September 9, The best approach is to review all the recommendations and guidance ensure all items are addressed, as applicable.

Transcription

1 September 9, 2013 Attached is a side-by-side review of Sections IX XXIII of the FDA s Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods and the Smoked Seafood Working Group s Listeria Monocytogenes Control Manual. The FDA document addresses all refrigerated and frozen ready-to-eat products (designated RF-RTE) and the SSWG document is limited to ready-to-eat seafood product, primarily cold smoked products (designated RTE). The documents provide recommendations and guidance for controlling Listeria in the processing environment from receipt of raw materials to finished product. Both documents acknowledge the microorganism is ubiquitous and it is virtually impossible to prevent entry into a processing facility. In the summary, the Section IX XXIII document topics were reviewed and key statements paraphrased along with the corresponding statements from the SSWG document where applicable. The documents addressed common issues although with different and unique verbiage. Each document addressed some issues the other did not. The best approach is to review all the recommendations and guidance ensure all items are addressed, as applicable. Chris Rezendes

2 IX. Ingredients and Raw Materials A. Use of Listericidal* Control Establish list of ingredients likely to be contaminated with Listeria monocytogenes and establish appropriate controls Handle raw foods and the ingredients as if they are contaminated with Listeria monocytogenes Use listericidal control during processing No other specifics given Decision tree provided for testing B. Testing Program B.1 If no Listericidal is Used Obtain Certificate of Compliance (COC) with specified period of guarantee and concurrence they are following guidance Recommends periodic testing as a verifications procedure Audit supplier at least annually IX. Ingredients and Raw Materials A. Use of Listericidal Control Use on raw fish by supplier or after receipt by processor, especially for fresh products List of possible compounds provided, e.g., chlorine, chlorine dioxide, calcium hydroxide B. Testing Program B.1 Program Content May include raw material testing Four testing program examples and one that includes raw material testing Ingredient and raw material testing may identify sources of Listeria monocytogenes B.2 If no Listericidal is Used Obtain Certificate of Analysis (COA) for each lot received and concurrence they are following guidance and provide analytical method and limits Test each lot until sufficient data to have confidence in supplier, then conduct periodic testing as a verification procedure B.3 In-House Testing Test every lot received if product supports growth of L. monocytogenes, or test periodically if product does not support growth * control measure to consistently destroy viable cells of Listeria monocytogenes and consistently leads to a finished product with less than 0.4 cfu of Listeria monocytogenes per gram of food

3 X. Storage Practices A. Recommendations Establish procedures for how long ingredients and raw materials, in-process and finished products are store Use first-in, first-out practices Maintain internal product temperature at <40 F (<4 C) during transit and storage of ingredients and raw materials, in-process materials and finished products During processing, establish and control amount of time ingredients and raw materials, in-process and finished products are held above 40 F (4 C) X. Storage Practices A. Recommendations Limited to discussion of separating raw product from in-process product Recommends a SOP covering control of handing and movement of raw and finished products

4 XI. Personnel Controls A. Training Provide training on health and hygienic practices for all employees and contractors who enter RF-RTE areas Conduct training before employee starts working and then annually B. Provides guidance on: 1. Health Exclude employees with symptoms of gastroenteritis from food production areas 2. Hand Washing, Gloves and Footwear Recommends hand-washing before entering RF-RTE production areas Recommends wearing gloves in RF-RTE areas, no bare hands Provides procedures for glove and footwear usage in RF-RTE areas Recommends non-cleated footwear XI. Personnel Controls A. Training Provide training on Listeria and hygienic practices when hired, before they start working and then annually There should be three training programs: Basic training in Listeria Training focused on preventing crosscontamination for employees working with exposed product Training for employees responsible for cleaning and sanitizing Provide training after changes in plant procedures Refers to Cornell University training materials (slide series) 3. Foot Bath Recommends foot bath or automatic spray foamer with sanitizer in RF-RTE areas to control potential footwear contaminants 4. Clothing Detailed recommendations for employee s street clothes and smocks 5. Lockers Recommends separate lockers, break areas and cafeteria for RF-RTE employees and employees handling raw materials 6. Maintenance Employees Requirement for maintenance personnel working in RF-RTE areas to follow RF-RTE procedures 7. Employees Handling Waste Employees handling trash should not handle food contact surfaces or packaging materials without following RF-RTE procedures

5 XII. Controls for Plant Design, Construction and Operations A. Design and Construction Recommends separate RF-RTE processing, exposure or storage areas from all other non-rf-rte areas Recommends positive air pressure on the RF-RTE side of the operations relative to the raw side Filter the room air of RF-RTE processing areas Design, install and maintain water systems to prevent backflow and cross-contamination between potable and non-potable water Equipment washing area should be separate from RF-RTE processing areas and raw food equipment washing area Provides guidance for drain construction Does not recommend trench drains Design plant to prevent condensation No wood construction in RF-RTE areas Design floors, walls, ceilings, windows, drains and overhead structures for easy cleaning, prevent harborage of microorganisms or deterioration Design roof to drain freely and not leak Windows should not open into RF-RTE processing areas Locate laboratory away from processing areas or in another building B. General Operations Control traffic patterns for employees, food products and equipment Wood pallets should not be used in RF-RTE production areas Clean and sanitize pallets and trolley wheels before entering RF-RTE production areas Recommends separate designated equipment (e.g., carts, forklift) for RF-RTE and raw food areas Provides recommendations for managing containers, e.g., labeling, color-coding, function, designated use area Recommends discarding or decontaminate brines Recommends no high pressure water hoses in RF- RTE processing areas C. Compressed Gas, Water and Ice Compressed gas in RF-RTE areas should be dried and filtered at point of use Handle and store ice and ice utensils properly to prevent contamination Mix hot and cold water at hand washing station XII. Controls for Plant Design, Construction and Operations A. General Considerations Identifies potential reservoirs of Listeria (e.g., floors, walls, ceiling, slicers, maintenance tools) Identifies potential sources of Listeria (e.g., equipment, racks, utensils, gloves, bins, ceilings) Identifies examples of situations that have caused problems (e.g., equipment issues, new employees unfamiliar with RTE procedures, personnel handle RTE materials after touching trash, drain back-ups) B. Processing Operations Arrange plant in linear flow, separate operations Control of traffic (e.g., people, equipment, forklifts) Don t allow movement from raw to RTE side unless precautionary steps taken Don t process raw and in-process products in the same area at the same time No direct employee entry into the RTE processing areas from exterior Separate equipment, utensils and cleaning tools should be used in RTE processing areas, and be color-coded or labeled Visitors, management and non-production must follow RTE procedures Containers should be color-coded or labeled (e.g, trash, finished product), and cleaned and sanitized Dedicated washing areas for RTE and raw equipment Eliminate standing water Hang up hoses off floor Does not recommend trench drains Raw-side drains should not connect to RTE areas Use and maintain footbaths or foamer with adequate sanitizer Wood pallets should not be used in RTE production areas C. Equipment Provides guidance on equipment design, evaluation and maintenance from a microbiological and sanitation standpoint, including used equipment Avoid overhead structures (e.g., conveyors) Equipment and framework should not be hollow that allows water to collect and harborage Listeria monocytogenes

6 XIII. Controls for Equipment Design, Construction and Maintenance A. Design and Construction Review design and construction of equipment for ease of cleaning and focus on microbial harborage potential, for both new and existing equipment Design catwalk frames, table legs, conveyor rollers and racks to prevent collection of water Avoid overhead conveyor and evaluate conveyor design (e.g., hollow conveyors) and location Design equipment (e.g., catwalk, ladders) to prevent contaminants falling into products below Recommend adding listericidal additives to lubricants Design controls for condensate from refrigeration evaporator coils Keep hoses off the floor in RF-RTE areas Ensure food-contact surfaces are smooth, nonabsorbent, sealed, cleanable, slope to drain and made of durable, non-corrosive and non-toxic materials; also ensure surfaces are free of pits, folds, cracks, crevices, open seams, cotter pins, exposed threads and piano hinges Pipes should not have dead ends or crossconnections between raw and RF-RTE foods B. Maintenance Establish a written preventative maintenance program to minimize breakdown and prevent contamination Establish a defined preventative maintenance schedule Change filters as per manufacturer s specifications or as needed Dedicate maintenance tools for RF-RTE areas Clean and sanitize equipment and food-contact surfaces after maintenance activities prior to resuming or starting production XIII. Controls for Equipment Design, Construction and Maintenance A. Design and Construction Design, evaluation and maintain equipment from a microbiological and sanitation standpoint, both new and existing Examine equipment for dead-ends, crevices, etc. that serve as harborages for Listeria Disassemble, clean and sanitize used equipment before bringing into production Minimize the use of nuts, bolts and threaded items Damaged, pitted, corroded or cracked equipment should be repaired or replaced Evaluate conveyor design (e.g., hollow rollers) Racks should have guards over the wheels Use lubricants with listericidal additives Design equipment (e.g., catwalk, ladders) to prevent contaminants falling into products below B. Maintenance Establish a written preventative maintenance program with a defined schedule Dedicate maintenance tools for RTE areas Clean and sanitize equipment and food-contact surfaces after maintenance activities prior to resuming or starting production Maintenance personnel must follow RTE procedures

7 XIV. Sanitation Program A. General Establish a written sanitation standard operating procedure (SSOP) provides guidance on content of a SSOP and recommends proper steps (sequence) for cleaning and sanitizing equipment and floors Prevent contamination when assembling cleaned and sanitized equipment Recommendations for preventing water splash from floor or unclean equipment onto clean equipment, don t place components on floor Separate cleaning system used for RF-RTE equipment from raw food system Dispose of wipes after each use Discard scouring pads daily, and keep dry or in a sanitizer solution between use during the day Mops, brushes, brushes, etc. should be cleaned and properly maintained, and be dedicated to each area using color-coding or other means B. Drains and Floors Provides guidance on cleaning and sanitizing floor drains (e.g., when, how, preventing splash) Provides guidance on steps to take if a drain backs up and water flows into the RF-RTE area Recommends employee change clothes after working on drain back-up, and wash and sanitize hands before touching RF-RTE food contact surfaces Bactericidal drain rings should be monitored and replaced when appropriate C. Sanitizers Recommends use of quaternary ammonium compounds and peroxyacetic acid Recommends rotating sanitizers Recommends using sanitizers in accordance with manufacturer s recommendations (label), and be aware of any requirements for temperature, ph and water hardness Hot water and steam are alternatives to chemicals D. Sanitation Monitoring and Records Monitor sanitation procedures and take corrective action when SSOP is not followed Cleaning and sanitizing of utensils and equipment frequency must prevent contamination of food, food-contact surfaces and packaging materials Maintain records of sanitation monitoring and corrections XIV. Sanitation Program A. General Provides guidance on sequential steps in cleaning and sanitizing of equipment, and disassembly when necessary Avoid high pressure hoses, especially near drains Cleaning crew should receive special training Prevent nesting of tubs and other containers Coolers for RTE product storage should be cleaned at least weekly, including condensate drip pans Freezers should be cleaned twice a year Compressed air used in cleaning should be filtered RTE products should not be present during sanitation procedures of coolers Racks may be cleaned with high heat or steam Cleaning tools should be sanitized in quaternary ammonium compound B. Drains and Floors Provides guidance on cleaning and sanitizing floor drains (e.g., when, how, preventing splash) Design drains to prevent back-up Provides guidance on steps to take if a drain backs up and water flows into the RTE area Recommends powdered caustic cleaner for floors Bactericidal drain rings are recommended Citric acid can be effective if applied after proper cleaning and sanitizing of floors C. Sanitizers Use sanitizers in accordance with manufacturer s recommendations (label) Recommends use of quaternary ammonium compounds and peroxyacetic acid Recommends rotating sanitizers D. Sanitation Monitoring Recommends dedicated person to monitor cleaning and sanitizing procedures to ensure it is done correctly Mid-shift cleaning is not recommended Hot water and steam are alternatives to chemical sanitizers Provides recommended schedule for sanitizing with quaternary ammonium compounds and peroxyacetic acid

8 XV. Transportation Controls A. General Recommends inspection of transportation vehicles for structural integrity, cleanliness and overall suitability Use transportation vehicles equipped to continuously control and monitor temperature Tankers to transport ingredients or finished products should be dedicated to specific use Cleaning and sanitizing of tankers should be verified XV. Transportation Controls A. General Not addressed in document other than noting forklifts, carts and hand trucks can be reservoirs of Listeria monocytogenes

9 XVI. Monitoring and Detection of Locations Harboring Listeria A. Plan Recommends a written plan for environmental samples from critical surfaces and areas for Listeria spp. or Listeria monocytogenes Evaluate plant, product and process to identify appropriate sampling points Use screening tests for Listeria spp. Test individual samples or test composite B. Critical Food-Contact Surfaces Collect samples from all, or a representative number, of all critical food-contact surfaces at least once per week If only a representative number, then the plan should result in sampling all sites each month Number of samples depends on plant size, a minimum of 5 samples is recommended for each production line Add other surfaces if results are consistently negative Collect samples prior to clean-up and after the midpoint of production List of recommended sites provided C. Critical Non-Food-Contact Surfaces and Areas Collect samples from all, or a representative number, of all critical non-food surfaces at least every two weeks In only a representative number, plan should result in sampling all sites each quarter Number of samples depends on plant size, a minimum of 5 samples is recommended of areas were RF-RTE foods are processed, exposed or stored Focus on high traffic and high moisture areas Vary collections sites on a rotating basis if results are consistently negative Samples can be collected at any time List of recommended sites provided D. Collection Procedures Recommended collection procedures provided XVI. Monitoring and Detection of Locations Harboring Listeria A. Plan Recommends a testing plan for each line Needs management commitment and employee s understanding of their role Plant, product and process must be evaluated to identify appropriate sampling sites Include food and non-food contact surfaces Product testing is a reliable indicator that Listeria monocytogenes contamination has not occur, emphasis is on testing for Listeria spp. in the environment to verify control Data should be organized and reviewed Periodic positive samples may occur and should be viewed as a success rather than a failure Plan should include pre-determined plan for positive results and need for product testing Investigate positive results B. Raw Materials Testing raw materials may identify sources of Listeria monocytogenes C. Product-Contact Surfaces Verifies sanitation controls are effective Sampling frequency based on historic results Plant should determine sites, time of sampling and frequency based on operation and controls Recommend sampling after equipment has run for a period of time D. Non-Food Contact Surfaces Plant should determine sites and frequency based on potential for finished product contamination, including floors, floor mats, walls, drains, tubs, totes, conveyances, racks, cooler coils and condensate collectors, seams and crevices in processing machinery, sponges, mops and other cleaning utensils Number and frequency should be increased when positive results occur Weekly sampling is recommended in wet areas, less in dry areas Sampling can occur at any time E. Collection Procedures Recommended collection procedures provided

10 XVII. Finished Product Testing A. Plan Recommends a written plan for periodic collection of finished product testing for Listeria spp. or Listeria monocytogenes Purpose is to provide historic reference and validate adequacy of controls, rather than determining whether to release product for distribution Plan should include sampling frequency XVII. Finished Product Testing A. Plan Finished product testing confirms effectiveness of sanitation program and other controls Finished product testing may be used as part of product release program Customers may request such testing Plan should define a production lot Sampled lots should be held pending analytical results Representative samples should be collected (refers to ICMSF for sampling guidance) Compositing of samples (single lot) may be considered but should be done by the laboratory

11 XVIII. Positive Listeria spp. Results for Critical Food- Contact Surface or Food A. Follow-Up Action Recommend testing to determine if Listeria spp. or Listeria monocytogenes or assume it is Listeria monocytogenes XVIII. Positive Listeria spp. Results for Critical Food- Contact Surface or Food A. Follow-Up Action See Sections XIX and XX B. Not Listeria monocytogenes Take corrective action for plant and processes See Section XIX C. Is Listeria monocytogenes See Sections XIX and XX

12 XIX. Plant Corrective Action for Listeria Positive Critical Food-Contact or Area or in Food A. Plant Corrective Action Follow corrective action plan that includes steps to be taken and assigned responsibility Clean and sanitize contaminated surface or area Conduct additional sampling to determine whether contamination has been eliminated If additional positive results, conduct more cleaning and sanitizing and re-testing until contamination is eliminated Review production, maintenance and sanitation procedures and modify if necessary Check maintenance records for modifications or repairs Interview and observe sanitation, maintenance and production employees to determine if procedures were followed Take corrective action as warranted Document corrective actions XIX. Plant Corrective Action for Listeria Positive Critical Food-Contact or Area or in Food A. Plant Corrective Action Not addressed directly See Sections XX

13 XX. Food Corrective Action for Listeria Positive Critical Food-Contact or in Food A. Food Corrective Action for Food that Support Listeria monocytogenes Take corrective action that describes the steps to be taken and assigns responsibility Segregate and hold any product that contacted contaminated food-contact surface until corrective action is completed, e.g., hold and segregate product since last negative test for Listeria spp. or was last cleaned and sanitized Determine and take corrective action for any food that contacted the contaminated surface options provided B. Food Corrective Action for Food that does not Support Listeria monocytogenes Segregate and hold any product that contacted contaminated food-contact surface until corrective action is completed, e.g., hold and segregate product since last negative test for Listeria spp. or was last cleaned and sanitized Determine and take corrective action for any food that contacted the contaminated surface options provided (different than A above) XX. Food Corrective Action for Listeria Positive Critical Food-Contact or in Food A. Positive Non-Food Contact Surface Plant should corrective action once trigger (i.e., specific number, target) has been exceeded Cleaning and sanitizing should be included in corrective action Corrective action for environmental positives may vary but: Indicates additional investigation should be taken Additional samples should be taken where contamination was detected If additional positive results are obtained, more intense cleaning and re-testing should occur Consider sampling food-contact surfaces where positive was detected B. Positive Product Contact Surface Pre-determined plan of action should be developed which may include cleaning and sanitizing, re-design of equipment, improved GMPs All positives should be investigated to determine reason Consider testing finished product C. Positive Finished Product Recall product from commerce Intensified cleaning and sanitizing Consider heat treatment of equipment Intensified sampling, no compositing

14 XXI. Training Provide training on health and hygienic practices or all employees and contractors who enter RF-RTE areas Conduct training before employee starts working, and annually Provide specialized training for personnel responsible for: Establishing effective listericidal and listeristatic control measures Collecting and testing environmental and finished product samples Determining and taking corrective actions Establishing and using Sanitation Standard Operating Procedure and monitoring XXI. Training Provide training on Listeria and hygienic practices when hired, before they start working and annually There should be three training programs: Basic training in Listeria; Training focused on preventing crosscontamination for employees working with exposed product Training for employees responsible for cleaning and sanitizing

15 XXII. Collection and Analytical Methods A. Sample Collection Not covered B. Preparing and Analyzing Samples Appendix describes procedures for preparing environmental samples for analysis FDA s Bacteriological analytical Manual Online (BAM), Chapter 10 should be used for preparing food samples for analysis FDA s BAM methods should be used for detecting Listeria spp and Listeria monocytogenes in environmental and food samples, and confirming Listeria spp. is Listeria monocytogenes ISO :1998 (E) should be used for enumerating Listeria monocytogenes FDA Guidance Document XXII. Collection and Analytical Methods A. Sample Collection Use consistent scientifically acceptable method If necessary, obtaining guidance or training from testing laboratory or other food safety professionals Environmental samples should represent a consistent area Plant may or may not want to sample floor drains, floors and floor mats B. Preparing and Analyzing Samples Not covered

16 XXIII. Records A. Records Recommends keeping the following records: Documentation of listeristatic control measures Documentation of listericidal control measures List of ingredients and raw materials COC and COA Written plan for collection and testing of environmental samples Written plan for sampling and testing finished product Written analytical methods other than BAM and ISO Results of tests to detect or enumerate Listeria spp or Listeria monocytogenes Documentation of corrective actions Written Sanitation Standard Operating Procedure Sanitation control records XXIII. Records A. Records Not covered B. Record Identification Recommend records include: Name and address The date and time of the activity that the record reflects Actual values Signature or initials of individual performing operation and the date Production code, where applicable

17 Other-Labeling Other-Labeling No covered Recommends finished product be labeled Important, must be kept refrigerated at 38 F or below Or as required by individual states or counties

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