Annex P-5 - Inspection Procedures for Meat Products in Hermetically Sealed Containers

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1. Scope

This procedure applies to thermally processed, hermetically sealed, commercially sterile (shelf stable) meat products packed in metal can glass jars or flexible containers and pasteurized meat products in cans.

2. Requirements

CFIA import inspection facilities must be approved with a "C" function code (dry storage facility) to conduct import inspection of commercially sterile, shelf stable, meat products. Lighting requirements are a minimum of 1000 lux for container integrity inspection area.

If the Inspector feels the lighting does not meet the requirement, a light meter should be used to evaluate the lighting.

CFIA Inspectors must have successfully completed the Metal Can Integrity Course to be qualified to do import can inspection. It is recommended that they be experienced in thermal processing inspection and have completed the thermal processing course.

3. Equipment Required

It is recommended that Inspectors be equipped with the following items during each inspection, however additional items may be required:

1. Magnifying glass, at least 5 x magnification;
2. Metal can defect manual;
3. Permanent marking pen;
4. Tags, labels and sample bags for sample identification; and

3.1 Key References for Inspection of Hermetically Sealed Meat Products

1. Chapter 15, Meat Hygiene Manual of Procedures: provides information on the canning process, inspection procedures and terminology.
2. Visual Inspection Protocol: provides the inspection protocol for low-acid and acidified low -acid foods in hermetically sealed containers.
3. Metal Can Defects Manual: provides information on the identification and classification of metal can defects.
4. Flexible Retort Pouch Manual: provides information of the identification and classification of retortable pouches.

4. Sampling and Inspection Procedures for Meat Products Packed in Hermetically Sealed Containers

The following procedures have been taken from the Visual Inspection Protocol for low acid and acidified low acid foods in hermetically sealed containers.

4.1 Definitions

The following definitions apply:

CANNED FOOD: Means a commercially sterile low acid or low acid food packed in hermetically sealed containers.

COMMERCIALLY STERILE: Means the condition obtained in a food which has been processed by the application of heat alone or in combination with other treatments to render the food free from visible forms of microorganisms, including spores, capable of growing in the food at temperatures at which the food is designed normally to be held during distribution and storage.

CONTAINER: Means the individual can or package containing the food product.

CULL: Means the removal of containers with serious defects from a lot of low acid or acidified low acid foods.

CULL REPORT: Means the Report submitted to the Regulatory agency having jurisdiction by the Legal agent detailing the procedures he used to cull the inspection lot and the number of affected containers that were removed and the number and types of defects found.

GOOD ORDER: Means acceptable to the Inspector to that point in the inspection protocol.

HERMETICALLY SEALED CONTAINER: Means a container designed and intended to be secure against the entry of microorganisms including spores.

INSPECTION: Means the physical examination of a lot of low acid or acidified low acid canned foods for the presence of serious defects.

INSPECTION LOT: Means a lot limited to one container type and size, one product type and style, originating from the processing establishment normally bearing one identical lot or production day code. In some cases, where production codes involve small quantities, or where goods are presented for inspection as mixed codes, the legal agent may request, subject to agreement by the regulatory agency having jurisdiction, that more than one production code form an inspection lot. The decision of the inspection applies to the entire inspection lot.

INSPECTOR: Means a person with adequate training who is charged with the responsibility of inspecting a lot of low acid or acidified low acid foods in hermetically sealed containers for the presence of serious defects.

LABORATORY: Means a laboratory acceptable to the regulatory agency having jurisdiction.

LEGAL AGENT: Means the person or company by whom or for whom the food was produced for sale or distribution. For meat products the legal agent is the importer.

MECHANICAL SCREENING PROCEDURE: Means the use of dud detector, or other automated equipment.

REINSPECTION: Means the inspection of the good order containers in a lot of low acid or low acid foods for the presence of serious defects after the lot has been culled.

SAMPLING AND SAMPLE SIZE: The sampling plan is based on a two class attribute acceptance plan.

Inspection: Sample size (n) is 200 containers and the acceptance number (c) is zero (0) serious defects.

Reinspection: Sample size (n) is 1250 containers and the acceptance number (c) is zero (0) serious defects.

OVERVIEW INSPECTION: Means a visual examination of the cases of the inspection lot to determine their condition.

SERIOUS DEFECT:

Means any container:

1. Which is swollen.
2. Which shows evidence that the hermetic seal is lost or seriously compromised.
3. With any serious defect in the Metal Can Defect Manual other than those identified in a. or b. above.

These defects are described in the Metal Can Manual. Some products may appear slightly swollen due to overfilling by design or due to gas packing. If this is verified by the Inspector, these containers are not considered to be swollen.

SORT: Means the segregation and control of cases that have been damaged during storage or transportation.

5. Overview/ Cursory Inspection

The shipment must be totally unloaded and staged so that all cases are visible. The inspection is conducted as per Annex 0 of this Chapter. Inspectors visually scan the shipment to identify any evidence of damaged or stained cartons, and to verify outer labels. No containers are to be opened at this time. A check should also be made for any objectionable odour. In those instances where suspected or actual unsatisfactory conditions are found, then a full inspection of affected cases must be carried out.

If the results of the cursory inspection show:

1. No wet, stained or damaged cases, commence Full Inspection. See section 6.
2. The presence of wet, stained or damaged cases. DETAIN THE WHOLE INSPECTION LOT. Proceed to section (7) - Wet, Stained or Damaged Cases.

Note: Refer to Diagram 1: Visual / Cursory Inspection Procedure, and Diagram 2: Sorting of Wet, Stained or Damaged Cases.

6. Full Inspection

6.1 Sampling Plan

The Import Inspection Report (IIR) will identify by number the sample units to be selected from each lot of product for full inspection. Procedures for selection of sample units are described in Annex P.

For lots with a minimum of 40 sample units, five containers from each sample unit will be examined for defects. When an IIR is not available, Inspectors are to refer to the Visual Inspection Protocol manual section 4.4.1 to determine the number of sample units and containers to examine. A minimum of 200 containers must be examined for each lot of product for full inspection. For inspection lots having less than 200 containers, all containers shall be examined by the Inspector.

The result of the examination is recorded on the form provided in Annex R of this chapter and maintained on file.

6.2 Label Verification

Verify that the label on the immediate container is correct and matches the description on the OMIC. Refer to Annex E of this Chapter for information on labelling requirements.

In the case of shelf stable, thermally processed, hermetically sealed meat products, and pasteurized meat products, the Inspector must verify the containers are permanently marked with the following information as required by sections 60 (d) and 123 (b) of the Meat Inspection Regulations 1990:

1. Country of origin or internationally recognized code for the country;
2. Establishment number;
3. Type of product; and
4. Production date or code for the production date.

The above information may be marked as part of a permanent lithograph label, embossed or directly printed in a permanent manner on the container or lid of a glass jar. Glued paper labels do not meet the requirements for permanent markings.

6.3 Inspection of Containers

All surface areas of the containers are examined for the presence of defects. The Metal Can Defect Manual or the Flexible Retort Pouch manual are to be consulted to identify and classify the defects as minor, serious or critical. The number and kind of defects are recorded on the visual inspection report, refer to Annex R of this Chapter. The label should be removed from containers only if it is necessary to ascertain the presence and nature of a defects (e.g. side seam defects, corrosion, rust or stained labels). If the label is removed, both surfaces of the label and the container must be examined for any indication of defects such as stains or evidence of external corrosion.

6.4 Decision

All the sub-sample containers shall be examined and defects classified before a decision is considered. If the results of the full inspection show:

1. no serious defects, permit distribution of inspection lot.
2. one or more serious defects, detain the inspection lot. Proceed to Section 6.5 - Serious Defects.
3. where an Inspector is unable to classify a defect or is uncertain whether a defect should be classified as a serious defect, the container with the defect in question, plus four other cans with defects (if possible) and five good order cans, must be sent to a laboratory for further analyses. The inspection lot must be detained pending a final decision.

6.5 Serious Defects

All containers with serious defects (other than those submitted to labs) shall be retained by the Inspector and the defects identified. No sale or distribution of the inspection lot is permitted. Control of all defective containers must be maintained until a final decision is reached as to the disposition of the inspection lot. When swollen or leaking container(s) are found, the cause must be determined. Proceed to section 9 - Swollen or Leaking Containers.

6.6 Laboratory Samples

Samples are to be submitted to laboratories:

1. when an Inspector is unable to classify a defect as in 6.4 c;
2. to determine the cause of swollen or leaking containers;
3. in accordance with Annex M-1 of this Chapter; or
4. in accordance with Area Microbiological or Compositional/Additive Sampling Plans.

6.7 Disposition of the Inspection Lot

Inspection lots, where the sample contains one or more serious defects, do not meet Canadian requirements and are not permitted for sale or distribution in Canada. The legal agent has three options:

1. remove the refused lot from Canada;
2. destroy the inspection lot under the supervision of the Inspector; or
3. request permission to cull the inspection lot.

If the Legal Agent requests permission to cull the inspection lot, proceed to section 8 - Inspection Lot Culling.

7. Wet, Stained or Damaged Cases

7.1 Investigation

The Inspector will examine the wet, stained or damaged cases and their containers in order to determine the reason the cases are wet, stained or damaged. Refer to Diagram 2 of this Chapter. Cases in close proximity to the wet, stained or damaged cases should be closely examined to determine if they may be the source of the problem.

If the problem is due to:

1. Swollen or leaking containers:

   No further inspection until the cause of the swelling or leakage has been determined. Proceed to section 9 - Swollen or Leaking Containers.

2. Physical damage to cases and/or containers (e.g. forklift) or other reasons (e.g., water damage, leakage from another inspection lot):

   Suspend the inspection until the wet, stained or damaged cases are segregated from the inspection lot by the legal agent. Proceed to Section 7.2 - Sorting or Wet, Stained or Damaged Cases. If wet or stained cases are due to leaking containers from other lots of foods in close proximity to the inspection lot, the lot which is the source of the problem must be identified and detained for further examination.

7.2 Sorting of Wet, Stained or Damaged Cases

If the legal agent chooses to sort the inspection lot, they must ensure that the wet, stained or damaged cases are segregated from the rest of the inspection lot. Proceed to section 5.2. If the legal agent does not sort the inspection lot, the lot remains under detention and is not permitted for sale or distribution.

The legal agent has two options:

1. Remove the refused lot from Canada.
2. Destroy the inspection lot under the supervision of the Inspector.

7.2.1 Identification

The number and location of wet, stained or damaged cases segregated from the inspection lot must be recorded. The legal agent must maintain control of these cases until a final decision on the inspection lot has been taken by the Inspector.

7.2.2 Inspection of Containers from Wet, Stained or Damaged Cases

The legal agent is responsible for examining the containers from the wet, stained or damaged cases. All containers showing evidence of stains or damage must be removed from the cases by the legal agent. The Inspector will examine all the segregated containers and if any serious defects, other than serious defects caused by physical damage are noted, they shall be part of the official sample taken for inspection. The good order containers from the wet, stained or damaged cases may be returned to the inspection lot.

The affected containers from the wet, stained or damaged cases must be kept under detention and disposed of under the supervision of the Inspector.

Note: If the Inspector confirms that the defect is due to physical damage and if the legal agent chooses not to remove the affected containers in the wet, stained or damaged cases, those cases shall be destroyed under the supervision of the Inspector.

7.2.3 Good Order Cases

Proceed to Section 6 - Full Inspection, to carry out the full inspection of the containers in the good order cases.

8. Inspection Lot Culling

Refer to Diagram 3.

8.1 Authorization

The legal agent shall request, in writing, authorization from the Inspector prior to culling an inspection lot and must provide the agency with a written procedure outlining the culling operation. An evaluation of the nature and number of defects observed during the inspection and the written procedure for culling submitted by the legal agent will be used to determine if a permission to cull will be granted. If the submitted procedure is not acceptable, the Inspector shall advise the legal agent in writing.

8.2 Decision

8.2.1 Cull Permitted

The legal agent is responsible to ensure that the cull is carried out according to the written procedure submitted to the Inspector. After the completion of the cull, the inspection lot shall be reinspected by the Inspector. Proceed to Section 10 - Reinspection of Culled Lots.

Note: All defective containers that are culled from the inspection lot must be segregated by the legal agent and kept for inspection by the Inspector. A cull report, detaining the number and types of defects, must be submitted to the Inspector at the completion of the cull.

Note: Lots requiring label removal for inspection and culling will likely not be permitted to be culled. There are no provisions for applying new foreign labels to imported meat products.

8.2.2 Cull Not Permitted

If the nature and quantity of serious defects indicate that culling would not be effective in removing these defects from the inspection lot or if the presence of swollen or leaking containers cannot be related to a serious defect or overfills, then the cull shall not be permitted. The inspection lot will not be permitted for sale or distribution.

The legal agent normally has two options:

1. remove the refused lot from Canada; or
2. destroy the inspection lot under the supervision of the Inspector.

9. Swollen or Leaking Containers

9.1 Laboratory Analysis

All swollen and leaking containers must be submitted to a laboratory to determine the cause of the swelling or leakage. Each container and its contents will be tested using appropriate microbiological methods.

9.1.2 Notification and Evaluation

Refer to Diagram 4.

If the reason for the swollen or leaking containers is due to:

a. Under processing

Food Recall and Emergency Response shall be notified if there is any possibility of this or similar product being in distribution.

Reject an inspection lot containing swollen or leaking containers which cannot be related to a container defect or overfill.

b. Container defects

The inspection lot cannot be sold. The legal agent normally has three options:

1. remove the refused lot from Canada;
2. destroy the inspection lot under the supervision of the Inspector; or
3. request permission to cull the inspection lot.

If the Legal Agent requests permission to cull the inspection lot, proceed to Section 8 - Inspection lot Culling. If the reason for the swollen or leaking containers is due to:

c. Overfills

Inspection lots with swollen containers due to overfills are a violation of Section B.27.003 of the Food and Drug Regulations and cannot be offered for sale or distribution in Canada. Where the swollen containers are not due to under processing, the inspection lots may be culled. Some products may appear slightly swollen due to overfilling by design or due to gas packing. If this is verified by the Inspector, these containers are not considered to be swollen.

Note: Culling of any inspection lot containing swollen or leaking containers will only be permitted in those cases in which the cause of the swelling or leaking has been identified and the cause of the swelling or leaking is not due to under processing. Refer to Diagram 4.

10. Reinspection of Culled Lots

Reinspection will be carried out by the Inspector.

10.1 Selection of Containers

Examine the culled defective containers in conjunction with the cull report to determine the level and type of defects. Evaluate the report to determine if a Health Hazard Evaluation is required to determine the acceptability of the inspection lot.

Select a minimum of 1250 containers. Select a minimum of 250 cases at random from the inspection lot. A copy of the random numbers table is found in Annex H-2 of this Chapter. No more than five containers are to be taken from each of the cases. Where there are less than 250 cases in an inspection lot, select the appropriate number of containers out of each case to make the required number.

Where there are less than 1250 containers in the inspection lot, each container must be examined and the number examined must be recorded on the report form.

Where the product after culling has been stacked right on skids and not in cases, the 1250 containers must be selected in a manner representative of the inspection lot.

Sample Examination: Examine each container for the presence of defects. The label should be removed only if it is necessary to ascertain the presence and nature of a defect (e.g., stains, external corrosion, etc.)

10.2 Decision

1. No serious defects - the inspection lot may be offered for sale or distribution.
2. One or more serious defects - The inspection lot may not be offered for sale or distribution.

The legal agent normally has two options:

1. Remove the refused lot from Canada: or
2. Destroy the inspection lot under the supervision of the Inspector.

11. Reporting Forms

The form provided in Annex R of this Chapter is for reporting the results of the visual inspection of low acid or acidified low acid foods in hermetically sealed containers. The type of defect and number of containers with the defect are to be reported on the form.

12. Inspection Procedures for Glass Containers

12.1 Complete visual/cursory inspection procedures as per Section 5 of this Annex. Check for damaged or wet cartons. Any broken containers damaged during handling, storage and transportation must be culled.

12.2 Shipments for full inspection are sampled as per Section 6 of this Annex. To prevent breakage of glass sample units, samples can be chosen from the outside of pallets.

12.2.1 Check sample units for the following serious defects:

Cracks, fractures, holes in the glass..........(not due to physical damage)
Leakage from glass..........(not due to physical damage)
Swollen caps..........(under processing or air leakage)
Loose caps..........(improper torque, tightening of lids)
Springing caps..........(under processing or air leakage)
Cap leakage..........(improper torque, tightening of lids)

Note: This list is not official but is followed by processors using Good Manufacturing Practices (GMP) guidelines.

Where an Inspector is unable to classify a defect or is uncertain whether a defect should be classified as a serious defect, the container in question plus four (4) other cans with defects if possible) and five (5) good order cans, must be sent to a laboratory for further analyses. The inspection lot must be detained pending a final decision. The same inspection and culling procedures apply to glass containers as for metal cans in regard to inspection, decisions, and procedures for handling shipments with critical defects.

13. Hermetically Sealed Commercially Sterile, Shelf Stable, Pouches and Film Sealed Trays

13.1 Visual/cursory inspection procedures are conducted as per Section 5 of this Annex. Check for damaged or wet cartons. Any containers damaged during handling, storage and transportation must be culled.

13.2 Shipments for full inspection are sampled as per Section 6 of this Annex. For flexible pouches, reference can be made to the Flexible Retort Pouch Manual inspection procedures and classification of defects.

For other types of containers (plastic trays with flexible seals) Inspectors should examine the condition of package (exterior and interior) and quality of seals or seams. Observe and feel for swelling of the container seal or for abnormalities such as ridges, delamination, preformations or unevenness in the seal. Any evidence that the package may lose or has lost its hermetic seal, or that microbial growth has occurred in the package contents warrants further investigation by the laboratory.

13.2.1 Serious Defects

Generally a serious defect is one which provides evidence that:

1. there is, or has been, microbial growth in the container contents; or
2. the hermetic seal of the container has been either lost or seriously compromised; or
3. The container is unsuitable for distribution and sale as stipulated in the Food and Drugs Act and Regulations.

Where an Inspector is unable to classify a defect or is uncertain whether a defect should be classified as a serious defect, the container in question plus four (4) other cans with defects (if possible) and five (5) good order cans, must be sent to a laboratory for further analyses. The inspection lot must be detained pending a final decision.

The same inspection and culling procedures apply to pouch containers as for metal cans in regard to inspection, decisions, and procedures for handling shipments with critical defects.

14. Pasteurized (not shelf stable) Canned Meat Products

Preservation of the products depends on refrigeration. Container integrity is of secondary importance in evaluating acceptability. At the inspection establishment, temperature records, covering the entire transportation period from the foreign export establishment to the reinspection establishment, must be examined and the findings reported on the IIR. It is also important to ensure that the sampling and inspection procedures do not jeopardize the required refrigeration temperature.

If it is found that at any stage, the temperature of storage has exceeded that specified on the label or 4°C, or if the temperature records are incomplete, the following procedure is to be followed:

• The shipment is to be held and five (5) containers selected and submitted to the laboratory. A detailed report on the Inspector's findings is to be submitted to the Chief, Import Programs.
• Provided refrigeration has been maintained and if numbers permit, thirty (30) containers are to be selected, drawn as representatively as possible from selected cartons. Where less than thirty (30) containers are present in a lot, all must be selected. Examination of the containers is the same as for shelf stable products.

Diagram 1: Cursory / Visual Inspection

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Cursory/visual inspection

Diagram 2: Sorting of Wet, Stained or Damaged Cases

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Sorting of Wet, Stained or Damaged Cases

Diagram 3: Inspection Lot Culling

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Inspection Lot Culling

Diagram 4: Procedures for Swollen or Leaking Containers

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Procedures for Swollen or Leaking Containers