FDA Proposes New Pre-Harvest Water Rules for Produce Farms (2021)

On December 2, 2021, the U.S. Food and Drug Administration (FDA) proposed replacing the microbial testing rules for the water that produce farms use on their crops before harvest. In place of fixed water-quality numbers, farms would carry out a yearly assessment of their water and act faster on hazards coming from nearby land. The proposal was published in the Federal Register on December 6, 2021, and was later finalized in 2024. The germs at the center of produce-safety rules are described on the site’s Escherichia coli and Cyclospora pages.

This page reports what the FDA’s own documents say: what was proposed and when, why the FDA said the earlier rules were being replaced, what the yearly water assessment would cover, how farms would respond to what they found, the compliance dates and the FDA’s enforcement plans in 2021, what the proposal did not do, its status as of October 18, 2026, and how it fits other FDA produce-safety actions. No farm, company or product is named here.

Table of Contents

  1. What the FDA Proposed in December 2021
  2. Pre-Harvest Water and the Produce Safety Rule
  3. Why the FDA Said the Earlier Rules Were Being Replaced
  4. What the Proposal Would Replace
  5. The Yearly Agricultural Water Assessment
  6. Corrective Measures and Faster Action on Nearby-Land Hazards
  7. Compliance Dates and Enforcement Discretion in 2021
  8. Public Meetings, an Online Tool and State Partners
  9. What the Proposal Did Not Do
  10. Dates and Legal Status as of October 18, 2026
  11. How It Fits Other FDA Produce-Safety Actions
  12. Primary Documents
  13. Key Research Papers
  14. Connections
  15. Featured Videos

1. What the FDA Proposed in December 2021

The FDA’s constituent update of December 2, 2021, “FDA Proposes Changes to Agricultural Water Requirements in the Produce Safety Rule,” announced that the agency had that day published a proposed rule that “would revise subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule to change certain pre-harvest agricultural water requirements for covered produce other than sprouts.”

The Federal Register record gives the details of the document:

A few terms explain the format. A proposed rule is a draft regulation that the public may comment on before the agency decides on a final version; it has no legal force by itself. The Federal Register is the U.S. government’s daily publication of rules and official notices, and “86 FR 69120” means volume 86, page 69120. A docket is the public file for an action, where the documents and comments are kept on regulations.gov. The Code of Federal Regulations (CFR) is the standing collection of federal rules; part 112 of title 21 is the produce safety regulation.

Back to Table of Contents

2. Pre-Harvest Water and the Produce Safety Rule

The constituent update states that in 2015 the FDA published the final Produce Safety Rule, “establishing science- and risk-based standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption.” The rule was issued under the FDA Food Safety Modernization Act, known as FSMA. Subpart E of the rule deals with agricultural water.

The 2021 proposal concerned pre-harvest agricultural water: water that a farm applies to a crop while it is still growing. The FDA’s later program page on the finalized rule lists the kinds of application methods involved, “such as overhead sprinkler or spray, drip, furrow, flood, and seepage irrigation.” Water used during and after harvest is covered by a separate set of requirements and was not the subject of this proposal.

Two more terms appear throughout the documents. Covered produce is produce that falls under the Produce Safety Rule, and a covered farm is a farm subject to its requirements. Sprouts are treated separately: the constituent update states that sprouts “are subject to different pre-harvest agricultural water testing requirements that are already in effect and are not impacted by this proposed rule.”

The FR abstract describes the public-health reason for the subject: the revisions, if finalized, “would more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem.”

Back to Table of Contents

3. Why the FDA Said the Earlier Rules Were Being Replaced

The FDA’s documents give three reasons.

The constituent update adds that the approach “was developed following hundreds of farm visits and meetings with stakeholders, including an Agricultural Water Summit hosted by the Produce Safety Alliance,” and that the requirements are meant to be “workable across produce farms of all sizes, both domestic and foreign, recognizing the wide variety of water systems, uses, and practices,” and “adaptable to future advancements in agricultural water quality science and technology.”

Back to Table of Contents

4. What the Proposal Would Replace

According to the FR abstract, the proposal “would replace the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts) with provisions for systems-based agricultural water assessments.”

Put simply, the 2015 rule judged pre-harvest water mainly by testing it for microbes against set microbial quality criteria. A systems-based assessment looks instead at the whole water system and how it is used, to identify conditions that could carry contamination onto a crop. The FR abstract says the new provisions are “designed to be more feasible to implement across the wide variety of agricultural water systems, uses, and practices, while also being adaptable to future advancements in agricultural water quality science and achieving improved public health protections.”

Testing does not disappear from the picture. The constituent update lists “the results of optional testing” among the factors an assessment would weigh. (The 2024 final rule, described in section 10, went further and requires testing in certain circumstances.)

Back to Table of Contents

5. The Yearly Agricultural Water Assessment

The constituent update states that, if the proposal were finalized, covered farms “would be required to conduct an assessment of their pre-harvest agricultural water annually, and whenever a significant change occurs, to identify any conditions likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces.”

The assessment, in the constituent update’s words, “would include an evaluation of”:

A hazard, in this setting, is a germ or other agent that could make the food unsafe. A food contact surface is a surface that comes into contact with the produce.

Back to Table of Contents

6. Corrective Measures and Faster Action on Nearby-Land Hazards

The assessment is meant to lead to a decision. The constituent update states that, based on their assessments, “farms would then determine whether corrective or mitigation measures are needed to reduce the potential for contamination.”

The proposal also singled out one kind of risk. The constituent update states: “In light of findings from several recent produce outbreak investigations, the proposal also includes expedited mitigation measures that would be required for specific types of hazards related to certain activities associated with adjacent and nearby lands.” The FR abstract uses nearly the same words. Expedited mitigation means steps that would have to be taken more quickly than for other hazards. The 2021 documents fetched for this page do not list the specific nearby-land activities; the 2024 final rule’s program page names them as animal activity, the application of biological soil amendments of animal origin (soil amendments made from animal materials), and untreated or improperly treated human waste.

Back to Table of Contents

7. Compliance Dates and Enforcement Discretion in 2021

A compliance date is the date by which a regulated business has to meet a requirement. The constituent update noted that the existing agricultural water compliance dates were “set to begin in January 2022,” only weeks after the proposal.

The FDA addressed this directly: “The agency intends to exercise enforcement discretion for the agricultural water requirements for covered produce (other than sprouts) while proposing to extend the compliance dates for all subpart E provisions applicable to such produce, with the goal of completing the compliance date rulemaking as quickly as possible.” Enforcement discretion means the agency states that it does not intend to enforce a requirement for a period, even though the requirement remains on the books.

The constituent update said that more information on the proposed compliance dates would follow in a separate Federal Register notice. That notice appeared on July 19, 2022, as a supplemental proposed rule (see section 10).

Back to Table of Contents

8. Public Meetings, an Online Tool and State Partners

The constituent update described several steps planned around the proposal:

Back to Table of Contents

9. What the Proposal Did Not Do

Back to Table of Contents

10. Dates and Legal Status as of October 18, 2026

Status as of October 18, 2026: final. The 2021 proposal became a final rule on May 6, 2024, in effect since July 5, 2024. The FR abstract of the final rule states that it replaces the earlier microbial criteria and testing requirements for pre-harvest water (other than sprouts) with “systems-based assessments, with required testing in certain circumstances,” and includes “a new requirement for expedited mitigation for certain hazards.” The FDA’s program page (content current as of September 30, 2025) adds that the final rule requires supervisory review of the written assessment, exempts farms from the assessment in certain cases (for example, water from a qualifying public water system, or water treated to the rule’s standards), and that routine inspections of the new pre-harvest provisions are “scheduled to begin one year after the compliance dates for each farm size.” A check of the Federal Register docket and FDA agricultural water documents through October 18, 2026 found no later document that changes the rule.

The program page also sets out what farms must do based on the outcome of the assessment under the final rule: for example, immediately stop using water found not safe or not of adequate sanitary quality for its intended use, and take corrective measures before using it again; carry out mitigation for nearby-land hazards “promptly, and no later than the same growing season”; and carry out mitigation for other hazards “as soon as practicable and no later than the following year,” or test the water as part of the assessment. These are the requirements of the final rule as the FDA describes them.

Back to Table of Contents

11. How It Fits Other FDA Produce-Safety Actions

The proposal is one step in the FDA’s work under FSMA on fresh produce, as the documents describe it:

Other FDA actions on produce safety are reported on their own pages. The 2022 food traceability final rule deals with tracing foods back through the supply chain during outbreaks. Among outbreak investigations, the 2021 onion Salmonella outbreak and the 2023 cantaloupe Salmonella outbreak are told separately. Other 2021 FDA food actions include the Closer to Zero action plan on toxic elements in foods for babies and young children and the voluntary sodium reduction targets.

Back to Table of Contents

12. Primary Documents

  1. Food and Drug Administration, HHS (2021). Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water. Proposed rule. Federal Register 86 FR 69120, December 6, 2021. Docket No. FDA-2021-N-0471; RIN 0910-AI49 — FR Doc. 2021-26127
  2. U.S. Food and Drug Administration. FDA Proposes Changes to Agricultural Water Requirements in the Produce Safety Rule. Constituent update, December 2, 2021 — fda.gov constituent update
  3. Food and Drug Administration, HHS (2022). Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water; Proposed Rule; Public Meetings; Request for Comments. Federal Register 87 FR 913, January 7, 2022. Docket No. FDA-2021-N-0471 — FR Doc. 2021-28503
  4. Food and Drug Administration, HHS (2022). Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water. Proposed rule; supplemental notice of proposed rulemaking. Federal Register 87 FR 42973, July 19, 2022. Docket No. FDA-2021-N-0471 — FR Doc. 2022-15134
  5. Food and Drug Administration, HHS (2024). Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water. Final rule. Federal Register 89 FR 37448, May 6, 2024, effective July 5, 2024. Docket No. FDA-2021-N-0471 — FR Doc. 2024-09153
  6. Food and Drug Administration, HHS (2024). Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability. Federal Register 89 FR 77775, September 24, 2024. Docket No. FDA-2011-N-0921 — FR Doc. 2024-21840
  7. U.S. Food and Drug Administration. FSMA Final Rule on Pre-Harvest Agricultural Water. Program page, content current as of September 30, 2025 — fda.gov pre-harvest agricultural water page
  8. Public docket FDA-2021-N-0471 — regulations.gov FDA-2021-N-0471

Back to Table of Contents

Key Research Papers

  1. Havelaar AH, Vazquez KM, Topalcengiz Z, Muñoz-Carpena R, Danyluk MD (2017). Evaluating the U.S. Food Safety Modernization Act Produce Safety Rule Standard for Microbial Quality of Agricultural Water for Growing Produce. Journal of Food Protection 80(11):1832-1841 — PubMed PMID: 28990819
  2. Gerdes ME, Cruz-Cano R, Solaiman S, Ammons S, Allard SM, Sapkota AR, Micallef SA, Goldstein RER (2022). Impact of irrigation water type and sampling frequency on Microbial Water Quality Profiles required for compliance with U.S. Food Safety Modernization Act Produce Safety Rule standards. Environmental Research 205:112480 — PubMed PMID: 34863989
  3. Pachepsky Y, Shelton D, Dorner S, Whelan G (2016). Can E. coli or thermotolerant coliform concentrations predict pathogen presence or prevalence in irrigation waters? Critical Reviews in Microbiology 42(3):384-393 — PubMed PMID: 25198779
  4. Allard SM, Callahan MT, Bui A, Ferelli AMC, Chopyk J, Chattopadhyay S, Mongodin EF, Micallef SA, et al. (2019). Creek to Table: Tracking fecal indicator bacteria, bacterial pathogens, and total bacterial communities from irrigation water to kale and radish crops. Science of the Total Environment 666:461-471 — PubMed PMID: 30802661
  5. Alegbeleye OO, Singleton I, Sant’Ana AS (2018). Sources and contamination routes of microbial pathogens to fresh produce during field cultivation: A review. Food Microbiology 73:177-208 — PubMed PMID: 29526204
  6. Marshall KE, Hexemer A, Seelman SL, Fatica MK, Blessington T, Hajmeer M, Kisselburgh H, Atkinson R, et al. (2020). Lessons Learned from a Decade of Investigations of Shiga Toxin-Producing Escherichia coli Outbreaks Linked to Leafy Greens, United States and Canada. Emerging Infectious Diseases 26(10):2319-2328 — PubMed PMID: 32946367

The first two papers examine the 2015 Produce Safety Rule’s microbial water-quality standard and how water type and sampling frequency affect the water-quality profiles it required. The third reviews whether E. coli and related indicator counts predict disease-causing germs in irrigation water. The fourth tracks bacteria from irrigation water onto crops. The last two review how germs reach produce in the field and what a decade of investigations of leafy-green outbreaks in the U.S. and Canada found.

PubMed Topic Searches

  1. PubMed: agricultural water and produce safety
  2. PubMed: irrigation water and fresh produce contamination
  3. PubMed: FSMA Produce Safety Rule

Back to Table of Contents

Connections

Back to Table of Contents