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On December 6, 2021, the Food & Drug Administration (FDA) published a new proposed rule that revises the pre-harvest agricultural water requirements for covered produce (other than sprouts) (Subpart E of the Produce Safety Rule (PSR)). This is the latest step in the FDA’s implementation of the Food Safety Modernization Act (FSMA). The FDA is holding two virtual public meetings about the proposed rule to discuss the proposed rule and to assist the public with the process of commenting on the proposed rule. To learn more about the proposed rule, how to attend the public meetings and submitting comments on the proposed rule, keep reading.
About the Proposed Rule
The proposed rule is entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.” It replaces the pre-harvest microbial water quality criteria and testing requirements with requirements for a systems-based pre-harvest agricultural water assessment to be used for hazard identification and risk management decision-making purposes. The proposed rule will require farms to “conduct annual systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water.” The FDA describes the assessments as including an evaluation of the water system, agricultural water-use practices, crop characteristics, environmental conditions, potential impacts on source water by activities conducted on adjacent and nearby land, and other relevant factors, such as the results of optional testing.
The goal is for farms to be able to identify conditions that would be reasonably likely to introduce known or reasonably foreseeable hazards into or onto produce or food contact surfaces using an assessment of five factors:
The Water System – location and source (ground/surface water), whether the distribution system is open or closed to the environment, and how much the water system is protected from possible sources of contamination (e.g., other users, impacts of animals).
Water practices – how the water is applied to the produce (e.g., overhead sprinkler, drip, flood, etc.) and time internal between last direct application of water and harvest.
Crop characteristics – susceptibility of the produce to adhesion or internalization.
Environmental conditions – rain events that could impact the ag water system, air temperature, sun exposure.
Other factors – could include results of testing if performed. However, testing is not required.
Following the assessment, the proposed rule requires that:
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, Biological Soil Amendment of Animal Origin (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 |
Corrective measures could include making needed changes and then reinspecting the ag water system. Mitigation measures outlined in the proposed rule include:
Making repairs.
Allowing for microbial die-off to occur by extending the time between water application and harvest or lengthening the shipping time after harvest.
Changing the method of water application.
Treating the water in line with the standards outlined in the Produce Safety Rule.
Implementing valid alternate measures for mitigation.
The assessment would be required to be conducted 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. The assessments, outcomes, and any corrective or mitigation measures taken must be documented in writing and reviewed by a supervisor.
The proposed rule does offer some flexibility in that farms would be exempt from conducting the assessment if they can demonstrate that their agricultural water meets certain requirements such as microbial quality criterion and testing requirements (e.g., for generic E. coli); is received from a supply (e.g., municipal water system) that meets relevant requirements; or is treated in line with the Produce Safety Rule standards.
No Changes to the Requirements for Harvest and Post-Harvest Agricultural Water
The proposed rule only deals with pre-harvest agricultural water. The FDA has not proposed changes to the requirements for harvest or post-harvest uses of agricultural water, or the agricultural water requirements for sprouts.
FDA Intends to Exercise Enforcement Discretion
As "covered growers" know, under the current rules for pre- and –post-harvest agricultural water, covered farms are supposed to be in compliance with the PSR’s agricultural water rules as of this month (January 2022) for all produce except sprouts. The FDA, however, has said that it intends to exercise enforcement discretion regarding the agricultural water requirements while the agency pursues a separate proposed rule to extend the compliance dates for the agricultural water requirements. The FDA will provide more information about the proposed compliance date extension in a forthcoming notice in the Federal Register.
How to Attend the Public Meetings
The FDA is holding two virtual public meetings on the proposed rule. The meetings are intended to facilitate and support the public's evaluation and commenting process on the proposed rule.
First Virtual Public Meeting - February 14, 2022 (11:45 am - 7:45 pm EST)
Second Virtual Public Meeting - February 25, 2022 (8:45 am - 4:45 pm EST
Registration is required to attend the virtual meetings. Registered participants will receive details on how and when to view the public meetings online.
For questions about the meetings, contact Juanita Yates, FDA, Center for Food Safety and Applied Nutrition: e-mail Juanita.Yates@fda.hhs.gov.
Submit Comments on the Proposed Rule
As required under section 553 of the Federal Administrative Procedures Act (5 U.S.C. §551 et seq. (1946)), the FDA is seeking comments from the public about the proposed rule. Electronic or written comments must be submitted by April 5, 2022. Comments that are thoughtful and substantive, containing real life examples and solutions, will be most helpful in creating a final rule that is better suited to the complexities of farming.
Attend a Produce Safety Rule Grower’s Training
Check ALEI’s Events webpage for upcoming FSMA Produce Safety Rule Grower Trainings in Maryland. Trainings are being held virtually as well as in-person.
More Information
For more information about FSMA and the Produce Safety Rule, search this blog using search terms “FSMA” or “Produce Safety Rule.”
For more information about food safety liability, Maryland Good Agricultural and Handling Practices, and the Food Safety Modernization Act (FSMA), go to ALEI’s Food Safety webpage.