In 2019, the Indiana Department of Health (IDOH), in accordance with Indiana Code ยง16-42-3.5, began inspections of produce farms that are subject to the Produce Safety Rule. All farms with an average of $28,075 or more in annual produce sales over the previous three years are subject to inspection. Prior to an inspection, the Indiana Produce Safety Team provides free farm consultations to identify steps that growers may take to comply with the Produce Safety Rule.
IDOH, Purdue University and the Indiana State Department of Agriculture provide outreach efforts and technical assistance to all Indiana produce growers, despite inspection status, to help growers gain an understanding of good agricultural practices.
The FDA has issued a final rule that revises certain pre-harvest agricultural water requirements for covered produce (other than sprouts) in Subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule. The final rule establishes requirements for farms to conduct pre-harvest agricultural water assessments to identify hazards and implement corrective actions or mitigation measures.
Farms are required to conduct assessments of their pre-harvest agricultural water annually, and whenever a significant change occurs, to identify any conditions likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces.
- Agricultural water assessments must evaluate a variety of factors that are key determinants of contamination risks associated with pre-harvest agricultural water. This includes an evaluation of the water system, water use practices, crop characteristics, environmental conditions, potential impacts on water from adjacent and nearby land, and other relevant factors.
- Farms will be required to implement effective mitigation measures within specific timeframes based on findings from their assessments.
- There are several options for mitigation measures, providing farms with flexibility in responding to findings from their pre-harvest agricultural water assessments.
Depending on the outcomes of a covered farm’s assessment, the farm may be required to implement corrective or mitigation measures to reduce the potential for contamination of covered produce or food contact surfaces as a result of the use of pre-harvest agricultural water.
Compliance dates
The rule establishes compliance dates for the pre-harvest agricultural water provisions for covered produce (other than sprouts) as follows:
- April 2027 very small farms
- April 2026 for small farms
- April 2025 for all other farms
Requirements for harvest and postharvest uses of agricultural water, as well as the agricultural water requirements for sprouts, have not changed.
As part of the assessment, farms are required to evaluate the following factors to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto produce or food contact surfaces:
Agricultural water systems |
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Agricultural water practices |
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Crop characteristics |
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Environmental conditions |
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Other relevant factors |
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Assessment Outcomes
Covered farms must use the outcomes of the pre-harvest agricultural water assessment to make written determinations about whether corrective or mitigation measures are needed to reduce the potential for contamination of covered produce (other than sprouts) or food contact surfaces with hazards associated with pre-harvest agricultural water.
If you determine | Then you must |
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That your agricultural water is not safe or is not of adequate sanitary quality for intended use(s) |
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There is one or more known or reasonably foreseeable hazards related to animal activity, BSAAO, or untreated or improperly treated human waste on adjacent or nearby land for which mitigation is reasonably necessary |
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There is one or more known or reasonably foreseeable hazards not related to animal activity, BSAAOs, or untreated or improperly treated human waste on adjacent or nearby land, for which mitigation is reasonably necessary |
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That there are no known or reasonably foreseeable hazards for which mitigation is reasonably necessary |
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Corrective measures
If a covered farm determines that its pre-harvest agricultural water is not safe or of adequate sanitary quality for its intended use(s), it is required to immediately discontinue such use. Corrective measures that a farm could take in order to resume such use include:
* Re-inspecting the entire affected agricultural water system under the farm’s control and, among other steps, making necessary changes, or
* Treating the water in accordance with the standards outlined in the Produce Safety Rule.
Mitigation measures
If a covered farm determines that mitigation measures are necessary to reduce the potential for contamination of produce or food contact surfaces with hazards associated with their pre-harvest agricultural water, it has various options to choose from, including:
- Making necessary changes such as repairs
- Increasing the time interval between the last direct application of agricultural water and harvest of the covered produce to allow for microbial die-off, with supporting scientific data and information
- Increasing the time interval between harvest and the end of the storage period and/or conducting other activities during or after harvest to allow for microbial die-off or removal, with supporting scientific data and information
- Changing the method of water application to reduce the likelihood of produce contamination (such as changing from overhead spray to subsurface drip irrigation for certain crops)
- Treating the water in accordance with the standards outlined in the Produce Safety Rule
- Taking alternative mitigation measures supported by scientific data and information
Reassessment
A covered farm is required to conduct a reassessment each year in which the farm applies pre-harvest agricultural water to covered produce (other than sprouts), and anytime there is a significant change in its agricultural water systems, agricultural water practices, crop characteristics, environmental conditions, or other relevant factors that make it reasonably likely that a hazard may be introduced into or onto covered produce or food contact surfaces through direct application of pre-harvest agricultural water.
For example, a change from an untreated ground water source to an untreated surface water source, or a change in agricultural water use practices, are significant changes that require a reassessment. The reassessment must evaluate the impacts of those changes on the factors discussed above, any new hazards identified, and the written determination of whether corrective or mitigation measures are needed to reduce the potential for contamination of produce or food contact surfaces.
Records
Covered farms are required to maintain written records of their pre-harvest agricultural water assessments, including descriptions of factors evaluated and their written determination. Supervisors are required to review the written pre-harvest agricultural water assessments and the determinations made based on the outcomes of the assessments.
Exemptions
Covered farms may be eligible for an exemption from conducting a pre-harvest agricultural water assessment if they can demonstrate that their pre-harvest agricultural water for covered produce (other than sprouts):
- Meets certain requirements that apply for harvest and post-harvest agricultural water (including the prohibition on the use of untreated surface water, the microbial quality criterion and if applicable, testing requirements for untreated ground water)
- Is received from a public water system or supply that meets requirements established in the rule (provided that the farm has public water system results or certificates of compliance demonstrating that the water meets relevant requirements)
- Is treated in accordance with the standards outlined in the Produce Safety Rule
- Additionally, in order to be eligible for an exemption, it must be reasonably likely that the quality of the previously described water will not change prior to the water being used as agricultural water (for example, due to the manner in which the water is held, stored or conveyed)
For more information about the new pre-harvest water requirements, visit FSMA Final Rule on Pre-Harvest Agricultural Water | FDA.