The U.S. Food and Drug Administration – acting under its Food Safety Modernization Act (FSMA), as amended, 21 U.S.C. § 2201 et seq., to address the safety of all FMSA-covered produce other than sprouts (Covered Produce) – on May 6, 2024, issued a final rule that amended its 2015 rule on the safety of produce. With certain exceptions for growers of Covered Produce, the FDA's new rule requires pre-harvest agricultural water assessments for hazard identification and risk management decision-making purposes. Requirements for harvest and post-harvest use of agricultural water have not changed. The FDA regulated sprouts specifically in an earlier pre-harvest agricultural water regulation that remains applicable to that produce.

"Agricultural water" encompasses water used for growing activities such as irrigation and the preparation of crop sprays and is water that is intended to, or is likely to, contact covered produce or food-contact surfaces. Farms subject to the FDA's produce safety rule (Covered Farms) must annually conduct agricultural water assessments. These assessments must evaluate various factors, among them the location and nature of the water source, the degree to which the water is protected from contamination and the susceptibility of the produce to hazards, such as other water users or nearby land uses related to animals, which could facilitate contamination of the produce.

The FDA final rule does not specifically mention per- and polyfluoroalkyl substances (PFAS). On April 10, 2024, the U.S. Environmental Protection Agency's (EPA) National Primary Drinking Water Regulation set Maximum Contaminant Levels (MCLs) and MCL Goals for six PFAS compounds in drinking water under the Safe Drinking Water Act. (See Holland & Knight's previous alert, "EPA Finalizes PFAS Drinking Water Regulation," April 17, 2024.) Given these MCLs and the EPA's review of PFAS in biosolids, it may be just a matter of time before an assessment of agricultural water undertaken under the FDA's new rule may need to consider PFAS. Biosolids have been found to be a source of PFAS contamination in groundwater on farms in Maine, which banned the application in 2022. It is expected that there will be increased focus on agricultural water in areas where biosolids were used as fertilizer. The FDA has regularly tested the food supply for PFAS since 2019. This testing resulted in two seafood products being recalled in 2022. (See Holland & Knight's previous alert, "FDA Ramps Up Actions on PFAS," April 3, 2024.)

The outcomes of any agricultural water assessment, and the actions the FDA requires in response to each outcome, are set forth in the rule at 21 C.F.R. § 112.43(c) and summarized in a chart, Table 4, in the rule's preamble. The FDA states at the beginning of the rule's preamble that its new rule aims to "more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness …" Preventing microbial contamination of Covered Produce appears to be the FDA's main objective in issuing the rule, but the aim of the rule is not limited to preventing foodborne illness caused by animal or human waste or soil biologically changed by animal activity. Read together, Table 4 and 21 C.F.R. § 112.43(c)(4) make it clear that action is required if an assessment finds one or more known or reasonably foreseeable hazards that are not related to animal activity, biological soil amendments of animal origin, or untreated or improperly treated human waste, and for which mitigation is reasonably necessary. In such instances, Covered Farms must either mitigate the hazard as soon as practicable and in no event more than one year after the assessment or test the water and take appropriate action.

Effective Dates

The rule becomes effective on July 7, 2024, but the date by which a Covered Farm must comply depends on the size of the business of the farm. Large farms must be in compliance by April 7, 2025, within nine months of the rule's effective date; small farms, by April 6, 2026, within one year and nine months of the effective date; and very small farms within two years and nine months, or by April 5, 2027. The size of a farm's business for the purposes of this rule is determined on a rolling basis by the average annual monetary value of the produce sold by the farm over the previous three years. A "very small business" is a farm that sells no more than $250,000 in produce over three years, and a "small business" is a farm that is not a very small business and has sold no more than $500,000 in produce over the previous three years. See 21 C.F.R. § 112.3. All other farms are large farms for the purpose of the determining the compliance date.

The Produce Safety Rule was originally finalized and implemented in January 2016 under the FMSA. The rule establishes science-based minimum standards for the safe growing, harvesting, packaging and growing of fresh produce, which means fruits and vegetables grown for human consumption. Produce that undergoes processing that adequately reduces microorganisms of public health significance can qualify for exemption from Produce Safety Rule requirements.