Achieving FSIS HACCP Validation Compliance. March 15 th and 17 th, 2016

Transcription

1 Achieving FSIS HACCP Validation Compliance March 15 th and 17 th, 2016

2 Questions? Please use the Chat function on the upper right hand of your screen. Send your questions to Michelle Rossman and she will address them to the speakers.

3 4/27/2016 Achieving FSIS HACCP Validation Compliance March 15 th and 17 th, 2016 Kerri B. Gehring, Ph.D. President/CEO, International HACCP Alliance Associate Professor, Dept. of Animal Science Texas A&M University Validation is the process of demonstrating that the HACCP system as designed can adequately control potential hazards. Validation of the HACCP system involves validation of the critical control points in the HACCP plan, as well as of any prerequisite programs used to support decisions in the hazard analysis (i.e., prerequisite programs). 1

4 4/27/2016 Basically, validation is showing that the HACCP system can function as intended and that together the CCPs and prerequisite programs are able to prevent or control the identified food safety hazards to ensure that the foods being produced are safe and wholesome. Element 1: Scientific or Technical Support relating to the design of the system. Element 2: Initial In plant Validation Data relating to the execution of the system. The theoretical principles, expert advice from processing authorities, scientific or technical data, peer reviewed journal articles, pathogen modeling programs, or other information demonstrating that particular process control measures can adequately prevent, reduce, or eliminate specific hazards. 2

5 4/27/2016 Published Processing Guidelines including FSIS Guidelines Best Practice Guidelines by Industry Peer reviewed Scientific Data/Information Challenge or Inoculated Pack Study Pathogen Modeling Program Regulatory Performance Standards Closely match the actual process, and Show that the establishment s process will prevent, reduce, or eliminate the hazard identified in the hazard analysis, and Identify the critical operational parameters from the scientific support relevant to the establishment s process. Establishments should use scientific support that relates to the process, product, and hazard identified in the hazard analysis. 3

6 4/27/2016 The scientific support should identify: The hazard (biological, physical, and chemical), The expected level of hazard reduction or prevention to be achieved, All critical operational parameters or conditions necessary, The processing steps that will achieve the specified reduction or prevention, and How these processing steps can be monitored. The food safety hazards addressed in the scientific support should be the same ones as identified in the hazard analysis. This will help ensure that the science supports the decision being made in the HACCP plan. FSIS has stated: That Appendix A for lethality can be used for pathogens other than Salmonella, such as E. coli O157:H7 and Listeria monocytogenes. That interventions validated to control E. coli O157:H7 should be effective in controlling non O157:H7 STECs. That indicator or surrogate organisms may be used if there are sufficient data to demonstrate a relationship between the pathogen or toxin and the indicator or surrogate. 4

7 4/27/2016 Once an establishment finds the appropriate scientific or technical support, then it can be used to set critical operational parameters. Critical operational parameters are the specific conditions that the intervention must operate under in order for it to be effective. (Frequently these become the critical limits for a specific CCP.) Examples of critical operational parameters include: Time Temperature Organic Acid Concentration Relative Humidity Dwell Time ph Contact Time Pressure 5

8 4/27/2016 The critical operational parameters provided in the scientific and technical support should be used to establish the process procedures or critical limits being applied in the establishment. If all of the critical operational parameters are not implemented, then there may be questions related to the in plant efficacy of controlling the food safety hazard. FSIS has stated that establishments should implement: the same parameters, or if it uses different parameters then it should support why those different parameters would be equally effective. FSIS has stated: It is recommended that the establishment incorporate all of the critical operational parameters into the critical limits of the CCP. An establishment may determine that some of the critical operational parameters will be measured on an on going basis as part of a prerequisite program. An establishment may also determine that some critical operational parameters are supported during the initial validation period. 6

9 4/27/2016 Prerequisite programs that are used to support a decision made in the hazard analysis or HACCP plan, such as: Supplier approval program Temperature control program Processing aid application Allergen control program Prerequisite programs designed to support a decision in a hazard analysis are part of the HACCP system and must be validated. For example, if an establishment determines that a food safety hazard is not reasonably likely to occur because of a prerequisite program, then the program should be validate. Only prerequisite programs that are part of the HACCP system must be validated. kbgehring@tamu.edu

10 ESTABLISHING IN PLANT INITIAL VALIDATIONS FOR ACHIEVING FSIS HACCP VALIDATION COMPLIANCE ALEX BRANDT ACHIEVING FSIS HACCP VALIDATION COMPLIANCE WEBINAR MARCH 15, 2016

11 WHO?? 2

12 HACCP AS PER USDA FSIS Meat, Poultry, and Egg Processing Establishments LARGE SMALL VERY SMALL 3

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14 HACCP SYSTEM VALIDATION Under 9 CFR 417.4(a)(1) there are two elements to validation of a HACCP System: DESIGN EXECUTION 5

15 HACCP SYSTEM VALIDATION EXECUTION involves collection of in plant validation data: In plant observations, measurements, microbiological test results, or other information demonstrating the control measures in the HACCP system can perform as expected within a particular establishment to achieve the intended food safety objective. 6

16 HACCP SYSTEM VALIDATION HACCP Plan CCPs are not the only elements that need validation. Also need to provide validation for: Interventions during slaughter RTE post lethality controls Pre requisite programs designed to prevent a hazard from being RLTO Product formulations Cooking instructions This data must be retained for the life of the HACCP Plan. 7

17 WHY?? 8

18 FSIS NOTICE (12/17/15) 9

19 FSIS NOTICE (12/17/15) FSIS has determined from its verification activities that many establishments have not properly validated their food safety systems. Some establishments have not collected the necessary in plant validation data demonstrating that the HACCP system is functioning as intended. 10

20 FSIS NOTICE (12/17/15) More specifically, FSIS has found that establishments have not done the following for their HACCP Plans: Proper System Design: Have not identified scientific support that properly relates to the establishments current processes. Have not identified the critical operating parameters in the scientific support necessary for the intervention to function as intended. Proper System Execution: Have not translated those critical operating parameters into their HACCP systems. Have not documented that they have validated their HACCP systems under actual in plant conditions. 11

21 WHEN?? 12

22 DEADLINES As of 01/04/16, FSIS has already begun issuing NRs for large establishments if it is discovered that they lack in plant validation data when FSIS personnel perform an HAV. Beginning on 04/04/16, FSIS will begin issuing NRs for small and very small establishments if it is discovered that they lack in plant validation data when FSIS personnel perform an HAV. After hazard analysis is conducted and HACCP plan has been developed, establishments are issued a conditional grant of inspection for up to 90 days during which they must complete initial validation as required in 9 CFR 304.3(b) and (b). 13

23 DEADLINES Likewise, establishments producing a new product must complete the initial validation within 90 days after the new product is produced for distribution into commerce. Also, if a HACCP plan must be modified (i.e. the results of a reassessment indicate that new in plant validation data should be collected), the establishment would again have 90 days to perform the initial validation. 14

24 DEADLINES 90 DAYS MEANS 90 CALENDAR DAYS FSIS realizes that for large establishments, 90 CALENDAR DAYS equates to roughly 60 production days. Likewise, FSIS realizes that for small and very small establishments, 90 CALENDAR DAYS equates to a minimum level of records from 13 production days. 15

25 HOW?? 16

26 GATHERING IN PLANT VALIDATION DATA 17

27 GATHERING IN PLANT VALIDATION DATA GENERAL DATA COLLECTION GUIDELINES: Establishments should maintain scientific support for ALL processes and products, but for in plant data collection: Are only required to identify at least one product from each HACCP category to gather in plant validation data. Typically a worst case scenario product within that category. Potential factors to consider: Species, processes, intrinsic factors, product public health risk, food safety hazards, fat content, size and shape of the food, number and type of processing steps or ingredients May consider collecting data for more than one product from a HACCP category; for instance RTE whole turkey breast and hot dogs. 18

28 GATHERING IN PLANT VALIDATION DATA GENERAL DATA COLLECTION GUIDELINES: Need to implement critical operational parameters in the actual production process consistent with the parameters in the scientific or technical support from DESIGN. Collect the in plant validation data to demonstrate the effectiveness of the implementation of the critical operational parameters. Analyze the data to determine whether the critical operational parameters are being implemented effectively. 19

29 TWO SCENARIOS: GATHERING IN PLANT VALIDATION DATA SCENARIO 1: The plant is implementing a process that is CONSISTENT WITH the critical operational parameters described in the scientific support, and the scientific support used contains microbiological data specifying the level of pathogen reduction achieved by the intervention strategy for the target pathogen identified in the hazard analysis SCENARIO 2: The establishment s process is NOT IMPLEMENTED in a manner that is CONSISTENT WITH the critical operational parameters described in the scientific support without justification, or the scientific support used DOES NOT CONTAIN MICROBIOLOGICAL DATA specifying the level of pathogen reduction achieved by the intervention strategy for the target pathogen identified in the hazard analysis. 20

30 SCENARIO 1 In SCENARIO 1, the establishment needs to: Identify the critical operating parameters in the scientific support. Implement those critical operational parameters in the establishment s production process CONSISTENT WITH the scientific support. Collect in plant data that demonstrates that the critical operating parameters are being met. This data will consist of quantifiable characteristics of the critical operational parameters, such as pressure, temperature and concentration. 21

31 SCENARIO 1 SCENARIO 1 TOOLS Timers Chemical Titration Kits ph Meter Pressure Gauges Temperature Probes Visual Observation 22

32 SCENARIO 1 SCENARIO 1 EXAMPLE: 23

33 SCENARIO 1 SCENARIO 1 EXAMPLE: 24

34 SCENARIO 1 SCENARIO 1 EXAMPLE: 25

35 SCENARIO 1 SCENARIO 1 EXAMPLE: 26

36 SCENARIO 1 SCENARIO 1 EXAMPLE: 27

37 SCENARIO 2 In SCENARIO 2, the establishment needs to: Identify the critical operating parameters in the actual process (either because they were modified from the scientific support without justification or the scientific support does not contain microbiological data. Collect in plant MICROBIOLOGICAL DATA that demonstrates the intervention s effectiveness under the actual in plant conditions or identify scientific support with microbiological data demonstrating the effectiveness of those critical operational parameters. Collect in plant data that demonstrates that the modified critical operating parameters are being met. MUST DO BOTH!! 28

38 SCENARIO 2 SCENARIO 2 TOOLS: Same as above for Scenario 1 Include microbiological sampling and testing 29

39 SCENARIO 2 EXAMPLE: SCENARIO 2 Poultry product further processor wants to use a new buffered sulfuric acid antimicrobial as intervention for blended raw poultry meat used as raw material for further processed products via a spray bar system prior to the meat being placed into a tumbler. No microbiological data is previously available in the literature or from the manufacturer for this matrix under these application conditions. Need to look at critical parameters: concentration, ph, application rate, contact time in blender. Need to collect data on the critical parameters for 90 days. Also need to collect microbiological data on the process for 90 days. Look at pre and post intervention microbiological levels. Can look at indicator organisms (APC, EB) for quantitative results, but may also look at Salmonella from a quantitative and semi quantitative standpoint (MPNs). Indicators may not always be the best measure. 30

40 SCENARIO 2 SCENARIO 2 EXAMPLE: 31

41 SCENARIO 2 SCENARIO 2 EXAMPLE: 32

42 THANKS!! 33

43 Questions? Please use the Chat function on the upper right hand of your screen. Send your questions to Michelle Rossman and she will address them to the speakers.