Process Verification Monitoring Program for generic E. coli – Biotype I for raw poultry
On this page
- 1. Introduction
- 2. Purpose
- 3. What is included
- 4. Roles and responsibilities
- 5. Definitions
- 6. Key sections of the written program
- 7. Poultry products subject to the Process Verification Monitoring
- 8.0 Sampling
- 9. Trend analysis and Process Verification Monitoring performance assessment
- 10. Corrective action procedures
- 11. Records
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.
- List of products
List all poultry products you prepare that are within scope of PVMP.
- The microbial pathogen controls
Describe the type and location of microbial control used to reduce microbial levels and/or eliminate contamination.
Review changes to operations such as changes in your facilities, equipment, personnel and procedures which may affect adequacy of process verification and controls.
The controls are to be validated for normal operating conditions as per the Microbial controls for meat products and food animals guidance to ensure that they will not result in a public health risk.
- Microbial staging of production process
If done, describe microbial testing done at various steps of your process and its associated controls.
Note: this is not a regulatory requirement.
- Process verification criteria
State the process verification criteria (PVC) you use.
- Sampling plan
Describe your sampling plan:
- number of samples to be taken
- who takes samples including identification of the designated employees who have completed the required training
- when will sample be taken
- where will sample be taken
- how random sampling will be achieved
Note: random refers to the time when the samples are selected and collected, not when the rinsing or sponging is initiated or completed.
- Pre-sampling preparation
Describe your pre-sample preparation procedures such as:
- check list of tasks to be performed prior to sample collection
- materials that will be needed for sample collection
- verification of the suitability of materials before testing (such as check rinse fluid and sponges to ensure they will support growth)
- Sample collection procedure
Describe your sampling procedures:
- designated trained employee who will conduct sampling
- location where sample will be taken (such as pre-chill, post-chill)
- when will sample be taken (as per sampling plan)
- how sample will be taken
- how many samples will be taken
- Sample shipping procedures
Describe your shipping procedures:
- identify the person who packages the sample
- location where packaging will be done
- location where are samples kept pending shipment
- identify the person who ships samples
- where are samples shipped for testing
- how are samples shipped (shipping agent)
- how temperature is maintained
- means to tamper-proof and protect the integrity of samples such as how samples are handled/packaged and shipped
- Testing laboratory details
Identify the laboratory that you use to perform your microbiological tests, and the following details:
- for in house testing, describe how your laboratory procedures are maintained. how they are equivalent with an accredited laboratory testing method, how you train your employees to perform testing, and when requested how you will present results to the CFIA
- Analytical procedures
Provide information on thetesting method you use:
- the name and/or identification number of the method used and proof that method used is from the Association of Official Agricultural Chemists (AOAC), Standards Council of Canada (SCC) or from another recognized scientific body
- Corrective action procedures
Describe the corrective action procedures when the PVMP is out of control.
Describe the procedures you take to evaluate the effectiveness of the corrective action procedures.
- Procedures to communicate test results
Describe how you will:
- make laboratory test results available for CFIA verification
- notify and report results to CFIA when the number of positive tests exceeds the "fail" threshold
- Records
Describe the record keeping procedures you use to review and compile test results:
- where are lab reports and worksheets are kept
- how analytical reports will be kept at the establishment for a period of not less than 24 months
- Additional internal control
Describe your additional internal validation, testing, monitoring and verification activities you perform to verify that your process verification criteria is met.
7. Poultry products subject to the Process Verification Monitoring
7.1 General considerations
- Only finished poultry product which has gone through all processing steps including intervention steps will be sampled for the PVMP
- The finished poultry product is to be sampled prior to freezing
- When a raw poultry product is produced over more than 1 shift, it should be randomly sampled over all shifts to ensure even representation
- When raw poultry product is produced over more than 1 line, it should be randomly sampled over all operational lines to ensure even representation
7.2 Product type within scope
Raw poultry carcasses
- Select raw whole carcasses of all poultry species which have intact skin
7.3 Product types out of scope
PVMP does not include in its scope the following products:
- carcass parts
- giblets
- salvage portions
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:
- Sample and test as per table 1, using random sampling methodologies
- Sample throughout the calendar year
- Refer to table 1 for production volume and associated test frequency
- When a new establishment starts operation, you should begin sampling and testing in the first week of operation
- If a sample is missed due to circumstances beyond your control or the laboratory rejects the sample or renders an inconclusive result, take a replacement sample as soon as possible
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:
- assessment of individual results
- trend analysis over the last 13 results
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.
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
- Report results to the minimum sensitivity of the test used. 0 is not be reported as a test result
- Record test results in the order they were sampled
This is useful to determine corrective action when process is out of control.
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:
- inform CFIA
- determine the cause of the failure (root cause analysis)
- determine and implement appropriate corrective action(s) that will:
- address the production step which may cause contamination
- prevent future PVMP failure
- verify effectiveness of corrective actions
- If positive trend continues:
- assess why previous corrective actions were ineffective
- conduct systematic review of your PCP
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.
- Keep records of all test results
- Keep separate PVMP log for each poultry species
- Keep these records for 24 months
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
- Annex – Sampling procedures for generic E. coli in raw poultry
- Pathogen Reduction Monitoring Program for Salmonella and Campylobacter for raw poultry
- Conducting a hazard analysis
- Corrective action procedures for your preventive control plan
- Risk Assessment models
- Evidence showing a control measure is effective
- Microbial controls for meat products and food animals
- Monitoring procedures for your preventive control plan
- Verification procedures for your preventive control plan
- Record keeping for your preventive control plan
- Date modified: