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Emerging Issue: Analysis of Agricultural Water and Spent Sprout Irrigation Water Nancy Hall University of Iowa Hygienic Laboratory Kaiping Deng Illinois Institute of Technology Sprout Safety Alliance Don Stoeckel Cornell University Produce Safety Alliance Midwest Region Extension Associate Webinar with APHL 15 April 2019
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Emerging Issue:Analysis of Agricultural Water and Spent Sprout Irrigation Water
Nancy HallUniversity of Iowa Hygienic Laboratory
Kaiping DengIllinois Institute of TechnologySprout Safety Alliance
Don StoeckelCornell UniversityProduce Safety AllianceMidwest Region Extension Associate
Webinar with APHL15 April 2019
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Thank you
• For taking the time to be with us today• This information is confusing to many farms• Laboratories have agricultural stakeholders who are
affected by the FSMA Produce Safety Rule– Agricultural water requirements are different from other
requirements (drinking water, rec water, etc)– Agricultural water compliance dates recently extended
(other than sprouts)– Farms have responsibilities related to use of sanitary water
• Laboratories help farms address these responsibilities
Many Multi-State Produce Outbreaks
2006 E.coli O157 Spinach 2012 E.coli Spinach
2008 Salmonella Produce Salmonella Mangos
2008 Salmonella Cantaloupe 2013 Cyclospora Fresh Produce
2009 Salmonella Alfalfa Sprouts 2014 Salmonella, L.mono Sprouts
2010 Salmonella Alfalfa Sprouts (1) Cyclospora Cilantro
Salmonella Alfalfa Sprouts (2) E.coli 021 Clover Sprouts
Salmonella Alfalfa Sprouts (3) 2016 Salmonella Alfalfa Sprouts (1)
2011 E.coli O157 Romaine Salmonella Alfalfa Sprouts (2)
Listeria monocytogenes Cantaloupe Salmonella Alfalfa Sprouts (3)
Salmonella Alfalfa Sprouts L. mono Packaged Salads
Salmonella Cantelopes 2017-18 E.coli O157 Romaine
Impetus to establish produce safety standards
• Produce is vulnerable to these microorganisms of public health significance
https://www.cdc.gov/foodsafety/outbreaks/multistate-outbreaks/index.html
Assessment of Produce Contamination
• Called Qualitative Assessment of Risk (QAR); findings used to finalize FMSA Produce Rule
• 5 Major Routes of Contamination = provisions for this Rule– Agriculture water– Soil amendments– Animals– Workers health/hygiene– Equipment/buildings
– Seeds, additional route of contamination for sprouts
• Benefits of Produce Rule– Prevent microbial contamination and reduce foodborne
illness– Ultimately protect public health!
Water Testing Requirements for Sprout Growers
Kaiping DengSprout Safety Alliance
April 15, 2019
The Sprout Industry
Sprout Safety Alliance (SSA)
• A public-private alliance
• Goal - to enhance the sprout industry's understanding and implementation of best practices and the Produce Safety Ruleo Develop a core curriculumo Establish training and outreach
programs
Compliance Dates for Sprout Operations
Size of Operation
Average Annual Produce Sale
Compliance Date
Large >$500k January 26, 2017Small $250k-500k January 26, 2018
Very Small $25k-250k January 28, 2019
Sprouting Conditions
sprouting
Warm, humid and nutritious conditions
If 0.1% seed was contaminated(e.g., a few seeds in 1 kg)
The entire growing unit could be contaminated
Sprout Safety Concerns
• Seed can be contaminated on farm• Sprout germination conditions also encourage the
proliferation of pathogens• Sprouts can be contaminated during production• Outbreaks associated with sprouts have occurred
Multi-hurdle Strategies
• Sanitary production environment• Good worker health and hygiene practices• Safe seed and water • Seed treatment• Verification of control measures
• Spent sprout irrigation water testing• Environmental monitoring
Produce Safety Requirements
• Develop and follow a written plan of spent sprout irrigation water sampling and testing
• Aseptically collect samples of spent sprout irrigation water (or in-process sprouts)
• Test for E. coli O157:H7 and Salmonella• Hold product unless pathogen results are negative• Maintain records
Preparation for Sampling
• Samples must be collected in an aseptic manner• Equipment and tools for sample collection must
be sterile
“Production Batch of Sprouts”- “All sprouts that are started at the same time in a single growing unit
(e.g., a single drum or bin, or a single rack of trays that are connected to each other),
whether or not the sprouts are grown from a single lot of seed
(including, for example, when multiple types of seeds are grown in a single growing unit).”
What to Sample
• Sample every production batch
Alfalfa sprouts
Growing Batch Examples
Two batches
Growing Batch Examples
One batch Two or three batches
Green Sprouts
Growing Batch Examples
Two batches
Mung bean sprouts
How Much Water to Sample
• Collect 1.5 L of spent sprout irrigation water from each batch
• FDA recommends testing more samples/batch for batches > 2400 lbs (1100 kg)
Sampling Sprouts instead of Water
• When sampling sprout irrigation water is not feasible, testing in-process sprouts is required
• Collect 30 sub-samples (50 g each) from different locations throughout production batch to obtain a representative sample
Testing Timeline
Day 0
• Start batch
Day 2
• Take samples, send to lab
Day 3
• Lab starts test• Assumes 1
day for shipping
Day 4
• Presumptive results
• STOP if result is negative
Day 5-7
• Confirmed results
Criteria for a Testing Lab
• Qualified microbial pathogen testingo Examples of accredited labs for microbiological
testing Meets ISO 17025 standards or Accredited by state or national authority
• Trained and experienced staff
Testing Timeline
Day 0
• Start batch
Day 2
• Take samples, send to lab
Day 3
• Lab starts test• Assumes 1
day for shipping
Day 4
• Presumptive results
• STOP if result is negative
Day 5-7
• Confirmed results
What to Test for
• The presence or absence of two major pathogenso E. coli O157:H7o Salmonella species
Testing Methods• FDA reference methods:http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm114664.htm
• Scientifically valid methods equivalent to the FDA methods in accuracy, precision, and sensitivity
FDA Reference Method for E. coli O157:H7
• 100 ml water sample or 25 g sprout sample for enrichment
• Presumptive screening- real-time PCR• Confirmation – culture identification by
serology (colony morphology/selective media/ serological identification
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm114664.htm
FDA Reference Method for Salmonella
• 375 ml water sample or 375 g sprout sample for enrichment
• Presumptive screening- classic culture method with generic identification
• Confirmation testing- culture identification by serology
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm114664.htm
Equivalent Methods for Testing Salmonella in Sprout Water
• AOAC Official Method 999.08. Transia® AG SalmonellaEIA
• AOAC Official Method 999.09. VIP • AOAC Official Method 2011.03. VIDAS® Salmonella (SLM)
Easy Salmonella• AOAC Official Method 2016.01. 3M™ Molecular
Detection Assay (MDA) 2https://www.fda.gov/downloads/Food/FoodScienceResearch/LaboratoryMethods/UCM622917.pdf
Equivalent Methods for Testing E. coli O157:H7 in Sprout Water
• AOAC Official Method 996.09. VIP for EHEC Assay*
• AOAC Official Methods 2000.13 and 2000.14. Reveal for E. coli O157:H7*
• AOAC Official Method 2005.04. Assurance GDS® for E. coli O157:H7
Testing Timeline
Day 0
• Start batch
Day 2
• Take samples, send to lab
Day 3
• Lab starts test• Assumes 1
day for shipping
Day 4
• Presumptive results
• STOP if result is negative
Day 5-7
• Confirmed results
Testing Result Decision TreeWas the screen result presumptive positive for
a pathogen?
No
Releaseproduct
Yes
Must ask lab to run confirmatory tests on original enrichment
Continue growing cycle and HOLD
Was the final result confirmedpositive?
No
Release product
Yes
Complete corrective action
Stop growing, take in-housecorrective action
FDA Reference Method for E. coli O157:H7
• 100 ml water sample or 25 g sprout sample for enrichment
• Presumptive screening- real-time PCR• Confirmation – culture identification by
serology (colony morphology/selective media/ serological identification
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm114664.htm
FDA Reference Method for Salmonella
• 375 ml water sample or 375 g sprouts for enrichment
• Presumptive screening- classic culture method with generic identification
• Confirmation testing- culture identification by serology
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm114664.htm
Important Notes of Testing Spent Sprout Irrigation Water
• Loaded microbial background
Important Notes of Testing Spent Sprout Irrigation Water
(cont.)
• Confirmatory testing should be performed using the same enrichment from the original sample
• Screening test kits cannot be used for confirmation
Other Testing Requirements for Sprout Growers
• Environmental testing for ListeriaoAt least monthly
• Inspection of water systemoWater testing if:Water problem is identifiedWell water is usedWater treatment is done
SSA Technical Assistance Network
https://fspca.force.com/FSPCA/s/sprouts?language=en_US
Analysis of Agricultural Water for Fresh Produce
Webinar with APHL15 April 2019
Don StoeckelCornell UniversityProduce Safety AllianceMidwest Region Extension Associate
Presenter
Presentation Notes
This talk is scheduled for 20 minutes
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About Produce Safety Alliance
• Cooperative agreement between Cornell University, FDA, and USDA
• Established in 2010• Focused on outreach and education • Assist with meeting regulatory requirements
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Labs Are One Source of Info• Farms have many other sources for reliable information
– Produce Safety Alliance at Cornell University– Produce Safety Network at FDA– Regional Coordination Centers
• Northeast Center to Advance Food Safety (NECAFS) at University of Vermont• Western Regional Center to Enhance Food Safety (WRCEFS) (four sub-regions)• North Central Region (NCR) Center for FSMA Training, Extension, and Technical
Assistance at Iowa State University• Southern Regional FSMA Training Center (SC) for Training, Education, Extension,
Outreach and Technical Assistance to Enhance Produce Safety at Univ. Florida
– The Native American Tribal Center for Food Safety Outreach, Education, Training and Technical Assistance with the Indigenous Food and Agricultural Initiative (IFAI) at University of Arkansas
– The Local Food Safety Collaborative (LFSC) with National Farmer’s Union Foundation and National Young Farmers’ Coalition
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Compliance Timeframe• FSMA PSR compliance dates for water other than sprouts
were extended until 2022 or laterThe reason given for this extension is“to address questions about the practical implementation
of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to protect public health”
• The Produce Safety Alliance-hosted Water Summit was a forum to discuss concerns and needs
• What, if anything, will change by 2022?– FDA clarifies that the compliance date extension rule “… does not address the
underlying requirements in subpart E, but only the compliance dates for those requirements (for covered produce other than sprouts).”
– FDA’s documentation associated with the compliance date: the focus of FDA re-evaluation is on pre-harvest water testing requirements.
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Other Considerations
• Farms still have water-related requirements• FD&C Act: sale of adulterated food into interstate
commerce, by anyone, is prohibited (since 1906)• Produce Safety Rule, §112.11: covered farms must
prevent introduction of hazards into covered produce (by general compliance date)
A helpful message for farms:– No requirement to sample for water quality now– Ongoing responsibility to avoid contamination of produce
by avoiding, for example, non-sanitary water
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Currently in the PSR:Core Requirements for Water
• Annual inspection of the agricultural water system
• Testing for generic E. coli as an indication of quality for agricultural water
• Maintenance of agricultural water quality during use– “maintain its safety and adequate sanitary quality”
The compliance dates for water rules (Subpart E except for sprouts) in the PSR are 2022 or later. Requirements may change.
Presenter
Presentation Notes
This slide includes review information; for more information about requirements in the Produce Safety Rule please refer to the PSA Fact Sheet FSMA Produce Safety Rule Water Requirements: Insights to Get You Organized! available at http://producesafetyalliance.cornell.edu under General Resources/Water
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Not All Water is Covered• Agricultural water used with a direct water
application method to covered produce• Agricultural water means water used in covered activities on
covered produce where water is intended to, or is likely to, contact covered produce or food contact surfaces.
• Direct water application method means using agricultural water in a manner whereby the water is intended to, or is likely to, contact covered produce or food contact surfaces during use of the water.
• Covered produce means produce that is subject to the Produce Safety Rule. The term “covered produce” refers to the harvestable or harvested part of the crop.
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§ 112.44(b): When you use agricultural water during growing activities for covered produce (other than sprouts) using a direct water application method, the following criteria apply (unless you establish and use alternative criteria in accordance with §112.49): (sub bullets deleted)
Criteria for Production Water
• Summary– For water used during production, two statistics based on
long-term E. coli test results are used as criteria:• Geometric Mean of 126 or less CFU/100 mL of water
AND• Statistical Threshold Value of 410 or less CFU/100 mL
The compliance dates for water rules (Subpart E except for sprouts) in the PSR are 2022 or later. Requirements may change.
Presenter
Presentation Notes
These same statistics and values can be found in recreational water monitoring. Don’t get confused by the similarities in the criteria. The agricultural water criteria are based on a different number of samples, and the samples might be collected in different places and at different times compared with recreational water systems. Later slides discuss the differences between monitoring strategies between recreational water and agricultural water. It is important information for laboratories to know what farm monitoring goals are. This affects recommendations about when and where to collect water samples if laboratories address these questions with farms.
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More Information About Production Water Criteria
FDA is re-evaluating the criteria and other requirements• There is no single-sample maximum in the Produce Rule
– This is different from some audit standards, like LGMA– There is no actionable level other than the calculated statistics
• The grower, the lab, or somebody else will need to calculate the statistics (GM and STV) for the farm– The statistics are calculated similar to the EPA 2012 revised
Recreational Water Quality Criteria but typically use a 4-year data set
The geometric mean (GM) is a log-scale average, the “typical” value
The statistical threshold value (STV) is a measure of variability, the estimated “high range” value (approximated 90th percentile)
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Other Information About Production Water Criteria
• The statistics (GM and STV) as used in the PSR are called a Microbial Water Quality Profile (MWQP)– Spreadsheets and extension documents are available
Publicly-Available Calculator Tools • wcfs.ucdavis.edu/• agwater.arizona.edu/• agwater.arizona.edu/onlinecalc/
Produce Safety Alliance Fact Sheet• producesafetyalliance.cornell.edu/
resources/general-resource-listing/
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§ 112.44(a): When you use agricultural water for any one or more of these following purposes, you must ensure there is no detectable generic Escherichia coli (E. coli) in 100 milliliters (mL) of agricultural water, and you must not use untreated surface water for any of these purposes (sub bullets deleted)
Criteria for Postharvest Water
• Summary– For water used during postharvest, E. coli test is required:
• No detectable E. coli in 100 mL water– Postharvest uses include washing and cooling produce,
harvest bin and pack house sanitation (food contact surfaces), hand washing, and others
– Untreated surface water cannot be used in postharvest even if the water is tested and meets the criterion
The compliance dates for water rules (Subpart E except for sprouts) in the PSR are 2022 or later. Requirements may change.
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Test methods
• FDA created a list of methods that are considered equivalent to modified mTEC (EPA Method 1603)– Similar to, but not the same as, EPA’s lists of approved
methods for ambient, drinking, and ground water– Other methods may also be used if there is scientific
information that supports equivalency
§ 112.151: You must test the quality of water using (a) The method of analysis published by the U.S. Environmental Protection Agency (EPA), “Method 1603 …” or (b) A scientifically valid method that is at least equivalent … in accuracy, precision, and sensitivity; or (c) For any other indicator of fecal contamination … a scientifically valid method
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FDA Fact Sheet: Equivalent Water Testing Methodologies (Quantitative)
Cited method in FDA Fact Sheet
Shorthand method name
EPA Method 1603 Modified mTEC agarEPA Method 1103.1, Standard Methods 9213 D, ASTM method D5392-93
mTEC agar
EPA Method 1604 MI agarStandard Methods 9222 B followed by 9222 G
m-Endo followed by NA-MUG agar
Hach method 10029 m-ColiBlue 24 ampules
Product/medium named in FDA Fact Sheet
Method notes
IDEXX Colilert test kit, only if using Quanti-Tray/2000
IDEXX Colilert-18 test kit, only if using Quanti-Tray/2000
Most probable number methods (quantitative)
Prod
uctio
n or
Pos
thar
vest
Wat
er
Membrane filtration methods (quantitative)
There are several formats for Colilert, be sure the lab uses the FDA-named quantitative format. One reference protocol for this product is Standard Methods 9223B.
www.fda.gov/downloads/Food/FoodScienceResearch/LaboratoryMethods/UCM575255.pdf
Presenter
Presentation Notes
In September 2017, FDA released a fact sheet that recognized several equivalent methods for enumeration of generic E. coli in agricultural water. The fact sheet states: FDA has determined that the following methods are “scientifically valid” and “at least equivalent to the method of analysis in § 112.151(a) in accuracy, precision, and sensitivity”. The methods are described in the slide, and references are provided below The list includes some, but not all, of the EPA-accepted methods for monitoring under the Clean Water Act (often, recreational water monitoring) that are listed in 40 CFR 136.3 Additional Resources: FDA Fact Sheet 2017. Equivalent Testing Methodologies for Agricultural Water. Available at www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm575251.htm EPA 2006. Method 1603: Escherichia coli (E. coli) in Water by Membrane Filtration Using Modified membrane-Thermotolerant Escherichia coli Agar (Modified mTEC). U.S. Environmental Protection Agency. EPA-821-R-06-011 EPA 2010. Escherichia coli (E. coli) in Water by Membrane Filtration Using membrane-Thermotolerant Escherichia coli Agar (mTEC). U.S. Environmental Protection Agency. EPA-821-R-10-002. APHA 2012. Natural Bathing Beaches (2007). In: Standard Methods for the Examination of Water and Wastewater, 22nd Edition (Rice E.W., et al., Ed.), 9-46 – 9-48. Washington, DC: American Public Health Association. (2012) ASTM 2000. Standard Test Method for Isolation and Enumeration of Escherichia coli in Water by the Two-Step Membrane Filter Procedure. In: Annual Book of ASTM Standards, Volume 11.02. ASTM International. (1996, 1999, 2000) Hach Company. Coliforms, Total and E. coli: m-ColiBlue24 Broth PourRite Ampules. Doc316.53.01213, Method 10029, Hach Company APHA 1997. Standard Total Coliform Membrane Filter Procedure (1997), followed by 9222 G – MF Partition Procedures (1997) using NA-MUG media. In: Standard Methods for the Examination of Water and Wastewater, 21st Edition (Eaton A.D., et al., Ed.), 9-60 – 9-65, and 9-70 – 9-71, respectively. Washington, DC: American Public Health Association. (2005). EPA 2002. Method 1604: Total Coliforms and Escherichia coli in Water by Membrane Filtration Using a Simultaneous Detection Technique (MI Medium). U.S. Environmental Protection Agency. EPA-821-R-02-024 Idexx, Inc. Colilert. Available at www.idexx.com/water/products/colilert.html Idexx, Inc. Colilert-18. Available at www.idexx.com/water/products/colilert-18.html
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FDA Fact Sheet: Equivalent Water Testing Methodologies (P/A)
Product/medium named in FDA Fact Sheet
Manufacturer/source
TECTATM EC/TC medium and instrument
Veolia Water Technologies
Modified Colitag, ATP D05-0035
CPI International
IDEXX Colilert test kit IDEXX Laboratories, Inc.IDEXX Colilert-18 test kit IDEXX Laboratories, Inc.IDEXX Colisure test kit IDEXX Laboratories, Inc.E*Colite Bag or Vial test Charm SciencesReadycult Coliforms 100 EMD Millipore, catalog 101298
Post
harv
est W
ater
Onl
y
Presence/absence methods (in 100 mL)
www.fda.gov/downloads/Food/FoodScienceResearch/LaboratoryMethods/UCM575255.pdf
Presenter
Presentation Notes
In July 2018, FDA updated the 2017 fact sheet to recognize presence/absence methods considered suitable for analysis of only postharvest agricultural water. TECTATM EC/TC medium and the TECTATM Instrument: A Presence/Absence Method for the Simultaneous Detection of Total Coliforms and Escherichia coli (E. coli) in Drinking Water. (2014). Veolia Water Technologies http://technomaps.veoliawatertechnologies.com/tecta/en/ Modified ColitagTM Test Method for the Simultaneous Detection of E. coli and other Total Coliforms in Water. ATP D05-0035. (2009). http://www.colitag.com/ IDEXX Colilert Test Kit https://www.idexx.com/en/water/water-products-services/colilert/ IDEXX Colilert-18 Test Kit https://www.idexx.com/en/water/water-products-services/colilert-18/ IDEXX Colisure Test Kit https://www.idexx.com/en/water/water-products-services/colisure/ E*Colite Bag or Vial Test for Total Coliforms and E. coli in Potable Water. Charm Sciences, Inc. https://www.charm.com/products/test-and-kits/microbial-detection-tests/ecolite-test/ 101298 Readycult Coliforms 100. EMD Millipore (division of Merck KGaA, Darmstadt, Germany). https://www.emdmillipore.com/US/en/product/Coliforms-100,MDA_CHEM-101298?CatalogCategoryID= The image on the top left is a membrane filtration test on modified mTEC; the image on the top right is a Colilert or Colilert-18 most-probable number test on Quantitray 2000. The image on the bottom is E*Colite Bag test (Charm Sciences) Additional Resources: FDA Fact Sheet 2018. Equivalent Testing Methodologies for Agricultural Water. Available at www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm575251.htm Idexx, Inc. Colilert. Available at www.idexx.com/water/products/colilert.html Idexx, Inc. Colilert-18. Available at www.idexx.com/water/products/colilert-18.html Code of Federal Regulations 2018 Alternative Testing Methods for Contaminants Listed at 40 CFR 141.21(f)(6) (E. coli) Modified Colitag Reference 13: Modified ColitagTM Method, “Modified ColitagTM Test Method for the Simultaneous Detection of E. coli and other Total Coliforms in Water (ATP D05-0035),” August 28, 2009. Available at http://www.nemi.gov or from CPI, International, 580 Skylane Boulevard, Santa Rosa, CA 95403 Code of Federal Regulations 2018 Alternative Testing Methods for Contaminants Listed at 40 CFR 141.402(c)(2) (E. coli) Readycult reference 20: Readycult® Method, “Readycult® Coliforms 100 Presence/Absence Test for Detection and Identification of Coliform Bacteria and Escherichia coli in Finished Waters,” January, 2007. Version 1.1. Available from EMD Millipore (division of Merck KGaA, Darmstadt, Germany), 290 Concord Road, Billerica, MA 01821 Colilert, Colisure, Colilert-18 referenced as Standard Methods 9223 B Tecta EC/TC Reference 33: Tecta EC/TC. “TechtaTMEC/TC Medium and TechtaTMInstrument: A Presence/Absence Method for the Simultaneous Detection of Total Coliforms and Escherichia coli (E. coli) in Drinking Water,” version 1.0, May 2014. Available from Pathogen Detection Systems, Inc., 382 King Street East, Kingston, Ontario, Canada, K7K 2Y2 Tecta EC/TC Reference 43: Tecta EC/TC. “TectaTM EC/TC Medium and the TectaTM Instrument: A Presence/Absence Method for the Simultaneous Detection of Total Coliforms and Escherichia coli (E. coli) in Drinking Water,” version 2.0, February 2017. Available from Pathogen Detection Systems, Inc., 382 King Street East, Kingston, Ontario, Canada, K7K 2Y2 Charm Sciences web site E*Colite Vial Test for Total Coliforms and E. coli in Potable Water: resources.charm.com/file/120 E*Colite: Test for Total Coliforms and E. coli in Potable Water: resources.charm.com/file/89
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Sampling Production Water• Build a 4-year data set under current PSR system
– For Ground water, 4 or more samples• Initial set of 4 or more samples over 1 year• 1 new sample added every year, 1 old sample may be dropped
– For Surface water, 20 or more samples• Initial set of 20 or more samples over 2-4 years• Ongoing rolling data set includes 4 years’ prior data• At least 5 new samples added every year
– Public water supply water: annual assurance from utility
• Compare this data set to the 5 samples over 30 days system often used for beaches
The compliance dates for water rules (Subpart E except for sprouts) in the PSR are 2022 or later. Requirements may change.
Presenter
Presentation Notes
The sampling requirements for postharvest water (ground water only) are the same; the difference is the criteria)
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When Labs May See Samples• Samples for compliance may begin arriving in 2022
For Farms Over $500,000 Annual Produce Sales
Sampling Schedule,MWQP
Compliance Date January 26, 2022All water requirements (other than sprouts)Water Source Type Surface Ground
Production WaterTypical growing season to meet requirements:
Begin Sampling 2022 2022
Complete Initial MWQP
By end of 2025
By end of 2022
Use MWQP to Make Decisions 2026 2023
• Small businesses (>$250K – 500K)• Compliance and
Sampling year = Table +1 year
• Very small businesses (up to $250K)• Compliance and
Sampling year = Table +2 years
The compliance dates for water rules (Subpart E except for sprouts) in the PSR are 2022 or later. Requirements may change.
Presenter
Presentation Notes
Activity schedule consistent with compliance dates, as described in Comment 6 of the final rule Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E. Published in the Federal Register 3/18/2019 MWQP requirements may change prior to the compliance date, which could change the requirements depicted in this table. Remember that farms selling less that $25K in produce (inflation adjusted) are exempt from the Produce Safety Rule and therefore they do not have to sample for compliance. The compliance date is January 26, 2022. The response to Comment 6 begins "Farms are not required to have completed a MWQP by their compliance date. A farm's compliance date means the date on which the farm must begin sampling a water source for its initial survey, which will eventually result in a MWQP" and goes on to say "compliance must begin by the first relevant time period that occurs after the compliance date." The response to comment 6 also provides scenarios consistent with the above table of activities. FDA is re-evaluating the requirements of Subpart E, and requirements may change prior to the compliance dates.
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§ 112.47: You may meet the requirements related to agricultural water testing required under § 112.46 using: (sub bullets deleted)
Sampling and Analysis
• Summary– The covered farm is responsible for appropriate sampling– Samples need to be collected properly (aseptic technique)– Only certain lab testing methods are allowed
Sterile bottles
Sampling technique
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Sample Delivery• FDA made no hold time specifications in the Produce
Safety Rule– Hold time requirements listed in some methods– Consider reference to Standard Methods 9060B
• Non-potable water for compliance purposes, quantitative test– Deliver within 6 hours of collection, sample analysis within 8 hours
• Prior to compliance date, quantitative tests for non-compliance– Do not exceed 24 hours hold time
• Drinking water, using presence/absence test, for compliance– Do not exceed 30 hours hold time
– Future guidance from FDA may address hold time
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Lab Mapping Effort• Initiative to map available laboratories for farm contact
– Aware of requirements– Offer analysis using
FDA-acceptable methods
Maps or lists of labs for ag water testing• Northeastern states map• Colorado map• Hawaii list• Iowa map, list• Kansas map• Kentucky map• Michigan fact sheet with map and list• Minnesota map• Missouri map• New Hampshire list• New Jersey map• North Carolina list• Virginia map, list• Washington map• Wisconsin map
Presenter
Presentation Notes
Laboratories may request to be added to these maps
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Record keeping
• The farm must keep results of all analytical tests in the farm records while used in a MWQP (4 years)
• Does the lab have to provide results to the state?– Each state can have its own inspectional system– Your state’s regulatory authority may have information
about providing results related to compliance• FDA may conduct compliance inspections in lieu of the State• The State may conduct compliance inspections under FDA
inspectional authority• The State may conduct compliance inspections under their own
inspectional authority
The compliance dates for water rules (Subpart E except for sprouts) in the PSR are 2022 or later. Requirements may change.
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Information for Farms• Farms may ask labs for help with
– Sample collection kits (sterile bottles)– Sampling instructions– Documentation (analytical results)– How to calculate MWQP statistics
• FDA recommends that farms– Are not expected to implement subpart E (including water sampling)
until the extended compliance dates (2022-2024)– Should focus attention on good agricultural practices
• Maintain water quality• Protect sources of water
– Continue testing water programs, or opt to begin testing
Presenter
Presentation Notes
(Comment 9) Comments stated that FDA should clearly communicate its expectations of agricultural water users during the extension. (Response 9) With this final rule, we are extending the compliance dates for subpart E of the produce safety regulation for covered produce other than sprouts. FDA will therefore not expect growers of covered produce(other than sprouts) to implement subpart E until the new compliance dates. In the meantime, farms should focus their attention on good agricultural practices to maintain and protect the quality of their water sources. (See, e.g., FDA’s ‘‘Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,’’ at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm064574.htm). Farms currently testing their water may choose to continue with their current water testing programs, and farms that are not currently testing their water may choose to begin doing so.
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Water-Specific Resources• PSA Fact Sheet The Water Analysis Method Requirement in the FSMA
Produce Safety Rule (rev 01/2018 link here) (being revised)• PSA Fact Sheet Geometric Means, Statistical Threshold Values, and
Microbial Die-Off Rates (longhand calculations) (02/17/2017 link here)• Western Center for Food Safety Tools to calculate Geometric Mean and
Statistical Threshold Value (UC Davis and University of Arizona link here)• FDA Fact Sheet Equivalent Testing Methodologies for Agricultural Water
(07/03/2018 link here)• FDA Question and Answer Sheet FSMA Final Rule for Produce Safety: How
Did FDA Establish Requirements for Water Quality and Testing of Irrigation Water? (November 2015; link here)
• FDA Rule Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E (03/18/2019 link here)
Presenter
Presentation Notes
PSA Fact Sheet The Water Analysis Method Requirement in the FSMA Produce Safety Rule (rev 01/2018 �https://producesafetyalliance.cornell.edu/sites/producesafetyalliance.cornell.edu/files/shared/documents/Water-Analysis.pdf) PSA Fact Sheet Geometric Means, Statistical Threshold Values, and Microbial Die-Off Rates (longhand calculations) (02/17/2017 �https://producesafetyalliance.cornell.edu/sites/producesafetyalliance.cornell.edu/files/shared/documents/2017 GM STV Worksheet v1.0.pdf) Western Center for Food Safety Tools to calculate Geometric Mean and Statistical Threshold Value (UC Davis and University of Arizona �http://wcfs.ucdavis.edu/) FDA Fact Sheet Equivalent Testing Methodologies for Agricultural Water (9/11/17 �https://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm575251.htm) FDA Question and Answer Sheet FSMA Final Rule for Produce Safety: How Did FDA Establish Requirements for Water Quality and Testing of Irrigation Water? (November 2015; �https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm472501.htm) FDA Rule Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E (03/18/2019) https://www.federalregister.gov/documents/2019/03/18/2019-04652/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption-extension
Suggestions to Laboratories• Contact the FSMA regional centers in your area
to see what impact this rule will have on your lab and how you can help– Iowa: 20 full compliance; 1000 qualified
compliance with no water testing at this time but could change depending on year
• Understand water testing aspects of rule to guide farmers what test and how many tests are needed, esp PA or Quantitative (MPN or CFU)– Automatic bottle order program helpful
• Provide a test result endpoint for the GM and STV calculations; NOT > values!– Examples: Colilert QT 2000, perform 1:10 dilution
for a range of 10-24000 MPN/100mL; for E.coli MF, use 10,1,0.1 mL sample for range of 10-60,000 CFU/100L
In Summary…
Suggestions to Labs (continued)
• Provide good collection instructions that includes aseptic techniques; poor collection can impact results
• If you have the capability to perform SSIW or sprout testing for Salmonella, need PCR method validations utilizing better enrichments to reduce the TAT and increase sensitivity– PCR will greatly shorten TAT (e.g. 7 to 4
days for neg)– For PCR and this challenging matrix, lactose
broth does not appear to be ideal– Enrichment alternatives could be Universal
Preenrichnment Broth (FDA) and 2XSelenite broth (SHL)
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APHL• Robyn Randolph, [email protected]• www.aphl.org
Iowa State Hygienic Laboratory@UI• Nancy Hall, [email protected]• www.shl.uiowa.edu
Sprout Safety Alliance• Kaiping Deng, [email protected]• www.ifsh.iit.edu/ssa
Produce Safety Alliance • Don Stoeckel, [email protected]• Any member of the PSA team• producesafetyalliance.cornell.edu
Questions?
