Workshop Overview 4/8/14. Linda J. Harris University of California, Davis. April 4, 2014

Transcription

1 Linda J. Harris University of California, Davis April 4, 2014 Workshop Overview High level coverage of validation For the pistachio industry Introduction Where to start? Hazard analysis Pathogen of concern Target level of inactivation Laboratory studies vs in-plant validation Most resistant pathogen vs surrogate organisms Defining: critical limits and operational parameters Facility sanitation programs and environmental monitoring 1

2 Current FDA validation review FDA s review of validation results of nut treatments has been limited to: Labeling a product as pasteurized Reconditioning of nuts involved in a reportable (RFR) event Food Safety Modernization Act Proposed Rule: Preventive Controls for Human Food Hazard analysis and risk-based preventive controls Food Safety Plan - Evaluate food safety hazards - Identify and implement preventive controls - Monitor controls - Maintain monitoring records - Conduct verification activities - Includes validation 2

3 Preventive Controls Rule Proposed Rule published in January 2013 (comment period ended November 22, 2013) December 19, 2013 FDA announced publishing proposed revised language for Produce Safety Rule summer 2014 with additional time for comment Water, manure, withdrawing of qualified exemption Certain provisions affecting mixed-use facilities Final Rule and Compliance Litigation by Center for Food Safety February 20, 2014 Consent Decree outlining dates for final rule Preventive Controls for Human Food Final Rule Preventive Controls for Animal Food Final Rule August 30, 2015 Effective dates: 60 days after publication (10/30/15) Proposed compliance dates: Very small businesses (3 years 10/30/18) Small businesses (2 years 10/30/17) All other (1 year 10/30/16) Produce Safety Final Rule October 31,

4 Preventive Controls Rule Food Safety Plan A Hazard Analysis that identifies and evaluates known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held at the facility Preventive controls Identified and implemented to provide assurances that hazards will be significantly minimized or prevented. Examples of preventative controls: (1) process controls, (2) food allergen controls, (3) sanitation controls, and (4) a recall plan. Food Safety Plan Verification activities include validation that the preventive controls are adequate for their purpose and are effective in controlling the hazard activities to verify that controls are operating as intended and review of monitoring records Today the focus is on biological hazards validation of preventive controls that address these hazards 4

5 Validation Provide documented evidence that the process is capable of reducing pathogens to predefined levels that significantly minimize or prevent the hazard. Review of the 5 Preliminary Steps 1. Assemble the HACCP team (and coordinator) 2. Define product, process and distribution 3. Define intended use and consumer 4. Develop a flow diagram 5. Confirm the flow diagram

6 Review of the 7 HACCP Principles 1. Conduct a hazard analysis 2. Determine critical control points 3. Establish critical limits 4. Establish monitoring procedures 5. Establish corrective actions 6. Establish verification (and validation) procedures 7. Establish documentation and record-keeping procedures Conducting a Validation 1 2 3* 4* Assess and improve current systems Assemble the Validation Team Determine the most resistant pathogen Validate the efficacy of the lethal process Conduct a hazard analysis Identify preventive control(s) for hazards reasonably likely to occur Consider the level of inactivation needed Assess the impact of the food matrix Define specific equipment and operating parameters Prevent recontamination Adapted from: AIOE,

7 Type of Validation Activities Literature Review Previously published studies Existing regulatory requirements Safe harbors Laboratory Studies Existing unpublished New targeted studies Modeling Commercial Facility/Equipment Studies Combination of the above Resources FDA Guidance Documents FDA is expected to publish several guidance documents Likely close to publication of final rule Focus on small/very small facilities FSPCA Standardized curriculum After publication of final rule h'p:// 7

8 Alliance.pmmi.org 1. Scroll down to Product Safety 2. Select View/Download: Validating the Reduction of Salmonella and Other Pathogens in Heat Processed Low-Moisture Foods 3. Create a password 4. Download document 8

9 More in- depth coverage IAPF meeting August

10 Conducting a Validation 1 2 3* 4* Assess and improve current systems Assemble the Validation Team Determine the most resistant pathogen Validate the efficacy of the lethal process Conduct a hazard analysis Identify preventive control(s) for hazards reasonably likely to occur Consider the level of inactivation needed Assess the impact of the food matrix Define specific equipment and operating parameters Prevent recontamination Adapted from: AIOE, 2012 Conducting a Validation 1 2 3* 4* Assess and improve current systems Assemble the Validation Team Determine the most resistant pathogen Validate the efficacy of the lethal process Conduct a hazard analysis Identify preventive control(s) for hazards reasonably likely to occur Consider the level of inactivation needed Assess the impact of the food matrix Define specific equipment and operating parameters Prevent recontamination Adapted from: AIOE,

11 Is the process ready to be validated? Described Measurable Controlled Operational procedures are in place and operational limits are stated. Analytical procedures exist. Process measures are accurate and precise. records are in place. Calibrated equipment is used. The process meets required operational limits (temperature, retention time, formulation, a w, moisture, etc.) Correction occurs when out of control Reproducible Process outputs are within spec day-to-day, season-to-season AIOE, 2012 Assemble the Validation Team Include persons familiar with The process Product formulation Validation data collection HACCP requirements Experimental design Process documentation Recordkeeping, record review Sample handling Data interpretation Reporting results Such as... Equipment operators Quality management Statistician Microbiologist Engineer Product developer Credit: AIOE,

12 Next up Dr. Gordon Davidson, University of California, Davis Hazard analysis pistachio processing 12