FSMA

FDA-approved test methods A Tool For Microbial Water Quality Profile (MWQP) Evaluation
As Per Produce Safety Rules (PSR)
Under Food Safety Modernization Act (FSMA)
(21CFR112)

Water requirements don't go into effect until January 2022 for large farms (more than $500,000 in average sales),
January 2023 for small farms (between $250,000 to $500,000 in average sales), and
January 2024 for very small farms (between $25,000 and $250,000 in average sales).

Uttam Saha, Rick Hitchcock, and Leticia Sonon

While using this Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) Online Calculator developed by University of Georgia (UGA), Agricultural and Environmental Services Laboratories (AESL), I agree with the following:
  1. I am using this FSMA Produce Safety Rule Online calculator and interpreter with my own responsibility.
  2. I understand the interpretation and advice obtained from this tool is based on FSMA produce safety rules and guidelines.
  3. This service is to assist the growers so that they can understand their current status of Microbial Water Quality Status corresponding relevant FSMA-PSR and make decisions their agricultural practices.
  4. The required data imported in this tool is accessible to the current users only. Multiple users using this tool at the same time will not be able to view, save, and use each other’s data.
  5. The tool neither keeps any personal information, nor water quality test results, nor sends them anywhere else.

Determine if your farm falls under the
Produce Safety Rules of the FSMA-FDA

Coverage and Exemptions/Exclusions for 21 PART 112

The Preventive Controls for Human Food rule clarified the definition of a farm to cover two types of farm operations, primary production farms and secondary activities farms. The same definition is used in the Produce Safety rule (section 112.3).

Below are basic criteria that determine whether an operation that meets the definition of “farm” is subject to the produce rule.

Does your farm grow, harvest, pack or hold produce?

Sections 112.1 and 112.3
We define "produce" in section 112.3.

Your farm is NOT covered by this rule.

Even though your activities are not covered by FSMA, consider water testing for safety of your produces to the workers and consumers.

Does your farm on average (in the previous three years) have $25k or less in annual produce sales?

Section 112.4(a)

Your farm is NOT covered by this rule.

Even though your activities are not covered by FSMA, consider water testing for safety of your produces to the workers and consumers.

Is your produce one of the commodities that FDA has identified as rarely consumed raw?

Section 112.2(a)(1)

If you grow, harvest, pack or hold more than one produce commodity, you must ask this question separately for each one to determine whether that particular produce commodity is covered by this rule.

This produce is NOT covered by this rule.

Even though your activities are not covered by FSMA, consider water testing for safety of your produces to the workers and consumers.

Is your produce for personal/on-farm consumption?

Section 112.2(a)(2)

This produce is NOT covered by this rule.

Even though your activities are not covered by FSMA, consider water testing for safety of your produces to the workers and consumers.

Is your produce intended for commercial processing that adequately reduces pathogens (for example, commercial processing with a “kill step”)?

Section 112.2(b)

This produce is eligible
for exemption from the rule,
provided you make certain statements in documents accompanying the produce, obtain certain written assurances, and keep certain documentation, as per Sections 112.2(b)(2) through (b)(6).

Does your farm on average (in the previous three years) as per Section 112.5:
have < $500k annual food sales,
AND
a majority of the food (by value) sold directly to “qualified end-users”?

Section 112.3

"Qualified End-User" as defined in Section 112.3 means:
  • the consumer of the food OR
  • a restaurant or retail food establishment that is located –
    1. in the same State or the same Indian reservation as the farm that produced the food; OR
    2. not more than 275 miles from such farm.
(The term “consumer” does not include a business.)

Your farm is eligible for a qualified exemption from this rule,
which means that you must comply with certain modified requirements and keep certain documentation, as per Sections 112.6 and 112.7.

YOU ARE COVERED BY THIS RULE.

What would you like to do?

Microbial Water Quality Profile (MWQP)
Calculation, Interpretation and Recommendations Tool
as per new Produce Safety Rules of FMSA

What is the type of use?
(Choose from one column, and check all that apply.)


What is the water source?


What is the stage of testing?


What is your test result?


What is the water source?


What is the stage of testing?


Test Result:

Do you already have geometric mean (GM) and statistical threshold (STV) calculated for a minimum of 20 samples test results for E. coli, collected as close as is practicable to harvest over the course of 2-4 years?

GM (Geometric Mean)
STV (Statistical Threshold)
Calculated Maximum Interval Between:
1) Last Irrigation and Harvest
or
2) Harvest and End of Storage

Results met the relevant produce safety criteria for initial survey. Water use can be continued for the selected purpose.

Keep testing at least 5 times annually using a minimum of one sample per occasion to demonstrate the relevant Geometric mean (GM) and Statistical Threshold Value (STV) to be obtained including those new samples are met.

Results do not meet the relevant produce safety criteria for initial survey.

Water use can be continued contingent corrective measure are required as soon as is practicable, but no later than the next year.

The other options include:

  1. Allow time for potentially dangerous microbes to die off on the field by using a certain time interval between last irrigation and harvest, but no more than four consecutive days.
  2. Allow time for potentially dangerous microbes to die off between harvest and end of storage, or to be removed during commercial activities such as washing, within appropriate limits.
  3. Treat the water.

Keep testing at least 5 times annually using a minimum of one sample per occasion to demonstrate the new Geometric mean (GM) and Statistical Threshold Value (STV) to be obtained including those samples are ≤126 MPN/100 mL and ≤410 MPN/100 mL, respectively.

Do you already have geometric mean (GM) and statistical threshold (STV) calculated for a minimum of 4 samples test results for E. coli, collected as close as is practicable (but prior) to harvest, during the growing season or over a period of one year?

GM (Geometric Mean)
STV (Statistical Threshold)
Calculated Maximum Interval Between:
1) Last Irrigation and Harvest
or
2) Harvest and End of Storage

Results met the relevant produce safety criteria for initial survey. Water use can be continued for the selected purpose.

Keep testing once annually using a minimum of one sample to demonstrate the new Geometric mean (GM) and Statistical Threshold Value (STV) to be obtained including those samples are ≤126 MPN/100 mL and ≤410 MPN/100 mL, respectively.

Results do not meet the relevant produce safety criteria for initial survey.

Water use can be continued contingent corrective measure are required as soon as is practicable, but no later than the next year.

The other options include:

  1. Allow time for potentially dangerous microbes to die off on the field by using a certain time interval between last irrigation and harvest, but no more than four consecutive days.
  2. Allow time for potentially dangerous microbes to die off between harvest and end of storage, or to be removed during commercial activities such as washing, within appropriate limits.
  3. Treat the water.

Keep testing at least once a year to demonstrate the new Geometric mean (GM) and Statistical Threshold Value (STV) to be obtained including this sample are ≤126 MPN/100 mL and ≤410 MPN/100 mL, respectively.

Do you already have geometric mean (GM) and statistical threshold (STV) calculated for a minimum of 20 E. coli samples comprising 15 previous most recent samples plus 5 new samples collected as close as is practicable to harvest over the course of one year?

GM (Geometric Mean)
STV (Statistical Threshold)
Calculated Maximum Interval Between:
1) Last Irrigation and Harvest
or
2) Harvest and End of Storage

Results met the relevant produce safety criteria. Water use can be continued for the selected purpose.

Keep testing at least 5 times annually using a minimum of one sample per occasion to demonstrate the new Geometric mean (GM) and Statistical Threshold Value (STV) to be obtained including those samples are ≤126 MPN/100 mL and ≤410 MPN/100 mL, respectively.

Results do not meet the relevant produce safety criteria.

Water use can be continued contingent corrective measure are required as soon as is practicable, but no later than the next year.

The other options include:

  1. Allow time for potentially dangerous microbes to die off on the field by using a certain time interval between last irrigation and harvest, but no more than four consecutive days.
  2. Allow time for potentially dangerous microbes to die off between harvest and end of storage, or to be removed during commercial activities such as washing, within appropriate limits.
  3. Treat the water.

Keep testing at least 5 times annually using a minimum of one sample per occasion to demonstrate the new Geometric mean (GM) and Statistical Threshold Value (STV) to be obtained including those samples are ≤126 MPN/100 mL and ≤410 MPN/100 mL, respectively.

Do you already have geometric mean (GM) and statistical threshold (STV) calculated for a minimum of 4 E. coli samples comprising 3 previous most recent samples plus 1 new sample collected as close as is practicable to harvest over the course of one year?

GM (Geometric Mean)
STV (Statistical Threshold)
Calculated Maximum Interval Between:
1) Last Irrigation and Harvest
or
2) Harvest and End of Storage

Results met the relevant produce safety criteria.

Water use can be continued for the selected purpose.

Keep testing at least one sample per year to demonstrate the new Geometric mean (GM) and Statistical Threshold Value (STV) to be obtained including this sample are <126 MPN/100 mL and <410 MPN/100 mL, respectively.

Results do not meet the relevant produce safety criteria.

Water use can be continued contingent corrective measure are required as soon as is practicable, but no later than the next year.

The other options include:

  1. Allow time for potentially dangerous microbes to die off on the field by using a certain time interval between last irrigation and harvest, but no more than four consecutive days.
  2. Allow time for potentially dangerous microbes to die off between harvest and end of storage, or to be removed during commercial activities such as washing, within appropriate limits.
  3. Treat the water.

Keep testing at least one sample per year to demonstrate the new Geometric mean (GM) and Statistical Threshold Value (STV) to be obtained including this sample are <126 MPN/100 mL and <410 MPN/100 mL, respectively.


Interpretation and Recommendations:

Not allowed
There is no requirement to test any agricultural water when the water is treated in accordance with the requirements of the section 112.43 of FSMA-PSR [see section 112.46(a)(3)]. It is a good idea to use treated water.
Meets the relevant produce safety criteria. Water use can be continued for the selected purpose. Test 4 times during the growing seasons or over a period of one year demonstrate E. coli is absent all 4 initial tests.
Does not meet the relevant produce safety criteria. Water use must be immediately discontinued and corrective measure taken. Test 4 times during the growing seasons or over a period of one year demonstrate E. coli is absent all 4 initial test.
Results met the relevant produce safety criteria. Water use can be continued for the selected purpose. Keep testing once annually using a minimum of one sample to demonstrate the absence of E. coli in the test results.
Results do not meet the relevant produce safety criteria. Water use must be immediately discontinued and corrective measure taken and re-testing shows absence of E. coli before re-use. Resume testing at least four times per growing season or year to demonstrate absence of E. coli in 4 consecutive sample test results.
Testing not needed as long as it meets requirements established in the rule (provided that the farm has Public Water System results or certificates of compliance demonstrating that the water meets relevant requirements), or if the water is treated in compliance with the FSMA’s treatment requirements.

Enter your data below. (You can copy/paste from Excel.)

Your name (optional)
Choose default units:

Measurement
Number
Date of Sample
(mm/dd/yyyy)
E. coli
Test Result
Results expressed as:
1
20 samples are required for compliance.
MWQP Parameter Your Microbial Water Quality Status
(MWQS)
Produce Safety Rule Criteria
(PSR)
Geometric Mean (GM) ≤126
90th percentile or
Statistical Threshold Value (STV)
≤410
Calculated Maximum Interval Between:
1) Last Irrigation and Harvest
or
2) Harvest and End of Storage
Is this Option Applicable Based on MWQP? Required Interval to Meet the
GM of PSR
(days)
Required Interval to Meet the
STV of PSR
(days)
INTERVAL TO BE ACTUALLY APPLIED
(days)
Yes

No. The MWQP shows too high E. coli counts, which prevents the use of this option.

Corrective measure is required to lower the level of E. coli, and re-testing is required.

COVERED PRODUCE VERSUS NOT-COVERED PRODUCE
AND THEIR PRACTICAL APPLICATIONS UNDER PRODUCE SAFETY RULES OF FSMA 1,2,3,4

A Covered produce is a produce that is subject to the produce safety rules under FSMA; these are the produce that are "usually consumed raw" in their unprocessed states.

FDA’s current list of covered produce includes, but is not limited to the following crops:

Almonds, apples, apricots, apriums, Artichokes-globe-type, Asian pears, avocados, babacos, bananas, Belgian endive, blackberries, blueberries, boysenberries, brazil nuts, broad beans, broccoli, Brussels sprouts, burdock, cabbages, Chinese cabbages (Bok Choy, mustard, and Napa), cantaloupes, carambolas, carrots, cauliflower, celeriac, celery, chayote fruit, cherries (sweet), chestnuts, chicory (roots and tops), citrus (such as clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines, tangors, and uniq fruit), cowpea beans, cress-garden, cucumbers, curly endive, currants, dandelion leaves, fennel-Florence, garlic, genip, gooseberries, grapes, green beans, guavas, herbs (such as basil, chives, cilantro, oregano, and parsley), honeydew, huckleberries, Jerusalem artichokes, kale, kiwifruit, kohlrabi, kumquats, leek, lettuce, lychees, macadamia nuts, mangos, other melons ( such as Canary, Crenshaw and Persian), mulberries, mushrooms, mustard greens, nectarines, onions, papayas, parsnips, passion fruit, peaches, pears, peas, peas-pigeon, peppers (such as bell and hot), pine nuts, pineapples, plantains, plums, plumcots, quince, radishes, raspberries, rhubarb, rutabagas, scallions, shallots, snow peas, soursop, spinach, sprouts (such as alfalfa and mung bean), strawberries, summer squash (such as patty pan, yellow and zucchini), sweetsop, Swiss chard, taro, tomatoes, turmeric, turnips (roots and tops), walnuts, watercress, watermelons, and yams.

Here is the FDA’s current complete list of produce that are "rarely consumed raw.":

Asparagus; black beans; great Northern beans; kidney beans; lima beans; navy beans; pinto beans; garden beets (roots and tops); sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.

Here are few examples in this regard:

If your farm grows only produce that is included in the FDA’s above list of "rarely consumed raw," then this rule does not apply to you, because your produce is not called covered produce.

If, however, your farm grows both covered and not-covered produce, and this rule will apply to the covered produce that your farm grows, if the not-covered produce is kept separate from the covered produce.

Name of the User:
MWQP Calculator and Interpreter Use Date:
Type of Use:
Type of Water:
Stage of Testing:
Disclaimer: Interpretations and recommendations given by this on-line tool, developed by University of Georgia (UGA), Agricultural and Environmental Services Laboratories (AESL), are based on Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR). However, your auditor reserves the final authority to determine your actual status of compliance or non-compliance regarding microbial water quality.