On December 6, 2021, the Food and Drug Administration (FDA) published a proposed rule to amend the agricultural water regulations found in Subpart E of the Produce Safety Rule (PSR). The PSR is one of seven main rules that implements the Food Safety Modernization Act (FSMA), a comprehensive food safety law passed in 2011 which aims to revamp the United States food safety system. The comment period for this proposed rule closes on April 5, 2022.

History of the Agricultural Water Rule

Before President Obama signed FSMA into law in 2011, the Food, Drug, and Cosmetic Act (FFDCA) was the primary statutory authority the FDA looked to when regulating food safety. Prior to 2011, the United States food safety system was reactionary, meaning FDA usually only addressed food safety concerns after people had already gotten sick. After many nationwide foodborne illness outbreaks, Congress wanted to create a food safety system that helps prevent food from becoming contaminated while also detecting contaminated food before it hits market shelves. As a result, Congress amended the FFDCA by passing FSMA.

In particular, FSMA added language to the FFDCA requiring the FDA “to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.” 21 U.S.C. § 350h.

In response, the FDA in 2013 published a proposed rule entitled “Standards for the growing, harvesting, packing, and holding of produce for human consumption.” 78 F.R. 3503. The FDA finalized this rule, commonly known as the PSR, in 2015. The PSR only applies to “covered produce” which includes fruits and vegetables that people regularly consumer raw. These include raw nuts, raw fruit, carrots, lettuce, spinach, onions, citrus, and many others. Those agricultural commodities that consumers usually cook before consuming (such as asparagus, beans, corn, cranberries, and pumpkins), which the FDA calls “rarely consumed raw” produce, are not considered covered produce. The PSR consists of many subparts. Subpart E regulates agricultural water. Subpart E, as it currently reads, requires farmers of covered produce to meet “microbial quality criteria” and to calculate a “geometric mean” and “statistical threshold value”, both of which measure the amount of E. coli in the water. The goal of these tests is to ensure the water used to irrigate the produce contains no detectible Escherichia coli (E. coli) in 100 milliliters of water.

The PSR originally established compliance dates by which farmers had to comply with the entire PSR. Under these compliance dates, very small producers (those who annually sold less than $250,000 worth of produce in the last three years) have to be in compliance by January 26, 2022; small producers (those who annually sold between $250,000 and $500,000 worth of produce in the last three years) had to be in compliance by January 26, 2021; and all other producers (those who annually sold more than $500,000 worth of produce in the last three years) were required to be in compliance by January 25, 2020.

However, since 2015 FDA has received feedback from producers and other stakeholders expressing concern about the microbial quality criteria and testing requirements. Specifically, these stakeholders find the water criteria and tests:

• inflexible because the current rule attempts to apply a “one-size-fits-all” approach but in reality, does not fit most;
• too complicated to understand, particularly the requirements that farmers calculate a “geometric mean” and “statistical threshold value”; and
• difficult to implement when a farm has more than one water source.

To give the FDA more time to consider how best to approach these concerns, the FDA published a proposed rule in 2017 to extend the compliance dates of Subpart E for all covered produce, except for sprouts. This rule was finalized in 2019. The new compliance dates require very small producers to comply by January 26, 2024; small producers to comply by January 26, 2023; and all other producers to comply by January 26, 2022. 84 F.R. 9706. The original compliance dates are still in effect for all other parts of the rule and sprout growers.

FDA Proposes to Rewrite Subpart E

The FDA’s December 6, 2021, proposed rule aims to substantially change Subpart E. According to the proposed rule “FDA is proposing to amend the [PSR] by revising certain provisions relating to pre-harvest agricultural water for covered produce other than sprouts, while retaining the existing standards applicable to agricultural water for sprouts and for harvest and post-harvest activities conducted by covered farms.” Harvest and post-harvest activities include harvesting, packing, and holding. Therefore, the proposed rule, if finalized, will only change the agricultural water requirements for farmers growing covered produce other than sprouts. The proposed rule will not change the requirements that apply to the water used to grow sprouts, and the water used in harvesting, packing, and holding all covered produce.

The proposed rule aims to require farmers to prepare a written agricultural water assessment annually, as well as whenever a significant change occurs to the farmer’s agricultural water system. In the assessment, farmers are to “identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce (other than sprouts)”.

The proposed rule lays out five factors for growers to consider when writing their agricultural water assessment. These factors include identifying whether the water is ground or surface water and whether the water is in an open or closed system; the type of irrigation system used, such as foliar spray or drip; the characteristics of the crop; environmental conditions such as heavy rain or extreme weather events; and results of any testing the farmer conducted. In proposing this change, the FDA hopes growers find the proposed rule more flexible, less complicated, and more applicable to farms that have more than one water source.

The proposed rule sets out three exemptions to the agricultural water assessment requirement. First, a farmer will be exempted from conducting an agricultural water assessment if they meet the requirements for water used on sprouts and in harvesting, packing, and holding. Second, a farmer will be exempt if they only use water from a Public Water System or public water supply. Finally, a farmer will be exempt if they treat the water they use on covered produce according to requirements laid out in the proposed rule.

Looking Forward

As a proposed rule, the December 6, 2021, rule does not change the current regulation. This means that on January 26, 2022 farms that annually sold over $500,000 in the past three years are technically required to come into compliance with the 2015 version of Subpart E. However, in the December 6, 2021 proposed rule the FDA said that it will “exercise enforcement discretion … while pursuing a targeted compliance date rulemaking, with the goals of completing the rulemaking as quickly as possible.” In other words, the FDA expects to publish a proposed rule that will again extend the compliance dates for Subpart E.

To read the proposed rule and to submit a comment, click here.

To read the National Agricultural Law Center’s fact sheet on the PSR, click here.

To read a National Agricultural Law Center blog post of leafy green contamination, click here.

To read a National Agricultural Law Center blog post on the regulatory process, click here.

For more National Agricultural Law Center resources on food safety, click here.

**This article was written by former NALC Staff Attorney Jana Caracciolo.