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Process Verification Monitoring Program for generic E. coli – Biotype I for raw poultry

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Keep in mind: the Process Verification Monitoring Program (PVMP) will be launched on January 1, 2023. All Safe Food for Canadians (SFC) licence holders who are slaughtering poultry are expected to begin implementation by March 1, 2023. Currently the scope of this program is limited to poultry carcasses.

1. Introduction

Generic Escherichia coli (E. coli) biotype I, is found in the feces and intestinal tract of all meat and poultry animals. For this reason, generic E. coli can be used as an indicator organism. Finding this bacterium on a slaughtered and dressed carcass is an indication that fecal contamination has occurred. Accordingly, food businesses that slaughter poultry need to consider the presence of generic E. coli as an indication that biological hazards may be present and may affect products and a means to verify effectiveness of control measures throughout their production process. Food businesses can verify the efficacy of their control measures, such as sanitary dressing procedures and antimicrobial interventions by testing carcasses for generic E. coli as described in the Process Verification Monitoring Program (PVMP).

2. Purpose

The Canadian Food Inspection Agency (CFIA) developed the following  microbial sampling measures to help food businesses comply with section 47 and 89(1)(c)(i) of the Safe Food for Canadians Regulations (SFCR).

Safe Food for Canadians (SFC) licence holders must identify and analyze the biological, chemical and physical hazards that present a risk of contamination of their food, and prevent, eliminate or reduce to an acceptable level the hazards identified by using control measures that are shown by evidence to be effective, including any treatment or process. PVMP provides evidence and means to verify that overall control measures are effective in reducing contamination in raw poultry and poultry products below established maximum limits described herein.

Note: the PVMP verifies overall process controls. This means that products are not tested for the purpose of determining their suitability, but rather as a means to verify the effectiveness of control measures in preventing, eliminating or reducing contamination in raw poultry and poultry products during slaughter process.

It's your choice!

You may use other sampling and testing procedures developed by provincial counterparts, industry associations, international partners or academic bodies as long as they can achieve the same outcome. Always ensure that the guidance you use is tailored for your particular business, product or products, and market requirements. Ensure to have the proposal verified by CFIA for foreign country equivalency assessment.

3. What is included

This document provides means to demonstrate the effectiveness of the control measures in your preventive control plan (PCP) by using generic E. coli biotype I as a microbiological indicator organism in key products to demonstrate process control.

4. Roles and responsibilities

Food businesses are responsible for complying with the law. They demonstrate compliance by ensuring that the commodities and processes for which they are responsible meet regulatory requirements. If a written PCP is required, the food business develops a PCP with supporting documents, monitors and maintains evidence of its implementation, and verifies that all control measures are effective.

The CFIA verifies the compliance of a food business by conducting activities that include inspection, and surveillance. When non-compliance is identified, the CFIA takes appropriate compliance and enforcement actions.

CFIA may request SFC licence holders to modify their monitoring procedures to ensure that effectiveness of processes can be continually demonstrated.

5. Definitions

The following definitions apply in this document.

Indicator organisms are microorganisms that, when present in a food products or in the environment, indicate the possible presence of pathogens, or potential deficiencies in the sanitation program or the actual process.

Process Verification Monitoring Program is a set of monitoring activities that verify the effectiveness of control measures to prevent, eliminate or reduce biological hazards to an acceptable level.

Process verification criteria is a microbiological criterion to measure effectiveness of actions taken at various process steps to reduce or eliminate contamination on raw poultry.

Raw poultry carcass is a whole poultry carcass which has not been cooked.

6. Key sections of the written program

A PCP allows you to identify and describe the biological hazards associated with the food, document how you intend to control those hazards, provide the information you used to develop your plan, and demonstrate through records (as defined in glossary) that you have implemented your plan. To help you understand these requirements in relation to process verification monitoring, specific criteria and examples are outlined below. The examples are not exhaustive but offer ideas on what you can do to incorporate your PVMP in your PCP.

7. Poultry products subject to the Process Verification Monitoring

7.1 General considerations

7.2 Product type within scope

Raw poultry carcasses

7.3 Product types out of scope

PVMP does not include in its scope the following products:

Note: salvaging means hot boning of carcasses off-line so as to recover the non-defective portions.

8.0 Sampling

8.1 Sampling location

You should sample raw poultry products for PVMP after chilling and completion of all interventions and processing steps, but before product leaves the establishment.

Select a sampling location where sampling can be done safely and represents normal production.

Note: when an antimicrobial is used, you should wait for at least 60 seconds to let product drip before sample collection. This will prevent excessive antimicrobial residual level in the collected sample. Residual antimicrobial can lead to lower bacterial counts which would not provide a true representation of the process control.

8.2 Sampling size and test frequency

The PVMP sampling is designed to provide information on process controls and to trigger an examination of process controls when necessary so that production can be improved. It provides sampling results that will inform you if a corrective action is required.

Important points you should consider for PVMP sampling and testing:

Table 1: Sampling frequency for generic E. coli
Species Production volume Test frequency Sample size unit per test
Chicken More than 440,000 birds per year Once every 22,000 carcasses 1 carcass for 1 test
Less than 440,000 birds per year Once a week
Other poultry species More than 60,000 birds per year Once every 3000 carcasses
Less than 60,000 birds per year Once a week

See Annex – Sampling procedures for generic E. coli in raw poultry

9. Trend analysis and Process Verification Monitoring performance assessment

You should assess the performance of your poultry production process by monitoring the results of your PVMP. PVMP assessment is based on the statistical Process Verification Criteria (PVC) principles. 2 complementary verifications are recommended:

Individual test assessment: assess each sample against accept, marginal "m", maximum/reject criteria "M" in table 2. The process is no longer in control when the test exceeds the "M" value, a corrective action is needed.

Trend analysis: is performed using a moving window of "n" 13 consecutive tests. Calculate the maximum number "c" of "m" tests in the last "n" that fall within the marginal "m" range. The process is no longer in control when the number of marginal results is 4 or more, a corrective action is needed.

Table 2: PVC for generic E.coli assessment in poultry carcasses
Individual carcass criteria Trend analysis
sampling method/
unit of measure
Maximum/reject
"M"
Marginal
"m"
Accept maximum number "c" of marginal "m" results for a sample "n" of 13 tests
carcass rinse cfu/ml 1000 100 – 1000 <100 3
sponge or excision
cfu/cm2
Licence holder to develop own PVC

"n" - sample size (n) is the value for total number of tests to be used for assessing PVC
"c" - maximum number of marginal results is the value used for trend analysis
"m" - marginal limit or lower control limit is an intermediate value somewhere between the average and "M"
"M" - maximum limit or absolute control limit is the maximum value beyond which any single result means that the process is no longer in control and corrective action is to take place

9.1 Recording test results

10. Corrective action procedures

The process is deemed out of control when the results do not meet PVMP criteria, this indicates that the procedures and associated antimicrobial intervention step(s) used to produce poultry product are unable to prevent, eliminate or reduce contamination to an acceptable level. In this case:

11. Records

In a PCP, systematic record keeping simplifies the retrieval of records when they are needed. They provide evidence that the PCP is implemented and working effectively.

Note: based on international trade agreements, CFIA may need to inform foreign trading partners of PVMP test results and trends.

Additional information – Further reading

The following references contain information on food safety controls, including examples. CFIA is not responsible for the content of documents that are created by other government agencies or other external sources.

CFIA references

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