The final Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Rule (“Produce Safety Rule”) has proven to be one of the more confusing foundational rules issued by the U.S. Food and Drug Administration (“FDA”) under the Food Safety Modernization Act (“FSMA”). In particular, farmers have struggled to understand and come into compliance with the Produce Safety Rule’s complex agricultural water standards ever since FDA finalized the rule in 2015. In recognition of these challenges, the FDA announced on March 20, 2017, that it is exploring ways to simplify the testing requirements for agricultural water.
Currently, the Produce Safety Rule sets microbial quality standards for agricultural water, as it can be a major source of produce contamination. The Rule establishes two sets of criteria for microbial water quality based on the presence of generic E. coli, which indicates the presence of fecal contamination.
- Under the Rule, no detectable generic E. coli are allowed for uses of agricultural water where there is a risk that microbes could be transferred to produce through direct or indirect contact. This includes water used for washing hands during and after harvest, water used on food contact surfaces, water that comes in direct contact with produce during or after harvest, and water used for sprout irrigation.
- The second standard sets numerical criteria for agricultural water that is applied directly to growing produce, other than sprouts. The criteria are based on two values-the geometric mean (“GM”) and the statistical threshold (“STV”). The GM essentially represents the average amount of generic E. coli levels in a water source. The STV reflects the amount of variability in the water quality, indicating E. coli levels when adverse conditions come into play, like rainfall or a high water levels that wash waste into rivers and canals.
In response to this rule, the FDA received a significant amount of feedback from the agricultural industry pointing out that these standards are too complicated and too difficult for regulated parties to understand, translate, and implement. As a result, the FDA plans to work closely with the agricultural industry to explore the possibility of simplifying the agricultural water standards. This process will likely take a considerable amount of time, as it will likely require a formal rulemaking since the current rule does not provide much flexibility.
Nevertheless, farmers that are subject to the Produce Safety Rule should remain mindful of the looming compliance deadlines. While the Rule establishes a staggered timeline designed to give some farmers extra time to come into compliance, the compliance date for the agricultural water-related requirements is January 27, 2020 for large businesses, January 26, 2021 for small businesses, and January 26, 2022 for very small businesses.
Ideally, FDA’s review of the standard will be quick, so that changes to the standard and testing frequencies are made before farms are expected to come into compliance. However, it is also possible that the FDA will extend the dates for complying beyond after the initial compliance deadline in 2020.