Which farms does the FSMA Produce Safety rule cover?

Farms that grow, harvest, pack or hold produce normally eaten raw and that have average annual produce sales above $25,000 over the previous three years. Produce the FDA lists as rarely consumed raw, and produce that will receive a commercial kill step such as canning, are not covered. Farms under $500,000 in food sales that sell mostly to consumers or local retailers may hold a qualified exemption with modified requirements.

When did the Produce Safety rule take effect?

The final rule took effect on January 26, 2016. Compliance was staggered by farm size: January 26, 2018 for the largest farms, January 28, 2019 for small businesses and January 27, 2020 for very small businesses, with sprout operations a year earlier at each size and the pre-harvest agricultural water provisions later, in 2025 to 2027.

What does the Produce Safety rule require for sprouts?

Seeds and beans used for sprouting must be treated, or documented as treated by the supplier, to prevent contamination; spent sprout irrigation water or in-process sprouts from each production batch must be tested for certain pathogens; the growing, harvesting, packing and holding environment must be tested for Listeria; and sprouts may not enter commerce until the required test results are negative.

Early access How it works

Produce Safety

The Produce Safety rule, 21 CFR part 112, is the first federal regulation to set minimum standards for growing, harvesting, packing and holding fruit and vegetables on the farm, and it is the rule a produce grower is inspected against where a manufacturer would be inspected against part 117.

What it is: FSMA final rule
Where it lives: 21 CFR part 112
Final rule: November 2015
Effective: January 26, 2016
Docket: FDA-2011-N-0921
Published by: U.S. Food and Drug Administration

Who it covers

Farms growing produce that is normally eaten raw, above a size threshold: a farm with average annual produce sales of $25,000 or less over the previous three years is not covered at all. The rule is written around the routes by which produce is contaminated before it reaches any facility, because for a product eaten raw nothing downstream of the field is a kill step.

Produce the FDA has identified as rarely consumed raw is outside the rule. The list is in section 112.2 and includes asparagus, dry beans, sugar beets, cashews, cocoa and coffee beans, sweet corn, cranberries, dates, eggplant, figs, ginger, hazelnuts, lentils, okra, peanuts, pecans, potatoes and others. Produce destined for a commercial processing step that kills pathogens, such as canning, can also be excluded, with documentation.

What it requires

Six areas. Agricultural water, whose pre-harvest provisions were replaced in 2024 by a separate final rule. Biological soil amendments of animal origin: untreated amendments such as raw manure must be applied so that they do not contact covered produce during application, and the rule sets microbial standards for composting processes. Sprouts, which have their own subpart because of their outbreak history. Domesticated and wild animals. Worker training, health and hygiene. Equipment, tools, buildings and sanitation.

Sprouts are the strictest case. Seeds must be treated or documented as treated, spent irrigation water or in-process sprouts must be tested for pathogens from every production batch, the growing environment must be tested for Listeria, and a batch cannot enter commerce until the required results are negative.

In the FDA’s words

“The Produce Safety rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.”

U.S. Food and Drug Administration, FSMA Final Rule on Produce Safety, updated 2024-11-13. Read 2026-09-16.

For the first time: before 2016 there was no federal regulation of growing practices at all, only guidance.

“Between 1996 and 2014, there were 43 outbreaks, 2,405 illnesses, and 171 hospitalizations, and 3 deaths associated with sprouts, including the first documented outbreak of Listeria monocytogenes associated with sprouts in the United States.”

U.S. Food and Drug Administration, FSMA Final Rule on Produce Safety, updated 2024-11-13. Read 2026-09-16.

Why sprouts have their own subpart, earlier compliance dates and a pathogen test on every batch.

“The final rule requires that untreated biological soil amendments of animal origin, such as raw manure, must be applied in a manner that does not contact covered produce during application and minimizes the potential for contact with covered produce after application.”

U.S. Food and Drug Administration, FSMA Final Rule on Produce Safety, updated 2024-11-13. Read 2026-09-16.

The FDA has not set a minimum interval between raw manure and harvest; it says it does not object to farms following the National Organic Program's 120 and 90 day intervals while its research continues.

Compliance dates

Who	Date
Farms with more than $500,000 in average annual produce sales	January 26, 2018
Small businesses, more than $250,000 but not more than $500,000	January 28, 2019
Very small businesses, more than $25,000 but not more than $250,000	January 27, 2020
Sprout operations: large farms	January 26, 2017
Sprout operations: small businesses	January 26, 2018
Sprout operations: very small businesses	January 28, 2019

Size is measured on a rolling basis over the previous three years. The pre-harvest agricultural water provisions have their own, later dates, running to April 2027.

The dates are the FDA’s, as stated on FSMA Final Rule on Produce Safety, updated 2024-11-13, read 2026-09-16. Compliance dates have been extended before; check that page before planning against any of them.

Exemptions

A qualified exemption with modified requirements is available to a farm with food sales averaging under $500,000 a year over the previous three years whose sales to qualified end-users, meaning consumers, or restaurants and retailers in the same state or within 275 miles, exceed its sales to everybody else. A farm holding the exemption still has to label its produce with its name and address, and the FDA can withdraw the exemption after an outbreak or where conditions warrant.

Where it is in 21 CFR

The rule is codified at 21 CFR part 112, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. Title 21 is a work of the United States government and in the public domain, so the regulation is reproduced in full on this site. These are the sections a reader of this page most often needs.

What goes wrong in practice

A rule describes the controls; the FDA’s recall records are what happened where a control was missing. These are the hazards and the kinds of food whose records this rule is most often written against.

Questions

Which farms does the FSMA Produce Safety rule cover?: Farms that grow, harvest, pack or hold produce normally eaten raw and that have average annual produce sales above $25,000 over the previous three years. Produce the FDA lists as rarely consumed raw, and produce that will receive a commercial kill step such as canning, are not covered. Farms under $500,000 in food sales that sell mostly to consumers or local retailers may hold a qualified exemption with modified requirements.
When did the Produce Safety rule take effect?: The final rule took effect on January 26, 2016. Compliance was staggered by farm size: January 26, 2018 for the largest farms, January 28, 2019 for small businesses and January 27, 2020 for very small businesses, with sprout operations a year earlier at each size and the pre-harvest agricultural water provisions later, in 2025 to 2027.
What does the Produce Safety rule require for sprouts?: Seeds and beans used for sprouting must be treated, or documented as treated by the supplier, to prevent contamination; spent sprout irrigation water or in-process sprouts from each production batch must be tested for certain pathogens; the growing, harvesting, packing and holding environment must be tested for Listeria; and sprouts may not enter commerce until the required test results are negative.

The other FSMA rules

FSMA is enforced as 10 rules, and a single business frequently sits under several. The Act itself, and how the rules fit together.

An inspection under this rule asks for the records behind each requirement, and finding them is the work. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.