FDA Announces Changes to Harvest and Post-Harvest Ag Water: What Does This Mean for Apple 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 “covered” farms will have to comply with the practices outlined in the Produce Safety Rule (PSR) for water used at harvest and after the crop is harvested. Those requirements are discussed in this document. The practices will be reviewed during regular farm inspections to verify compliance with the PSR. In North Carolina, 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 was written for apple farms and packing houses using examples that are relevant to the apple industry and based on practices followed in North Carolina. 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 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 your 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.

Link to  template to determine the farm’s status under the Produce Safety Rule

Compliance dates for covered farms and packinghouses is as follows (use 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 apple industry, this includes:

  • Water used for hand-washing during harvest and post harvest activities.
  • Water used to clean and/or sanitize bins, pick sacks and any other containers that come in contact with the fruit in the field at the time of harvest.
  • Water used to wash apples in dump tanks and with spray bars.
  • 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 apples or food contact surfaces during and after harvest is also included.

Overall requirements for farms and packing houses

  1. 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.
  1. 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.
  2. Maintain agricultural water sources and distribution systems.
  3. If water is treated, the process has to be monitored to ensure water is safe.
  1. 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, ponds

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                              OR                  test 4 times over a 1-year period.

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.

Water testing

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.

  1. EPA Method 1603
  2. Method 1103.1
  3. Method 1604
  4. 9213 D
  5. 9222 B
  6. D 5392-93
  7. Hach Method 10029 for Coliforms
  8. IDEXX Colilert Test Kit, but only if using IDEXX Quanti-Tray/2000 for quantification.
  9. IDEXX Colilert-18 Test Kit, but only if using IDEXX Quanti-Tray/2000 for quantification.

For complete details on laboratory methods

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 or packing house.

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.

Washing produce

Manage water quality in tanks by monitoring turbidity of the water for buildup of organic material (soil and plant debris). Also, establish and follow water-change schedules for re-circulated water, to maintain its safety and adequate sanitary quality and minimize the potential for contamination of the apples being washed and the food contact surfaces.

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.

When using a dump tank

Infiltration can occur when the temperature differential between the pulp of the apple and the water is 10°F or greater. Apples are washed using cold water, if field heat has not been removed the inside core of the apple may be warm. The cold water causes air pockets within the apple to contract, creating a pressure differential that pulls water into the apple. If dump tank water is contaminated, microbes can be drawn into the apples along with the water.

The farm is required to maintain and monitor the temperature of the water to prevent infiltration of water into the fruit. Also consider that if apples are left submerged in a tank longer than 5 minutes, this may increase water and pathogen infiltration.

Corrective actions

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.

Records

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 the municipality/water company showing water is safe.
  • Monitoring of wash water.

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.

Requirements for Harvest and Post-Harvest Agricultural Water in Subpart E for Covered Produce Other than Sprouts

References