FDA Publishes Final Rule for Use of Agricultural Water on FSMA Covered Produce

FDA released their final rule on agricultural water for produce. "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."   The rule provides the various factors that go into the evaluation.  

 "The final rule replaces certain pre-harvest agricultural water requirements for covered produce (other than sprouts) in the 2015 produce safety rule with requirements for systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water."  It "establishes requirements for agricultural water assessments that 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."


https://www.fda.gov/food/cfsan-constituent-updates/fda-publishes-landmark-final-rule-enhance-safety-agricultural-water?utm_medium=email&utm_source=govdelivery
FDA Publishes Landmark Final Rule to Enhance the Safety of Agricultural Water
Constituent Update
May 2, 2024

Today, the U.S. Food and Drug Administration (FDA) published a final rule on agricultural water that represents an important step toward enhancing the safety of produce. The revised requirements are intended to enhance public health by improving the safety of water used in produce cultivation. The revisions are also designed to be practical across various agricultural water systems, uses, and practices, while remaining adaptable to future advancements in agricultural water quality science.

The final rule replaces certain pre-harvest agricultural water requirements for covered produce (other than sprouts) in the 2015 produce safety rule with requirements for systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water. Specifically, this rule:

• Establishes requirements for agricultural water assessments that 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.
• Includes testing pre-harvest agricultural water as part of an assessment in certain circumstances.
• Requires farms to implement effective mitigation measures within specific timeframes based on findings from their assessments. Hazards related to certain activities associated with adjacent and nearby land uses are subject to expedited mitigation.
• Adds new options for mitigation measures, providing farms with additional flexibility in responding to findings from their pre-harvest agricultural water assessments.

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.

These revised requirements reflect recent science, findings from investigations of several produce-related outbreaks, and feedback from a variety of stakeholders on the agricultural water requirements in the Produce Safety Rule, which were previously published in 2015. These revisions will more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness.




The rule also finalizes the dates for compliance with the pre-harvest agricultural water requirements for non-sprout covered produce as follows:




For very small farms: 2 years, 9 months after the effective date of the final rule

For small farms: 1 year, 9 months after the effective date of the final rule

For all other farms: 9 months after the effective date of the final rule

The rule does not alter existing requirements for agricultural water for sprouts, for which compliance dates have passed. It also does not alter existing requirements for harvest and post-harvest agricultural water activities. Additional information about compliance dates can be found on the FDA Proposes Compliance Date Extension for Pre-Harvest Agricultural Water Requirements webpage.




The agency is committed to taking an “educate before and while we regulate” approach to supporting compliance. Along with the rule, the FDA also released a number of fact sheets, including one that provides an overview of agriculture water assessments and mitigation measures, and another that offers more details on factors for conducting these assessments. These resources are available in Spanish. The FDA has also updated the Agriculture Water Assessment Builder. Additionally, the Agency is planning a webinar for all interested stakeholders. Registration information will be provided in a forthcoming announcement.




Importantly, the FDA will work closely with our state partners to implement these changes. The agency plans to work closely with state regulators, National Association of State Departments of Agriculture (NASDA), educators, and others, including the Produce Safety Alliance, to provide the necessary training to implement these changes to the agricultural water requirements.

https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-pre-harvest-agricultural-water

FSMA Final Rule on Pre-Harvest Agricultural Water

Introduction

The FDA published a final rule that revises certain pre-harvest agricultural water provisions for covered produce (other than sprouts) in Subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule. Specifically, this rule replaces the previous pre-harvest water microbial quality criteria and testing requirements for covered produce (other than sprouts) with requirements for systems-based, pre-harvest agricultural water assessments for hazard identification and risk management decision-making purposes.




These assessments are used to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto produce or food contact surfaces, and to determine whether, and how soon, corrective or mitigation measures must be implemented to minimize risks associated with pre-harvest agricultural water.




These requirements reflect recent science, findings from investigations of several produce-related outbreaks, and information and feedback from a variety of stakeholders. The requirements are designed to achieve improved public health protections, while also being more feasible to implement across the wide variety of agricultural water systems, uses, and practices, and adaptable to future advancements in agricultural water quality science.




Requirements for harvest and post-harvest uses of agricultural water, and the agricultural water requirements for sprouts, have not changed. Sprouts are subject to specific pre-harvest agricultural water requirement, and the compliance dates are for sprouts requirements have passed.




Overview

1. Agricultural Water Assessment

Agricultural Water Assessment Fact Sheet

(PDF: 104KB)




Agricultural Water Assessment Builder




The final rule establishes requirements for systems-based pre-harvest agricultural water assessments for hazard identification and risk management decision-making. Covered farms - those that are subject to the requirements in the Produce Safety Rule – that use pre-harvest agricultural water for covered produce (other than sprouts) are required to conduct agricultural water assessments once annually, and whenever a significant change occurs that increases the likelihood that a known or reasonably foreseeable hazard will be introduced into or onto produce or food contact surfaces. As part of their pre-harvest agricultural water assessments, farms are required to evaluate certain factors (overview below) that could impact produce safety as a result of the use of pre-harvest agricultural water.




Table 1. Summary of Factors Evaluated as Part of a Pre-Harvest Agricultural Water Assessment




Factor Description

Agricultural water system(s)

The location and nature of the water source (for example, whether it is ground water or surface water)

The type of water distribution system (for example, whether it is open or closed to the environment)

The degree to which the system is protected from possible sources of contamination, including:

other users of the water system

animal impacts (such as from grazing animals, working animals, and animal intrusion)

adjacent and nearby land uses related to animal activity, the application of biological soil amendments of animal origin (BSAAOs), or the presence of untreated or improperly treated human waste

Agricultural water practices

The type of application method (such as overhead sprinkler or spray, drip, furrow, flood, and seepage irrigation)

The time interval between the last direct application of agricultural water and harvest of the covered produce (other than sprouts)

Crop characteristics

Susceptibility of the covered produce to surface adhesion or internalization of hazards

Environmental conditions

Frequency of heavy rain or extreme weather events that may impact the agricultural water system (such as by stirring sediments that may contain human pathogens) or that may impact or damage produce. Damage can increase the susceptibility of produce to contamination.

Air temperatures

Sun (UV) exposure

Other relevant factors

Including, if applicable, results of testing to inform the assessment

Expanded Table on Factors for Agricultural Water Assessment to Consider

(PDF: 115KB)




Corrective and Mitigation Measures for Pre-harvest Agricultural Water for Non-Sprout Covered Produce

(PDF: 129KB)




2. Outcomes

Based on findings of their agricultural water assessments, covered farms are required to determine if corrective or mitigation measures are reasonably necessary to reduce the potential for contamination of covered produce (other than sprouts) or food contact surfaces with hazards associated with pre-harvest agricultural water. This includes expedited mitigation measures to address known or reasonably foreseeable hazards in agricultural water systems associated with animal activity, biological soil amendments of animal origin (BSAAOs), or untreated or improperly treated human waste on adjacent and nearby land. The following chart summarizes the actions covered farms are required to take based on the outcomes of their agricultural water assessments:




If you determine Then you must

that your agricultural water is not safe or is not of adequate sanitary quality for intended use(s)




immediately discontinue use(s)

AND




take corrective measures before resuming use of the water for pre-harvest activities

there is one or more known or reasonably foreseeable hazards related to animal activity, BSAAOs, or untreated or improperly treated human waste on adjacent or nearby land for which mitigation is reasonably necessary

implement mitigation measures promptly, and no later than the same growing season

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

implement mitigation measures as soon as practicable and no later than the following year

OR




test water as part of the assessment and implement measures, as needed, based on the outcome of the assessment

there are not any known or reasonably foreseeable hazards for which mitigation is reasonably necessary

regularly (at least once each year) inspect and adequately maintain the water system(s)

Annual Agricultural Water Assessments and Risk-Based Outcomes (PDF: 141KB)




3. Required Management Review of Pre-harvest Agricultural Water Assessments

The final rule includes a requirement for supervisory review of the written pre-harvest agricultural water assessment and the determinations that were made based on the outcomes of the assessment.




Exemptions

The final rule exempts covered farms 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, the 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), or

is treated in accordance with the standards outlined in the Produce Safety Rule, and

it is reasonably likely that the quality of the aforementioned 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).

4. Compliance Dates

The rule establishes compliance dates for the pre-harvest agricultural water provisions for covered produce (other than sprouts) as follows:




2 years and 9 months after the effective date of the final rule for very small businesses.

1 year and 9 months after the effective date of the final rule for small businesses, and

9 months after the effective date of a final rule for all other businesses.

The effective date is 60 days after publication of the final rule.


FSMA Final Rule on Pre-harvest Agricultural Water:
Factors for Agricultural Water Assessment to Consider