Main Content
Wes Kline
As to the Produce Safety Rule, there are changes related to pre-harvest water. The requirements
for pre-harvest (irrigation, spraying, etc.) the new regulations go into effect for operation $250,000 or
higher this year. For those $25,000 to $250,000 they take affect next April. Water testing has been
deemphasized. 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.
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.
Requirements for Inspecting and Maintaining Agricultural Water Systems
As part of the rule, growers must inspect the whole water system (pre-harvest, harvest and postharvest)
at the beginning of the season and make a written report. This includes:
- 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). - 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?
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 likely to
introduce know or foreseeable hazards into or onto cover produce or food contact surfaces.
Parts of the assessment
- Location and nature of water source (e.g., ground water/wells, surface water/pond, stream, etc.)
- How water is distributed (e.g., underground main, lay flat, canals, etc.)
- How system is protected from contamination (animals, runoff from nearby land, manure
applications, etc.) - How water is applied and time between last irrigation and harvest
- Crop characteristics (e.g., waxy surface-cabbage, netted surface-muskmelons, etc.) and
likelihood of surface adhesion or internalization of hazards. - Environmental conditions e.g., damage from frost, hail, blowing sand, sunburn, high
temperatures, etc.) - 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
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 using it immediately and take one of the following
corrective measures or mitigation measures.
- 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). - Any other conditions not related to animal activity impacting on 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. - If no known 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 reinspecting
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 inspected at the
beginning of the season. This is to ensure 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 samples 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 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 non-detectable generic
E. coli standard and be 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 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-safetymodernization-
act-fsma/fsma-final-rule-pre-harvest-agricultural-water
Equivalent Testing Methodologies for Agricultural Water
https://www.fda.gov/food/laboratory-methodsfood/
equivalent-testing-methodology-agricultural-water