Newly proposed FSMA water rule

A previous version of this blog had the incorrect dates for the comment period for the proposed water rule. Apologies for any inconvenience. The comment period has closed. You can read submitted comments to the FDA on the proposed rule here.

The long-awaited FDA revised water rule has arrived! This proposed rule does away with the extensive testing scheme mandated in the original water rule. The new approach would be entirely risk-assessment based, giving farmers both the freedom and responsibility to decide the relative safety of their water source for pre-harvest on-farm uses.

The new proposed rule only impacts the use of pre-harvest water for uses such as irrigation, frost protection, and any other field applications. In 2015, when the FDA first issued the Produce Safety Rule, they required 20 tests over a 2-4 year period to establish a “microbial water quality profile” for surface water. Compared to guidelines used by GAP Certification Standards (adopted from the National Organic Program rules), which required only three annual tests for surface water a year, this was a surprising amount of testing. Farmer-led advocacy against the onerous water rule led to the FDA delaying compliance dates for that portion of the Produce Safety Rule until January of 2022 while they reconsidered their original rule.

In the new proposed rule, we see that the FDA seems to have done a complete 180 in its approach to on-farm water quality assessment. Now, rather than mandate an extensive testing scheme, the proposed rule leaves evaluation of water quality almost wholly in the hands of individual farmers. Testing is still a tool in the farmer’s toolbox if they so elect. Being given this responsibility and freedom might be appreciated if assessing water quality was an easy task for a farmer to do. Really, it is a tall order.

Granted, the FDA announced on March 21 that they had published a tool to help farmers with their newfound water assessment freedom. For any farmer that’s conducted a risk assessment for any aspect of their farm, this process will be familiar. A risk assessment is an open-ended series of prompts that walks a farmer through the most significant risks to, in this case, water quality. With this tool, farmers answer questions about whether their surface water source is at risk of runoff from neighboring properties or how often they monitor their distribution system.

The previous testing standards weren’t perfect, but at least they were an objective measure. Even with the provided assessment tool, the farmer will need to be making subjective decisions about water quality. What if an Inspector and a farmer disagree about one of those subjective assessments? How will a farmer know how often to “regularly monitor” their irrigation pond to “prevent reasonably foreseeable hazards”? The original proposed water rule focused too much on numerical microbial levels in the water but limiting the use of testing might be throwing the baby out with the (untested) bathwater.

You can read about the new proposed rule here. If you need a refresher on the rules as they currently stand, including whether you fall under the Produce Safety Rule at all, please refer to our FSMA Compliance Flow Chart.