Chapter 4 - Meat Processing Controls and Procedures

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Table of Contents

Annexes

Memoranda

Addtional Informaation

Acronyms used in this chapter

"Act"

means the Meat Inspection Act

"Chief"

means the Chief, Meat Processing

"CVS"

means the Compliance Verification System

"Divisional"

means by the Meat Programs Division (MPD)

"Director"

means the Director of the MPD

"EDO"

means the Area Executive Director, Operations, as designated by the President of the Agency

"FSEP"

means the Food Safety Enhancement System

"FTM"

means finely textured meat

"HACCP"

means Hazard Analysis and Critical Control Point

"MIR"

means the Meat Inspection Regulations, 1990

"MSM"

means mechanically separated meat

"MOP"

means the Meat Hygiene Manual of Procedures

"NRTE"

means non ready-to-eat

"Registered"

means registered under the authority of the Meat Inspection Act and Regulations

"RTE"

means ready-to-eat

"SRM"

means specified risk material

Glossary of Terms

Adulterated:

for the purposes of this chapter, in respect of a meat product intended for sale, use or consumption as an edible meat product in Canada, means containing an ingredient, food additive, poison, decomposed substance, visible contamination, any pathogenic microorganisms that are injurious to health or failing to meet the standards set out in Part I, Standards and Identification of Edible Meat Products of the Meat Inspection Regulations, 1990.

Assembled/Combination Products:

foods that contain as ingredients foods from more than one food commodity. Some examples include pizza (bread-type crust, vegetables, meat and cheese), lasagna (pasta, vegetables and cheese).

Compatible:

in respect of activities taking place in a registered establishment, activities that can take place at the same time, in the same area and do not create a risk of adulterating meat products. In respect of food or other materials, products that are capable of existing together in the same area, at the same time without creating a risk of adulterating meat products.

Casing:

means a skin-like container used for a meat product, as per the Meat Inspection Regulations, 1990.

Component:

an individual unit of food that is combined with one or more other individual units of food to form an ingredient, as per the Meat Inspection Regulations, 1990.

Condemn:

means, in respect of a meat product, to determine that the meat product is inedible, as per the Meat Inspection Regulations, 1990.

Container:

means a package in which a meat product is placed to be offered for sale, or intended to be offered for sale, but does not include a lining, a bulk container, or a transport container, as per the Meat Inspection Regulations, 1990.

Control Program:

a control program consisting of actions and activities that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Critical Control Point:

a point in a process at which control is to be applied in order to prevent or eliminate a hazard or reduce a hazard to an acceptable level, as per the Meat Inspection Regulations, 1990.

Critical Limit:

the minimum or maximum value to which a hazard must be controlled at a critical control point to prevent or eliminate the hazard or reduce it to an acceptable level, as per the Meat Inspection Regulations, 1990.

Cured:

in respect of an edible meat product, that salt together with at least 100 parts per million (ppm), but not more than 200 ppm, of sodium nitrite, potassium nitrite, sodium nitrate or potassium nitrate, or any combination thereof, except in the case of side bacon, where the maximum is 120 ppm, calculated prior to any smoking, cooking or fermentation.

Durable Life:

the period, commencing on the day on which a meat product is packaged, during which the meat product, when it is stored under conditions appropriate to that product, will retain, without any appreciable deterioration, its normal edibility, palatability, nutritional value and any other qualities claimed for it by the manufacturer, as per the Meat Inspection Regulations, 1990.

Edible:

in respect of a meat product, a meat product that is fit for use as human food, as per the Meat Inspection Regulations, 1990.

Edible Rendering:

to extract fats and oils from edible animal tissues by the application of heat for consumption as an edible product.

Egg:

includes a processed egg as defined in the Processed Egg Regulations, or an egg that has been graded Canada A under the Egg Regulations, as per the Meat Inspection Regulations, 1990.

Extended Meat Product:

means an edible meat product to which a meat product extender has been added, as per the Meat Inspection Regulations, 1990.

Fermentation:

means a process which promotes the growth of lactic acid bacteria in order to acidify the product.

Filler:

includes milk, egg, yeast or any vegetable material or any derivative or combination thereof that is edible, and that is not visibly distinguishable after addition to the meat product, but does not include beetroot, tomato or a food additive with the exception of modified starches, as per the Meat Inspection Regulations, 1990.

Finely Textured Meat:

means an edible meat product that does not contain more than 0.15 per cent of calcium in the product and any bone particles larger than 1.5 mm in size and a maximum of 20% of the bone particles larger than 1 mm in size, that was obtained by removing most of the bone and cartilage from a comminuted meat product from which the bone and cartilage had not been previously removed.

Flavour Enhancer:

means an ingredient that enhances the natural flavour of a meat product, as per the Meat Inspection Regulations, 1990.

Food:

includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose, as defined by the Food and Drugs Act.

Food Contact Surface:

A food contact surface (FCS) is any surface or object that comes into contact with the meat product.

Fresh Meat Product:

not cooked or preserved.

FSEP Manual:

the Food Safety Enhancement Program Manual (FSEP) published by the Agency, as amended from time to time.

Gelling Agent:

means gelatin, agar or carrageenan, as per the Meat Inspection Regulations, 1990.

HACCP plan:

a hazard analysis critical control points plan that is prepared in accordance with the FSEP Manual for a process or product and that specifies, in respect of the process or product, all the hazards, critical control points, critical limits, monitoring procedures, deviation procedures, verification procedures and records, as per the Meat Inspection Regulations, 1990.

Ham:

the edible meat product that is derived from the hind leg of a dressed swine carcass above the tarsal joint, as per the Meat Inspection Regulations, 1990.

Hazard:

means a biological, chemical or physical agent or factor that has the potential to cause a food to be unsafe for human consumption in the absence of its control, as per the Meat Inspection Regulations, 1990.

Ingredient:

an individual unit of food that is combined with one or more other individual units of food so that the individual unit are no longer distinguishable as separate units.

Inspection:

for the purposes of this chapter, includes the examination of a product or sample from a shipment or other collection of products, or, in respect of a process, the verification or monitoring of the process.

Intact Meat Products:

piece of meat whose internal structure has not been modified. Non-comminuted meat products are considered to be intact meat products.

Lethality Treatment:

refers to the treatment delivered to a meat product to achieve a reduction in the viable pathogenic organisms.

pH:

measures acidity or alkalinity on a scale of 0 to 14 with 7 as the neutral point.

Post-Cook Stabilization:

The set of measures applied to protect a cooked meat product against the possible outgrowth of heat shocked Clostridium spp. spores to dangerous levels during the interval following cooking. Refer to section 4.5 for these requirements.

Post-Lethality Procedure:

procedures implemented by operators in the post-lethality processing environment to control or eliminate pathogenic microorganisms in ready-to-eat meat and poultry products. For example, a post-lethality treatment is considered satisfactory when it achieves at least 3-log reduction in number of L. monocytogenes in ready-to-eat meat products, e.g., High-Pressure Processing (HPP) at 87000 psi for 3 minutes.

Low-acid Meat Product:

an edible meat product which has a pH value above 4.6 and a water activity above 0.85, as per the Meat Inspection Regulations, 1990.

Meat:

the edible part of a carcass that is the muscle associated with the skeleton, tongue, diaphragm, heart, gizzard or mammalian oesophagus, with or without accompanying and overlying fat, together with those parts of the bones, skin, sinews, nerves, blood vessels and other tissues that normally accompany the muscle and are not ordinarily removed in dressing a carcass, but does not include the muscle associated with the lips, snout, scalp or ears, mechanically separated meat or meat to which an ingredient other than meat has been added, as per the Meat Inspection Regulations, 1990.

Meat By-product:

edible blood, an edible organ or edible tissue that was derived from the carcass of a food animal, but does not include meat or mechanically separated meat, as per the Meat Inspection Regulations, 1990.

Meat Product:

includes a carcass, the blood of an animal or a product or by-product of a carcass, or any product containing blood, a product of by-product of an animal, as defined by the Meat Inspection Act.

Mechanically Separated Meat:

means an edible meat product that does not contain more than 0.027 per cent of calcium for every one per cent of protein in the product or any bone particles larger than 2 mm in size and that was obtained by removing most of the bone and cartilage from a comminuted meat product from which the bone and cartilage had not been previously removed, as per the Meat Inspection Regulations, 1990.

Non Ready-to-Eat (NRTE) meat products:

a meat product that has not received a full lethality treatment for pathogens of concern at the establishment, e.g., par-fried breaded chicken nuggets, or, the meat component in an assembled food is in the ready-to-eat stage while at least one other ingredient is in the non ready-to-eat stage and will require further cooking for lethality before consumption, e.g., pizza with raw dough, frozen entrees with NRTE vegetables and clearly labelled with adequate cooking instructions.

Package:

means an inner or outer receptacle or covering used or to be used in connection with a meat product, as defined by the Meat Inspection Act.

Prepared:

a meat product that has been cooked or dehydrated or to which has been added any substance other than meat, a meat by-product or mechanically separated meat, as per the Meat Inspection Regulations, 1990.

Prerequisite Programs:

steps or procedures that control the operational conditions within a food establishment allowing for environmental conditions that are favourable to the production of safe food. The programs cover premises; transportation, receiving, storage and shipping; equipment; personnel; sanitation and pest control; health and safety recall procedures, and allergen control.

Preserved:

salted, pickled, dried, cured, smoked or treated by other similar means, but does not include refrigerated or frozen.

Process:

to substantially change the appearance or nature of a meat product. Example include to debone, comminute, preserve, dehydrate, ferment, render or assemble with an ingredient other than a meat product, but does not include to dress, trim, refrigerate, freeze or defrost.

Ready-to-eat Meat Product:

a meat product that has been subjected to a lethality process sufficient to inactivate vegetative pathogenic microorganisms or their toxins and control spores of foodborne pathogenic bacteria so that the meat product does not require further preparation before consumption except washing, thawing or exposing the product to sufficient heat to warm the product without cooking it, as per the Meat Inspection Regulations, 1990.

Recipe:

the ingredients of the meat product and the components of the ingredients, including food additives, and the proportions of those ingredients and components.

Refrigerate:

means to lower the temperature of a meat product to, and to maintain the temperature at, 4°C or lower, but does not include to freeze, as per the Meat Inspection Regulations, 1990.

Thermal Lethality:

the ability of a given heating process to kill bacteria. It is most often expressed in quantitative terms, i.e., as the amount of heat energy that must be applied to a specific meat product to achieve a given log10 reduction of a particular microorganism.

1 log10 reduction = a tenfold reduction (1 x 101) = a 1D reduction
2 log10 reduction = a hundredfold reduction (1 x 102) = a 2D reduction
3 log10 reduction = a thousandfold reduction (1 x 103) = a 3D reduction etc.

For example, a 3D reduction would destroy 99.9% of the organisms.

Unsanitary Conditions:

conditions or circumstances that might contaminate a food with dirt or filth, or render injurious to health, as defined by the Food and Drugs Act.

Unstandardized Food:

for the purposes of this chapter, means any food for which a standard is not prescribed in the Food and Drug Regulations or the Meat Inspection Regulations.

Water Activity (aw):

the amount of free or available water in a meat product.

"Where necessary", "Where appropriate", "Adequate" and "Sufficient":

Where this chapter of the Meat Hygiene Manual of Procedures uses the terminology "where necessary", "where appropriate", "adequate", or "sufficient", it is up to the operator of a registered establishment in first instance to decide whether a requirement is necessary, appropriate, adequate, or sufficient to achieve the objectives of the Meat Inspection Regulations, 1990. In determining whether a requirement is necessary, appropriate, adequate, or sufficient to achieve the objectives of the Regulations, account should be taken of the nature of the operation/activity and of its intended use. The operator may justify his choice under the procedures based on the Hazard Analysis Critical Control Points (HACCP) principles or under the operational procedures of a registered establishment.

4.1 Introduction

Requirements for processed meat products are governed by the both the Meat Inspection Regulations, 1990 (MIR) and the Food and Drug Regulations (FDR). The operator must ensure, through the establishment's mandatory Prerequisite Programs and HACCP Plan (Control Programs) that these regulatory requirements are met.

For details on mandatory prerequisite programs and HACCP plans to meet regulatory requirements, please refer to the Meat Hygiene Manual of Procedures (MOP) Chapter 3, Pre-requisite Programs and the Food Safety Enhancement Program (FSEP) Manual.

The main objectives and expected outcomes of process control requirements and performance requirements are to prevent, eliminate or reduce to an acceptable level, hazards that can lead to food safety compromises, during the specific meat transformation processes conducted in the establishment.

It is the operator's responsibility to develop and implement Control Programs that meet the mandatory process control requirements and performance requirements outlined in this chapter.

Meat Inspection Regulations, 1990:

9. (1) Subject to subsection (2) and section 121, no meat product shall be identified as edible unless

  • (c) the meat product conforms to the applicable standards prescribed by these Regulations and the Food and Drug Regulations.

22.1. Every operator that prepares meat products must prepare them in accordance with the process control requirements specified in the Manual of Procedures

30.1 (1) The operator of an establishment shall develop, implement and maintain

  • (a) the required prerequisite programs, HACCP plans and other control programs as set out in the FSEP Manual and the Manual of Procedures; and
  • (b) the procedures to ensure compliance with the performance requirements set out in the Manual of Procedures.

57.2 Every operator shall carry out control programs in accordance with the FSEP Manual and the Manual of Procedures to ensure that

  • (c) the requirements of the Act and these Regulations are met in respect of the registered establishment, equipment, food animals, meat products, ingredients, food additives, chemical agents, packaging and labelling materials, training and any other requirement of a control program set out in the FSEP Manual and the Manual of Procedures; and
  • (d) in all other respects, inspection programs or examination programs, as the case may be, are operated in accordance with the Act and these Regulations.

Food and Drugs Act:

4. (1) No person shall sell an article of food that

  • (a) has in or on it any poisonous or harmful substance;
  • (b) is unfit for human consumption;
  • (c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance;
  • (d) is adulterated; or
  • (e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.

4.2 Handling of Meat Products

Processing rooms (cutting and boning, formulation rooms, kitchens, packaging, etc.) must be equipped to accommodate the particular process or processes conducted therein.

4.2.1 Requirements for Cooling, Freezing and Room Temperatures

4.2.1.1 Refrigeration

In the Meat Inspection Regulations, 1990 (MIR) "refrigerate" means to lower the temperature of a meat product to, and to maintain the temperature at, 4°C or lower, but does not include to freeze.

For products stored under refrigerated conditions, the operator must have in place Control Programs to monitor the temperature of these products, such that the internal temperature of each product is 4°C or less but not frozen.

The mandatory outcome of refrigeration is to retarding outgrowth of pathogens and spoilage bacteria.

4.2.1.2 Environmental Temperature Conditions

Meat Inspection Regulations, 1990 (MIR):

36. The temperature in a room or area of a registered establishment where a meat product is processed, packaged, labelled or handled shall be appropriate to ensure the preservation of a meat product.

The required outcome is to control the growth of microorganisms in the room or area used for the processing, packaging, labelling or handling of meat products. Room or area temperatures must also ensure control of product temperature during processing activities, such that there is no increase in bacterial growth of the product that would affect the validation of any further lethality step or validation of product shelf life.

The operator's written control program must justify the room or area temperature most appropriate for the specific processing step conducted therein, specifying hazards related to temperature abuse in the establishment HACCP system. Historically, a room temperature of 10°C has been considered sufficient by the CFIA for the preservation of meat products for most processing activities and steps. Alternative temperature control measures must provide the same or better outcome.

Where processing equipment, such as automated grinding, mechanical separation and other comminuting procedures, produce enough heat that could warm up the product's internal temperature significantly, the specific hazard for temperature abuse must be accounted for in the operator's HACCP system.

4.2.1.3 Freezing

Freezing reduces the temperature of a meat product below the freezing point, changing the state of water from liquid to solid form (ice). The formation of ice concentrates the dissolved solutes and reduces the water activity of the meat product. Freezing prevents the growth of, but does not destroy, microorganisms in food products.

The rate of freezing is important to prevent growth of microorganisms or production of their toxins prior to the product reaching freezing temperatures. Oxidative rancidity and other organoleptic quality issues can occur if freezing rates are slow. Operators should validate that their processes reduce the core temperature of products preserved by freezing, to a core temperature of -18°C within a time frame allowing for the preservation of organoleptic and microbiological qualities.

It is recommended that holding freezers be capable of maintaining temperatures of -18°C or colder.

Refer to Annex P of this chapter for the CFIA procedures to evaluate bulk container freezing processes for meat products.

Freezing as an application for destruction of the parasites Trichinella, and Cysticercus, is described in Annex B of this chapter and Chapter 17 respectively.

4.2.1.4 Crust Freezing

Rapid chilling methods which temporarily freeze a thin outer layer of skin and muscle (usually 3 to 4 mm thick) may be allowed under the following conditions:

  • the operator must submit to the Inspection In Charge, a written documented protocol for each product, outlining how the product will be identified and segregated into lots, the packaging method, type and temperature of the coolant, the duration of exposure to sub-freezing temperatures and the time period and location for the equilibrium of internal and external product temperatures such that an internal temperature is achieved at or below 4°C (but above -2°C);
  • the surface crusting must disappear within 2.5 hours (150 minutes) of completing the crust freezing process;
  • the process must be monitored, by a designated plant employee, a minimum of every two (2) hours for crust disappearance and internal product temperature;
  • the product must be labelled as either "previously frozen" or "frozen" whenever crust disappearance takes more than 150 minutes; and
  • records demonstrating compliance with all of the above listed requirements must be stored at the establishment for at least one year for each lot of product which is crust frozen.

4.2.2 Environmental Contamination

The operators must have procedures for control of environmental sources of contamination of meat product, including disposition of meat that has fallen on the floor, risk of contamination from condensation and storage of equipment. It the operator's responsibility to ensure that the procedures for environmental risk factors for contamination of product are effective and verifiable.

4.2.3 Defrosting or Thawing

Defrosting or thawing may be performed in air or water. The operator is responsible to ensure that the temperature of the meat is controlled to minimize the time that any portion of a meat product is above 4°C. Operators are responsible for establishing appropriate best before dates which take into account the length of time elapsed before the product was originally frozen.

The placing of frozen meat into cooking kettles without prior thawing is permitted only when a representative sample of the entire lot has been thawed and found to be sound and unadulterated.

Meat products which have been frozen and thawed for sale in a refrigerated state must be labeled in accordance with article B.01.080 of the Food and Drug Regulations as "previously frozen".

4.2.4 Rework

This is defined as the inclusion of a prepared meat product into another meat product. It is the responsibility of the operator to ensure that all the ingredients and components of the rework material are permitted in the meat product to which they are added. Special attention must 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 must be accurately declared in the ingredients list of the resulting meat product. For more information see Chapter 7.

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.

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.

4.3 Fresh Meat Control Programs

4.3.1 Boning and Cutting

Cutting, boning, slicing and dicing of fresh meat product are done, by present industry practices, either manually (hand saws, knives, wizards and electric saws) by designated employees or by automated equipment (such as may be used for poultry cutting and breast boning). In either case, the operator's Control Programs must include procedures that address the build-up of product material on the equipment, to minimize cross contamination of product over time on a given production line.

A carcass re-inspection station located prior to cutting and/or boning is required for red meat and must be equiped as per MOP Chapter 3, section 3.4.12, Check Trim Station. This station must be equipped with a directly drained and remote controlled or timed hand wash facility, an 82°C water sanitizer and adequate lighting. Facilities for the removal of bones and trimmings must be provided.

Establishments receiving beef carcasses or partial carcasses from cattle 30 months or older containing SRM must follow control procedures as outlined in Chapter 17 of the MOP.

4.3.1.1 Terminology

Boneless Red Meat:

Boneless meat from cattle, calf, sheep, goat, horse or swine carcasses, including boneless cuts and trimmings.

Trimmings:

Meat pieces obtained during deboning and which do not meet any meat cut labelling specification.

Lot (for the purposes of this section):

For the purposes of this section a lot is whichever is the lesser of:

  • a shipment or part of a shipment of boneless manufacturing meat derived from a single species going to a single destination; or
  • 4 hours of production of boneless manufacturing meat derived from a single species from a single boning line.
Boneless Meat Verification:

Evaluation technique of CFIA inspectors, in which samples are taken from the assembled "lot" of product to determine its wholesomeness.

Lot Examination:

An evaluation technique of the operator in which samples are taken from the assembled lot of product.

On-Line Examination:

Operator's 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.

4.3.1.2 Control Program for Boneless Fresh Meat

The operator must include in the establishment's control program for raw meat derived from any species, a monitoring program for incoming products, destined for cutting, boning, slicing or dicing, as a fresh meat product. For guidelines, refer to Annex F. If the operator chooses to use methods for the control programs, other than those outlined in Annex F, these must be evaluated by the CFIA to ensure that they reach the same outcome, taking into account volume of production, establishment layout and species of fresh meat.

The mandatory outcome of the boneless fresh meat control program is to minimize the outgrowth of pathogens either in an end-product for the consumer or when the product is destined for further processing. It the operator's responsibility to ensure that the control program for environmental risk factors for contamination of product are effective and verifiable.

The optional use of antimicrobial agents, when used as pathogen reduction procedures for cutting of raw meat, must be included as part of the operator's control program. The agent must be an agent approved by Health Canada. Contact the CFIA Area Program Specialist for information for approved antimicrobial agents for meat products. Concentration and rinse/drip times are key steps that must be included in the operator's control program, to avoid build-up of chemical residues on the end-product.

4.3.1.2.1 Lot Examination

Sampling plans, methods and criteria for disposition of lots of boneless meat are found in Annex F, Part 1. Should the operator elect to use alternate sampling plans, methods and/or criteria, these must be evaluated by the CFIA to ensure that they are at least equivalent with Annex F, Part 1. The operator's approved alternative plan is then monitored by the CFIA.

Each time a lot is evaluated, the following procedure should be followed by the operator:

  • Once the lot is completely assembled, determine its size (in kg), and select the corresponding sampling plan (with reference to Annex F, Part 1).
  • Randomly select the containers from the lot in proportion to different code marks, and remove the required number of 5.5 kg sample units from the containers.
  • Examine the product, classify defects using the defect criteria table and determine acceptance or rejection according to the sampling plan.
  • Record results.
  • If the lot is rejected: After reconditioning, re-inspect the rejected lot using the next, higher sampling plan and double the frequency of monitoring for the rest of the production shift.
4.3.1.2.2 On-line Examination

The operator of the establishment must design, document and implement 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 one year.

The minimum sampling size and schedule per boning line should be 15 kg for each 30 minutes of production (random time sampling twice hourly).

The examination program must be capable of achieving the following results:

  • Assure that all boneless meat produced under the program is capable of passing the lot inspection/examination program previously described using the designated sampling plans and defect criteria.
  • Reject, hold and recondition product when defects exceed limits. Product produced since the last satisfactory evaluation must be reconditioned.

Prior to approval by the Inspector in Charge, the effectiveness of the program must be evaluated using lot examination to assure that on-line examination achieves equivalent or better results than lot examination. The supporting documentation and evaluation must be kept in file by the CFIA.

4.3.2 Comminuting

Comminuting processes include mechanical separation, flaking and grinding. Potential hazards associated with these automated processes include pathogen outgrowth from precursor materials and temperature abuse during production, metal particles from the equipment, excessive amounts of bone fragments and residual SRM.

See Annex O for policy specifications on the detection of E. coli O157:H7 in raw beef.

4.3.3 Mechanically Separated Meat (MSM) and Finely Textured Meat (FTM)

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 beef).

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

  • no more than 0.027% of calcium for every 1% of protein;
  • no bone particles larger than 2 mm in size; and
  • a minimum protein content of:
    • 10%; or
    • if destined for retail sale, 14%.

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

  • no skin;
  • no more than 0.15% of calcium;
  • 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
  • a minimum protein content of:
    • 10%; or
    • if destined for retail sale, 14%.

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

  • it has a minimum protein content of 14%; and
  • bones emerging from separation equipment must be essentially intact and recognizable to assure that the bones are not being crushed, ground or pulverized; and
  • it complies with the standards set out within Schedule I of the Meat Inspection Regulations, 1990. 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).

4.3.3.1 Raw Material Used in the Preparation of FTM and MSM

The regulatory definition for MSM prohibits the use of any previously deboned meat as input material. In FTM, hand or mechanically deboned trimmings that contain bone particles or cartilage may be used.

Important considerations:

  • lungs must be removed from all poultry carcasses and portions prior to their use as material for mechanical separation;
  • poultry carcasses dressed with kidneys may be used for MSM only, as long as the resulting product is properly labelled. The statement "Contains kidneys" or "With kidneys" must appear by the product name. It is to be noted that this mention must also appear on the ingredients list of any product made with MSM containing kidneys;
  • skulls must not be used; and
  • the spinal cord must be removed from ruminant, equine and porcine carcasses and portions prior to their use as material for mechanical separation.

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

Bones must be:

  • maintained at a temperature not exceeding 10°C and mechanically separated within 5 hours of boning; or
  • refrigerated to 4°C and mechanically separated within 72 hours of boning; or
  • refrigerated to -2°C and mechanically separated within 120 hours of boning; or
  • immediately placed in a freezer and frozen within 48 hours of boning.

4.3.3.2 Control of Lungs and Kidneys in Poultry Carcasses and Parts of Carcasses

Kidneys and lungs must be removed from poultry carcasses and portions prior to their use as material for mechanical separation. Kidneys may be left in FTM/MSM input materials where the product is labelled as containing kidneys and is produced for export or for use other than as an ingredient in a prepared meat product.

The operator must have a control program in place 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.

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 at the establishment or prior to the processing of the material, the operator must perform a random selection of 20 carcasses or 20 units per combo or a lot of similar size.

  • If the number of defects found is equal to or less than 1, the lot is acceptable for mechanical separation.
  • If the number of defects found is equal to or greater than 4, the lot must be rejected.
  • If the number of defects found is between 1 and 4, a second sample of 20 units must be evaluated. The number of defects in the first and second sample must be totalled.
  • If the cumulative number of defects found is equal to or less than 4, the lot is acceptable for mechanical separation.
  • If the cumulative number of defects found is equal to or greater than 5, the lot must be rejected.

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

If the operator chooses to use methods for the control programs, other than those outlined above, these must be evaluated by the CFIA to ensure that they reach the same outcome, taking into account volume of production.

4.3.3.3 Use of Pork or Poultry Skin as Raw Material When Producing 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 MSM; 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 Regulations, 1990 (MIR). MSM made from skinless raw material may be labelled as "Skinless - Sans peau".

When using skinless MSM in the formulation of a meat product, up to 8% of skin from the named species is permitted under the MIR Schedule I. 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:

a) 55 kg of skinless pork trim:

25 kg of pork MSM
20 kg of water
kg of pork skin

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:

50.6 kg of skinless pork trim + 4.4 kg of pork skin
25 kg of pork MSM
20 kg of water

b) 55 kg of skinless pork trim:

25 kg of pork MSM without skin
20 kg of water
kg of pork skin

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:

50.6 kg of skinless pork trim + 4.4 kg of pork skin
23 kg of pork MSM without skin + 2 kg of pork skin
20 kg of water

4.3.3.3.1 Sampling Procedure and Tolerance for Pork or Poultry Skin

The operator must have a control program in place for skinless MSM which includes a sampling plan. For the purpose of this sampling plan the definition of a lot is the same as in the above item 4.3.3.2 Control of Lungs and Kidneys in Poultry Carcasses and Parts of Carcasses.

The total skin area of all sample units (up to 20) cannot exceed 25 cm2 (i.e.in2).

  • Select a 10 unit sample at random and examine for the presence of skin. A unit is an intact piece, e.g. front half shell, breast frame, shell, skinless back or neck.
  • If no skin is found, the mechanically separated meat may be identified as "Skinless - Sans peau".
  • If the total skin on the first 10 units exceeds 25 cm2, the lot cannot be used in the preparation of "Skinless - Sans peau" products unless it is reworked to remove the skin and presented for reinspection.
  • Any skin found in the first 10 sample units not exceeding the tolerance, requires random selection of a second 10 unit sample from the same lot. Product where the skin found in the total 20 unit sample does not exceed the tolerance may be used in the preparation of "Skinless - Sans peau" products. Products where the skin exceeds the tolerance must be reworked to remove the skin and presented for reinspection.

If the operator chooses to use methods for the control programs, other than those outlined above, these must be evaluated by the CFIA to ensure that they reach the same outcome, taking into account volume of production.

4.3.3.4 Handling of MSM and FTM

Unless MSM or FTM is used directly after the separation process as an ingredient of a meat product, it must be:

  • cooled to a temperature close to 0°C (±2°C) in conjunction with the deboning process or immediately afterwards;
  • cooled to a temperature close to 0°C (±2°C) in conjunction with the deboning process or immediately afterwards and cured; or
  • frozen immediately after the deboning process.

4.3.3.5 Shipment of MSM From One Registered Establishment to Another for Incorporation Into a Prepared Meat Product

MSM may be shipped from one registered establishment to another in the refrigerated, refrigerated and cured or frozen state. The operator is responsible to implement proper controls over the conditions under which the product is handled to ensure its wholesomeness.

Refrigerated MSM (cured or non-cured) should be maintained at temperatures close to 0°C and should be closely monitored from production to utilization.

4.3.3.6 Control Program for MSM and FTM

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.

Start-up plan

This plan is used when the equipment is first installed, when major components are replaced (e.g. a 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 8 hours (480 minutes) sampling must be done every 24 minutes (480/20 = 24 minutes). Likewise, if the scheduled lot run is 6 hours (360 minutes) sampling must be done every 18 minutes (360/20 = 18 minutes).

The shift must be a minimum of 4 hours to be considered in this start-up plan, unless the operator's normal operating shift is less than 4 hours.

Each sub-sample should be about 30 grams. The samples may be placed in the same container (e.g. a 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.

Monitoring plan

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

For the purpose of this monitoring plan a sample of at least 500 g shall be taken randomly from the production lot. The tested lots may move freely prior to receipt of the laboratory report.

Performance Criteria and Tolerances for Results Analysis
Performance Criteria and Tolerances for Results Analysis for Mechanically separated meat
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
Performance Criteria and Tolerances for Results Analysis for finely textured meat
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

In the case of protein the results must be rounded to the nearest 0.1% (i.e. 9.76% would be rounded to 9.8, not 10%).

The operator must have deviation procedures for product which does not meet the standards outlined in 4.3.3.

4.4 Cooking

Operators are responsible for determining whether their meat product is ready-to-eat (RTE) according to this section.

The temperature and duration of the cooking process for heat treated meat products should be such that the heat treatment alone or in combination with other preserving processes is sufficient to destroy pathogens and toxins.

It is the operator's responsibility to determine compatible areas and non-compatible areas for different processing steps, as part of the prerequisite program and HACCP system. Refer to the FSEP Manual and Chapter 3, Prerequisite Programs for more details. Establishments should separate the handling of cooked, partially cooked and raw products to prevent recontamination.

Any deviation in cooking processes must be brought to the attention of the Inspector in Charge.

Chilling begins immediately after the cooking cycle is completed and according to section 4.5 of this chapter.

Environmental and product samples in ready-to-eat products are required. See Annex H for mandatory requirements for Listeria spp.

4.4.1 Control Program Requirements for Operators Manufacturing Cooked Ready-to-Eat (RTE) Meat Products

The operator must implement a control program for each individual cooked ready-to-eat meat product which contains:

  • A manufacturing process specified in writing by the operator and used to cook a particular meat product. It must indicate the minimum internal temperature reached during the process and, where applicable, the minimum holding (or dwell) time at the minimum internal temperature. The combination used must provide enough heat energy to achieve at least a:
    • 6.5 log10 (6.5D) reduction in Salmonella spp. in meat products that contain no poultry;
    • 7.0 log10 (7.0D) reduction in Salmonella spp. in meat products containing poultry.
  • A validation referencing a combination of internal product temperatures and minimum holding time (Annex D), or submission of a scientifically validated alternative from a Process Authority that suitably demonstrates that the manufacturing process is designed to deliver the necessary amount of thermal lethality.
  • The operator's control programs must include ongoing verification that the operating procedures and equipment used to make the meat product on a day-to-day basis will deliver the manufacturing process as designed. Worst case scenarios must be included, specifically, the coldest spot of both the equipment and the product.
  • When steam is generated, it must be properly vented out of the area and not allowed to permeate into adjoining rooms.
  • Measuring and/or recording equipment suitable to accurately and consistently measure and/or record the data used to verify that the control limits identified in the manufacturing process are being met. The operator must ensure that the monitoring limits used in their manufacturing process are adjusted by at least the amount of degrees or time specified by the equipment manufacturer as the acceptable measurement error.

    Monitoring equipment capable of measuring within the following limits is required:

    • temperature ± 1.0°C;
    • time ± one minute; and
    • relative humidity (where specified) ± 5%.

    When the operator is using time as a critical limit in the process, they must have automatic recording devices which can capture this data and that are capable of measuring within the following limits:

    • time:
      • ± 1 minute when the minimum internal (dwell) time is at least 10 minutes. The manufacturing process must allow an extra 1 minute of dwell time to compensate for measurement error.
      • ± 5 seconds when the minimum internal (dwell) time is at least 200 seconds. The manufacturing process must allow an extra 5 seconds of dwell time to compensate for measurement error.
      • ± 1 second when the minimum internal (dwell) time is at less than 30 seconds. The manufacturing process must allow an extra 1 second of dwell time to compensate for measurement error.

    If the operator is cooking a pork product in order to make it RTE, use of a recording thermograph is required when the product is not subjected to other Trichinella controls.

4.4.2 Requirements for Heat Treated Non Ready-to-Eat (NRTE) Meat Products

These meat products have been heated to improve their appearance or flavor but the process does not result in a ready-to-eat product. In all cases, the products must be cooked prior to consumption.

Unlike cooked ready-to-eat meat products, the operator is not required to verify at the time of manufacture that non ready-to-eat products have been subjected to a minimum amount of thermal lethality.

However, labelling of the product must comply with Section 94(6.1) of the MIR which stipulates:

"If any meat product is not a ready-to-eat meat product but has the appearance of or could be mistaken for a ready-to-eat meat product, the meat product shall bear the following information on its label:

  • the words "must be cooked", "raw product", "uncooked" or any equivalent words or word as part of the common name of the product to indicate that the product requires cooking before consumption; and
  • comprehensive cooking instructions such as an internal temperature-time relationship that, if followed, will result in a ready-to-eat meat product."

In order to meet these requirements, the operator must label the meat product to prevent it from being mistaken for a cooked RTE product and provide clear preparation instructions that when followed by the consumer will fully cook the product (i.e. provide instructions to achieve a 6.5D or 7.0D reduction in Salmonella spp.).

The text will be the same size as the rest of the common name. Article B.01.006 of the Food and Drug Regulations requires that the common name of the food be shown on the principal display panel, therefore if re-packaged, heated NRTE meat products will have to display the appropriate NRTE qualifiers.

The operator is required to validate the preparation instructions:

  • ensuring that they will yield the appropriate D reduction in Salmonella spp.;
  • ensuring that the instructions are representative of the cooking devices available to the consumer; and
  • ensuring that the minimum amount of thermal lethality must be received in a single dose, it is not acceptable to use a dose cumulative approach, i.e. add the amount of lethality provided at the manufacturing facility to the amount which will be added by end-user preparation as per instructions.

4.5 Cooling of Heat Processed Meat Products

The operator is responsible for ensuring that all heat processed meat and poultry products are handled and chilled so that the product is maintained in a wholesome and unadulterated state. A cooling schedule must be developed and filed for every type of heat processed product. The chilling process must be monitored to demonstrate that each lot complies with the validated established cooling schedules. Those records showing adherence to the schedule (product time/temperature) should be maintained on file for a period of at least 12 months beyond the shelf life (best before) of the product and made available to the inspector on request.

4.5.1 Cooling of Heat Processed Meat Products

Cooling must be continuous and begins immediately after the heating cycle is completed.

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 to prevent the outgrowth of heat shocked pathogen spores including the Clostridium species.

The operator must use one the following cooling schedules, appropriate to the product type, to cool all heat processed products in order to minimize growth of pathogenic bacteria in/on their products.

4.5.1.1 Requirements for Specific Heat Processed Products Using a Slow Cooling Rate

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

  • with a water activity (aw) of above 0.92, no less than 120 ppm of sodium nitrite (or its equivalent in KNO2) and a brine concentration of 3.5% in the finished product or more; or
  • with a water activity (aw) above 0.92, no less than 40 ppm of sodium nitrite (or its equivalent in KNO2) and a brine concentration of 6% or more in the finished product; or
  • with a water activity (aw) that is less than or equal to 0.92 at the beginning of the cooling process, with or without nitrite (such as dried products); or
  • with a water activity (aw) of above 0.92, no less than 180 ppm of sodium nitrite (or its equivalent in KNO2) and a brine concentration of 2.3% in the finished product or more.

Example:

Brine concentration in the finished product = [% salt / (% salt + % moisture in end product)] x 100

Example: If 2.8% of salt in the formulation and the end product has a moisture level of 72%, the brine concentration is:

{(2.8/100) / [(2.8/100) + (72/100)]} X 100 =
[0.028 / (0.028 + 0.72)] X 100 =
2.8 / 0.748 = 3.74%

Requirement for slow cooling:

Condition 1 and one of the two options in condition 2 must be met:

Condition 1:

The internal temperature does not remain between 49°C and 4°C for more than 20 hours;

and

Condition 2:

The cooling process:

  • causes a continuous drop in product's temperature; or
  • controls the product's surface temperature so that it does not stay between 49°C and 20°C for more than two (2) hours.

4.5.1.2 Rapid Cooling Rate

During cooling, the product's maximum internal temperature must not remain between 54°C and 27°C for more than two (2) hours nor from 54°C to 4°C for more than 7 hours.

Alternatively, products consisting of a piece of intact (excluding tenderized) muscle such as roast beef, moist cooked beef, turkey breast or pork loin, may be cooled to 4°C within 7.5 hours from the initiation of the cooling process while taking no more than two hours for the 50°C to 20°C temperature zone.

4.5.1.3 Interrupted Cooling Rate

Cooked products that are cooled from 54°C to 18°C within 2 hours may be held for up to 4 hours if they are:

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

4.5.2 Deviation From the Approved Cooling Process

Any deviation from the approved process must be assessed by the operator as part of the establishment control programs. If the product is deemed acceptable, there must be scientific evidence to support this decision.

Whenever there is a cooling deviation, if the operator intends to distribute the product, they must conduct a risk assessment on the product.

Computer modeling may be used to evaluate the safety of the product. Other parameters in evaluating the deviation must be taken into account. Review of the cooking process and product formulation must also be done.

The level of estimated increase in Clostridium perfringens concentration (log increase) will depend on the quality of data obtained by an evaluator and input into the program. Characterization of heat resistance of spores recovered from raw products would further facilitate the assessment of the cooling process parameters. The potential increase in the concentration of Clostridium perfringens during cooling depends on the concentration of heat resistant spores in the product. Cooling regimens for meat products should result in no more than a 1-log CFU/g increase of C. perfringens and no growth of C. botulinum.

End product sampling for Clostridium perfringens (viable cells) can be done as an additional safety measure but is not sufficient on its own.

4.5.3 Alternate Cooling Process

Any alternate cooling process must be submitted by the operator to the Inspector in Charge, who will consult with the Area Program Specialist. The protocol will then be evaluated by the National Specialist, Meat Processing in collaboration with the food safety group. The proposal must be supported by scientific data to validate the submission. Microbial testing alone is not sufficient for this purpose. This documentation package should include, but not be limited to, a recommendation from a process authority demonstrating that the alternate cooling process is as effective as the current performance standards.

The alternate cooling process cannot be used prior to acceptance by the National Specialist, Meat Processing.

4.5.4 Product Storage Temperatures of Heat Processed Meat Products

Refrigerated meat products which have been previously heat processed must not be packaged until chilled to 4°C unless it can be demonstrated, through a process validation, that packaging does not interfere with the cooling schedule or the product safety.

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

4.6 Edible Rendering

Edible rendering is the heat treatment of edible animal tissues to extract fats and oils. The standards for lard, shortening and tallow are listed in Schedule I of the Meat Inspection Regulations, 1990. The operator must demonstrate compliance of the final product to Schedule I of the MIR.

4.7 Canning

Canned food means commercially sterile low-acid or acidified low-acid food packed in hermetically sealed containers. This includes the use of cans, glass jars, retortable pouches or other containers. For production specifications please consult Chapter 15 of the MOP.

4.8 Casings

When using or preparing casings, the following requirements must be met:

  • mesentery and fat must be removed;
  • lumenal content and mucosa and removed;
  • casings and rinsed and cleaned; and
  • casings are sorted for defects.

4.9 Emulsification

Potential hazards associated with emulsification include pathogen outgrowth from precursor materials, temperature abuse during production, and metal particles from the equipment.

See Annex O for policy specifications on the detection of E. coli O157:H7 in raw beef.

4.10 Aging and Tenderizing

Aging of beef has traditionally been used to increase tenderness and flavour and involves holding a carcass for up to 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.

Other methods include:

  • treatment with enzymes (enzymes that are approved for use in Canada as defined in the Food and Drug Regulations - Division 16, Table 5);
  • electrical stimulation;
  • holding muscles in traction during rigor mortis;
  • use of fibre breakers or other mechanical means (needles, blades);
  • manufacture of flaked-formed meats; and
  • curing.

These procedures help tenderize the meat and are used in quality control and finish of the product, rather than food safety. With traditional aging, however, temperature and humidity abuse can result in mould growth, and spoilage bacterial growth, both of which can be indicators of possible pathogenic bacterial outgrowth. The operator must implement a program for the control of aging and tenderizing processes. The use of an alternative process or new technology must be approved by the CFIA prior to use.

4.11 Drying Treatments

4.11.1 Dehydration

This is accomplished by drying-in air, the application of heat or by freeze-drying. This form of preservation depends on a lowering of the water activity (aw) 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. It must be remembered that a reduction in water activity neither destroys microorganisms nor toxins; it only retards the growth of microorganisms.

When the aw of a product is a critical limit set out in the manufacturing process for a meat product, accurate measurement devices must be employed. The instructions for use, maintenance and calibration of measurement devices and instruments must be included in the operator's prerequisite programs and HACCP system.

If a dehydrated product that is not cooked is sold as shelf-stable (i.e., there is no "keep refrigerated" statement), it has to meet the same applicable controls as shelf-stable fermented meat products (see section 4.16.3).

4.11.1.1 Facility and Equipment Requirements

Equipment used in the dehydration process must be included in the operator's prerequisite control programs. These must include the following elements:

  • The temperature in the drying chamber/room must be uniform and controlled to prevent any fluctuation that could impact on the safety of the final product.
  • The drying chamber/room must be equipped with a shatter resistant indicating thermometer (or equivalent), with graduations of 1°C or less. All thermometers must be located such that they can be easily read.
  • Indicating and recording thermometers must be calibrated.
  • Drying and aging rooms must be equipped with humidity recorders in order to prevent uncontrolled fluctuations of the relative humidity. The only alternative to an automatic humidity recorder in these rooms would be for the company to manually monitor and record ambient humidity twice a day (morning and afternoon) every day with a properly calibrated portable humidity recorder.
  • aw measurement.

4.11.2 Salted and Dried Products

Salting lowers the aw to achieve a reduction in water activity that retards the growth of microorganisms but does not alter the microbiological load of the incoming product. Therefore, the operator must have a program in place to assess the incoming product.

4.11.3 Cooked and Dried Products

As dried beef products may pose a hazard associated with E. coli O157:H7, these products must be submitted to a heat treatment before the drying process.

The following methods have been found acceptable for this purpose:

  • cooking the product so it reaches an internal temperature of 71°C for 15 seconds before starting the drying process;
  • a process validated as achieving a 5D reduction in E. coli O157:H7. Refer to section 4.16.2.2 for recognized processing parameters; and
  • an alternative challenge study of a design acceptable to the CFIA and Health Canada achieving a 5D reduction in E. coli O157:H7 can be used.

4.12 Formulation

Care must be taken as to the location where ingredients are stored, prepared, mixed or measured. It is the operator's responsibility to determine compatible areas and non-compatible areas for different processing steps, as part of the prerequisite program and HACCP system. Refer to the FSEP Manual and Chapter 3, Prerequisite Programs for more details.

The formulation of all prepared meat products, including potential allergens, must be controlled as part of the operator's HACCP system. Refer to the CFIA website for additional information on allergens.

A standardized meat product is one that has a standard prescribed by regulation. The Food and Drug Regulations (Divisions 14 and 22) and the Meat Inspection Regulations, 1990 (Schedule I) prescribe the standards for meat products manufactured in Canada. This means that the food must contain only the ingredients included in the standard, within the limits established by the standard. All food additives used in meat product formulations must be listed in the Tables of Division 16 of the Food and Drug Regulations and used according to the provisions in those tables.

An unstandardized food is any product for which a standard is not prescribed in regulation. Unstandardized foods must meet also meet regulatory requirements under the FDR and MIR, such as those for minimum protein requirements. In addition, only those food additives for which provision has been made in the the Tables of Division 16 of the Food and Drug Regulations either for that food specifically or for "unstandardized foods" in general may be used.

4.12.1 Control Over the Use of Restricted Non Meat Food Products

Restricted non-meat food products are described in Division 16 of the Food and Drug Regulations.

The operator's prerequisite program and HACCP system must include a control program for restricted non-meat food products that includes:

  • storage of bulk restricted curing agents must be in a locked area; and
  • a log book for nitrates/nitrites including quantity on hand, quantity used, date and signature of employee.

4.12.2 Use of Eggs in Registered Establishments

The operator of the registered establishment must use pasteurized processed egg which originates from a registered processed egg station or may purchase grade "Canada A" shell eggs from a registered egg station.

The operator's prerequisite program and HACCP system must include a control program for the use of eggs that includes:

  • temperature of shell eggs and processed egg must be maintained at 4°C;
  • visual monitoring of eggs for defects;
  • control of egg shells to prevent contamination;
  • egg shells and defective eggs must be handled as inedible product; and
  • no fresh or frozen liquid egg is to leave the premises unless it is marked "Inedible egg - unfit for human consumption", as it does not meet federal or provincial requirements.

4.13 Preservation

Preserved products must comply with section B 14.031 of the Food and Drug Regulations.

4.13.1 Curing

"Curing" means, in respect of an edible meat product, that salt together with at least 100 parts per million (ppm) and not more than 200 ppm of sodium nitrite, potassium nitrite, sodium nitrate or potassium nitrate or any combination thereof, was added to the meat product during its preparation.

Nitrite or nitrate salts or both, in combination with salt (NaCl) and other curing aids are added to meat products to improve colour, texture and flavour and to prevent or delay undesirable microbial growth and toxin production.

The operator must have a program in place to assess the incoming product.

Additional explanation on nitrate/nitrite and phosphate calculations for formulated products is provided in Annex C of this chapter.

4.13.2 Salting

This is the preservation of meat products by the addition of ingredients and additives that reduce the water activity (aw). Meat products packed in salt or saturated salt solution are considered shelf stable. A saturated salt solution has a salt content of 26.4% and a salinometer reading of 100.

4.13.3 Pickling

Pickling, the addition of an acidulant such as acetic acid or citric acid, lowers the pH value of the meat product.

4.14 Tumbling, Massaging and Injection

The incorporation of ground meat or poultry pieces with intact muscle cuts is accomplished by mixing, tumbling or massaging 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 paddles, 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.

The injection of ground or emulsified trimmings into solid muscle cuts must meet the following requirements:

  • The ground or emulsified trimmings originate from like cuts of meat. The exact source and quantity of ground meat must be indicated in the product formulation on label submittals.
  • Ground or emulsified trimmings may be injected in a quantity of up to 15% of the fresh weight at the time of formulation without having to be declared on the label. Products containing more than 15% of ground or emulsified trimmings must be labelled to indicate the presence of ground trimmings into the whole muscle piece of meat. (See Chapter 7 for labelling information).
  • The operator's control program must include the conditions of storage of the emulsified suspension.

4.15 Smoking

This is achieved by the use of smoke generated from hardwood, hardwood sawdust, or vaporized liquid smoke derived from the aforementioned sources.

Smoking is used mainly for flavouring and development of surface colouring in meat products.

Cold smoke temperatures are generally less than 30°C. Products that are cold smoked and have the appearance of being ready-to-eat must be labelled as per section 94(6.1) of the MIR.

If the smoking process results in the production of ready-to-eat meat products, all additional requirements applicable to cooked products are to be met.

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.

When the smoking of pork products is used with heat to destroy Trichinella, 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. The operator must ensure the heat process is sufficient to destroy trichinae.

4.16 Fermentation

Fermentation relies on good control over a complex and precise combination of time, temperature, nitrites, salt concentration, pH and aw factors to ensure food safety.

4.16.1 Control Program Requirements for Fermented Meat Products

It is the operator's responsibility to develop and implement Control Programs that meet the requirements outlined in this section.

4.16.1.1 Incoming Materials

The operator must have a program in place to assess the incoming product. This program should outline specifications for the incoming ingredients.

Records of microbiological tests performed on ingredients must be available to the inspector on request.

4.16.1.2 Facility and Equipment Requirements

Equipment used in the fermentation process must be included in the operator's prerequisite control programs. These must include the following elements:

  • Temperature in the fermentation, drying and smoking chambers must be uniform and controlled to prevent any fluctuation that could impact on the safety of the final product.
  • Fermentation, drying and smoking chambers must be equipped with a shatter resistant indicating thermometer, (or equivalent), with graduations of 1°C or less. If mercury thermometers are used, their mercury columns must be free from separations. All thermometers must be located such that they can be easily read.
  • Fermentation and smoking chambers must be equipped with a recording thermometer for determining degree-hours calculations in a reliable manner. Recording thermometers are also preferable in drying and aging rooms but, in these rooms, it may be sufficient to read and record the temperatures 2 times a day.
  • Drying and aging rooms must be equipped with humidity recorders in order to prevent uncontrolled fluctuations of the relative humidity. The only alternative to an automatic humidity recorder in these rooms would be for the company to manually monitor and record ambient humidity twice a day (morning and afternoon) every day with a properly calibrated portable humidity recorder.
  • For routine monitoring, accurate measurement electronic pH meters (± 0.05 units) should be employed. It is 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 aw of a product is a critical limit set out in the HACCP plan for a meat product, accurate measurement devices must be employed. It is important that the manufacturer's instructions for use, maintenance and calibration of the instrument be followed.

4.16.1.3 Starter Culture

The operator must have a control program in place to prevent the transmission of pathogens from when using the inoculum from a previous batch (back slopping) to initiate the fermentation process of a new batch. These must include:

  • The storage temperature must be maintained at 4°C or less and a pH of 5.3 or less.
  • Samples for microbiological analysis must be taken to ensure that the process is in line with the specifications.
  • The frequency of sampling is to be adjusted according to compliance to specifications.
  • Any batch of inoculum which has a pH greater than 5.3 must be analysed to detect at least Staphylococcus aureus. Only upon satisfactory results will this inoculum be permitted for use in back slopping.

4.16.1.4 Chemical Acidification

If product is chemically acidified by addition of citric acid, gluconodelta-lactone or another chemical agent approved for this purpose, controls must be in place and records kept to ensure that a pH of 5.3 or lower is achieved by the end of the fermentation process.

4.16.1.5 Water Activity Critical Limits

The aw may be reduced by adding solutes (salt, sugar) or removing moisture.

Approximate minimum levels of aw (if considered alone) for the growth of:

molds: 0.61 to 0.96

yeasts: 0.62 to 0.90

bacteria: 0.86 to 0.97

  • Clostridium botulinum: 0.95 to 0.97
  • Clostridium perfringens: 0.95
  • Enterobacteriaceae: 0.94 to 0.97
  • Pseudomonas fluorescens: 0.97
  • Salmonella: 0.92 - 0.95
  • Staphylococcus aureus: 0.86

parasites: Trichinella spiralis will survive at an aw of 0.93 but is destroyed at an aw 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, Staphylococcus aureus enterotoxins are not produced below aw 0.86, although in vacuum packed products this is unlikely below aw 0.89.

4.16.2 Pathogen Control

4.16.2.1 Time and Temperature for Fermented Products

The operator is required to implement a control program based on 4.16.2.1.1, Fermentation Done at a Constant Temperature (Constant Temperature Process) and 4.16.2.1.2, Fermentation Done at Different Temperatures (Variable Temperature Processes) to control pathogens.

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.

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 for growth of Staphylococcus aureus). Degree-hours are calculated for each temperature used in the process. The limitation of the number of degree-hours depends upon the highest temperature in the fermentation process prior to the time that a pH of 5.3 or less is attained.

The operator is encouraged to measure temperatures at the surface of the product. Where this is not possible, the operator should utilize fermentation room temperatures. The degree hour calculations are based on fermentation room temperatures. Temperature and humidity should be uniform throughout the fermentation room.

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

  • fewer than 665 degree-hours when the highest fermentation temperature is less than 33°C;
  • fewer than 555 degree-hours when the highest fermentation temperature is between 33° and 37°C; and
  • fewer than 500 degree-hours when the highest fermentation temperature is greater than 37°C.
4.16.2.1.1 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.

Fermentation Done at a Constant Temperature (Constant Temperature Process)
Degree-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:

Example 1:

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

Degrees above 15.6°C: 26°C - 15.6°C = 10.4°C
Hours to reach pH of 5.3: 55
Degree-hours calculation: (10.4°C) x (55) = 572 degree-hours

The corresponding degree-hours limit (less than 33°C) is 665 degree-hours.

Conclusion: Example 1 meets the guideline because its degree-hours are less than the limit.

Example 2:

Fermentation room temperature is a constant 35°C. It takes 40 hours for the pH to reach 5.3.

Degrees above 15.6°C: 35°C - 15.6°C = 19.4°C
Hours to reach pH of 5.3: 40
Degree-hours calculation: (19.4°C) x (40) = 776 degree-hours

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

Conclusion: Example 2 does not meet the guideline because its degree-hours exceed the limit - hold the product and refer to sub-section 4.16.2.1.3.

4.16.2.1.2 Fermentation Done at Different Temperatures (Variable Temperature Process)

When the fermentation takes place at various temperatures, each temperature step in the process is analyzed 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.

Example 1:

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.

Step 1

Degrees above 15.6°C: 24°C - 15.6°C = 8.4°C
Hours to reach pH of 5.3: 10
Degree-hours calculation: (8.4°C) x (10) = 84 degree-hours

Step 2

Degrees above 15.6°C: 30°C - 15.6°C = 14.4°C
Hours to reach pH of 5.3: 10
Degree-hours calculation: (14.4°C) x (10) = 144 degree-hours

Step 3

Degrees above 15.6°C: 35°C - 15.6°C = 19.4°C
Hours to reach pH of 5.3: 15
Degree-hours calculation: (19.4°C) x (15) = 291 degree-hours

Degree-hours calculation for the entire fermentation process = 84 + 144 + 291 = 519

The highest temperature reached = 35°C

The corresponding degree-hour limit = 555 (between 33°C and 37°C)

Conclusion: Example 1 meets the guideline because its degree-hours are less than the limit.

Example 2:

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 the second 10 hours and 37°C for the final 18 hours.

Step 1

Degrees above 15.6°C: 24°C - 15.6°C = 8.4°C
Hours to reach pH of 5.3: 10
Degree-hours calculation: (8.4°C) x (10) = 84 degree-hours

Step 2

Degrees above 15.6°C: 30°C - 15.6°C = 14.4°C
Hours to reach pH of 5.3: 10
Degree-hours calculation: (14.4°C) x (10) = 144 degree-hours

Step 3

Degrees above 15.6°C: 37°C - 15.6°C = 21.4°C
Hours to reach pH of 5.3: 18
Degree-hours calculation: (21.4°C) x (18) = 385.2 degree-hours

Degree-hours calculation for the entire fermentation process = 84 + 144 + 385.2 = 613.2

The highest temperature reached = 37°C

The corresponding degree-hour limit = 555 (between 33°C and 37°C)

Conclusion: Example 2 does not meet the guidelines because its degree-hours exceed the limit; hold the product and refer to sub-section 4.16.2.1.3

4.16.2.1.3 Disposition of Lots Which Have Not Met Degree-hours Limits

The operator must notify the CFIA 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 for Staphylococcus aureus and its enterotoxin, and for principal pathogens, such as E. coli O157:H7, Salmonella, and Clostridium botulinum and Listeria monocytogenes.

  • If the bacteriological evaluation proves that there are fewer than 104 Staphylococcus aureus per gram and that no enterotoxin or other pathogens are detected, then the product may be sold provided that it is labelled as requiring refrigeration.
  • In the case of a Staphylococcus aureus level higher than 104 per gram with no enterotoxin present the product may be used in the production of a cooked product but only if the heating process achieves full lethality applicable to the meat product.
  • In the case where Staphylococcus aureus enterotoxin is detected in the product the product must be destroyed.
4.16.2.2 E. coli and Salmonella Control Options in Fermented Sausages

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 E. coli including E. coli O157:H7 and Salmonella when they make this type of product.

The operator is required to use one of the five (5) options outlined in this section when manufacturing a dry or semi-dry fermented meat sausage product:

  • establishments which use beef as an ingredient in a dry or semi-dry fermented meat sausage;
  • establishments which store or handle uncooked beef on site;
  • establishments which obtain raw meat from a supplying establishment which stores or handles uncooked beef on site.

Establishments which do not use beef and do not obtain meat ingredients from establishments which handle beef are not currently required 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 the presence of E. coli O157:H7 or Salmonella in the finished product.

To ensure that all of the requirements corresponding to the selected option are met, and to suitably demonstrate this, operators of registered establishments who manufacture a dry/semi-dry fermented sausage are required to complete a copy of Annex K "Option used for the control of E. coli O157:H7 in dry and semi-dry fermented sausage" for each different product and attach all the required information.

This material will be screened by the Inspector in Charge and forwarded to the Area Program Specialist for verification.

An establishment must use option 3 if option 1, 2, 4 or 5 are not used. If an establishment which is required to do end product testing as per option 3 refuses to do the required testing on the finished product, the CFIA must 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.

4.16.2.2.1 Option 1:

Include as part of the manufacture of the sausage, one of the following heat processes which are 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 section 4.4 of this chapter).

Heat process recognized as controlling Escherichia coli O157:H7 where it is not required to test for Escherichia coli O157:H7
Minimum internal temperature
maintained during the entire process
Minimum processing time in minutes
after the minimum temperature
has been reached
130°F (54.4°C) 121
131°F (55°C) 97
132°F (55.6°C) 77
133°F (56.1°C) 62
134°F (56.7°C) 47
135°F (57.2°C) 37
136°F (57.8°C) 32
137°F (58.4°C) 24
138°F (58.9°C) 19
139°F (59.5°C) 15
140°F (60°C) 12
141°F (60.6°C) 10
142°F (61.1°C) 8
143°F (61.7°C) 6
144°F (62.2°C) 5
145°F (62.8°C) 4

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.

4.16.2.2.2 Option 2:

Use a manufacturing process (combination of fermentation, heating, holding and/or drying) which has already been scientifically validated to achieve a 5D 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) of this section.

Under this option, it is not required to test each lot for E. coli O157:H7 or Salmonella. The operator is required to implement a microbiological testing program for E. coli 0157 and Salmonella 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, aw.)

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

The following processes have been scientifically validated as achieving a 5D or greater reduction of Escherichia coli O157:H7
Fermentation
chamber
temperature
pH at the end of
fermentation
process
Casing
diameter
Subsequent process (dry, hold or cook) Reference
70°F (21°C) > 5.0 < 55 mm heat (1 hr @ 110°F and 6 hrs @ 125°F) 1
90°F (32°C) < 4.6 < 55 mm hold @ 90°F for > 6 days 1
90°F (32°C) < 4.6 < 55 mm heat (1 hr @ 110°F then 6 hrs @ 125°F) 1
90°F (32°C) < 4.6 56 to 105 mm heat (1 hr @100°F, 1 hr @ 110°F, 1 hr @ 120°F, then 7 hrs @ 125°F) 1
90°F (32°C) > 5.0 56 to 105 mm heat (1 hr @100°F, 1 hr @ 110°F, 1 hr @ 120°F, then 7 hrs @ 125°F) 1
96°F (36°C) < 5.0 < 55 mm heat (1 hr @ 128°F internal product temperature) and dry (at 55°F and 65% relative humidity to a moisture protein ratio of < 1.6:1) 2
110°F (43°C) < 4.6 < 55 mm hold @ 110°F for > 4 days 1
110°F (43°C) < 4.6 56 to 105 mm hold @ 110°F for > 4 days 1
110°F (43°C) > 5.0 56 to 105 mm hold @ 110°F for > 7 days 1

1 Nicholson, R., et al, Dry fermented sausage and Escherichia 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.

4.16.2.2.3 Option 3:

Where the manufacturing process does not correspond to one of the processes set out under options 1, 2 or 4 of this section and has not been assessed in accordance with option 5 of this section, the operator is required to test and hold each production lot pending satisfactory results.

  • The definition of lot for the 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.
  • For each lot, the operator must take 30 samples of finished product and submit them for analysis. The sampling plan must be representative of the lot.
  • Each sample must consist of at least 25 g of product. Samples must be taken in accordance with standard microbiological techniques to avoid contamination of product. Sampling of intact product packages is strongly recommended. It is unacceptable to take multiple samples from one intact package as this is not considered statistically representative of the lot.
  • 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.
  • At a minimum, each composite sample must be tested for the presence of E. coli O157:H7 and Salmonella.
  • The method used to analyse the end product samples must 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).
  • Results must be reported in writing, identified as to the lot of product being tested and must include individual results for each test performed, method used and minimum sensitivity of the test used.
  • 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.
  • 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 an accepted lethality process or be destroyed. Possible cross-contamination of other lots must also be assessed.
  • Records of test results must be kept for a minimum of 24 months beyond the release date of the product.
4.16.2.2.4 Option 4:

This option specifically requires a microbiological testing program of raw meat and batter for E. coli 0157:H7 and Salmonella as part of the operator's existing HACCP system and a manufacturing process (fermentation and holding, heating and/or drying) which has been scientifically validated as achieving at least 2D reduction of E. coli O157:H7.

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, sub-section 4.16.2.2.5). A number of manufacturing processes have been scientifically demonstrated as achieving a 2D to 5D reduction. The sampling program must be in accordance with the following requirements:

  • The definition of lot for the 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. 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 day's production of raw batter.
  • For each lot, the operator must take 15 samples of raw batter and submit them for analysis. The sample plan must be representative of the lot.
  • Each sample must consist of at least 25 g of product. Samples must be taken in accordance with standard microbiological techniques to avoid contamination of product. Sampling of intact product packages is strongly recommended. It is unacceptable to take multiple samples from one intact package as this is not considered statistically representative of the lot.
  • 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.
  • At a minimum, each composite sample must be tested for the presence of E. coli O157:H7 and Salmonella.
  • The method used to analyse the end product samples must 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).
  • Results must be reported in writing, identified as to the lot of product being tested and must include individual results for each test performed, method used and minimum sensitivity of the test used.
  • 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.
  • 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 an accepted lethality process or be destroyed. Possible cross-contamination of other lots must also be assessed.
  • Records of test results must be kept for a minimum of 24 months beyond the release date of the product.

For reference, the following methods have been scientifically documented as achieving a minimum 2D reduction in E. coli O157:H7:

The following methods have been scientifically documented as achieving a minimum 2D reduction in Escherichia coli O157:H7
Fermentation
chamber
temperature
pH at the end of fermentation Casing
diameter
Subsequent process
(dry, hold or cook)
Reference
70°F (21°C) > 5.0 56 to 105 mm heat(1 hr@ 110°Fand 6 hours @ 125°F) 1
90°F (32°C) < 4.6 56 to 105 mm hold @ 90°F for 7 days then dry 1
90°F (32°C) > 5.0 56 to 105 mm hold @ 90°F for 7 days then dry 1
110°F (43°C) > 5.0 < 55 mm hold @ 110°F for 7 days then dry 1
110°F (43°C) > 5.0 56 to 105 mm heat (1 hr @ 110°F and 6 hours @ 125°F) 1

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

4.16.2.2.5 Option 5:

This option is a validation challenge study to demonstrate that the manufacturing process achieves as 5D reduction of E. coli 0157:H7.

Establishments which elect to use this option to demonstrate that their manufacturing process achieves a 5D reduction of E. coli O157:H7, may be able to manufacture product according to the requirements of Option 2 (e.g., not be required to test each lot of product for E. coli O157:H7 and Salmonella). Alternatively if their manufacturing process achieves a 2D reduction of E. coli O157:H7 they may be able to manufacture product according to the requirements of Option 4 (e.g., HACCP system and testing of raw batter).

The operator must make a request for the evaluation of the alternative manufacturing process to the Meat Programs Division and the Food Safety Division. Upon completion of a successful evaluation, the operator must be provided in writing 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 operator using the process. Until such confirmation is received, the operator must manufacture product in accordance to one of the other 4 options outlined in this section.

4.16.2.2.6 Challenge Study Protocol Requirements
  • This 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.
  • 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.
  • 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% of the total inoculum.
  • 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 least a 5 log reduction in the level of the inoculum between the initial count in the meat mixture and the finished product.
  • 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:
    • add inoculum to meats while grinding or chopping the meats to the desired consistency;
    • mix in cure (if used), salt and spices;
    • blend in starter culture (if used) near end of mixing cycle; and
    • stuff batter into casings.
  • 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.
  • 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.
  • 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 plate 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.
  • 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.

    Therefore, total number of samples for microbiological analysis:

    Time zero (0) = 2
    After fermentation = 0
    During drying = 0
    End drying = 2
    Total = 4
    Number of replicates x 3
    Total samples = 12

  • Measurement of process parameters used to determine when a product is finished at each stage of production (control program 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, aw, and titratable acidity.

    Therefore, total number of samples for additional analysis:

    Time zero (0) = 2
    After fermentation = 2
    During drying = 2
    End drying = 2
    Total = 8
    Number of replicates x 3
    Total samples = 24

4.16.2.3 Controls For the aw and pH of Product

The aw and pH values are critical in the control of pathogens as well as to ensure shelf-stability in all semi-dry and dry fermented meat products. Each production lot must be tested for aw and/or pH in order to verify that the critical limits are met.

Although aw measurement is mandatory only for shelf stable products, it is strongly recommended that the operator determine the aw values achieved for each product type they manufacture and for each production line. Once this has been established, frequent regular checks should be made.

4.16.3 Requirements for Shelf Stable Fermented Meat Products

For all fermented meat products, in order to minimize the danger of outgrowth of Clostridium botulinum spores and development of the botulinal toxin in fermented product, nitrite/nitrate shall be added at a minimum level of 100 ppm along with a minimum of 2.5% of salt.

In order to be considered "shelf-stable" and not require refrigeration, a fermented meat product must have a minimum of 100 ppm nitrite/nitrate, a minimum of 2.5% of salt, meet degree hours requirements (4.16.2.1) and meet one of the following sets of specific requirements.

  • The pH of the finished product is of 4.6 or less, regardless to its final aw.
  • The aw of the finished product is 0.85 or less, regardless of its final pH.
  • The pH is 5.3 or lower at the end of the fermentation period and the end product has an aw of 0.90 or lower.

The level of nitrate-nitrite should not interfere with the process of fermentation.

Fermented products which do not meet these requirements must be labeled with a refrigeration statement.

Operators of registered establishments who wish to market a meat product without a refrigeration declaration which does not meet the "shelf stable" criteria set out above, must submit a request for the acceptance of their proposal to the Inspector in Charge. The submission must be accompanied by detailed recipe, formulation and processing information for the product. Submissions will be sent to the Area Program Specialist for review with a Food Safety Microbiology Specialist and Health Canada.

4.17 Post Processing Lethality Procedures

4.17.1 Post Process Pasteurization of Ready-to-Eat Meat Products

Pasteurization of packaged ready-to-eat meat products may be used to extend shelf life and to prevent pathogen growth in ready-to-eat meat products.

Packaging materials used for this purpose must be specifically designed to withstand the pasteurization process. The operator must keep records of all products pasteurized. The process may be designed to achieve surface heating only; however, the product must be immediately cooled to 4°C within the requirements of section 4.5 of this chapter.

4.17.2 High Pressure Processing for Ready-to-Eat Meat Products

High pressure processing is an approved post-lethality, post-packaging intervention step for RTE meats for the control of Listeria spp. This process may be used as an additional step to enhance the microbiological safety of these products.

4.17.2.1 Process Parameters for High Pressure Processing

  • The chamber must be pressurized to 87,000 PSI* (or 600 MPa**).
  • The pressure must be maintained for 3 - 9 minutes
  • A maximum of three cycles is permitted.
  • The pressure is released and the treated containers are packed and ready for shipping.

* PSI: Pounds per square inch
** MPa: Megapascal

4.17.2.2 Packaging Material for Use in High Pressure Processing

The operator is required to ensure that any packaging material that is used in the sale of food products will not impart any undesirable substance to the meat product, either chemically, physically or microbiologically and must protect them sufficiently to avoid contamination.

Operators must provide evidence that the packaging material used is appropriate to undergo high pressure processing treatment. Concerning the acceptability of packaging material to high pressure processing, packaging material companies should send their requests to the CFIA's Food Safety Risk Analysis.

The CFIA website provides additional information on the submission process.

Where applicable, packages treated with high pressure processing require refrigeration.

There are no mandatory labelling requirements associated with the use of high pressure processing.

4.17.3 Antimicrobial Interventions

For information on the use of antimicrobial interventions in ready-to-eat meat products, see Chapter 4, Annex H, Section 3.1, Antimicrobial agents and post-lethality procedures.

4.18 Packaging

Packaging materials include cartons, wrapping materials, films, synthetic casings, nettings, trays, pouches, bags and any other material which may come into contact with a meat product. This also includes gases used in modified atmosphere packaging. Packaging materials must not impart any undesirable substance to the meat product, either chemically, physically or microbiologically and must protect them sufficiently to avoid contamination (See MIR, 92, FDR B.23.001)

Packaging procedures must be included it the operator's prerequisite programs and HACCP system.

It is the operator's responsibility to determine compatible areas and non-compatible areas for different processing steps, as part of the prerequisite program and HACCP system. Refer to the FSEP Manual and Chapter 3, Prerequisite Programs for more details.

Storage conditions must in accordance with Chapter 3 of this manual.

Liners must be used when packaging exposed meat products into unwaxed cardboard containers. Every effort must be made to prevent the meat products from coming into contact with the exposed surfaces of any shipping containers during filling.

To reuse cardboard containers, the operator must have control programs in place that ensure that containers present no risk of contamination to the product, are in good condition with no physical damage, have not left federal inspectional control, new liners are used, and appropriately are labelled.

The operator is required to maintain a listing of all of the packaging material used in the establishment. Packaging materials, including gases, must be listed in the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products.

The operator is required to maintain a listing of all of the packaging material used in the establishment. It is no longer mandatory to register packaging materials and non-food chemicals. The existing reference listing will continue to be accessible on the CFIA website but will no longer be updated. Please refer to Chapter 3.6, Pre-requisite Programs for the requirements for acceptable packaging materials and non-food chemical products.

4.18.1 Combo Bins

Acceptably constructed combo bins may be used for storage and transportation of refrigerated or frozen meat products. Whenever combo bins are used for the storage of meat products in freezers or for the shipment of refrigerated or frozen meat products from a registered establishment, the meat products must be protected by adequate lids or covers to prevent contamination.

Combo bins cannot not be stored, assembled and/or filled directly on the floor. The operator must prevent leakage.

4.18.2 Reusable Shipping Containers

Accepted reusable shipping containers may be used in registered establishments provided the following conditions are met:

  • It is the operator's responsibility to determine compatible areas and non-compatible areas for different processing steps, as part of the prerequisite program and HACCP system. Refer to the FSEP Manual and Chapter 3, Prerequisite Programs for more details. Specifically:
    • The operator must control the risk of cross contamination from non cleaned containers.
    • The washing and rinsing must ensure that the containers are visibly clean. The state of these containers should be maintained in a condition that will be acceptable as a food contact surface.
    • Storage conditions must in accordance with Chapter 3 of this manual.
    • Shipping containers with a lid qualifying for direct food contact must be of sufficient strength to support the weight of the ones above. They can not have perforations; if perforated, a liner must be used. The lid must be adequately designed to prevent contamination of the product.
    • When using shipping containers without a lid, the bottom of the stacked shipping containers must not be supported by the shipping containers below. The bottom of the container cannot have drainage holes or perforations. Only product packaged in sealed bags may be shipped in these shipping containers without lids.
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