Annex Y: Guidance for Operators Submitting Protocols to the CFIA and for the Veterinarian in Charge (VIC) for Evaluating Protocols Submitted by Operators for CFIA Acceptance

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  1. Ensure that the applicable product(s) are covered by the revised US moisture retention requirements (see Annex Y-1). The explanatory information for their moisture retention requirements on the FSIS website.

    FSIS Directive 6700.1 (2002/11/27) indicates the following:

    1. The following are examples of post-evisceration processes involving the use of water that would subject products to the requirements of 9 CFR 441.10 (Retained Water):
      1. Post-evisceration washing of livestock and poultry carcasses with hot water, cold water, or an antimicrobial, including on-line reprocessing systems.
      2. Livestock carcass spray chilling with or without an antimicrobial.
      3. Water or ice chilling of poultry carcasses or giblets with or without an antimicrobial.
      4. Water or ice chilling with or without an antimicrobial used to remove heat from parts: hearts, kidneys, livers, tongues, cheeks, salivary glands, spleens, pancreases, ears, tails, or head meat trimmings, including head meat, cheek meat, or tongue
      5. Post chill spraying of meat and poultry carcasses or parts, with water or an antimicrobial solution.
      6. Spraying by-products (e.g. hearts, livers, tongues, cheeks, salivary glands, spleens, pancreases, chitterlings, stomachs, ears, and tails) with an antimicrobial after they have been converted from their natural state to an edible state (e.g., after the lining has been removed from tripe, and the tripe has been cleaned).
      7. Spraying bones with an antimicrobial used for advanced meat recovery systems or for mechanical deboning.
      8. Spraying meat trimmings, including head meat, cheek meat, or tongue meat, with an antimicrobial solution.
    2. The following are examples of post-evisceration processes involving the use of water that would not subject products to 9 CFR 441.10.
      1. Flushing stomachs, small intestines, large intestines, rectum, braided marrow gut, and chitterlings to remove digestive tract contents.
      2. Scalding of pork stomachs, pork tongues, and beef lips, intestines, and stomachs.
      3. Flushing the gizzard with water to remove digestive tract contents.
      4. Washing with water to remove excess blood, e.g., washing hearts, livers, brains, and tendons.
      5. Washing beef heads with water.

      Note: On a case-by-case basis, the Inspector-in-Charge, in consultation with his or her supervisor and the Technical Service Center, will evaluate other post-evisceration processes involving the use of water to determine whether the resulting products are subject to 9 CFR 441.10.

  2. Ensure that all elements required by the US regulations have been included in the proposed protocol (complete the checklist issued by the USDA for this purpose and as contained in Attachment 1)
  3. Contents of the proposed protocol. Compare to the example protocols as developed by the USDA and as included in Attachment 2 (steer/heifer) and 3 (young chicken).
  4. Variable factors. For red meat and poultry, if no moisture retention occurs, then only one test, comprised of the standard procedure, is required. If moisture retention occurs, e.g. cheek meat or poultry carcasses chilled by immersion in water, then refer to the example protocols developed by the USDA and as included in Attachment  2 (steer/heifer) and 3 (young chicken).
  5. Testing methodology - sample size. For red meat, accept if the total number of carcasses (divided into several groups as specified in the example protocol) is equal to or greater than that specified in section 4.10.1(4)(c), Chapter 4, of this manual. For poultry, accept if the total number of carcasses (divided up into several groups as specified in the example protocol) is equal to or greater than 50 carcasses as specified in section 19.8.3.3, chapter 19, of the Meat Hygiene Manual of Procedures (MOP).
  6. Pathogen reduction measurement. USDA has informed CFIA verbally that US industry is not performing Salmonella testing as part of validating proposed protocol(s). Rather, USDA continues to collect sample carcasses for Salmonella testing as per their standard procedure. Suggest that after all the tests have been completed (one for each combination of factors), that a series of 51 sample carcasses be tested for Salmonella with the chilling system operating according to the revised chilling procedure as based on the variable factors corresponding to the lowest level of moisture retention.
  7. The protocol should be copied to your Area Red Meat Program or Poultry Inspection Program Specialist for their input if the Veterinarian in Charge has any questions concerning the adequacy of the proposed protocol or if the level of moisture retention is above 0% for the product.
  8. The Veterinarian in Charge (or the Area Program specialist if the level of moisture retention is above 0%) should Issue an official letter on behalf of CFIA indicating objection or no objection to the proposed protocol (refer to the templates developed by USDA and as amended for use by the CFIA and included in Attachments 4 (no objection) and 5 (objection).

Guidance for Operators Validating Protocols Accepted by the CFIA and for the Veterinarian in Charge (VIC) for Determining If Moisture Retention has been Minimized Consistent With and Food Safety Requirements

  1. Parameters. Ensure that each set of variable factors is tested according to the procedures contained in the protocol accepted by the CFIA.
  2. Observations, records. Critical operating parameters of the chilling system should be documented as indicated in the CFIA accepted protocol for each test; e.g. sampling time and location, "green" and final weight for each sample carcass, transit/chilling time, air or water temperature, revolutions per minute for paddle chillers, cycle time and spraying time for spray chilling systems, surface and/or internal temperature of carcasses, etc.
  3. Minimizing moisture retention. Confirm that there is zero net moisture absorption and retention ("green" weight after evisceration but before contact with water post evisceration compared to product final weight as packaged). If not, copy the protocol to the Area Program Specialist for their assessment if the moisture retention has been minimized.

    The operator may appeal decisions by the area program specialist to the applicable program chief at CFIA headquarters.

  4. CFIA oversight during experimentation as described in the CFIA accepted protocol. Activities should include review and analysis of data and observation of processes (minimum bi-weekly) carried out by the operator as part of the experimentation. These activities will be performed at the discretion of the Veterinarian in Charge using a checklist designed to verify that the protocols are being followed (copy included in Attachment 6).
  5. Food safety. Compliance with the US Pathogen Reduction/Hazard Analysis and Critical Control Points (PR/HACCP) requirements should be considered as satisfying food safety requirements. Salmonella and E. coli samples should be collected during operations consistent with variables corresponding to the lowest moisture retention. Test results should be assessed for compliance with the PR/HACCP requirements as listed in Annex Q of the US section of chapter 11 of this manual.
  6. Labelling. Examples of acceptable labels for exported raw single ingredient meat (including poultry) products are posted at the USDA website.

    Labels may be accepted by the Veterinarian in Charge. The Veterinarian in Charge should continue to refer labels to the area program specialist(s) for advice and/or a decision as appropriate.

Attachment 1

Proposed Moisture Retention Protocol
Elements Checklist

  1. Purpose statement: The primary purpose of the protocol should be clearly and succinctly stated.
  2. Type of washing and chilling system used should be carefully described.
  3. Configuration and any modifications of the chiller system components, including the number and type of chillers in a series and arrangements of the chilling system components, and the number of evisceration lines feeding into a chiller system, should be carefully described.
  4. Special features in the chilling process should be described, including antimicrobial treatments, length and speed of the dripping line.
  5. Variable factors that affect water absorption and retention, such as time in the chiller water, water temperature, agitation, and other factors, must be described.
  6. Standards to be met by the chilling system must be described.
  7. Testing methods used, both for measuring water absorption and retention and for sampling and testing product for pathogen reductions at various chilling equipment settings and chilling time-and-temperature combinations, should be described. The number of samples, type of samples, sampling time period, and type of testing or measurement should be included.
  8. The protocol should explain how data obtained are to be reported and summarized. The criteria for evaluating the results and the basis for conclusions to be drawn should be explained.
  9. Conclusions. The protocol should provide for a statement of what the data obtained demonstrated and what conclusions were reached.

Attachment 2

Protocol for Evaluating Retained Water
in the Following Single Ingredient Red Meat Product:
Steer/Heifer Carcasses

Note:
The following is an example protocol and should not to be used verbatim. Because each establishment is unique, each establishment should design their protocol to reflect the individual characteristics of their operations.

1.0 Purpose Statement

1.1 The purpose of this protocol is to determine the amount of water absorption and retention in steer/heifer carcasses that is unavoidable while achieving the regulatory pathogen reduction performance standard for Salmonella (as set forth in the PR/HACCP) regulations - 9 CFR 310.25(b).

2.0 Type of washing and chilling system

2.1 The facility slaughter/dressing line utilizes a final carcass washer at the end of the dressing procedures. This is followed by a carcass rinses that includes the antimicrobial intervention (*insert example) prior to entry into the carcass cooler. The carcass cooler is maintained around 34°F.

3.0 Configuration and modification of the chiller system components

3.1 The establishment uses a carcass water spray system in the carcass cooler to chill carcasses rapidly. The carcass water spray system consists of intermittent sprays of water during the carcass cooling process.

4.0 Special features in the chilling process:

4.1 Chlorine is added to the carcass water spray as an antimicrobial intervention at 20-50 ppm. The carcasses freely drain before exiting the carcass cooler and prior to further processing in the establishment or prior to shipping.

5.0 Variable factors that affect water absorption and retention

5.1 The final carcass wash cabinet consists of a number of spray nozzles at a selected pressure at selected spray directions by the establishment. The final carcass wash water is the normal ambient water temperature from the municipality or of the well water. The number and size of spray nozzles, direction of nozzles, water pressure, and the length of time in the final wash cabinet may be changed depending upon the size of the carcasses, season of the year, and changes in the dressing procedures. The carcasses are in the chiller system (cooler) usually from 18 to 24 hours. The carcass cooler temperature is usually maintained around 34°F. The temperature of the water in the carcass water spray is the normal ambient water temperature from the municipality or of the well water. The frequency and length of intermittent sprays of water per bay during the carcass cooling, the carcass cooler temperature and the drain time from the last spray prior to exiting the cooler may be varied.

6.0 Standards to be met by the chilling system:

6.1 The current FSIS Salmonella pathogen reduction performance standards, as set forth in the PR/HACCP final rule, will be met.

7.0 Testing methodology

7.1 Water absorption and retention.

7.1.1 Samples will be collected immediately prior to the final carcass wash on the slaughter/dressing line to determine the "green" weight of the carcasses.

7.1.1.1. *(insert number) random carcasses will be tagged and weighed in *(insert number) groups of *(insert number) carcasses. The *(insert number) groups will be distributed evenly throughout the production period (beginning, middle, and end) with the production period being defined as sanitation to sanitation.

7.1.2 Samples will be collected from carcasses at point exiting the cooler.

7.1.2.1 The tagged carcasses from 7.1.1.1 will be weighed immediately prior to further processing or shipping.

7.1.2.2 These post-cooler weights will be compared to the pre-final carcass wash weights to determine the retained water gained using a mathematical difference calculation (cooler exit weight minus "green" weight [pre-final carcass wash weight]) as a percentage.

7.2 Pathogen reduction measurement.

7.2.1 *(insert number) groups of *(insert number) carcasses will be randomly selected post-cooler from the same lots as those tested in Section 7.1. The *(insert number) groups will be distributed evenly throughout the production period (beginning, middle, and end) with the production period being defined as sanitation to sanitation.

7.2.1.1 The percent Salmonella positive rate will be determined using the post-cooler carcass swabs Salmonella performance standard methodology.

7.3 Evaluation of cooler factors

7.3.1 The frequency and length of intermittent carcass sprays per cooler bay.

7.3.1.1 Three frequency and length of sprays will be evaluated.

7.3.1.1.1 Fifteen minute interval: Spray for 1 minute, spray off for 14 minutes.

7.3.1.1.2 Thirty minute interval: spray for 3 minutes, spray off for 27 minutes.

7.3.1.1.3 Sixty minute interval: spray for 3 minutes, spray off for 57 minutes.

7.3.2 The carcass cooler temperature will remain around 34°F.

7.3.3 The drain time from the last carcass spray until exit.

7.3.3.1 Two drain times will be evaluated.

7.3.3.1.1 Four (4) hours after last spray.

7.3.3.1.2 Six (6) hours after last spray.

7.3.4 Study design.

7.3.4.1 A three-by-two factorial table will be used to evaluate the effect of these cooler factor settings on the percent moisture retention (Section 7.1) and on the pathogen reduction measurements (Section 7.2).

7.3.4.2 Each of the six cooler setting combinations will be evaluated for three processing periods (defined as sanitation to sanitation). Each processing period will be considered a replicate.

8.0 Evaluation and Reporting of Data

8.1 The results achieved from the three replicates per cooler setting combination will be averaged and reported as the final result for each cooler setting combination.

8.1.1 Carcass weight differences will be determined using a mathematical difference calculation (cooler exit weight minus "green" weight) for each carcass group resulting in recorded weight difference results. The weight difference obtained per carcass group will be divided by the "green" weight per carcass group to determine the % moisture retention cooler exit per group. The results will be averaged to obtain the estimated average % moisture retention at point of cooler exit.

8.1.2 The Salmonella data will be reported as the number of positive samples/number of samples tested × 100 (% positive).

9.0 Explanation of how the conclusions will be determined.

9.1 Conclusions will be determined by comparing the baseline pathogen reduction levels achieved pre-protocol implementation with the post-protocol implementation pathogen reduction results. This comparison will be evaluated according to the specifications detailed in section 6.1.

9.2 The amount of moisture retention that is unavoidable to achieve the above food safety criteria will be reported.

(*) Each establishment should insert statistically significant and verifiable information that reflects their unique operations.

Attachment 3

Protocol for Evaluating Retained Water
in the Following Single Ingredient Poultry Product:
Young Chicken Carcasses

Note:
The following is an example protocol and should not to be used verbatim. Because each establishment is unique, each establishment should design their protocol to reflect the individual characteristics of their operations.

1.0 Purpose Statement

1.1 The purpose of this protocol is to determine the amount of water absorption and retention in young chicken carcasses that is unavoidable while achieving the regulatory pathogen reduction performance standard for Salmonella (as set forth in the PR/HACCP regulations - 9 CFR 381.94(b) and the time/temperature requirements set forth in 9 CFR 381.66.

2.0 Type of washing and chilling system

2.1 The facility evisceration lines utilize a series of two pre-chiller external sprays, one inside-outside bird washer, immediately followed by the trisodium phosphate antimicrobial system. This is followed by a 60 second drip period prior to entering the cold-water chiller. The chiller is a Stork Gamco model RS-6 which uses a drag-through type mechanism to transport the birds through the chiller. It has a prechiller section which receives water from the main body of the chiller. Chilled water from the fresh and recirculated sources is added.

3.0 Configuration and modification of the chiller system components

3.1 The prechiller length is 50 feet with a dwell time of 20 minutes. The main chiller length is 100 feet with a dwell time of 45 minutes. The number of evisceration lines feeding into the chiller system is 2.

4.0 Special features in the chilling process:

4.1 The chiller uses chlorine as an antimicrobial at 20 ppm. After exiting the chiller system the birds are placed on a drip line that is 100 feet in length and drains the whole carcasses for 5 minutes before reaching whole carcass packaging.

5.0 Variable factors that affect water absorption and retention

5.1 The scalding temperature used is approximately 138°F. The birds are in the chiller system for 65 minutes. The water temperature of the pre-chiller is 65°F. The water temperature in the main chiller is 36°F. The chiller uses air type agitation.

6.0 Standards to be met by the chilling system:

6.1 The current FSIS Salmonella pathogen reduction performance standards, as set forth in the PR/HACCP final rule, will be met.

7.0 Testing methodology

7.1 Water absorption and retention.

7.1.1 Samples will be collected immediately prior to the two pre-chiller rinses on the evisceration line.

7.1.1.1 *(insert number) random A-grade carcasses will be tagged and weighed in *(insert number) groups of *(insert number) carcasses. The *(insert number) groups will be distributed evenly throughout the production period (beginning, middle, and end) with the production period being defined as sanitation to sanitation.

7.1.2 Samples will be collected from carcasses at point of packaging.

7.1.2.1 The tagged carcasses from 7.1.1.1 will be weighed immediately prior to packaging.

7.1.2.2 These post-chiller weights will be compared to the pre-chiller weights to determine the retained water gained using a mathematical difference calculation (pre-packaging weight minus pre-chiller weight) as a percentage.

7.2 Pathogen reduction measurement

7.2.1 *(insert number) groups of *(insert number) carcasses will be randomly selected post-chiller from the same flocks as those tested in Section 7.1. The *(insert number) groups will be distributed evenly throughout the production period (beginning, middle, and end) with the production period being defined as sanitation to sanitation.

7.2.1.1 The percent Salmonella positive rate will be determined using the post-chiller carcass rinse Salmonella performance standard methodology.

7.3 Evaluation of chiller factors.

7.3.1 Water temperature.

7.3.1.1 Two chiller settings will be evaluated.

7.3.1.1.1 Temperature setting of 36°F.

7.3.1.1.2 Temperature setting of 39°F.

7.3.2 Air agitation.

7.3.2.1 Two chiller settings will be evaluated.

7.3.2.1.1 Air agitation setting of 80 rpm.

7.3.2.1.2 Air agitation setting of 40 rpm.

7.3.3 Study design.

7.3.3.1 A two-by-two factorial table will be used to evaluate the effect of these chiller settings on the percent moisture retention (Section 7.1) and on the pathogen reduction measurements (Section 7.2).

7.3.3.2 Each of the four chiller setting combinations will be evaluated for three processing periods (defined as sanitation to sanitation). Each processing period will be considered a replicate.

8.0 Evaluation and Reporting of Data

8.1 The results achieved from the three replicates per chiller setting combination will be averaged and reported as the final result for each chiller setting combination.

8.1.1 Carcass weight differences will be determined using a mathematical difference calculation (pre-packaging weight minus pre-chiller weight) for each carcass group resulting in recorded weight difference results. The weight difference obtained per carcass group will be divided by the pre-chiller wash weight per carcass group to determine the % moisture retention pre-packaging per group. The results will be averaged to obtain the estimated average % moisture retention at point of packaging.

8.1.2 The Salmonella data will be reported as the number of positive samples/number of samples tested x 100 (% positive).

9.0 Explanation of how the conclusions will be determined

9.1 Conclusions will be determined by comparing the baseline pathogen reduction levels achieved pre-protocol implementation with the post-protocol implementation pathogen reduction results. This comparison will be evaluated according to the specifications detailed in section 6.1.

9.2 The amount of moisture retention that is unavoidable to achieve the above food safety criteria will be reported.

(*) Each establishment should insert statistically significant and verifiable information that reflects their unique operations.

Attachment 4

Sample No Objection Letter

Mr. John Doe
Quality Assurance Manager
Generic Establishment
Anywhere Lane
Anywhere City, Province, Postal Code

Dear Mr. Doe:

I have received and reviewed your written protocol determining the amount of water absorption and retention that is an unavoidable consequence of your process used to meet food safety requirements.

Based on the information and data submitted, I have no objection to the written protocol. Please be advised that this protocol must be maintained on file and available to the Canadian Food Inspection Agency (CFIA). Any revisions to this protocol must be submitted to this office for review.

Sincerely,

VIC
Generic Establishment
Anywhere Lane
Anywhere City, Province 00000

cc:
Area Program Specialist
Inspection Manager

Attachment 5

Sample Objection Letter

Mr. John Doe
Quality Assurance Manager
Generic Establishment
Anywhere Lane
Anywhere City, State 00000

Dear Mr. Doe:

I have received and reviewed your written protocol determining the amount of water absorption and retention that is an unavoidable consequence of your process used to meet food safety requirements.

Based on the information and data submitted, the following checked items have not been included and must be submitted with a revised protocol:

  1. space Purpose statement.
  2. space Type of washing and chilling system used.
  3. space Configuration and any modifications of the chiller system components.
  4. space Special features in the chilling process.
  5. space Description of variable factors in the chilling system.
  6. space Standards to be met by the chilling system.
  7. space Testing methods to be employed.
  8. space Reporting of data and evaluation of results. Should explain how data obtained are to be reported and summarized. The criteria for evaluating the results and the basis for conclusions to be drawn should be explained.
  9. space Conclusions. The protocol should provide for a statement of what the data obtained demonstrated and what conclusions were reached.

If you have any further questions, please contact me.

Sincerely,

VIC
Generic Establishment
Anywhere Lane
Anywhere City, province 000000

cc:
Area Program Specialist
Inspection Manager

Attachment 6

Retained Moisture Checklist for VICs

Establishment Name:

Establishment Number:

  1. Product covered by the establishment's protocol: space.
  2. Date of CFIA no-objection letter that applies to the protocol: space.
  3. Indicate where product sampling occurs during the sampling and analysis to determine post-evisceration and retained water: space.
  4. Date of bi-weekly check to verify that establishment is following the protocol: space.
  5. At the end of the experimentation period:
    1. Retained moisture for the product described in 1. above: space.
    2. Check to indicate that you have examined all labels relating to the product described in 1. above: space.
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