Chapter 4 - Annex I

---

Risk-based Verification Sampling of Ready-to-Eat (RTE) Meat and Poultry Products

1. Introduction and scope

The following sampling plan must be implemented by operators who produce ready-to-eat (RTE) meat and poultry products that are exposed to the environment after processing.

The implementation date for this sampling plan was April 1, 2009.

2. Classification of establishments

Establishments producing RTE meat and poultry products are classified according to the risk category of products produced (1, 2A or 2B) and the Relative Risk Level (RRL) under which these products are produced (Annex H, section 3.3). The RRL of L. monocytogenes is determined according to the following factors, as applicable:

1. Risk Category of the RTE meat and poultry product
2. Antimicrobial agents/processes, and
3. Post-lethality procedures

3. Frequency of testing

The testing frequency increases as the level of associated food safety risk increases. The testing frequency of an establishment is based on the risk category of RTE products (1, 2A or 2B) and the RRL under which these products are produced (Very low to High). For an establishment producing more than one category of RTE products under different RRLs, the establishment's sampling frequency will default to the RRL under which the highest risk category product(s) is produced. The following product sampling frequencies should be followed:

Product sampling frequency based on RRL

Risk Category of RTE product(s)	Antimicrobial agent*	Post-lethality treatment: None	Post-lethality treatment: Yes
Category 1	None	12 samples per year	9 samples per year
Category 1	Yes	9 samples per year	6 samples per year
Category 2A	None	6 samples per year	4 samples per year
Category 2A	Yes	4 samples per year	3 samples per year
Category 2B	NA	3 samples per year	1 sample per year

*Antimicrobial agent allows no more than 2 log CFU/g increase in L. monocytogenes throughout the stated shelf-life of the product; NA: Not applicable

4. Sample collection

The operator is responsible for the sample collection process that includes the following steps:

4.1. Training of the designated employee(s) who will work with the sampling plan in order to meet the sampling plan's objectives and specifications.

4.2. Collecting samples in the post-processing RTE area of the establishment according to Appendix B. This must be done under direct CFIA supervision.

4.3. Operators shall prepare and have a written sampling program for risk-based testing of RTE products that covers sample collection, preparation and shipping procedures. It shall also cover means to ensure tamper-evidence, to protect the integrity of samples and to maintain the chain of custody (e.g., how samples are handled, packaged and shipped).

Samples must be appropriately sealed under CFIA supervision (tamper evident).

The shipping procedures shall specify:

• who packages the samples and where the packaging is done;
• where samples are kept pending shipment;
• who ships the samples; and
• where samples are shipped (laboratory) and how samples are shipped (shipping agent).

The general guideline for the sample collection, shipping and integrity protection is provided in Appendix B.

4.4 The VIC/IIC (Veterinarian/Inspector-in-Charge) will review and approve the establishment's written program. The VIC/IIC will verify the sampling activities and will complete the appropriate inspection tasks as per the Compliance Verification System (CVS).

It is recommended to hold the sampled "lot" pending laboratory result.

5. Target Pathogens

The samples will be analysed for L. monocytogenes and Salmonella spp. If the product is an uncooked dry or semi-dry fermented sausage and contains beef, it will also be analysed for E. coli O157:H7.

6. Methods of analysis

For each sample, five 25 g test portions/samples for a total of 125 g sample size for Category 1 product, and five 10 g test portions/samples for a total of 50 g sample size for Category 2 product, as defined by Health Canada's "Policy on L. monocytogenes in Ready-to-Eat Foods" (2010), will be analysed for L. monocytogenes; and five 65 g test portions/samples for a total of 325 g sample size will be analysed for Salmonella spp. The analysis for E. coli O157:H7, when required, will be conducted on five 65 g test portions/samples for a total of 325 g sample size.

The following analytical methods are to be used:

• L. monocytogenes

  The Compendium methods MFHPB-30 and MFLP-28. Alternate methods*: the FSIS MLG 8.07 and 8A.04.

• Salmonella spp.

  The Compendium methods MFHPB-20 and MFLP-29. Alternate methods*: the FSIS MLG 4.05 and 4C.03.

• E. coli O157:H7 and O157:NM (Nonmotile)

  The Compendium methods MFLP-80 and MFLP-30. Alternate methods*: the FSIS MLG 5.05 and 5A.02.

*Note: Alternate methods will be considered exclusively for products to be exported to the USA.

The samples must be analysed in a laboratory accredited by the Standards Council of Canada (SCC) and the required methods must be included in the laboratory scope of accreditation. The operator must therefore ensure that the methods used, which are not yet in the scope of accreditation, are included in the scope for the next SCC audit.

Approved methods can be found in the Health Canada Compendium of Analytical Methods at the following site, but the "application" section must be appropriate for the intended purpose.

7. Laboratory reports

• The laboratory report must clearly indicate the common name of the product tested as well as the date on which the sample was collected by the operator.
• The laboratory report must be sent simultaneously to both the operator and the CFIA's National Micro Sampling Plans Unit in Ottawa at the following address:

  National Micro Sampling Plans
  Floor 4, Room 250
  1400 Merivale Road, Tower 2
  Ottawa, (ON), K1A 0Y9
  or fax: (613) 773-5957
  or email: RTE-PAM@inspection.gc.ca

• The operator must also advise the IIC upon reception of the laboratory analysis.

Please note that if, for whatever reason, the laboratory is unable to analyse and make an evaluation of the sample submitted for analysis, a replacement sample must be sent as soon as possible.

8. Follow-up on positive results

When pathogens are detected in a sample, the sampled lot is considered contaminated (adulterated) and following measures must be taken:

8.1. The contaminated lot must remain under the operator's control.

8.2. The IIC will issue a Corrective Action Request (CAR) that requires the operator to submit an action plan to the IIC within five working days of the notification of an unsatisfactory test result. The action plan must meet all requirements of an acceptable action plan as stated in Chapter 18 of the Meat Hygiene Manual of Procedures. The action plan must clearly state which subsequent production lots will be tested for the pathogen to verify the effectiveness of the corrective actions and preventative measures.

Please refer to the Meat Hygiene Manual of Procedures (MOP Chapter 18) for additional information on specific follow-ups.

8.3. The CFIA notification procedures must be clearly outlined in the written sampling program (e.g., who in the company will notify the VIC/IIC when the analysis is completed and the result is unsatisfactory, e.g., Listeria monocytogenes was detected in a sample).

8.4. In the unlikely event that the sampled lot was distributed before the positive result was received or if it is determined that there are other products in distribution that are implicated by the positive result, the CFIA will immediately notify the OFSR (Office of Food Safety and Recall). If any of the involved product was exported, the regulatory authority of concerned countries would also be immediately notified (e.g.: FSIS {Food Safety and Inspection Service} would be informed and provided with the distribution details if the products had been exported to the USA).

8.5. For RTE meat and poultry products, zero tolerance applies for tested pathogens, including Listeria monocytogenes, in products that support its growth (Category 1). Importing countries may have different requirements; refer to MOP Chapter 11 for country specific requirements.

9. Record keeping

All laboratory reports should be kept for at least one year after the end of the sampled product's shelf life.

Other records should be kept as per the operator's HACCP plan.

---

Appendix A

The following list must be used when two or more products are produced on the day of testing.

The highest risk post-lethality exposed RTE product produced at the time of collection must be sampled. The products are listed in decreasing order of risk (sliced deli meats being the highest risk):

1. Deli meats that are sliced in the federal registered establishment
2. Deli meats shipped whole from the federal establishment. (This does not include cook-in-bag products; only those exposed post-lethality.)
3. Hotdog products
4. Deli salads, pâtés, and meat spreads
5. Fully cooked type products (other than cooked products in 1-4 above)
6. Fermented products
7. Dried products
8. Salt-cured products
9. Products labelled as "Keep Frozen"

Note: All these products will be considered as Category 1 products if they don't meet the physico-chemical and other relevant processing parameters of Categories 2A or 2B products as per section 3.0 of Annex H. Any deviation in the key processing parameter must be corrected and verified to confirm compliance and classification of product(s) into Category 2A or 2B.

---

Appendix B

The following general guidelines should be followed for sample collection and shipping procedure, and for the maintenance of the integrity of samples:

1. Sample collection must be carried out on the RTE finished products that were post-lethality exposed.
2. Sample collection will be carried out by the individual who is designated in the establishment's written protocol and has received the required training. Sampling supplies, such as sterile gloves, sterile sampling solutions, hand soap, sanitizing solution, etc., as well as specific materials needed for sampling, will need to be assembled prior to beginning sample collection.
3. A sample consisting of five sample units shall be drawn at random from each lot selected for sampling. Each sample unit shall consist of 250 g or five intact units weighing at least a total of 1250 g. Do not sample the same lot for M200 or M200RB (managed by the CFIA) and Risk-based (managed by industry) programs.
4. Unopened, original containers shall be sampled, when possible.
5. If the product is in bulk, several sample units can be collected from one container, while ensuring that the total number of sample units is not collected from one container. More than one sample unit may also be collected from large institutional or bulk containers when the total number of sample units required exceeds the number of containers in the lot. The collected sample units shall be placed in sterile containers. A sample unit will consist of more than one container when the lot consists of containers smaller than 150 g (e.g., six - 25 g containers in each sample unit).
6. Aseptic techniques shall be employed in collecting the sample units.
7. The sample must be properly identified. This includes the name of the product, the production date or code, and the lot of production it represents (in the event that the laboratory result should be unsatisfactory). The production lot must be identified and approved according to CFIA policy (Please refer to the glossary for lot definition).
8. Depending on the nature of the product, the sample units must either be kept refrigerated (0-4°C) or frozen at all times. The temperature of refrigerated samples must not exceed 7°C upon its arrival at the laboratory.
9. The operators must have a written procedure explaining how they ensure that samples are protected from temperature abuse during sampling, storage and transportation to the laboratory, as well as from potential tampering.
10. Samples must be sent to a laboratory accredited to perform the analysis by the methods considered acceptable.

---

Next page: Annex K | Previous page: Annex H