FDA Proposes Substantial Changes to Agricultural Water Requirements

On December 6, 2021, FDA published a proposed rule to reorganize and amend the highly criticized agricultural water provisions of the Produce Safety Rule (PSR). This marks the Agency’s latest effort to balance public health protections with covered farms’ persistent concerns that the current provisions are overly complex, difficult to implement, and ill-suited to address the diversity of water uses and sources in the produce industry.

The proposed changes are extensive, but the three main takeaways to note are that the proposed rule:

• will replace microbial quality and testing requirements with systems-based agricultural water assessments;
• will enhance risk-based mitigation measures with expedited mitigation for known or reasonably foreseeable hazards from animal activity, biological soil amendments of animal origin, or improperly treated human waste associated with adjacent or nearby lands; and
• emphasizes flexibility for covered farms to choose how to comply with the agricultural water requirements.

These changes are described in greater detail below. We note that the proposal concerns pre-harvest activities and the existing standards for covered farms’ harvest and post-harvest activities are not affected by the proposed rule. Also, the proposal concerns all produce except for sprouts, which are subject to separate requirements.

Background

The PSR, finalized in 2015 under the Food Safety Modernization Act (FSMA) and codified at 21 C.F.R. Part 112, established (for the first time ever) mandatory federal science-based minimum standards for the safe production and harvesting of produce for human consumption. FDA has long recognized (in its own investigations and based on decades of scientific research) that the quality of agricultural water is an important factor in produce safety. Subpart E of the PSR was specifically developed to address agricultural water quality control.  Among other requirements, it establishes testing obligations and microbial quality criteria for agricultural water based on the water’s intended use, e.g., irrigation water, water used in preparing crop sprays, etc.). In addition, Subpart E includes measures that a covered farm must take if its agricultural water fails to meet these requirements.

FDA quickly found itself in troubled waters with these new requirements. The regulated industry criticized the complexity and the one-size-fits-all approach of Subpart E.  In 2017, in an effort to lighten the burden for affected parties, FDA proposed to extend compliance dates until at least Jan. 26, 2022.  Despite opposition, FDA finalized the proposal to extend the compliance dates in March 2019.

Now, six years after finalizing the PSR but before the compliance date, FDA published a proposal to address stakeholders’ concerns about the PSR’s agricultural water requirements.

Testing the waters with a comprehensive assessment framework

FDA proposes to replace Subpart E’s prescriptive and highly technical testing requirements and microbial water quality criteria with more flexible provisions. These provisions will instead require covered farms to perform comprehensive, systems-based, and management-reviewed agricultural water assessments to identify and address potential risks associated with pre-harvest agricultural water.

If finalized, covered farms will be required to conduct written pre-harvest agricultural water assessments annually. The assessments must include all possible sources which are reasonably likely to introduce known or reasonably foreseeable hazards regardless of whether the farm has control over those hazards, specifically:

• The location, nature, and current and previous use(s) of the water source;
• The type of water distribution system;
• The degree to which the system is protected from possible sources of contamination, such as adjacent and nearby land uses, and particularly animal impacts;
• The type of application method (e.g., overhead sprinkler or seepage irrigation);
• The time interval between the last direct application of agricultural water and harvest of the covered produce;
• Crop characteristics that make covered produce vulnerable to contamination (e.g., susceptibility of the produce to surface adhesion or internalization of contaminants);
• Environmental conditions (e.g., rainfall patterns that may impact the agricultural water system or damage produce); and
• Other relevant factors that could inform the assessment (e.g., optional testing).

Covered farms will also be required to conduct pre-harvest agricultural water assessments whenever a significant change occurs that may increase the likelihood that a known or reasonably foreseeable hazard will be introduced into or onto produce or food contact surfaces. In other words, any change in the factors considered in the agricultural water assessment will trigger a reassessment requirement if that change may impact hazard identification or a risk management determination. For example, a change in the manner of water application will require a farm to conduct another agricultural water assessment if that change introduces, or increases the chance of introducing, a known or foreseeable hazard into or onto produce or food contact surfaces.

This comprehensive assessment approach is adaptable to diverse and changing circumstances.  The proposal recognizes that many interconnected factors, such as variability in agricultural water sources, systems, and practices, nearby land uses, crop characteristics, and environmental conditions, pose possible sources of contamination which differ from farm to farm. In addition, the proposed rule is designed to accommodate future improvements in agricultural water quality science. For instance, although generic E. coli is currently the preferred indicator for monitoring water quality, future scientific developments may provide for the use of viral indicators, such as coliphages, to inform water quality assessments. As FDA explains, “as new science [becomes] available in the realm of water quality monitoring, farms should have the flexibility to take those findings into account when establishing or updating their sampling programs.”

The proposed rule further provides covered farms the flexibility to choose whether to test their pre-harvest agricultural water for generic E. coli and, as science evolves, other appropriate organisms or analytes. This option, which would be in addition to the required agricultural water assessments, includes detailed requirements for sample collection, testing frequency, and validation to ensure that the testing is adequate to supplement a farm’s agricultural water assessment. Optional testing helps alleviate the burden on produce farms that lack nearby laboratories capable of testing water samples, or that rely on water sources that are too numerous or inconsistent to provide representative water sampling.

Finally, proposed exemption provisions add flexibility to the regulations. FDA proposes to exempt covered farms from conducting a pre-harvest agricultural water assessment if they can demonstrate that their pre-harvest agricultural water for covered produce:

• meets the PSR requirements 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 that meets Safe Drinking Water Act or state regulations (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 applicable PSR standards (i.e., the method, delivery, and monitoring of the treatment are done in a manner that is effective to make the water safe and of adequate sanitary quality for its intended use).

Corrective and mitigation measures to keep farmers’ heads above water

FDA proposes that covered farms use the assessments to determine whether corrective or mitigation measures will be necessary to reduce the risk of contamination of their pre-harvest agricultural water, or whether routine inspections and maintenance will suffice to ensure the water’s safety and sanitary quality. The assessments also allow covered farms to evaluate trends impacting their agricultural water systems and the effectiveness of any mitigation measures taken.

FDA is proposing to require that corrective or mitigation measures be taken based on certain findings, displayed in the chart below.

Even though the proposed rule prescribes measures that covered farms must take based on findings from their agricultural water assessments, it provides covered farms with choices of mitigation measures.  For example, they may adopt microbial die-off or removal post-harvest activities (e.g., commercial washing) as a mitigation measure.

By providing covered farms with options rather than being prescriptive, the proposed rule helps address the root cause of covered farms’ complaints that Subpart E’s requirements are too complex and rigid to implement effectively.

It’s Time to Sink or Swim: Proposed Effective and Compliance Dates

As mentioned above, the earliest compliance date for Subpart E is Jan. 26, 2022 (the compliance date for small farms is Jan. 26, 2023, and the compliance date for very small farms is Jan. 26, 2024). Since the current requirements are likely to change, FDA proposes to exercise enforcement discretion for the agricultural water requirements for covered produce while it works to extend the compliance dates until after the proposed rule has been finalized.

FDA has not identified a target date for publication of the final rule. Comments to the proposed rule may be submitted until Apr. 5, 2022 here.