Six years after FDA’s publication of FSMA’s Produce Safety Rule, the agency has published the long-awaited proposed rule revising the pre-harvest agricultural water requirements for covered produce other than sprouts (Subpart E of the rule). With stakeholders having pushed back on Subpart E in the original proposal – citing certain pre-harvest microbial quality criteria and testing requirements as too difficult to understand, interpret, and implement – FDA had extended the compliance dates for these provisions.
On December 6, the agency published its new proposed rule providing an alternative way for farms to comply with the requirements. Some of the immediate reaction to the proposed rule is that the produce industry is already doing what the rule requires.
If passed, the 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.” In brief, FDA describes the assessment 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 proposal 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.
Through this process, farms could identify conditions that would be reasonably likely to introduce known or reasonably foreseeable hazards into or onto produce or food contact surfaces through 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 reinspection of 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, as well, 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.
Recognizing that the current agricultural water compliance dates are set to begin in January 2022, FDA intends to exercise enforcement discretion for these requirements while proposing to extend the compliance dates, with the goal of completing the compliance date rulemaking as quickly as possible. The proposed rule is available for public comment submitted to Docket – FDA-2021-N-0471 until April 5, 2022. If passed, the effective date will be 60 days after publication of the final rule.
While FDA’s new proposal takes the notion of risk-based preventive controls to water risks in produce it provides a systems-based assessment option for complying with agricultural water requirements, the assessments still necessitate in-depth expertise, literature review and knowledge, and technical judgment to evaluate the parameters, determine overall level of concern, and identify mitigations. To do so, covered farms will need to develop programs and, despite the lack of testing requirements, will still need to conduct testing for verification – leaving farms with a great deal of complexity in compliance.
As with all such rules, the devil will be in the details and the interpretation of what constitutes a risk that needs to be controlled. For example, the interpretation of a reasonably foreseeable hazard related to animal activity is subjective. Thus, we hope that the rule will be accompanied by some solid guidance documents to help the industry understand what the FDA sees as risks that need to be controlled.
Should you need assistance, give TAG a call. We have produce safety experts who can help.
