Let the Record Reflect—FSMA Produce Safety Record Keeping for Water- Part I

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Produce production requires lots of water — water for irrigation, water for cleaning tools and facilities, water for cleaning the produce, etc. Water used on farms can come from a variety of sources — from wells, ponds, streams, rivers, captured rainwater, lakes, and even municipal water sources. The Food Safety Modernization Act (FSMA) Produce Safety Rule has numerous regulatory requirements related to water use designed to ensure that water that touches produce is not contaminated with bacteria that might cause illness. These regulations center around testing requirements which vary depending upon the source of the water and how it is used. Testing requirements will be phased in based upon the size of the farm:

· Farms with sales over $500,000 will have to comply beginning January 2022

· Farms with sales from $250,000 — $500,000 will have to comply beginning January 2023

· Farms with sales under $250,000 will have to comply beginning January 2024.

Yes — the FSMA Produce Safety Rule water regulations will eventually apply to ALL FARMS that sell produce — even down to the small family farm selling at the local farmer’s market.

The FSMA Produce Safety Rule applies to “agricultural water,” which is defined as:

water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food contact surfaces, including water used in growing activities (including irrigation water applied using direct water application methods, water used for preparing crop sprays, and water used for growing sprouts) and in harvesting, packing, and holding activities (including water used for washing or cooling harvested produce and water used for preventing dehydration of covered produce)

21 CFR §112.3. One very important point to keep in mind is that if the water does not actually touch the produce — such as drip irrigation used to water tomato plants — it is not “agricultural water.” Only water that actually touches the produce (or touches a surface that touches the produce) is “agricultural water.”

If water used on the farm meets the definition of “agricultural water,” then what kind of testing does the farmer have to do and what records does she have to keep? The FDA has selected generic e. coli as the indicator of water quality. Consequently, the testing required by the Produce Safety Rule is for generic e. coli. The amount of e. coli permitted to be present in the water depends on how and when the water is used.

Water used during growing can have:

· No more than 126 colony forming units (CFU) of generic e. coli per 100 ml water as a geometric mean. [A geometric mean is essentially an average.] AND

· No more than 410 CFU of generic e. coli per 100 ml of water statistical threshold value [which measure variations in water quality over time].

However, water that touches produce (or a surface that touches produce) during or after harvest can have NO detectable e. coli. 21 CFR §112.44.

How frequently the farm has to test its water depends on the source of the water.

· Water obtained from a municipal source does not have to be tested, BUT the farm has to maintain copies of certificates from the public water source certifying that it meets the requirements of the Safe Drinking Water Act (or has no detectable e. coli.).

· Ground water, i.e., water from a well, has to be tested, initially 4 or more times during a growing season and then at least once a year every year thereafter.

· Surface water, i.e., water from ponds, streams, lakes, etc., has to be tested, initially, 20 or more times over a 2- 4 year period and then 5 or more times every year thereafter.

21 CFR §112.46. Each different source of water — such as a well and a stream — that the farm uses has to be tested and monitored individually.

Records related to water quality have to be kept at every step of the process. The farm has to keep records of:

· Amount of sales to define which category it fits to determine its compliance date;

· The source(s) of its water;

· Inspections of the farm’s water distribution system(s);

· How the water is used, e.g., drip irrigation, direct spray, etc.;

· When, i.e., the dates, the water was applied;

· Dates of water testing;

· Locations from which water samples were taken;

· The test methodology used to determine presence and amount of e. coli;

· Records to document the adequacy of the testing methodology used by the farm to detect e. coli;

· All test results;

· Water quality certificates from municipal sources, if applicable.

What happens if your farm’s water contains more e. coli that is permitted by the Produce Safety Rule? Stay tuned — that will be the topic of an upcoming post.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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