When you go to the grocery store or farmer’s market and buy produce (I prefer the latter), do you consider how safe the produce is?  If you are anything like me, perhaps you have wondered about the regulatory requirements farmers follow in order to help ensure that our produce is safe to eat. 

The Food Safety Modernization Act (FSMA) Produce Safety Rule has numerous regulatory requirements designed to ensure that water that touches produce (known as “agricultural water”) is not contaminated with bacteria that might cause illness. When originally enacted, these regulations centered around numerous water testing requirements which varied depending upon the source of the water and how it was used.  These requirements were the topic of a previous article.  

The agricultural water testing regulations were to be phased in over several years with the compliance deadline for the largest farmers (those with sales over $500,000) in January 2022.  By January 2024, the water testing requirements would have applied to all commercial farms, except those with annual sales of $25,000 or less (although those farms would need to keep records to demonstrate their sales level).  21 .C.F.R. § 112.4

The water testing requirements provided for multiple tests over an extended period of time, meaning that farms subject to the requirement needed to start testing in advance of the compliance date.  21 C.F.R. § 46  As farms began to perform the testing, it proved difficult for some to implement due to the multitude of types of water sources and circumstances on individual farms.  In response to concerns raised by farmers, the FDA has proposed amendments to the agricultural water rules intended to make it easier for farmers to comply while still protecting public safety.  The comment period on the proposed new rules expires on April 5, 2022.

The proposed amendments require farms to conduct individualized pre-harvest agricultural water assessments annually and whenever a change occurs that could result in a known or foreseeable contaminant coming in contact with produce or a food contact surface.  The proposed amendments would then require farms to take action to (1) stop using any agricultural water found to be unsafe, and (2) mitigate hazards identified in the agricultural water assessment.

An agricultural water assessment would require a farm to evaluate:

• Its agricultural water system (all water sources, distribution systems, equipment, structures, etc., used to irrigate or clean produce), including: 

  • Type of water source, e.g., ground water or surface water

  • How the water is distributed, e.g., is the water enclosed or open to possible contaminants

  • Whether and/or how much the water system is protected from possible contamination

• How the water is used on the farm, including:

  • How water is applied to crops

  • The amount of time between the application of water to the crop and harvest

• Type of crop and how susceptible it is to contamination

• Environmental conditions, including:

  • Frequency of rain, storms, etc., that could stir up contamination that could impact the crop

  • Temperature

  • Sun exposure

• Any other factors specific to the farm and crop that could impact contamination concerns, including the results of any water testing that may be done.

Based upon the agricultural water assessment, farms would have to immediately discontinue use of any agricultural water deemed not safe and take corrective action to make the water safe before using it again.  For hazards identified in the assessment, if those hazards involved animal contamination, biological soil amendments or human waste, the farm would have to undertake mitigation efforts during that growing season.  For other types of hazards, mitigation efforts would have to be undertaken as soon as practicable, but no later than within the following year.

Fewer than fifty comments on the proposed amendments have been made to date.  In general, the comments are favorable, recognizing that farmers are in the best position to understand their water sources and ensure their safety.  However, a couple of insightful farmers noted the extensive nature of the recordkeeping burden imposed upon farmers and the lack of specific instruction on, for example, how much mitigation would be sufficient to correct hazards, which could lead to differing interpretations by different inspectors and uncertainty for farmers.

The FDA has stated that it intends to use discretion in enforcing the agricultural water rules and will work with state regulators, farmers and others involved to implement the proposed amendments, if they are adopted.  Hopefully, the FDA’s discretion and the learning experiences flowing from it will provide farmers with the needed guidance to address the concerns raised in the comments to the proposed amendments.