be permitted in the milkhouse. The milkhouse shall be free of trash, animals and fowl.

Public Health Reason:

Cleanliness in the milkhouse reduces the likelihood of contamination of the milk.

The  milkhouse floors, walls, ceilings, windows, tables, shelves, cabinets, wash vats, non-product contact surfaces of milk containers, utensils and equipment and other milkhouse equipment must be kept clean. Only articles directly related to the milkhouse activities shall be permitted in the milkhouse. The milkhouse shall be free of trash, animals, and fowl. Any room or office that opens directly into the milkroom, with no intervening solid door shall be considered as part of the milkroom and during inspection are subject to milk room requirements. Watch for trash and debris, unclean handwashing sink, cluttered desk or cabinet in the milkroom, algae and mold buildup on the walls and ceilings, cats or dogs in the milkroom, dust or farm tools on top of the bulk tank, unclean hoseport, and calf buckets or bottles stored in the utensil sink.


ITEM 7r. TOILET

7.   Toilet

     Every dairy farm shall be provided with one or more toilets; conveniently located; properly constructed; operated; and maintained in a sanitary manner. The waste shall be inaccessible to insects and shall not pollute the soil surfaces or contaminate any water supply.

Public Health Reason:

     The organisms of typhoid fever, dysentery and gastrointestinal disorders may be present in the body wastes of persons who have these diseases. In the case of typhoid fever, well persons (carriers) also may discharge the organisms in their body wastes. If a toilet is not fly-tight and so constructed as to prevent overflow, infection may be carried from the excreta to the milk, either by flies or through the pollution of ground water supplies or streams to which the lactating animals have access.

Dangerous bacteria or viruses carried by people could possibly contaminate milk, either by flies or the pollution of ground or surface water to which lactating animals or humans have access. Specifically,

  1. The toilet facility should be constructed in accordance with the State Regulatory Agency recommendations.
  2. The toilet room must be kept clean and provided with adequate toilet tissue and waste receptacles. Toilet room must never open directly into the milkroom, unless they are equipped with a tight fitting self-closing solid door.
  3. Septic tanks should not be overflowing and there should be no breaks in the sewerage lines
  4. Sewage from the toilet must never discharge into the animal waste lagoon.
  5. Toilet room fixtures must be in good repair, the toilet bowl floor seal must not be leaking and the room and all fixtures must be kept clean.
  6. There should be no evidence of used toilet paper on the floor or in trash container that shows evidence of fecal material.
  7. Pit privies must have fly tight pits, including self-closing risers and screened vents. Ther must be no openings into the pit where insects may gain entry.
  8. Adequate lighting or ventilation and screens on windows or doors must be in good condition and effective against the entrance of insects.

NOTE: Small family operations not employing persons on the dairy operation may be allowed to use their residence facilities provided the toilet room in their residence is convenient to the milking operation.


ITEM 8r. WATER SUPPLY

8.   Water supply

     Water for milkhouse and milking operations shall be from a supply properly located, protected and operated and shall be easily accessible, adequate and of a safe, sanitary quality.

Public Health Reason:

     A dairy farm water supply should be accessible in order to encourage its use in ample quantity in cleaning operations; it should be adequate so that cleaning and rinsing will be thorough; and it should be of a safe, sanitary quality in order to avoid contamination of milk utensils. A polluted water supply, used in the rinsing of dairy utensils and containers, may be more dangerous than a similar water supply that is used for drinking purposes only. Bacteria grow much faster in milk than in water and the severity of an attack of a given disease depends largely upon the size of the dose of disease organisms taken into the system. Therefore, a small number of disease organisms consumed in a glass of water from a polluted well may possibly result in no harm; whereas, if left in a milk utensil, which has been rinsed with the water, they may after several hours growth, in the milk, increase in such numbers as to cause disease when consumed.

     Water under pressure is required for the proper cleaning of the milk house and for the proper cleaning and sanitizing of the milk containers, equipment and utensils. Therefore, the milk house shall be piped water under pressure. A dairy farm water supp­ly should be: a) ac­cessible in or­der to encourage its use in cleaning opera­tions; b) adequate so that cleaning and rinsing will be thorough; and c) safe, of sanitary qual­ity in order to avoid con­tamina­tion of milk utensils. To meet these requirements, the following items are necessary:

  1. The water supply for the milkhouse and milking operations is approved as safe by the state water control authority, and in the case of individual water systems complies with the specifications outlined in Appendix D and the bacteriological standards outlined in Appendix G of the PMO.
  2. No cross connections exist between a safe water supply and any unsafe or questionable water supply, or any other source of pollution.
  3. There are no submerged inlets through which a safe water supply may be contaminated.
  4. The well or other source of water is located and constructed in such a manner that neither underground nor surface contamination from any sewerage system, privy, or other source of pollution can reach such water supply.
  5. New individual water supplies and water supply systems which have been repaired or otherwise become contaminated are thoroughly disinfected before being placed in use. The supply shall be made free of the disinfectant by pumping to waste before any sample for bacteriological testing shall be collected.
  6. All containers and tanks used in the transportation of water are sealed and protected from possible contamination. These containers and tanks shall be subjected to a thorough cleaning and a bacteriological treatment prior to filling with potable water to be used at the dairy farm. To minimize the possibility of contamination of the water during its transfer from the potable tanks to the elevated or ground water storage at the dairy farm, a suitable pump, hose and fittings shall be provided. When the pump, hose, and fittings are not being used, the outlets shall be capped and stored in a suitable dust proof enclosure so as to prevent their contamination. The storage tank at the dairy farm shall be constructed of impervious material provided with a dust and rainproof cover, and also provided with an approved type vent and roof hatch. All new reservoirs or reservoirs which have been cleaned shall be disinfected prior to placing them into service (see, PMO - Appendix D). 
  1. Samples for bacteriological examination are taken upon initial approval of the physical structure, based upon the requirements of this Ordinance and when any repair or alteration of the water supply system has been made, and at least every three years. Provided, that water supplies with buried well casing seals, installed prior to the adoption of this section, shall be tested at intervals no greater than 6 months apart. Whenever such samples indicate either the presence of bacteria of the coliform group, or whenever the well casing, pump or seal need replacing or repair, the well casing and seal shall be brought above the ground surface and shall comply with all other applicable construction criteria of this Section.

 

When water is hauled to the dairy farm, such water shall be sampled at the point of use and at least four times in separate months in any consecutive six months, for bacteriological examination at the point of use and submitted to an approved laboratory each month. Bacteriological examinations shall be conducted in a laboratory acceptable to the regulatory agency.

 

  1. Individual wells located in “existing” pits shall comply with the following requirements:
    1. Concrete floors sloped to drain
    2. Water tight walls extending a minimum of 15 inches above the established ground surface at all points.
    3. Sump pumps or gravity drains terminating at the surface at least 30 feet from the pit.
    4. Impervious covers
    5. Water pump mounted on a concrete surface 12 inches above the pit floor level. 
  1. Current records of water test results shall be retained on file with the regulatory agency, or as the regulatory agency directs. 
  1. State water control authority requirements that are less stringent than the PMO shall be superseded by the PMO. 
  1. In regards to wooden storage tanks on farms, the PMO specifically requires impervious tanks be used on dairy farms. Currently the interpretation is that for existing wood tanks, professional judgment is to be used. All new reservoirs must meet the requirements. 

Location:

                The water source must be located in an area so that it will not become contaminated by surface nor sewerage system contamination.

                Table 10, in Appendix D of the PMO, requires that the water sources located in favorable (unconsolidated) subsoil formations be located a minimum of 50 feet from all sources of contamination such as human or animal excreta, cesspools, dry wells, disposal and waste injection wells, deep leaching pits, areas of limited filtration or questionable aquifer formations, and/or near sources of concentrated multiple contaminants. Lesser distances are acceptable only after approval of the State Water Authority following a comprehensive sanitary survey.

                Individual well construction standards may be found in Appendix D of the PMO.

Examples of common violations found on dairy farms:

1.       Submerged inlets, including hoses or automatic filler valves located below overflow level in stock tanks and hoses submerged in utensil wash vats, if there is a drain plug in the drain.

2.       Wells located in or immediately adjacent to the cowyard.

3.       Chemical injector systems that feed directly into the potable water supply without adequate protection (drums of udder wash or sanitizer)

4.       Wells in pits without the required drain, cement floors, or impervious covers over the pit

5.       Improperly installed high pressure water pumps. Unprotected high pressure water pumps are those which are not either a) connected to a separate water supply, b) connected to a separate properly designed tank or reservoir, or c) fitted with a properly installed low pressure cut-off switch which deactivates the pump under a pre-set low pressure condition. This includes also a properly installed shut-off valve upstream from the switch.

6.       Milkhouse water supply connected directly to unapproved water supplies (such as back-up wells, that may be irrigation wells, or other unacceptable water supplies) are prohibited.

7.       Incorrect type of vacuum breaker on systems.

8.       Loose or missing well seal or cover.

9.       Unprotected water tanks or reservoirs.

10.   Inadequate air gaps. A proper air gap is defined as equal to or greater than twice the diameter of the inlet pipe from the overflow, but never less than one inch.

11.   Water supplies inaccessible for inspection.

12.   Unscreened well vents or other unprotected openings into the well.

13.   Unprotected springs.

14.   Tubular or plate cooler water with submerged inlet at the discharge.

15.   Potable water line runs through a non-potable source, such as stock tank feeder lines.

16.   Use of check valve(s) instead of an acceptable back siphonage device to protect a water line from back siphonage.

17.   Suction pipe below the ground surface which is not fitted with a water-tight casing.

18.   Loose or ill-fitting manhole covers over a dug well or tank, or one without the necessary locked or bolted overlapping watertight cover.

19.   Abandoned uncapped well in close proximity to the well supplying the milkhouse.

20.   Reuse of air compressor cooling water or plate cooler water without the necessary controls (requires 6 month sampling, proper protection, no submerged inlets, etc).

21.   Installation of “frost-free” hydrant (with internal drain) directly on the well slab or within 10 feet of the supply casing or in areas whereby the supply may become contaminated (cattle housing area, cowyard, adjacent to stock watering founts, etc). These installations may be acceptable if the hydrant is equipped with an acceptable back flow preventer or hose bibb type vacuum breaker.

22.   Use of untreated surface water (ponds, ditches, etc) or other unacceptable water supplies for udder washing and/or sanitizing, the cleaning of milking area surfaces (floors, walls, etc) or other non-product contact surfaces (outside of pipelines, milking units, receiver units) is a violation of this item.


ITEM 9r. UTILITIES AND EQUIPMENT - CONSTRUCTION

9.   Utilities and equipment – construction

     All multi-use containers, utensils and equipment used in the handling, storage or transportation of milk shall be made of smooth, nonabsorbent, corrosion-resistant, non-toxic materials, and shall be so constructed as to be easily cleaned. All containers, utensils and equipment shall be in good repair. Multiple-use woven material shall not be used for straining milk. All single-service articles shall have been manufactured, packaged, transported and handled in a sanitary manner and shall comply with the applicable requirements of Item 11p of this Section. Articles intended for single-service use shall not be reused. Farm holding/cooling tanks, welded sanitary piping and transportation tanks shall comply with the applicable requirements of Items 10p and 11p of this Section.

Public Health Reason:

     Milk containers and other utensils without flush joints and seams, without smooth, easily cleaned, and accessible surfaces, and not made of durable, non-corrodible material, are apt to harbor accumulations in which undesirable bacterial growth is supported. Single-service articles, which have not been manufactured and handled in a sanitary manner, may contaminate the milk.

     The proper design and construction of milk containers, equipment and utensils is extremely important because it will have an impact on the ease and effectiveness of cleaning and sanitizing.

     Milk contact surfaces are those parts of milk utensils and equipment that are exposed to milk or milk products, or from which liquids may drip, drain or be drawn into milk or milk or milk products. These surfaces must meet specific PMO criteria of design and construction so that they can be cleaned and sanitized effectively to minimize milk contamination. 

Single-use articles such as paper milk filters can not be reused and they shall be manufactured, packaged, transported and handled in a sanitary manner.  Single-service articles, which have not been manufactured of approved material or have not been handled in a sanitary manner, may contaminate the milk.

Mechanically cleaned or Clean-In-Placed (CIP) is a method of cleaning the interior surfaces of milk pipelines, milking machines, tanks, and associated fittings without disassembly.

CIP systems are frequently employed in the dairy and food industry where a high level of hygiene is required. The benefits of CIP systems include: a) cleaning is faster, b) less labor intensive, c) repeatable, and d) poses less of a chemical exposure risk to people. CIP systems can be as simple as the utilization of a balance tank, centrifugal pump, and a connection to the system being cleaned, or more complicated to involve a fully automated programmable logic controller, multiple balance tanks, sensors, valves, heat exchangers, and data acquisition systems.

            The major inspectional concern of a CIP system is whether it is properly cleaning and sanitizing all the connected components.  Therefore, the PMO focuses on major issues having to do with the proper design of CIP systems and the accessibility of the system to inspection. For example, the PMO stipulates that new pipeline CIP systems must submit plans for approval before installation or major alteration and that remodeled pipeline CIP systems shall be inspected for approval prior to use. The design should result in: a) milk pipelines and return-solution lines that are self-draining, b) pipeline inlets that are located in approved milking areas only, and c) a separate wash manifold in all new or extensively remodeled installations.  Wash harnesses or connections between the bottom of the trap and receiver jar-pump area that are not allowed during milking.

            Accessibility for inspection is an important design and construction consideration.  Receiver jars and all milking equipment must be accessible for inspection.  In systems with welded pipelines diameters of 2" or more, inspection points, in addition to entrances and exits, are to be provid­ed at intervals sufficient to determine general condition of the interior surfaces.  Circular pipelines should follow the recommendations of the state regulatory agency (RA) for access/inspection points.  In many states, access points are required at four equi-distant points in these rotary type milking barns. The receiver jar can be considered one inspection port if it is accessible.  Where hex nuts are present on milking machines or plate coolers then a wrench must be available for disassembly so they can be inspected.  Milk pipelines should not be covered with sacks, newspaper or other material because they cannot be easily inspected for proper slope or construction. Since 1997, the PMO has stipulated that a separate CIP manifold is required in all new or extensively remodeled facilities.

            Gaskets, if used, shall be self-positioning and shall be of such design, finish and ap­plica­tion as to form a smooth, flush, inter­ior surface.  If gaskets are not used, all fittings shall have self-positioning faces designed to form a smooth, flush, interior surface. 

            Interior surfaces of welded joints in pipelines shall be smooth and free of pits, cracks and inclusions and shall be in good repair.

            By-passes around plate or tubular coolers should have adequate inspection access points on milk lines.

            Flexible plastic tubing may be used between the fill valves of bottom fill and top fill bulk milk storage tanks, when needed for functional purposes.  All new installations will have stainless steel piping or vulcanized hoses for top filling. Such hoses shall be drainable, be as short as practical, have sanitary fittings, and be supported to maintain uniform slope and alignment. The end fittings of such hoses shall be permanently attached in such a manner that will result in a crevice-free joint between the hose and the fitting, which can be cleaned by mechanical means (CIP). 

            Vacuum line connecting the milk receiver to the trap should be in­stalled in accordance with the 3-A Standard Number 606-05.  This trap must be installed adjacent to the milk receiver and connected by readily disassem­bled sanitary piping.  The vertical rise of this connec­tion shall not exceed 12 inches including the elbow and shall slope toward the trap.  The purpose of this configuration is to prevent any liquid collect­ed in the trap from getting into the milk receiver.

            Direct read milk measuring tubes must be installed to be easily clean­able, readily accessible for inspection and designed so that all product in the gauge will discarded so that no product will enter the tank outlet line nor re-enter the tank.  The valves serving these tubes must be close-cou­pled.. 

            Bulk milk tankers must meet the construction requirements of Items 10 and 11p of the PMO.



ITEM 10r. UTENSILS AND EQUIPMENT - CLEANING

10. Utensils and equipment – cleaning

     The product contact surfaces of all multi-use containers, equipment and utensils used in the handling, storage, or transportation of milk shall be cleaned after each usage.

Public Health Reason:

     Milk cannot be kept clean or free of contamination if permitted to come into contact with unclean containers, utensils or equipment.

     Milk contact surfaces that are not clean are the most significant sources of microbial growth and the subse­quent contamina­tion of milk. A small residue on any milk contact surface will promote bacteri­al growth and deposit or "seed" the milk supply with undesir­able mi­crobes.

Cleaning procedures will vary based on the equipment size and design. For example, some newer installations have installed combination milk receiver/CIP tanks. These must be reviewed individually for compliance with Items 6r (Clean­ing Facilities), Item 8r (Water Supply), Item 9r (Construction), Item 16r (Protec­tion from Contamina­tion), Items 10r (Utensils and Equipment, Cleaning) and 11r (Utensils and Equipment, Sanitizing).

Other cleaning procedures use a basic two compartment sink for cleaning utensils and equipment manually. A method used to clean milking utensils and equipment follow­ing each usage would incorporate the following basic steps.  Other methods may be used; however most will follow the example provided.

            1. Rinse all milk contact surfaces with clean warm (typically 43 - 490C) water. Do not use hot water since this could "set" or affix milk protein on the inner surfaces, coagulate the milk or actually cook milk onto the surfaces, or damage the equip­ment.  A proper rinse prior to washing will also effec­tively remove any excess milk and foam which could interfere with the cleaning properties of the washing chemi­cals.
            2.  Wash either by hand or via a CIP system to remove milk residues and soil.  Most operations use the CIP meth­od of cleaning. The recommended amount of acceptable dairy cleaner (usually chlorinated) is added to the cleaning com­partment of the utensil sink or the CIP system. On those dairy farms with private, individual water systems, testing for water hard­ness may be necessary to determine the proper cleaning compounds to be used.

            3. Rinse thor­oughly with clean water and allow the items to com­pletely drain. These cleaned items must now be protected from contamination during storage.

Inspection of milk contact surfaces should occur during non-milking times. Special problem areas include:

1.       Pay close attention to the bulk tank, bulk tank agitator paddle, milk tank inlets such as measuring stick or inlet pipe openings, bulk tank outlet valve, milk receiver, a representative number of inflations, milk lines, milk inlets of the milk lines, bulk tank “swing line”, weigh jar probes, etc.

2.       The sanitary trap and line attaching it to the milk receiver is classified officially as milk contact surfaces and should be inspected regularly for any cleaning problem.

3.       A milk contact surface that is not clean is a significant source of microbial growth and the subsequent contamination of milk. Residues will promote the growth of microorganisms which will grossly contaminate the succeeding portions of milk.  Most cleaning systems involve some variation of a pre-rinse with clean cool or tepid water, followed by a washing cycle (usually involving a chlorinated dairy cleaner), then a thorough rinse with clean water and then stored to completely drain and is protected from contamination.

4. Any milk contact surface that is not clean is an automatic violation and will result in a re-inspection of the dairy operation within 14 days.

Equipment should be evaluated for the materials or deposits shown in the chart below:

Residue Identification Chart

RESIDUE

DESCRIPTION

CAUSE

REMOVAL

PREVENTION

PROTEIN

Blue rainbow hue

varnish like, "apple

sauce" or yellow

varnish-like

appearance

1.Using non-chlorinated

cleaner

2.Inadequate prerinse

3.Improper cleaning

 

Chlorinated alkaline

detergent

 

1.Adequate pre-rinse

2.Proper cleaning

w/proper use dilution

after each usage

3.Chlorinated alkaline

detergent

MILKSTONE

White to yellow,

chalky white to grey

water spots and film,

bluish cast to

stainless steel.

Minerals from milk

Acid wash

White to yellow,

chalky white to grey

water spots and film,

bluish cast to

stainless steel.

FAT/GREASE

Hanging water droplets

or beading greasy

look, Greasy (white)

appearance, soft

yellow films, dull

surface

1.Low water temperatures

2.Improper detergent

concentration, i.e.,

alkaline detergent

solution below pH 10

3. Regular use of

acids in place of

alkaline detergent.

4. Rinsing only (not

washing) after

milking

1. Proper water temperature,

minimum of

120 deg F at end of

wash cycle.

2.Correct concentration

of alkaline detergent

3. For removing heavy

deposits, use

chlorinated alkaline

detergent and acid

rinse at twice the

recommended strength

Regular and proper

cleaning procedures

coupled w/acidified

rinse

MINERAL (Calcium, Magnesium)

White (water-stone)

chalky to gray

1.Rinse too hot, dropout

of minerals from

water supply

2.Failure to use acid

detergents

3.No acidified rinse or

using acid rinse with

hot water.

4.Alkaline detergent

used cannot handle

hard water at present

concentration

Acid wash, at

recommended

strength, for a

minimum of 10

minutes. Repeat as

necessary.

1.Acid wash

2.Alkaline detergent

used has good water

conditioning

(sequestering

properties )

3.Water softener or

treatment may be

necessary

4. Acid rinse

temperature below

120 deg F.

IRON

Red to brown/black

1.Water supply

2.Using chlorine with

high iron water

Acid wash

1. Water treatment.

2. Proper selection of

sanitizer.

3. Regular effective

acid rinse.

 


ITEM 11r. UTENSILS AND EQUIPMENT - SANITIZATION

11. Utensils and equipment – sanitization

     The product contact surfaces of all multi-use containers, equipment, and utensils used in the handling, storage, or transportation of milk shall be sanitized before each usage.

Public Health Reason:

     Mere cleaning of containers, equipment, and utensils does not insure the removal or destruction of all disease organisms that have been present. Even very small numbers remaining may grow to dangerous proportions, since many kinds of disease bacteria grow rapidly in milk. For this reason, all milk containers, equipment, and utensils must be treated with an effective sanitizer before each usage.

                Immediately prior to milking the equipment should be treated with an effective sanitizer. Most often, this is a chlorine rinse circulated in the system assuring contact with all milk contact surfaces. Once the equipment has been properly sanitized it must not be exposed to possible contamination in any manner. The lids and covers must be left in place and not lifted or uncovered following the sanitizing operation. The sanitizer must be labeled for food contact surfaces and used at the recommended strengths and temperatures. 

It is important to use only acceptable sanitizer in the milking operation. Finally, never follow the sanitizing operation with a clear water rinse. This will remove the sanitizing residual and negate the purpose of sanitizing the milk equipment. The following table lists approved sanitizers for milk equipment.

HYPOCHLORITE

Calcium or sodium hypochoride in powder or   solution

50 ppm                           

1 minute

Limitations - unreliable in

presence of large amounts of milk residue.

When used in spray form

doubling strength is

recommended

Test kits available -

litmus paper type.

Readily affected by

organic in solution.

ORGANIC CHLORINE COMPOUNDS

200 ppm - 7.2 pH

100 ppm - 6.8 pH

50 ppm - 6.4 pH

Limitations - Significantly

affected by pH

(Trichloromelamine may

not be used to sanitize

milk surfaces)

Test kits available. Chloramine

T is limited to low

pH situations

QUATERNARY AMMONIUM COMPOUNDS

n-alkyl, dimethyl, and ethybenzyl benzyl ammonium chlorides

200 ppm,

30 seconds,

at pH level >5.0,

at 24o C (75o F) or

higher

Limitations - affected by

interfering substances in

the water. (Extremely hard

water will reduce effectiveness

significantly). Affected

by pH and temperature

of solution

Test kits available. Less

affected by organics in

the solution. Stability is

more than the Cl2

sanitizer.

IODINE COMPOUNDS

A halogen sanitizer combining iodine and non-ionic substances

12.5 ppm,

temperatures up

to 49o C (120o F),

1 minute,

teat dips are used

at over 2500 ppm

Limitations - Colorations

may appear on equipment.

Test kits available.

Strength is relative to

color of solution

Iodophors are yellow or

amber and the intensity is

proportional to the concentration.

HEAT

STEAM

HOT WATER

 

Exposure for 5

minutes after

reaching 200o F

Exposure for 5

minutes at 170o F

 

Limitations-availability,

economics, exposure

times, practicality.

Same

 

n/a

 

Following proper sanitization, the equipment must not be exposed to possible contamination in any manner. For this reason, dairy equipment should be sanitized immediately prior to use.   The lids and covers must be left in place and not lifted or uncovered following the sanitizing operation.  Milk lines once sanitized must never be taken apart without re-washing and re-sanitizing. This practice will help eliminate the many possibilities of contami­nating the milk contact surfaces during extended periods of storage. 

Prolonged exposure to sanitizer is not recommended. Although it may seem like a sound reasoning to have the milking system or equipment flooded with sanitizing solutions in between milkings, this practice, if used on a regular basis could be harmful to the milk equipment.  Rubber gaskets and other surfaces will deteriorate or discolor upon prolonged exposure to certain chemicals and chlorine chemicals are corrosive to stainless surfaces. Always follow the manufacturer’s recommended concentrations and exposure times.

 

ITEM 12r. UTENSILS AND EQUIPMENT - STORAGE

12. Utensils and equipment – storage

     All containers, utensils and equipment used in the handling, storage or transportation of milk, unless stored in sanitizing solutions, shall be stored to assure complete drainage and shall be protected from contamination prior to use. Provided, that pipeline milking equipment such as milker claws, inflations, weigh jars, meters, milk hoses, milk receivers, tubular coolers, plate coolers and milk pumps which are designed for CIP cleaning and other equipment, as accepted by FDA, which meets these criteria, may be stored in the milking barn or parlor, provided this equipment is designed, installed and operated to protect the product and solution-contact surfaces from contamination at all times.

Public Health Reason:

Careless storage of milk containers, utensils and equipment, which previously have been properly treated, is apt to result in recontamination of such utensils, thus rendering them unsafe.

Equipment must be protected from contamination by splash, dust, insects, drips, etc., and must be stored to assure complete drainage and drying following the cleaning cycles. Milk receivers and other equipment are not to be located in milking areas where cattle are housed and all manual cleaning of milk contact surfaces must be done in the milkroom. Clean equipment must be stored off the floor on clean racks or other surfaces. Single service milk filters, strainer pads, and similar single service articles in use must be stored in a suitable cabinet or container and protected against contamination from dust, dirt, moisture, insects, etc. Filters are best kept in their original carton.

Inspectional areas of emphasis or special problem areas:

            1. The inspector needs to carefully examine the storage conditions and location of cleaned items to insure that they are protected from contamination. Extreme care must be used to protect the milk contact surfaces of equip­ment after cleaning during the storage period(s). 

            2. Surfaces must not be left exposed to contamina­tion after cleaning operations by splash, dust, insects, and drippings. Openings to the outside must be screened so as to prevent entry by birds and rodents. There should be solid doors to adjacent rooms.

            3.  Equipment must be stored to assure complete draining/drying following the cleaning cycles.  This includes all milk lines, inlets, the receiver, bulk milk tank, milking units (claws), etc.

            4. Filter boxes or dispensers must be placed or stored in the milk house. Unopened filter boxes should be stored in a clean, dry area where they cannot be contaminated. For example, filters must not be stored below drugs or other chemicals.  They should be dispensed from the original box, torn only on the perforated lines, unless the dispenser is made of stainless and clean. Allowing in-line filter units and/or the filters to contact unclean surfaces during instal­lation must never be allowed.

            5. Milk receivers and other equipment are not to be located in milking areas where cattle are housed.  

            6.  Manual cleaning of all milk contact surfaces must be done in the milk ro­om.

            7.  Milk inlets that are not positioned either horizontally or upwards are in violation of this item of the PMO. (Down­ward positioned inlets will not allow for complete drainage of the system.)

            8.  Clean equipment must be stored off the floor on clean racks or other surfaces.

 Milking units that are cleaned in the milk room may be left in the utensil sink following cleaning.  This will protect them from contamination and facilitate subsequent sanitization prior to the next milk­ing.

            9.  Wash units located in the parlor should be properly stored. Jetter-cup covers must be provided and used.

ITEM 13r. MILKING - FLANKS, UDDERS AND TEATS

13. Milking – flanks, udders, and teats

     Milking shall be done in the milking barn, stable, or parlor. The flanks, udders, bellies, and tails of all milking lactating animals shall be free from visible dirt. All brushing shall be completed prior to milking. The udders and teats of all milking lactating animals shall be clean and dry before milking. Teats shall be treated with a sanitizing solution just prior to the time of milking, and shall be dry before milking. Wet hand milking is prohibited.

Public Health Reason:

     If milking is done elsewhere other than in a suitable place provided for this purpose, the milk may become contaminated. Cleanliness of the lactating animals is one of the most important factors affecting the bacterial count of the milk. Under usual farm conditions, lactating animals contaminate their udders by standing in polluted water or by lying down in the pasture or cowyard. Unless the udders and teats are clean and dry before milking, particles of filth or contaminated water are apt to drop or be drawn into the milk. Such contamination of the milk is particularly dangerous because manure may contain the organisms of brucellosis and tuberculosis, and polluted water may contain the organisms of typhoid fever and other intestinal diseases. Application of sanitizing solutions to the teats, followed by thorough drying just prior to the time of milking, has the advantage of giving an additional margin of safety with reference to such disease organisms as they are not removed by ordinary cleaning and it is helpful in the control of mastitis.

     Cow cleanliness plays an important role in total herd health and bacterial loads in the milk supply. Cleanliness of cows is directly related to item 4r, Cowyard Cleanliness and must be evaluated at every inspection. Effective maintenance of the cowyard and housing areas is a significant contributing factor to cleanliness of the milking herd. Lactating animals with caked manure on their flanks should be considered a violation, although professional judgment is allowed.

     The FDA has declared that the sanitizing of teats shall not be required if the udder is dry and the teats have been thoroughly cleaned and dried prior to milking. The determination of what constitutes a dry udder and cleaned and dried teats shall be made by the regulatory authority.


ITEM 14r. PROTECTION FROM CONTAMINATION

14. Protection from contamination

     Milking and milkhouse operations, equipment and facilities shall be located and conducted to prevent any contamination of milk, containers, utensils and equipment. No milk shall be strained, poured, transferred or stored unless it is properly protected from contamination. After sanitization, all containers, utensils and equipment shall be handled in such a manner as to prevent contamination of any product-contact surface. Vehicles used to transport milk from the dairy farm to the milk plant, receiving station or transfer station shall be constructed and operated to protect their contents from sun, freezing and contamination. Such vehicles shall be kept clean, inside and out, and no substance capable of contaminating the milk shall be transported with the milk.

Public Health Reason:

     Because of the nature of milk and its susceptibility to contamination by disease producing bacteria and other contaminants, every effort should be made to provide adequate protection for the milk at all times. This should include the proper placement of equipment so that work areas in the milking barn and milkhouse are not overcrowded. The quality of any air that is used for the agitation or movement of milk or is directed at a milk product-contact surface should be such that it will not contaminate the milk. The effect of sanitization of equipment can be nullified if the equipment is not protected after sanitizing. To protect milk during transportation, delivery vehicles must be properly constructed and operated.

     Adequate protection for the milk should be provided at all times. This includes protection from contamination by adulterants including bacteria, drugs, and chemicals. To achieve this, milking and milkhouse operations, equipment, and facilities shall be located and conducted to prevent any contamination of milk, equipment, containers, and utensils. 

     When there is milk in the bulk tank, all openings must be protected or capped to prevent entry of contaminants. Any air directed towards milk contact surfaces must be from a clean source and be adequately filtered. Filters should be in good condition and replaced regularly and installed in a clean environment. cleaners and sanitizers must be labeled with the product name, chemical description, use directions, precautionary statements, first aid instructions, container storage instructions, and the name and address of the manufacturer (this pertains to the storage container and not generally to the transfer buckets, scoops, dippers, etc.). During milking the CIP lines terminating into the utensil sink must be effectively disconnected if these lines directly connect to the milk line/circuit in the milking area.

     Other conditions which may violate this item include:

  1. Uncapped bulk tank outlets, following sanitization or with milk in the tank
  2. Milk transfer pumps and hoses that have been sanitized that are not protected from contamination.
  3. The improper handling or storage of sanitized milk contact surfaces.
  4. Contamination of a sanitized milk bulk tank or other milking appurtenances prior to use without re-sanitization.
  5. Any opening which would allow for contamination of the milk stored in the bulk tank.
  6. Agitators not located in the milkroom need to be properly protected, or
  7. Measuring lines on bulk milk tanks need to be designed so that backflow of the measured milk does not reenter the tank, and is properly drained to the floor prior to load-out.

ITEM 15r. DRUG AND CHEMICAL CONTROL

15. Drug and chemical control

     Cleaners and sanitizers shall be stored in properly identified, dedicated end-use containers.
Animal drugs and drug administration equipment shall be stored in such a way that milk, milking
equipment, wash vats and hand sinks are not subject to contamination. Animal drugs shall be properly labeled and segregated, lactating from non-lactating. Unapproved drugs shall not be used.


Public Health Reason:

     Accidental misuse of cleaners or sanitizers can result in adulteration of the milk.
Animal drugs can result in adverse reactions in people sensitive to those residues and can
contribute to the development of strains of drug resistant human pathogens.


Video: Intro part 1

Video: Intro part 2

Video: More info about residues

     If cleaners and/or sanitizers are purchased in bulk and transferred to a container at the dairy farm, this container must meet the following requirements:
  1. Be a specifically designed and maintained dedicated end-use container for the use of the specified chemical agent.
  2. The end-use container must contain a label which shall include the product name, chemical description, use directions, precautionary and warning statement, first aid instructions, container storage and maintenance instructions and the name and address of the manufacturer or distributor.

PMO Drug Labeling and Storage Requirements

Video: Why worry about contamination - part 1

Video: Why worry about contamination - part 2

To prevent contamination of milk which can result in adverse reactions in people sensitive to those residues and development of strains of drug-resistant human pathogens, animal drugs and drug administration equipment must be stored in such a way that milk, milking equipment, wash vats and hand sinks are not subject to contamination.

Video: Wash area part 1

Video: Wash area part 2

 For example, equipment used to administer drugs should not be cleaned in wash vats and stored so that they do not contaminate the milk or milk-contact surfaces.

Video: Segregation of drugs, part 1

Video: Segregation of drugs, part 2

 Also, animal drugs must be properly labeled and segregated (lactating from non-lactating on separate shelves in cabinets, refrigerators or other storage facilities), and unapproved drugs must not be used. Drugs need to be properly labeled to include the name and address of the manufacturer or distributor for over-the-counter (OTC) drugs, or veterinary practitioner dispensing the product for Rx and extra label use drugs. Drug labels also need to include: a) directions for use (dosage/route of administration, duration of therapy), b) prescribed withholding times for meat and milk, even if zero, c) cautionary statements, if needed, and d) active ingredient(s) in the drug product.

Unapproved and/or improperly labeled medicines/drugs are not to be used to treat dairy animals and shall not be stored in the milkhouse, milking barn, stable, or parlor. They should be stored in such a manner that they cannot contaminate the milk or milk product-contact surfaces of the containers, utensils, or equipment.

Video: Drug storage, part 1

Video: Drug storage, part 2

Video: Drug storage, part 3

Video: Drug storage, part 4

Proper labeling and storage of drugs on the dairy is important to ensure that the producer has adequate directions for use in hand every time a drug is administered. Drugs should be stored in areas where they may be reviewed during routine inspections, state ratings, and FDA check-ratings. FDA defines that inspection of Grade “A” dairy operations includes the milkhouse, milking barn, stable or parlor, adjacent storage areas, cow yard and cattle housing areas, surroundings, waste disposal areas, and the water supply and its distribution system.

Video: Drug Inspection Locations

Any area reasonably expected to contain drugs used to treat lactating cattle, cattle that may soon be place in or returned to a milking herd, or other cattle intended for milk production (replacement heifers) is considered to be part of the milking operation and therefore within the scope of a dairy inspection. Private residences and vehicles are not included without the permission of the owner or their authorized agent.

Video: If Problems... 

What is a drug?

Video: Drug definition

                A drug is defined in the PMO, Section 1, and Section 201(g) of the Federal Food, Drug, and Cosmetic Act (FFD&CA, or the Act) as follows:

a.       Articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and

b.      Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

c.       Articles (other than food) intended to affect the structure of function of the body of man or other animals; and

d.      Articles intended for use as a component of any articles specified in clause (a), (b), or (c); but does not include devices or their components, parts, or accessories.

Vaccines and other Biologics

                Vaccines and biologics are exempt from the labeling provisions of the PMO. Biologics are regulated under the Virus, Serum, and Toxin Act (VST Act) administered by the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS). The VST Act prohibits the production for sale or interstate movement of worthless, contaminated, dangerous or harmful biologics intended for use in the diagnosis or treatment of animal diseases. A biologic can usually be identified by the USDA License number on the label. Some biologics contain antibiotics as preservatives; however the concentrations used in the biologics are well below the levels that are capable of producing a residue in milk or meat.

            Pesticides


Video: Introduction to pesticides, rodenticides, and insecticides

Video: Pesticides part 2

                Pesticides, rodenticides, and insecticides are registered and regulated by the Environmental Protection Agency (EPA), and will usually be identifiable by the presence of an EPA registration number on the label. Only products labeled for use on or around dairy animals or milking equipment should be sued and then only according to their label directions. Using unapproved pesticides, rodenticides, or insecticides or not in accordance with their label directions is considered a violation of Item 19r – Insect and Rodent Control of the PMO and would not be debited under Item 15.

            Feeds

                Animal feeds are regulated by FDA and by State governments. An animal food is defined in Section 201(x) of the FD&CA Act as “an article which is intended for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal”. Animal feeds need to be differentiated from medicated animal feeds which are drugs. Medicated feeds must be properly labeled and stored to comply with the PMO Item 15r.

Drugs can be categorized by virtue of the labeling requirements associated with their use into:

Veterinary Prescription Drug (Rx Drug): a drug intended for veterinary use which because of its toxicity, other potential for harmful effect, or the method of its use; the drug is not safe for animal use except under the supervision of a licensed veterinarian. Adequate directions for use by the lay person cannot be prepared, as such, the drug is restricted to use by or on the order of a licensed veterinarian. All veterinary prescription drugs are required to bear the statement:

“CAUTION: Federal (USA) Law restricts this drug to use by or on the order of a licensed veterinarian.”

Over-The-Counter Drug (OTC): A drug which can be purchased and used by a layperson without the supervision of a veterinarian. The label of an OTC drug bears adequate directions for use by a layperson and is written to be understood by a layperson. When used by a layperson in the absence of a veterinarian’s order, an OTC drug must be used in accordance with its labeling. 

Video: OTC drugs

Video: Prescription drugs

Video: Labeling part 1

Video: Labeling part 2

Extra-Label Use (ELU)

Video: Extra-Label Use, part 1

Video: Extra-Label Use, part 2

Video: Extra-Label Use, part 3

Indicates actual use or intended use of a drug in animals in a manner not in accordance with its approved labeling. Only a veterinarian may use a drug in an extra-label manner. This use is provided for under the parameters described in FDA’s Animal Medicinal Use Clarification Act (AMDUCA) regulations in 21 CFR part 530. The AMDUCA allows veterinarians to prescribe FDA approved animal and human drugs for extra label purposes in their treatment of animals. Certain restrictions apply, such as no ELU in or on animal feed and certain drugs are prohibited from ELU in food animals.

Video: Extra-Label Use, part 4

Video: Extra-Label Use, part 5


 In order for a veterinarian to prescribe a drug for ELU, a valid Veterinary-Client-Patient Relationship (VCPR) must exist. A VCPR exists when:

1.       The veterinarian has assumed responsibility for making judgments regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the instruction of the veterinarian; and when,

2.       There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that that veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animals are kept; and when,

3.       The practicing veterinarian is readily available for follow-up in case of adverse reactions or failures of the regimen of therapy.

Extra-label drugs must bear the authorizing veterinarian’s name and address, specify the active ingredient of the drug, contain directions for use (including dosage, route of administration, and duration of therapy), specify meat and milk withholding times (even if zero), and include necessary cautionary statements.

Labeling guidance

1.     Drug labeling requirements for OTC, Rx, and Extra Label Use.
  1. Over-the-counter (OTC) drugs used as labeled must:
    1. Bear a manufacturer’s label with the active ingredient(s) and indications for use (which must include dosage, route of administration and duration of therapy) in LACTATING dairy cattle including meat and milk withholding times, OR
    2. Bear a manufacturer's label with the active ingredients and indications for use in NON-LACTATING cattle.
    3. No other additional veterinary label is required when such OTC drugs are used according to label directions.
    4. Instructions for use must include dosage, route of administration and duration of therapy
  2. Prescription (Rx) drugs used as labeled must:
    1. Bear the prescribing veterinarian's name and address in addition to the manufacturer's label which must include the active ingredient(s) and indications for use (dosage, route of administration and duration of therapy) in LACTATING dairy cattle including meat and milk withholding times, OR
    2. Bear the prescribing veterinarian's name and address in addition to the manufacturer's label which must include the active ingredient(s) and indications for use in NON-LACTATING cattle,

 

REMEMBER - the prescription legend reads "Caution: Federal (USA) Law restricts this drug to use by or on the order of a licensed veterinarian."

 

NOTE: The requirement for displaying the active ingredient(s) on the label is fulfilled by listing the drug's common, generic, scientific, or chemical name. Listing of a trade name or brand name alone is not acceptable.

  1. Labels for Small and Irregularly Shaped Containers

The only exceptions to the PMO requirements for individual container labeling pertain to containers that are too small or are shaped in such a manner that they will not accommodate a label bearing all the required information. In these cases, the label issued by the dispensing veterinarian is required to be affixed to the next largest package size. Examples include:

       if a product that is too small to be labeled is packaged in a multi-vial carton; then a label affixed to the carton would be acceptable. If the veterinarian does not want to prescribe a carton, then the vials should be put in a container (such as a Ziploc plastic bag) and the label affixed to the container.

       Some products are packaged in single vial containers of sufficient size to accommodate a label but the immediate container is sealed within a hard plastic outer container. Since the integrity of the seal is an indication of whether or not tampering has occurred, a label is permitted to be affixed to the outer container instead of requiring a label to be affixed to the immediate container itself.

       Many dairies use prescription intra-mammary infusion tubes for both lactating and non-lactating animals. These tubes are packaged in multiple tube boxes and must bear a label with the prescribing veterinarians name and address.

       Labeling the outside of cases or cartons of drugs does not meet current labeling requirements. The smallest unit size that can practically be labeled is required to bear the PMO required information.

  1. Identification of the dispensing or prescribing veterinarian’s name on the label:

A veterinarian’s name and address is required on all prescription and extra-label use drugs. Many clinic labels will list more than one veterinarian’s name. in such cases, the name of the individual who actually dispensed or prescribed the drug must be identified on the label. Identification is most often accomplished by underlining, circling, or checking the name of the veterinarian who dispensed or prescribed the drug.

Veterinarians may own or be full time employees on some dairy farms. All drugs in use or stored on the dairy operation of these farms must comply with the labeling and storage requirements of the PMO.

2.     Drug storage requirements

The PMO requires that lactating and non-lactating cattle drugs must be stored separately. A separate shelf in cabinets, refrigerators, or other storage facilities satisfies this item. Labeling the shelves (lactating/non-lactating) is recommended but not a PMO requirement. All drugs must be stored in such a manner that they cannot contaminate the milk or milk product contact surface of the equipment, containers, or utensils. Unapproved and/or improperly labeled drugs should not be used to treat dairy animals and are not to be stored in the milkhouse, milking barn, stable or parlor.

A.      Satisfactory labeling of the drug product.

Video: Satisfactory labeling


The labeling of a shelf, wall or carton is not discouraged, but will not satisfy the PMO requirements. If a shelf, wall or carton is labeled instead of the immediate container then adequate directions for use would not be in hand at the time the drug is administered. This is especially important when multiple people or crews treat cows on a farm. They need adequate directions for use to avoid residues in the milk.

B.      Posting of drug use protocols

FDA encourages any mechanism a veterinarian or layperson may deem appropriate to educate the producer and his employees to strictly follow the labeled directions and veterinarian’s instructions. The posting of a treatment protocol may help achieve adherence to label directions, however this would not obviate the need for individual container labeling, which is required by the PMO and the FD&C Act.

C.      Use of package inserts

Federal law allows drug sponsors to include the necessary use information on drug package inserts. If the PMO required drug labeling information is included on the insert and not on the vial label the insert must be readily available at inspection time.

D.      Veterinarian prescriptions

Many veterinarians prefer to write prescriptions for drug distributors to fill and deliver prescriptions or extra-label use drugs to dairy farms. The PMO does not mandate who should dispense the drug or who should affix the necessary label information. The regulation as to who may dispense veterinary drugs and who may label drug products can vary between States. The appropriate State agency should be consulted. For PMO purposes the drugs must be properly labeled at inspection time. The PMO does not specify who is allowed to label a product.

                The producer is ultimately responsible for assuring that the veterinarian has provided the specific label information required by the PMO. These minimum label requirements provide inspectional evidence that adequate directions for use of the product are available to the dairy farmer and, in the case of veterinary prescription drugs or extra-label use drugs, that a veterinarian has prescribed the product.

 

Types of drugs exempt from the labeling and storage requirements of the PMO

                Certain antiseptics, wound dressing, vaccines and other biologic and dosage form vitamin and/or mineral products are exempt from the labeling and storage requirements of the PMO, except when it is determined that they are stored in such a manner that they may contaminate the milk or milk product surfaces of containers or utensils. These products are not exempt from the labeling requirements of the FD&C Act. The products may be sold as OTC or prescription drugs.

  1. Hormones: Prostaglandins, oxytocin, and certain other pituitary hormones are exempt from the labeling requirements on State and Federal check ratings (this is different from Ovarian and Adrenal Hormones).
    1. Prostaglandins

                                                               i.      Cloprostenol (Estrumate)

                                                             ii.      Dinoprost (Lutalyse)

    1. Pituitary hormones

                                                               i.      Oxytocin

                                                             ii.      Luteinizing Hormones (PLH, LH)

                                                            iii.      Chorionic Gonadotropin (C.G., HCG)

                                                           iv.      Corticotropin (ACTH)

                                                             v.      Follicle Stimulating Hormone (FSH)

  1. Dosage form vitamin and/or mineral products exempt from the labeling and storage requirements: Some products in this category may be labeled and marketed as prescription or OTC, and may have species other than cattle on the label. They are exempt from the labeling and storage requirements, but must be stored in a manner that they will not contaminate the milk or milk product surfaces of containers or utensils. Some of the products in this category that may be found on farms include:
    1. Calcium products, injectable or oral use
    2. Calcium and dextrose products
    3. Calcium in combination with other minerals such as magnesium, potassium, and/or phosphorous
    4. Dextrose alone or in combination with other minerals
    5. Lactated Ringers
    6. Sodium Chloride
    7. Sterile Water
    8. Potassium Chloride alone or in combination with other minerals or dextrose
    9. Electrolytes for oral or injectable use
    10. Vitamin A and D
    11. Vitamin E and Selenium combinations
    12. Vitamin E alone
    13. Selenium compounds for oral use
    14. Vitamin B complex
    15. Vitamin B1 (Thiamine)
    16. Vitamin B12 (Cyanocobalamin)
    17. Vitamin B6 (Pyridoxine)
    18. Vitamin B2 (Riboflavin)
    19. Vitamin C, and Vitamin K
    20. Choline
    21. Pantothenic Acid
    22. Folacin (Folic Acid, Pteroylglutamic Acid)
    23. Copper containing compounds for injection or oral use
    24. Iron containing compounds for injection or oral use
    25. Propylene glycol
    26. Bicarbonate; injectable and oral formulations
  2. Topical antiseptics and wound dressings: Unless intended for direct injection into the teat, topical antiseptics and wound dressings are exempt from the labeling requirements. Topically applied drugs that are not antiseptics or wound dressings must comply with all labeling, use, and storage requirements. This category includes creams, ointments, sprays, wound dressings, some foot products, teat dips, tincture of iodine and others. They should only be used topically and must be stored so as not to contaminate the milk or product contact surfaces. Some of the products that may be found on farms include:
    1. Iodine
    2. Alcohol
    3. Hydrogen peroxide
    4. Teat dips/udder washes
    5. Chlorine bleach
    6. Formalin (for cattle foot baths)
    7. Blue Coat
    8. Kopertox
    9. Granulex Spray
    10. Trypzyme Aerosol
    11. Chlorhexidine solutions, ointments, salves, and creams for topical use only.
  3. Footbaths: Video: Footbaths  Medicated foot baths and sprays are used to treat and control cattle foot rot and heel warts. These baths and sprays often contain antibiotics such as oxytetracycline. To comply with the PMO these types of baths and sprays must be operated in a manner that will not contaminate the milk or surface of the milk product contact surface of the milk product contact equipment. The use of antibiotics for foot baths/sprays constitutes extra label use, and veterinarians need to comply with the labeling requirements for extra label use of drugs under PMO Item 15r.

To prevent milk contamination, foot baths generally should be located on the exit side of the milking area (walk-through after milking). Spraying medication onto the cattle’s hooves should not occur in the milking area during milking time.

  1. Combination penicillin/streptomycin dihydrostreptomycin for injection or feed use: Procaine penicillin combined with streptomycin and/or dihydrostreptomycin were removed from approval by FDA on November 19, 1992. If found on dairy farms during inspections, they are in violation of Item 15r of the PMO. Intra-mammary infusion products containing the two drug combination are currently still approved legal products.
  2. DMSO: Dimethylsulfoxide is able to carry some drugs rapidly through the skin and other tissues. There are no FDA approved uses for DMSO in food-producing animals. Approvals do exist for uses in horses and dogs. FDA considers the use of DMSO for any veterinary purposes other than approved uses in dogs and horses to be illegal. DMSO is an unapproved new animal drug which is unsafe with the meaning of the Act. Such use causes the product to be adulterated under section 501(a)(5) of the Federal Food, Drug and Cosmetic Act. The use of DMSO on dairy animals or the storage of DMSO in dairy farm drug cabinets violates item 15r of the PMO.
  3. Dipyrone: Dipyrone may adversely change the bone marrow if ingested by humans. Dipyrone is not approved for any use in food producing animals. If Dipyrone is observed on a dairy farm during a rating or check rating, it is in violation of Item 15r of the PMO.

 

Systemically acting drugs that are applied topically and not exempt from the labeling and storage requirements

                The following is a list of FDA approved drugs that are applied as topical’s for their systemic effect against internal parasites, cattle grubs, or external insects such as lice. They are not topical antiseptics or wound dressings and are not labeled for use in lactating dairy cattle; therefore they are not exempt under Item 15r. Because of their potential to cause residues in milk, the use of these drugs on lactating dairy cattle or their storage with the lactating cattle drugs is a violation of Item 15r.

DRUG

TRADE NAME EXAMPLES

Fenthion

Spotton Cattle Insecticide

Tiguvon Pour On

Famphur and Xylene

Purina Grub Kill

Warbex Famphur Pour On

Phosmet

Star Bar GX-118

Prolate 1-E

Ivermectins and Avermectins

Ivomec Pour On

Doramectin Pour On

Levamisole

Tramisol Pour On

Totalon

 

Pesticides/rodenticides; Insecticide Sprays, Dusts, Powders and Pour-On

                Pesticides/rodenticides/insecticides are usually regulated by the Environmental Protection Agency (EPA) and can be identified by the EPA registration number on the label. Only products labeled for use on or around dairy cattle or milking equipment should be used and only according to their labels.

                Pesticides should be mixed correctly and applied nor more frequently than specified on the label. EPA regulated pesticides and rodenticides are exempt from the labeling requirements of 15r, but the improper labeling, use, or storage of pesticides or rodenticides violates section 19r of the PMO.

 

Ovarian Hormones and Adrenal Hormones

                Ovarian (estrogens and progesterone) and Adrenalin (epinephrine) hormones are not exempted from the PMO drug labeling and storage requirements. Estrogen compounds such as estradiol cypionate (ECP) may be present in products, and may bear an Rx label. None have ever been approved by FDA for use in animals. ECP is no longer marketed in the United States and should not be used or stored on dairy operations. Progesterone is sometimes used for reproductive diseases in cattle. These are Rx products and must comply with Item 15r of the PMO.

                Epinephrine is a hormone from the adrenal glands, and is used to treat shock in animals. Usually full strength epinephrine is labeled as an Rx drug; however there are less concentrated OTC formulations available. Such products should be properly labeled or extra-labeled by a veterinarian.

 

Medicated and Non-Medicated Cattle Feed and Blocks 

Video: Medicated feed and blocks

                Some cattle feeds and blocks contain drugs. These medicated feeds or blocks must be labeled and stored properly. A common cause of violative drug residues is mistakenly feeding a medicated feed or block intended for use in calves or replacement heifers to the lactating herd.

                All medicated feeds or blocks should be segregated from non-medicated feeds or blocks. Medicated feed or blocks intended for non-lactating cattle must be stored inaccessible to lactating dairy cattle.

                FDA’s Extra Label Use regulations (AMDUCA) prohibits veterinarians from combining or mixing drugs in, or on animal feed.

 

Prohibited Drugs 

Video: Prohibited Drugs

                Because of human food safety concerns, some drugs may not be used to treat food-producing animals, even in an extra-label manner (current as of April 2012. Check for updates on the FDA website at www.fda.gov/cvm).  These include:

·         Chloramphenicol

·         Clenbuterol

·         Diethylstilbesterol (DES)

·         Dimetridazole

·         Ipronidazole

·         Other Nitroimidazoles (metronidazole)

·         Nitrofuran drugs, Furazolidone, and Nitrofurazone

·         Sulfonamide drugs in lactating dairy cows (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine)

 

·         Fluoroquinolones

 

·         Glycopeptides (example: vancomycin)

 

·         Phenybutazone in female dairy cattle 20 months of age or older

·         Adamantane and neuraminidase inhibitor classes of drugs that are approved for treating or preventing influenza A are prohibited therapy in chickens, turkeys, and ducks (Effective: June 20, 2006)

·         Cephalosporin (excluding cephapirin) in cattle, swine, chickens, or turkeys (Effective April 5, 2012)

o    Using cephalosporin drugs at unapproved dose levels, frequencies, durations or routes of administration is prohibited

o    Using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (e.g., cephalosporin drugs intended for humans or companion animals);

o    Using cephalosporin drugs for disease prevention

Additional discussion regarding specific drug issues

Nitrofuran drugs: Furazolidone and Nitrofurazone

                Nitrofuran drugs are listed with those of highest priority for regulatory attention. The use of furazolidone, nitrofurzone or other nitrofuran in food-producing animals in any form is no longer allowed. In addition, nitrofuran drugs approved for topical use in other species are not to be used or stored on dairy farms.  These include salves, ointments, liquid, and spray or puffer dry powder topicals (e.g. pink eye and wound treatments). The use or storage of any withdrawn nitrofuran drug or the use of solutions, ointments, sprays and creams labeled as topicals for non-dairy animals violates Item 15r of the PMO.

            Homeopathic drugs, Colloidal Silver, Aloe Vera and other drugs

                The PMO states that unapproved and/or improperly labeled medicinals/drugs are not used to treat dairy animals and are not stored in the milkhouse, milking barn, stable or parlor. The PMO further requires that all drugs be properly labeled and that drugs intended for the treatment of lactating dairy animals are segregated from those drugs to be used on non-lactating animals.

                Homeopathic drugs: FDA can find no justification for regulating veterinary homeopathic drugs any differently from other drugs subject to the FD&C Act. There are currently NO FDA APPROVED HOMEOPATHIC DRUGS for veterinary use. If homeopathic drugs are found on dairy operations, they must comply with all labeling and storage requirements otherwise they may be considered to be unapproved drugs. Homeopathic drugs are subject to the same storage requirements as any other drug.

                Colloidal Silver: the use of colloidal silver containing products constitutes a potentially serious public health concern because of the possibility of residues in milk or meat. The consumption of silver by humans may result in argyria, a permanent ashen-grey or blue discoloration of the skin, conjunctiva, and internal organs. Colloidal silver products are not to be used or stored on dairy farms, and constitute a violation of Item 15r.

                Aloe Vera: No aloe vera product has been approved for the treatment of mastitis or calf diarrhea, or to increase milk production. Aloe vera products for animals bearing these types of claims are unapproved new animal drugs. Aloe vera products intended for animal use that do not bear adequate directions for animal use are ‘misbranded’. Use of unapproved drugs violates Item 15r.

                Drugs packaged for injection or udder infusion but labeled for oral or topical use: FDA is very concerned about the safety of products not approved for parenteral use which are infused or injected into food producing animals. FDA believes that the packaging and labeling of these products is a subterfuge to avoid the more stringent regulatory requirements for parenteral drugs. Products that are intended for oral or topical administration should not be packaged to facilitate parenteral administration (e.g. injection or udder infusion). Such drugs will be considered to be misbranded if theyh do not contain directions for their packaged use.

ITEM 16r. PERSONNEL - HANDWASHING FACILITIES

16. Hand washing facilities

     Adequate hand washing facilities shall be provided, including a lavatory fixture with hot and cold, or warm running water, soap or detergent, and individual sanitary towels, convenient to the milkhouse, milking barn, stable, parlor and flush toilet.

Public Health Reason:

     Adequate handwashing facilities are essential to personal cleanliness and minimize the likelihood of contamination of the milk. Handwashing facilities are required in order to increase the assurance that milker's and bulk milk hauler/sampler's hands will be washed.

An item could possibly be satisfied with one hand washing sink convenient to all three locations. The area must never be used as a storage area for items such as outlet valves, drink cans, insecticide bombs, medication devices, brushes, etc. Utensil wash and rinse vats shall not be used as hand washing facilities.

ITEM 17r. PERSONNEL - CLEANLINESS

17. Personal cleanliness

     Hands shall be washed clean and dried with an individual sanitary towel immediately before milking, before performing any milkhouse function, and immediately after the interruption of any of these activities. Milkers and bulk milk haulers/samplers shall wear clean outer garments while milking or handling milk, milk containers, utensils, or equipment. Observation for compliance with this item is usually made during milking time. The use of tobacco in any form should be discouraged while performing milking operations.

Public Health Reason:
 
     The reasons for clean hands of the persons doing the milking are similar to those for the cleanliness of the lactating animal's udder. The milker's hands may have been exposed to contamination during the course of their normal duties on the farm and at milking time. Because the hands of all workers frequently come into contact with their clothing it is important that the clothes worn, during milking and the handling of milk, be clean.

ITEM 18r. RAW MILK COOLING

18. Raw milk cooling

     Raw milk for pasteurization shall be cooled to 10ºC (50ºF) or less within four (4) hours or less, of the commencement of the first milking, and to 7ºC (45ºF) 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 10ºC (50ºF).

Public Health Reason:

     Milk produced by disease-free lactating animals and under clean conditions usually contains relatively few bacteria immediately after milking. These can multiply to enormous numbers in a few hours unless the milk is cooled. However, when the milk is cooled quickly to 7ºC (45ºF) or less, there is only a slow increase in the numbers of bacteria. Usually, the bacteria in milk are harmless, and if this were always true there would be no reason to cool milk, except to delay souring. There is; however, no way for the dairy operator or regulating officer to be absolutely sure that no disease bacteria have entered the milk, even though observance of the other Items of this Ordinance will greatly reduce this likelihood. The likelihood of transmitting disease is much increased when the milk contains large numbers of disease bacteria. Therefore, it is extremely important for milk to be cooled quickly, so that small numbers of bacteria, which may have entered the milk, will not multiply.

     The time it takes bacteria to divide or double is referred to as the doubling time or generation time. At optimum growth temperatures, the doubling time can be as little as 20 minutes for many milk-borne bacteria and pathogens. Fortunately, when the temperature of milk is lowered (cooling) the doubling times of bacteria become much longer and the rate of growth is slowed considerably. For many bacteria, growth will actually stop at proper refrigeration temperatures (70 C (450 F)).  A few examples of how temperature affects the growth rate of bacteria are presented in the following table.

 

Bacterium

Temperature

Doubling time

Time to one million

 

0F

0C

minutes

hours

hours

days

Escherichia coli

100

37.8

20

0.3

6.7

0.3

 

80

26.7

30

0.5

10.0

0.4

 

60

15.6

120

2.0

40.0

1.7

 

50

10

180

3.0

60.0

2.5

 

45

7.2

 

 

 

 

 

 

 

 

 

 

 

Staphylococcus aureus

100

37.8

20

0.3

6.7

0.3

 

80

26.7

42

0.7

14.0

0.6

 

60

15.6

210

3.5

70.0

2.9

 

50

10

666

11.1

222.0

9.3

 

45

7.2

 

 

 

 

 

 

 

 

 

 

 

Listeria monocytogenes

100

37.8

50

0.8

16.7

0.7

 

80

26.7

90

1.5

30.0

1.3

 

60

15.6

120

2.0

40.0

1.7

 

50

10

522

8.7

174.0

7.3

 

45

7.2

1320

22.0

440.0

18.3

  Proper cooling requires lowering the temperature of the milk quickly enough to prevent excessive microbial growth, while slow cooling or improper cooling provides an opportunity for bacterial growth. After milk is cooled properly it is also important that the temperature be maintained and monitored during storage. The PMO stipulates that raw milk for pasteurization shall be cooled to 10C (50F) or less within 4 hours or less of the commencement of the first milking and to 7C (45F) or less within 2 hours after the completion of milking. Provided, that the blend temperature after the first milking and subsequent milkings does not exceed 10C (50F). It is extremely important for milk to be cooled quickly, so that small numbers of bacteria which may have entered the milk will not multiply.

Farm bulk tanks usually cool milk in one of two ways: direct expansive cooling or ice bank cooling.  The most common method is direct expansive cooling where a refrigerant compressor pumps the coolant gas directly to the inside lining of the tank and the refrigerant cools the stainless steel of the tank which in turn cools the milk. A variation of this is referred to as the ice bank method because the refrigerant compressor cools a liquid and the cooled liquid is then circulated through the inner lining of the tank to cool the stainless steel which then cools the milk. Note that in both systems the coolant gas or the cooled liquid never makes contact directly with the milk.

        Pre-coolers are tubular or plate heat exchangers that rely on the counter flow of cool water (from well water, an ice builder, or the condensing unit) to effect indirect cooling of the warm milk prior to the milk entering the tank.They cool milk by running water and milk in opposite flow channels over a series of metal plates. Warm raw milk is cooled as its heat is transferred to the cool water on the opposite side of each plate. The cooling occurs before the milk enters the bulk tank, so that cooled milk, rather than warm milk, is being added to the tank.  Some systems are open systems, i.e., the cooling water goes through the heat exchanger and then flows out of the system. In this system, discharge water that is warmed from the milk cooling process may be piped for other on farm purposes.  Other systems are referred to as closed systems because the cooling water/fluid is continuously cooled and re-circulated and not discharged.

        Instant cooler refers to a system down stream from the pre-cooler (or combined with it) that actually cools the incoming milk to all the way to 7.2ºC (45ºF), or less, before the milk enters an insulated bulk storage tank.  If an operator is directly loading a farm bulk milk pickup tanker with milk during the milking operation than the milk shall be cooled to 7.2ºC (45ºF), or less, prior to pumping to the bulk milk pickup tanker. This would require the use of an instant cooler.      
An excellent description of cooling of milk can be found at this website.

Raw Milk Cooling and Public Health

The proper cooling and holding of raw milk at 7.2ºC (45ºF), or less, prior to pasteurization will prevent or at least control the rapid grow of bacteria in the milk.  However, cooling raw milk properly and maintaining it at 7.2ºC (45ºF), or less, will not improve the inherent safety of the milk. If pathogens of concern are in the raw milk when it enters the farm bulk tank, they will be there when the milk leaves the farm bulk tank.  The numbers of pathogens will probably not be increased, but they still will be there at their original levels. It is only through the proper application of milk pasteurization that we can eliminate the pathogens of concern.  The consumption of raw milk that is cooled properly and maintained at 7.2ºC (45ºF), or less, still represents a health hazard.

After January 1, 2000, all newly manufactured farm bulk tanks shall be equipped with an approved temperature recording device and shall meet the additional requirements in the PMO, such as no overlapping on the charts and the charts must be maintained for six months. In addition, recording devices shall be verified every six months.


ITEM 19r. INSECT AND RODENT CONTROL

19. Insect and rodent control

     Effective measures shall be taken to prevent the contamination of milk, containers, utensils and equipment by insects and rodents and by chemicals used to control such vermin. Milkhouses shall be free of insects and rodents. Surroundings shall be kept neat, clean and free of conditions, which might harbor or be conducive to the breeding of insects and rodents. Feed shall be stored in such a manner that it will not attract birds, rodents or insects.

Public Health Reason:

     Proper manure disposal reduces the breeding of flies, which are considered capable of transmitting infection by physical contact or through excreta to milk or milk containers, utensils or equipment. Insects visit unsanitary places, they may carry pathogenic organisms on their bodies and they may carry living bacteria for as long as four (4) weeks within their bodies, and they may pass them on to succeeding generations by infecting their eggs. Effective screening tends to prevent the presence of flies, which are a public health menace. Flies may contaminate the milk with microorganisms, which may multiply and become sufficiently numerous to present a public health hazard. The surroundings of a dairy should be kept neat and clean in order to reduce insect and rodent harborages.

     The contamination of milk, containers, equipment and utensils by insects and rodents and by chemicals used to control such vermin must be effectively prevented. Keeping the milkhouse and surroundings of a dairy neat and clean will reduce harborage or be less conducive to the breeding of insects and rodents. Feed needs to be stored in such a manner that it will not attract birds, rodents, or insects. The following items are areas of special emphasis:

  1. Specific guidelines are provided for manure disposal practices. Manure piled on the ground surface during fly breeding season may not be stored longer than 4 days. If the manure is stored in a concrete manure bin the period may be extended to 7 days maximum.
  2. All attempts to minimize fly breeding and rodent harborage activities must be made. This includes manure disposal practices, effective garbage and refuse disposal, and maintenance of surroundings in a neat and clean conditions. Spilled or decaying feeds around silos provide excellent conditions for fly breeding; therefore these areas must be regularly cleaned. Feeds must be stored so as not to attract flies. Outside refuse containers should be kept covered and relatively clean. Used single service filters must be kept in a fly tight container and disposed of in a timely manner.
  3. Good sanitation practices are the best fly control program. Biological control and reliance on continued application of pesticides has not been shown to be effective in the overall control of house and stable flies.
  4. Pesticides used on dairy farms must be approved for dairy farm usage by the Environmental Protection Agency (EPA), and the label on the pesticide container must contain the EPA Registration Number, name of pesticide, chemical composition, methods of use, including strengths, cautions against use on certain food animals, and any other restriction for use on dairy farms.
  5. Automatic electronic timer insecticide misters must be installed so that they cannot operate during milking and/or equipment cleaning periods. They must also be installed so as not to contaminate the milk or feed in the milking area and are prohibited from being installed in the milkhouse, provided that small canister type approved insecticide “bombs” may be used in accordance with manufacturer’ recommendations. Only approved pesticides may be used in these devices.
  6. Only those pesticides approved for use in the milkhouse may be used and/or stored in the milkhouse. Paints containing insecticide must not be used in the milkroom. “Sticky” fly paper should not be allowed in the milkhouse as they tend to become over laden with dead insects which then become a cleanliness problem.
  7. Milkhouse doors shall be tight and self-closing and there shall not be any direct opening to the outside that is not effectively protected against the entrance of vermin into the milkroom. This includes overhead vents and windows. Screen doors must open outward which helps in preventing flies from entering the milkroom.
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