Chapter General §101. Definitions [formerly paragraph 1: 001]


§2105. General Requirements



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§2105. General Requirements

A. In addition to the requirements for dairy plants, all dairy plants that condense, concentrate, dry or blend dry dairy products shall conform with the additional requirements contained in this Subchapter.

B. Pasteurization, ultra-pasteurization or aseptic processing shall be performed in accordance with the requirements for pasteurization or ultra-pasteurization contained in the PMO.

C. In all cases, pasteurization, ultra-pasteurization or aseptic processing of raw milk, raw milk products, whey or whey products shall be performed before any raw milk, raw milk products, whey or whey products enter the evaporator, reverse-osmosis, ultra-filtration or condensing equipment and shall be performed in the plant in which the evaporation or condensing is done.

D. All condensed/concentrated milk transported to a dairy products drying plant shall be re-pasteurized at the plant at which it is dried. When condensed whey contains at least 40 percent total solids and has been partially crystallized by cooling, it may be transported to a separate drying plant for drying without re-pasteurization provided, the following conditions are complied with:

1. The condensed/concentrated, partially crystallized whey shall be cooled and maintained at 7C (45F) or less;

2. Milk transport tanks used to transport the condensed/concentrated, partially crystallized whey shall be cleaned and sanitized prior to filling and are sealed after filling until unloaded; and,

3. Separate unloading pumps and pipelines shall be provided and used only for the unloading of the condensed/concentrated, partially crystallized whey. Such pumps and pipelines shall be cleaned and sanitized as a separate cleaning circuit.

E. All monitoring devices, such as metal detectors, etc., shall be calibrated at the frequency recommended by the manufacturer with the concurrence of the FDA.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2699 (September 2011).

§2107. Cleaning and Sanitizing of Containers and Equipment

A. The product contact surfaces of all multi-use containers and equipment used in the processing, drying, storing, handling and transporting of milk, milk products, dairy products, whey, whey products, condensed or dry milk and buttermilk shall be properly cleaned and sanitized before each use. Each dairy plant that condenses, concentrates, dries or blends dry dairy products shall develop and implement effective cleaning and sanitizing programs based upon the recommendations of the manufacturer of the equipment and the recommendations contained in the PMO, Appendix F. Each dairy plant handling dry or blended dry dairy products shall be equipped with a heavy duty industrial type vacuum cleaner, so designed as not to recontaminate the atmosphere for cleaning areas in which powder accumulates.

B. Non-product contact surfaces of utensils and equipment shall be kept clean.

C. Effective cleaning and sanitizing regimen instructions, including solution mixing directions, solution strength requirements, testing and recording procedures, temperature requirements, circulation times and all other pertinent information necessary to properly clean and sanitize equipment, shall be posted adjacent to all equipment used in cleaning and sanitizing dairy equipment.

D. The posted procedures and instructions shall be followed in the cleaning and sanitization of dairy equipment.

E. Storage tanks shall be cleaned and sanitized when emptied and shall be emptied at least every 72 hours provided, that the state health officer may with the concurrence of FDA authorize an interval greater than 72 hours, determined on a case by case basis.

F. Drying equipment, blending equipment, cloth-collector systems, packaging equipment and multi-use dry dairy products and dry whey storage containers shall be cleaned at intervals and by methods recommended by the manufacturer or the PMO, Appendix F and approved by the state health officer. Such methods may include cleaning without water by use of vacuum cleaners, brushes or scrapers; such equipment and brushes shall be used exclusively for cleaning product contact surfaces. After cleaning, such equipment is sanitized by a method approved by the state health officer. Cloth collector systems and all dry product contact surfaces downstream from the dryer shall be sanitized or purged at intervals and by methods recommended by the manufacturer and approved by the state health officer. Sanitary single service outer clothing and shoe covers shall be provided for personnel and worn exclusively when it is necessary to enter the interior of the dryer to perform the cleaning operation.

G. Storage bins or totes used to transport dry products shall be dry cleaned after each usage and wet-cleaned and sanitized at regular intervals.

H. Pipelines and equipment designed for mechanical cleaning shall meet the following requirements:

1. operating instructions shall be posted near the cleaning equipment and shall be followed;

2. a temperature recording device, complying with the requirements contained in the PMO or a recording device which has been approved by the FDA and found to provide sufficient information to adequately evaluate the cleaning and sanitizing regimen and which is approved by the state health officer, shall be installed in the return solution line or other appropriate area to record the temperature and time during which the line or equipment is exposed to cleaning and sanitizing solutions;

3. pipelines and equipment designed for automated mechanical cleaning of evaporators shall have a pH recording device in the return lines to record the pH and time which the line or equipment is exposed during cleaning and sanitizing operations. These charts shall be identified, dated and initialed by the operator and maintained for three months;

4. temperature and pH recording charts shall be signed, dated and retained for three months;

5. during each inspection, the state health officer shall examine and initial a representative sample of each type of temperature recording charts to verify the time of exposure to solutions and their temperatures.

I. All multi-use containers, equipment, and utensils shall be sanitized before use, employing one or a combination of the following methods or any other method which has been demonstrated to be equally efficient and has been approved by the state health officer:

1. exposure to an enclosed jet of steam for not less than one minute;

2. complete immersion in hot water at a temperature of at least 77C (170F), for at least five minutes or exposure to a flow of hot water at a temperature of at least 77C (170F), as determined by use of a suitable accurate thermometer located at the outlet, for at least five minutes;

3. exposure to hot air at a temperature of at least 83C (180F) for at least 20 minutes as measured by an acceptable indicating thermometer located in the coldest zone;

4. complete immersion for at least one minute in, or exposure for at least one minute to a flow of a chemical sanitizer of acceptable strength. All product-contact surfaces must be wetted by the sanitizing solution, and piping so treated must be filled. Sanitizing sprays may be used. Chemical solutions, once used, shall not be reused for sanitizing but may be reused for other purposes approved by FDA. Assembled equipment shall be sanitized prior to each day’s run;

5. All thermometers and temperature recorders shall be calibrated at least once every three-month period and a log identifying the thermometers calibrated, date and the initials of the person performing the calibration shall be maintained and made available to the state health officer; and

6. All other monitoring devices and equipment such as metal detectors, etc., shall be calibrated at the frequency recommended by the manufacturer and a log identifying the device or equipment calibrated, date calibrated, the name and initials of the person performing the calibration shall be maintained and made available to the state health officer.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2699 (September 2011).

§2109. Packaging and Container Filling

A. The filling of condensed and dry dairy product containers shall be done only by mechanical equipment and by methods which preclude contamination.

B. Approval in writing by the state health officer, shall be obtained prior to the installation, operation or modification of any such equipment.

C. Dry dairy products shall be packaged in unused single service containers, which protect the contents from contamination. These containers shall be obtained from a source approved by the state health officer and after packaging shall be stored in a sanitary manner.

D. Condensed and dry dairy product containers shall be stored in a sanitary manner.

E. Condensed and dry dairy products may be transported from one plant to another for further processing or packaging, provided that the products are transported in sealed containers whose construction conforms with 3-A Standards.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2700 (September 2011).

§2111. Container Closure, Sealing and Storage

A. Closing or sealing of dry dairy products shall be done in a sanitary manner.

B. The closing and sealing of containers of sizes of 6 gallons (net contents) or less shall be done in mechanical equipment, approved by the state health officer, using methods which preclude product contamination.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2700 (September 2011).

§2113. Cooling of Milk, Milk Products, Whey, Whey Products, and Condensed Dairy Products

A. All raw milk and dairy products shall be maintained at 7C (45F) or less until processed except that acid-type whey with a titratable acidity of 0.40 percent or above, or a pH of 4.6 or below, is exempted from these temperature requirements.

B. All whey and whey products for condensing or drying shall be maintained at a temperature of 7C (45F) or less; or 57C (135F) or greater until processed. Storage tanks containing whey and whey products above 7C (45F) and below 57C (135F) shall be emptied, cleaned and sanitized after each four hours of use or less.

1. Whey and whey products in balance (constant level) tanks or hot wells may be allowed to remain at temperatures above 7C (45F) and below 57C (135F) for a period not to exceed four hours.

2. The balance tank or hot well shall be emptied, cleaned and sanitized at least once each four hours of operation.

3. Whey and whey products in balance tanks or hot wells that are maintained at temperatures of 57C (135F) or above are exempt from the four hour cleaning and sanitizing requirement as long as a continuous flow is maintained (with a retention time not to exceed one hour). All such balance tanks or hot wells shall be cleaned and sanitized at least once every 24 hours.

C. All pasteurized milk and dairy products (including pasteurized whey and condensed dairy products), except those to be dried immediately, shall be cooled immediately in approved equipment to a temperature of 7C (45F) or less. All pasteurized milk and dairy products (including pasteurized whey and condensed dairy products), shall be stored at a temperature of 7C (45F) or less and be maintained thereat until further processing. Whenever pasteurized milk and dairy products are to be condensed and/or dried and storage tanks are used between the condenser and dryer, any such storage tank(s) containing pasteurized milk or milk products (including pasteurized whey and condensed dairy products), stored above 7°C (45°F) and below 57°C (135°F) shall be completely emptied, cleaned, and sanitized after four hours of operation or less.

D. All indicating and recording thermometers shall be calibrated at least once each three-month period and a log indicating each thermometer and recorder calibrated and the initials of the person performing the calibration shall be maintained and made available to the state health officer.

E. All condensed whey and whey products shall be cooled during the crystallization process to 7C (45F) or less, within 72 hours of condensing including the filling and emptying time, unless filling occurs above 57°C (135°F), in which case, the 72 hour time period begins when the cooling is started.

F. Each refrigerated room in which milk , dairy products or whey are stored shall be equipped with an indicating thermometer approved by the state health officer. Such thermometer shall be located in the warmest zone of the refrigerator room.

G. Each storage tank shall be equipped with an indicating thermometer, the sensor of which shall be located to permit the registering of the temperature of the contents when the tank contains no more than 20 percent of its calibrated capacity.

H. All surface coolers shall comply with the following specifications:

1. The section of open-surface coolers shall be so installed as to leave a gap of at least 6.4 millimeters (0.25 inch) between the header sections to permit easy cleaning;

2. Where header ends are not completely enclosed within the cooler covers, condensation or leakage from the headers shall be prevented from entering the product by so shaping the exposed header faces, above and below all gaps, that condensation is directed away from the tubes, and by using deflectors at the bottom of the headers, or by shortening the bottom trough or by some other approved method;

3. The location of supports of cooler sections shall prevent drip from entering the milk or dairy products ; and,

4. All open surface coolers shall be provided with tight-fitting shields which protect the product from contamination by flies, dust, drip, splash or manual contact.

I. Re-circulated cooling water which is used in coolers and exchangers, including those systems in which a freezing point depressant is used, shall be from a safe source and protected from contamination. Such water shall be tested at the minimum frequencies specified in §2117 of this Part and shall otherwise comply with the requirements of §2117 of this Part. Re-circulated water systems which become contaminated through repair work or otherwise shall be properly treated and tested before being returned to use. Freezing point depressants, when used in re-circulating systems, shall be non-toxic.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2700 (September 2011).

§2115. Separate Rooms

A. There shall be separate rooms for:

1. pasteurizing, processing, cooling, condensing, drying and blending of milk, dairy products, whey, whey products, buttermilk or condensed products;

2. packaging or filling of bulk bins, drums, bags or other bulk containers;

3. hopper or dump room for the transfer of bulk dry dairy products from bags or drums to the hoppers or conveyors which lead to the container fillers;

4. repackaging room for the filling of small packages with dry dairy products from bulk containers;

5. cleaning of milk cans and containers and dry product containers;

6. receiving cans of milk and dairy products in plants receiving cans of milk;

7. receiving milk, cleaning and sanitizing milk tank trucks in plants receiving milk or whey in tank trucks; and

8. boilers and other non-processing mechanical equipment and shop areas.

B. Rooms in which milk, dairy products, whey or whey products are handled, processed, stored, dried, condensed or in which containers, utensils and equipment are cleaned or stored, shall not open directly into any stable, farmstead or area in which meat, poultry or any non-dairy foods of animal origin are handled or stored or any room used for domestic purposes.

C. All rooms shall be of sufficient size for their intended purposes.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2701 (September 2011).

§2117. Reclaimed Waterdp

A. Condensing water for dairy product evaporators, and water used to produce vacuum or to condense vapors in vacuum heat processing equipment, shall be from a source complying with §925.B.1 of this Part. Provided, that when approved by the state health officer, water from sources not complying with §925.B.1 of this Part may be used when the condenser or vacuum heat equipment is constructed and operated to preclude contamination of such equipment, or its contents, by condensing water or by water used to produce vacuum. Means of preventing such contamination include:

1. use of a surface type condenser in which the condensing water is physically separated from the vapors and condensate; or

2. use of reliable safeguards to prevent the overflow of condensing water from the condenser into the evaporator. Such safeguards include a barometric leg extending at least 35 feet vertically from the invert of the outgoing condensing water line to the free level at which the leg discharges, and/or a safety shutoff valve, located on the water feed line to the condenser, automatically actuated by a control which will shutoff the in-flowing water when the water level rises above a predetermined point in the condenser. This valve may be actuated by water, air or electricity, and shall be designed so that failure of the primary motivating power will automatically stop the flow of water into the condenser.







VACUUM PAN DETAIL
(For Informational Purposes Only)


FIGURE 2117.A


BAROMETRIC LEG DETAIL (For Informational Purposes Only)

FIGURE 2117.A.2

B. Condensing water for dairy product evaporators complying with this Section and water reclaimed from milk or dairy products may be reused when all necessary means of protection are afforded and it complies with the procedures outlined in this Part and the PMO.

C. Reclaimed waterdp shall comply with the following requirements:

1. Reclaimed waterdp shall comply with the bacteriological standards of Appendix G, Section I of the PMO.

2. Samples of reclaimed waterdp shall be collected daily for two weeks following initial approval of the installation and semi-annually thereafter, provided, that daily tests shall be conducted for one week following any repairs or alterations to the system.

3. The organic content of reclaimed waterdp shall be less than 12.0 milligrams per liter as measured by the chemical oxygen demand or permanganate consumed test; or a standard turbidity of less than 5.0 units.

4. Automatic fail-safe monitoring devices shall be used to monitor and automatically divert to the sewer any reclaimed waterdp which exceeds the standards.

5. The reclaimed waterdp shall be of satisfactory organoleptic quality and shall have no off-flavors, odors or slime formations.

6. The reclaimed waterdp shall be sampled and tested organoleptically at weekly intervals.

7. Approved chemicals, such as chlorine, with suitable detention period may be used to suppress the development of bacterial growth and prevent the development of tastes and odors in reclaimed waterdp.

8. The addition of approved chemicals shall be by an automatic proportioning device prior to the reclaimed waterdp entering the storage tank to assure satisfactory quality reclaimed waterdp in the storage tank at all times.

9. When chemicals are added, a daily testing program for such added chemicals shall be in effect and shall not add substances that will prove deleterious to use of the reclaimed waterdp or contribute to product contamination.

10. The storage vessel shall be properly constructed of such material that it will not contaminate the reclaimed waterdp and can be satisfactory cleaned.

11. The distribution system within a plant for such reclaimed waterdp shall be a separate system with no cross-connections to a municipal or private water system or any other potable water distribution system.

12. All physical, chemical, radiological and microbiological tests on the reclaimed waterdp shall be conducted in accordance with the latest edition of Standard Methods for the Examination of Water and Wastewater.

D. When §2117.C.1 through §2117.C.12 of this Section are satisfied and documented, reclaimed waterdp may be used for the following limited applications:

1. pre-rinsing of the product contact surfaces where pre-rinses will not be used in food products; and,

2. cleaning solution make-up water; provided that for either of these uses, the following additional items are complied with:

a. there is no carry-over of reclaimed waterdp from one day to the next, and any reclaimed waterdp collected is used promptly or the temperature of all reclaimed waterdp in the storage and distribution system is maintained at 63C (145F) or higher by automatic means; or, the reclaimed waterdp is treated with a suitable, approved chemical to suppress bacterial propagation by means of an automatic proportioning device, prior to the reclaimed waterdp entering the storage tank;

b. distribution lines and hose stations are clearly identified in accordance with LAC 51:XIV.607 as limited use reclaimed waterdp;

c. water handling practices and guidelines are clearly described and prominently displayed at appropriate locations within the plant; and

d. these water lines are not permanently connected to product vessels, without a break to the atmosphere and sufficient automatic controls, to prevent the inadvertent addition of this water to product streams.

E. Reclaimed waterdp may be used as boiler feed-water for boilers which are not used for generating culinary steam, or in a thick, double walled, enclosed heat exchanger.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2701 (September 2011), amended LR 38:2793 (November 2012).

§2119. Air for Dairy Product Drying Equipment and Air under Pressure-Direct Contact with Milk and Dairy Products or Milk and Dairy Product Contact Surfaces

A. Air for dairy product drying equipment shall conform with the following:

1. Air intake and pipeline filters shall consist of fiberglass with downstream backing dense enough to prevent fiberglass break off from passing through, cotton flannel, wool flannel, spun metal, electrostatic material, or other equally acceptable filtering media, which do not release to the air toxic volatiles or other contaminants or volatiles which may impart any flavor or odor to the product. Disposable media filters shall consist of cotton flannel, wool flannel, spun metal, non-woven fabric, United States Pharmacopeia (USP) absorbent cotton fiber, or suitable inorganic materials which, under conditions of use, are non-toxic and non-shedding. Chemical bonding material contained in the media shall be non-toxic, non-volatile, and insoluble under all conditions of use. Disposable media shall not be cleaned and reused.

2. The efficiency of the initial or primary supply air filters for air which will be heated before it comes in contact with non-food contact surfaces shall be designed, selected to operate at a face velocity, and installed in a manner which will allow the filter manufacturer’s rating to be 90 percent or higher, when tested in accordance with the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Synthetic Dust Arrestance test (ASHRAE Standard 52.1-1992). The efficiency of the initial or primary supply air filters for air, which will not be heated before it comes in contact with non-food contact surfaces shall be of a design, selected to operate at a face velocity, and installed in a manner which will allow the filter manufacturer’s rating to be 85 percent or higher when tested in accordance with the ASHRAE Atmospheric Dust Spot Method (ASHRAE Standard 52.1-1992).

3. Air-intakes for drying equipment shall be located so as to minimize atmospheric contamination and shall be equipped with suitable single-service filters or multi-use systems approved by the state health officer.

B. Air under pressure which comes into direct contact with milk or dairy products or milk or dairy product contact surfaces shall comply with §929.I of this Part and the following:

1. Air intake and pipeline filters shall consist of fiberglass with downstream backing dense enough to prevent fiberglass break off from passing through, cotton flannel, wool flannel, spun metal, electrostatic material, or other equally acceptable filtering media, which do not release to the air toxic volatiles or other contaminants or volatiles which may impart any flavor or odor to the product. Disposable media filters shall consist of cotton flannel, wool flannel, spun metal, non-woven fabric, USP absorbent cotton fiber, or suitable inorganic materials which, under conditions of use, are non-toxic and non-shedding. Chemical bonding material contained in the media shall be non-toxic, non-volatile, and insoluble under all conditions of use. Disposable media shall not be cleaned and reused.

2. The efficiency of the initial or primary supply air filters for air which will be heated before it comes in contact with milk or dairy products or milk or dairy product contact surfaces shall be designed, selected to operate at a face velocity, and installed in a manner which will allow the filter manufacturer’s rating to be 90 percent or higher, when tested in accordance with the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Synthetic Dust Arrestance test (ASHRAE Standard 52.1 - 1992). The efficiency of the initial or primary supply air filters for air, which will not be heated before it comes in contact with milk or dairy products or milk or dairy product contact surfaces shall be of a design, selected to operate at a face velocity, and installed in a manner which will allow the filter manufacturer’s rating to be 85 percent or higher when tested in accordance with the ASHRAE Atmospheric Dust Spot Method (ASHRAE Standard 52.1 - 1992).

3. Air which will come into direct contact with milk or dairy products or milk or dairy product contact surfaces shall first pass through the initial or primary supply air filters meeting the requirements of Paragraph 2 of this Subsection. The initially filtered air in the pipeline downstream from the initial or primary supply air filters shall be used as the supply air for downstream (secondary) air filters on the air pipeline. The efficiency of such secondary air filters shall be at least 98 percent in accord with the Society of Automotive Engineers (SAE) Standard J726 - June 1987 using the Air Cleaner (AC) coarse test dust. All air that comes into direct contact with milk or dairy products or milk or dairy product contact surfaces shall additionally pass through further downstream (tertiary) air filters on the air pipeline. The filter efficiency of the final filter before coming into direct contact with milk or dairy products or milk or dairy product contact surfaces shall be at least 99 percent as measured by the Dioctylphthalate Fog Method (DOP) test (with a mean particle diameter of 0.3 microns) per Military Standard 282 (MIL-STD-282: Method 102.9.1). When commercially sterile air is required, the final filter efficiency shall be at least 99.99 percent as measured by the DOP test.

C. Air exhausts from dryer systems shall be covered when dryers are not in operation.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2905 (September 2011).



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