Chapter 19 Appendices

Appendix 1 Culinary Steam

"Culinary steam" refers to steam used in direct contact with milk and dairy products.

The following dairy plant uses are examples of processes requiring culinary type steam:

  1. Steam injection into product hot wells for production of evaporated milk, sweetened condensed milk, dry milk powders, etc.
  2. Making ricotta or cottage type cheeses with direct steam injection.
  3. Steam injection into the heating chamber of "vacreator" or similar continuous pasteurizing or sterilizing equipment.
  4. For direct heating of cheese in a process cheese cooker.
  5. For direct injection heating of water to be recirculated in a continuous type mozzarella curd mixer.
  6. For direct injection heating of water to be added to melted butter in melting vats or at the separator during the manufacture of butter oil.
  7. Any similar heating application where appreciable amounts of steam contact the product.

The following methods and procedures will provide steam of culinary quality for use in the processing of milk and milk products.

Source of Boiler Feed Water

Potable water or water supplies, acceptable to the regulatory agency, will be used.

Feed Water Treatment

Feed waters may be treated, if necessary, for proper boiler care and operation. Boiler feed water treatment and control shall be under supervision of trained personnel or a firm specializing in industrial water conditioning. Such personnel shall be informed that the steam is to be used for culinary purposes. Pretreatment of feed waters for boilers or steam generating systems to reduce water hardness, before entering the boiler or steam generator by ion exchange or other acceptable procedures, is preferable to the addition of conditioning compounds to boiler waters. Only compounds complying with regulations may be used to prevent corrosion and scale in boilers, or to facilitate sludge removal.

Greater amounts shall not be used of the boiler water treatment compounds than the minimum necessary for controlling boiler scale or other boiler water treatment purposes. No greater amount of steam shall be used for the treatment and/or pasteurization of milk and milk products than necessary.

It should be noted that tannin, which is also frequently added to boiler water to facilitate sludge removal during boiler blowdown, has been reported to give rise to odour problems. and should be used with caution.

Boiler compounds containing cyclohexylamine, morpholine, octadecylamine, diethylaminoethanol, trisodium nitrilotriacetate, and hydrazine are not be permitted for use in steam in contact with milk and milk products.

Boiler Operation

A supply of clean, dry saturated steam is necessary for proper equipment operation. Boilers and steam generation equipment shall be operated in such a manner as to prevent foaming, priming, carryover and excessive entrainment of boiler water into the steam. Carryover of boiler water additives can result in the production of milk off-flavours. manufacturer's instructions regarding recommended water level and blow-down should be consulted and rigorously followed. The blow-down of the boiler should be carefully watched, so that an over-concentration of the boiler solids and foaming is avoided. It is recommended that periodic analysis be made to condensate samples. Such samples should be taken from the line between the final steam separating equipment and the point of the introduction of steam into the product.

Piping Assemblies

See illustrations on page 27-App. 1-3 for suggested piping assemblies for steam infusion or injection.  Other assemblies which will assure a clean, dry saturated steam are acceptable.

Note: For additional details, see 3 A Accepted Practices for a Method of Producing Steam of Culinary Quality, Number 609-01.

Click on Image for Larger View

Image - Culinary Steam Piping Assembly for Steam Infusion or Injection
Description of image - Culinary Steam Piping Assembly for Steam Infusion or Injection

Click on Image for Larger View

Image - Culinary Steam Piping Assembly for Airspace Heating or Defoaming
Description of image - Culinary Steam Piping Assembly for Airspace Heating or Defoaming
  • Grade "A" Pasteurized Milk Ordinance 1993
  • U.S. Department of Health and Human Services
  • Public Health Service, Food and Drug Administration

Appendix 2 Compressed Air - Milk and Milk Product Contact Surfaces

Material

Filter Media
Air intake and pipeline filters shall consist of fibreglass, cotton flannel, wool flannel, spun metal, electrostatic material or other equally acceptable filtering media, which are non-shedding and which do not release to the air, toxic volatiles, or volatiles which may impart any flavour or odour to the product.

Disposable media filters shall consist of cotton flannel, wool flannel, spun metal, non-woven fabric, absorbent cotton fibre or suitable inorganic materials which, under conditions of use, are non-toxic and nonshedding. Chemical bonding material, contained in the media, shall be non-toxic, nonvolatile and insoluble under all conditions of use. Disposable media shall not be cleaned and reused.

Filter Performance
The efficiency of intake filters shall be at least 50 percent as measured by the National Bureau of Standards "Dust Spot method" using atmospheric dust as the test aerosol.

The efficiency of either air pipeline filters or disposable filters shall be at least 50 percent as measured by the DOP (dioctyl phthalate) test.

Piping
Air distribution piping, fittings and gaskets between the terminal filter and any product contact surface, shall be sanitary milk piping, except, where compressing equipment is of the fan or blower type. When the air is used for such operations, as removing containers from mandrels, other non-toxic materials may be used.

Fabrication and Installation

Air Supply Equipment
The compressing equipment shall be designed to preclude contamination of the air with lubricant vapours and fumes. Oil-free air may be produced by one of the following methods or their equivalent:

  1. Use of carbon ring piston compressor
  2. Use of oil-lubricated compressor with effective provision for removal of any oil vapour by cooling the compressed air
  3. Water-lubricated or non-lubricated blowers

The air supply shall be taken from a clean air space or from relatively clean outer air and shall pass through a filter upstream from the compressing equipment. This filter shall be located and constructed so that it is easily accessible for examination, and the filter media are easily removable for cleaning or replacing. The filter shall be protected from weather, drainage, water, product spillage and physical damage.

Moisture Removal Equipment

If it is necessary to cool the compressed air, and aftercooler shall be installed between the compressor and the air storage tank for the purpose removing moisture from compressed air.

Filters and Moisture Traps
Filters shall be constructed so as to assure effective passage of air through the filter media only.

The air under pressure shall pass through an oil-free filter and moisture trap for removal of solids and liquids. The filter and trap shall be located in the air pipeline, downstream from the compressing equipment, and from the air tank, if one is used. Air pipeline filters and moisture traps, downstream from the compressing equipment, shall not be required where the compressing equipment is of the fan or blower type.

A disposable media filter shall be located in the sanitary air pipelines upstream from and as close as possible to each point of application or ultimate use of the air.

Air Piping
The air piping from the compressing equipment to the filter and the moisture trap shall be readily drainable.

The product check valve of sanitary design shall be installed in the air piping, downstream from the disposable media filter, to prevent backflow of product into the air pipeline, except that a check valve shall not be required if the air piping enters the product zone from a point higher than the product overflow level which is open to atmosphere.

The requirements of this section do not apply when the compressing equipment is of the fan or blower type. See illustrations depicting various air supply systems.

Note : For additional details, see 3 A Accepted Practices for Supplying Air Under Pressure in Contact with Milk, Milk Products and Product Contact Surfaces, Number 604-04.

Compressed Air Systems

Figure 1 - Individual Blower Type Air Supply

Image - Individual blower type air supply

Figure 2 - Individual Fan Type Air Supply

Image - Individual fan type air supply

Figure 3 - Central Compression - Type Air Supply

Image - Central Compression-Type Air Supply
Description of image - Central Compression-Type Air Supply

Figure 4 - Individual Compression - Type Air Supply

Image - Individual Comression-Type Air Supply
Description of image - Individual Compression-Type Air Supply

Figure 5 - Rotating Mandrel Assembly

Image - Rotating Mandrel Assembly
Description of image - Rotating Mandrel Assembly

Reference

  • Grade "A" Pasteurized Milk Ordinance 1993
  • U.S. Department of Health and Human Services
  • Public Health Service, Food and Drug Administration

Appendix 3 Balance Tank Design

Constant Level Tank

Figure 1 - Constant Level Tank Overview

Image - Constant Level Tank
Description of image - Constant Level Tank

Figure 2 - Constant Level Tank with Elevated Bridge and Vent

Image - Constant Level Tank with Elevated Bridge and Vent
Description of image - Constant Level Tank with Elevated Bridge and Vent

Figure 3- Side Overflow (Elbow)

Image - Side Overflow (Elbow)
Description of image - Side Overflow (Elbow)

Figure 4 - Internal Overflow

Image - Internal Overflow
Description of image - Internal Overflow

Appendix 4 Meter Based Timing System

The magnetic flow meter is used to measure the flow rate in HTST, HHST, and Aseptic Processing and Packaging systems. It is essentially a short piece of tubing (approximately 10 inches (25.4 cm) long) surrounded by a housing, inside of which are located coils which generate a magnetic field. Two stainless steel electrodes about a quarter inch in diameter protrude approximately one-inch through the teflon lined tube and provide the contact points for the fluid (a conductor) passing through the magnetic fluid. These electrodes pick up a signal from the moving fluid and activate a transmitter. The signal is sent to other instrumentation where it is recorded and acted upon.

Industries have found magnetic flow meters advantageous over other types of flow control devices since they:

  1. Provide no obstruction to the fluid
  2. Contain no moving parts
  3. Remain unaffected by changes in conductivity, viscosity, density or temperature
  4. Produce negligible pressure loss
  5. Do not require purging
  6. May be installed at nearly any point along a pipeline

Magnetic flow meters do nothing but measure flow. Other components regulate the flow.

Only those meter based timing meter components that have been reviewed and found acceptable by FDA's Milk Safety Branch and Food Engineering Branch or are fit for purpose may be used as a replacement for a flow control device on critical process systems (HTST, HHST, APPS). Systems not reviewed and found acceptable by FDA's Milk Safety Branch and Food Engineering Branch will be assessed on a case by case basis.

To be considered satisfactory as a flow control device within a critical process system the Meter Based Timing System must consist of the following components:

  1. Centrifugal or positive displacement timing pump
  2. Magnetic flow meter
  3. Product check valve or normally closed air operated valve
  4. Flow recorder with event pen
  5. High flow alarm
  6. Low flow/loss of signal alarm
  7. Flow control (with operator interfaced flow controller): (a) control valve or (b) AC variable frequency drive

Operation, Installation and Design Requirements Of A Meter Based Timing System

AC Variable frequency drive system

The operation, installation and design requirements of a Meter Based Timing System with an AC variable frequency drive system shall comply with the following:

  1. The systems shall have a suitable flow recorder capable of recording flow at the high flow alarm set point and also at least five (5) gallons (19 litres) per minute higher than the high flow alarm setting. The flow recorder shall have an event or divert pen which shall record the duration of the alarm condition.
  2. A high flow alarm with an adjustable set point shall be installed within the system which will automatically cause the flow diversion device to be moved to the divert position whenever excessive flow rate causes the product holding time to be less than the legal holding time for the pasteurization process being used. Such adjustment shall be tested and sealed.
  3. A low flow or loss of signal alarm shall be installed with the system which will automatically cause the flow diversion device to be moved to the divert position whenever there is a loss of signal from the meter or the flow rate is below 5% of the maximum signal alarm set point. See Figure 1 Logic Diagram.
  4. When the legal flow rate has been re-established following an excessive flow rate, a time delay must be instituted which will prevent the flow diversion device from assuming the forward flow position until a least a 15 second (milk) (HTST)or 25 second (frozen dessert mix)(HTST) or 1 second (APPS and HHST), continuous legal flow has been re-established. The time delay must be tested and if it is of the adjustable type it shall be sealed.
  5. A sanitary product check valve or normally closed air operated valve shall be installed in the system to prevent positive pressure in the raw milk side of the regenerator whenever a power failure or shut down occurs. The check valve or normally closed air operated valve must be placed between the magnetic flow meter and the start of the holding tube.
  6. The placement of the individual components in the system shall comply with the following conditions:
    1. The AC variable frequency controlled centrifugal or positive displacement pump shall be located downstream from the raw milk regenerator section if a regenerator is used.
    2. The magnetic flow meter shall be placed downstream from the AC variable frequency centrifugal or positive displacement pump. There shall be no intervening components in the system other than normal sanitary piping with no valves or control devices between them.
    3. Both the AC variable frequency centrifugal or positive displacement pump and the magnetic flow meter shall be located upstream from the holding tube.
    4. All other flow promoting devices such as booster pumps, stuffing pumps, separators, clarifiers and homogenizers, as well as the AC variable frequency centrifugal or positive displacement pump, shall be properly inter-wired with the flow diversion device so that they may run and produce flow through the system only when the flow diversion device is in the fully diverted or fully forward flow position when in product run mode. Separators or clarifiers which continue to run after power is shut off to them must be automatically valved out of the system with fail-safe valves so that they are incapable of producing flow during this period and when the flow diversion device is in the diverted flow position. In the case of aseptic processing systems utilizing indirect or direct heating systems, the product divert device will remain in the divert position when the flow rate is higher that the specified value in the scheduled process.
    5. There shall be no product entering or leaving the system (i.e. cream or skim from a separator or other product components) between the AC variable frequency centrifugal or positive displacement pump and the flow diversion device.
    6. The magnetic flow meter shall be so installed that the product has contact with both electrodes at all times when there is flow through the system. This is most easily accomplished by mounting the flow tube of the magnetic flow meter in a vertical position with the direction of flow from the bottom to the top. However, horizontal mounting is acceptable when other precautions are taken to assure that both electrodes are in contact with product. They should not be mounted on a high horizontal line which may be only partially full and thereby trap air.
    7. The magnetic flow meter shall be piped in such a manner that at least 10 pipe diameters of straight pipe exists upstream and downstream from the centre of  the meter before any elbow or change of direction takes place.
  7. When a regenerator is used with these systems, it probably will be necessary to bypass the regenerator during start-up and when the flow diversion device is in the diverted flow position. Care should be taken in the design of such bypass systems to assure that a dead-end does not exist. A dead-end could allow product to remain at ambient temperature for long periods of time and allow bacterial growth in the product. Caution should also be observed with such bypass systems and any valves used in them so that raw milk product will not be trapped under pressure in the raw regenerator plates and not have free drainage back to the constant level tank when shutdown occurs.
  8. Most such systems will utilize a dual stem flow diversion device and will be using the AC variable frequency centrifugal pump during the CIP cleaning cycle. All controls required of such systems must be applicable. When switching to the CIP position, the flow diversion device must move to the divert position and must remain in the diverted flow position for at least 10 minutes of the CIP cycle regardless of temperature and the booster pump cannot run during the first 10 minutes of the CIP cycle. Once the CIP cycle has been activated the operator has 10 minutes to switch back to "process mode".
  9. When public health computers or programmable logic controllers are used with these systems, they must be installed in such a manner that no public health controls are under the computer or programmable logic controller during the product run operations except that the computer or programmable logic controller may control the speed of the AC variable frequency centrifugal or positive displacement pump provided the high flow alarm is set and sealed to provide for diversion of the flow diversion device whenever the design flow rate is exceeded.
  10. All required controls shall be tested at the recommended frequency. Where adjustment or changes can be made to these devices or controls, appropriate seals shall be applied so that changes cannot be made without detection.
  11. Upon initial installation and at the recommended frequency, all Meter Based Timing Systems shall be tested for holding times. Tests shall be performed in forward flow (above legal temperature) and diverted flow (below legal temperature). At least six (6) consecutive results shall be within a half (0.5) second range of each other. If six (6) consecutive times within a half (0.5) second range cannot be obtained in forward and diverted flow, the designer of the installation should be contacted to correct the problem before using the system. All timing tests shall be performed in accordance with the procedures outlined in CFIA's "Test Procedures For Critical Processes Equipment and Controls" manual. The system must be designed and installed so that the timing tests can be conducted in automatic mode in both forward and diverted flow. Automatic mode means that the flow through the system is under control of the magnetic flow meter, and the system controls will automatically vary the speed of the centrifugal pump to maintain a constant flow rate through the system. In automatic mode, the set point of the automatically controlled flow rate must be manually adjustable.

Control valve system

The operation, installation and placement requirements for a Meter Based Timing System utilizing, a single speed centrifugal or positive displacement pump and control valve shall comply with the following:

  1. The systems shall have a suitable flow recorder capable of recording flow at the high flow alarm set point and also at least five (5) gallons (19 litres) per minute higher than the high flow alarm setting. The flow recorder shall have an event or divert pen which shall record the duration of the alarm condition.
  2. A high flow alarm with an adjustable set point shall be installed within the system which will automatically cause the flow diversion device to be moved to the divert position whenever excessive flow rate causes the product holding time to be less than the legal holding time for the pasteurization process being used. Such adjustment shall be tested and sealed.
  3. A low flow or loss of signal alarm shall be installed with the system which will automatically cause the flow diversion device to be moved to the divert position whenever there is a loss of signal from the meter or the flow rate is below 5% of the maximum signal alarm set point. See Figure 1 Logic Diagram.
  4. When the legal flow rate has been re-established following an excessive flow rate, a time delay must be instituted which will prevent the flow diversion device from assuming the forward flow position until a least a 15 second (milk) (HTST)or 25 second (frozen dessert mix)(HTST) or 1 second (APPS and HHST), continuous legal flow has been re-established. The time delay must be tested and if it is of the adjustable type it shall be sealed.
  5. A sanitary product check valve or normally closed air operated valve shall be installed in the system to prevent positive pressure in the raw milk side of the regenerator whenever a power failure or shut down occurs. The check valve or normally closed air operated valve must be placed between the magnetic flow meter and the start of the holding tube.
  6. The placement of the individual components in the system shall comply with the following conditions:
    1. The centrifugal or positive displacement pump shall be located downstream from the raw milk section if a regenerator is used.
    2. The magnetic flow meter shall be placed downstream from the centrifugal or positive displacement pump. There shall be no intervening components in the system other than normal sanitary piping with no valves or control devices between them.
    3. The control valve must be placed downstream from the magnetic flow meter and upstream from the start of the holding tube.
    4. The centrifugal or positive displacement pump, the magnetic flow meter and the control valve shall be located upstream from the holding tube.
    5. All other flow promoting devices such as booster pumps, stuffer pumps, separators, clarifiers and homogenizers, as well as the centrifugal or positive displacement pump, shall be properly inter-wired with the flow diversion device so that they may run and produce flow through the system only when the flow diversion device is in the fully diverted or safe forward position when in product run mode. Separators or clarifiers which continue to run after power is shut off to them must be automatically valved out of the system with fail-safe valves so that they are incapable of producing flow during this period and when the flow diversion device is in the diverted flow position. In the case of aseptic processing systems utilizing indirect or direct heating systems, the product divert device will remain in the divert position when the flow rate is higher that the specified value in the scheduled process.
    6. There shall be no product entering or leaving the system (i.e. cream or skim from a separator or other product components) between the centrifugal or positive displacement pump and the flow diversion device.
    7. The magnetic flow meter shall be so installed that the product has contact with both electrodes at all times when there is flow through the system. This is most easily accomplished by mounting the flow tube of the magnetic flow meter in a vertical position with the direction of flow from the bottom to the top. However, horizontal mounting is acceptable when other precautions are taken to assure that both electrodes are in contact with product. They should not be mounted on a high horizontal line which may be only partially full and thereby trap air.
    8. The magnetic flow meter shall be piped in such a manner that at least 10 pipe diameters of straight pipe exists upstream and downstream from the centre of the meter before any elbow or change of direction takes place.
  7. When a regenerator is used with these systems, it probably will be necessary to bypass the regenerator during start-up and when the flow diversion device is in the diverted flow position. Care should be taken in the design of such bypass systems to assure that a dead-end does not exist. A dead-end could allow product to remain at ambient temperature for long periods of time and allow bacterial growth in the product. Caution should also be observed with such bypass systems and any valves used in them so that raw milk product will not be trapped under pressure in the raw regenerator plates and not have free drainage back to the constant level tank when shutdown occurs.
  8. Most such systems will utilize a dual stem flow diversion device and will be using the AC variable frequency centrifugal pump during the C.I.P. cleaning cycle. All controls required of such systems must be applicable. When switching to the C.I.P. position, the flow diversion device must move to the divert position and must remain in the diverted flow position for at least 10 minutes of the C.I.P. cycle regardless of temperature and the booster pump cannot run during the first 10 minutes of the C.I.P. cycle. Once the C.I.P. cycle has been activated the operator has 10 minutes to switch back to "process mode".
  9. When public health computers or programmable logic controllers are used with these systems, they must be installed in such a manner that no public health controls are under the computer or programmable logic controller during the product run operations except that the computer or programmable logic controller may control the speed of the AC variable frequency centrifugal or positive displacement pump provided the high flow alarm is set and sealed to provide for diversion of the flow diversion device whenever the design flow rate is exceeded.
  10. All required controls shall be tested at the recommended frequency. Where adjustment or changes can be made to these devices or controls, appropriate seals shall be applied so that changes cannot be made without detection.
  11. Upon initial installation and at the recommended frequency, all Meter Based Timing Systems shall be tested for holding times. Tests shall be performed in forward flow (above legal temperature) and diverted flow (below legal temperature). At least six (6) consecutive results shall be within a half (0.5) second range of each other. If six (6) consecutive times within a half (0.5) second range cannot be obtained in forward and diverted flow, the designer of the installation should be contacted to correct the problem before using the system. All timing tests shall be performed in accordance with the procedures outlined in CFIA's "Test Procedures For Critical Processes Equipment and Controls" manual. The system must be designed and installed so that the timing tests can be conducted in automatic mode in both forward and diverted flow. Automatic mode means that the flow through the system is under control of the magnetic flow meter, and the system controls will automatically vary the speed of the centrifugal pump to maintain a constant flow rate through the system. In automatic mode, the set point of the automatically controlled flow rate must be manually adjustable.

This image shows an HTST System with Magnetic Flow Meter Using an AC Variable Speed Centrifugal Pump

  • Starting with raw milk coming in through the Raw In and into the Constant Level Tank, the material goes into the Booster Pump, past the Booster Pressure Differential Switch, through the Regenerator for initial warming, and through the Separator Feed Valve. It passes through the Separator which separates the milk into skim milk and raw cream. The raw cream exits through the raw cream outlet. The skim milk continues and goes through the Skim Back Pressure Valve, the Separator By-Pass Valve, and into the AC Drive Centrifugal Timing Pump. It then passes through the Magnetic Flow Meter. The Magnetic Flow Meter measures the flow rate for display and recording on the Flow Rate Recorder which is connected to the Flow Alarm by means of a Pneumatic Transducer.
  • After passing the flow meter, the milk flows through the Check Valve and into the homogenizer for homogenization. Milk then moves to the Heater where it is heated before entering the Holding Tube. After holding, it flows past the indicating and recording thermometers, and into the Flow Diversion Device. If the Safety Thermal Limit Recorder (STLR) records a satisfactory holding temperature, the flow will continue to the regenerator for pre cooling, and through the cooler for final cooling. Pasteurized product goes past the vacuum breaker out through the pasteurized out line, or back through the recycle line to the constant level tank. If the milk does not meet time and temperature requirements, the flow diversion device sends it back to the constant level tank for recirculation.
  • Flow rates and temperatures are recorded for process control records.

Click on Image for Larger View
Image - High temperature, short-time system with magnetic flow meter using an alternating current variable speed centrifugal pump
Description of image - High temperature, short-time system with magnetic flow meter using an alternating current variable speed centrifugal pump

Reference:

  • Grade "A" Pasteurized Milk Ordinance 1993
  • U.S. Department of Health and Human Services
  • Public Health Service, Food and Drug Administration

This image shows an HTST System with Magnetic Flow Meter Using a Constant Speed Centrifugal Pump and a Control Valve

  • Starting with raw milk coming in through the Raw In and into the Constant Level Tank, the material goes into the Booster Pump, past the Booster Pressure Differential Switch, through the Regenerator for initial warming, and through the Separator Feed Pump and through the separator feed valve to the separator. The Separator separates the milk into skim milk and raw cream. The raw cream exits through the raw cream outlet. The skim milk continues and goes through the Skim Back Pressure Valve, the Separator By-Pass Valve, and into the Centrifugal Timing Pump. It then passes through the Magnetic Flow Meter. The Magnetic Flow Meter measures the flow rate for display and recording on the Flow Rate Recorder which is connected to the Flow Alarm by means of a Pneumatic Transducer.
  • After passing the flow meter, the milk flows through the Flow Control Valve, to the Heater where it is heated before entering the Holding Tube. After holding, it flows past the indicating and recording thermometers, and into the Flow Diversion Device. If the Safety Thermal Limit Recorder (STLR) records a satisfactory holding temperature, the flow will continue to the regenerator and past the vacuum breaker out through the pasteurized out line, or back through the recycle line to the constant level tank. If the milk does not meet temperature requirements, the flow diversion device sends it back to the constant level tank for recirculation.
  • Flow rates and temperatures are recorded for process control records.

Click on Image for Larger View
Image - High temperature, short-time system with magnetic flow meter using a constant speed centrifugal pump and a control valve
Description of image - High temperature, short-time system with magnetic flow meter using a constant speed centrifugal pump and a control valve

Reference:

  • Grade "A" Pasteurized Milk Ordinance 1993
  • U.S. Department of Health and Human Services
  • Public Health Service, Food and Drug Administration

Appendix 5 Criteria for the Evaluation of Computerized Public Health Controls Glossary

Address: A numerical label on each input or output of the computer. The computer uses this address when communicating with the input or output.

Computer: A very large number of on-off switches arranged in a manner to sequentially perform logical and numerical functions.

Default mode: The predescribed position of some memory locations during start-up and standby operations.

Electrically Alterable Programmable, Read Only Memory (EAPROM): An electrically alterable programmable, read only memory. Individual memory locations may be altered without erasing the remaining memory.

Electrically Erasable Programmable, Read Only Memory (EEPROM): An electrically erasable programmable, read only memory. The entire memory is erased with one electrical signal.

Erasable, Programmable, Read-only Memory (ERPOM): An erasable, programmable, read-only memory. The entire memory is erased by exposure to ultra-violet light.

Fail Safe: Design considerations that cause the instrument or system to move to the safe position upon failure of electricity, air, or other support systems.

Field alterable: A device having a specific design or function that is readily changed by user and/or maintenance personnel.

Force off: A programmable computer instruction that places any input or output in the "off" state, independently of any other program instructions.

Force on: A programmable computer instruction that places any input or output in the "on" state, independently of any other program instructions.

Input: A data set applied to the input bus of the computer that is used by the computer to make logical decisions an whether or not to activate one or more outputs. Input consists of data from temperature and pressure instruments, liquid level controls, tachometers, microswitches, and operator-controlled panel switches.

Input/Output bus: An electrical connection panel that provides for the connection of all inputs and outputs to the computer. The input/output address labels are found on this panel. Indicator lights showing the status (on/off) of all inputs and outputs are usually available on this panel.

Last state switch: A manually operated switch located on the input/output bus that instructs the computer to place all outputs in the "on", "off" or "last state" during a start up. The "last state" position instructs the computer to place the outputs in whatever state (on or off) occurred during the last loss of power.

Operator override switch: A manually operated switch located on the input/output bus that permits the operator to place any input or output in the on or off position, independently of any program instructions.

Output: Electrical signals from the computer that turn on or off: valves, motors, lights, horns, and other devices being controlled by the computer. Outputs may also consist of messages and data to the operator.

Programmable controller: A computer, with only limited mathematical ability, that is used to control industrial machines, instruments and processes. Most computers used on high-temperature short-time (HTST) pasteurizers will be programmable controllers.

Random access memory (RAM): A memory used by the computer to run programs, store data, read input and control outputs. The computer may either read the memory or write data into the memory.

Read-only memory (ROM): A memory used by the computer to run its own internal unchangeable programs. The computer may only read from the memory; it cannot write into the memory or alter the memory in any way.

Standby status: The computer is turned on, running, and waiting for instructions to start processing input data. This instruction is usually accomplished by a manually operated switch.

Status printing: Some computers are programmed to interrupt printing of the chart record print the status of key set points and conditions such as: cold milk temperature, holding tube temperature, diversion temperature setting and chart speed.

Criteria

The following listed criteria shall be complied with for all computers or programmable controllers when applied to HTST, high heat short time (HHST) and ultra-high temperature (UHT) pasteurization systems used for milk and milk products. In addition, all systems shall conform to all other requirements outlined in the Dairy Products Inspection Manual.

  1. A computer or programmable controller used for public health control of pasteurizers must be a system dedicated only to the public health control of the pasteurizer. The public health computer shall have no other assignments involving the routine operation of the plant.
  2. The public health computer shall not be under the command or control of any other computer system. It shall not have an address to be addressable by any other computer system. A host computer cannot override its commands or place it on standby status. All output addresses of the public health computer must be ready to process data at any time.
  3. A separate public health computer must be used on each pasteurizing system.
  4. The status of the Input/Output bus of the public health computer may be provided as inputs-only, to other computer systems. The wiring connections must be provided with isolation protection such as solenoid relays, diodes, or optical-coupling devices to prevent the public health Input/Output bus from being driven by the other computer system.
  5. On loss of power to the computer, all public health controls must assume the fail-safe position. Most computers can be placed in standby status by either a program instruction or manual switches. When the computer is in standby status, all public health controls must assume the fail-safe position. Some computers have internal diagnostic checks that are performed automatically during start-up. During this time, the computer places all outputs in default mode. In this default mode, all public health controls must be in the fail-safe position.
  6. Some computers or programmable controllers have Input/Output buses with " last state switches" that permit the operator to decide what state the output bus will take on power-up after a shutdown or loss of power. The choices are on, off, or "last state" occurring when the computer lost power. These "last state switches" must be placed in the fail-safe position.
  7. The computer performs its tasks sequentially, and for most of real time, the computer outputs are locked in the ON or OFF position, while waiting for the computer to come back through the cycle. Consequently, the computer program must be written so that the computer monitors all inputs, and updates all outputs on a precise schedule - at least once every second. Most computers will be capable of performing this function many times in one second.
  8. Programs must be stored in some form of read-only memory, and be available when the computer is turned on. Tapes or disks are nor acceptable.
  9. The computer program access must be sealed. Any telephone modem accesses must also be sealed. If the Input/Output bus contains "last state switches,  "the Input/Output bus must be sealed. The vendor must supply the Regulatory Official with procedures and instructions to confirm that the program currently in use by the computer is the correct program. The Regulatory Official will use this test procedure to confirm that the correct program is in use, during a start-up, and whenever the seal is broken.
  10. If the computer contains FORCE-ON, FORCE-OFF functions, the computer must provide indicator lights showing the status of the FORCE-ON, FORCE-OFF function. The vendor instructions must remind the Regulatory Official that all FORCE-ON, FORCE-OFF function must be cleared before the computer is sealed.
  11. The input/output buses of the public health computer shall contain no operator override switches.
  12. Computerized systems which provide for printing the recording chart by the computer must ensure that proper calibration is maintained. During chart printing, the computer must not be diverted from its public health tasks for more than one second. Upon returning to public health control, the computer shall complete at least one full cycle of its public health tasks before returning to chart printing.
  13. When printing a chart, some systems provide status reports on the chart paper of selected Input/Output conditions. This is usually done by interrupting the printing of the chart and printing the Input/Output conditions. Such interrupts, for status printing, are permitted only when a continuous record is recorded on the chart. When an interrupt is started, the time of the start of the interrupt will be printed on the chart at the beginning of the interrupt and at the end of the interrupt. The time interval during which the computer is diverted from its public health control tasks for status printing shall not exceed one second. Upon returning to public health control, the computer shall complete at least one full cycle of its public health tasks before returning to status printing.
  14. When the computer prints the temperature trace of temperature in the holding tube, at specific intervals, rather than a continuously changing line, temperature readings shall be printed not less than once every five seconds, except that during the thermometric lag test, the temperature shall be printed or indicated fast enough that the Regulatory Official can place the temperature sensor in a bath at a temperature 4°C (7°F) above the diversion setting and accurately determine the point in time when the temperature rises to a point  7°C (12°F) below the diversion point setting so that the Regulatory Official can start the timing of the thermometric lag test.
  15. When the computer prints the frequency pen position (the position of the flow diversion device, forward or divert) at specific intervals, rather than continuously, all changes of position shall he recognized by the computer and printed on the chart. In addition, the frequency pen position and temperature in the holding tube must be printed on the chart in a manner that the temperature in the holding tube can be determined at the moment of a change of position of the flow diversion device.
  16. The vendor shall provide a built-in program for test procedures, or a protocol shall be provided so that all applicable tests outlined in Canadian Food Inspection Agency's (CFIA) "Critical Process Test Procedures" for each instrument can be performed by a recognized official:

    Recording Thermometers

    • temperature accuracy
    • time accuracy
    • check against indicating thermometer
    • thermometric response

    Flow Diversion Devices

    • valve seat leakage
    • operation of valve stem(s)
    • device assembly
    • manual diversion
    • response time
    • time delay intervals if used

    Booster Pumps

    • proper wiring
    • proper pressure control settings

    Flow Promoting Devices (timing pumps)

    • holding time in holder
    • proper wiring interlocks
  17. Computers require high quality (clean) well regulated power supplies to operate reliably and safely. Spurious voltage spikes can cause unwanted changes in computer RAM. Some mechanical and electrical components also deteriorate with age. One solution is to have two permanent programs in the computer; one in RAM and one in ROM. Through a self-diagnostic test, these two programs could be compared routinely. If there were differences in the programs, the computer would go into default mode. Another solution would be to download the program from ROM to RAM at every start-up. A third solution would be to have the computer read program directly from ROM, that is unchangeable. However, this approach is practical only in large volume applications such as microwave ovens. For most small volume applications, the read-only memories are field alterable, such as EPROM, EEPROM and EAPROM. EPROM, EEPROM, and EAPROM cannot be relied upon to maintain a permanent record. Something is needed to ensure that the proper program is in computer memory when Regulatory Official seals the computer.
  18. Computer program used for Public Health Controls Pasteurizers must conform to the attached logic diagrams. Minor modifications to these diagrams are permissible to accommodate or delete items that are unique to a specific HTST Pasteurizer system such as; magnetic flow meters used as replacement for timing pump, the flush cycle on the detect stem of the flow diversion device, and the ten minute delay of the booster pump and flow diversion device that permits the timing pump to run during cleaning operations. The vendor must provide a protocol in the user's manual so that the installer, user, and/or Regulatory Official can demonstrate that the program performs as designed under actual production conditions.
  19. The logic diagrams for the flow diversion device and booster pump show a programmed clean in-place (CIP) operation as part of the computerized system. Some plant operators may wish to use another computer for CIP operations, so that CIP programs may be changed by plant personnel, as needed to achieve good plant sanitation. When this is done, the connections between the flow diversion device, booster pump, and plant computer, must be provided with solenoid relays or similar devices on the outputs to the flow diversion device and booster pump to prevent them from being operated by the plant computer, except when the mode switch of the flow diversion device is in the "CIP" position.

Test Procedure

One method of confirming proper operation of all required public health controls is as follows:

  1. Identify all system components which are micro-processor controlled for CIP.
  2. Locate and identify outputs for the above.
  3. With the Inspect-Process-CIP selector switch at CIP and after 10 minutes time delay, manually Force On each output and confirm the operation of the controlled component.
  4. Then with the Inspect-Process-CIP selector switch at Process, again Force On the above defined outputs. The booster pump, Flow Diversion Device (FDD) and devices interlocked with these components shall not operate. And, with the FCD (timing pump) off, those components required to be interlocked with the FCD (timing pump) shall not operate.

Click on Image for Larger View
Flowchart - Logic Diagram Flow Diversion Device (Divert Valve Stem)
Description for Flowchart - Logic Diagram Flow Diversion Device (Divert Valve Stem)

Click on Image for Larger View
Flowchart - Logic Diagram Flow Diversion Device (Leak Detect Valve Stem)
Description for Flowchart - Logic Diagram Flow Diversion Device (Leak Detect Valve Stem)

Click on Image for Larger View
Flowchart - Logic Diagram Safety Thermal Limit Recorder - Controller
Description for Flowchart - Logic Diagram Safety Thermal Limit Recorder - Controller

Click on Image for Larger View
Flowchart - Logic Diagram Flow Control Device
Description for Flowchart - Logic Diagram Flow Control Device

Click on Image for Larger View
Flowchart - Logic Diagram Booster Pump
Description for Flowchart - Logic Diagram Booster Pump

Appendix 6 Minimum Frequency for Critical Processes Equipment and Controls Tests

This page is currently under review

Appendix 7 Valves

Figure 1 - Close Coupled Outlet Valves

Image - Close Coupled Outlet Valves
Description of image - Close Coupled Outlet Valves

Figure 2 - Inlet Leak Protector Valve

Image - Inlet Leak Protector Valve
Description of image - Inlet Leak Protector Valve

Figure 3 - Importance of Proper Stops on Plug Valves

Image - importance of Proper Stops on Plug Valves
Desciption of image - Importance of Proper Stops on Plug Valves

Figure 4 - Air Space Heating

Image - Air Space Heating
Description of image - Air Space Heating

Reference

  • Grade "A" Pasteurized Milk Ordinance 1993
  • U.S. Department of Health and Human Services
  • Public Health Service, Food and Drug Administration

Note: For addition details see Part Two of the 3A Accepted Practices for Fittings Used on Milk and Milk Products Equipment and Used on Sanitary Lines conducting Milk and Milk Products Number 08-17 Rev.

Appendix 8 Cheese Spread Microbiological Stability Chart for Non-refrigerated Products

Chart - Cheese Spread Microbiological Stability Chart For Non-Refrigerated Products
Description of image - Cheese Spread Microbiological Stability Chart For Non-Refrigerated Products

 

Appendix 9 Double Seam Dimensional Technology

This page is currently under review

Appendix 10 Preventing Cross Connections in Dairy Plants

This page is currently under review

Appendix 11 Policy for the Use of Wood in Dairy Establishments

Purpose: To outline the national policy regarding the use of wood for cheese curing.

Scope: This policy is only applicable when wood is used for shelving in cheese curing rooms for bacterial surface ripened cheeses*.

Other than wood used for 640's with appropriate liners and pallets, which both must be well controlled, wood must not be used in dairy establishments for food contact surfaces, supplementary utensils or physical structures where product is exposed or placed at risk of contamination.

Rationale: For reasons of tradition and suitability, wood has been used to aid the surface ripening of cheeses. The bacteria (usually Brevibacterium linens) on the shelf surface break down part of the cheese protein and form the rind. The cheeses are washed and turned regularly during ripening. The cheese shelves are seeded with the bacteria which become ingrained in the wood. Under controlled conditions, the harmless bacteria significantly outnumber the undesirable microorganisms and therefore the risk of contamination is minimized.

No other areas of the dairy establishment require an active bacteria culture on their surface. Since wood is an absorbent surface that is difficult to clean to keep it free of contaminating bacteria, it is not permitted elsewhere in dairy establishments.

Conditions:

  1. Wood used for cheese shelves to cure bacterial surface ripened cheeses must be smooth and either unsealed or sealed with an approved sealant. Supports for the shelves should be stainless steel or a non-corrosive, nonabsorbent material.
  2. The establishment must have a written, effective program to clean and maintain their shelves. The program needs to specify: the frequency and methods of washing; checking and replacing for physical condition (splinters, cracks, mite infestation); and if required, environmental sample monitoring of the product contact surfaces and the room environment. Applicable records must be kept.
  3. If experience or scientific evidence indicates that the use of wood shelves used to cure bacterial surface ripened cheeses poses a biological risk to the cheese, this policy will be reevaluated.

*bacterial surface ripened cheeses - cheeses whose rind is formed by bacterial action (e.g. Saint Paulin, Bel Pase, Tilsit, etc.).

Appendix 12 Water reclaimed from the condensing of milk and milk products

Condensed water from milk evaporators and water reclaimed from milk and milk products may be re-used within the establishment. This water must be safe for its intended use and should not jeopardize the safety of the product through the introduction of chemical, microbiological or physical contaminants. Acceptable uses of this water falls into three categories:

  1. Reclaimed water which may be used for all potable water purposes including the production of culinary steam,
  2. Reclaimed water which may be used for limited purposes including the production of culinary steam, and
  3. Use of reclaimed water not meeting the requirements of this appendix.

Category 1 - Reclaimed water to be used for potable water purposes, including the production of culinary steam, shall meet the following requirements:

  1. Water must be monitored and controlled to ensure the water is safe and suitable for use:
    1. Water must be sampled daily for two weeks following initial approval of the installation and semi- annually thereafter.
    2. Water must be sampled daily for one week following any repairs or alterations to the system.
  2. Water must meet the following criteria, tested monthly, using acceptable test methodology:
    1. E. Coli (or thermotolerant coliforms) are absent in a 100 mL water sample. Depending on the jurisdiction, demonstration of the absence of total coliforms may be required in place of, or in addition to, the absence of E. Coli (or thermotolerant coliforms),
    2. Heterotrophic plate count (standard plate count) does not exceed 500 cfu/mL,
    3. The standard turbidity is less than 5 NTU (nephelometric turbidity units).

      (Note: Health Canada guidelines say drinking water cannot exceed one NTU, unless it can be shown that the water is adequately disinfected, in which case it is drinkable up to five NTUs).
  3. The water must not impart any off-taste and off-odours. The water should not feel or appear slimy. The water must be assessed weekly for off-odours and appearance (clarity, colour).
  4. The usage of chemicals:
    1. Water treatment chemicals, where used, are listed in the "Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products" published by CFIA or the manufacturer has a "letter of no objection" from Health Canada.
    2. Where used, the addition of chemicals must be by an automatic metering device, prior to the water entering the storage tank, to assure satisfactory water quality in the storage tank at all times.
    3. Where used, a twice a day testing program for such added chemicals must be in effect
    4. Where used, chemicals do not pose a contamination risk to the water or the product.
  5. The operator must have procedures in place in the event that the water exceeds the requirements and poses a microbiological and chemical risk. For example the processor could install an automatic fail-safe monitoring device so that the water would be automatically diverted to the sewer if the water exceeded the standards.
  6. Design of the water storage system:
    1. Storage facilities are designed, constructed and maintained to prevent contamination, e.g. covered, properly constructed of material(s) that will not contaminate the water and should allow for periodic cleaning and sanitizing. For example, these could be approved materials from the CWWA (Canadian Water and Wastewater Association) or materials for such use as per manufacturer's guidelines. Without proper design, operation, and maintenance of these facilities, stored water may easily become stagnant and subject to loss of chlorine residual, as well as bacterial regrowth, contaminant entry, and a host of other water quality problems.
    2. The distribution system, within the establishment, must be a separate system with no cross-connections to a municipal or private water system.

Category 2 - Reclaimed water may be used for limited purposes including:

  1. Production of culinary steam.
  2. Pre-rinsing of the product surfaces where pre-rinses will not be used in food products.
  3. Cleaning solution make-up water.

For these uses, items 2c) - 6 above must be satisfied and in addition:

  1. There is no carry-over of water from one day to the next, and any water collected is used promptly; or the temperature of all water in the storage and distribution system is maintained at 63ºC (145ºF) or higher by automatic means; or the water is treated with a suitable approved chemical to suppress bacterial propagation by means of an automatic metering device prior to the water entering the storage tank; and that,
  2. Distribution lines and hose stations are clearly identified as "limited use reclaimed water"; and
  3. Water handling practices and guidelines are clearly described and prominently displayed at appropriate locations within the establishment; and
  4. 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.

Category 3 - Reclaimed water not meeting the above requirements may be used as boiler feed water for boilers, not used for generating culinary steam, or a thick, double walled, enclosed heat exchanger.

References:

Grade A Pasteurized Milk Ordinance 1999 Revision
Guidelines for Canadian Drinking Water Quality Sixth Edition
Standard Methods for the Examination of Water and Wastewater, latest edition

Appendix 12A Water Treatment Devices

Depending on the source of the water, conditions of use, and magnitude and extent of microbiological contamination, disinfection may be needed occasionally over short periods of time or on a continuous basis.

Private wells can become contaminated if they are poorly constructed or improperly sifted or if they have been infiltrated by contaminated surface water. The aquifer (the water-bearing underground layer of porous rock or sand) itself can be a source of contamination. Surface waters and unprotected groundwater are susceptible to faecal contamination from humans, livestock, wild animals and house pets.

When water must be continuously disinfected because of the unacceptable quality of the supply, the possibility of sporadic contamination or the presence of cysts, a water treatment device incorporating filtration and disinfection should be used. There are several types of water treatment devices available for the disinfection of water. These can be divided into point-of-use devices which are portable and are used to treat the water at a single tap or multi-taps and point-of-entry devices which are installed on the main water supply and treat the water as it enters the facility. Since most disinfection systems require clear water to ensure maximum efficiency, it may be necessary to combine two specific devices, one to remove various organic or inorganic compounds or to reduce turbidity in the water and one to reduce microbiological contamination. It is recommended that the operator consult a water treatment specialist prior to installing a disinfection system to ensure the system will be effective and will be installed correctly.

The best approach to ensure complete disinfection of water intended for human use and consumption may be a multi-barrier one, consisting of collecting water from the cleanest source possible, followed by filtration and disinfection.

Some water treatment devices include:

  1. Chlorinators, iodinators and ultraviolet light (UV) are most practical to disinfect the water system.

    Chlorine and iodine kill most disease-causing organisms and require short to moderate contact times, but do not provide protection against protozoa such as Giardia lamblia and Cryptosporidium parvum. It is recommended that if the presence of protozoa is probable, the water be filtered through a filter with a 1 micron or smaller pore size to remove these parasites and then treated with chlorine or iodine to kill bacteria and viruses. Iodine disinfection should not be used for long term continuous disinfection as ingestion in excessive amounts can be harmful.

    UV devices are also effective against bacteria and viruses, produce no taste or odour and only require a few seconds exposure if the water is clear, but they do not ensure the safety of the water beyond point of application, so that flushing of the system is recommended after periods of non-use. In the case of UV devices a pre-filter should always be used to remove protozoan cysts and reduce turbidity, which will also improve the effectiveness of the UV light. If the water is above a certain level of turbidity post-filtration or if certain chemicals are present in the water, then UV disinfection will not be effective.

  2. Ceramic or glass fibre filters handle smaller amounts of water and are useful when water from just one tap is to be treated.

    These filters can remove bacteria and protozoa from mildly contaminated water, but are not suitable for removing viruses or for treating highly contaminated water. When treating surface water, It is recommended that these filters be used in conjunction with disinfection.

  3. Distillers and ozonators are point-of-use devices running on electricity and require sufficient space to install.

    Distillation is commonly used to reduce the levels of all chemicals in drinking water and are effective for the removal of inorganic chemicals including heavy metals and some organic chemicals, but are often combined with activated carbon for the removal of certain "volatile" chemicals. There are no known beneficial or harmful health effects associated with the ingestion of demineralized or distilled water.

    Ozonators produce small quantities of ozone, a strong oxidizing agent that is effective in killing pathogens over a short period of time. It produces no taste or odour in the water. When using this method it is important to have good mixing of ozone with water. Unlike chlorine and iodine, ozone does not protect the water after application and is often combined with activated carbon filtration to achieve more complete water treatment.

Appendix 12B Sterile Water for Rinsing of Aseptic Packages

This page is currently under review

Appendix 12C Risk-Based Selection of Backflow Preventers for Dairy Establishments

This page is currently under review

Appendix 13 Design Requirements for Digital Thermometers for Use in Critical Processes (HTST, batch, HTST/ESL and UHT Processing Systems)

The following criteria shall be used to evaluate resistance temperature devices (RTD's) for use as alternatives to mercury actuated direct reading indicating thermometers on pipelines in High Temperature, Short Time (HTST); Batch; Higher Heat, Shorter Time (HHST) or Extended Shelf Life (ESL); and Ultra High temperature (UHT) systems.

These criteria are:

  1. No more than 0.25°C (0.5°F) drift over 3 months use when compared to a certified source.
  2. Readout is displayed in units of temperature with a graduation of at least 0.1°C.
  3. Display changes at a rate that can be noted by the operator or responsible regulatory authority during the thermometric lag test.
  4. Self-diagnostic circuitry which provides constant monitoring of all sensing, input and conditioning circuits. The diagnostic circuitry should be capable of detecting "open circuits", "short" circuits, poor connections and faulty components. Upon detection of failure of any component, the device shall blank or become unreadable.
  5. The effect of electrical noise shall be documented and available to responsible regulatory authority. Protocols for these tests shall be developed by vendors.
  6. The effect of high temperature and high humidity environment shall be documented. The device should show no effect after exposure to 38°C and 80% relative humidity for 7 days.
  7. Both probe and display case shall be constructed so that they may be sealed.
  8. Calibration of the device shall be protected against unauthorized changes.
  9. The device shall be protected against unauthorized component or sensing element replacement. Replacement of any component or sensing element shall be regarded as a replacement of the indicating thermometer and subject to all applicable tests identified under the CFIA's Critical Process Test Procedures.
  10. The sensing element shall be encased in appropriate material constructed in such a way that the final assembly meets Equipment Table 1 requirements of the Dairy Establishment Inspection Manual.

In addition, all parts of the DEIM inspection manual currently applicable to the indicating thermometer shall apply to any new device being proposed.

Appendix 14 Fo Value

The Fo value is a concept associated with the thermal destruction of microorganisms relative to food preservation and canning.

The F value is used to designate the time necessary to destroy a given number of microorganisms at a reference temperature, usually 121°C for spores or 60°C for vegetative cells. To avoid confusion the temperature can be added as a subscript to F. It represents the total time-temperature combination received by a food.

The integrated lethal value of heat received by all points in a container during processing is designated Fo. Fo is used to describe processes that operate at 121°C, which are based on a micro-organism with a z value (degrees required for the thermal death destruction curve to travers one log cycle) of 10°C. It represents a measure of the capacity of a heat process to reduce the number of spores or vegetative cells of a given organism per container. When there is instant heating and cooling throughout the container of spores, vegetative cells or foods, Fo is derived as follows:

Fo = Dr (log a - log b)

where a = number of cells in the initial population, and b = number of cells in the final population

Dr = when D is determined at 250°F

D = Decimal reduction time, or the time required to destroy the 90% of the organisms. This value is numerically equal to the number of minutes required for the survivor curve to travers one log cycle. It is the measure of the death rate of an organism.

For example if F250 = 3.0, this is the time in minutes at 250°F (121°C) required to achieve sterility of a suspension containing a known number of cells or spores.(Commercial sterility).

References: Basic Food Microbiology, second edition, George J. Banwart, 1989, Published by Chapman & Hall Modern Food Microbiology, third edition, James M. Jay, 1986, Published by Van Nostrand Reinhold

Appendix 15 Examples of Steam Injectors

These three figures are examples of different types of steam injectors; a Creamery Package injector, a De Laval Injector, and a Cherry Burrell injector. These are used to heat the product to pasteurization temperature by injecting steam into the milk stream.

Creamery Package Injector

Image - Creamery package injector, which shows where the product goes in and where the steam comes out.

DeLaval Injection

Image - DeLaval Injection. It also shows the 19̊ steam, where the product goes in, and Section AA.

Cherry Burrell Injector

Image - Cherry burrell injector. The steam, spacer, product and O ring are labelled on the image.

Appendix 16 Pressure Switch Settings

This chart shows the operating temperatures of different pressure switch settings at sea level.

  • At temperatures of 191° Fahrenheit (F) to 210° Fahrenheit the pressure switch setting is 10 pounds per square inch gauge (PSIG) at sea level.
  • At 220°F the pressure switch setting is 12 PSIG at sea level
  • At 230°F the pressure switch setting is 16 PSIG at sea level.
  • At 240°F the pressure switch setting is 20 PSIG at sea level.
  • At 250°F the pressure switch setting is 23 PSIG at sea level.
  • At 260°F the pressure switch setting is 30 PSIG at sea level
  • At 270°F the pressure switch setting is 35 PSIG at sea level.
  • At 280°F the pressure switch setting is 42 PSIG at sea level.
  • At 290°F the pressure switch setting is 51 PSIG at sea level.
  • At 300°F the pressure switch setting is 61 PSIG at sea level.

Chart - Pressure Switch Settings
Description of image - Pressure Switch Settings Chart

Appendix 17 Thermal Processing Temperatures and Guidelines

High Temperature Short Time (HTST)

  • Temperatures up to 100°C with a holding time of 0.01 second or longer
  • Chapter 11 (HTST) of the Dairy Establishment Inspection Manual

High Heat Short Time (HHST)

  • Temperatures > 100°C
  • Not shelf stable product
  • System becomes unstable when the temperature goes above 100°C, especially the pressure requirements for the product to be maintained in the liquid state
  • Assume viscous product, therefore need to use calculated hold method
  • Requires new guidelines to be developed

Aseptic Processing and Packaging System (APPS)

  • Temperatures > 100°C
  • Shelf stable product (minimum Fo = 3.0 as a minimum)
  • Chapter 14 (APPS) of the Dairy Establishment Inspection Manual

Appendix 18 Vacuum Breaker

Image - Vacuum Breaker
Description of image - Vacuum Breaker

Appendix 20 Prerequisite Programs Cross-Reference with FSEP Prerequisite Program Bullets

(A.1.1) Outside Property
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
A.1.1.1
Building facility is located away from or protected against potential sources of external contaminants that may compromise the safety of food.
The surrounding/roadways are free of debris and refuse, adequately drained and maintained to minimize environmental hazards.		 1.10.01.03


(A.2.1) Building Design, Construction and Maintenance
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
A.2.1.1
The building is designed and constructed:
  • To meet regulatory and CFIA program requirements
  • So its access is secure
  • So the roof, air intakes, foundation, walls, doors and windows prevent leakage and entry of contaminants and pests
  • To effectively separate incompatible operations*
  • To provide hygienic operations by means of a regulated flow from point of entry to the premises to the final product*
  • To effectively prevent cross-contamination due to employee traffic pattern, food product flow and equipment*
  • So living quarters and areas where animals are kept are separated from and do not open directly into food processing or packaging areas
  • So incoming materials (food, non-food, packaging) are received in an area separate from food processing areas
  • So washrooms, lunchrooms and change rooms are separated from and do not open directly into food processing areas
  • So separate and adequate facilities are provided for:
    • The storage of waste and inedible products*
    • The cleaning and sanitizing of waste/inedible equipment*
    • The cleaning of equipment*
  • To prevent cross-connection between:
    • the effluent of human wastes and production drainage wastes in the establishments
    • potable water lines and non-potable water supply systems
      • Non-potable re-circulated/reused/recycled water has a separate distribution system which is readily identifiable in the facility
  • So the sewage and the waste effluent system do not pass directly over or through production unless they are controlled to prevent contamination
  • So drainage and sewage systems are equipped with functional traps and vents
  • So floors permit liquids to drain to trapped outlets
  • So floors, walls, doors, windows, ceilings, overheads and other structures in rooms or areas where food is manufactured, stored, packaged, received or shipped are cleanable, prevent contamination, prohibit deterioration, are suitable for the activities in each area and are free of any noxious constituents**

* If the building is not designed to effectively separate incompatible operations and/or to prevent cross-contamination, operational procedures to control cross-contamination must be defined in the General Food Hygiene Program D.2.1.1. and/or the Sanitation Program E.1.1.1.

**Reference Listing of Accepted Construction Materials can be found at:
http://www.inspection.gc.ca/english/fssa/reference/refere.shtml. See B.2.1.1 for purchasing control of construction material.

 1.10.01.02
1.10.01.03
1.10.01.04
1.10.01.05
1.10.01.06
1.10.01.08
1.10.01.09
1.10.02.03
A.2.1.2
The building is maintained so:
  • The roof, air intakes, foundation, walls, doors and windows prevent leakage and entry of contaminants and pests
  • The drainage and sewage systems prevent backflow and pooling liquids on floors
  • Floors, walls, ceilings, overheads, doors, windows, stairs, elevators and other structures exhibit no evidence of degradation that would cause contamination and are cleanable
 1.10.01.03
1.10.01.04


(A.2.2) Lighting
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
A.2.2.1
Lighting is appropriate such that food colour is not altered and the intended production or inspection activity can be effectively conducted.		 1.10.01.04
A.2.2.2
Light bulbs and fixtures located in areas where there is exposed food or packaging materials are of a safety type or are protected to prevent contamination of food in case of breakage.		 1.10.01.04


(A.2.3) Ventilation
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
A.2.3.1
Ventilation provides sufficient air exchanges to prevent unacceptable accumulations of steam, condensation or dust and to remove contaminated air.
Filters are cleaned or replaced as appropriate.		 1.10.01.04
1.10.01.10
A.2.3.2
Ventilation systems ensure that air flows from the least contaminated areas to the most contaminated areas.		 1.10.01.04
A.2.3.3
Where required, ambient air, compressed air or gases utilized in processing equipment that contact product or packaging are appropriately sourced and treated to minimize contamination of product and packaging.		 1.10.03.02 (air in contact with product/ packaging) Appendix 2


(A.2.4) Waste & Inedible/Food Waste Program
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
A.2.4.1
The establishment has and implements documented procedures to control the hazards associated with waste and inedible/food waste products.  The procedures shall include but are not limited to:
  • An identification system for utensils and containers used for collection and holding of waste and inedible/food waste materials
  • The frequency of removal of waste during operations
  • If applicable, the frequency of removal of inedible/food waste products during operations
  • If applicable, procedures for storage of waste and inedible/food waste products
  • If applicable (see regulatory requirement for the commodity), a denaturing protocol, including methods and chemical(s) used for denaturing
  • The frequency of removal of waste from the establishment
  • If applicable, the frequency of removal of inedible/food waste product from the establishment
  • Procedures for maintenance of waste/inedible/food waste equipment (Equipment must be leak proof and where appropriate, covered)
 Not all of these bullets will apply to the dairy program

1.10.01.05


(A.3.1) Employees Facilities
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
A.3.1.1
Washrooms have hot and cold or warm potable running water, soap dispensers, soap, sanitary hand drying equipment or supplies and cleanable waste receptacles.
Hand washing notices are posted in appropriate areas.		 1.10.01.06
1.10.01.07
A.3.1.2
As required, washrooms, lunchrooms and change rooms are provided with adequate floor drainage and ventilation. They are maintained in a manner to prevent contamination.		 1.10.01.06


(A.3.2) Hand-washing Stations and Sanitizing Installations
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
A.3.2.1
Where required or appropriate, areas of the establishment are provided with an adequate number of conveniently located hands free hand-washing stations with trapped waste pipes to drains.

Hand-washing stations are properly maintained and are provided with hot and cold or warm potable running water, soap dispensers, soap, sanitary hand drying equipment or supplies and cleanable waste receptacles.

Hand-washing notices are posted in appropriate areas.		 1.10.01.06
1.10.01.07
A.3.2.2
Where required/appropriate, areas of the establishment are provided with sanitizing installations, such as:
  • Sanitizing installations for hands
  • Sanitizing installations for boots
  • Sanitizer for operational equipment
Sanitizing installations are properly maintained and are provided with potable water at temperatures and, where applicable, chemical concentrations appropriate for their intended use.		 1.10.01.06


(A.4.1) Water/Ice/Steam Quality, Protection and Supply/strong>
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
A.4.1.1
The establishment has and implements documented water safety procedures to ensure that water and ice meet the potability requirements of the appropriate regulatory authority.

The water safety procedures shall include but are not limited to:
  • Name or title of personnel responsible for the implementation of the water safety procedures
  • Identification of the source of water supply (municipality, private well(s), storage tank(s), etc)
  • Water sampling and testing schedule(s)
  • Identification of the sampling site(s)
  • Water and ice sampling procedures
  • Description of testing activities to be performed
  • Water potability criteria
  • Documentation requirements (records should include the water source(s), sampling site(s), analytical results, analyst and date of sample(s)
  • Deviation procedures when water testing results indicate water potability criteria have not been met
  • Deviation procedures to be applied at the establishment in instances where the municipality identifies a failure with the water system 
  • Record(s)to be kept
 1.10.01.09
Appendix 12 A
A.4.1.2
Where applicable, the establishment has and implements documented water treatment procedures to ensure that:
  • Boiler feed water treatment or any chemically treated water (e.g., corrosion inhibitors, water conditioning and chlorination) that has direct product impact or is used on product contact surfaces meets the appropriate regulatory requirement and is potable
  • Water mixed with chemical and applied on product to reduce the microbial load meets the acceptable chemical concentration for the intended purpose
  • Re-circulated water for reuse meets the appropriate regulatory requirement
The water treatment procedures shall include but are not limited to:
  • Name or title of personnel responsible for the implementation of the water treatment procedures
  • Identification of water treatment activities to be performed
  • Water treatment method/frequency
  • Chemicals used
  • Proper handling and application of water treatment chemicals
  • Acceptable chemical concentrations
  • If applicable, description of any automatic warning control
  • Testing procedure, including testing frequency, to ensure proper concentration is consistently met
  • Documentation requirements (records should include method of treatment, sample site, analytical result, analyst and date)
  • Deviation procedure when the criteria have not been met
  • Record(s) to be kept.
 1.10.01.09
Appendix 1
Appendix 12
Appendix 12 A
A.4.1.3
Where required, hoses, taps or other similar sources of possible contamination are designed to prevent back-flow or back siphonage.		 1.10.01.09
Appendix 12 C
A.4.1.4
Where filters are used they are kept effective and maintained in a sanitary manner.		 1.10.01.09
A.4.1.5
The volume, temperature and pressure of the potable water/steam are adequate for all operational and cleanup demands.		 1.10.01.09
A.4.1.6
Where it is necessary to store water or ice, storage facilities are adequately designed, constructed, and maintained to prevent contamination.		 1.10.01.09


(B 1.1) Food Carriers
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
B.1.1.1
Carriers used for transport of food:
  • Are designed, constructed, maintained and cleaned to prevent contamination, damage and deterioration of the food product
  • Are equipped, where applicable, to maintain food products in a refrigerated or frozen state
  • Are not being used for the transport of any material or substance that might adulterate the food product
 1.10.02.02
B.1.1.2
Carriers are loaded, arranged and unloaded in a manner that:
  • Prevents outside contaminants from entering the establishment
  • Prevents damage and contamination of the finished product, raw materials, ingredients and incoming materials that come in contact with the product or are used in preparing the product
 1.10.02.02


(B.2.1) Purchasing / Receiving / Shipping
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
B.2.1.1
The establishment has and implements documented purchasing procedures to ensure that:
  • Raw material and ingredients are ordered from suppliers/sources approved by the establishment
  • The required information on raw materials and ingredients is maintained on file (e.g., specifications, letters of guarantee, certificate of analysis)
  • Construction materials, packaging materials and non-food chemical products are listed in CFIA's Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products*. Otherwise, the manufacturer has a letter of no objection from Health Canada
 1.10.02.01 (documented purchasing procedures not part of DEIM)
1.10.02.03
1.10.02.04
1.10.02.08
1.10.01.04
B.2.1.2
Returned, defective or suspect product is clearly identified and isolated in a designated storage area, assessed and dispositioned appropriately.		 1.10.02.05
B.2.1.3
Where applicable, receiving of live animals is controlled as per regulatory requirements.
Only approved raw materials, ingredients and materials are received into the establishment.

Incoming raw materials and ingredients are assessed at receiving, where possible, to ensure that the purchasing specifications have been met.*

*Where organoleptic inspections are not effective as a means of confirming material acceptability for these materials, certificate of analysis may be used as a means to verify the commitment made by the suppliers.		 1.10.02.03

1.10.02.04
B.2.1.4
All food safety specifications or requirements of the finished product have been met prior to shipping to retail/the customer. (e.g., temperature, certificate of analysis)

Finished product is adequately protected against intentional or unintentional contamination and deterioration prior to shipping.		 1.10.07.03
1.10.07.04
1.10.02.02


(B.2.2) Storage
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
B.2.2.1
Temperatures of storage areas, processing areas, coolers and freezers meet regulated and/or acceptable temperatures.		 1.10.02.05
1.10.02.06
1.10.02.07
B.2.2.2
Ingredients, finished products and packaging materials are handled and stored in a manner to prevent damage, deterioration and contamination.

Where applicable, ingredients and finished products are prepared in a manner to prevent time and temperature abuse associated with food safety or shelf life.

Where appropriate, rotation is controlled to prevent deterioration.		 1.10.02.03 (B)
1.10.02.05
1.10.02.06
B.2.2.3
Non-food chemicals are received and stored in a dry, adequately ventilated area which is designed such that there is no possibility for cross-contamination of food, packaging materials or food contact surfaces.

When required for ongoing use in food handling areas, non-food chemicals are stored in a manner that prevents contamination of food, food contact surfaces or packaging material.

Non-food chemicals are mixed in clean, correctly labelled containers and dispensed and handled only by authorized and properly trained personnel.		 1.10.02.08


(C.1.1) Design & Installation
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
C.1.1.1
Equipment is designed, constructed and installed to ensure that:
  • It meets regulatory and CFIA program requirements
  • It is capable of delivering the requirements of the process and the sanitation program
  • It is accessible for cleaning, sanitizing, maintenance and inspection and is easily disassembled for those purposes
  • Contamination of the product and food contact surfaces is prevented during operations
  • It permits proper drainage and where appropriate, it is connected directly to drains
  • It is smooth, non corrosive, non absorbent, non toxic, free from pitting, cracks and crevices where there are food contact surfaces
  • It is, where necessary, exhausted to the outside to prevent condensation
Utensils are constructed of non-toxic materials, do not present a foreign material hazard that could contaminate the food, and are easy to clean and sanitize.		 1.10.01.08
1.10.03.01
1.10.03.04
Chapter 16


(C.1.2) Equipment Maintenance Program and Calibration
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
C.1.2.1
The establishment has and implements a documented Preventative Equipment Maintenance Program which includes but is not limited to:
  • A list of equipment that may impact on food safety requiring regular maintenance
  • A preventative maintenance schedule or frequency of preventative maintenance activities
  • The maintenance procedures to perform for each preventative maintenance task
  • Records to be kept to demonstrate that the preventative maintenance tasks have been completed
 1.10.03.01
1.10.03.03
1.10.03.04
1.10.03.05
C.1.2.2
The establishment has and implements a documented Equipment Calibration Program which includes but is not limited to:
  • A list of equipment monitoring and controlling devices that may impact on food safety requiring regular calibration
  • A calibration schedule or frequency of calibration activities
  • The calibration procedures to perform for each calibration task
  • Records to be kept to demonstrate that the calibration tasks have been completed
 1.10.03.01
1.10.03.05
Chapter 18
Appendix 5
Appendix 6


(D.1.1) General Food Hygiene Training
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
D.1.1.1
The establishment has and implements a documented general food hygiene training program which includes but is not limited to:
  • The establishment’s general food hygiene program (see D.2.1.1)
  • A list of employee positions who must receive the training
    • All food handling employees and other employees that may work in food handling areas (e.g., maintenance staff, quality assurance (QA) staff, supervisors, etc.)
  • The frequency of training
    • The training is delivered at the start of employment, whenever changes are made to the program and reinforced at appropriate intervals
  • Records to be kept to prove completion of personnel training.
1.10.04.01


(D.1.2) Technical Training Program
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
D.1.2.1
The establishment has and implements a documented Technical Training Program which includes but is not limited to:
  • The prerequisite programs
  • The CCP(s), if applicable
  • The process control(s), if applicable
  • Any additional external technical training that is necessary to ensure current knowledge of equipment and process technology (e.g., licenses/certification required to operate equipment - HTST operator’s certification / retort operator certification)
  • A list of employee positions who must receive the training
    • Designated employees involved in the delivery of procedures developed in response to the prerequisite programs requirements, CCPs, and process controls
  • The frequency of training
    • The training is delivered before the beginning of assignment and reinforced whenever changes are made and at appropriate intervals
  • A method to confirm that the training has been effectively understood
  • Records to be kept to prove completion of personnel training
 1.10.04.01


(D.2.1) General Food Hygiene Program
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
D.2.1.1
The establishment has and implements a documented General Food Hygiene Program which includes, but is not limited to:
  • Good Manufacturing and Personnel Hygiene Practices:
    • Methods for hand washing/sanitizing
    • Correct use of protective clothing, hair coverings, gloves, footwear
    • Prohibited practices at the establishment
    • Hygienic handling of food
    • Correct use of utensils and equipment
    • Storage of personal effects to prevent cross-contamination
    • Where required, restricted access to areas of the facilities by specific employees to prevent cross-contamination
    • When required, procedures to prevent contamination due to the process flow, employee flow, product flow, equipment or incompatible operations
    • When required, procedures to prevent cross-contamination during production. For example:
      • Glass control and breakage procedures
      • Procedures to follow when:
        • Product falls on the floor
        • Product is exposed to dripping condensation
  • Procedures for visitors and contractors during production including:
    • Restricted Access
    • Hygienic Practices
  • Personnel Health Status:
    • The program must clearly state that personnel must advise management when known to be suffering from a disease likely to be transmitted through food
    • No person is permitted to work in a food handling area when he or she is known to be suffering or a carrier of a disease likely to be transmitted through food
    • Employees having open cuts or wounds should not handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering
 1.10.04.02
1.10.04.03
1.10.04.04
1.10.01.11


(E.1.1) Sanitation Program
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
E.1.1.1
The establishment has and implements a documented Sanitation Program which includes but is not limited to:
  • The sanitation schedule/frequency for all equipment, and for all rooms within the establishment including livestock holding facilities, utensils, waste and inedible/food waste equipment and facilities, work gear etc that, if not kept in a clean/sanitary condition, would have a negative effect on food safety
  • Cleaning and sanitizing procedures including:
    • Details and specifics describing the method and procedures for equipment and room cleaning and sanitizing
    • The chemicals required
    • The chemical concentration level required
    • Proper handling and application of chemicals (duration of application, etc)
    • The chemical solution temperatures, where applicable
    • Equipment disassembly and assembly instructions
    • Methods to prevent cross-contamination, where necessary
  • Housekeeping and sanitation procedures required during operations
  • Pre-operational inspection procedures
  • Environmental sampling procedures, if any
  • Corrective actions to be taken for non-compliant situations observed during pre-operational inspection activities and unsatisfactory environmental testing results
  • Records to be kept
 1.10.05.01
1.10.05.02
1.10.05.03
1.10.07.03


(E.2.1) Pest Control Program
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
E.2.1.1
The establishment has and implements a documented Pest Control Program which includes but is not limited to:
  • Where applicable, the name of the pest control company or the name of the person contracted for the pest control program
  • The name of the person at the establishment assigned responsibility for pest control
  • A schedule or frequency of pest control activities
  • Pest control procedures for the exterior and interior of the establishment including:
    • The pest control activities to be performed
    • The chemicals required for the effective implementation of the pest control program
    • The methods for proper handling and application of pest control chemicals
    • The type and location of pest control devices
    • Corrective actions to be taken for non-compliant situations observed during pest control activities
    • Records to be kept
 1.10.05.04


(F 1.1) Recall Plan
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
F.1.1.1
The establishment has and implements a documented Recall Plan which includes but is not limited to: See FSEP Manual – F.1.1.1		 1.10.06


(F 1.2) Product coding and labelling
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
F.1.2.1
The establishment has and implements documented operational procedures to ensure that:
  • Finished products are correctly and legibly coded
  • The finished product label information accurately represents the product name and the composition of the product on which the label is affixed
The procedure to prevent product mislabelling/miscoding shall include but is not limited to:
  • The names or title of personnel responsible for particular task
  • Frequency of activity
  • Description of the task to be performed
  • Corrective actions to be taken when product is mislabelled or miscoded
  • Operational records to be kept
 1.10.06
1.10.07.01
1.10.07.02


(G.1.1) Allergen Control Program
FSEP Manual 2010
Prerequisite Program Requirements		 Reference to Chapter 10 DEIM – Prerequisite Programs
G.1.1.1
Where applicable, procedures and/or policies are developed and implemented to ensure proper control of new or modified product formulations. This must include a minimum of:
  • A product development and approval process flow including steps to be followed when modifications to existing product formulations are made
  • Communication links among all the steps in the chain of production once a new formulation or changes in a formulation have been approved
 1.10.07.01
1.10.07.02
G.1.1.2
Where applicable, procedures and/or policies related to purchasing of ingredients are developed and implemented to ensure proper control and identification of allergens for incoming ingredients. This must include a minimum of:
  • Identification of any allergens not allowed in an establishment if such a policy is in place
  • A list of approved suppliers and ingredients
  • Supplier specification for each ingredient or ingredient blend clearly listing each ingredient and, where applicable, components of ingredients
  • Documentation indicating that the supplier will:
    • Meet the establishment’s specifications
    • Notify the establishment when a change is made to their ingredient blend formula which adds or eliminates an allergen or in the case of sulphites, increases or decreases the level of sulphites
 1.10.02.03
1.10.07.01
1.10.07.02
(DEIM not as detailed as in FSEP)
G.1.1.3
Where applicable, procedures and/or policies are developed and implemented to ensure proper control of new or modified labels. This must include a minimum of:
  • A label approval process including steps to be followed in case of re-approval of product labels resulting from modifications to existing product formulations 
  • Communication links among all the steps in the chain of production once a new label, or changes to a new label, have been approved
 1.10.07.01
1.10.07.02
G.1.1.4
Where applicable, procedures and/or policies related to receiving of ingredients and externally printed labels are developed and implemented to ensure that:
  • Only approved ingredients from approved suppliers/sources are received
  • The labels of approved ingredients received match the establishment’s finished product list of ingredients and components of ingredients
  • Externally printed labels meet the specifications
 1.10.02.03
1.10.07.02
G.1.1.5
Where applicable, procedures associated with Weighing/Blending/Mixing/Formulation are developed and implemented to ensure that the correct ingredient is added to the correct product as indicated in the formula. This must include a minimum of:
  • The names or titles of personnel responsible for these particular tasks
  • Methods or instructions for the task(s) to be performed
  • Corrective actions to be taken when deviant situations occur during any of these steps
  • Operational records to be kept
 1.10.07.01
1.10.07.02
G.1.1.6
Where applicable, procedures and/or policies related to the use of rework are developed and implemented to ensure that the rework formulation ingredients and the product formulation ingredients match, specifically as it applies to allergen ingredients.		 1.10.02.05 (F)
1.10.07.01
1.10.07.02
G.1.1.7
Where applicable, procedures related to labelling of finished product are developed and implemented to ensure that the finished product label information accurately represents the product name and the composition of the product on which the label is affixed
This must include a minimum of:
  • The names or title of personnel responsible for particular tasks
  • Frequency of activity
  • Methods or instructions for the task(s) to be performed
  • Corrective actions to be taken when product is mislabelled
  • Operational records to be kept
 1.10.07.02
G.1.1.8
Where applicable, procedures and/or policies for disposal of obsolete materials are developed and implemented to prevent their inadvertent use. Obsolete materials include:
  • Labels (refers to any pre-printed packaging that bears a list of ingredients)
  • Formula documents, and
  • Ingredients and work in process
 Requirement not in DEIM
G.1.1.9
Where applicable, procedures and/or policies are developed and implemented to control cross-contamination of undeclared allergens in the food products. Procedures include as a minimum, the management and control of:
  • Production scheduling if dedicated lines for allergens are not available
  • Traffic patterns of employees who handle allergens and non allergens
  • The traffic flow and handling of ingredients containing allergens during receiving, storage, processing and packaging
  • Dedicated or segregated storage of ingredients containing allergens
  • The identification and sanitation of bulk containers housing allergens or ingredients containing allergens
  • Dedicated utensils, equipment and areas used to handle allergens
  • The handling and storage of rework product(s) containing allergen ingredients
  • Cleaning of equipment/food contact surfaces/areas during operations if dedicated lines/equipment/areas for allergens are not available
 1.10.07.02 (DEIM not as detailed as in FSEP).
1.10.05.01
1.10.04.02
1.10.04.04
1.10.02.05 (B)