FDA Proposes Rule on Assessment of Agricultural Water Used on Crops Covered in Produce Safety Rule

FDA proposed updated rules on the agricultural waters used on covered produce (other than sprouts).  In the initial release as part of the Produce Safety Rule, there were requirements for pre-harvest microbial quality criteria and testing.  In the proposed rule, there are systems-based pre-harvest agricultural water assessments.  "These assessments would be 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 corrective or mitigation measures are needed to minimize the risks associated with pre-harvest agricultural water."

This assessment would take various factors into account including:

• The Agricultural water system - the location and nature of the water source, the type of water distribution system and the degree to which the system is protected from possible sources of contamination,
• Agricultural water practices - the type of application method (such as overhead sprinkler or spray; drip, furrow, flood, and seepage irrigation) and 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 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, air temperatures and sun (UV) exposure
• Other factors

FSMA Proposed Rule on Agricultural Water | FDA
FSMA Proposed Rule on Agricultural Water

The FDA is proposing a revision to Subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule that would change the pre-harvest agricultural water requirements for covered produce (other than sprouts). The requirements in this proposed rule, if finalized, would replace the pre-harvest microbial quality criteria and testing requirements in the Produce Safety Rule with requirements for systems-based pre-harvest agricultural water assessments. These assessments would be 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 corrective or mitigation measures are needed to minimize the risks associated with pre-harvest agricultural water.

These proposed requirements are intended to address stakeholder concerns about the complexity and practical implementation of certain pre-harvest agricultural water requirements in the Produce Safety Rule while continuing to protect public health. The requirements also are designed to be adaptable to future advancements in agricultural water quality science.

We are not proposing to change the requirements for harvest and post-harvest uses of agricultural water, or the agricultural water requirements for sprouts. Sprouts are subject to specific pre-harvest agricultural water requirements, and the compliance dates for those sprouts requirements have passed.
Overview

1. Agricultural Water Assessment


Agricultural Water Assessment Fact Sheet
(PDF: 291KB)

The proposed rule, if finalized, would replace the pre-harvest microbial quality criteria and testing requirements in the Produce Safety Rule for covered produce (other than sprouts) with requirements for systems-based pre-harvest agricultural water assessments to be used for hazard identification and risk management decision-making (see the webpage for the final Produce Safety Rule for a description of the requirements as currently written). Under the proposed requirements, covered farms would be required to conduct pre-harvest agricultural water assessments once annually, and whenever a 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, these farms would be required to evaluate certain factors (listed below) that could impact produce safety.

Factors that Covered Farms would be Required to Assess as Part of an Agricultural Water Assessment, If the Proposed Rule is Finalized

Factor	Description
Agricultural water system(s)	The location and nature of the water source (including whether it is ground water or surface water) The type of water distribution system (such as 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, 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 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 that could inform the assessment

Expanded Table on Factors to be Considered as Part of Agricultural Water Assessment (PDF: 122KB)

2. Outcomes

If finalized as proposed, covered farms may need to implement corrective or mitigation measures based on the outcomes of their pre-harvest agricultural water assessments. This could include 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 proposed requirements for actions taken following the agricultural water assessment determinations:

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 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, 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
that there are no known or reasonably foreseeable hazards for which mitigation is reasonably necessary	Inspect and adequately maintain the water system(s) regularly, and at least once each year

3. Required management review of Pre-harvest Agricultural Water Assessments

The proposed rule also includes a requirement for supervisory review of the written pre-harvest agricultural water assessment and the determinations that were made about corrective or mitigation measures based on the outcomes of the assessment.
Exemptions

The proposed 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 (such as the microbial quality criterion and 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.
Other

In light of stakeholder concerns about complexity, we are proposing to reorganize subpart E to more clearly delineate which provisions apply based on how the water is used. This means that some requirements may be renumbered. However, FDA is not proposing to alter the requirements in subpart E for sprouts; for water used during harvest, packing and holding activities; or for treatment of agricultural water. In addition, the proposed rule contains definitions for “agricultural water assessment” and “agricultural water system” to provide additional clarity.
Implementation

The FDA recognizes that the current agricultural water compliance dates are set to begin in January 2022. The agency intends to exercise enforcement discretion for the agricultural water requirements for covered produce (other than sprouts) while proposing to extend the compliance dates, with the goal of completing the compliance date rulemaking as quickly as possible. More information on the proposed compliance dates will be announced in a forthcoming notice in the Federal Register.

Importantly, the FDA also intends to work closely with our state partners to implement these changes, if finalized. Through the FDA-State Produce Safety Implementation Cooperative Agreement Program most states have developed produce safety programs which have included training and educating farms, and conducting inspections. The agency intends to continue to work closely with state regulators, educators and others, including the Produce Safety Alliance, to provide the necessary training for agricultural water requirements.
Contact Us

The proposed rule is available for public comment for 120 days. Comments should be submitted to docket FDA-2021-N-0471 on Regulations.gov.

The FDA encourages comments and questions to be submitted to the docket so that the agency can fully consider all feedback.

Additional questions, and requests for meeting and speaker engagements can be submitted via the forms below. For meeting and speaking requests, please include a completed request form when you contact us.

Submit an Inquiry

Meeting Request Form (email to AgWater@fda.hhs.gov)

Speaker Request Form (email to AgWater@fda.hhs.gov)
Related Information
FSMA Final Rule on Produce Safety
Constituent Update: FDA Proposes Changes to Agricultural Water Requirements in the Produce Safety Rule (2021)
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water (Proposed Rule) Preliminary Regulatory Impact Analysis
Federal Register Notice: Extension of Compliance Dates for Subpart E of the Final Rule on Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption (2019)
Constituent Update: FDA Finalizes New Compliance Dates for Agricultural Water Requirements (2019)
Announcement: FDA Considering Simplifying Agricultural Water StandardsExternal Link Disclaimer (2017)