Introduction to the FSMA Produce Safety Rule

Contents

Introduction
Exemptions
Requirement Areas

Agricultural Water
Biological Soil Amendments
Sprouts
Domesticated and Wild Animals
Worker Training, Health & Hygiene
Equipment, Tools, & Buildings

Introduction

The produce safety rule is a section of FSMA which provides standards for the growing, harvesting, packing, and holding of fruits and vegetables. The regulation acknowledges that farms may not be currently implementing these practices and it aims to educate before strictly enforcing these provisions.

It includes six requirement areas, which are described below:

Agricultural Water
Biological Soil Amendments
Sprouts
Domesticated and Wild Animals
Working Traning and Health and Hygiene
Equipment, Tools, and Buildings

Exemptions

For an overview of exemptions to the Produce Safety Rule see this flowchart

Requirement Areas

Agricultural Water:

The Produce Safety Rule regulates water based on how it will be used. There are several different uses for water in agricultural contexts — for example irrigation water versus water used in produce washing — and each of them has specific requirements for quality and testing. There is no expectation that a farm achieve a perfect result in every test. Rather, the goal is to understand water quality over time and support farms in accessing viable long term water sources.

Requirements for Water used in Produce Processing

This includes water used for produce washing, hand washing, and cleaning food contact surfaces. Any water used after harvesting that could reasonably contaminate produce product is held to this standard. The requirements are

All water used for these purposes must be treated (e.g. you cannot use un-treated well-water)
There can be no detectable presence of E. coli in these water types.
If any E. coli is detected, that water use must be immediately discontinued.

Requirements for Water used in Growing Produce

This refers to water which is directly applied to growing produce (e.g. irrigation water). There are two values that are used to determine whether this use of water achieves the requirement. Collectively, these two figures are referred to as “microbial water quality profile”:

Geometric Mean (GM) Test: There must be an average of fewer than 126 E. Coli CFU (a.k.a. colony forming units, which is how bacteria is commonly quantified) per 100ml of water.
Statistical Threshold Value (STV) Test: The maximum STV is 416 E. Coli CFU per 100ml of water. You can think of the STV as the level at which 90% of samples fall below this value.

What Happens When You Receive a Failing Result?

This section demonstrates the flexibility of the regulation. Corrective action is required “as soon as possible” and no later than the following year. Examples of corrective action that a farm may take after receiving a positive E Coli test result include,

Treating the water supply
Implementing a time interval between last irrigation and harvest (which allows bacteria that may have been present in irrigation water to die off)
Using washing or other commercial activities to reduce microbe levels

Testing Water Supply

This section describes testing requirements based on water source.

Public Water: This is typically the safest source of water, insofar as it aligns with national water standards. There is no requirement to test agricultural water drawn from a public water supply.

Untreated Surface Water: This is considered the most vulnerable type of water supply. When untreated surface water is applied to growing produce, farm must order tests for GM and STV (see above) using the following timeframe:

Initial survey: twenty samples must be taken at a time that is as close to harvest as possible. These samples may be taken over the course of 2-4 years.
Annual surveys: five new samples must be taken annually to replace the oldest results.

Untreated Ground Water (For Direct Application to Growing Crops: When untreated water is applied to growing crops, the following testing procedure is required:

Initial survey: four samples must be taken at a time that is as close to harvest as possible. These samples must be taken during the growing season (i.e. in a single year)
Annual survey: one new sample must be taken annually to replace the oldest result.

Untreated ground Water Used in Food Processing (where there is a zero-tolerance threshold for E. coli), a different testing schedule applies.

Initial survey: four samples must be taken at a time that is as close to harvest as possible. These samples must be taken during the growing season (i.e. in a single year)
Annual survey: If the initial survey results meet the “no detectable E. coli” standard, then only one annual sample is required. If the initial result does not meet the standard (or any subsequent result) then four samples must be tested the following year.

Biological Soil Amendments (e.g. Compost)

Use of Raw Manure:

While the FDA regulations are still being developed as of 2019, there are two general requirements:

Raw manure must be applied in a way that does not contact the produce when it is applied.
The farmer minimizes the potential for contact between manure and produce.

In the absence of clearer regulation, the FDA recommendation is that farmers adopt the standards outlined in the USDA’s national Organic Program. These call for:

120 day interval between application of raw manure on crops that contact the soil (e.g. melon)
90 day interval between the application of raw manure on crops that do not contact the soil (e.g. tomatoes)

Stabilized Compost:

For compost which has been processed to reduce pathogens, there are specific threshold levels for soil-based pathogens. This section offers guidance for how a farm may choose a suitable method for treating their soil amendments

Sprouts

Sprouts are particularly vulnerable to the growth of dangerous microbes because of the conditions required to grow them — warm moist environments. The major requirements for farming sprouts includes:

Treating seeds that will be used as sprouts (or sourcing pre-treated seeds)
Re-collecting and testing the water which was used to irrigate sprouts. Sprouts may not legally enter commerce until negative results are achieved.
Environmental testing for Listeria.
Taking appropriate corrective action if any tests come back positive.

Domesticated and Wild Animals

This section acknowledges that farms may have animals onsite. At the same time, fecal contamination from livestock is a frequent source of produce contamination. Although the rule does not mandate that animals be excluded from outdoor growing areas it does describes some requirements for managing animals reduce the contamination hazard. They describe:

All farming areas and produce must be inspected for sources of contamination.
When contamination has occurred (from either wild or domestic animal droppings), these areas should be marked and corrective action taken.
Although it is not required, the FDA recommends that farms implement waiting periods between when land is grazed on and when produce is harvested from that land.

Worker Training, Health and Hygiene

This section outlines measures to prevent contamination of produce by sick employees. To reduce this risk, may exhibit the following programs (you can also read about them in our Personnel guidance)

Using basic hygiene practices (e.g. hand washing)
Implementing an employee health policy which requires sick food handlers to notify their employers if they may have a contagious disease which could contaminate food.
Training farm workers to safely handle produce.

Equipment, Tools, & Buildings

This section of the rule describes the standards for equipment, tools and buildings. This may cover areas such as greenhouses, germination areas, and also toilet/hand washing facilities and outlines specific requirements for