Canadian Food Inspection Agency - Meat Hygiene Manual of Procedures - Chapter 4

Refrigeration, which includes both chilling and freezing, plays such an integral role in the production and storage of meat products, that its importance cannot be over-stressed. Because refrigeration is involved so extensively in many operations, many references will be found in other chapters and sections of this manual, and these will be indicated as cross-references in the text of this section. There are, however, several aspects of refrigeration which will only be dealt with here.

The primary purpose of refrigeration is to preserve meat products by slowing down the chemical and enzymatic changes which occur in tissues after slaughter, and by slowing down or stopping the multiplication of microorganisms which might give rise to spoilage or food poisoning. Refrigeration of the environment in which meat products are handled is also important, not only in producing and maintaining lowered temperatures in the products themselves, but also in depressing the rate of multiplication of microorganisms in the environment. Refrigeration has, therefore, an important role to play in the field of sanitation (see Chapter 3). A secondary purpose of refrigeration is its application to destroy parasites (trichinae and cysticercus) which may be present in certain meat products (see 4.10.2).

A major problem experienced with refrigeration is condensation, which occurs when relatively warm, humid air strikes a cold surface. Condensation can be reduced by insulating cold surfaces, increasing air circulation within a room, and by reducing the flow of warm air into refrigerated areas. In rooms where condensation occurs, measures must be taken to protect meat products. This latter type of control consists of the use of drip pans and ducts, the wiping or sponging of surfaces and the placement of exposed product in areas where the dripping of condensation does not occur.

(4) Refrigeration of red meat products (including ostriches, emus and rheas but excluding other poultry )

The specifications for rooms and equipment used for the chilling, storing and freezing of red meat, red meat products and edible offal are found in Chapter 2, sub sections 2.8.5 thru 2.8.7 of this manual.

Includes all products defined as a meat by-product under the Meat Inspection Regulations (e.g. kidneys, livers, tendons, stomachs, rumen parts, lungs, spinal cords, etc.) and the following products defined as meat under the Meat Inspection Regulations: tongues, diaphragms, feet, cheek meat, head meat, hearts, oesophagus and tails.

Includes dressed carcasses, parts of dressed carcasses including trimmings, offal as defined above, ground meat and mechanically separated meat, either fresh or frozen.

(a) Cooling performance standards for the chilling of RED MEAT CARCASSES AND CUTS (primal cuts, sub-primal cuts, cuts, trim and offal)

Cooling performance standards are designed to prevent the outgrowth of pathogenic bacteria and spoilage organisms that can be caused by inadequate cooling practices. As a general rule, refrigeration of carcasses must begin promptly after the end of carcass dressing and product should be cooled as quickly as possible.

Tongues, cheek meat, head meat, skirt meat, feet and tails are to be cooled in the same manner as other red meat offal - refer to section 4.8.

The operator shall ensure and demonstrate in an ongoing manner through their HACCP system that they are achieving compliance with the following cooling performance standard for red meat carcasses and cuts:

Alternative cooling processes are defined as cooling processes which do not meet the cooling performance standard defined above. Operators who wish to apply for acceptance of an alternative cooling process should present the draft project to the Inspector in Charge who will contact the Red Meat Programs Specialist for the Area. The proposal will need to be assessed at the headquarters level, and may involve a review by Health Canada. The proposal must be supported by scientific data provided within the submission. Operators should be advised that the time required to review and accept an alternative cooling process will depend on the quality of the submission and will be lengthy. The alternative cooling process cannot be used prior to having been accepted by the Chief, Red Meat Inspection Programs.

Fat which is collected during evisceration or boning/cut-up and which is directly sent to edible rendering, (excluding the fabrication of partially defatted meats as described in section 7.22.8), does not have to be pre-cooled to 4°C. However the operator must handle and send the fat to the rendering facility in a manner which ensures its wholesomeness and prevents its rancidity.

There is no provision in the Meat Inspection Regulations for raw, single-ingredient meat products to retain water as the result of post-evisceration processing in excess of naturally occurring moisture except as provided for dressed poultry carcasses in Section 25. However, data recently made available by the industry to the CFIA indicates that raw single-ingredient meat products, other than red meat carcasses, may contain water absorbed and retained as a result of washing and chilling procedures.

The United States Department of Agriculture / Food Safety and Inspection Service (USDA / FSIS) implemented on January 9, 2003, regulations that limit water retained by raw single-ingredient meat products from post-evisceration processing, such as carcass washing and chilling, to the amount that is unavoidable in meeting applicable food safety requirements and that require labelling for the amount of water retained. Raw single-ingredient meat products, including carcasses, carcass parts, offal, etc. will not be permitted by FSIS to retain water resulting from post-evisceration processing unless the establishment preparing those products, demonstrates with data collected in accordance with a written protocol, that any water retained in the products is an inevitable consequence of the process used to meet applicable food safety requirements. In addition, the establishment will be required to disclose on the label the maximum percentage of retained water in the raw single-ingredient meat product.

The CFIA is considering amending the Meat Inspection Regulations to harmonize them with the US Finale Rule: Retained Water in Raw, Single-Ingredient Meat and Poultry Products. In the interim, processes (e.g. chilling, pathogen reduction interventions) by which offals are retaining water will be tolerated on the condition that the operator develops and implements a written and validated retained water control program as per the FSIS regulatory amendment (for details refer to Annex Y and Y-1, US section, Chapter 11, of this manual).

Operators using a post-evisceration process that results in water retention in a raw single-ingredient meat product must maintain on file a written data-collection protocol in accordance with Annex Y and Y-1, US section, Chapter 11, of this manual).

An operator does not have to maintain a protocol on file if it has data or information that clearly demonstrate that its products do not retain water as a result of the process. However, the test data and a copy of the corresponding carcass washing and chilling procedures shall be maintained on file and be copied to the Veterinarian-in- Charge.

A no-retained-water statement may be included on the label when product has not been exposed to a post-evisceration process that adds water, or the establishment has data or information that establishes that the process does not add water to the product. Further information on the labelling of moisture retention declarations is contained in Chapter 7, section 7.6.9 of this manual.

CFIA does not require establishments to use any specific method to make a retained water determination. The method chosen in calculating water absorption and retention, however, should be reproducible and verifiable. For example, an operator may use physical water pick-up tests, weighing carcasses post-evisceration, before the use of water directly contacting product, and again just prior to final packaging and labelling. Likewise, an operator may develop a protocol based on laboratory analysis for naturally occurring and total water content of carcasses before and after the application of water for food safety purposes. Further details on laboratory testing is contained at the end of Annex Y-1, US section, Chapter 11, of this manual.

The following are examples of post evisceration processes involving the use of water that would not require subject products to be processed under a retained water control program:

However, if the scalded, flushed or washed products are then chilled by contact with water and /or ice, then the chilling procedures (only) would require a written and validated retained water control protocol.

Note: On a case-by-case basis, the Veterinarian-in-Charge, in consultation with his or her Regional Veterinary Officer and the Area Program Network Officers will evaluate other post evisceration processes involving the use of water to determine whether the resulting products require a retained water control program.

Food safety requirements which must be met and which must be included in the protocol are cooling performance standards listed in 4.10.1(4)(a).

(i) Dressed carcasses and cuts (primal cuts, sub-primal cuts, cuts and trim) :

Carcasses shall be dressed, including trimming and washing, as per sub section 4.5 of this chapter. Thereafter, carcasses shall be chilled according to a cooling process which achieves the performance standards as indicated in the previous sub section 4.10.1.(4)(a). Chilling operations shall be performed according to the applicable HACCP system, and the corresponding written and validated program to control retained water. A separate retained water control program is required for each species of livestock including ostriches, rheas, and emus and shall cover young (e.g. hide-on calves) as well as for mature livestock (e.g. one for heifers, steers, cows, and bulls).

For carcasses and / or parts, if the initial validation data indicates that less than 0.5% water is retained by the washed and chilled carcasses as shipped or when packaged as portions, then no further testing is required by the Operator to monitor moisture retention other than a single annual test to verify that less than 0.5% water is retained by the washed and chilled carcasses. Test data and a copy of the corresponding carcass washing and chilling procedures shall be maintained on file and be copied to the Veterinarian-in-Charge. However, for carcasses which are spray chilled, refer to sub section 4.10.1(4)(c), below, of this chapter.

If the edible offals retain water at or above 0.5%, the sample size, sampling frequency and accept/reject criteria for the applicable retained water control program(s) shall be at least equivalent to that specified for poultry carcasses as contained in sub section 4.10.1(6), of this chapter. However, if the moisture retention is less than 0.5%, as shown by the written and validated retained water control program specified above, then further sampling and testing is not required by the Operator to monitor moisture retention, other than a single annual test to verify that less than 0.5% water is retained by the washed and chilled edible offal, if the operating parameters specified in the protocol are monitored and controlled as part of a HACCP System for the chilling of edible offal. Test data and a copy of the corresponding offal harvesting and washing procedures shall be maintained on file and be copied to the Veterinarian-in-Charge.

However, no protocol is required for offal that is harvested and washed as per section 4.8 of this chapter and then has no other contact with water, provided that water which is absorbed and retained as a result of the washing process is less than 0.5%. Test data and a copy of the corresponding offal harvesting and washing procedures shall be maintained on file and copied to the Veterinarian-in-Charge.

(c) Requirements to permit spray chilling of red meat carcasses (including ostriches, rheas and emus but excluding other poultry)

Spray chilling of beef and hog carcasses has become a relatively common procedure. There have been certain complaints as to the possibility of reduced shelf life in product chilled in this manner but this is considered to be an industry problem to be reconciled by the industry unless a health hazard becomes demonstrable. The other problem is the possibility of increasing the weight of the carcass over its hot dressed weight. Because of this latter possibility the following requirement is being imposed on establishments using or contemplating the use of spray chilling for red meat (including ostrich, rhea and emu) carcasses.

Management are to put in place a documented control program for moisture pickup in carcasses involving the random selection and weighing of sample carcasses prior to leaving the coolers for shipping or further processing to assure that their weight does not exceed the green weight as recorded on the kill floor after trimming and before carcass washing.

The sample size in the following table is based on "Sampling Plans Indexed by Acceptance Quality Limit (AQL) for Lot-by-Lot Inspection", ISO/ 2859-1, (Identical to Canadian Government Specifications Board (CGSB) STANDARD ON INSPECTION BY ATTRIBUTES 105-GP-1 or Military Standard 105-D (MIL-STD-105D) of the United States Department of Defence). However, the Acceptance Quality Limit (AQL) has not been determined from a baseline survey but has been found to be very low in practice resulting in an AQL of 0.40 being selected for this test. Therefore, throughout the table, the accept number is always zero (0) and the reject number is one (1).

Management are to divide the carcasses into lots of a designated size. The maximum lot size that can be defined is the production from one kill shift. The number of carcasses that make up the sample depends on the lot size according to the following table:

		Number to be weighed
Lot size	*(Code Letter)**	Normal	Reduced
1-25	A/B	2	2
26-150	C/D	8	3
151-280	E	13	5
281-500	F	20	8
501-1200	G	32	13
1201-3200	H	50	20
3201 & over	J	80	32
	* for reference only

The carcasses to make up the sample are selected at random, prior to the final wash and leaving the kill floor and are identified. Their weights are noted and totalled. In plants where computer tracking systems or their equivalent are installed the information generated by these systems may be used as an alternative for identifying and tracking carcass weights. After chilling, and before further processing or shipping the carcasses are reweighed and the total combined weight of the sample carcasses is calculated. If the combined weight of the sample carcasses making up an individual lot after chilling is equal to or less than the combined hot green weights of the same sample carcasses taken prior to the final carcass wash when leaving the kill floor then the process is considered to be in control.

To account for scale variability a tolerance of no more than 0.5% over the hot green weight is permissible in the weight of the sample lot after spray chilling. If the combined chilled weights of the sample lot are greater than the combined hot green weights of the sample lot plus a tolerance of 0.5% then the process is considered to be out of control and corrective actions are to be implemented.

Corrective actions will include immediately notifying the Veterinarian-in-Charge or inspection staff of the establishment that the process is out of control. The establishment will begin an immediate investigation of the non-conformance and steps will be taken to correct the process adjusting spray chill, etc. if required and the Veterinarian-in-Charge advised of the corrective action taken.

Although a tolerance of 0.5% is permitted to allow for scale variability on an individual lot basis if any increases over hot, green weight after spray chilling occur routinely then the process will be judged to be out of compliance and corrective action required.

Initially the normal sample size is to be used until 5 consecutive lots have been found in compliance. At this time the company may switch to the reduced sample size and sample only one out of 5 consecutive production shifts. If at any time a lot is found to be out of compliance, sampling using the normal sample size must be resumed until 5 consecutive lots are in compliance. Product out of compliance shall be detained until brought back into compliance with applicable retained water requirements in the Meat Inspection regulations and this manual.

The company must keep records indicating the date of slaughter, sample carcass identity, hot green weight and weight prior to further processing or shipping. Records of action taken when non-compliance is detected must also be kept. All records should be retained for at least 12 months.

1. write and validate a proposed protocol to control the amount of water for each applicable single-ingredient meat product for which water is added and retained as a result of post-evisceration contact with water

2. submit each written and validated protocol to the Veterinarian or Inspector-in-Charge for CFIA acceptance.

3. operate retained water control programs according to the corresponding CFIA accepted retained water control protocol and so as to ensure compliance with the Meat Inspection Regulations and this manual

4. inform the Veterinarian or Inspector-in-Charge whenever changes will be made to operations covered by a CFIA accepted retained water control protocol

5. obtain CFIA acceptance for any amendments to a CFIA accepted retained water control protocols

6. maintain a copy of all CFIA accepted retained water control protocols on-site

The Veterinarian or Inspector-in-Charge is to assess (in consultation with the area red meat program officers) submitted new or amended proposed retained water control protocols and accept those which are deemed to be satisfactory.

As determined by the Multi Commodity Activities Program (MCAP), inspectors are to verify that operations conform to the CFIA accepted retained water programs, check company records and physically monitor the weighing process. Records are to be kept of the verification inspections performed and of the results and retained at least 12 months.

Freezers, whether blast or holding freezers, should be routinely monitored with respect to proper maintenance. Since product in freezers is routinely protected, there is less risk of the product being contaminated than in coolers, but continuous monitoring for broken cartons or accidentally exposed product should be undertaken. Such product is at risk not only to contamination, but also to freezer burn.

Good housekeeping in freezers is important. Ice build-up should not be tolerated and cartons should be stacked neatly. Badly stacked cartons and ice accumulation pose a real safety risk. A record of product in storage must be maintained and product turnover practised by plant management to prevent frozen product remaining in storage for extended periods of time.

Ice is extensively used in registered establishments, particularly in poultry operations.

All ice-making and crushing equipment and storage facilities must be closely and carefully monitored for correct maintenance. Ice bins should be carefully checked when empty. Ice should be frequently and carefully examined for the presence of foreign material. If ice is brought in from an outside source, transport vehicles must be monitored and all ice must be clean before its use in the establishment can be permitted.

If it is necessary for employees to enter the ice storage area, they must do so while wearing a pair of clean rubber boots which are exclusively used for this purpose. These boots must be adequately identified and never worn outside the ice storage area. All equipment used in handling the ice (shovels, pails, chutes, crushers, etc.) must be constructed of approved materials and be kept in a good state of repair.

Ice samples shall be subjected to routine testing (see 3.2). If ice is brought in from an outside source, it must also be tested.

(6) Refrigeration of poultry meat products (excluding ostriches, rheas and emus)

Chilling requirements for ostriches, rheas and emus are contained in section 4.10.1(4), "Refrigeration of red meat products (including ostriches, emus and rheas but excluding other poultry)", of this chapter.

Carcasses of cattle and sheep showing a slight infestation, as indicated in 4.7 may be passed as food if:

(i) the lesions of Cysticercus bovis and Cysticercus ovis and the surrounding tissues are removed and condemned; and

(ii) the carcass or the meat derived from the carcass that was affected by Cysticercus bovis is held in a freezer under inspectional control. The temperature shall not exceed -10 C and be maintained for not less than 10 days; or

(iii) under inspectional control for meat product mentioned in (ii) above, the meat is heated throughout to a temperature of at least 60 C.

Pork products (striated muscle) or meat products containing pork striated muscle, which are customarily eaten without further cooking or which have the appearance of a cooked meat product, shall be subjected to cooking, freezing, curing or another approved procedure to ensure the destruction of all live Trichinella.

All forms of fresh pork containing striated muscle, including fresh unsmoked sausage containing pork muscle tissue, and pork products designated as side bacon, Wiltshire bacon or smoked pork jowls are exempted when prepared for the Canadian market and, unless specified otherwise in Chapter 11 of the MOP, for export markets.

All smokehouses or other cooking devices, freezers, and any other room/device, used for the destruction of Trichinella in pork or pork products shall be equipped with accurate automatic devices that continuously record time/ temperature (see 2.8.11).

Time/temperature recorders and thermometers used in registered establishments shall be tested for accuracy against a known accurate standard thermometer and clock. Such tests shall be performed just prior to installation and at least once a year thereafter or more frequently as may be necessary to ensure their accuracy. A dated record of such tests shall be kept, along with the responsible person, and the necessary information on deviations and appropriate corrective actions.

For heating and curing methods used to ensure the destruction of viable Trichinella in striated pork muscle or meat product containing striated pork muscle, the operator is responsible for keeping current and accurate records which document all parameters required for process control (e.g. lot identification, time/temperature records, % salt, casing diameter, etc.), the critical limits which must be respected as well as the actual measurements confirming that the critical limits were met and, when a process deviation has occurred, the corrective action taken.

The controls for the freezing of product to ensure the destruction of Trichinella are described under section 4.10.2.(2) (b).

All control records shall be verified on a regular basis and kept at the establishment for at least one year or for the duration of the shelf life of the product if the latter is greater than one year. The inspector is responsible to maintain freezing log books. Curing and heating records shall be available to the inspection staff at all time upon request.

All parts of the pork muscle tissue shall be heated according to one of the time/temperature combinations listed in table 4.10.2.(2) (a).

1 - The time to raise internal product temperature from 15°C to 49°C shall not exceed 2 hours unless the product is cured or fermented.

2 - Time, when in combination with internal product temperatures of 59°C to 62°C, does not need to be monitored if the product's minimum thickness exceeds 5,1 cm and refrigeration of the product does not begin within 5 minutes of attaining 59°C.

The operator shall use procedures which ensure the proper heating of all parts of the product. It is important that each piece of sausage, ham, and other product treated by heating in water be kept entirely submerged throughout the heating period; and that the largest pieces in a lot, the innermost links of bunched sausage or other massed articles, and those pieces placed in the coolest part of a heating cabinet, compartment or cooking vat be included in the temperature test.

Temperature monitoring shall therefore be conducted at the center of the largest pieces and at the coldest spot of the vat, heating cabinet or smokehouse. Plant management shall keep records of their monitoring procedures including results, process deviations and corrective actions. Both plant monitoring procedures and records should be routinely verified by inspection staff. Written records are to be kept to that effect by inspection staff.

Freezers or floor to ceiling cages used for the destruction of Trichinella shall be kept locked by the Inspector-in-Charge to ensure that product is not tampered with.

The keeping of the freezing log book is the inspectors's responsibility. Before product can be put in or be removed from the locked freezing area, the log book (as per annex B/1) shall be completed by the inspector. After having checked that the lot has met critical limits, the inspector will sign the log book and allow product to be removed from the freezing area.

After completion of the prescribed freezing, boxed product shall be stamped on the main panel of each box "Frozen for the control of Trichinella ". The letters of the stamp shall be of a minimum of 5 mm. These stamps shall be kept under the inspector's control at all time. In the case where the treated product is intended for export, the inspector will complete the attestation of freezing (see annex B/2) and will send the completed form with the CFIA 1454 to the veterinarian who will sign the export documents.

Highlights of the various approved freezing methods for destroying trichinae

When this method is used, pork striated muscle or products containing pork striated muscle tissue, after preparatory chilling to a temperature of 4°C or less, shall be kept frozen at the indicated temperature for an uninterrupted length of time equal or longer to the one specified in the following schedule:

Insulating packaging material shall be removed prior to the commencement of the freezing process. Boxes shall be stacked in such a way as to permit air circulation and to permit product to reach the freezing room temperature as quickly as possible (spacers required and no shrink wrap).

Freezing time calculation shall begin only from the moment that the freezer's temperature reaches the specified value. In cases where the freezer temperature exceeds the specified maximum temperature indicated in the freezing schedule, the operator shall either use a different time-temperature schedule which allows for the higher temperature or shall restart the counting of the number of uninterrupted freezing days from the moment that the freezer temperature returns below the specified maximum.

When this method is used, pork muscle or products containing pork muscle tissue, after preparatory chilling to a temperature of 4°C or less, shall be kept frozen at the indicated temperature for an uninterrupted length of time equal or longer to the one specified in schedule 4.10.2. (2) (b) (ii).

In case of doubts, the documented case should be submitted to the Chief, Food Borne Pathogen Unit of the Science and Technology Services.

In lieu of the methods prescribed in sections 4.10.2. (2) (b) (i) and (ii) above, products containing pork striated muscle may be treated by means of commercial freeze drying or controlled freezing. When using this method # 3,there is no obligation to use spacers and the use of shrink wrap around pallets is acceptable.

Product brought in already frozen shall be treated in accordance with one of the time/product internal temperature combinations specified in table 4.10.2. (2) (b) (iii). For each lot, the internal temperature is to be monitored by a thermocouple placed in the CENTRE of the thickest piece of meat and in the warmest location of the freezer (not close to cooling equipment). The temperature shall be measured with properly calibrated thermoelectric instruments (recording thermometers) and continuously recorded. The charts shall include pertinent information and, at least, the lot number, its description, the number of boxes, date in, date out, and the signature of the inspector.

Table 4.10.2. (2) (b) (iii) Freezing Method # 3 to Ensure Destruction of Trichinella
*Product Internal* Temperature(°C)**	Minimum Time (hours)
-18.0	106
-21.0	82
-23.5	63
-26.0	48
-29.0	35
-32.0	22
-35.0	8
-37.0	½

¹ Temperature, when measured in degrees Celsius, shall be measured to the next lowest tenth of a degree C° or, in the case of temperature measuring devices unable to attain such a degree of accuracy, to the next lowest degree C. For example, if a thermometer is not accurate enough to read -23.5°C, the meat shall be frozen to -24°C.

For methods # 1 and # 2, the control of the freezing temperature is accomplished by monitoring the freezer's ambient temperature.

For method # 3, the same control is exerted through the use of a thermocouple in the centre of the warmest piece of meat.

A fourth method has been found acceptable. This method is based on both types of controls to ensure the destruction of trichina.

When using this method # 4, there is no obligation to use spacers and the use of shrink wrap around pallets is acceptable.

The purpose of this first step is to ensure that the temperature of all products of the lot to be treated has attained a temperature equilibrium with the freezer' temperature. For each lot, the internal temperature is to be monitored by a thermocouple placed in the CENTRE of the thickest piece of meat and in the warmest location of the freezer (not close to cooling equipment). For doing so, as soon as the product is brought into the freezer, a thermocouple is placed at the centre of the warmest box of the lot. This box is then placed at the centre of the largest pallet. The temperature shall then be measured with properly calibrated thermoelectric instruments (recording thermometers) and continuously recorded until product temperature at the centre of this box is the same as the freezer's ambient temperature.

At this time, the thermocouple may be removed. The freezing time calculation may begin. The treated products shall be kept frozen at the indicated temperature for an uninterrupted length of time equal or longer to the one specified in schedule 4.10.2. (2) (b) (i) or 4.10.2. (2) (b) (ii).

For each lot treated, the operator shall keep the charts of the two steps to clearly demonstrate the control that is exerted. Records for the two steps shall be kept on file for each lot. The charts shall include all pertinent information and, at least, the lot number, its description, the number of boxes, date in, date out, the freezing method used and the signature of the inspector. In any case, the official log book (Annex B/1) shall be completed.

This method is based on the protocol for freezing meat products in bulk containers (see Annex P) and Table 4.10.2 (2)(b)(iii). It applies only to big cuts of meat in bulk containers (e.g., a ham with bone) and has two steps.

The first step consists in ensuring that all refrigerated products that will be put in bulk containers will reach a temperature of -18°C or lower, according to a protocol that has been validated and approved by the CFIA.

From the outset of the freezing process, core temperature must be monitored for each lot to be treated using a thermocouple inserted in the MIDDLE of the biggest cut of meat located in the warmest part of the freezer (not close to a refrigeration unit). Temperature must be recorded on a continuous basis using properly calibrated thermoelectric instruments (recording thermometers).

A protocol must be submitted, validated and approved in compliance with Annex P of this chapter.

Freezing time for the treatment to destroy trichinae starts now. Treated products must be kept at the prescribed temperature without interruption for the amount of time specified in Table 4.10.2. (2)(b)(iii).

The thermograms for each lot processed in each step should be preserved to clearly demonstrate that the proper controls have been applied. The temperature recordings for both steps must be kept, along with all pertinent information, notably the lot number, lot description, number of bulk containers, date of entry and removal, and the inspector’s signature. The official logbook (Appendix B/1) must always be completed.

Acceptable curing methods to ensure the destruction of Trichinella in striated pork muscle and meat products containing striated pork muscle are provided in Annex A of this chapter.

Subject to approval by the Director, Meat & Poultry Products Division, treatment processes for the destruction of infective Trichinella in pork striated muscle and meat products containing pork striated muscle, other than those identified in sections 4.10.2 (2) (a), (b), and (c), may be used.

Proposed methods must be demonstrated to the satisfaction of the Director to be safe and to be verifiable by inspection staff. Data must be collected for assessment according to an experimental protocol which has been previously reviewed and accepted by the Director.

The purpose of this section is not to explore the processing procedures in great detail, but rather to indicate the more important points of control where an inspector should direct his efforts when monitoring such operations. Inspectors must familiarize themselves with all operations and processes that are being carried out in establishments under their control. It is recommended that an inspector consults text-books in order to better understand the physical and chemical changes that may occur in meat products undergoing various forms of manipulation.

Sanitation is all important, particularly where complex pieces of equipment are utilized. The inspector must monitor that this equipment is being adequately dismantled and cleaned and is receiving a careful preoperational inspection by management. Also, in respect to sanitation, room temperatures are critical and those rooms which requires low temperatures must be strictly monitored for compliance and prompt corrective action must be initiated where necessary. Processing often requires adherence to a standard or registered formulation. Where a formulation is involved, recipes must be available to both the responsible, assigned employees and to inspection staff for reference purposes.

This may be performed in either air or water. Thawing of meat must be done as rapidly as possible given the defrosting process being used. The temperature of the meat is to be controlled to minimize the time that the temperature, in any portion of the meat, is above 4°C. Acceptable active methods could be, for example, the use of microwaves, forced air, continuously circulating water, etc. that are operated under Good Manufacturing Practices. When air is used as a thawing medium, the product surface temperature shall not exceed 7°C. Where meat products are thawed in water, the water must be cold, potable and continuously exchanged. Packaging material (e.g., boxes) shall be removed prior to thawing. However, meat products packaged in plastic bags may be thawed without removing these plastic bags.

Thawing shall be monitored to determine when all portions of the meat have thawed (i.e., have reached a temperature of 0°C or greater). As soon as thawing is complete, product is immediately processed or stored at a temperature of 4°C or less. When water is used, it is directly drained before storage.

In order to achieve proper cooking, the internal temperature of a cooked meat product must be taken at the coldest spot in the cooking device and in the centre of the largest piece of meat. It is the operators responsibility to ensure that the minimum internal temperature of the cooked meat product meets regulatory requirements. When steam is generated, it must be properly vented out of the area and not allowed to permeate into adjoining rooms. It is the operators responsibility to ensure internal temperatures are taken and records are kept. Cooking records include at least; time and date, name of product, batch number (if more than one batch), quantity of product, cooking device (if more than one), required internal temperature, internal temperature measured and the responsible employees initial.

A potential hazard associated with Salmonellae and Clostridium perfringens food poisoning from consumption of pre-cooked rare beef has been identified. In order to avoid incidents of this nature, cooking procedures employed in registered establishments must ensure the destruction of all vegetative forms of these pathogens.

Beef heated to an internal temperature of less than 60C retains a bright red internal colour (rare beef); that heated to an internal temperature of 60 - 70C develops a pink internal colour (medium cooked beef); and that heated to an internal temperature of 70 - 80C develops a greyish-brown colour throughout (well done beef).

The achievement of an internal temperature of 63C in a meat product will effectively destroy Salmonellae and vegetative Clostridium perfringens organisms. These pathogens will be destroyed at lower internal temperatures provided these temperatures are maintained over a longer period of time.

In registered establishments, pre-cooked beef shall be prepared by a procedure that achieves a minimum internal temperature of 63C, verified by readings taken with a thermometer having a precision of plus or minus 0.6C, or shall be prepared by one of the alternative processes detailed under (3), on condition that:

(i) Alternative Process Number 1 (Preparation of Moist Cooked Beef or Cooked Corned Beef)

The beef is prepared by packaging in an impermeable film prior to heating. The heat treatment shall comply with one of the temperature/time relationships outlined in the following table:

*Minimum Internal Temperature/Times*
C	*Minutes*
62.5	5
62.0	6
61.5	8
60.5	10
60.0	12
59.5	15
59.0	19
58.5	24

(ii) Alternative process Number 2 (Preparation of Roast Beef at a Specified Relative Humidity)

In this process beef is cooked, without being packaged in impermeable film, by the application of dry heat or steam at a specified relative humidity. Although the time/temperature relationships listed in Alternative Number 1 must be respected, a minimum maintenance time is required even at the higher internal temperatures. This time shall be at least one hour in an oven while maintaining a relative humidity of not less than 90%.

(iii) Alternative Process Number 3 (Preparation of Roast Beef without a Specified Relative Humidity)

Processes similar to, but not incorporating the relative humidity requirements of Alternative Process Number 2, may be used for beef cuts which have an individual weight of 4.5 kilograms or more. The time/temperature relationships outlined in Alternative Number 1 must be complied with; however, the oven temperature shall be maintained at 121C or higher throughout the process.

To prevent growth of heat shocked Clostridium perfringens spores, the moist cooked beef and roast beef shall be cooled quickly, traversing the "danger zone" between 50 and 20C in less than 2 hours. Cooked corned beef shall be cooled according to Section 4.10.3(4) of this manual.

Manufacturers must code or calendar date all containers of cooked beef, roast beef and cooked corned beef.

This section is intended to guide both industry and inspection personnel in their evaluation of cooling procedures for heat processed meat and poultry products. It should not be interpreted as a standard but more as a guideline for companies to adopt good manufacturing practices. Its application will contribute to the microbiological safety of such products.

To comply with sections 4, 9, 20 and 22 of the Meat Inspection Regulations, Part I, the processor is responsible for ensuring that all heat processed meat and poultry products are handled and chilled so the product is maintained in a wholesome and unadulterated state. A cooling schedule should be developed and filed for every type of heat processed product. Even though each lot does not necessarily have to be monitored, the chilling process shall be monitored to demonstrate that each lot complies with the established cooling schedules. Those records showing adherence to the schedule (product time/temperature) should be maintained on file for a period of at least twelve months beyond the shelf life (best before) of the product and made available to the inspector on request. These guidelines are in line with Health Canada's proposed GMP Regulations.

The actual section covers all heat processed (including pasteurized products) red meat and poultry products except:

Most common food-poisoning bacteria can grow from 0°C up to 54°C; however, their range of rapid growth is from 27°C to 54°C. Thus, it is very important to cool product effectively but it is even more important to cool it quickly through this rapid growth range.

These guidelines for slow cooling are applicable for a meat product that is formulated:

Processors may elect to use the slow cooling schedule for those heat processed cured products previously defined if the product satisfies condition 1 and one of the two choices in condition 2:

With the exception of those products included in section 1.1, processors should use the following rapid cooling schedule to rapidly and continuously cool all heat processed products, in order to minimize growth of pathogenic bacteria in/on their products,

To cool their products rapidly and continuously, processors should use one of the 2 following alternatives:

The following applies to heat processed product kept in intermediate storage temperatures. Products heat processed to 69°C or more and then cooled from 54°C to 18°C within 2 hours may be held for up to 4 hours if they are:

1. kept below 18°C during the 4 hours, AND
2. protected from post cooking contamination (e.g., covered, wrapped,...), AND
3. cooled to 4°C within 2 hours immediately at the end of the 4 hour holding period.

For any other chilling process not meeting the previous guidelines (slow, intermediate or rapid cooling rates), submit the cooling process and all relevant data for evaluation to the Chief Processing Inspection Programs who will consult with the Chief, Foodborne Pathogen Unit and, as necessary with Health Canada, and modify the guidelines accordingly.

It is generally recognized that heat processed meat products should be stored at temperatures less than or equal to 4°C. Refrigerated meat products which have been previously heat processed must not be packaged until chilled to 4°C unless it can be demonstrated that packaging does not interfere with the cooling schedule. For uncured processed products, temperature between -1°C and 1,5°C is most suitable, especially if the storage period is to exceed one week.

If kept hot, heat processed meat products should always be kept at 60°C or above. Product temperature is to be taken and recorded on a regular basis during storage to monitor compliance with these guidelines.

As this is being carried out in increasingly enclosed equipment, it is difficult to monitor operations. Incoming material should be monitored for prohibited product, e.g., kidneys or improperly trimmed material, e.g., pork heads. Adequate venting and proper air flow must be maintained to prevent contamination or the intrusion of odours into other areas of the establishment. The inspector must satisfy himself that equipment and pipes are adequately cleaned.

Aging of beef has traditionally been used to increase tenderness and flavour and involves holding a carcass for 7-14 days under refrigeration. Where carcasses are aged in this manner, attention must be paid to temperature and humidity, to avoid the development of mould.

To speed up the tenderization process, other methods have been developed and these include:

Wherever management wishes to introduce an alternative or new method to achieve tenderness, the inspector should verify that the method and the equipment to be used have been cleared for use in a registered establishment.

Refer to the Annex F at the end of this chapter for the reinspection of lots of carcasses and parts, including poultry.

A properly equipped and functioning check-trim station is essential prior to boning operations. Sanitizers must be maintained at operational temperatures. Moving belts, conveyors and cutting boards should be monitored for wear and tear. Plant employees must be trained to store their equipment, e.g., knives, steels, gloves and aprons in designated areas. It is not permitted to store this equipment on top of the meat or boning table.

In the case of retail cuts, conformation to definition must be monitored. Company quality control systems in regard to product defects must be monitored.

Boneless manufacturing meats, even though previously inspected and passed, may be inspected by federal meat inspectors as often as deemed necessary to ascertain that such meat products are meeting domestic and export requirements.

Inspection of boneless manufacturing meat is performed by inspectors using lot inspection techniques. Establishment employees are using either lot or on-line examination procedures. When establishment employees are performing examinations, inspectors should determine through monitoring if an establishment's process is resulting in wholesome product. These determinations are made by the inspector while performing regular inspection duties or tasks under the inspection program (TIP).

It should be noted that end-product examination/inspection should only be used as one step in the process to produce boneless manufacturing meat to domestic and export requirements. Quality assurance procedures must be instituted by the operator at various points in the process to detect and eliminate any problems as early as possible.

Boneless Manufacturing Meat is boneless meat from either cattle, calf, sheep, goat, horse or swine carcasses which includes boneless cuts and trimmings.

Lot Inspection/Examination. An inspection/examination technique in which samples are taken from the entire "lot" of product to determine the products's wholesomeness.

On-Line Examination. An examination technique in which product is sampled from each production line or common source at a specified frequency to determine the ability of the process to produce wholesome product.

The inspector may evaluate, as often as he deems necessary, the records of those establishments using "on-line" examination procedures for timeliness, completeness and accuracy. If there is evidence that the following actions are being taken by the operator, an inspector should not normally require the operator to carry out lot examinations:

Sampling plans, methods and criteria for disposition of lots of boneless meat are given in Annex F.

The operator is responsible for grouping product into coded lots acceptable to the inspector in charge, and for adequately identifying and reconditioning rejected lots.

Each time the boneless meat reinspection task is assigned, the inspector should:

The operator of the establishment shall design, document and institute an on-line sampling and examination program for boneless meat at a point close to where the product is placed into containers. Examination results must be retained for a minimum of 12 months.

The minimum sampling size and schedule per boning line should be 15 kg sample size for each 30 minutes of production (random time sampling twice hourly). Inspectors shall be made aware of the schedule on a weekly basis.

The examination program must be approved by the inspector-in-charge and must be capable of achieving the following results.

Prior to approval by the inspector in charge the effectiveness of the program must be evaluated using lot examination to assure that it can meet the above-mentioned criteria.

Each time the boneless meat reinspection task is assigned, the inspector should:

It is the responsibility of management to make sure that the inspection legend applied on cuts and carcasses is legible. However, inspectors should monitor the procedure and advise management when it is not satisfactory.

The use of two-inch needle point stamps has proven to be much more effective in reproducing the inspection legend.

(9) Mechanical separation of muscle tissue from bones - production of finely textured meat and mechanically separated meat.

Manufacturers of Mechanically Separated Meat (MSM) and Finely Textured Meat (FTM) (NOTE: The term "meat" is replaced with the name of the animal species, for example, beef, pork or chicken) must operate Quality Control programs and testing programs in accord with requirements set out in parts g) and h) of this section.

Mechanical meat/bone separation equipment operates by using mechanical pressure to separate muscle tissue from the attached bones. The equipment operates on the differing resistance of bone and soft tissue to pass through small openings, such as sieves or screens. Depending on the composition of the final product, the resulting edible product is referred to as finely textured meat or mechanically separated meat (e.g. finely textured chicken or mechanically separated chicken).

Mechanically Separated Meat (MSM) is an edible product obtained by removing muscle tissue attached to bones by the means of mechanical meat/bone separation equipment that contains:

Finely Textured Meat (FTM) is an edible product obtained by removing muscle tissue attached to bones by the means of mechanical meat/bone separation equipment that contains:

iii) no bone particles larger than 1.5 mm in size and a maximum of 20% of the bone particles larger than 1 mm in size, and

FTM can be used in the preparation of ground meat or identified as ground meat when :

ii) it complies with the standards set out within the Meat Inspection Regulations. The term "regular", "medium", "lean" or "extra lean" must be used as appropriate in order to indicate the maximum fat content (i.e. 30%, 23%, 17% or 10% respectively).

(b) Raw material used in the preparation of Finely Textured Meat and Mechanically Separated Meat

Only bones, dressed carcasses or parts of dressed carcasses from food animals which have been approved for human consumption may be used. With regards to FTM, hand or mechanically deboned trimmings that contain bone particles or cartilage may be used. For MSM, the regulatory definition prohibits the use of any previously deboned meat as input material. Please note that the raw material used can only make one passing through the mechanical separation equipment.

Bones, carcasses or parts of a carcass shall be kept or transported at time/temperature combinations that will ensure their hygienic acceptability when used for mechanical separation.

ii) refrigerated to 4 C and mechanically separated within 72 hours of boning; or

iii) refrigerated to -2 C and mechanically separated within 120 hours of boning; or

(d) Use of poultry carcasses and parts of carcasses containing kidneys (when the resulting product is not labelled as containing kidneys)) and lungs as raw material

Kidneys (for FTM and MSM which will not be labelled as containing kidneys), and lungs must be removed from poultry carcasses and portions prior to their use as material for mechanical separation.

In order to ensure proper removal of kidneys (when appropriate), and lungs in poultry carcasses and parts of carcasses used as raw material in the preparation of MSM or FTM, operators shall monitor this raw material as per the following protocol. This protocol is based on ISO Table #2859-1 at an inspection level of S-4, for a lot or batch size ranging from 1,201 to 10,000 units.

Upon arrival of the raw material to the establishment or prior to the processing of the material, the operator shall perform a random selection of 20 carcasses or units per combo or a lot of similar size.

One defect is defined as a carcass or unit with kidney (when not acceptable) and/or lung. The rejected product must be either reworked and resubmitted for sampling, or returned to the originator, or treated as inedible product.

The presence of kidney is defined as the presence of a part of a lobule or several lobules measuring at least 0.5 cm x 0.5 cm. The presence of lung is defined as a part of lung measuring at least 1 cm x 1 cm.

The inspection staff will monitor the compliance to these tolerances using the same protocol. The inspection service sampling will take place as deemed necessary based on previous compliance of the operator or of the supplier. It will also be incorporated in the inspection tasks for the plant. Any defective lots will be brought to the attention of the operator for appropriate corrective action.

(e) Use of pork or poultry skin as raw material when producing Mechanically Separated Meat (MSM)

Mechanically Separated Pork or Poultry Meat will be deemed to contain skin unless the manufacturer indicates otherwise on the product’s label.

Only pieces which have naturally adhering skin can be used to make Mechanically Separated Meat; detached skin or pieces which have loose skin flaps cannot be used. For example, skin-on necks which have attached neck skin can be used to make MSM but necks to which flaps of breast or back skin have been left attached cannot be used.

When MSM is used in the manufacture of a formulated meat product, unless the MSM is free of skin and has been identified as such by the supplier, it is considered as containing the allowed eight percent (8%) skin as indicated in notes 2(h) and 2(j) of Schedule I of the Meat Inspection Regulation (MIR). MSM made from skinless raw material may be labelled as "Skinless - Sans peau". It is then possible to add, when formulating the product, up to 8% of skin from the concerned species as stipulated in the notes of the MIR Schedule I. Please note that the added 8% can only be applied to products which have skin on them (for example, it would not apply to beef tongues or gizzards).

Examples: Determination of the quantity of pork skin which may be added to the following recipes:

As the MSM is not labelled as "skinless", the amount of skin that may added is calculated for the 55 kg of skinless pork trim only, which gives us an "x" value of 4.4 kg (8% of 55 kg). This gives us the following final recipe:

As the MSM is labelled as "skinless", the amount of skin that may be added is calculated for both the pork trim AND the MSM which gives us an "x" value of 6.4 kg: 4.4 kg for the pork trim and 2 kg for the MSM (8% of 80 kg). This gives us the following final recipe:

In order to use the mention "Skinless - Sans peau" the manufacturer must operate a raw material monitoring protocol in accordance with the following specifications:

For the purpose of this sampling plan the definition of a lot is the same as in the above item (d) Use of poultry carcasses and parts of carcasses containing kidneys and lungs.

The total skin area of all sample units (up to twenty) cannot exceed 25 square centimetres (i.e. 4 square inches).

The inspection staff will monitor compliance using the same protocol. Monitoring by the inspection personnel will take place as deemed necessary based on previous compliance of the operator and as prescribed by the inspection tasks for the plant. Any defective lots will be brought to the attention of the operator for appropriate action.

Unless mechanically separated meat or finely textured meat is used directly after the separation process as an ingredient of a meat product, it shall be:

i) cooled to a temperature of 0C (±2^oC) in conjunction with the deboning process or immediately afterwards;

ii) cooled to a temperature close to 0°C (±2^oC) in conjunction with the deboning process or immediately afterwards and cured; or

N.B. See section 8.7 (chapter 8) for shipment of products obtained from mechanical separation.

(g) Quality Control Program and compliance monitoring for Mechanically Separated Meat and Finely Textured Meat

Operators are required to maintain a quality control program and appropriate records to demonstrate that the process is under control and that mechanically separated meat and finely textured meat are meeting the standards.

The operator shall submit a copy of their proposed quality control program to the CFIA inspector-in-charge who will comment and then forward to the Area program specialist, Animal Products Program Network, for review and approval.

D. The length of time data generated by the program is retained -- e.g. All records generated by this quality control (QC) program are retained for a minimum of one year.

E. Commitment to make all data, records and information, generated as a result of the program, readily available to CFIA officials.

F. Signature of the establishment's official responsible for the program -- e.g., Quality Control Manager.

G. A statement that the quality control personnel have the authority to halt production and restrict shipment of product if standards established in this program are not met.

A complete and effective quality control program must contain the following information:

Example: Mechanically separated pork (2,000 kg/day), Finely textured beef (1,000 kg/day), Regular ground chicken (2,000 kg/day).

Provide names and establishment numbers of raw material suppliers. The date and time of production must be legibly printed on each container (combo bin or other). If the source of bones is an outside establishment, arrangements shall be made with the supplier(s) to print date and time of production on each container.

d. A bone control is in place to make sure there is no spinal cord in bones from ruminant, equine and porcine carcasses.

1. Provide name, model number and the Food of Animal Origin Division approval number for all equipment used in the process, including the heat exchanger if applicable.

2. All sections of the sanitation and maintenance programs which are applicable to the equipment installed must be evaluated and approved by the inspection service before it is used in the establishment.

a. Speed of raw material in feed and raw material batch load size (e.g. 5000 kg of raw material is processed every hour, this represents 250 batches of 20 kg of raw material).

d. Maximum pressure applied to raw material (e.g. maximum roller pressure = 5 bars, maximum belt pressure = 40 bars, etc.)

f. Specify how each operating parameter (e.g. speed of process, batch load size, maximum cylinder pressure, pressure time, etc.) is adjusted and controlled. Indicate what the reading on the equipment's monitor should be. For example, visual indicator "A" will display the number 10 to indicate that the maximum dwell time is 10 seconds; visual indicator "B" will display the number 2 when the maximum pressure applied to the product is 5 bars; etc.

Product produced from a single species in no more than one continuous shift of up to twelve hours.

Example: One full time QC technician collects the samples, performs the tests (calcium, proteins and bone particles) and records all the results.

Example: All retained product is tagged with a company tag and placed in the area designated for retained product. CFIA inspector is notified.

2. All information and data generated by this program should be clearly and accurately recorded. Example copies of all forms, tags, and charts used must be included as part of the program.

(h) Sampling and testing procedures for Mechanically Separated Meat and Finely Textured Meat

As a minimum the following procedure will be use by the operator to maintain assurance that the production process is delivering a product in compliance.

For purposes of this program, a lot shall consist of the mechanically separated meat or finely textured meat produced from a single species in no more than one continuous shift of up to 12 hours.

Samples and mixed sub-samples must not to be ground or crushed before the analysis.

This plan is used when the equipment is first installed, when major components are replaced (for example, separating drum or filter, separating screens, screen plates or perforated screen, feeding screw [i.e. worm], etc.) or when major repairs are made.

Under this sampling plan the operator must test each lot for calcium, protein and bone particle until 10 consecutive lots are in compliance. Once this is achieved the monitoring plan can be used.

The sample to be analysed shall consist of 20 sub-samples taken during the lot run. If the shift is eight hours (480 minutes) sampling must be done every 24 minutes (480/20 = 24 minutes). Likewise, if the scheduled lot run is six hours (360 minutes) sampling must be done every 18 minutes (360/20 = 18 minutes).

The shift must be a minimum of four hours to be considered in this start-up plan. If the shift is less than four hours the total sample collected will be sent for analysis, however, this shortened shift will not be counted as part of the 10 consecutive lots that must be in compliance.

Each sub-sample should be about 30 grams. The samples may be placed in the same container (e.g., plastic bag) so that at the end of the lot run it will contain about 600 grams of product.

The tested lots are to be held until receipt of an acceptable laboratory report.

This plan is uses after having successfully completed the start-up plan. Under this sampling plan the operator must test for calcium, protein and bone particle 1 lot out of 5 lots.

For the purpose of this monitoring plan a sample of at least 500 grams shall be taken randomly from the production lot. The tested lots may move freely prior to receipt of the laboratory report. If a lot is found to be in noncompliance for any of the prescribed standards the following procedure shall be followed.

When a noncompliant result is reported, the lot shall be disposed of as described in section (i) Disposition of product not meeting the performance criteria. The operator shall sample subsequent lots using the start-up plan and shall document the preventive actions taken to prevent re-occurrences.

Mechanically separated meat	Performance criteria	Tolerance
Bone particle	No bone particle larger than 2 mm	NONE
Calcium	No more than 0.027% of calcium for every 1% of protein	0.03 %
Protein	Minimum of 10% or 14% according to declared use	NONE
Finely textured meat	Performance criteria	Tolerance
Bone particle	No bone particle larger than 1.5 mm and a maximum of 20% of the bone particles larger than 1 mm	NONE
Calcium	No more than 0.15%	0.03 %
Protein	Minimum of 10% or 14% according to declared use	NONE

For finely textured mest a lot is deemed out of compliance if the calcium content of any single analytical result is more than 0.18%, or if the protein content of any single analytical result is less than 10.0%. In the case of protein the results shall be rounded to the nearest 0.1 percent (e.g. 9.5% or 9.7% would not be rounded to 10%).

a) Receipt of test results indicating that the criterion for calcium is not met:

b) Receipt of test results indicating that the criterion for proteins is not met:

When the lot is no longer under the operator’s control: it is not required to recall the product and it may remain in distribution.

c) Receipt of test results indicating that the criteria for bone fragments are not met:

In all cases where there is a bone fragment greater than 2 mm – the product must be recalled by the manufacturer. The product may then be directed for edible rendering/extraction or be treated as inedible.

E. coli O157:H7 in raw ground beef is considered a biological hazard which is reasonably likely to occur and which must be addressed by the operator's HACCP system.

Should E. coli O157:H7 be detected in raw ground beef product, the CFIA must immediately be informed. If product has left the control of the establishment, the Office of Food Safety and Recall will coordinate a recall of all potentially affected products.

If the lot of ground product found positive for E. coli O157:H7 included raw ground beef material made during a previous production run (i.e. rework or carry-over), in order to address the possibility that the bacteria may have come from the original lot(s) of ground beef product and limit consumers’ exposure to potentially contaminated lots with E. coli O157:H7, the recall will be extended in a similar manner to include all products made from the original lot(s).

For this reason, the practice of carrying over raw ground beef product made during prior production runs (i.e., before clean-up) as a rework ingredient in post-cleanup production runs is discouraged.

Where such carry-over of raw ground materials as rework does take place, the operator MUST:

(i) - - have controls built into their HACCP system (as per FSEP) which address the potential hazard for cross-contamination of lots with E. coli O157:H7.

(ii) - - handle the product in such a way to limit the number of lots to be recalled in the event of a positive finding of E. coli O157:H7, for example, by limiting the types of fresh product which are made with rework ground beef and scheduling regular "breaks" which stop any carry-over of rework product from previous days; and

(iii) - - include control measures to ensure the immediate traceback of rework ingredients and traceout of all affected product in the event of an E. coli O157:H7 result.

In addition, the operators procedures must be provided to the CFIA for review. This package needs to include :

The material is first provided to the CFIA Inspector-in-Charge(IIC). The IIC will review the document and determine if it is complete and effective. If this is not the case, the operator must make the appropriate modifications to their procedures. If acceptable, the IIC will state this in writing and forward the package to the area program network (meat hygiene) specialist for oversight review.

The results of the oversight review by the program network specialist will be provided in writing to the IIC, operator and a copy of the entire package will be forwarded with the oversight review to headquarters (Ottawa) for verification and records purposes.

This is accomplished by drying-in air, or the application of heat or by freeze-drying (lyophilization). This form of preservation depends on a lowering of the water activity of the product to inhibit the growth of microorganisms. The lowering of the water activity may also be accomplished by the addition of sugars or salt (NaCl). It must be remembered that a reduction in water activity neither destroys microorganisms nor toxins. It only retards the growth of microorganisms.

The initial microbial load should be as low as possible and therefore the incoming product should be assessed for microbiological quality.

If a dehydrated product is sold as shelf-stable (i.e., there is no "keep refrigerated" statement), it has to meet the same requirements as shelf-stable fermented meat products (see section 4.10.3(15)(a)2)).

E. coli O157:H7 is a hazard deemed reasonably likely to occur in beef products. If a dehydrated product is made with beef, i.e. BEEF JERKY, the manufacturing process must include a kill step for E. coli O157:H7. The operator is responsible for selecting the appropriate kill step. The following methods have been found acceptable for this purpose:

Curing is the treatment of meat products with nitrite or nitrate salts or both, and in combination with salt (NaCl) and other curing aids to improve colour, texture and flavour and to prevent or delay undesirable microbial growth and toxin production.

Most cured meat products are subsequently heated, i.e. cooked or smoked (wieners, loaves, bologna, bacon, etc.). The heating process should be sufficient to destroy vegetative forms of pathogens. Heating to 69 or maintaining temperatures above 60 for an adequate period of time generally achieves this purpose.

With the exception of shelf stable meat products such as commercially sterile meat products in hermetically sealed containers, fermented, acidified and dried meat products, cured meat products rely on refrigeration for preservation.

It is advisable to conduct microbiological testing of meat products of unknown quality prior to subjecting them to a curing process which does not involve heating.

Use of nitrite and nitrate salts
(Sodium nitrite, potassium nitrite, sodium nitrate, potassium nitrate)

N.B. Whenever potassium nitrite or nitrate salt is used instead of sodium nitrite or nitrate salt, multiply the amount indicated with a factor of 1.23.

In the curing of meat products other than side bacon, the maximum input level of sodium nitrite salts is 20 g per l00 kg of meat product, i.e. 200 ppm. In the curing of side bacon, the maximum input level of sodium nitrite salts is l2 g per l00 kg of pork bellies, i.e. l20 ppm.

In the production of slow cured meat products, sodium nitrate salt at a maximum input level of 20 g per l00 kg of meat products, i.e. 200 ppm, may be used in addition to the nitrite salts.

N.B. In the formulation of a cured meat product, the use of a previously cured meat product as ingredient in excess of 10 % will necessitate recalculation of the nitrite/nitrate input to account for the contribution from those ingredients.

In the production of dry rub cured meat products on racks, the maximum level of use is 62 g of sodium nitrite salts and l86 g of nitrate salts per l00 kg of meat product.

N.B.Registered establishments that store bulk nitrite or nitrate salts rather than premixes shall keep those salts under lock and key and account for their use to prevent an accidental misuse of those potentially dangerous compounds. Binder units must have curing salts packaged separately in a coloured bag.

It is not necessary to make adjustments for the addition of rework, provided the quantity of "rework" material is not more than 10% of the batch weight.

In the case of bone-in meat cuts, the pumping percentage will be calculated on a boneless basis. The amount of bone in a bone-in ham is approximately 15% by weight.

In the case of injected products with rind on (ham, bacon, etc.), no consideration is necessary for the weight of the rind. Rind may be considered as meat.

The incorporation of ground meat or poultry pieces with intact muscle cuts is accomplished by either mixing or tumbling the ground meat with the larger pieces. The cure or brine can be added to the tumbler mixer and be incorporated into the product by the physical action of tumbling. Another method that is currently used is the incorporation of the cure or brine by injecting the solution into large meat pieces then by mixing the ground meat with the injected meat. To improve the appearance of the finished product some tumbler mixers have been modified by adding blades or spikes in the tumblers so that during the tumbling action, the ground meat and cure is pushed into the solid meat cuts. This process accelerates the cure process and enhances the appearance of the finished product.

A third process can be used. That new process consists in emulsifying trimmings or ground pork, beef or poultry, and injecting these meat particle suspension into solid muscle cuts along with the brine and then placing these meat pieces into a mixer or tumbler.

(13) Pickling This is the preservation of meat products by the addition of ingredients and additives that reduce the water activity or lower the pH value of the meat product (e.g., salt and vinegar).

(14) Smoking This is achieved by the use of smoke generated from hardwood, hardwood sawdust, or vapourized liquid smoke derived from the aforementioned sources. Smoke racks (trees) and the interiors of smokehouses must be adequately cleaned to prevent the contamination of meat products with soot. If wood chips or sawdust are used for smoke generation, their storage and use must not pose a sanitary hazard. Smokehouses must be adequately vented. As smoking of pork products is used to destroy trichinae by means of heat, the temperatures maintained must be carefully monitored. Recording thermometers must be present and properly functioning. The accuracy of these must be checked periodically against a mercury thermometer. Management shall take internal temperatures of smoked pork products, at the time of removal from the smokehouse, to ensure that temperatures reached are sufficient to destroy trichinae. This procedure is monitored by the inspector who must periodically take internal temperatures for verification purposes (see 4.10.2).

Preservation of meat products by fermentation has been used for hundreds of years. Similarly to other processes used in the preparation of ready-to-eat meat products, the manufacturing process for fermented meat products achieves a reduction of micro-organisms of concern to human health by creating an environment unsuitable for their survival. Fermentation also imparts a particular flavour to meat products.

Unlike cooked meat products which generally rely on cooking to act as a thermal "kill step", the manufacture of fermented meat products relies on a complex and precise combinations of time, temperature, nitrites, salt concentration, pH and a_w factors.

pH: pH is the negative logarithm of the hydrogen ion or proton concentration. The pH measures acidity or alkalinity on a scale of 0 to 14 with 7 as the neutral point. The lower the pH the higher the acidity.

a_w: The water activity (a_w) of a food is the ratio of the water vapour pressure of the food to that of pure water at the same temperature. It is measured at a scale of 0.00 to 1.00 with 0.00 indicating total dryness and 1.00 pure water.

All Food borne pathogens which have been linked to the consumption of a ready-to-eat meat product can affect fermented meat product. However, a number of organisms are considered to be of particular importance and establishments which manufacture dry or semi-dry fermented meat products must have corresponding controls in place to address each of these hazards. In addition, when a_w or pH is a critical factor in the manufacture of product, each production lot must be tested for these factors (refer to section (d) 7.)

Organism	Refer to
Trichinella spiralis	Part (d) 4) of this section
Enterotoxic Staphylococcus aureus	Part (d) 5) of this section
Verotoxinogenic E. coli (e.g., E. coli O157:H7) and Salmonella in fermented sausages	Part (d) 6) of this section and Annex K of this chapter

To be assessed as complete, an operator’s HACCP plan for the manufacture of dry or semi-dry fermented meat products must have Critical Control Points in place which address these specific organisms in accordance to the requirements set out in this section. Other Food borne pathogens and hazards such as Salmonella and Listeria monocytogenes must also be analysed and addressed in an appropriate manner. Facility and equipment requirements for the manufacture of fermented meat products are outlined in part (c) of this section must also be met.

Many different types of manufacturing processes exist for making fermented meat products. Not all of these processes allow the finished product to be stored at ambient temperature.

In order to be considered "shelf-stable" and not require refrigeration, a fermented meat product must meet one of the following sets of specific requirements. Fermented products which do not meet these requirements must be labelled with a refrigeration statement.

a) The pH of the finished product is of 4.6 or less, regardless to its final a_w.

Note: degree-hours requirements must be met (refer to part (d) 5) of this section);

+ the product contains not less than 100 ppm nitrite or nitrate with salt as calculated at the moment of formulation; and

Note: for all fermented meat products which is treated as shelf-stable: To minimize the danger of outgrowth of Clostridium botulinum spores and development of the botulinal toxin in shelf-stable fermented product, nitrite/nitrate shall be added at a minimum level of 100 ppm along with a minimum of 2.5% of salt. The level of nitrate-nitrite should not interfere with the process of fermentation.

Operators who manufacture a fermented meat product which is sold as shelf-stable must have specific controls in place. Refer to part (d) 7) of this section.

Please note that, with the exception of meat products made by a retort process, non-fermented meat products must have a finished product a_w of 0.85 or less in order for the product to be considered shelf-stable. If the process cannot achieve this a_w of 0.85 or less, then the product must be labelled with a refrigeration statement.

Operators of registered establishments who wish to market a meat product without a refrigeration declaration and which does not meet the criteria set out above, must submit a request for the acceptance of their proposal to the Chief, Program development and evaluation, Food Borne Pathogen Unit, Laboratory Services Division. The submission must be accompanied by detailed recipe, formulation and processing information for the product. Submissions will be evaluated and a letter of assessment indicating if the product can be considered shelf stable will be sent to the operator. This letter of assessment must be made available to the inspector when requested.

Dry or semi-dry fermented sausages are prepared by mixing ground meat with various combinations of spices, flavourings, salt, sugar, additives and bacterial cultures. The mixtures, in bulk or after stuffing, are allowed to ferment at different temperatures for varying periods of time. Following fermentation, the product may be smoked and/or dried under controlled conditions of temperature and relative humidity.

There are many ways to classify or define the various types of sausages which are manufactured using a fermentation process. We have retained the following definitions:

(i) Dry Sausages: Dry Sausages are made with chopped or ground meat products that, as a result of bacterial action, or chemical acidification, reach a pH of 5.3 or less at the end of the fermentation period. Subsequently they are dried in a drying room to reduce their a_w to 0.90 or less.

(ii) Semi-Dry Sausages: Semi-Dry Sausages are made with chopped or ground meat products that, as a result of bacterial action, or chemical acidification, reach a pH of 5.3 or lower. Their a_w is reduced during the process but only to values above 0.90. This means they have to be kept refrigerated. In general, the semi-dry sausages are not subsequently dried in a drying room but are packaged soon after the fermentation/heating process is completed. They are generally smoked during the fermentation cycle.

Because of the complex nature of the fermentation process, it is critical that ingredients be especially well controlled and that the microbiological load of the meat used be as low as possible. The use of mechanically separated meat or finely textured meat in the fabrication of fermented meat products is strongly discouraged for this reason.

The fermentation process involves the growth of lactic acid bacteria in order to acidify the product. Providing raw materials are of excellent microbiological quality, during fermentation the combined effect of curing salts, curing aids and temperature encourages the gradual replacement of the contaminating flora including pathogens (such as Salmonella, Campylobacter and Staphylococci) by lactobacilli, pediococci and micrococci.

While it was once necessary to rely on environmental conditions for natural fermentation to occur, or to inoculate new batches with a portion of raw mixture from a previous batch (commonly referred to as "back slopping"), these methods were not always successful and represented significant risks. Commercial starter cultures are most often used today as they offer a degree of consistency and safety not found in other methods.

Contamination by pathogenic organisms at the outset of the process may have a critical effect on finished product. Bacterial competition, pH and a_w values are important factors in the control of the development or die-off of pathogenic organisms.

Lactobacilli and pediococci are primarily responsible for converting sugars into lactic acid thereby lowering the pH of the meat product. Where nitrate salts are used for curing in slow cured sausages, micrococci present convert nitrate salts to nitrite salts.

Lactobacilli with or without micrococci are components of starter cultures available for use in slow fermentation (25°C) whereas pediococci with or without micrococci are used in starter cultures for rapid fermentation at higher temperatures (25°C to 37°C). Pediococci do not occur in fresh meat products in numbers large enough to be a significant factor in traditional slow fermentation and therefore are only important in meat product fermentation if they are added in starter cultures.

When fermented cured sausages are subjected to an extended drying period, lactobacilli act to significantly reduce the number of undesirable microorganisms including pathogens.

The predominant type of fermenting organism combined with the formulation and process schedule will give a product its characteristic flavour.

Chemical acidification may be used to help lowering the pH. Citric acid or glucono delta lactone are commonly used for this purpose.

Most fermented products are also subject to a drying process which reduces the amount of available water (a_w) and thus further limits the survival or growth of pathogenic bacteria and spoilage organisms. This drying takes place during the fermentation process itself or as a separate activity after fermentation has been completed. Heat can also be used during drying.

The physical characteristics of the meat and fat particles (such as particle size, product temperature, etc...) are important in achieving a reduced a_w. The meat particles must be of such size that would efficiently allow release of moisture and the cut edges must be without fat smearing. Sharp and efficient grinding or chopping equipment and mixers are necessary.

The growth and metabolism of microorganisms demands the presence of water in available form. The most useful measurement of the availability of water in meat products is water activity (a_w). The a_w may be reduced by adding solutes (salt, sugar) or removing moisture.

Trichinella spiralis will survive at an a_w of 0.93 but is destroyed at an a_w of 0.85 or less.

The above levels are based on the absence of other inhibitory effects such as nitrite, competitive growth, sub-optimum temperatures, etc., which may be present in meat products. In normal conditions, enterotoxin formation by Staphylococcus aureus has not been observed at a_w below 0.92.

- Reading of the temperature of the indicating thermometer and the relative humidity

For routine monitoring, accurate measurement electronic pH metres (± 0.05 units) should be employed. It is most important that the manufacturer's instructions for use, maintenance and calibration of the instrument as well as recommended sample preparation and testing be followed.

When the a_w of product is a critical limit set out in the manufacturing process or HACCP plan for a meat product, accurate measurement devices shall be employed. It is most important that the manufacturer's instructions for use, maintenance and calibration of the instrument as well as recommended sample preparation and testing be followed.

The operator must have physical and microbiological specifications for ALL ingredients that may represent a hazard when used in the preparation of a fermented meat product. To ensure that the initial bacterial load is acceptable, microbiological specifications will be maintained for meat, starter culture and, where back slopping is used, the raw batter used for new batches. Records of microbiological tests performed to ensure compliance to determine specifications shall be available to the inspector on request.

(i) If commercial starter cultures are used, they shall have been listed in annex G of this chapter. There must be microbiological specifications for the cultures. Commercial cultures shall be stored according to the culture manufacturer's directions.

In order for a new commercial starter culture to be added to the list, details of commercial starter cultures for use in registered establishments must be submitted for review by the Chief, Program development and evaluation, Food Borne Pathogen Unit, Laboratory Services Division.

(ii) "Back Slopping" is the process of using Inoculum from a previous batch to initiate the fermentation process of a new batch. Because of the risk of transmitting pathogens from the Inoculum to the new batch, strict controls are required when using this technique.

Inoculum used for back slopping shall be carefully handled and stored to avoid any contamination. The storage temperature for that Inoculum shall be maintained at 4 C or less and a pH of 5.3 or less. Samples for microbiological analysis shall be taken to ensure that the process is in line with the specifications. The frequency of that sampling is to be adjusted according to compliance to specifications. Each batch of Inoculum which will have a pH > 5.3 shall be analysed to detect at least Staphylococcus aureus. Only on satisfactory results, will this Inoculum be allowed to be used for back slopping.

(iii) "Natural fermentation", is a process which relies on the fermentation process self-initiating without help of commercial starter culture nor Inoculum from a previous batch. Because of the high potential for process failure, this process is not considered acceptable.

If product is chemically acidified by addition of citric acid, glucono delta lactone or another chemical agent approved for this purpose, controls shall be in place and records kept to ensure that pH of 5.3 or lower is achieved by the conclusion of the process.

Certain strains of the bacteria Staphylococcus aureus are capable of producing a highly heat stable toxin that causes illness in humans. Above a critical temperature of 15.6°C, Staphylococcus aureus multiplication and toxin production can take place. Once a pH of 5.3 is reached, Staphylococcus aureus multiplication and toxin production are stopped. Processors are required to control this hazard by verifying that their product attains a pH of 5.3 within pre-defined degree/hours limits.

As part of their control, processors shall verify the pH of each lot and record the time that it took from the moment of formulation until the pH of the sausage achieved a pH of 5.3 or less. This normally is done when each batch of product leaves the "green room".

When a process has not met degree/hours limits, the lot shall be dealt with in accordance with part (iv) of this section.

A process can be judged acceptable as long as the product consistently reaches a pH of 5.3 using:

1) fewer than 665 degree/hours when the highest fermentation temperature is less than 33°C.

2) fewer than 555 degree/hours when the highest fermentation temperature is between 33° and 37°C.

3) fewer than 500 degree/hours when the highest fermentation temperature is greater than 37°C.

Degree/Hours are the product of time as measured in hours at a particular temperature multiplied by the "degrees" measured in excess of 15.6°C (the critical temperature at which staphylococcal growth effectively begins). Degree/Hours are calculated for each temperature used in the process. The limitation of the number of degree/hours indicated in points (1), (2) and (3) above depends upon the highest temperature in the fermentation process prior to the time that a pH of 5.3 or less is attained.

Manufacturers are encouraged to measure temperatures at the surface of the product. Where this is not possible, manufacturers should utilize fermentation room temperatures. The table and examples are based on fermentation room temperatures. Temperature and humidity should be uniform throughout the fermentation room.

(ii) Fermentation done at a constant temperature (Constant Temperature Process)

When fermentation is done at a constant temperature, operators can either use the following table or the calculation method (see examples below) for determining degree-hours limits and maximum time for fermentation at a given room temperature.

Degrees-hours limit for the corresponding temperature	Fermentation Room Temperature (C)	Maximum Allowed Hours to Achieve a pH of 5,3 (Based on Guideline)
665	20	150.0
665	22	103.4
665	24	78.9
665	26	63.8
665	28	53.6
665	30	46.2
665	32	40.5
555	33	31.8
555	34	30.1
555	35	28.6
555	36	27.2
555	37	25.9
500	38	22.3
500	40	20.5
500	42	18.9
500	44	17.6
500	46	16.4
500	48	15.4
500	50	14.5

EXAMPLES OF HOW TO USE THE CALCULATION METHOD FOR CONSTANT TEMPERATURE PROCESSES:

Process A: Fermentation room temperature is a constant 26°C. It takes 55 hours for the pH to reach 5.3.

Conclusion: Process A meets the guideline because its degree/hours is less than the limit.

Process B: Fermentation Room temperature is a constant 35°C. It takes 40 hours for the pH to reach 5.3.

The corresponding degree/hours limit (between 33 and 37°C) is 555 degree/hours.

Conclusion: Process B does not meet the guideline because its degree/hours exceeds the limit - hold the product and refer to part (iv) of this section.

(iii) Fermentation done at different temperatures (Variable Temperature Processes)

When the fermentation takes place at various temperatures, each step in the progression is analysed for the number of degree/hours it contributes. The degree/hours limit for the entire fermentation process is based on the highest temperature reached during fermentation.

EXAMPLES OF HOW TO USE THE CALCULATION METHOD FOR VARIABLE TEMPERATURE PROCESSES:

Process C: It takes 35 hours for product to reach a pH of 5.3 or less. Fermentation room temperature is 24°C for the first 10 hours, 30°C for second 10 hours and 35°C for the final 15 hours.

Hours	Fermentation room temperature (°C)	Critical Temperature Adjustment	Degrees above 15.6°C	Degree/hours
10	24°	(24°-15.6°)	= 8.4°	84
10	30°	(30°-15.6°)	= 14.4°	144
15	35°	(35°-15.6°)	= 19.4°	291
pH=5.3			Total:	519

Conclusion: Process C meets the guideline because its degree/hours is less than the limit.

Process D: It takes 38 hours for product to reach a pH of 5.3 or less. Fermentation room temperature is 24°C for the first 10 hours, 30°C for second 10 hours and 37°C for the final 18 hours.

Hours	Fermentation room temperature (°C)	Critical Temperature Adjustment	Degrees above 15.6°C	Degree/hours
10	24°	(24°-15.6°)	= 8.4°	84
10	30°	(30°-15.6°)	= 14.4°	144
18	37°	(37°-15.6°)	= 21.4°	385.2
pH=5.3			Total:	613.2

Conclusion: Process D does not meet the guidelines because its degree/hours exceeds the limit. ö hold the product and refer to part (iv) of this section.

The inspector in charge must be notified of each case where degree/hours limits have been exceeded. Such lots must be held and samples of product submitted for microbiological laboratory examination after the drying period has been completed. Analyses should be done, at least for Staphylococcus aureus and its enterotoxin, and for principal pathogens such as E. coli O157:H7, Salmonella, Listeria monocytogenes, etc.

6) Controls to address hazards related to Verotoxinogenic E. coli (e.g., E. coli O157:H7) and to Salmonella in fermented sausages

Outbreaks of human illness associated with the consumption of fermented sausages which were found to contain Verotoxinogenic E. coli and E. coli O157:H7 have been reported in the United States (1994), Australia (1995) and Canada (1998, 1999).

Following the 1994 US outbreak, work by the United States Department of Agriculture (USDA) and a task force composed of US industry and academia scientifically confirmed that some fermentation processes used by industry were effective (5 D reduction - A unit which expresses the lethality of a process. This is the time required to destroy 90% of the organisms present. Hence, a 5 D reduction would destroy 99.999% of the organisms or 10⁵ organisms) against E. coli O157:H7 but others were only partially effective (between 2 and 5 D reduction). The task force recommended five possible ways to minimize the risk of E. coli O157:H7 in fermented sausages. At the same time, it has been established that Salmonella may also be found in the resulting product.

In order to suitably control these hazards and prevent incidents of food borne disease, registered establishments who manufacture fermented sausages are required to use one of the five following options for the control of Verotoxinogenic lang="la">E. coli and E. coli O157:H7 when they make this type of product.

To date, outbreaks of E. coli O157:H7 reported in association with dry/semi-dry fermented sausages have been linked to beef meat ingredients. The following establishments must therefore use one of the five options outlined in this section when manufacturing a dry or semi-dry fermented meat sausage product:

Other establishments (for example establishments which only handle pork and who do not obtain meat ingredients from establishments which handle beef) are therefore not currently obliged to use one of the five options for the control of E. coli O157:H7 in dry/semi-dry fermented sausages. However, they must validate through a microbiological testing program that their process will not result in presence of E. coli O157:H7 or Salmonella in finished product. They are not required to use the testing protocol outlined under Option 3.

To ensure that all of the requirements corresponding to the selected option are met, and to suitably demonstrate this, operators of registered establishments who fabricate a dry/semi-dry fermented sausage are required to:

This material will be screened by the Inspector-in-charge and forwarded to the area CFIA program office for verification.

If an establishment does not follow one of the other available options, they are automatically considered to be using Option 3, end product testing. If an establishment which has to do end product testing as per Option 3 refuses to do the required testing on the finished product, they are creating a situation whereby the CFIA inspector must take action to deal with a potential health hazard. In such a case, the CFIA inspector shall formally detain the affected product, take measures to prevent cross-contamination of other product and inform the establishment that, if they do not provide the necessary test results within 60 days, the affected product will be treated as inedible and condemned.

(i) Option 1: Include as part of the manufacture of the sausage, one of the following heat process which is recognized as controlling E. coli O157:H7. Under this option, it is not required to test for E. coli O157:H7. Time and temperature controls will be documented in the same manner as is required for other similar cooking processes (refer to Chapter 4, Sections 4.10.2 (2) and 4.10.3 (3) ).

Minimum internal temperature maintained during the entire process		Minimum processing time in minutes after the minimum temperature has been reached
(°F)	(°C)
130	54.4	121
131	55	97
132	55.6	77
133	56.1	62
134	56.7	47
135	57.2	37
136	57.8	32
137	58.4	24
138	58.9	19
139	59.5	15
140	60	12
141	60.6	10
142	61.1	8
143	61.7	6
144	62.2	5
145	62.8	4 ¹

¹ This table is identical to the roast beef cooking table with one exception: the minimum processing time for a minimum internal product temperature of 145°F/62.8°C is 4 minutes instead of "instantaneous". This difference is because the sausage product’s smaller size results in a much quicker cooling and decreased cumulative lethality.

(ii) Option 2: Use a manufacturing process (combination of fermentation, heating, holding and/or drying) which has already been scientifically validated to achieve a 5 D reduction of E. coli O157:H7.

Manufacturing processes used to make fermented sausages are only considered effective against E. coli O157:H7 if it is shown that they achieve a 5D reduction or more of E. coli O157:H7. The manufacturing process used must be evaluated in a scientific manner consistent with the challenge study recommendations (refer to "Option 5", part (iv)) of this section.

Under this option #2, it is not required to test each lot for E. coli O157:H7 or Salmonella. The operator shall nevertheless conduct some degree of testing for these organisms as a verification procedure for their process.

The operator must maintain suitable records to demonstrate that all of the critical control points (CCP) for the process have been met (for example, casing diameter, fermentation room (green room) thermographs, pH at the end of the fermentation step of the process, a_w, etc.)

The following processes have been scientifically validated as achieving a 5D or greater reduction of E. coli O157:H7.

Fermentation chamber temperature		pH at the end of fermentation process	Casing diameter	Subsequent process (dry, hold or cook)	Reference
°F	°C	pH at the end of fermentation process	Casing diameter	Subsequent process (dry, hold or cook)	Reference
70	21	>5.0	< 55 mm	HEAT (1hr @ 110°F and 6 hours @ 125°F)	¹
90	32	<4.6	< 55 mm	HOLD @ 90°F for >6 days	¹
90	32	<4.6	< 55 mm	HEAT (1hr @ 110°F then 6 hrs @ 125°F)	¹
90	32	<4.6	56 to 105 mm	HEAT (1hr @100°, 1hr @110°F, 1hr @120°F, then 7hrs @ 125°F)	¹
90	32	>5.0	56 to 105 mm	HEAT (1hr @100°, 1hr @110°F, 1hr @120°F, then 7hrs @ 125°F)	¹
96	36	<5.0	< 55 mm	HEAT (128°F internal product temperature x 60 minutes) and DRY (at 55°F and 65% Relative Humidity to a Moisture Protein Ration of < 1.6:1)	²
110	43	<4.6	< 55 mm	HOLD @ 110°F for > 4 days	¹
110	43	<4.6	56 to 105 mm	HOLD @ 110°F for > 4 days	¹
110	43	>5.0	56 to 105 mm	HOLD @ 110°F for > 7 days	¹

¹- Nicholson, R., et al, Dry fermented sausage and Eshcerichia coli O157:H7. National Cattlemen’s Beef Association, Research Report Number 11-316, Chicago, Illinois, 1996.

²- Hinkens, J.C., et al, Validation of Pepperoni Processes for Control of Escherichia coli O157:H7, Journal of Food Protection, Volume 59, Number 12, 1996, pp. 1260-1266.

(iii) Option 3: Where the manufacturing process does not correspond to one of the processes set out under options 2 or 4 of this section and has not been assessed in accordance to option 5 of this section, do microbiological end-product testing of each production lot and hold the lots pending reception of results;

(a) Definition of "lot": The definition of "lot" for purposes of sampling must be statistically sound and must correspond to product manufactured under the same conditions. A lot cannot exceed a single day’s production.

(b) Sampling plan: For each lot, the operator shall take 30 samples of finished product and submit them for analysis. The sample plan must be representative of the lot.

(c) Sample size: Each sample shall consist of at least 25 g of product. Samples must be taken in accordance to standard microbiological techniques to avoid contamination of product and sampling of intact product packages is strongly recommended. It is unacceptable to take multiple sample from one intact package as this is not considered statistically representative of the lot.

(d) Compositing of samples by the laboratory for analysis: It is acceptable to combine a maximum of three (3) samples into a composite for purposes of analysis when testing is done for E. coli O157:H7 and Salmonella.

(e) Organisms to be tested: At a minimum, each composite sample shall be tested for the presence of E. coli O157:H7 and Salmonella.

(f) Laboratory requirements: CAUTION! - Since E. coli O157:H7 are pathogenic to humans, the tests should be conducted by appropriately trained personnel.

(g) Method used: The method used to analyse the end product samples shall be one of the methods listed in Health Canada’s Compendium of Analytical Methods, Volume 3, Laboratory Procedures for the Microbiological Analysis of Foods (ISBN 0-921317-17-4).

(h) Reporting of results: Results shall be reported in writing. Results shall be identified to the lot of product being tested and shall include individual results for each test performed, method used, minimum sensitivity of the test used, lot for which these results apply.

(i) Release of product: Product will be held under the control of the operator until the written results of analysis have been received. In order to be released, all tests must be negative for the presence of E. coli O157:H7 and Salmonella and any other pathogens tested.

(j) In case of a positive result for either E. coli O157:H7 or Salmonella or another pathogen: the entire lot must be held and either submitted to a 5D reduction process or be destroyed. Possible cross-contamination of other lots shall also be assessed.

(k) Keeping of records: Records of test results shall be kept for a minimum of 24 months beyond the release date of the product.

(iv) Option 4: Implement a HACCP system at the establishment which includes testing of raw meat and batter, and use a manufacturing process (fermentation and holding, heating and/or drying) which has been scientifically validated as achieving at least 2 D reduction of E. coli O157:H7.

To be eligible to use this option, the operator must have implemented a HACCP system which is meeting CFIA’s FSEP approach. Sampling of raw batter must be done in accordance to the requirements set out in parts (a) to (k) of this section.

Manufacturing processes used to make fermented sausages are considered partially effective against E. coli O157:H7 if it is shown that they achieve 2D to 5D reduction of E. coli O157:H7. The manufacturing process used must be evaluated in a scientific manner consistent with the challenge study recommendations (refer to "Option 5", part (iv) of this section). A number of manufacturing processes have been scientifically demonstrated as achieving a 2D to 5D reduction, refer to part (l) of this section.

(a) Definition of "lot": The definition of "lot" for purposes of sampling must be statistically sound and must correspond to like production practices. Provided that effective controls for tracing product are in place and all corresponding dry fermented sausage manufacturing processes have been validated as achieving at least a 2D reduction of E. coli O157:H7, it would be acceptable to conduct one single series of sampling on batter which is used in different sausages. A lot cannot exceed one days production of raw batter.

(b) Sampling plan: For each lot, the operator shall take 15 samples of raw batter and submit them for analysis. The sample plan must be representative of the lot.

(c) Sample size: Each sample shall consist of at least 25 g of product. Samples must be taken in accordance to standard microbiological techniques to avoid contamination of product. It is unacceptable to take multiple samples from one site as this is not considered statistically representative of the lot.

(e) Organisms to be tested: At a minimum, each composite sample shall be tested for the presence of E. coli O157:H7 and Salmonella.

(f) Laboratory requirements: CAUTION! - Since E. coli O157:H7 are pathogenic to humans, the tests should be conducted by appropriately trained personnel.

(j) In case of a positive result for either E. coli O157:H7 or Salmonella: the entire lot must be held and either submitted to a 5D reduction process or be destroyed.

(k) Keeping of records: Records of test results shall be kept for a minimum of 24 months beyond the release date of the product.

(l) Methods which have been scientifically documented as achieving a minimum 2D reduction in E. coli O157:H7.

Fermentation chamber temperature		pH at the end of fermentation	Casing diameter	Subsequent process (dry, hold or cook)	Reference
°F	°C	pH at the end of fermentation	Casing diameter	Subsequent process (dry, hold or cook)	Reference
70	21	>5.0	56 to 105 mm	HEAT (1hr @ 110°F and 6 hours @ 125°F)	¹
90	32	<4.6	56 to 105 mm	HOLD @ 90°F for 7 days then dry	¹
90	32	>5.0	56 to 105 mm	HOLD @ 90°F for 7 days then dry	¹
110	43	>5.0	< 55 mm	HOLD @ 110°F for 7 days then dry	¹
110	43	>5.0	56 to 105 mm	HEAT (1hour @ 110°F and 6 hours @ 125°F)	¹

¹- Nicholson, R., et al, Dry fermented sausage and Eshcerichia coli O157:H7. National Cattlemen’s Beef Association, Research Report Number 11-316, Chicago, Illinois, 1996.

(v) Option 5: Use an alternative manufacturing process which is scientifically validated against E. coli O157:H7.

(a) Establishments which elect to use this option may choose to demonstrate that:

(b) The manufacturer shall make a request for the evaluation of the alternative manufacturing process to the Chief, Program development and evaluation, Food Borne Pathogen Unit, Laboratory Services Division. To allow the process to be evaluated, manufacturers shall use the challenge protocol developed by the USDA for such purposes and which is listed under part (d) below. Because of the complex nature of the protocol, it is strongly recommended that the services of an experienced food technology centre be retained.

(c) Upon completion of a successful evaluation, the operator shall be provided in writing, with a letter stating that the CFIA has evaluated the process for its ability to control E. coli O157:H7 and that it does not object to the manufacturer using the process. Until such confirmation is received, the operator will have to manufacture product in accordance to one of the other 4 options outlined in this section.

(d) Challenge protocol for the evaluation of a fermented sausage manufacturing process ability to control E. coli O157:H7

1. Biosafety requirements: CAUTION! - This protocol is a laboratory-based validation procedure that employs cultures that are pathogenic to humans. THE VALIDATION SHOULD NOT BE CONDUCTED WITHIN AN ACTUAL FOOD MANUFACTURING FACILITY. Work should be conducted in a Biosafety level II facility by appropriately trained personnel. Following use, autoclave all inoculated product and sanitize processing equipment. Follow appropriate procedures for the disposal of waste.

2. Types and numbers of strains of E. coli O157:H7 to use as an Inoculum: at least five (5) strains of E. coli O157:H7 should be used including representatives of strains associated with human illness and strains isolated from meat and poultry products. One isolate from an outbreak associated with a dry fermented sausage product must be included.

3. Methods of production, enumeration and standardization of Inoculum: Individual cultures of each strain should be prepared by inoculating an appropriate growth media, such as Tryptic Soy or Trypticase Soy broth, supplemented with 1% glucose and incubating for 18 to 24 hours at 37°C to obtain stationary phase cells. The additional glucose is added to ensure that the Inoculum is pre-adapted for acid tolerance. Cultures should be grown the day prior to product inoculation with a minimum holding period prior to actual use. Each strain should be centrifuged, washed and resuspended in 0.1% peptone broth. Dilutions of each strain should be made to yield approximately equal numbers of each of the five strains. The five strains should be thoroughly mixed prior to being used as an Inoculum. After the mixed working Inoculum is prepared, the viable count of the mixture should be determined by direct surface plating on MacConkey sorbitol agar (MSA). Each of the individual strains in the Inoculum should contribute about 20 percent of the total Inoculum.

4. Size of Inoculum to be used: the final concentration of E. coli O157:H7 in the meat mixture should be no less than 2.0 x 10⁷ CFU/g of meat mixture. The actual Inoculum level in the meat mixture should be confirmed by sampling the inoculated meat mixture immediately after the inoculation using the above media. At this concentration, product can be serially diluted and direct plated without the need for enrichment to recover low levels of Inoculum. The initial Inoculum level was chosen to allow direct enumeration of at lest a 5 log reduction in the level of the Inoculum between the initial count in the meat mixture and the finished product.

5. Method of inoculation to be used: the Inoculum must be added to the meat and mixed prior to the addition of the other ingredients or a starter culture to the meat mixture. The use of a non-inhibitory, food grade, green dye added to the Inoculum may aid in determining the uniform distribution of Inoculum. The following procedure is recommended:

i. Add Inoculum to meats while grinding or chopping the meats to the desired consistency

6. Stuffing product into casings: Inoculated product should be stuffed into casing as usual to approximate normal production procedures. A shorter length may be used as long as the length is approximately twice the diameter of the stuffed casing.

7. Sample size, sampling time, sampling location and number of samples to test: Select two sausage sticks at the end of the drying period (finished product). From each stick selected, cut multiple cross-sectional slices from multiple locations on each stick to a final analytical sample weight of 25 g per stick.

8. Methods of microbial analysis: Blend each of the two 25 gram samples (one per stick) in separate 225 ml portions of buffered peptone water. Serially dilute the homogenates in buffered peptone water and surface plat 0.1 ml portions from the dilutions onto MSA plates in duplicate. Count plates after incubation at 42°C overnight. Confirm 5-10 randomly selected colonies by serological and biochemical methods as necessary. Report count per gram of finished product. Report initial Inoculum level.

9. Number of replicates: a minimum of three replicates of the study should be performed. Three separate formulation batches can, however, be processed concurrently following stuffing.

10. Measurement of process parameters used to determine when a product is finished at each stage of production (process control criteria): Duplicate uninoculated samples of the product which are collected after stuffing and at each production stage should be assayed for moisture, fat, protein, salt content, pH, a_w, and titratable acidity.

a_w and pH values are critical for processes used to ensure the control of pathogens in all semi-dry and dry fermented meat products as well as to ensure shelf-stability of certain of these products. a_w and pH values may vary greatly between individual production lots. Consequently, if a_w or pH value is a identified as a critical factor in the manufacture of dry fermented meat products, each production lot must be tested for a_w and/or pH in order to verify that the critical limits are met.

With the exception of products with a pH of 4.6 or less, fermented dry sausages and fermented meat products sold as shelf-stable must have an a_w value of 0.90 or less before release. Even though a_w measurement is mandatory only for shelf stable products, it is strongly recommended that plant management determine the norm for a_w values achieved for each product type they manufacture and for each production line (room). Once this has been established, frequent regular checks should be made.

The inspector should regularly review plant management's controls and testing activities, and the results obtained. The inspector should verify if all applicable controls are in place. Plant managements' determination of pH and a_w values should be verified, periodically, by observing the operator doing actual a_w and pH measurements and by observing the operators calibration activities for a_w and pH measuring equipment. Any discrepancy should be checked by repeating the sampling and testing procedures. Any product found in non compliance shall be held pending further evaluation.

When a company is submitting a sample for laboratory examination due to product not meeting pH and a_w requirements, the inspector should take a paired sample and submit it to departmental laboratory for bacteriological evaluation. In order to minimize disruption to scheduled monitoring programs, the inspector shall consult with his regional office before the submission of those samples.

(f) Summary of the Control Points Applicable to Dry/Semi-Dry Fermented Meat Products

Food products that are pasteurized prior to or immediately after packaging under modified atmosphere (vacuum packaging, gas flushing) in hermetically sealed containers such as flexible pouches/ plastic trays/bowls/cups and require refrigeration throughout their shelf-life, shall be prepared under strict rules. The most important groups of products processed in this way are "cooked and assembled" and "sous vide" products.

The requirements applicable to the preparation of this type of product are provided in the "CANADIAN CODE OF RECOMMENDED MANUFACTURING PRACTICES FOR PASTEURISED/MODIFIED ATMOSPHERE PACKAGED/REFRIGERATED FOOD" - March, 1990, produced by the Agrifood Safety Division of the Canadian Food Inspection Agency.

N.B.This code is not intended for the preparation of pasteurized products to which preservatives are added. It is intended only for foods that rely only on refrigeration to ensure their quality and safety.

The handling of ready-to-eat meat products is very critical because these meats will be eaten by consumers without further cooking, or any other antibacterial treatment. Exposure of the product to any contamination, from the time it is cooked until the time it is sold, must be as minimal as practically possible. Any known contamination imparted to a ready-to-eat meat product in a registered establishment must be dealt drastically and without compromise. The following general procedure should be followed when dealing with ready-to-eat meat products which have fallen on the floor:

A suitable work surface, different from other meat handling surfaces should be used for the above procedure and be sanitized after each use.

If the management decides not to follow the above procedures , product is to be treated as condemned.

This is defined as the inclusion of a prepared meat product into another meat product. It is the responsibility of plant management to ensure that all the ingredients and components of the rework material are allowed into the meat product to which they are added. A special attention shall be paid to the list of ingredients of the resulting meat product; all ingredients added either directly or by the means of a rework product shall be accurately declared.

It should be noted that the presence of some curing aids may be found in significant amounts in the final product if their presence in the rework was not taken into consideration. In that respect, the level of nitrite/nitrate salts and of phosphates must be recalculated if the amount of rework material added to the formulation is in excess of 10% (see 4.10.3(11)).

Sausages in artificial edible casings (e.g. collagen) are allowed as rework material in the preparation of sausages wrapped in artificial edible casings or natural casings, to a limit of 3% in weight of the new meat product. The artificial edible casing does not have to be declared on the label of the product.

Sausages in natural casings are only allowed as rework material in the preparation of equivalent meat products (i.e. also wrapped in natural casing), to a limit of 3% in weight of the new meat product. When meat products in natural casings are reworked special attention must be paid to the animal species from which the casings were derived in order to verify that labelling requirements are met. For more information see chapter 7, section 7.6.1 (c).

Packaging operations shall be conducted in a sanitary manner. Contact surfaces such as tables, knives, equipment, aprons, etc., shall be kept in a suitably sanitary condition at all times during operations. Adequate separation, to prevent product contamination, shall be maintained between packaging materials brought into the room for use and exposed product (eg: separate tables). Only enough packaging materials for one shift are to be moved into the packaging room. Packaging materials shall not be stored in the packaging room past the end of the shift. If packaging materials need to be returned to the dry storage area, they must be clean and properly protected. Employees must exercise care when conducting operations to ensure that product is maintained in a satisfactory condition and is not exposed to contamination risks.

Packaging operations for incompatible types of product (eg: ready-to-eat/non ready-to-eat meats) are segregated physically, or when such separation is not possible, segregated operationally; suitably documented operational controls shall be established, maintained and implemented.

All packaging materials coming into contact with meat products must be approved (eg: insert liners, plastic trays, pads, films,waxed cartons, plastic liners, etc.) Refer to section 4.12 (5) for information on the approval process for packaging materials.

Because of the potential severe consequences linked to the presence of E. coli O157:H7 in raw beef, all operators of meat registered establishments handling raw beef are required to reassess their HACCP system if they are FSEP recognized or to implement HACCP-based process controls to clearly indicate that E. coli O157:H7 is a likely hazard associated with raw beef. The Operators are also to implement pathogen reduction step(s) to manage the risk, if not already in place, to validate their HACCP system or HACCP-based process controls using as per established guidelines (see Annex O of this chapter) and to implement verification procedures. Inspection personnel will review the establishment reassessment and take appropriate regulatory measures if procedures are found incomplete or ineffective.

Rooms used for the storage of palletized meat products should be provided with suitable shelving when pallets are stored in superposition.

Where storage rooms are not provided with suitable shelving and pallets are stacked the following provisions apply:

N.B.: The operator must ensure that pallets are in good repair and clean before use. In some cases, where problems are encountered, the use will require restriction or change to appropriate alternate equipment.

Chapter 4 - Inspection procedures, dispositions, monitoring and controls