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Annex Q: Pathogen Reduction and HACCP Systems; Final Rule

General Requirements and Implementation

Q.1 Introduction

The "Pathogen Reduction and Hazard Analysis and Critical Control Point (HACCP) Systems; Final Rule" dated July 25, 1996, outlines specific requirements which must be met in all establishments inspected in the USA by the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS). These requirements must also be implemented in an equivalent manner in all foreign establishments exporting to the USA.

Q.1.1 "Pathogen Reduction and HACCP Systems; Final Rule" Requirements

In order to appear on the list of establishments eligible to export to the USA, Canadian establishments must meet the following requirements outlined in the Final Rule on "Pathogen Reduction/HACCP Systems" (ref: Federal Register, vol. 61, No 144).

a) Standard Sanitary Operating Procedures (SSOPs)

The Canadian requirements (found in Chapter 3 of the Manuel of Procedures and in the Food Safety Enhancement Program Manual) have been deemed equivalent to the USDA requirements.

Verification of compliance is done through inspection verification tasks under the Compliance Verification System (CVS) (refer to Chapter 18).

b) Hazard Analysis and Critical Control Point (HACCP) Systems

Canadian HACCP requirements are deemed equivalent to FSIS requirements with the exception of pre-shipment review requirements. The following section outlines the requirements for pre-shipment review and the steps needed for its implementation:

Pre-shipment review
  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 are 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 effective;
    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. 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 CVS verification task (task 3101).

    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); and
    2. that the pre-shipment review has been signed and dated by an establishment employee.
c) Testing for generic E. coli - Biotype I as a verification of slaughter procedures and CCPs

Refer to Annex T.

Implementation will be verified through the Compliance Verification System (CVS) (refer to Chapter 18).

d) Testing for Salmonella to verify the operator's HACCP system's effectiveness in achieving Pathogen Reduction Goals

Refer to Annex U.

Implementation will be verified through the Compliance Verification System (CVS) (refer to Chapter 18).

Q.1.2 Canadian Registered Establishments Affected by These Requirements

The requirements are applicable to establishments that produce meat products amenable to USDA/FSIS legislation (Documentation required: CFIA/ACIA 4546 and FSIS 9510-1).

Red Meat species: cattle, swine (including wild boar), sheep, goat, horse, mule and other equine;

Poultry species: chickens (including broilers, roasters, fowl and Cornish game birds), turkeys (including wild turkeys), ducks, geese, ratites, squabs and guineas.

Further, the operator must ensure that all meat and meat products received from other registered establishments (Canadian and foreign) which are exported to the USA by the establishment or used in the preparation of meat product exported to the USA, originate from establishments which comply with and meet all applicable USDA requirements including Pathogen Reduction and HACCP Systems; Final Rule requirements.

Note: USDA/FSIS requirements are not applicable to meat products amenable to Food and Drug Administration legislation such as meat products derived from a species not mentioned above or other meat products not amenable to USDA/FSIS requirements because of the small quantity of meat they contain or for other reasons. FSIS import inspection in the FSIS, Office of International Affairs or the Labeling and Program Development Division (LPDD) must be contacted when the jurisdiction over a specific meat product is unclear. A copy of the ruling obtained must be kept on file and made available to the CFIA inspector upon request. Products amenable to FDA legislation can be exported from any Canadian registered establishment (documentation required: CFIA/ACIA 1454).

Q.2 Verification of Compliance

Approaches taken by the USDA and the CFIA for incorporating HACCP into food safety regulatory programs

Following the publication of the Pathogen Reduction and HACCP System; Final Rule in 1996, the USDA replaced traditional processing inspection tasks by HACCP-system inspection tasks but retained its traditional inspection frequencies.

In Canada, HACCP became mandatory in 2005 for all registered establishments and the Compliance Verification System (CVS) was implemented in 2008 to ensure compliance with FSEP/HACCP requirements. Verification tasks are recorded on the Verification Worksheet. More information on the CVS can be found in Chapter 18 of the MOP.

Q.2.1 Verification of Controls Over Incoming Products

Each establishment listed in Annex W, during the period of time it is considered eligible for export, must keep receiving (e.g., copy of the Official Meat Inspection Certificate (OMIC), shipping marks, receiving controls, marking of boxes, storage controls), production and shipping records to ensure and demonstrate traceability of eligible products, i.e., that all USA-exported product is composed only of USA eligible meat. The CFIA will periodically verify the establishment's program to determine if it is effective (CVS task 3102). It is not necessary to verify the company's system for each lot exported when the control program is deemed effective.

Meat and meat products from foreign establishments cannot be directly re-exported to the USA. They can only be used in the fabrication of meat products exported to the USA provided that they meet all the requirements outlined in Q.1.2 above.

Q 2.2 Determination of Compliance Status of Imported Meat Products

Certain countries require that all meat exported to Canada meets also all USDA-FSIS requirements (see Table Q.2.3 below).

Table Q.2.3
Countries that produce meat exported to Canada also in accordance to USDA-FSIS requirements

Other countries make the trading parties responsible for taking the necessary steps to obtain the required additional attestations. In this case, the importer is responsible to make the necessary arrangements to ensure that the required supplementary attestation is entered on the Official Meat Inspection Certificate (OMIC) issued by the exporting country. Attestations required are as follows:

For other countries except Brazil and Chile:

"The meat product contained in the shipment has been produced in premises listed for export to the USA and is eligible for export to the USA."

For Brazil: Brazil has chosen to include the following attestation to all beef products certified for export to Canada.

"All the meat certified for export to Canada from Brazil is also eligible for export to USA from the point of view of USDA Final Rule on Pathogen Reduction and HACCP Systems".

Note: Given that only prepared cooked beef products are exported to Canada the declaration specific to Pathogen reduction and HACCP systems has been found acceptable.

For Chile: Chile has chosen to certify compliance with FSIS requirements on a case by case basis by providing the following attestation:

"The pork meat products indicated on the certificate No CHL space, come from the establishment space, which is authorized to export to the United States (9CFR Part 327; RIN 0583-AD16) and are eligible for export to the USA."

An operator may want to use imported product in the manufacture of a meat product for export to the USA from a country not listed above. Before this can occur, the Competent Authority of the country of interest must contact the CFIA to negotiate the appropriate certification statement(s).

In order to allow the CFIA to establish the compliance of the imported meat product with USDA/FSIS requirement, the competent authorities of the countries exporting meat products to Canada must supply on a voluntary basis (as this is not a Canadian import requirement), written guarantees that imported products qualify for use in the manufacturing of meat products destined to the USA.

Recently, Mexico has started issuing an additional document for meat products imported into Canada and destined for export to the US, titled: "Annex to the Zoosanitary Export Certificate No (Official Meat Inspection Certificate number) of meat of (species) With Destination to Canada that will be re-exported to the USA." (Annex Q-1)

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