Developing Recall/Withdrawal Procedures

Regulatory Authority - Health of Animals Regulations 170.1

• Every person who imports, manufactures, packages, labels, stores, distributes, sells, or advertises for sale any animal food for ruminants, equines, porcines, chickens, turkeys, ducks, geese, ratites or game birds shall establish and maintain written procedures to facilitate an effective recall of the animal food.

General Principles

• When a human or animal health risk is identified, there is a need to remove affected animal food (feeds) from the marketplace and/or discontinue access to food-producing animals as quickly as possible.
• Feed manufacturers need to identify batches/lots of feed in a manner that supports their rapid and complete withdrawal from the marketplace or production unit in the event that a system failure results/or potentially could result in a human or animal health risk.
• Records should be maintained and be readily available regarding the production, distribution and use of feeds ingredients to facilitate their prompt trace-back and trace-forward to the next subsequent recipients.
• Production units should develop a method of maintaining the identity of the livestock consuming a particular lot of animal food.
• An assessment of the effectiveness of the recall should be completed.

The following principles should be considered when designing the recall/withdrawal procedures used in a particular facility:

1. The recall/withdrawal procedure must be defined

This written procedure should specify:

• The person(s) responsible for implementing the recall (e.g. the composition of the recall management team and after-hours contact information)
• The food safety/animal health assessment process to be used to identify whether a recall is required
  • the establishment and maintenance of a complaint file
  • the criteria for a recall to be implemented
  • the criteria for contacting the Canadian Food Inspection Agency (CFIA) and/or other competent authority
• The method used to identify, locate and control affected feed
  • a system of records and procedures that ensure that individual lots of feed ingredients can be linked to their suppliers
  • details of the amount of affected feed produced, in inventory and distributed; name and lot identification of recalled feed; reason for the recall; area of distribution of the affected feed – local, national, international
  • handling procedures for affected feed including disposition of the affected feed
  • identification of livestock receiving the affected feed (on farm)
  • handling procedures for animal receiving the affected feed (on farm)
  • a requirement to investigate other feeds that may be affected and that should be included in the recall
• Records to be maintained in the event that a feed is recalled

Note: It is recognized that a recall on-farm is primarily the procedures that are implemented to ensure that animals no longer have access to contaminated feed that could negatively impact on animal or human health.

2. Assessing Recall Effectiveness

If a recall or mock recall was conducted, the following actions should have been taken:

• the manufacturing error/complaint was identified
• manufacturing errors and/or complaints were assessed to determine whether a recall/withdrawal was required
• written recall/withdrawal procedures were followed and were effective
• affected feed was disposed of appropriately
• corrective actions were taken including implementation of preventative measure to reduce likelihood of future occurrences
• when appropriate CFIA or competent authority was contacted
• records have been maintained for the minimum time required by the Health of Animals Regulations (two years or at least since July 12, 2007)

To verify and document the effectiveness of any recall or mock recall conducted, e.g., the capability to rapidly identify and control a lot of potentially affected product and reconcile the amount of product produced, in inventory and in distribution, the following information should be gathered.

• Notification efficiency % of customers notified (commercial feed mills)
• Traceability efficiency % of affected feed traced
• Recovery efficiency
  • % of affected feed recovered, time based
  • % of affected feed located
  • % of affected feed no longer accessible to animals, time based (on farm feed mills)

Deficiencies identified by the assessment of the recall procedures need to be corrected.

3. Documentation and Records

The following documents and records are required:

• Written product recall/withdrawal procedures
• Records including:
  • Mixing formula
  • Mixing sheet (including an alpha-numeric lot identification number)
  • Distribution records (name and address of any person to whom the feed is distributed or sold)
  • Invoices for purchased products
  • Recall Record (available for use when needed)
    • Problem identification (internal)/notification (external)
    • Identification of affected lots of feed
    • Result of risk assessment
    • Corrective actions
    • Recall contact/notification list

Appendices

• Appendix I: Sample Recall Record
• Appendix II: References

Appendix I

Sample Recall Records Commercial Feed Mill/Distributor

A: Product Information

B: Distribution List table

Name	Address	Telephone Number	Quantity Located/Recovered	Quantity Shipped
Total

Total Quantity Located (A):

Total Quantity Produced (B):

A/B x 100 = % recovered

C: Corrective Actions

Sample Recall Records On-Farm Feed Mill

Reason for Recall:

Feed Distribution List table:

Barn Site	Bin #	Barn Manager	Phone #	Time CalledTable Note 1	Tonnes Shipped	Tonnes Picked Up	Comments

Table Notes

Table Note 1

Record time when Barn Manager was personally reached (not when message was left)

Return to table note 1 referrer

Disposition of: Re-Use / Reprocess / Dispose

Taken To:

Other Action or Precautions Required:

Recall Team Members:

Sample Recall Records Reprocessing of Feed Report (On-Farm)

Sample Taken: Yes N/A

Reason for Reprocessing:

Receiving / Storage Information:

How is feed being stored:

Date of storage: Bin #

Feed went through Receiving Pit / Drag / Leg to Bulk Ingredient Bin:

Yes Amount:
N/A

Reprocessing Information:

Ration used for Reprocessing Feed:

Reprocessing information table

Date	Lot #	Amount Used	Date	Lot #	Amount Used	Date	Lot #	Amount used

Feed Department notified that feed has been reprocessed:

After Reprocessing Is Complete:

Feed went through Screw Conveyor To Main Scale:

Yes Amount:
N/A

Feed was stored in Bulk Ingredient Bin:

Yes Amount: Bin #
N/A

Appendix II

References

1. CQA Producer Manual. Canadian Pork Council 2006.
2. Feed Assure Prerequisite Program Manual 2007.
3. Code of Practice on Good Animal Feeding CAC/RCP 54-2004