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Agriculture water rule risk assessment

Risk Assessment Is Key to Compliance with New Ag Water Rule

If you take away nothing else from FDA’s May 2, 2024, publication of the final rule on pre-harvest Agricultural water (ag water) (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water), know that compliance is based on the execution and results of a risk assessment to drive your compliance and any corrective action. If your assessment identifies no known or reasonably foreseeable hazards, no corrective or mitigation measures are needed.

As FDA puts it, “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.” As such, farms that must comply to the produce safety rule are required to conduct assessments annually and whenever a significant change occurs. The purpose is to identify any conditions likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces.

Specifically, the rule requires the pre-harvest agricultural water assessment (which is similar to a risk assessment) to include evaluation of the water system, water use practices, crop characteristics, environmental conditions, potential impacts on water from nutrient management activities, animal activity and nearby land (which may be subject to expedited mitigation), and other relevant factors, including optional water testing. Based on findings from the assessments, the rule also requires that farms implement effective corrective or mitigation measures within specific timeframes.

TAG’s review of the rule found key changes from the 2015 Final Produce Safety Rule (Subpart E) to be:

  • There is no longer a requirement for compulsory generic E. coli water quality parameters for pre-harvest agricultural water (i.e., farms are not required to conduct 20 tests for surface water and 4 for ground water five times a year to create a rolling average with results based on a geometric mean for generic E. coli of 126 CFU/100 mL and a statistical threshold value of under 410 generic E. coli CFU/100 mL as required by parts 112.44 and 112.45 of the 2015 rule).  
  • Addition of a written agricultural water assessment, with specific factors to be considered and outcomes to be completed at least annually for all ag water systems. This is similar to a risk assessment, and the record must be reviewed by a trained supervisor.
  • Addition of requirements for specific corrective actions or mitigation measures to be completed in specific timelines if the ag water assessment results deem it necessary to ensure that water used on crops is of adequate sanitary quality for its intended use. In some cases, the timeline is expedited compared to the original rule.
  • The addition of new options for mitigation measures, providing for more flexibility in addressing results of the pre-harvest agricultural water assessment. 

Key changes from the 2022 proposed rule to the final rule are:

  • While the proposed rule provided for exemptions from the agricultural water assessment requirement if a public water supply were used, the final rule adds that the exemption cannot be claimed if the water quality could be likely to change prior to being used as ag water (e.g., the public water is stored in open holding tanks before use) (112.43.b.2).
  • With regards to mitigation measures to be conducted based on the outcomes of the water assessment:
    • Rather than the proposed requirement for a minimum of four days between the last direct water application and harvest, the final rule makes no minimum day statement and focuses solely on requiring scientifically valid information to inform days-to-dieoff (112.45.b.1.ii).
    • The proposed rule mention of commercial washing as an example for pathogen reduction was removed in the final rule (112.45.b.1.iii). 

Remaining the same as the 2015 rule are the definition of agricultural water, the requirement for annual ag water system inspections, and sprout water requirements.

Given all this, key areas TAG sees as critical in complying with the rule are:

  • For pre-harvest water: If you are currently testing your water, you can continue to do so, and use the tests as a part of the ag water assessment as these can, in some cases, inform specific mitigation measures. Additionally, your audit scheme may still require generic E. coli water testing for the foreseeable future.
  • For harvest and post-harvest water: Issuance of this final rule does not affect regulations on harvest and post-harvest water quality. These requirements are already in effect, with enforcement discretion having ended for large and small businesses, and ending for very small businesses January 26, 2025.

As the agency has done in the past, FDA intends to take an “educate before and while we regulate” approach, with compliance dates based on the effective date of the final rule being July 5, 2024:

  • Very small farms: 2 years, 9 months after the effective date of the final rule
  • Small farms: 1 year, 9 months after the effective date of the final rule
  • All other farms: 9 months after the effective date of the final rule

There is a lot to understand with the newly finalized ag water rule and its application on your farm, with the development of the agricultural water assessment and determination of appropriate mitigation strategies and/or correction actions for identified risks as both the most complex and the most critical.

With scientific expertise in agriculture and regulation, TAG can help reduce that complexity – such as assisting in the determination of trigger points for re-analysis of your ag water assessment appropriate to your specific farm risks, providing analysis of the susceptibility of your crop to surface adhesion of pathogens, and recommendations on validation approach for using alternative indicators for water testing. We can help you understand what you need to do and assist in development of a risk assessment that ensures you are in compliance with the new rule when your compliance date rolls around.

Give us a call to help!


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