FSMA’s Produce Safety Rule: An Overview

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As part of the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) developed “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”. These standards are commonly referred to as the Produce Safety Rule. The rule sets forth procedures, processes and practices that minimize the risks for consumers of eating raw fruit and vegetables that could be contaminated with bacteria, viruses or parasitic organisms that cause food borne illness. This rule was effective January 26, 2016 and it has different compliance dates for farms based on annual sales.

The Produce Safety Rule targets produce (fruits and vegetables) that are usually eaten raw or considered raw agricultural commodities (RACs) by FDA. Produce that is affected by the rule and that will be inspected is referred to as “covered produce”. Produce can be considered covered, not covered (if it is rarely consumed raw or grown for personal consumption of the farmer) or can be exempt if it is destined for further processing. For a thorough explanation of how produce is categorized and what the requirements are for each category see how produce is classified under the PSR Rule.

Produce farms fall into one of three major categories:

a) Not covered by the Produce Safety Rule. These are farms that sell $26,632 or less in produce annually over the last 3 years.

b) Farms eligible for a qualified exemption and modified requirements.

These farms must meet these two requirements:

  1. The farm must sell the majority of the food* directly to consumers, restaurants or retail food establishments** within NC or not more than 275 miles of the farm or via internet sales. If the farm sells produce to a broker or any other type of business, those sales should be 49% of less of total food sales.
  2. The total food* sales for the farm must be less than $532,645 annually (to calculate sales use years 2014-2016).
*Food is defined as articles used for food or drink for man or animals, or articles used to make components of it. It includes seeds and beans used to grow sprouts. As farms calculate food sales take into account that cotton, tobacco and timber are not considered food.
**A “retail food establishment” is an establishment that sells food products directly to consumers as its primary function. A “retail food establishment” includes grocery stores, convenience stores, and vending machine locations.
The two requirements that these farms must fulfill are:
  1. 1Farms must keep financial records to prove food sales are under $532,645 for the last three years.
  2. The labeling requirement consists of including the name and complete business address of the farm where the produce was grown either on the label of the produce or to display the same information at the point-of-purchase. The labeling requirement will be effective on 1/20/2020.
As long as a farm satisfies the requirements listed above or FDA has not withdrawn a qualified exemption then the farm is compliant with the Produce Safety Rule.
FDA will withdraw a qualified exemption if produce has been grown, harvested, packed or held under such conditions that it is unfit for food or if it has been prepared, packed or held under insanitary conditions where it can be contaminated with filth or have been rendered injurious to health.
For more details on Qualified Exemptions and modified requirements see Exemptions.

c) Covered farms.

These farms did not meet the conditions set for a qualified exemption and have to comply with the provisions set for “covered farms”. These are farms that sell more than $532,645 in food sales (average of the last three years) or that even though they sell less than $532,645 in food sales, they sell the majority of their produce to brokers or businesses that are not considered direct marketing channels or are located more than 275 miles from the farm.

Covered farms need to have at least one representative attend a Produce Safety Alliance (PSA) Grower training by the respective compliance date. This is a one-day training that provides an overview of the Produce Safety Rule and good agricultural practices. See more information about PSA Trainings in North Carolina.

Covered farms must follow the standards set for worker health and hygiene, agricultural water, biological soil amendments, domesticated and wild animals, equipment, tools, sanitation and growing, harvesting, packing and holding activities.

Compliance dates for “Covered Farms”.




All other businesses

(Sales over $500K)

Small businesses

($250K-$500K Produce sales)

Very small


($25K-$250K Produce sales)

Most provisions in the Produce Safety Rule 1/26/2018 1/28/2019 1/27/2020
For water related regulations outlined in the PS Rule 1/27/2020 1/26/2021 1/26/2022
Sprouts 1/26/2017 1/26/2018 1/28/2019

Overview of the Standards in the Produce Safety Rule for “covered farms”.

1. Worker Training and Health and Hygiene.

  • Establishes qualification and training requirements for all personnel who handle (contact) covered produce or food-contact surfaces and their supervisors.
  • Requires documentation of required training and corrective actions; and
  • Establishes hygienic practices and other measures needed to prevent persons, including visitors, from contaminating produce with microorganisms of public health significance.

2. Agricultural Water (this SUBPART is under revision by FDA 3/20/2017)

  • Requires that all agricultural water must be safe and of adequate sanitary quality for its intended use. Agricultural water is defined in part as water that is intended to, or is likely to, contact the harvestable portion of covered produce or food-contact surfaces;
  • Establishes requirements for inspection, maintenance, and certain other actions related to the use of agricultural water, water sources, and water distribution systems associated with growing, harvesting, packing, and holding of covered produce.
  • If a farm chooses to treat agricultural water to meet relevant requirements for its intended use, establish requirements related to methods of treatment and monitoring such treatment;
  • Establishes specific requirements for the microbial quality of agricultural water that is used for certain specified purposes, including provisions requiring periodic analytical testing of such water (with exemptions provided for use of public water supplies, under certain specified conditions, and treated water), and requiring certain actions to be taken when such water is not safe or of adequate sanitary quality for its intended use and/or does not meet the microbial quality requirements AND provide for the use of alternative requirements for certain provisions under certain conditions; and
  • Requires certain records, including documentation of inspection findings, water testing results, scientific data or information relied on to support the adequacy of water treatment methods, treatment monitoring results, scientific data or information relied on to support microbial die-off or removal rates or any permitted alternatives to requirements, time intervals or log reductions applied, and corrective actions.

3. Biological Soil Amendments.

  • Establishes requirements for determining the status of a biological soil amendment of animal origin as treated or untreated, and for their handling, conveying, and storing.
  • Prohibits the use of human waste for growing covered produce except in compliance with U.S. Environmental Protection Agency (EPA) regulations for such uses or equivalent regulatory requirements;
  • Establishes requirements for treatment of biological soil amendments of animal origin with scientifically valid, controlled, biological, physical and/or chemical processes that satisfy certain specific microbial standards, including examples of such processes;
  • Establishes application requirements and minimum application intervals for untreated and treated biological soil amendments of animal origin; and
  • Requires certain records, including documentation from suppliers of treated biological soil amendments of animal origin, documentation that process controls were achieved, and corrective actions.

4. Domesticated and Wild Animals.

  • If there is a reasonable probability that grazing animals, working animals, or animal intrusion will contaminate covered produce, require measures to assess as needed relevant areas during growing and, if significant evidence of potential contamination is found, take measures reasonably necessary to assist later during harvest when the farm must identify, and not harvest, covered produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard.

5. Equipment, Tools, and Buildings.

  • Establishes requirements related to equipment and tools that contact covered produce and instruments and controls (including equipment used in transport), buildings, domesticated animals in and around fully-enclosed buildings, pest control, hand-washing and toilet facilities, sewage, trash, plumbing, and animal excreta; and
  • Requires certain records related to the date and method of cleaning or sanitizing equipment used in growing operations for sprouts, and in covered harvesting, packing, or holding activities, and corrective actions.


  • Establishes scope of applicability of sprout provisions;
  • Establishes measures that must be taken related to seeds or beans for sprouting
  • Establishes measures that must be taken for the growing, harvesting, packing, and holding of sprouts;
  • Requires testing the growing environment for Listeria species (Listeria spp.) or Listeria monocytogenes (L. monocytogenes) and testing each production batch of spent sprout irrigation water or sprouts for Escherichia coli (E. coli) O157:H7, Salmonella species (Salmonella spp.) and, under certain conditions, other pathogen(s), and taking appropriate follow-up actions; and
  • Requires certain records, including documentation of treatment of seeds or beans for sprouting, a written environmental monitoring plan and sampling plan, test results, certain test methods used, and corrective actions.

All the documents and information from FDA pertaining to the Produce Safety Rule can be found in the FDA FSMA website.