Alabama Administrative Code
Title 420 - ALABAMA STATE BOARD OF HEALTH
Chapter 420-3-16 - PRODUCTION, PROCESSING, HANDLING OR DISTRIBUTION OF MILK, MILK PRODUCTS AND FROZEN DESSERTS
Section 420-3-16-.09 - Sanitation Requirements For Grade A Raw Milk For Pasteurization, Ultra-Pasteurized, Aseptically Processing And Packaging, Or Retort Processed After Packaging

1. The health of lactating animals is a very important consideration because a number of diseases of lactating animals, including salmonellosis, staphylococcal 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.

2. 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 the disease is often caused by a staphylococcus or other infectious agent. Occasionally, lactating animals' udders become infected with hemolytic streptococci of human origin, which may result in milk borne 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.

1. Milk from lactating animals being treated with medicinal agents which are capable of being secreted in the milk, is not offered for sale for such period as is recommended by the attending veterinarian or as indicated on the package label of the medicinal agent.

2. Milk from lactating animals treated with or exposed to insecticides not approved for use on dairy cattle by the U.S. EPA is not offered for sale.

3. The Health Officer requires such additional tests for the detection of abnormal milk as he/she deems necessary.

4. Bloody, stringy, off-colored milk or milk that is abnormal to sight or odor, is so handled and disposed of as to preclude the infection of other cows and the contamination of milk utensils.

5. Lactating animals secreting milk with abnormalities are milked last or in separate equipment, which effectively prevents the contamination of the wholesome supply. Milking equipment used on animals with abnormalities in their milk is maintained clean to reduce the possibility of reinfecting or cross infection of the dairy animals.

6. Equipment, utensils, and containers used for the handling of abnormal milk are not used for the handling of milk to be offered for sale unless they are first cleaned and effectively sanitized.

7. Processed animal waste derivatives, used as a feed ingredient for any portion of the total ration of the lactating dairy animal have been:

8. Unprocessed poultry litter and unprocessed recycled animal body discharges are not fed to lactating dairy animals.

1. Have floors 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.

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

3. Have separate stalls or pens for horses, calves, and bulls.

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.

6. Not be overcrowded, and

7. Have dust-tight, covered boxes or bins, or separate storage facilities for ground, chopped, or concentrated feed.

1. A milking barn or parlor is provided on all dairy farms.

2. Gutters, floors, and feed troughs are constructed of good quality concrete or equally impervious material. Floors shall be easily cleaned (brushed surfaces permitted) and shall be graded to drain and maintained in good repair and free of excessive breaks or worn areas that may create pools.

3. Gravity flow manure channels in milking barns, if used, shall be constructed in accordance with the specifications of Appendix C.

4. Stall barns, when used with gutter grates over manure storage pits, are designed and constructed in accordance with the specifications of Appendix C.

5. Walls are finished with tile, smooth-surfaced concrete, cement plaster, brick, or other equivalent materials with light-colored surfaces; provided, existing barns with wood walls will not be considered a violation provided they are properly maintained. Walls, partitions, doors, shelves, windows, and ceilings shall be kept in good repair, and surfaces shall be refinished whenever wear or discoloration is evident. Ceilings are constructed of smooth dressed lumber, plywood, or similar material. Whenever feed is stored overhead, ceilings shall be constructed to prevent the sifting of chaff and dust into the milking barn or parlor. If an opening is provided from a loft into the milking portion of the barn, such opening shall be provided with a dust-tight door which shall be kept closed during milking operations.

6. Bullpens, maternity calf stalls, and horse stalls are partitioned from the milking portion of the barn. Such portions of the barn that are not separated by tight partitions shall comply with all requirements of this item.

7. The milking barn is provided with natural and/or artificial light to ensure that all surfaces and particularly the working areas will be plainly visible. The equivalent of at least 20 foot-candles (110 lux) of light in all working areas shall be provided.

8. Air circulation is sufficient to minimize odors and to prevent condensation upon walls and ceilings.

9. Overcrowding is not evidenced by the presence of calves, lactating animals, or other barnyard animals in walks or feed alleys. Inadequate ventilation and excessive odors may also be evidence of an overcrowded barn.

10. A dust-tight partition provided with doors that are kept closed, except when in actual use, shall separate the milking portion of the barn from any feed room or silo in which feed is ground or mixed or in which sweet feed is stored. Feed may be stored in the milking portion of the barn, only in such manner as will not increase the dust content of the air, attract flies, or interfere with cleaning of the floor (as in covered, dust-tight boxes or bins). Open feed dollies or carts may be used for distributing the feed, but not storing feed in the milking barn. When conditions warrant, the Health Officer may approve a barn without four walls extending from floor to roof or a shed-type barn provided the requirement of paragraph 3, prohibiting animals and fowl entering the barn is satisfied. Animal housing areas (stables without stanchions, such as loose-housing stables, pen stables, resting barns, free-stall barns, holding barns, loafing sheds, wandering sheds) may be of shed-type construction provided no milking is conducted therein. They are classified as part of the animal yard under Rule 430-3-16-.09(4).

1. The interior of the milking barn or parlor is kept clean.

2. Leftover feed in feed mangers appears fresh and is not wet or soggy.

3. The bedding material, if used, does not contain more manure than has accumulated since the previous milking.

4. Outside surfaces of pipeline systems located in milking barn or parlor are reasonably clean.

5. Gutter cleaners are reasonably clean.

6. All pens, calf stalls, and bullpens, if not separated from the milking barn, stable, or parlor, are clean.

7. Swine, fowl, and animals other than the milking herd are kept out of the milking barn.

8. Gravity flow manure channels in milking barns, if used, shall be maintained in accordance with Appendix C.

9. Stall barns, when used with gutter grates over manure storage pits, are operated and maintained in accordance with the specifications of Appendix C.

10. Milk stools are not padded and are constructed to be easily cleaned. Milk stools, surcingles, and antikickers are kept clean and are stored above the floor in a clean place in the milking barn, stable, parlor, or milkhouse when not in use.

11. In barns in which water under pressure is not available, the floors may be brushed dry and limed. In the latter event, care should be exercised to prevent caking of the lime. When lime or phosphate is used, it shall be spread evenly on the floor as a thin coating. If clean floors are not maintained by this method, the sanitarian should require cleaning with water.

1. The animal yard, which is the enclosed or unenclosed area adjacent to the milking barn in which the lactating animals may congregate, including animal housing areas and feed lots, is graded and drained; depressions and soggy areas are filled; lactating animal lanes are reasonably dry.

2. Approaches to the barn door and the surroundings of stock watering and feeding stations are solid to the footing of the animal.

3. Wastes from the barn or milkhouse are not allowed to pool in the cowyard. Cowyards which are muddy due to recent rains should not be considered as violating this item.

4. Manure, soiled bedding, and waste feed are not stored or permitted to accumulate therein in such a manner as to permit the soiling of lactating animal's udders and flanks. Animal-housing areas (stables without stanchions, such as loose-housing stables, pen stables, resting barns, and holding barns, shall be considered a part of the cowyard. Manure packs shall be solid to the footing of the animal (see Appendix C).

5. Cowyards are kept reasonably free of animal droppings. Animal droppings shall not be allowed to accumulate in piles that are accessible to the animals.

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 Appendix H, IV. Temperature-recording devices used in storage tanks and V., Criteria 4, 7, 8, 9, 11, and 12 with or without hard copy, may be used in place of temperature-recording records (refer to the Note: on page 51). 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 Health Officer. 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 Health Officer.

3. The milk shall be sampled at the direction of the Health Officer 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.

(I) 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 the Health Officer's 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 studding the milk transfer and associated CIP cleaned lines outside the milkhouse wall in accordance with Rule 420-3-16-.09 Administrative Procedures 13.

(II) To assure continued protection of the milk, the milk tank truck manhole shall be sealed after the truck has been cleaned and sanitized.

(III) The milk tank truck shall be washed and sanitized at the permitted milk plant, receiving station, or transfer station receiving the milk, or a permitted milk tank truck cleaning facility.

(IV) 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. Temperature-recording devices used in storage tanks and V., Criteria 4, 7, 8, 9, 11, and 12 with or without hard copy, may be used in place of temperature-recording records (refer to the Note: on page 51). 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.

(V) 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 Health Officer. 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 Health Officer.

(VI) The milk shall be sampled at the direction of the Health Officer, 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.

(VII) The milk tank truck shall be parked on a self-draining concrete or equally impervious surface during filling and storage.

(VIII) 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 Rule 420-3-16-.10(5), Administrative Procedures 13, overhead protection of the milk hose connection to the milk tank truck shall be provided.

1. A separate milkhouse of sufficient size is provided for the cooling, handling, and storing of milk and the washing, sanitizing, and storing of milk containers and utensils; except as provided for in Rule 420-3-16-.10(12).

2. The floors of all milkhouses are constructed of good quality concrete (float finish permissible) or equally impervious tile or brick laid closely with impervious material, or metal surfacing with impervious joints or other material the equivalent of concrete and maintained free of breaks, depressions, and surface peelings.

3. The floor slopes to drain so that there are no pools of standing water. The joints between the floor and the walls shall be water tight.

4. The liquid wastes are disposed of in a sanitary manner. All floor drains are accessible and are trapped and grated, if connected to a sanitary sewer.

5. Walls are finished with tile, smooth, surfaced concrete, cement plaster, cement block, or other equivalent materials with light-colored surfaces. The surfaces and joints shall be smooth. Ceilings are constructed of smooth dressed lumber, plywood, or similar materials. Walls, partitions, doors, shelves, windows, and ceilings shall be kept in good repair; and surfaces shall be refinished whenever wear or discoloration is evident. Walls (other than tile) and ceilings are well-painted with a light-colored, washable paint. Sheet metal, tile, cement block, brick, concrete, cement plaster, or similar materials of light color may be used and the surfaces and joints shall be smooth.

6. A minimum of 20 foot-candles (220 lux) of light is provided at all working areas from natural and/or artificial light for milkhouse operations.

7. The milkhouse is adequately ventilated to minimize condensation on floors, walls, ceilings, and clean utensils. Windows and solid doors are closed during dusty weather.

8. The milkhouse is adequately ventilated to minimize odors and condensation on floors, walls, ceilings, and clean utensils.

9. Vents, if installed, and lighting fixtures are installed in a manner to preclude the contamination of bulk milk tanks or clean utensil storage areas.

10. The milkhouse is used for no other purpose than milkhouse operations.

11. There is no direct opening into any barn or room used for domestic purposes; except that an opening between the milkhouse and milking barn or parlor is permitted with a tight-fitting, self-closing solid door(s) hinged to be single or double acting is provided. Except that screened vents are permitted in the wall between the milkhouse and a breezeway, which separates the milkhouse from the milking parlor, provided animals are not housed within the milking facility.

12. A vestibule, if used, complies with the applicable milkhouse construction requirements.

13. The transfer of milk from a bulk milk tank to a bulk milk pickup tanker is through a hose port located in the milkhouse wall. The hose port shall be fitted with a tight door, which shall be in good repair. It shall be kept closed except when the hose port is in use. An easily cleanable surface shall be constructed under the hose port, adjacent to the outside wall and sufficiently large to protect the milk hose from contamination.

1. A concrete slab of adequate size, to protect the transfer hose, shall be provided under the stubbed sanitary milk and CIP cleaned lines.

2. The outside wall of the milkhouse, where the sanitary piping and concrete slab are located shall be properly maintained and kept in good repair.

3. The sanitary piping, stubbed outside the milkhouse, shall be properly sloped to assure complete drainage and the ends of the piping, which are located outside, shall be capped when the transfer hose is disconnected.

4. After the completion of milk transfer, the milk lines, and transfer hose shall be properly CIP cleaned.

5. After the CIP cleaning process has been completed; the transfer hose shall be disconnected, drained, and stored in the milkhouse. Proper storage of the transfer hose includes capping the ends and storing the entire hose up off the floor. The sanitary piping outside the milkhouse shall be capped at all times, except when transferring milk or being CIP cleaned. When the caps are not being used, they shall be properly cleaned and sanitized after each use and stored in the milkhouse to protect them from contamination. A transfer hose manufactured with permanent hose end fittings, attached in such a manner that will assure a crevice-free joint between the hose and the fitting, may be stored outside of the milkhouse, provided, it is CIP cleaned; the stubbed piping and hose length are of sufficient design to allow complete drainage after cleaning and sanitizing; and the hose remains connected to the stubbed piping when not in use.

6. Means shall be provided to sanitize the milk-contact surfaces of the transfer hose and bulk milk pickup tanker fittings prior to the connection of the transfer hose to the bulk milk pickup tanker.

7. At all times, the bulk milk pickup tanker manhole opening(s) shall remain closed, except for brief periods for sampling and examination, when environmental conditions permit.

8. Water under pressure is piped into the milkhouse.

9. Each milkhouse is provided with facilities for heating water in sufficient quantity and to such temperatures for the effective cleaning of all equipment and utensils (see Appendix C).

10. The milkhouse is equipped with a wash-and-rinse vat having at least two (2) compartments. Each compartment must be of sufficient size to accommodate the largest utensil or container used. The cleaning-in-place vat for milk pipelines and milk machines may be accepted as one part of the two-compartment vat; provided, the cleaning-in-place station rack in or on the vat and the milking machine inflations and appurtenances are completely removed from the vat during the washing, rinsing, and/or sanitizing of other utensils and equipment. Where CIP cleaning/re-circulated systems eliminate the need for hand washing of equipment, the presence of the second wash vat compartment may be optional, if so determined by the Health Officer on an individual basis. Hot and cold water is piped to each compartment.

11. A transportation tank may be used for cooling and/or storing 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. 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 Health Officer 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 Rule 420-3-16-.10(05), Administrative Procedures 13.

2. To assure continued protection of the milk, the milk tank truck manhole shall 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 7°C (45°F) or less. Electronic records that comply with Appendix H, IV, and V, Criteria 4, 7, 8, 9, 11, and 12 with or without hard copy, may be used in place of temperature-recording records (refer to the Note: on page 51). 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 records 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 Health Officer. 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 Health Officer.

6. The milk shall be sampled at the direction of the Health Officer, 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 Rule 420-3-16-.10(05), Administrative Procedures 13, overhead protection of the milk hose connection to the milk tank truck shall be provided.

Note: With the identified Criteria 4, 7, 8, 9, 11, and 12 cited within Appendix H, V, the words "dairy farm" shall be substituted for "milk plant" wherever the words "milk plant" appears.

1. The milkroom structure, equipment, and other milkroom facilities used in its operation or maintenance are clean at all times.

2. Incidental articles such as desks, refrigerators, and storage cabinets may be in the milkroom provided they are kept clean and ample space is available to conduct the normal operations in the milkroom and will not cause contamination of the milk.

3. Vestibules, if provided, are kept clean.

4. Animals and fowl are kept out of the milkroom.

1. There is at least one (1) flush toilet connected to a public sewer system or to an individual sewage-disposal system. Such sewage systems shall be constructed and operated in accordance with plans and instructions of the State Board of Health.

2. A toilet is convenient to the milking barn and the milkroom. There shall be no evidence of human defecation or urination about the premises.

3. No toilet opens directly into the milkroom.

4. The toilet room, including all fixtures and facilities, is kept clean and free of flies and odors.

5. Where flush toilets are used, doors to toilet rooms are tight and self-closing. All outer openings in toilet rooms shall be screened or otherwise protected against the entrance of insects.

6. All new or extensively remodeled barns must be provided with a flush type toilet connected to a public sewer or an individual sewage disposal system.

1. 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 safe, sanitary quality in order to avoid the contamination of milk utensils.

2. A polluted water supply used in the rinsing of the dairy utensils and containers may be more dangerous than a similar water supply which is used for drinking purposes only. Bacteria grows 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, grow in the milk, increase in such numbers as to cause disease when consumed.

1. The water supply for milkhouse and milking operations is approved as safe by the appropriate regulatory agency and, in the case of individual water systems, complies with the specifications outlined in Appendix D, and the bacteriological standards outlined in Appendix G.

2. No cross-connection exists 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 or 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 disinfection by pumping the 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 Appendix D).

7. Samples for bacteriological examination are taken upon the initial approval of the physical structure based upon the requirements of these rules; and when any repair or alteration of the water supply system has been made, and at least every three (3) 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 six (6) months apart. Whenever such samples indicate either the presence of E. coli bacteria or the coliform group or whenever the well casing, pump, or seal needs 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 paragraph; provided, that when water is hauled to the dairy farm, such water shall be sampled for bacteriological examination at the point of use and submitted to a laboratory at least four (4) times in separate months during any consecutive six (6) months. Bacteriological examinations shall be conducted in a laboratory acceptable to the Health Officer.

8. Current records of water test results shall be retained on file with the Health Department; provided, that when water is hauled to the dairy farm, such water shall be sampled for bacteriological examination at the point of use and submitted to a laboratory at least four (4) times in separate months during any consecutive six (6) months. Bacteriological examinations shall be conducted in a laboratory acceptable to the Health Officer. To determine if water samples have been taken at the frequency established in this section, the interval shall include the designated period plus the remaining days of the month in which the sample is due.

1. 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.

2. Milk pails of small-mouth design, known as hooded milk pails, decrease the possibility of hairs, dust, chaff, and other undesirable foreign substances getting into the milk at the time of milking.

1. All multi-use containers, equipment, and utensils which are exposed to milk or milk products, or from which liquids may drip, drain, or be drawn into milk or milk products, are made of smooth, impervious, nonabsorbent, safe materials of the following types:

2. Single-service articles have been manufactured, packaged, transported, and handled in a sanitary manner and comply with the applicable requirements of Rule 420-3-16-.10(11).

3. Articles intended for single-service use are not reused.

4. All containers, equipment, and utensils are free of breaks and corrosion.

5. All joints in such containers, equipment, and utensils are smooth and free from pits, cracks, or inclusions.

6. Cleaned-in-place milk pipelines and return-solution lines are self-draining. If gaskets are used, they shall be self-positioning and of material meeting specifications described in 1.(iv) above 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. All interior surfaces of welded joints in pipelines shall be smooth and free of pits, cracks, and inclusions.

7. Detailed plans for cleaned-in-place pipeline systems are submitted to the Health Officer for written approval prior to installation. No alteration or addition shall be made to any milk pipeline system without prior written approval of the Health Officer.

8. Strainers, if used, are of perforated metal design or so constructed as to utilize single-service strainer media.

9. Seamless hooded pails having an opening not exceeding one-third the area of that of an open pail of the same size are used for hand milking and hand stripping.

10. All milking machines, including heads, milk claws, milk tubing, and other milk-contact surfaces can be easily cleaned and inspected. Pipelines, milking equipment, and appurtenances, which require a screwdriver or special tool, shall be considered easily accessible for inspection providing the necessary tools are available at the milkhouse. Milking systems shall not have components incorporated in the return solution lines, which by design do not comply with the criteria for product-contact surfaces. Some examples of these are:

11. Milk cans have umbrella-type lids.

12. Farm holding-cooling tanks, welded sanitary piping, and transportation tanks comply with the applicable requirements of Rule 420-3-16-.10(10) and 420-3-16-.1 0 (11).

13. During filling, flexible plastic/rubber hoses may be used between the fill valves of bottom fill and top fill bulk milk storage tanks, when needed for functional purposes. Such hoses shall be drainable, be as short as practical, have sanitary fitting, 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 assure a crevice-free joint between the hose and the fitting, which can be cleaned by mechanical means. The hoses shall be included as part of a CIP cleaning system.

14. Transparent flexible plastic tubing (up to 150 feet in length) used in connection with milk transfer stations shall be considered acceptable if it meets the "3-A Sanitary Standards for Multiple-Use Plastic Materials Used as Product Contact Surfaces for Dairy Equipment, Number 20#" and if it remains sufficiently clear that the interior surfaces can be properly inspected. Short lengths of flexible plastic tubing (8 feet or less) may be inspected for cleanliness by sight or by use of a "rod." The transparency or opacity of such tubing under this condition is not a factor in determining cleanliness.

15. AMIs shall comply with all applicable PMO requirements and/or 3-A Standards.

1. There shall be a separate wash manifold for all CIP cleaned milk pipelines in all new or extensively remodeled facilities.

2. The product-contact surface of all multi-use containers, equipment, and utensils used in the handling, storage or transportation of milk are cleaned after each milking or once every twenty-four (24) hours for continuous operations.

3. There shall not be any partial removal of milk from milk storage/holding tanks by the bulk milk hauler/sampler, except partial pickups may be permitted when the milk storage/holding tank is equipped with a seven (7) day recording device complying with the specifications of Appendix H or other recording device acceptable to the Health Officer, provided the milk storage/holding tank shall be clean and sanitized when empty and shall be emptied at least every seventy-two (72) hours. In the absence of a temperature-recording device, partial pickups may be permitted as long as the milk storage/holding tank is completely empty, clean, and sanitized prior to the next milking. In the event of an emergency situation, such as inclement weather, natural disaster, etc., a variance may be permitted at the discretion of the Health Officer.

1. Complete immersion in hot water at a temperature of at least 170°F (77°C) for at least five (5) minutes or exposure to a flow of hot water at a temperature of at least 170°F (77°C) as determined by use of a suitable accurate thermometer (at the outlet) for at least five (5) minutes.

2. Certain chemical compounds are effective for the sanitization of milk utensils, containers, and equipment. These are contained in 40 CFR 180.940 and shall be used in accordance with label directions or the electro-chemical activation (ECA) device manufacturer's instructions, if produced onsite in accordance with Appendix F for further discussion of approved sanitizing procedures.

1. Proper location of equipment.

2. Proper drainage of equipment.

3. Adequate and properly located lighting and ventilation.

1. All milk containers, utensils, and equipment, including milking machine vacuum hoses, are stored in the milkhouse in a sanitizing solution or on racks until used. Milk pipelines and 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 mechanical cleaning and other equipment as accepted by FDA, which meet these criteria may be mechanically cleaned, sanitized, and stored in the milking barn or parlor, provided this equipment is designed, installed, and operated to protect the product and solution contact surface from contamination at all times. Some of the parameters to be considered in determining protection are proper location of equipment, proper drainage of equipment, and adequate and properly located lighting and ventilation. The milking barn or parlor must be used only for milking. Concentrates may be fed in the barn during milking, but the barn shall not be used for the housing of animals. When manual cleaning of product-contact surfaces is necessary, the cleaning shall be done in the milkhouse.

2. Means are provided to effect complete drainage of equipment when such equipment cannot be stored to drain freely.

3. Clean cans or other containers are stored in the milkhouse within a reasonable time after delivery to the dairy farm.

4. Strainer pads, parchment papers, gaskets, and similar single-service articles are stored in a suitable container or cabinet and protected against contamination.

1. Sanitized product-contact surfaces, including farm cooling holding tank openings and outlets, are protected against contact with unsanitized equipment and utensils, hands, clothing, splash, condensation, and other sources of contamination.

2. Any sanitized product-contact surface which has been otherwise exposed to contamination is again cleaned and sanitized before being used.

1. Milking is done in a milking barn or parlor.

2. Brushing is completed prior to milking.

3. Flanks, bellies, tails, and udders are clipped as often as necessary to facilitate cleaning of these areas and are free from dirt. The hair on the udders shall be of such length that it is not incorporated with the teat in the inflation during milking.

4. Udders and teats of all milking animals are clean and dry before milking. Teats shall be cleaned, treated with a sanitizing solution, and dry just prior to milking. Provided that the sanitizing of teats shall be required if the udder is dry and the teats have been thoroughly cleaned (not dry wiped) and dried (manually wiped dry) prior to milking. The determination of what constitutes a dry udder and cleaned and dried teats shall be made by the Health Officer.

Note: Additional alternative udder preparation methods may also be used once they have been evaluated by FDA and found acceptable.

5. Wet hand milking is prohibited.

1. Milk stools are not padded and are constructed to be easily cleaned.

2. Milk stools, surcingles, and anti-kickers are kept clean and are stored above the floor in a clean place in the milking barn, parlor, or milkhouse when not in use.

1. Milk shall not be strained, poured, transferred, or stored unless it is properly protected from contamination.

2. After sanitization, all containers, utensils, and equipment shall be handled in such a manner as to prevent the contamination of any milk product-contact surface.

3. 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 any substance capable of contaminating the milk shall not be transported with the milk.

1. Equipment and operations are so located within the milking barn and milkhouse as to prevent overcrowding and contamination of cleaned and sanitized containers, equipment, and utensils by splash, condensation, or manual contact.

2. During processing, pipelines and equipment used to contain or conduct milk and milk products shall be effectively separated from tanks or circuits containing cleaning and/or sanitizing solutions.

3. All milk which has overflowed, leaked, been spilled, or improperly handled is discarded.

4. All product-contact surfaces of containers, equipment, and utensils are covered or otherwise protected to prevent the access of insects, dust, condensation, and other contamination. All openings, including valves and piping attached to milk storage and transport tanks, pumps, or vats shall be capped or otherwise properly protected. Gravity type strainers used in the milkhouse do not have to be covered. Milk pipelines used to convey milk from pre-coolers to the farm bulk tank must be fitted with effective drip deflectors.

5. The receiving receptacle is raised above the floor (as on a dolly or cart) or placed at a distance from the lactating animals to protect it against manure and splash when milk is poured and/or strained in the milking barn. Such receptacle shall have a tight-fitting cover, which shall be closed except when milk is being poured.

6. Each pail or container of milk is transferred immediately from the milking barn, stable, or parlor to the milkhouse.

7. Pails, cans, and other equipment containing milk are properly covered during transfer and storage.

8. Whenever air under pressure is used for the agitation or movement of milk or is directed at a milk-contact surface, it is free of oil, dust, rust, excessive moisture, extraneous materials, and odor, and shall otherwise comply with the applicable standards of Appendix H.

9. Sanitized product-contact surfaces, including bulk milk tank openings and outlets, are protected against contact with unsanitized utensils and equipment, hands, clothing, splash, condensation, and other sources of contamination.

10. Any sanitized product-contact surface, which has been otherwise exposed to contamination, is again cleaned and sanitized before being used.

11. Vehicles used to transport milk from the dairy farm to the milk plant, receiving station, or transfer station are constructed and operated to protect their contents from sun, freezing, and contamination.

12. Vehicles have bodies with solid enclosures and tight, solid doors.

13. Vehicles are kept clean, inside and out.

14. No substance capable of contaminating milk is transported with the milk (refer to Items 10 and 11 and Appendix B for information on the construction of milk tank trucks).

1. The name and address of the manufacturer or distributor (for O.T.C. medicinals/drugs) or veterinary practitioner dispensing the product (for Rx and extra-label use medicinals/drugs) and, if the drug is dispensed by a pharmacy on the order of a veterinarian, the labeling shall include the name of the prescribing veterinarian and the name and address of the dispensing pharmacy, and may include the address of the prescribing veterinarian.

2. Directions for use and prescribed holding times.

3. Cautionary statements, if needed.

4. Active ingredient(s) in the drug product.

5. 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. Medicinals/drugs intended for treatment of non-lactating dairy animals are segregated from those medicinals/drugs used for lactating animals (separate shelves in cabinets, refrigerators, or other storage facilities satisfied this item).

Note: Topical antiseptics, wound dressings, (unless intended for direct injection into the teat) vaccines, and other biologies and dosage form vitamins and/or mineral products are exempt from labeling and storage requirements, 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.

1. Handwashing facilities are located in the milkhouse and in/or convenient to the milking barn, parlor, or flush toilet.

2. Handwashing facilities include soap or detergent, hot and cold running water, individual sanitary towels, and a lavatory fixture. Utensil wash and rinse vats shall not be considered as handwashing facilities.

1. Hands are 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.

2. Milkers, milk haulers, or samplers wear clean outer garments while milking or handling milk, milk containers, utensils, or equipment.

1. Milk produced by disease-free animals and under clean conditions usually contains relatively few bacteria immediately after milking. These multiply to enormous numbers in a few hours unless the milk is cooled. When the milk is cooled quickly to 45°F (7°C) or less, there is only a slow increase in numbers of bacteria. In order to understand this, it is necessary to recall merely that bacteria are actually infinitesimal plants and that most plants do not grow in cold weather.

2. 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 dairyman or Health Officer to be absolutely sure that no disease bacteria have entered the milk even though observance of the other items of these rules will greatly reduce this likelihood. The likelihood of transmitting disease is much increased then 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 will not multiply.

1. Raw milk for pasteurization is cooled to 10°C (50°F) or less within two (2) hours of the commencement of the first milking; provided that the blend temperature after the first milking and subsequent milkings does not exceed 10°F (50°F).

2. Recirculated cold water which is used in plate or tubular coolers or heat exchanges is from a safe source and protected from contamination. Such water shall be tested semi-annually and shall comply with the current bacteriological standards established by the EPA for drinking water.

3. All farm bulk tanks manufactured after January 1, 2000, shall be equipped with an approved temperature-recording device.

1. Vehicles used to transport milk from the dairy farm to the milk plant or receiving station are constructed and operated to protect their contents from the sun, freezing, and contamination.

2. Vehicles have bodies with solid enclosures and tight, solid doors.

3. Vehicles are kept clean inside and out.

4. No substance capable of contaminating the milk is transported with the milk.

Note: See Rule 420-3-16-.09 ( 9) and 420-3-16-.09(10) for information on the construction of bulk milk pickup tankers.

1. Surroundings are kept neat, clean, and free of conditions which might harbor or be conducive to the breeding of insects and rodents. Manure shall be spread directly on the fields or stored for not more than four (4) days in a pile on the ground surface and then spread on the fields or stored for not more than seven (7) days in a impervious-floored bin or on an impervious-curbed platform and then spread or stored in a tight-screened and trapped manure shed or effectively treated with larvicides or disposed of in any other manner which controls insect breeding.

2. Manure packs in loafing areas, stables without stanchions, pen stables, resting barns, wandering sheds, and free-stall housing are properly bedded and managed to prevent fly breeding.

3. Milkrooms are free of insects and rodents.

4. Milkrooms are effectively screened or otherwise protected against the entrance of vermin.

5. Outer milkhouse doors are tight and self-closing. Screen doors shall open outward.

6. Effective measures are taken to prevent the contamination of milk, containers, utensils, and equipment by insects and rodents, and by chemicals used to control such vermin. Insecticides and rodenticides not approved for use in the milkhouse shall not be stored in the milkhouse.

7. Only insecticides and rodenticides approved for use by the Health Officer and/or registered with the EPA are used for insect and rodent control (see Appendix C).

8. Insecticides and rodenticides are used only in accordance with the manufacturer's label directions and are used so as to prevent the contamination of milk, milk containers, equipment, utensils, feed, and water.

9. Covered boxes, bins, or separate storage facilities for ground, chopped, or concentrated feeds are provided.

10. Feed may be stored in the milking portion of the barn only in such a manner as will not attract birds, insects, or rodents. Open feed dollies or carts may be used for distributing the feed, but not storing feed, in the milking barn. Feed dollies, carts, fully automated feeding systems, or other feed containers, may be exempt from the use of covers, provided they do not attract birds, insects, or rodents.

Note: A convenient inspection form for producer dairy farms which summarizes the applicable sanitation requirements is found in Appendix M.