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Annex S HACCP REQUIREMENTS (ref. 9 CFR Part 417)

1. Introduction

The USDA "Pathogen Reduction and HACCP Systems; Final Rule" requires that establishments inspected in the USA by the USDA Food Safety Inspection Service (FSIS) implement working HACCP plans covering all types of meat and meat products manufactured at the establishment. Storages with or without import inspection, do not manufacture products and are, therefore not required to develop HACCP plans.

HACCP plans must be developed, implemented, validated and maintained in a manner consistent with the seven HACCP principles of the Codex Alimentarius.

Establishments inspected by FSIS in the USA must have operating HACCP plans for meat products. HACCP plans must be validated by the operator. In the case of new establishments, or new products, HACCP plans must be developed by the operator before the establishment is allowed to operate or to manufacture the products for distribution in commerce. The operator will be allowed to operate or to manufacture new products for distribution in commerce only if the validation requirements are met within the following 90 days.

FSIS defines "validation" as documenting that critical control points effectively address relevant hazards and "involves scientifically demonstrating that a HACCP system as designed is effective in controlling the food safety hazards identified through the hazard analysis" (ref. Federal Register, Volume 61, no. 144, page 38826). This may be done by relying on CCP’s which have been scientifically validated and reported in the literature; and using the services of laboratories or processing authorities to validate CCP’s. Validation also includes verifying that the proposed CCP is effective under every day operating conditions at the establishment.

FSIS inspection staff will conduct activities using the current "Performance Based Inspection System (PBIS)" According to FSIS, "verification" will include review of the HACCP plans and activities such as "sampling activities, hands-on verification, and review of establishment monitoring records".

The Food Safety Enhancement Program (FSEP) is the tool used to implement HACCP in Canada. A decision was made to use FSEP to verify that establishments’ implementation of HACCP meets Codex and FSIS requirements.

2. Specific requirements - Pre-shipment review

Canadian HACCP requirements are deemed equivalent to FSIS requirements with the exception of pre-shipment review requirements.

2.1 Requirements applicable to operators

Prior to shipping any meat product from the establishment, the operator shall review all the CCP records associated with the production of that product to ensure completeness, that is:

• CCPs were monitored and documented as required,
• the determination that all critical limits were met and,
• if appropriate, corrective actions were taken, including the proper disposition of product.

This review shall be conducted, where practicable, by an individual who did not produce the record(s) or by the responsible establishment official. That person shall be trained in accordance with FSEP prerequisite program (technical training, sub-element D 1.2).

Pre-shipment records must be signed and dated by the designated plant employee.

Pre-shipment review can be done as part of the HACCP system verification procedures as long as this is defined in the establishment’s HACCP written program and that all pre-shipment (see above) and FSEP requirements are being met; otherwise, the operator will have to develop a written auditable protocol specifically for pre-shipment review.

In any case, frequency of pre-shipment review and deviation procedures to initiate whenever pre-shipment requirements are not being met need to be specified for each HACCP plan.

The frequency of pre-shipment review should prevent the shipment of products prior to completion of the review of required records. It is strongly suggested to adapt the frequency based on the establishment production context (e.g. continuous production, multiple lines, product flow, etc).

Note: Pre-shipment review can be accomplished at a location other than the producing establishment for products being sent to storage when:

1. the written procedures developed by the operator is acceptable to the responsible inspector at the producing establishment and a copy of these procedures are available to the inspector at the shipping establishment;

2. the procedures implemented by the operator at both establishments are being followed and are efficient;

3. the review of appropriate documents and compliance with pre-shipment review requirements occur before the product leaves the control of the operator of the producing establishment; and

4. the establishment where the product is stored is part of the same company as the producing establishment in order to ensure appropriate controls.

2.2 Verification of compliance with pre-shipment review requirements by the CFIA.

Verifying that the establishment has completed pre-shipment review enables inspection program personnel to know whether the company has taken full and final responsibility for applying its HACCP controls to the product that it has produced. The responsible inspector shall perform a verification check by doing, in addition to the record review, on-site observations. The on-site observations do not involve the actual audit of the CCPs; the purpose of these observations is to confirm that the CCPs are monitored, that appropriate corrective actions are taken by the operator whenever critical limits are not met, that pre-shipment procedures are being followed and that pre-shipment review is completed prior to shipping any meat product from the establishment (unless provisions as per above are met). Pre-shipment requirements are verified through the applicable MCAP inspection task.

When verifying an establishment’s pre-shipment review the inspector should verify:

1. That the operator has reviewed all the CCP records associated with the production of the product, prior to shipment (the CCPs were monitored and documented as required, all critical limits were met and, corrective actions were taken, including the proper disposition of product, when applicable).

2. That the pre-shipment review has been signed and dated by an establishment employee.

Annex C | Annex D | Annex D-1 | Annex E | Annex J (PDF) | Annex K (PDF) | Annex L | Annex M | Annex Q |
Annex R | Annex S | Annex T | Annex U | Annex W | Annex W-1 | Annex W-1 | Annex X | Annex Y |
Annex Z | Annex Z-1 | Annex Z-2 |