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Chapter 4 - Annex P

CFIA Protocol for Evaluating Bulk Container Freezing Processes for Meat Products

1. Introduction

This protocol sets out the steps operators are to follow when developing a method for freezing meat products (eg, carcasses, carcass portions and offal) in bulk containers (hereinafter "bulk container freezing"). In order to validate their Hazard Analysis Critical Control Point (HACCP) systems, operators must show that their processes reduce the core temperature of these products to -18°C within a time frame allowing for the preservation of organoleptic and microbiological qualities.

2. Scope

The following processes must be evaluated in accordance with the present protocol:

• Pallets (without spacers) of boxes of meat products that were pre-cooled (4°C) with a view to subsequent freezing.
• Combo bins of meat products that were pre-cooled (4°C) with a view to subsequent freezing.

Additional conditions may apply if freezing is intended to prepare products for subsequent treatment (eg, to destroy trichinosis or cysticercosis parasite).

The present protocol does not cover situations in which products that have not reached a core temperature of 4°C are placed in bulk containers for freezing purposes. Processes that involve this approach (i.e. placing products that have not yet reached this temperature in bulk containers) are subject to the requirements set out in the "Alternative cooling processes" section 4.10.1 of the Manual of Procedures.

3. Prerequisites for freezing meat products in bulk containers

	Have a functional HACCP system. Establishments may freeze products in bulk containers, provided that the validity of their methods has been proven through tests. Functional HACCP controls are required in order to conduct the tests, and the establishment’s HACCP system must be adjusted to encompass data collection. The results of tests conducted in this manner are used to validate the HACCP system itself.
	Establishments that produce meat to be frozen in bulk containers must have determined and validated the shelf life of all of these meat products in order to confirm that a given product will have reached the freezing temperature during its specified shelf life. This will ensure that frozen meat products in bulk containers have the requisite microbiological quality upon thawing.
	Specify the products targeted, the packaging method (including palletization method) and the freezing method. This must be determined jointly by the establishment producing and packaging the meat products and by the establishment freezing the meat products, as appropriate.

Once a method has been selected, the test results cannot be used to validate another process. Here are examples of bulk container freezing that an operator might want to validate:

A) Pork hams weighing between X and Y kg (market weight animals) are received at a temperature not exceeding 4°C in a cardboard combo with a sealed PVC lining. The maximum quantity per combo bin is 800 kg. Combo bins are stored in a warehouse at -18°C for five days; they are stacked five high on racks with spacing of at least ..... between each combo level and row. Air velocity ... Estimated time to reach -18°C: 48 hours....

B) Cuts of beef (the largest being an outside round weighing x kg), vacuum-packed and received at a temperature not exceeding 4°C, are stored five per box. The boxes are stacked five high, with x boxes per row, and stretch-wrapped. They are kept in a freezer at -25°C with spacing of at least .... between pallets. The air velocity is .... Estimated time to reach -10°C: 48 hours.... Once the temperature is reached, the boxes are palletized without spacers and stored for 10 days...

Have labelled containers.

The inspector will determine whether the proposed method enables him/her to identify containers that undergo testing.

Determine a method for taking temperature readings that accurately reflects the process to be tested.

Temperature readings taken during testing will be used to demonstrate that the freezing method, when properly applied, guarantees that the temperatures required in order to control unacceptable bacterial growth are reached within a given time frame. The operator must prove that the data collected during testing represent the worst-case scenario.

Determine the temperature profile of the freezer rooms.

If the temperature of the freezer room is uniform throughout the room, the test may be conducted anywhere in the room. If the temperature is not uniform, the data must be collected in the warmest part of the room to reflect the worst-case scenario.

Identify and analyse hazards specific to the process that is the subject of the request.

The capacity to systematically cool meat products to a specific temperature within a given time frame depends on how precisely the process under evaluation is applied. When the cooling process is not rigorously implemented, bacteria may have the opportunity to grow, resulting in an unacceptable risk.

For each parameter of the bulk container freezing process that is the subject of the request, the operator must identify the hazards that could arise in the event that the process is not strictly followed.

To continue with the examples above, the following hazards could pose an unacceptable risk and need to be assessed:

• Presence of pathogens because the product is delivered in a state that makes it unsuitable for freezing in a bulk container.
• Bacterial growth that occurs between the time the product is received and the time it reaches a temperature at which bacteria are no longer able to grow.
• Bacterial growth resulting from failure to maintain the ambient temperature required for the process.
• Bacterial growth resulting from a slowdown in freezing caused by packaging that does not comply with the specifications of the process being evaluated.
• etc.

Incorporate each new hazard into the HACCP plan (i.e., apply the decision tree and determine whether the hazard is controlled by prerequisite programs or whether a CCP needs to be established).

4. Submitting the request for in-plant testing to the inspector

Before a bulk container freezing process can be adopted, testing needs to be done to identify potential shortcomings. The management of the establishment must submit the following documents before testing can be authorized.

Item No. 1. A letter from management containing:

• a brief description of the proposed process
• a statement explaining that the hazard analysis of the process complied with HACCP principles and that the HACCP system was modified in order to monitor the hazards during testing
• a statement explaining that, for testing purposes, the company agrees to submit only those analysis results obtained using recognized laboratory methods
• a statement explaining that quality control officials have been instructed to stop the test if they feel it is not being carried out in the manner agreed upon with the CFIA.

Item No. 2. The dated test protocol specifying:

• The name of the official to be contacted in the event of problems during the test
• The duration of the test (start and end date)
• The number of lots proposed for testing before the process can be implemented in normal production operations
• The method for taking temperature readings of products and in cooling rooms that will be used during testing, including:
• Who will take the temperature readings - How - How often - Number of samples - What products - etc.
• Data on the microbiological quality of meat products at the start of the bulk container freezing process. Microbiological data generated for the validation of the product’s shelf life may be used.
  
• When applicable, the microbiological method that will be used during testing, including:
  • Who will take the samples - How - How often - Number of samples - Type of analysis to be conducted - etc.
• A model of the table to be used to record temperatures from the time the product is received to the time the product reaches a temperature at which bacteria are no longer able to grow. This must include the temperature range from 4°C to -5°C.
• The date on which management is expected to submit its test report to the CFIA following data collection and analysis.

NB: When responsibility for ensuring the microbiological quality of frozen products in bulk containers is to be shared between two or more establishments, the cover letter and the test protocol must be signed by the management of all the establishments concerned.

5. CFIA decision on whether the testing may be authorized

The inspector who receives the request determines whether it includes all of the information required. With the assistance of the program specialist, the inspector determines whether the request appears to be compatible with sound hygiene practices and whether any changes need to be made to the protocol before the testing can be conducted. Together with the program specialist, the inspector gives the go-ahead for the testing when he/she is satisfied that the test protocol is complete and acceptable.

6. Conducting the test

The operator must conduct the test in compliance with the approved test protocol. The operator must inform the inspector in writing if it becomes necessary to modify the protocol before, during or after the test. The inspector may temporarily halt the test to discuss protocol changes with the program specialist. The inspector may also require that the test be stopped if changes are made to the protocol without his/her knowledge.

7. Test report: analysing and submitting collected data

The operator is responsible for collecting and analysing data gathered during testing and submitting them to the inspector within the agreed time frame. To this end, the operator will submit a report to the inspector. The report must be prepared in a such manner that anyone who reviews the report (eg, foreign auditor) has all of the necessary information. Therefore, the test report must include the following:

• An introduction summarizing (in a few lines) the purpose of the test and providing an accurate description of the process tested.
• A methodology section summarizing (in a few lines) how the test was conducted. The test protocol may be appended to the report to avoid the need to write a methodology section.
• A results section summarizing the main observations made during testing.
• If needed, a discussion section clarifying results that may raise questions.
• A conclusion outlining whether the company will be applying the new process on a regular basis.
• An appendix, including at least the following:
  • The data set out in a table
  • Cooling curves based on the data collected. The curves must show that the cooling is continuous.
  • Instead of data tables and curves, it is encouraged that sensors attached to a thermograph be used to automatically record temperatures.
  • The results of microbiological analyses conducted during testing.

8. CFIA approval

The inspector will review the report submitted by the operator to ensure that it is complete and to assess its content. This involves determining whether the conditions described in the report clearly reflect what he/she knows to be true about the conditions in which the test was conducted and whether the operator satisfactorily explained all of the results that raised questions, in the "discussion" section. If the report is incomplete, the inspector will ask the operator to review the sections in question. When the report is deemed complete, the inspector will forward it to the program specialist with his/her comments on the report’s content. The program specialist will then determine whether the proposed process is acceptable and recommend that the inspector authorize or reject the bulk container freezing process for meat products.