FDA Announces Changes to Harvest and Post-Harvest Ag Water: What Does This Mean for Small Fruit Farms and Packing Houses?
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FDA announced January 13, 2023 the end of the enforcement discretion period for requirements for water used during harvest and post-harvest in produce operations effective Jan. 26, 2023. This means that starting in 2023 during regular farm inspections to verify compliance with FSMA’s Produce Safety Rule, “covered” farms will have to comply with the requirements described in this document. These inspections are conducted by the NCDA&CS Produce Safety Program. This document does not discuss any requirements from third party food safety audits or specific buyer requirements pertaining water use.
It is important to note that this publication focuses on farms that grow different kinds of small fruit (blueberries, strawberries, muscadines, blackberries, fresh-market bunch grapes etc.) using examples that are relevant to these industries and based on practices followed in North Carolina (NC). Nonetheless, these requirements apply to all covered produce outlined in the Produce Safety Rule that is grown in “covered” farms.
What farms are “covered” and required to implement practices?
Produce farms can fall under one of three categories in the Produce Safety Rule (PSR): not covered, qualified exempt with modified requirements or be “covered” farms. This regulation affects ONLY “covered” farms.
To determine the farm’s compliance date to implement practices for water used at harvest and post-harvest, first complete the template available from NC State University to determine where the farm falls under the PSR. Once it is determined that the farm is a “covered” farm, then calculate the average produce sales for the past three years.
Compliance dates for covered farms and packinghouses is as follows (average produce sales from the past three years):
- January 26, 2023 for covered farms (produce sales more than $500,000).
- January 26, 2024 for covered small businesses (produce sales up to $500,000)
- January 26, 2025 for covered very small businesses (produce sales no more than $250,000)
The practices that will be discussed are for agricultural water used during harvest and post-harvest ONLY.
For the NC blackberry, strawberry, blueberry, fresh-market bunch grape and strawberry industries this includes:
- Water used for hand-washing during harvest and post-harvest activities.
- Water used to clean and/or sanitize bins, buckets and any other containers that are not single use that come in contact with the fruit in the field at the time of harvest or during packing.
- Even though berries are not typically washed, this includes water used in spray bars used to wash berries in special circumstances (e.g. for certain processing activities).
- Water used to clean and sanitize packing lines and other food contact surfaces in packing houses.
- Any water that is likely to come in contact with the fruit or food contact surfaces during and after harvest is also included.
Overall requirements for farms and packing houses
- Ensure there is no detectable generic E. coli per 100 ml of agricultural water. Untreated surface water must never be used in harvest or post-harvest operations.
- At least once per season, inspect the agricultural water system to the extent it’s under the farm’s control to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards.
- Maintain agricultural water sources and distribution systems.
- If water is treated, the process has to be monitored to ensure water is safe.
- Monitor water quality when washing produce.
Requirements based on water source used by farm or packinghouse
|Public water system/ Public water supply
|Ground water – Wells
|Surface water- Creeks, springs, rivers
No testing is required.
Public water system results or certificates of compliance that demonstrate that the water meets standard must be on file annually.
For untreated water:
Year 1: Test 4 times during the growing season
over a 1-year period test 4 times.
Year 2: Test annually thereafter.
If annual test fails to meet standard of no detectable generic E. coli per 100 ml resume testing four times per growing season.
Never use untreated surface water.
If this is the only water source available, treat it before using it in harvest and post-harvest operations.
When water testing is conducted all samples must be aseptically collected. ONLY the following methods can be used by the laboratory to analyze the samples. Make sure the testing method is outlined with the water test results by the laboratory.
- EPA Method 1603
- Method 1103.1
- Method 1604
- 9213 D
- 9222 B
- D 5392-93
- Hach Method 10029 for Coliforms
- IDEXX Colilert Test Kit, but only if using IDEXX Quanti-Tray/2000 for quantification.
- IDEXX Colilert-18 Test Kit, but only if using IDEXX Quanti-Tray/2000 for quantification.
For complete details on laboratory methods go to: Equivalent testing methodology for agricultural water from FDA
Agricultural water system
FDA defines an ‘‘agricultural water system’’ as the source of agricultural water, the water distribution system, any building or structure that is part of the water distribution system (such as a well house, pump station, or shed), and any equipment used for application of agricultural water to covered produce during growing, harvesting, packing, or holding activities.
The farm is required to inspect the agricultural water system at least once a year. This should be done at the beginning of the growing season and as needed.
To determine the frequency of these inspections, consider factors such as: degree of protection of each water source, adjacent and nearby land use and likelihood of introduction of hazards to the water by another user before the water gets to the farm.
Maintain agricultural water sources and distribution system
Adequately maintain all agricultural water sources to the extent they are under your control (such as wells).
Maintenance includes regularly inspecting each source to identify any conditions that are reasonably likely to introduce known or foreseeable hazards that can contaminate the water source or the fruit.
Correct any significant deficiencies (e.g., repairs to well cap, well casing, sanitary seals, piping tanks and treatment equipment, and control of cross-connections); and keeping the source free of debris, trash, domesticated animals, and other possible sources of contamination.
Treatment of water sources
Water treatment is not mandated in the PSR. If the farm chooses to treat water because it is necessary to meet the microbial criteria of no detectable generic E. coli then the following apply:
- The method used (including physical treatment, an EPA-registered antimicrobial pesticide product, or other suitable method) must be effective to make the water safe and of adequate sanitary quality for its intended use and/or meet the microbial criterion of no detectable generic E. coli per 100 mL of water.
- Treatment must be delivered in a manner, and monitored at a frequency adequate, to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended use and/or consistently meets the microbial criterion of no detectable generic E. coli per 100 mL of water.
- Records will be kept on file for the water treatment program.
- Treated water does not need to be tested.
Monitor any treatment used in the water to prevent cross contamination. Depending on the sanitizer used, the farm will need to monitor parameters such as sanitizer concentration and water pH. These parameters must be recorded.
If the farm has reason to believe that water is unsafe or of unsanitary quality because a test showed detectable generic E. coli or other factors lead to this conclusion, stop using the water. Steps must be taken to correct the problem. These steps can include reinspecting the entire agricultural water system (that’s under the farm’s control), making necessary changes or treating the water using guidelines previously discussed.
These records must be kept for 2 years and provided during farm inspections.
- Agricultural water system inspection record.
- If water testing is conducted, testing results must be on file.
- Document corrective actions implemented.
- If water treatment is conducted, records proving treatment is applied correctly.
- If public water supply is used, annual record from municipality/water company showing water is safe.
Status of rulemaking for water used during the growing season
As of February 1, 2023 FDA continues to exercise enforcement discretion until the final rule is published. During regular farm inspections, the inspector will not go over this part of the rule until the rule is finalized and compliance dates become effective. All farms are encouraged to do an inspection of the agricultural water system at least once annually.
This document is not intended to be legal advice but a summary of the requirements published by FDA regarding Harvest and Post-Harvest Agricultural Water in Subpart E on January 13, 2023.