Food Safety Plan – Water Source & Use (WSU5-SOP) Water Sampling SOP (for water that contacts crops during GROWING) Policy Purpose Type farm/business name here performs water sample testing on a scheduled basis to detect any potential or existing contamination on all water sources including well, ditch, canal, pond, reservoir, river and reclaimed water. This SOP refers to water that contacts crops during growing. This SOP does not include requirements for sprouts. For water used in any manner that contacts produce during/after harvest (for example, water applied to produce for washing or cooling, used to prevent dehydration before cooling, used to make ice that directly contacts produce, used on food contact surfaces or used for washing hands during and after harvest activities), refer to the Crop Handling (CH) section. Laboratory test results and any corrective actions are recorded. This SOP includes employee training for water sample collection, water sampling schedule, sampling method, the logging activities and requirements, water sample result requirements, understanding water sample results and calculations, corrective actions, and activities that may lead to audit failure. Procedures Employee Training for WSU5-SOP and WSU5-Log Document employee training in the employee training log (FSP2- Primary Training Log). Water Sampling Schedule Water sample testing is scheduled throughout the year, especially throughout the growing season prior to harvest by trained employees. Document water testing schedule in the Farm Plan Calendar (Calendar). Water sample testing frequency depends on the type of water source (i.e. surface or ground water). There are no requirements to test: Municipal or public water as long as testing results from the facility are kept From any water that has been treated using an EPA-approved method If untreated SURFACE or GROUND water is used, you must use the following testing schedules and requirements: Testing schedule for untreated SURFACE water samples The FDA requires: 1. Initial survey (2-4 year process) All food safety policies and procedures should be developed using national, state and local guidelines. Information presented in these on-farm food safety materials was compiled from reputable sources, such as USDA-FSIS, FDA and the Food Safety Modernization Act final rules. The information is provided for educational purposes only and should not be considered legal advice. Therefore, no responsibility is assumed or implied by CSU, Chico Research Foundation or CSU, Chico. 1 Revision Date: July 24, 2016 Food Safety Plan – Water Source & Use (WSU5-SOP) Collect a minimum of 20 samples, as close to harvest as possible over 2-4 years 2. Annual survey Collect a minimum of 5 samples each year Testing schedule for untreated GROUND water samples The FDA requires: 1. Initial survey (1 year process) Collect a minimum of 4 samples, as close to harvest as possible over 1 year 2. Annual survey Collect a minimum of 1 sample per year Water Sampling Method 1. Organize supplies Most contract labs will provide a 100 mL sterile container with a snap or screwcapped lid for sampling Label the bottle with: Location where water sample was collected using Growing Area Map (Map) Date of sample collection Time of sample collection Initials of the person taking the sample 2. Water source preparation If you are collecting from a spigot or shunt valve, turn on water to the highest flow possible for four minutes and then turn it off Wipe the inside of the spigot or valve opening with a 10% bleach solution and let sit for one minute before collecting the sample 3. Taking water sample(s) If you are collecting samples from multiple places like different wells, spigots, valves, etc. make sure that you wash your hands and use gloves before collecting each sample to avoid contamination Turn the water to a moderate, steady flow Keep the container closed until the sample is ready to prevent dust, soil, or other debris from contacting the sample container Do not touch the underside of the bottle lid, the bottle lip, or inside of the bottle Do not rinse the bottle before filling Look for the fill-line or a 100 milliliter mark It is important to fill the bottle past this line for an accurate sample analysis If the bottle does not have a mark or instructions, fill the bottle to the top Replace the lid and wipe the outside of the container with a clean paper towel All food safety policies and procedures should be developed using national, state and local guidelines. Information presented in these on-farm food safety materials was compiled from reputable sources, such as USDA-FSIS, FDA and the Food Safety Modernization Act final rules. The information is provided for educational purposes only and should not be considered legal advice. Therefore, no responsibility is assumed or implied by CSU, Chico Research Foundation or CSU, Chico. 2 Revision Date: July 24, 2016 Food Safety Plan – Water Source & Use (WSU5-SOP) 4. Transporting sample(s) The sample(s) should be placed on ice/cooler immediately after collection Samples should be received by the contract lab within 24 hours of collection or according to their directions, whichever is earlier Samples should be tested for generic E. coli or for what your buyers/regulators require Water Sample Logging Activities Use the WSU5-Log to record water sample test results and corrective actions. Testing calculations will fill-in automatically. Use Growing Area Map (Map) to record water sample collection location. The following tables are provided in the WSU5-Log: Table 1: Initial SURFACE water sample results (complete 20 samples over first 2-4 years) Table 2: Ongoing SURFACE water sample results (complete 5 additional samples each year) Table 3: Initial GROUND water sample results (complete 4 samples over first year) Table 4: Ongoing GROUND water sample results (complete 1 additional sample each year) Table 5: Microbial Die-off Rate method used when inspection, treatment & retesting does not occur Before the initial GM and STV for SURFACE water can be calculated, collect 20 samples over 2-4 years and complete Table 1. After the initial GM and STV have been completed in Table 1, collect 5 new samples each year to recalculate the GM and STV for SURFACE water in Table 2. Before the initial GM and STV for GROUND water can be calculated, collect 4 samples over 1 year and complete Table 3. After the initial GM and STV have been completed in Table 3, collect 1 new sample each year to recalculate the GM and STV for GROUND water in Table 4. Water Sample Result Requirements Water testing results must follow two requirements: 1. Geometric Mean (GM) must be <126 MPN or CFUs of generic E.coli per 100 mL of water. 2. Statistical Threshold Value (STV) must be <410 MPN or CFUs of generic E.coli in 100 mL of water. Understanding Water Sample Results and Calculations What is Most Probable Number (MPN) or Colony Forming Units (CFUs)? The water sample test results will be provided by the lab as Most Probable Number (MPN) or Colony Forming Units (CFUs). These two types of units essentially provide the same information and quantify or measure how much bacteria is in the water sample. The MPN or CFUs results, provided by the lab, need to be less than (<) the maximum acceptable FDA requirements. All food safety policies and procedures should be developed using national, state and local guidelines. Information presented in these on-farm food safety materials was compiled from reputable sources, such as USDA-FSIS, FDA and the Food Safety Modernization Act final rules. The information is provided for educational purposes only and should not be considered legal advice. Therefore, no responsibility is assumed or implied by CSU, Chico Research Foundation or CSU, Chico. 3 Revision Date: July 24, 2016 Food Safety Plan – Water Source & Use (WSU5-SOP) What is a Geometric Mean (GM)? The Geometric Mean (GM) is the average test results. See Appendix A below for details. What is Statistical Threshold Value (STV)? The Statistical Threshold Value (STV) indicates the consistency of the sample test results. See Appendix A below for details. Remember, once the water sample results are entered, the GM and STV will automatically be calculated for you. Notes about test results: 1. If a result provided by the lab contains a “<” symbol (i.e. <2, <1 or <0.5), use one half of that value for the test result in the log. For example, if a result provided by the lab is <1, use 0.5 for the test result column. 2. If your test result is so high that there is a “>”symbol, such as >2419.6, then there was either excessively dangerous amounts of microbial contamination or a mistake could have been made in the lab or during sample collection. In this case, take one of the three corrective actions listed in the Corrective Action section below, take a new sample and retest. Examples of Tables 1-4 for tracking SURFACE and GROUND water sample results are found on the following pages below: Table 1: Initial SURFACE water sample results (complete 20 samples over first 2-4 years) Page 5 Table 2: Ongoing SURFACE water sample results (complete 5 additional samples each year) Page 6 Table 3: Initial GROUND water sample results (complete 4 samples over first year) Page 7 Table 4: Ongoing GROUND water sample results (complete 1 additional sample each year) Page 7 All food safety policies and procedures should be developed using national, state and local guidelines. Information presented in these on-farm food safety materials was compiled from reputable sources, such as USDA-FSIS, FDA and the Food Safety Modernization Act final rules. The information is provided for educational purposes only and should not be considered legal advice. Therefore, no responsibility is assumed or implied by CSU, Chico Research Foundation or CSU, Chico. 4 Revision Date: July 24, 2016 Food Safety Plan – Water Source & Use (WSU5-SOP) Example Table 1: Initial SURFACE water sample results (complete 20 samples over first 2-4 years). D at e of s am pl e c ol l ec t i on Ti m e of s am pl e c ol l ec t i on St af f who c ol l ec t ed s am pl e Tes t res u l t s 8/1/17 2:00 PM Smith 106.6 9/1/17 2:00 PM Smith 325.5 10/1/17 9:30 AM Smith 387.8 11/1/17 7:30 AM Jones 435.2 12/1/17 10:45 AM Smith 313.0 1/1/18 2:00 PM Smith 128.1 2/1/18 9:30 AM Smith 124.6 3/1/18 7:30 AM Smith 46.4 4/1/18 10:45 AM Jones 69.5 5/1/18 2:00 PM Jones 60.5 6/1/18 9:30 AM Smith 43.2 7/1/18 7:30 AM Smith 41.7 8/1/18 10:45 AM Smith 40.6 9/1/18 2:00 PM Jones 39.7 10/1/18 9:30 AM Smith 39.8 11/1/18 7:30 AM Smith 410.6 12/1/18 10:45 AM Smith 387.3 2/1/19 2:00 PM Jones 307.6 5/1/19 9:30 AM Smith 115.3 8/1/19 7:30 AM Smith 146.7 G eom et ri c M ean ( G M ) * St at i s t i c al Thres hol d Val u e ( STV) * 122 399 Com m en t s an d/or Correc t i ve Ac t i on s *The GM and STV for SURFACE water are calculated by using the most recent 20 water samples. The GM requirement for sample test results cannot exceed 126 MPN or CFUs of generic E.coli per 100 mL of water. The STV cannot exceed 410 MPN or CFUs of generic E.coli in 100 mL of water. All food safety policies and procedures should be developed using national, state and local guidelines. Information presented in these on-farm food safety materials was compiled from reputable sources, such as USDA-FSIS, FDA and the Food Safety Modernization Act final rules. The information is provided for educational purposes only and should not be considered legal advice. Therefore, no responsibility is assumed or implied by CSU, Chico Research Foundation or CSU, Chico. 5 Revision Date: July 24, 2016 Food Safety Plan – Water Source & Use (WSU5-SOP) Example Table 2. Ongoing SURFACE water sample results (complete 5 additional samples each year). Use table 2 for every new year. Tes t res u l t s Dat e of s am pl e c ol l ec t i on Ti m e of s am pl e c ol l ec t i on St af f who c ol l ec t ed s am pl e 9/1/17 2:00 PM Smith 325.5 10/1/17 9:30 AM Smith 387.8 11/10/17 7:30 AM Jones 435.2 12/1/17 10:45 AM Smith 313.0 1/1/18 2:00 PM Smith 128.1 2/1/18 9:30 AM Smith 124.6 3/1/18 7:30 AM Smith 46.4 4/1/18 10:45 AM Jones 69.5 5/1/18 2:00 PM Jones 60.5 6/1/18 9:30 AM Smith 43.2 7/1/18 7:30 AM Smith 41.7 8/1/18 10:45 AM Smith 40.6 Use last 19 result s Geom et ri c M ean ( GM ) * St at i s t i c al Thres hol d Val u e ( STV) * 124 405 f rom previous yr 9/1/18 2:00 PM Jones 39.7 10/1/18 9:30 AM Smith 39.8 11/1/18 7:30 AM Smith 410.6 12/1/18 10:45 AM Smith 387.3 2/1/19 2:00 PM Jones 307.6 5/1/19 9:30 AM Smith 115.3 8/1/19 7:30 AM Smith 146.7 10/1/19 10:45 AM Smith 141.4 1/10/2021 12:30 PM Smith 155.1 119 377 4/1/20 12:45 PM Smith 164.8 114 344 7/1/20 1:45 PM Smith 135.3 108 301 Com m en t s an d/or Correc t i ve Ac t i on s 1/1/20 test result = 501.2 MPN. GM above 126 MPN. STV above 410 MPN. Stopped using water. Inspected water system, cow broke through fence and fixed fence. Retest on 1/10/20. GM and STV recalculated and water safe to use. *The GM and STV for SURFACE water are calculated by using the most recent 20 water samples. The GM requirement for sample test results cannot exceed 126 MPN or CFUs of generic E.coli per 100 mL of water. The STV cannot exceed 410 MPN or CFUs of generic E.coli in 100 mL of water. All food safety policies and procedures should be developed using national, state and local guidelines. Information presented in these on-farm food safety materials was compiled from reputable sources, such as USDA-FSIS, FDA and the Food Safety Modernization Act final rules. The information is provided for educational purposes only and should not be considered legal advice. Therefore, no responsibility is assumed or implied by CSU, Chico Research Foundation or CSU, Chico. 6 Revision Date: July 24, 2016 Food Safety Plan – Water Source & Use (WSU5-SOP) Example Table 3. Initial GROUND water sample results (complete 4 samples over first year). Dat e of s ampl e c ol l ec t i on 1/1/17 Ti me of s ampl e c ol l ec t i on 2:00 PM St af f who c ol l ec t ed s ampl e Smith 4/1/17 9:30 AM Smith 122.3 7/1/17 7:30 AM Jones 95.9 10/1/17 10:45 AM Smith 101.0 Tes t res u l t s Geomet ri c M ean ( GM ) * St at i s t i c al Thres hol d Val u e ( STV) * 106 121 Commen t s an d/or Correc t i ve Ac t i on s 106.6 *The GM and STV for GROUND water are calculated by using the most recent 4 water samples. The GM requirement for sample test results cannot exceed 126 MPN or CFUs of generic E.coli per 100 mL of water. The STV cannot exceed 410 MPN or CFUs of generic E.coli in 100 mL of water. Example Table 4. Ongoing GROUND water sample results (complete 1 additional sample each year). Use table 4 for every new year. Tes t res u l t s D at e of s am pl e c ol l ec t i on Ti m e of s am pl e c ol l ec t i on St af f who c ol l ec t ed s am pl e 4/1/17 9:30 AM Smith 123.4 7/1/17 7:30 AM Jones 121.0 10/1/17 10:45 AM Smith 125.0 1/1/18 1:00 PM Smith Use last 3 result s G eom et ri c M ean ( G M ) * f rom previous yr 524.7 177 St at i s t i c al Thres hol d Val u e ( STV) * Com m en t s an d/or Correc t i ve Ac t i on s 448 1/1/18 test result = 524.7 MPN. GM above 126 MPN. Calculated die-off using Table 5 in WSU5-Log and stopped using water for 1 day between irrigation and harvest. No retest needed because used die-off method. *The GM and STV for GROUND water are calculated by using the most recent 4 water samples. The GM requirement for sample test results cannot exceed 126 MPN or CFUs of generic E.coli per 100 mL of water. The STV cannot exceed 410 MPN or CFUs of generic E.coli in 100 mL of water. Corrective Actions If the water does not meet these criteria, corrective actions are required as soon as possible. There are 3 corrective action options: 1. Re-inspect the water, remove any identifiable hazards and retest the water (a lab test will usually take 24 hours) 2. Follow the Microbial Die-off Rate method in Table 5 of the WSU5-Log. This method allows time for potentially dangerous microbes to die-off on the field from sunlight and changes in moisture, temperature, pH, etc. between last irrigation and harvest. The maximum number of days you need to wait using this method is 4 consecutive days. o Microbial die-off and appropriate waiting period between the last day of irrigation and when produce is safe to harvest can be calculated automatically using Table 5 in WSU5-log. Enter the GM and STV values in the boxes for Day 1 and the die-off will automatically be calculated for days 1-4. All food safety policies and procedures should be developed using national, state and local guidelines. Information presented in these on-farm food safety materials was compiled from reputable sources, such as USDA-FSIS, FDA and the Food Safety Modernization Act final rules. The information is provided for educational purposes only and should not be considered legal advice. Therefore, no responsibility is assumed or implied by CSU, Chico Research Foundation or CSU, Chico. 7 Revision Date: July 24, 2016 Food Safety Plan – Water Source & Use (WSU5-SOP) o The appropriate waiting period (i.e. number of days) between irrigation and harvest is determined by the results in these die-off columns. The waiting period depends on when both the: 1. GM is < 126 MPN or CFUs of generic E.coli per 100 mL of water 2. STV is < 410 MPN or CFUs of generic E.coli per 100 mL of water Example Table 5. Microbial Die-off Rate method used when inspection, treatment & retesting does not occur.* Geomet ri c M ean ( GM ) GM Di e-of f ( goal < 126 M P N or CFUs ) ** St at i s t i c al Thres hol d Val u e ( STV) STV Di e-of f ( goal < 410 M P N or CFUs ) ** Day 1 177 53 448 135 Day 2 53 16 135 41 Day 3 16 5 41 12 5 1 12 4 Wai t i n g P eri od Day 4*** *Complete this table if GM from Tables 1-4 is > 126 MPN or CFUs and/or STV > 410 MPN or CFUs. **The appropriate waiting period (i.e. number of days) between irrigation and harvest is determined by the results in these die-off columns. The waiting period depends on when the GM is < 126 MPN or CFUs of generic E.coli per 100 mL of water and when the STV is < 410 MPN or CFUs of generic E.coli per 100 mL of water. *** Maximum waiting period necessary between the last day of irrigation and the day of harvest. o See Appendix A below for detailed explanation of Microbial Die-off Rate method. 3. Treating (i.e. chlorination) the water (See WSU6-SOP and WSU6-Log) Audit Failure Audit failure will occur if: 1. GM is >126 MPN or CFUs of generic E. coli per 100 mL of water or STV is >410 MPN or CFUs of generic E. coli per 100 mL of water and no corrective action was performed. 2. Irrigation water sample tests are not conducted as indicated in the Water Sample Schedule section above for EACH water source (per FSMA). 3. Presence of E coli O157:H7 and/or salmonella found in water currently being used can result in automatic audit failure by a third party auditor. All food safety policies and procedures should be developed using national, state and local guidelines. Information presented in these on-farm food safety materials was compiled from reputable sources, such as USDA-FSIS, FDA and the Food Safety Modernization Act final rules. The information is provided for educational purposes only and should not be considered legal advice. Therefore, no responsibility is assumed or implied by CSU, Chico Research Foundation or CSU, Chico. 8 Revision Date: July 24, 2016 Food Safety Plan – Water Source & Use (WSU5-SOP) Appendix A Geometric Mean (GM) Calculation Formula Used =GEOMEAN(Sample 1:Sample 20) Statistical Threshold Value (STV) Calculation Formula Used =EXP((1.282*(STDEV.S(ln(Sample 1):ln(Sample 20))))+(AVERAGE(ln(Sample 1):ln(Sample 20)))) Details on Microbial Die-off Rate Calculation Method Microbial die-off or log reduction like a “0.5-log reduction” refers to amount of the bacteria that has died-off or been reduced each day. Here are 2 examples: 1. If your water samples have a GM value of 177 MPN or CFUs and STV value of 448 MPN or CFUs, you do not meet the requirements for the GM of < 126 MPN or CFUs or the STV of < 410 MPN or CFUs. Using a microbial reduction rate of 0.5 log per day: For GM: o Day 1 (-log0.5)*177 = 53 MPN or CFUs (safe) o Day 2 (-log0.5)*53 = 16 MPN or CFUs (safe) o Day 3 (-log0.5)*16 = 5 MPN or CFUs (safe) o Day 4 (-log0.5)*5 = 1 MPN or CFUs (safe) For STV: o Day 1 (-log0.5)*448 = 135 MPN or CFUs (safe) o Day 2 (-log0.5)*135 = 41 MPN or CFUs (safe) o Day 3 (-log0.5)*41 =12 MPN or CFUs (safe) o Day 4 (-log0.5)*12 = 4 MPN or CFUs (safe) Therefore, a 1 day waiting period is sufficient to assume the produce is safe to harvest. Geomet ri c M ean ( GM ) GM Di e-of f ( goal < 126 M P N or CFUs ) ** St at i s t i c al Thres hol d Val u e ( STV) STV Di e-of f ( goal < 410 M P N or CFUs ) ** Day 1 177 53 448 135 Day 2 53 16 135 41 Day 3 16 5 41 12 5 1 12 4 Wai t i n g P eri od Day 4*** 2. If your water samples have a GM value of 1,790 MPN or CFUs and a STV value of 2,236 MPN or CFUs, you do not meet the requirements for the GM of < 126 MPN or CFUs or the STV of < 410 MPN or CFUs. Using a microbial reduction rate of 0.5 log per day: For GM: o Day 1 (-log0.5)*1790 = 539 MPN or CFUs o Day 2 (-log0.5)*539 = 162 MPN or CFUs All food safety policies and procedures should be developed using national, state and local guidelines. Information presented in these on-farm food safety materials was compiled from reputable sources, such as USDA-FSIS, FDA and the Food Safety Modernization Act final rules. The information is provided for educational purposes only and should not be considered legal advice. Therefore, no responsibility is assumed or implied by CSU, Chico Research Foundation or CSU, Chico. 9 Revision Date: July 24, 2016 Food Safety Plan – Water Source & Use (WSU5-SOP) o Day 3 (-log0.5)*162 = 49 MPN or CFUs (safe) o Day 4 (-log0.5)*49= 15 MPN or CFUs (safe) For STV: o Day 1 (-log0.5)*2236= 673 MPN or CFUs o Day 2 (-log0.5)*673 = 203 MPN or CFUs (STV is <410, but GM too high on Day 2) o Day 3 (-log0.5)*203 = 61 MPN or CFUs (safe) o Day 4 (-log0.5)*61= 18 MPN or CFUs (safe) Therefore, a 3 day waiting period is sufficient to assume the produce is safe to harvest. Geomet ri c M ean ( GM ) GM Di e-of f ( goal < 126 M P N or CFUs ) ** St at i s t i c al Thres hol d Val u e ( STV) STV Di e-of f ( goal < 410 M P N or Day 1 1790 539 2236 673 Day 2 539 162 673 203 Day 3 162 49 203 61 Day 4*** 49 15 61 18 Wai t i n g P eri od Microbial Die-off Rate Calculation Formula Used =-LOG10(0.5)*GM =-LOG10(0.5)*STV All food safety policies and procedures should be developed using national, state and local guidelines. Information presented in these on-farm food safety materials was compiled from reputable sources, such as USDA-FSIS, FDA and the Food Safety Modernization Act final rules. The information is provided for educational purposes only and should not be considered legal advice. Therefore, no responsibility is assumed or implied by CSU, Chico Research Foundation or CSU, Chico. 10 Revision Date: July 24, 2016