Newly Finalized Food Safety Modernization Act/ Produce Safety Rule- Agricultural Water Rule

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There are two parts to the water rule (pre-harvest and harvest/post-harvest), and they are handled
differently which I will review. Agricultural water must be safe and adequate sanitary quality for its
i n tended use.

Pre-Harvest Water
The pre-harvest water (irrigation, spray water, frost protection, fertigation, dust abatement, etc.)
requirements for the FSMA/PSR became effective on July 5, 2024, however this does not mean a
grower needed to start complying on that date. Compliance dates are staggered over the next three
years depending on the size of the operation.
Size of Operation Compliance Dates
Operations over $500,000 April 7, 2025
Small operations (> $250,000-500,000) April 6, 2026
Very Small operations (> $25,000-250,000) April 5, 2027
It is important to understand what is considered Agricultural Water. Water that is intended to or will
likely touch produce is considered agricultural water. In the context of pre-harvest water that means
any water you are using for irrigation, frost protection etc. that touches the harvestable crop. If you are
using drip irrigation for staked tomatoes this is NOT agricultural water as the water is not touching the
fruit. If you are using drip irrigation on carrots, this IS agricultural water, as the water is touching the
crop. A grower needs to think about how each water source is used before they decide whether it is
agricultural water or not.

Water testing is not a requirement for pre-harvest water but can be part of the agricultural water
assessment of the whole water system. This means an inspector will ask the grower to explain their
system and how they minimize risks to the covered crops.

Requirements for Inspecting and Maintaining Agricultural Water Systems
As part of the rule, growers must inspect the whole water system (pre-harvest, harvest and post-harvest) at the beginning of the season and make a written report. This includes:

  • The water source (well and surface); the extent of the grower’s control and how each source is
    protected. This includes knowing where all the water lines are located, checking for leaks and
    making repairs at the beginning of the season.
  • Use of adjacent and nearby land (e.g., horse or cattle farm next door; runoff from roads). What
    is the possibility that this will impact a production field?
  • If surface water is used (e.g., stream, lake, or pond)- what is the chance a food safety hazard
    could enter the water before it got to your farm? (e.g., dairy farm upstream where cows get in
    the stream).

Requirements for Agricultural Water Assessment
The rule requires that a pre-harvest water assessment must be completed at the beginning of
the season, the assessment only applies to pre-harvest water use!

The assessment must be written, dated and signed at the beginning of the season, annually or
anytime major changes are made to the system or water source. The inspection report can be
incorporated into the assessment.

The initial assessment must identify conditions that are reasonably likely to introduce know or reasonably foreseeable hazards into or onto cover produce or food contact surfaces.

  • Parts of the assessment

o Location and nature of water source (e.g., ground water/wells, surface water/pond,
stream, etc.)
o How water is distributed (e.g., underground main, lay flat, canals, etc.)
o How system is protected from contamination (animals, runoff from nearby land, manure
applications, etc.)
o How water is applied and time between last irrigation and harvest
o Crop characteristics (e.g., waxy surface-cabbage, netted surface-muskmelons, etc.) and
likelihood of surface adhesion or internalization of hazards.
o Environmental conditions e.g., damage from frost, hail, blowing sand, sunburn, high
temperatures, etc.)
o Other factors – Water testing, but the assessment cannot be based just on water testing.
It is only part of the assessment.

If the operation meets any of the following, they can be exempt from performing a water assessment.

  • No untreated surface water applied.
  • Untreated groundwater is tested following the protocol for harvest and post-harvest water
    (four samples the first year for generic E. coli and one sample every year after if no generic E.
    coli is found).
  • Public water system water use.
  • Water is treated, monitored and to be of a safe and adequate sanitary quality.

Outcome from the assessment

Based on the assessment there are several options for reducing risks. If the water source is not safe or is not of adequate sanitary quality, you must stop use immediately and take one of the following corrective measures or mitigation measures.

  1. If the problem is related to biological soil amendments of animal or human origin on adjacent or nearby land, mitigation measures to stop and prevent the contamination must be implemented the same growing season (e.g., building a berm around the field to avoid runoff from a horse pasture).
  2. Any other conditions not related to animal activity impacting the quality of the water must be remediated as soon as practical and no later than the following year. The other option is to test the water source as part of the assessment and implement changes if needed.
  3. If no know or foreseeable hazards have been identified, the system should be inspected and maintained with a new inspection at least annually.

Corrective measures are activities that must be taken before using the water source. Such as
re-in-specting the water system making and verifying any changes or treating the water following FSMA/PSR standards.

Mitigation measures can take many forms including making a repair, increasing the time from the last irrigation to harvest, die off rate, changing the water application method or source, etc.

Harvest and Post Harvest Water
FDA defines harvest and post-harvest agricultural water as water used in harvesting, packing, and holding activities, such as water used to prevent dehydration, for transport, cooling and washing. This includes water used to make ice that contacts covered produce or food contact surfaces and water used for handwashing.

The rule is now in effect for all uses that fall under the Produce Safety Rule. Inspectors will want to review the inspection report.

As with the pre-harvest water, the harvest and post-harvest water system must be evaluated at the beginning of the season. This is to insure there are no leaks or parts that may be contaminated prior to use. This inspection must be written, dated and signed off by a supervisor. Also, for the first year four water sample must be collected and tested for generic E. coli before use. The results must show no detectable E. coli for the four samples. After the first year only one sample is required if there is no detectable generic E. coli. If the one sample does have detectable generic E. coli, then four samples must be collected.

If the water source/distribution system is found to be unsafe the operation must immediately stop using it, reinspect the entire system under the grower’s control, make necessary changes or treat the water with approved an antimicrobial material. The treatment must meet the no detectable generic E. coli standard and monitored to ensure it is maintained. The same exemptions apply to harvest and post-harvest water as under pre-harvest water.
There are additional water management and monitoring requirements for harvest and post-harvest water including:

  • Establishing a water change schedule for non-single-pass water
  • Visually monitoring the water for buildup or organic material
  • Maintaining and monitoring the water temperature that is appropriate for the commodity to reduce the chance of infiltration of microorganisms.

Additional Information

FSMA Final Rule on Produce Safety:
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm

FSMA Produce Safety Rule, Subpart E- Agricultural water (§§ 112.40-112.50)
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-112#subpart-E

FSMA Final Rule on Pre-harvest Agricultural Water
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-pre-harvest-agricultural-water

Equivalent Testing Methodologies for Agricultural Water
https://www.fda.gov/food/laboratory-methods-food/equivalent-testing-methodology-agricultural-water