0816 Sprouts GFI

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption - Agricultural Water - FINAL RULE

0816 Sprouts GFI

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Compliance with and Recommendations
for Implementation of the Standards for
the Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption for Sprout Operations:
Guidance for Industry
Draft Guidance
This guidance is being distributed for comment purposes only.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that
the agency considers your comment on this draft guidance before it begins work on the final version
of the guidance, submit written or electronic comments on the draft guidance within 180 days of
publication in the Federal Register of the notice announcing the availability of the draft guidance.
Submit electronic comments to https://www.regulations.gov/. Submit written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA2017-D-0175 listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition
(CFSAN) at 240-402-1700.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
January 2017

Contains Nonbinding Recommendations
Draft-Not for Implementation

Table of Contents

Table of Contents ................................................................................................................................. 2
I.

Introduction .................................................................................................................................... 6

II.

Background .................................................................................................................................... 8
A. Other FDA Efforts Related to Sprouts ....................................................................................... 8
B. Coverage of the Produce Safety Rule ......................................................................................... 9
C. Coverage of Subpart M ............................................................................................................ 10
D. Compliance Dates for Sprouts .................................................................................................. 11
E.

III.

Definitions ................................................................................................................................ 11
General Sprout Production ....................................................................................................... 16

A. Sprout Production ..................................................................................................................... 16
B. Seed Receipt ............................................................................................................................. 17
C. Seed Storage ............................................................................................................................. 17
D. Initial Seed Rinse ...................................................................................................................... 17
E.

Treating Seeds to Reduce Microorganisms of Public Health Significance .............................. 18

Pre-germination Seed Soak ...................................................................................................... 19

G. Germination and Growth .......................................................................................................... 19
H. Sampling and Testing Spent Sprout Irrigation Water (or In-Process Sprouts) for Pathogens
(including E. coli O157:H7 and Salmonella species) ...................................................................... 20
I.

Harvest ...................................................................................................................................... 21

Wash/Drain and Cool ............................................................................................................... 21

K. Packing/Packaging ................................................................................................................... 22
L.
IV.

Storage and Distribution ........................................................................................................... 23
Buildings, Tools and Equipment .............................................................................................. 23

A. Requirements for Buildings ...................................................................................................... 23
B. Toilet and Hand Washing Facilities ......................................................................................... 25
C. Plumbing Systems for Water .................................................................................................... 26
D. Sewage and Waste Management .............................................................................................. 26
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Equipment and Tools................................................................................................................ 27

V. Cleaning and Sanitizing................................................................................................................ 28
A. Frequency of Cleaning and Sanitizing ..................................................................................... 28
B. Sanitation Standard Operating Procedures (SSOPs) and Recordkeeping ................................ 30
C. Cleaning.................................................................................................................................... 30
D. Sanitizing .................................................................................................................................. 31
E.

Verification of Cleaning and Sanitizing ................................................................................... 32

Cleaning and Sanitizing Conducted in Response to Suspected or Known Contamination ...... 32

VI.

Agricultural Water in Sprout Operations.................................................................................. 34

A. Numerical Microbial Quality Criterion for Agricultural Water Used in a Sprouting Operation
(§ 112.44(a))..................................................................................................................................... 34
B. Agricultural Water Systems and How the Source Type and Treatment Status Affect Relevant
Requirements.................................................................................................................................... 36
C. Safe and of Adequate Sanitary Quality (§ 112.41) ................................................................... 38
D. Reuse of Sprout Irrigation Water.............................................................................................. 39
E.

Agricultural Water Testing Frequency, Sampling, and Test Methods ..................................... 40

Post-Harvest Water Management ............................................................................................. 41

VII.

Seeds for Sprouting .................................................................................................................. 42

A. Seed Receiving, Handling and Storage .................................................................................... 42
1.

Seed receiving by a sprout operation .................................................................................... 43

Visual inspection of seeds and their packaging .................................................................... 44

Seed testing ........................................................................................................................... 45

Seed storage .......................................................................................................................... 46

B. Seed Treatment ......................................................................................................................... 47
1.

Choosing a seed treatment .................................................................................................... 48

Seed treatment efficacy......................................................................................................... 49

Using pre-treated seeds ......................................................................................................... 51

Proprietary treatments........................................................................................................... 51

Additional considerations for treating seeds for sprouting ................................................... 52

C. Corrective Actions for Seeds That May Be Contaminated With a Pathogen ........................... 54
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D. Recordkeeping .......................................................................................................................... 58
VIII. Sampling and Testing of Spent Sprout Irrigation Water (or In-Process Sprouts) .................... 61
A. Developing a Sampling Plan .................................................................................................... 61
B. Collecting and Shipping Samples ............................................................................................. 63
1.

Preparing for sample collection ............................................................................................ 63

Collecting the sample ........................................................................................................... 64

Preparing the sample for shipping, and shipping the sample for testing .............................. 69

C. Preventing Production Batches of Sprouts from Entering Commerce ..................................... 69
D. Choosing a Test Method ........................................................................................................... 70
E.

Interpreting Test Results........................................................................................................... 71

Choosing a Laboratory ............................................................................................................. 72

G. Developing a Corrective Action Plan and Taking Corrective Actions .................................... 72
H. Recordkeeping .......................................................................................................................... 74
I.

Additional Voluntary Testing ................................................................................................... 76

IX.

Environmental Monitoring ....................................................................................................... 77

A. Principles for Developing an Environmental Monitoring Plan ................................................ 77
B. The Written Environmental Monitoring Plan........................................................................... 78
C. Developing a Sampling Plan .................................................................................................... 79
D. Testing for Listeria spp. or L. monocytogenes ......................................................................... 79
E.

Person(s) Collecting Samples ................................................................................................... 80

Establishing Sample Collection Locations and Frequency ...................................................... 80
1.

Identifying sample collection locations ................................................................................ 80

Number of food contact surface and non-food contact surface sampling sites .................... 81

Identifying sampling frequency ............................................................................................ 82

G. Timing of Sample Collection ................................................................................................... 83
H. Sample Collection and Shipping .............................................................................................. 83
I.

Testing ...................................................................................................................................... 84
1.

Test methods for Listeria spp. or L. monocytogenes ............................................................ 84

Alternate methods under § 112.152(b) ................................................................................. 85

Interpreting test results ......................................................................................................... 85
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4.
J.

Laboratory that conducts testing........................................................................................... 87
Developing a Corrective Action Plan and Taking Corrective Actions .................................... 87

Corrective action plan ........................................................................................................... 87

Implementing corrective actions........................................................................................... 88

K. Voluntary Periodic Sampling and Testing of Sprouts ............................................................ 101
L.

Analysis of Data for Trends ................................................................................................... 102

Recordkeeping .................................................................................................................... 102

X. Recordkeeping ............................................................................................................................ 104
A. Recordkeeping Overview ....................................................................................................... 104
1.

General requirements .......................................................................................................... 104

Duplication not required ..................................................................................................... 106

Record retention and availability ........................................................................................ 106

Format ................................................................................................................................. 107

B. Sprouts-Specific Record Requirements .................................................................................. 107
C. Other Required Records ......................................................................................................... 109
D. Supervisory Review of Records ............................................................................................. 111
XI.

Appendices ............................................................................................................................. 111

A. Appendix 1. Aseptic Sampling ............................................................................................... 111
B. Appendix 2. Recommended Procedures for Collecting Environmental Samples .................. 115
C. Appendix 3. Potential Sources of L. monocytogenes for Sampling in a Sprout Operation .... 118
XII.

References .............................................................................................................................. 119

Contains Nonbinding Recommendations
Draft-Not for Implementation

This draft guidance, when finalized, will represent the current thinking of the Food and Drug
Administration's (FDA or we) on this topic. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of
the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
responsible for this guidance as listed on the title page.

Introduction

While fruits and vegetables are important to the health and wellbeing of the American consumer, a
variety of produce commodities have also been associated with foodborne illness outbreaks. On
November 27, 2015, we published in the Federal Register (80 FR 74353) a final rule entitled,
“Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”
(the Produce Safety Rule or the Rule), establishing for the first time U.S. Federal requirements for
the growing, harvesting, packing, and holding of produce for human consumption, including sprouts
(Title 21 Code of Federal Regulations Part 112 (21 CFR Part 112)). Produce that is covered by the
rule is referred to as “covered produce.”
The Produce Safety Rule focuses on conditions and practices identified as potential contributing
factors for microbial contamination of produce (similar to the areas covered by the 1998 Guidance,
“Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” (GAPs Guide))
(Ref. 1). The Rule establishes requirements addressing certain common routes of contamination,
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This guidance has been prepared by the Office of Food Safety, Division of Safety in the Center for Food Safety and
Applied Nutrition at the U.S. Food and Drug Administration.

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including: agricultural water; biological soil amendments of animal origin; worker health and
hygiene; equipment, tools, buildings and sanitation; domesticated and wild animals; and conditions
for growing, harvesting, packing and holding activities.
Sprouts represent a special food safety concern because the conditions under which sprouts are
produced (time, temperature, water activity, pH and available nutrients) are also ideal for the growth
of pathogens, if present (Ref. 2). Between 1996 and July 2016 in the United States, there were a total
of approximately 46 reported outbreaks associated with sprouts, accounting for 2474 illnesses, 187
hospitalizations, and three deaths, including two documented outbreaks of Listeria monocytogenes
(Ref. 3, Ref. 4, Ref. 5). In foodborne illness outbreaks associated with sprouts, epidemiological
investigations often identify the most likely source of contamination as seeds used for sprouting (Ref.
2). However, poor sanitation and unhygienic practices at the sprout operation can also contribute to
the contamination of sprouts (Ref. 2).
Because the distinctive practices and conditions for growing sprouts present unique risks, we also
established sprout-specific requirements in Subpart M (Sprouts) of the Produce Safety Rule. In
general, Subpart M aligns with, and expands upon, the recommendations in our prior guidances on
sprouts. However, unlike our sprout guidances, the Rule is binding and has the force and effect of
law. Sprout operations subject to the Produce Safety Rule must comply with all applicable
requirements in the Rule, including, but not limited to, all applicable requirements in Subpart M.
This guidance is intended to assist sprout operations subject to the Produce Safety Rule (80 FR
74353), and primarily focuses on assisting such operations in complying with the sprout-specific
requirements in Subpart M. It provides this assistance in part by describing voluntary practices,
including some practices that can help operations avoid problems under these requirements. It also
includes limited discussion on certain other applicable requirements. In addition, this guidance may
also be useful to sprout operations that are not subject to the Produce Safety Rule that voluntarily
choose to follow the standards established in the Rule.
Because of the diversity of sprout production practices and types of sprouts, the recommendations in
this guidance will be most effective when you adapt these recommendations to the specific practices,
processes and procedures at your operation. This guidance focuses primarily on providing
recommendations to assist sprout operations covered by Subpart M in complying with the
requirements in the Produce Safety Rule applicable to sprouts. It does not describe all aspects of all
requirements of the Produce Safety Rule, but rather highlights certain sprout-specific requirements
(Subpart M), and briefly discusses certain other Rule requirements from the perspective of a sprout
operation (e.g., certain requirements in Subparts E and L of the Rule relating to Agricultural Water,
and Equipment, Tools, Buildings, and Sanitation, respectively).
This guidance does not attempt to cover best practices or requirements outside the scope of the
Produce Safety Rule. For example, the Produce Safety Rule does not address chemical or physical
hazards. You have a responsibility to ensure that your sprouts are not adulterated or misbranded
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. §§ 301 et seq.) and are in
compliance with all applicable laws.
The requirements in the Produce Safety Rule are directed specifically to covered farms (as that term
is defined in the Rule) that grow, harvest, pack or hold covered produce, including sprouts. Covered
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farms that grow, harvest, pack or hold sprouts are referred to in this guidance as “sprout operations.”
The Produce Safety Rule and this guidance document are not directed to steps in the seed and sprout
supply chain that do not occur at covered farms, such as to operations growing, conditioning, and
distributing seed for sprouting provided these operations are not also growing, harvesting, packing,
or holding sprouts; or to the handling of sprouts at a retail food establishment. However, as noted in
our prior sprout guidances and our May 2009 letter to suppliers and distributors of seed for sprouting
and sprout operations (Ref. 6), everyone in the food supply chain has a responsibility for ensuring
food safety. We encourage parties in the sprout supply chain to work together towards this end.
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed
only as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in FDA guidances means that something is suggested or recommended, but not
specifically required.

II.

Background
A.

Other FDA Efforts Related to Sprouts

On October 27, 1999, we published a notice of availability in the Federal Register (64 FR 57893) for
two guidance documents to inform all parties involved in the production of sprouts (i.e., producers,
conditioners, and distributors of seeds used for sprouting, and sprout producers) that sprouts have
been recognized as an important cause of foodborne illness and to provide recommendations for
preventive controls that we believed should be taken immediately to reduce the likelihood of sprouts
serving as a vehicle for foodborne illness. We refer to these prior (now withdrawn) guidance
documents collectively as the 1999 Sprout Guidances.
FDA and our food safety partners in the public and private sectors have engaged in education and
outreach to industry to promote adoption of our recommendations. We have also worked with the
sprout industry to advance the scientific knowledge applicable to enhancing the safety of sprouts.
For example, in 2000, we collaborated with the California Department of Public Health, in
cooperation with the industry and academia, to develop an educational video entitled “The Safer
Production of Sprouts” (Ref. 7). We have also provided technical assistance to the Illinois Institute
of Technology’s Institute for Food Safety and Health (IIT IFSH) Sprout Safety Taskforce in
developing their Sprout Grower – Packer Operations Food Safety Standard and an Auditing and
Inspection Checklist for Sprouting Facilities (Ref. 8).
We are also working with the Sprout Safety Alliance (SSA), established in 2012, to enhance the
industry's understanding and implementation of best practices for improving sprout safety (Ref. 9,
Ref. 10). The SSA has developed a core curriculum and training and outreach programs for
stakeholders in the sprout production community. The SSA is composed of the food industry,
academia, and members from federal, state, and local food protection agencies. The SSA is funded
by a grant from FDA to IIT IFSH.
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Coverage of the Produce Safety Rule

Under § 112.1 of the Produce Safety Rule, unless specifically excluded under § 112.2, food that is
produce (as that term is defined in the Rule), and that is a raw agricultural commodity (RAC), is
covered by the Rule. This includes a produce RAC that is grown domestically and a produce RAC
that will be imported or offered for import in any State or territory of the United States, the District
of Columbia, or the Commonwealth of Puerto Rico. Covered farms subject to the Produce Safety
Rule must comply with all applicable requirements of the Rule when conducting a covered activity
on covered produce (see § 112.4). There are certain exemptions and limitations on which farms are
“covered farms” (see § 112.4).
Sprouts are produce as we defined that term in the Produce Safety Rule (see § 112.3, defining
“Produce” in part as “any fruit or vegetable… and includes… sprouts (irrespective of seed source)”).
Sprouts are also RACs when they are in their raw or natural state (see § 112.3, defining “Raw
agricultural commodity (RAC)” as that term is defined in section 201(r) of the FD&C Act (21 U.S.C.
321(r)): “any food in its raw or natural state, including all fruits that are washed, colored, or
otherwise treated in their unpeeled natural form prior to marketing.” Therefore, sprouts in their raw
or natural state are covered produce, except as otherwise provided in § 112.2.
If sprouts are made into processed food(s), those processed foods are not covered by the Produce
Safety Rule (see § 112.2(a)(3)). Processed foods are not subject to the Produce Safety Rule. An
example of a processed food made using sprouts is sprouted seed butter. The coverage limitation in
§ 112.2(a)(3) does not mean that sprout RACs that will be made into processed food are themselves
exempt from the Produce Safety Rule simply because those RACs will later be transformed into
processed food. It means only that the Produce Safety Rule only applies during the time that the
sprouts are RACs. Once they are transformed into processed food, other requirements (such as those
in 21 CFR Part 117) may apply, depending on the circumstances.
Sprouts do not qualify for the exemption in § 112.2(a)(1) for produce that is rarely consumed raw.
This provision contains an exhaustive (all inclusive) list of produce commodities (such as potatoes)
that, based on our analysis of dietary consumption patterns, are rarely consumed raw. This
exemption applies only to the commodities identified in § 112.2(a)(1), none of which are sprouts.
Some sprouts may be eligible for exemption from the Produce Safety Rule under § 112.2(b) for
produce that receives commercial processing that adequately reduces the presence of microorganisms
of public health significance. Examples of commercial processing that adequately reduces the
presence of microorganisms of public health significance appear in § 112.2(b)(1). This exemption
also requires certain documentation and disclosures set forth in § 112.2(b)(2). Sprouts that receive
commercial processing to create sprouted seed products (e.g., canned, shelf-stable mung bean
sprouts; sprouted seed butters; powdered sprouted seed products; dehydrated sprouts) could
potentially qualify for this exemption from the Produce Safety Rule, but only if the commercial
processing adequately reduces the presence of microorganisms of public health significance and all
documentation and disclosure requirements are met. We note that simply drying/dehydrating sprouts
may not adequately reduce the presence of microorganisms of public health significance (Ref. 11,
Ref. 12).

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Coverage of Subpart M

The requirements in 21 CFR Part 112, Subpart M apply to the growing, harvesting, packing and
holding of all sprouts except sprouts that are grown in soil or non-soil substrates (e.g., mats, perlite or
other growth media) and that are harvested above the soil or substrate line without their roots. See §
112.141. We determined that soil- or substrate-grown sprouts that are harvested above the soil or
substrate line, such that their roots are not harvested for human consumption, do not present the same
risks as other types of sprouts and, therefore, we excluded them from the sprout-specific
requirements in subpart M (80 FR 74353 at 74497). However, the requirements of subpart M do
apply to soil- or substrate-grown sprouts that are harvested with the roots. If you use soil or substrate
as growth media in your operation, you must comply with the applicable requirements in 21 CFR
Part 112, Subpart F (Biological Soil Amendments of Animal Origin and Human Waste). We have
not included a detailed discussion of the requirements of Subpart F in this guidance, since our
understanding of the sprout industry is that the majority of sprouts grown in soil- or substrate are
harvested above the soil line and therefore not covered by Subpart M (and this guidance primarily
focuses on the requirements in Subpart M).
We recognize that certain soil or substrate grown sprout types, such as wheatgrass, may be sold by
sprout operations to retail establishments or other customers in a tray used for growing with the
soil/substrate, and roots, intact. In such cases, the farm has harvested the sprouts with the roots and
they are subject to Subpart M (see § 112.141). However, we understand that such sprouts may then
be cut above the soil and/or substrate line at the retail establishment immediately before use. When a
sprout operation sells sprouts with the roots intact in soil or substrate, and the customer will cut the
sprouts above the soil or substrate line before use, we intend to exercise enforcement discretion for
the requirements of Subpart M if the sprout operation annually collects written assurances from the
customer stating that the sprouts will be cut above the soil or substrate line before use.
Note that soil- or substrate-grown sprouts harvested above the soil line are still considered covered
produce and, unless exempt or excluded under the provisions of 21 CFR Part 112, Subpart A, are
subject to all other applicable requirements of the Produce Safety Rule. To the extent production
practices for soil- or substrate-grown sprouts that are harvested above the soil or substrate line may
present risks similar to those associated with other sprouts, we encourage such operations to consider
voluntarily implementing the standards in subpart M, in addition to complying with the required
provisions of all other subparts in the Produce Safety Rule.
In addition, we note that microgreens and sprouts are different products. This interpretation is
consistent with our prior sprout guidances and with other public and private standards, e.g., the IFSH
Sprout Taskforce sprout-specific audit check list (Ref. 8) and the Food Safety Australia New Zealand
(FSANZ) standards (Ref. 13) for sprouts. Historically, the primary criterion we have used to
distinguish between the two product categories has been the growth stage of the leaves. Sprouts are
usually harvested when the cotyledons (or seed leaves) are still un- or under-developed and true
leaves have not begun to emerge. In contrast, microgreens reach a later stage of growth, typically
associated with the emergence of “true” leaves. Microgreens are also typically grown in soil or
substrate and harvested above the soil or substrate line. Because microgreens are not sprouts, they
are not subject to the requirements in subpart M (Ref. 14). However, microgreens are considered
covered produce for the purposes of the Produce Safety Rule and, unless exempt or excluded under
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the provisions in subpart A, microgreens and microgreen farms are subject to all other subparts of the
Produce Safety Rule (80 FR 74353 at 74497, comment/response 363).

Compliance Dates for Sprouts

The compliance dates for sprouts subject to Subpart M are earlier than the compliance dates for all
other covered produce. Sprout operations subject to Subpart M need to be in compliance with all
applicable provisions of the Produce Safety Rule with respect to such sprouts by January 28, 2019
(very small businesses); January 26, 2018 (small businesses); or January 26, 2017 (all other
businesses). The additional two years beyond other compliance dates provided for some farms to
comply with certain provisions related to agricultural water provisions do not apply to sprouts subject
to Subpart M. Farms eligible for the qualified exemption from the Produce Safety Rule that grow,
harvest, pack, or hold sprouts that would be subject to Subpart M if they did not receive the qualified
exemption also have earlier compliance dates for certain modified requirements than other farms
covered by the Rule. The same is true for farms relying on the exemption in § 112.2(b) for sprouts
that would otherwise be subject to Subpart M that receive commercial processing that adequately
reduces microorganisms of public health concern.
The same compliance dates that apply to all other covered produce apply to sprouts that are not
subject to subpart M (i.e., soil- or substrate-grown sprouts harvested without their roots).

Definitions

The Produce Safety Rule contains definitions of many important terms in § 112.3. We use some of
these defined terms in this document. For your convenience, we reproduce some relevant definitions
from the Rule here. In addition, the definitions and interpretations of terms in section 201 of the
FD&C Act apply to such terms when used in the Produce Safety Rule.
Adequate means that which is needed to accomplish the intended purpose in keeping with good
public health practice.
Adequately reduce microorganisms of public health significance means reduce the presence of such
microorganisms to an extent sufficient to prevent illness.
Agricultural water means water used in covered activities on covered produce where water is
intended to, or is likely to, contact covered produce or food contact surfaces, including water used in
growing activities (including irrigation water applied using direct water application methods, water
used for preparing crop sprays, and water used for growing sprouts) and in harvesting, packing, and
holding activities (including water used for washing or cooling harvested produce and water used for
preventing dehydration of covered produce).
Covered activity means growing, harvesting, packing, or holding covered produce on a farm.
Covered activity includes manufacturing/processing of covered produce on a farm, but only to the
extent that such activities are performed on raw agricultural commodities and only to the extent that
such activities are within the meaning of “farm” as defined in [Chapter I of Title 21 of the Code of
Federal Regulations]. Providing, acting consistently with, and documenting actions taken in
compliance with written assurances as described in § 112.2(b) are also covered activities. [21 CFR
Part 112] does not apply to activities of a facility that are subject to [21 CFR Part 117].
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Covered produce means produce that is subject to the requirements of [21 CFR Part 112] in
accordance with §§ 112.1 and 112.2. The term “covered produce” refers to the harvestable or
harvested part of the crop.
Direct water application method means using agricultural water in a manner whereby the water is
intended to, or is likely to, contact covered produce or food contact surfaces during use of the water.
Farm means: (1) Primary production farm. A primary production farm is an operation under one
management in one general (but not necessarily contiguous) physical location devoted to the growing
of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of
these activities. The term “farm” includes operations that, in addition to these activities:
(i) Pack or hold raw agricultural commodities;
(ii) Pack or hold processed food, provided that all processed food used in such activities is either
consumed on that farm or another farm under the same management, or is processed food identified
in paragraph (1)(iii)(B)(1) of this definition; and
(iii) Manufacture/process food, provided that:
(A) All food used in such activities is consumed on that farm or another farm under the same
management; or
(B) Any manufacturing/processing of food that is not consumed on that farm or another farm under
the same management consists only of:
(1) Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as
drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities,
without additional manufacturing/processing (an example of additional manufacturing/processing is
slicing);
(2) Treatment to manipulate the ripening of raw agricultural commodities (such as by treating
produce with ethylene gas), and packaging and labeling treated raw agricultural commodities,
without additional manufacturing/processing; and
(3) Packaging and labeling raw agricultural commodities, when these activities do not involve
additional manufacturing/processing (an example of additional manufacturing/processing is
irradiation); or
(2) Secondary activities farm. A secondary activities farm is an operation, not located on a primary
production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw
agricultural commodities, provided that the primary production farm(s) that grows, harvests, and/or
raises the majority of the raw agricultural commodities harvested, packed, and/or held by the
secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm.
A secondary activities farm may also conduct those additional activities allowed on a primary
production farm as described in paragraphs (1)(ii) and (iii) of this definition.
Food means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic (FD&C) Act
and includes seeds and beans used to grow sprouts.
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Food contact surfaces means those surfaces that contact human food and those surfaces from which
drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs
during the normal course of operations. “Food contact surfaces” includes food contact surfaces of
equipment and tools used during harvest, packing and holding.
Ground water means the supply of fresh water found beneath the Earth’s surface, usually in aquifers,
which supply wells and springs. Ground water does not include any water that meets the definition of
surface water.
Growth media means material that acts as a substrate during the growth of covered produce (such as
mushrooms and some sprouts) that contains, may contain, or consists of components that may
include any animal waste (such as stabilized compost, manure, non-fecal animal byproducts or table
waste).
Harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally
performed on farms for the purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as food. Harvesting is limited to activities
performed on raw agricultural commodities, or on processed foods created by drying/dehydrating a
raw agricultural commodity without additional manufacturing/processing, on a farm. Harvesting does
not include activities that transform a raw agricultural commodity into a processed food as defined in
section 201(gg) of the FD&C Act. Examples of harvesting include cutting (or otherwise separating)
the edible portion of the raw agricultural commodity from the crop plant and removing or trimming
part of the raw agricultural commodity (e.g., foliage, husks, roots or stems). Examples of harvesting
also include cooling, field coring, filtering, gathering, hulling, shelling, sifting, threshing, trimming
of outer leaves of, and washing raw agricultural commodities grown on a farm.
Hazard means any biological agent that has the potential to cause illness or injury in the absence of
its control.
Holding means storage of food and also includes activities performed incidental to storage of a food
(e.g., activities performed for the safe or effective storage of that food, such as fumigating food
during storage, and drying/dehydrating raw agricultural commodities when the drying/ dehydrating
does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding also
includes activities performed as a practical necessity for the distribution of that food (such as
blending of the same raw agricultural commodity and breaking down pallets), but does not include
activities that transform a raw agricultural commodity into a processed food as defined in section
201(gg) of the FD&C Act. Holding facilities could include warehouses, cold storage facilities,
storage silos, grain elevators, and liquid storage tanks.
Known or reasonably foreseeable hazard means a biological hazard that is known to be, or has the
potential to be, associated with the farm or the food.
Manufacturing/processing means making food from one or more ingredients, or synthesizing,
preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples
of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling,
cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity
(such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice,
formulating, freezing, grinding, homogenizing, labeling, milling, mixing, packaging (including
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modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening,
trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/processing
does not include activities that are part of harvesting, packing, or holding.
Manure means animal excreta, alone or in combination with litter (such as straw and feathers used
for animal bedding) for use as a soil amendment.
Microorganisms means yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and
includes species having public health significance. The term “undesirable microorganisms” includes
those microorganisms that are of public health significance, that subject food to decomposition, that
indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated.
Mixed-type facility means an establishment that engages in both activities that are exempt from
registration under section 415 of the FD&C Act and activities that require the establishment to be
registered. An example of such a facility is a “farm mixed-type facility,” which is an establishment
that is a farm, but that also conducts activities outside the farm definition that require the
establishment to be registered.
Monitor means to conduct a planned sequence of observations or measurements to assess whether a
process, point or procedure is under control and, when required, to produce an accurate record of the
observation or measurement.
Packing means placing food into a container other than packaging the food and also includes repacking and activities performed incidental to packing or re-packing a food (e.g., activities
performed for the safe or effective packing or re-packing of that food (such as sorting, culling,
grading, and weighing or conveying incidental to packing or re-packing)), but does not include
activities that transform a raw agricultural commodity into a processed food as defined in section
201(gg) of the FD&C Act.
Pest means any objectionable animals or insects, including birds, rodents, flies, and larvae.
Produce means any fruit or vegetable (including mixes of intact fruits and vegetables) and includes
mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs. A fruit is the edible
reproductive body of a seed plant or tree nut (such as apple, orange, and almond) such that fruit
means the harvestable or harvested part of a plant developed from a flower. A vegetable is the edible
part of an herbaceous plant (such as cabbage or potato) or fleshy fruiting body of a fungus (such as
white button or shiitake) grown for an edible part such that vegetable means the harvestable or
harvested part of any plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, bulbs,
stems, leaves, or flower parts are used as food and includes mushrooms, sprouts, and herbs (such as
basil or cilantro). Produce does not include food grains meaning the small, hard fruits or seeds of
arable crops, or the crops bearing these fruits or seeds, that are primarily grown and processed for use
as meal, flour, baked goods, cereals and oils rather than for direct consumption as small, hard fruits
or seeds (including cereal grains, pseudo cereals, oilseeds and other plants used in the same fashion).
Examples of food grains include barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth,
quinoa, buckwheat, and oilseeds (e.g., cotton seed, flax seed, rapeseed, soybean, and sunflower seed).
Production batch of sprouts means all sprouts that are started at the same time in a single growing
unit (e.g., a single drum or bin, or a single rack of trays that are connected to each other), whether or
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not the sprouts are grown from a single lot of seed (including, for example, when multiple types of
seeds are grown in a single growing unit).
Qualified end-user, with respect to a food, means the consumer of the food (where the term
consumer does not include a business); or a restaurant or retail food establishment (as those terms are
defined in § 1.227) that is located:
(1) In the same State or the same Indian reservation as the farm that produced the food; or
(2) Not more than 275 miles from such farm.
Raw agricultural commodity (RAC) means “raw agricultural commodity” as defined in section 201(r)
of the FD&C Act.
Sanitize means to adequately treat cleaned surfaces by a process that is effective in destroying
vegetative cells of microorganisms of public health significance, and in substantially reducing
numbers of other undesirable microorganisms, but without adversely affecting the product or its
safety for the consumer.
Small business means a farm that is subject to any of the requirements of [21 CFR Part 112] and, on a
rolling basis, the average annual monetary value of produce (as defined in [21 CFR 112.3]) the farm
sold during the previous 3-year period is no more than $500,000; and the farm is not a very small
business as defined in [21 CFR 112.3].
Soil amendment means any chemical, biological, or physical material (such as elemental fertilizers,
stabilized compost, manure, non-fecal animal byproducts, peat moss, perlite, pre-consumer
vegetative waste, sewage sludge biosolids, table waste, agricultural tea and yard trimmings)
intentionally added to the soil to improve the chemical or physical condition of soil in relation to
plant growth or to improve the capacity of the soil to hold water. The term soil amendment also
includes growth media that serve as the entire substrate during the growth of covered produce (such
as mushrooms and some sprouts).
Spent sprout irrigation water means water that has been used in the growing of sprouts.
Surface water means all water open to the atmosphere (rivers, lakes, reservoirs, streams,
impoundments, seas, estuaries, etc.) and all springs, wells, or other collectors that are directly
influenced by surface water.
Very small business means a farm that is subject to any of the requirements of [21 CFR Part 112]
and, on a rolling basis, the average annual monetary value of produce (as defined in [21 CFR 112.3])
the farm sold during the previous 3-year period is no more than $250,000.
Visitor means any person (other than personnel) who enters your covered farm with your permission.
Water distribution system means a system to carry water from its primary source to its point of use,
including pipes, sprinklers, irrigation canals, pumps, valves, storage tanks, reservoirs, meters, and
fittings.
We means the U.S. Food and Drug Administration (FDA).
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You, for purposes of [21 CFR Part 112], means the owner, operator, or agent in charge of a covered
farm that is subject to some or all of the requirements of [21 CFR Part 112].

III. General Sprout Production
This section discusses common production practices for growing, harvesting, packing, packaging and
holding of sprouted seeds, and provides a brief overview of some of the most important requirements
relevant to your sprout operation that apply at each stage of production. This section does not
necessarily cover all relevant requirements but instead provides a high-level overview, and refers in
various places to other sections of this guidance that discuss certain practices in greater detail.
Although seed is often identified as the most likely source of contamination in many sproutassociated foodborne illness outbreaks, the practices and conditions at your operation may increase
or decrease the extent of the microbial hazards (Ref. 2).
Note that throughout this guidance, for the ease of the reader, we often refer collectively to
everything sprouted to produce sprouts for human consumption, including beans, simply as “seeds.”
In the Rule, we used the phrase “seeds or beans” to remove any potential confusion as to whether
beans for sprouting were included. References to “seeds” in this guidance should not be read to
exclude other things that are sprouted to produce sprouts for human consumption, such as beans.

Sprout Production

Typically, sprout production consists broadly of the steps depicted in Figure 1. Your operation may
add to or omit some of these practices (or do them in a different order) depending on a number of
factors, including: the type of seeds you sprout; whether the required seed treatment is applied by
you, your seed supplier, or both; and the size and resources of your operation. Each stage of typical
sprout production is described in more detail below.
Many of the steps in sprout production, such as rinsing and soaking seed, irrigating sprouts and
washing finished product, involve the use of water. The Produce Safety Rule establishes certain
requirements for water used in covered activities on covered produce where water is intended to or
likely to contact food or food contact surfaces (FCSs), or “agricultural water”. Certain uses of
“agricultural water” (including sprout irrigation water) are subject to a microbial water quality
requirement of no detectable generic E. coli per 100 ml (see § 112.44(a)), and all water supplied to
hand-washing facilities at sprouting operations is required to meet the same standard (see §
112.130(a) and (b)(2); see also § 112.143(a)). We are not aware of any uses of water common in
sprouting operations that are intended to or likely to contact food or FCSs that are not subject to this
microbial quality requirement. Agricultural water quality requirements for sprout production
operations and how you can meet them are further discussed in Section VI (Agricultural Water in
Sprout Operations) of this guidance.

Figure 1. Typical Sprout Production Processes (Adapted from Ref. 2)
Seed Receipt  Seed Storage  Initial Seed Rinse  Seed Treatment  Pre-germination Seed
Soak  Germination and Growth  Microbial testing of SIW (or in-process sprouts)  Harvest 
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Wash/Drain Sprouts Bulk Cool/Spin Dry  Pack and/or Package  Cooling & Storage 
Distribution

Seed Receipt

You must visually examine seeds, and packaging used to ship seeds, for signs of potential
contamination with known or reasonably foreseeable hazards (§ 112.142(d)). This visual exam of
seeds and their packaging upon receipt is one of the first steps to take at your operation to reduce the
chance of seeds serving as a source of contamination in the sprouts you produce (See also Section
VII. (Seeds for Sprouting) for more information).
In addition, when receiving seeds used for sprouting, you must take any other measures that are
reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into or
onto the seeds during that process (§ 112.142(a)).

Seed Storage

When storing seeds used for sprouting, you must take measures reasonably necessary to prevent the
introduction of known or reasonably foreseeable hazards into or onto the seeds (§ 112.142(a)). The
measures you take to prevent seeds from being contaminated should vary depending on, for example,
the quantity of seeds you order or store at your operation, size and type of storage containers, and
how quickly you use them. For example, we recommend you purchase quantities of seed that are
based on your short-term production needs, rather than purchasing larger amounts and storing seed at
your operation for prolonged periods of time.
Seeds you use for sprouting should be handled and stored in a manner that will prevent any type of
damage and contamination. As mentioned in Section I (Introduction) of this guidance, the Produce
Safety Rule focuses on microbial contamination, conditions and practices identified as potential
contributing factors for microbial contamination of produce, and steps to protect against
contamination. The Produce Safety Rule does not address chemical or physical hazards. You have a
responsibility to ensure that your sprouts are not adulterated or misbranded under the FD&C Act and
are in compliance with all applicable laws.

Initial Seed Rinse

Seeds are typically rinsed before treatment. While the Produce Safety Rule does not require pretreatment rinsing, we recommend that seeds be rinsed thoroughly before treatment to reduce
microorganisms of public health significance, to remove dirt, and to increase the efficiency of the
treatment. If you do rinse seeds before treatment, you should repeat the rinsing process with new
water until most of the dirt is removed and rinse water runs clear. We also recommend that you
conduct your rinse in such a way as to maximize seed surface contact with water (e.g., by mixing or
agitating).
If you do rinse seeds before treatment, water used to rinse seed must meet the microbial quality
criterion in § 112.44(a) (i.e., no detectable generic Escherichia coli (E. coli) in 100 milliliters (mL) of
water), and related requirements elsewhere in Subpart E, because such water contacts FCSs (surfaces
of the rinse container that also contact seeds used for sprouting) during the covered activity of
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growing covered produce (sprouts) (See § 112.144(a)(3)); see also Section VI. (Agricultural Water in
Sprout Operations)).
In addition, if you do rinse seeds before treatment, you must clean and sanitize the FCSs of your
tools and equipment that you use for this purpose before they contact the seeds (§ 112.143(b); see
also Section V (Cleaning and Sanitizing)). These are FCSs used during the covered activity of
growing covered produce (sprouts).
In addition, if you do rinse seeds used for sprouting, you must take any other measures that are
reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into or
onto the seeds during that process (§ 112.142(a)).

Treating Seeds to Reduce Microorganisms of Public Health Significance

The Produce Safety Rule requires that seeds that will be used to grow sprouts be treated using a
scientifically valid method to reduce microorganisms of public health significance (§ 112.142(e)).
You have two options for meeting this requirement:
(1) You may treat the seeds prior to sprouting at your operation, or
(2) You may rely on prior treatment of seeds conducted by a grower, distributor, or supplier of
the seeds (whether to fulfill this requirement completely or for the purpose of considering
such prior treatment when applying appropriate additional treatment of the seeds at your
operation immediately before sprouting).
If you treat seeds at your operation, you must use a scientifically valid method to reduce
microorganisms of public health significance (§ 112.142(e)(1)). This includes ensuring that the
treatment procedures are followed correctly and taking steps to control all factors that impact the
efficacy of the treatment, including, as appropriate:
•
•
•

treatment time, temperature and pH;
volume of treatment solution to seeds (if the treatment involves a solution); and
agitation, as appropriate, to maximize contact between seed and the treatment solution or gas.

The specific factors you will need to monitor and control will depend on the type of treatment you
use (e.g., chemical, physical or a combination of treatments) and the procedures for its use. In
addition, if you choose to conduct the required seed treatment at your operation, you must take any
other measures that are reasonably necessary to prevent the introduction of known or reasonably
foreseeable hazards into or onto the seeds during that process (§ 112.142(a)).
If you rely, in whole or in part, on prior treatment by a grower, distributor, or supplier of seeds, you
must obtain documentation (such as a Certificate of Conformance) from the grower, distributor, or
supplier that the prior treatment was conducted using a scientifically valid method to reduce
microorganisms of public health significance, and that the treated seeds were handled and packaged
following the treatment in a manner that minimizes the potential for contamination (§ 112.142(e)(2))
(See Section VII (Seeds for Sprouting).

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Pre-germination Seed Soak

Soaking causes seeds to swell and softens hulls to allow the sprout to grow out of the seed.
Depending on your production practices and the type of seeds you use, a pre-germination soak may
be necessary to improve germination. Pre-germination soaking is not required by the Produce Safety
Rule. However, if you soak seeds before germination, FCSs of containers and other tools or
equipment used for soaking must be cleaned and sanitized prior to contact with seeds used to grow
sprouts (§ 112.143(b)) (See Section IV (Buildings, Tools and Equipment). These are FCSs used
during the covered activity of growing covered produce (sprouts). For both seed soaking and any
additional rinses you may conduct after soaking, you must use water that meets the microbial quality
criterion in § 112.44(a), and related requirements elsewhere in Subpart E. Such water contacts FCSs
(surfaces of the soak/rinse container that also contact seeds used for sprouting) during the covered
activity of growing covered produce (sprouts) (See § 112.144(a)(3)); see also Section VI
(Agricultural Water in Sprout Operations)).
In addition, if you choose to conduct a pre-germination seed soak you must take any other measures
that are reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards
into or onto seeds during that process (§ 112.142(a)).

Germination and Growth

Sprout operations use different types of growing units. Some examples of typical growing units
include rotating drums, bins, and racks of trays. In terms of potential for contamination, we consider
that there are two categories of growing units, “stationary” and “mixed”. The first
category(“stationary” growing units) are those growing units that do not mix sprouts during growing
(e.g., bins and racks of trays). We expect these types of growing units to produce sprouts that are
less homogenous with regard to contamination, meaning that they are somewhat more likely to keep
contamination of the production batch of sprouts, if it occurs, localized to particular area(s) of the
growing unit (i.e., “hot spots”) (Ref. 14a). The other category (“mixed” growing units) are those
growing units that mix sprouts during growing (e.g., rotary drums). We expect the sprouts from this
type of growing unit to be more homogenous with respect to contamination (i.e., “hot spots” are less
likely, and contamination, if it occurs, is more likely to be widespread) due to the mixing that occurs
during growing (Ref. 14a). These differences lead to certain considerations that are specific to the
type of growing unit used. For example, collecting a representative spent sprout irrigation water
sample can be more challenging from stationary growing units (particularly those with multiple drain
points), while mixed growing units present certain unique considerations when determining
appropriate corrective actions in response to a positive environmental sample on the growing unit
FCS (See Section IX. (Environmental Monitoring)).
Because of the potential for pathogen growth during the sprouting process, it is especially critical that
you keep the sprout production area, and the tools and equipment that contact sprouts and FCSs,
clean to avoid potential contamination.
You must inspect, maintain, clean, and sanitize all FCSs of tools and equipment as frequently as
reasonably necessary to protect against contamination of covered produce, and before they contact
sprouts, or seeds used for sprouting (§§ 112.123(d)(1), 112.143(b)). This includes FCSs of growing
units (e.g., interior surfaces of rotating drums, bins, and trays). Growing units should be cleaned and
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sanitized before starting to grow each new production batch (see Section V. (Cleaning and
Sanitizing)).
Your building must be suitable in size, construction, and design to facilitate maintenance and sanitary
operations for covered activities to reduce the potential for contamination of covered produce or
FCSs, including by separation of operations in which contamination is likely to occur (§
112.126(a)(1)(ii)). For example, the germination and growing area (along with harvesting, packing
and packaging areas) should be physically separated from the receiving, storage and seed disinfecting
areas and should be protected from outside contaminants.
You must also implement measures to prevent contamination of your covered produce and FCSs in
your buildings, as appropriate, considering the potential for such contamination through floors, walls,
ceilings, fixtures, ducts, or pipes, and drip or condensate (§ 112.126(b)). You should consider the
placement of tools and equipment with respect to potential routes of contamination, such as splash
from the floor or overhead condensate, and take appropriate steps in compliance with § 112.126(b).
For example, you might use wall mounted racks and clean pallets to ensure that tools and equipment
(such as shovels, stackable bins, and perforated spinning baskets) and product do not contact the
floor, especially in areas where water accumulates. If condensation is a problem that you cannot
otherwise fix through maintenance (such as roof repair), you might consider installing drip guards to
collect and/or divert condensate that might otherwise contact covered produce and food contact
surfaces. You should also consider the placement of exposed product and food contact surfaces
relative to floors, walls, ceilings, fixtures, ducts, or pipes, and drip or condensate to minimize their
potential to serve as a source of contamination. You should also implement measures to ensure that
cleaning and sanitizing activities (such as washing floors, walls, and ceilings) are conducted at a time
and in a manner so as not to serve as a source of contamination for covered produce and food contact
surfaces. As an example, if you wash your floors with high pressure hoses, we recommend you
move your in-process and finished sprouts from the area during cleaning to minimize the potential
for contamination from water splashing off the floor and on to product.
You must use irrigation water that meets the microbial quality criterion in § 112.44(a), and related
requirements elsewhere in Subpart E. (See Section VI. (Agricultural Water in Sprout Operations) for
more information).
In addition, you must take any other measures that are reasonably necessary to prevent the
introduction of known or reasonably foreseeable hazards into or onto seeds during germination and
growth (§ 112.142(a)).

Sampling and Testing Spent Sprout Irrigation Water (or In-Process Sprouts)
for Pathogens (including E. coli O157:H7 and Salmonella species)

The Produce Safety Rule requires that you conduct microbial testing of spent sprout irrigation water
(SIW) (or in-process sprouts) from each production batch of sprouts to help minimize the likelihood
that pathogens are present on sprouts entering the food supply (§ 112.144(b)). Specifically, in
accordance with the requirements of § 112.147, you must test spent sprout irrigation water (or inprocess sprouts) from each production batch of sprouts during germination and growth for E. coli
O157:H7, Salmonella species, and any pathogens meeting the criteria in § 112.144(c). Testing for
additional pathogens (besides E. coli O157:H7 and Salmonella species) is only required under
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certain, specific circumstances. See Section VIII (Sampling and Testing of Spent Sprout Irrigation
Water or In-Process Sprouts) for more detailed information on this topic and for more detailed
information on spent sprout irrigation water testing and in-process sprout testing.

Harvest

You must handle harvested sprouts in a manner that protects against contamination with known or
reasonably foreseeable hazards (§ 112.113). For example, you should avoid contact between sprouts
and the floor (or other potentially contaminated surfaces) during harvest, and you should not
distribute sprouts that may have dropped to the floor during harvest. As another example, if
harvested sprouts are placed in perforated containers, you should handle these containers in a way
that minimizes the potential for contamination of the sprouts, such as placing them on clean pallets,
off the floor.
You must ensure all tools and equipment used to transfer sprouts from growing units to harvest
containers are of adequate design, construction, and workmanship to enable them to be adequately
cleaned and properly maintained (§ 112.123(a)).
You must inspect, maintain, clean, and sanitize FCSs of tools and equipment used during harvest as
frequently as reasonably necessary to protect against contamination of covered produce, and before
they contact sprouts, or seeds used for sprouting (§§ 112.123(d)(1), 112.143(b)). FCSs of tools and
equipment used in harvesting sprouts should be cleaned and sanitized at least daily in most
circumstances, and before starting to harvest each new production batch of sprouts. (See Section V
(Cleaning and Sanitizing)).

Wash/Drain and Cool

After sprouts are removed from the growing unit, some sprout operations wash sprouts with cool
water to remove hulls and/or to help lower the temperature of the sprouts. Some operations use a
bubbling water bath to loosen and float off hulls. Occasionally, sprouts are washed in recirculating
water in a flume system. Any agricultural water that is applied in any manner that is intended to or
likely to contact covered produce, including sprouts, during or after harvest activities must meet the
microbial quality criterion in § 112.44(a), and related requirements elsewhere in Subpart E. This
includes water that is applied to sprouts for washing or cooling activities such as those described in
this paragraph. There are also additional requirements for maintaining and monitoring the quality of
water used during harvest, packing, and holding activities (§ 112.48) (See Section VI (Agricultural
Water in Sprout Operations)).
After washing, sprouts are usually spin-dried using a centrifuge. As with all FCSs used in growing,
harvesting, packing, and holding sprouts, FCSs of sprout drying equipment must be inspected,
maintained, cleaned, and sanitized as frequently as reasonably necessary to protect against
contamination of covered produce, and prior to contact with sprouts (§§ 112.123(d)(1), 112.143(b);
see also Section V (Cleaning and Sanitizing)). Such equipment must also be of adequate design,
construction, and workmanship to enable them to be adequately cleaned and properly maintained (§
112.123(a)). For example, such equipment should be constructed of food grade materials.
Sprouts are often placed in a cold room between harvest and packing/packaging to remove heat
generated during the sprouting process. You must inspect, maintain, clean, and sanitize all FCSs of
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tools and equipment as frequently as reasonably necessary to protect against contamination of
covered produce, and before they contact sprouts, or seeds used for sprouting (§§ 112.123(d)(1),
112.143(b); see also Section V (Cleaning and Sanitizing)). This includes FCSs used during cooling
harvested sprouts, which should be cleaned and sanitized daily in most circumstances, and before
starting to cool each new production batch. You must also implement measures to prevent
contamination of your covered produce and FCSs in your buildings, as appropriate, considering the
potential for such contamination through floors, walls, ceilings, fixtures, ducts, or pipes, and drip or
condensate (§ 112.126(b)). For example, if you use a cold room for cooling harvested sprouts, you
should monitor the cold room for drip or condensate (e.g., from the ceiling over exposed sprouts) and
take appropriate steps to minimize the potential for contamination of sprouts and FCSs in compliance
with § 112.126(b).
In addition, we recommend that you take steps to minimize the potential for separate production
batches of sprouts to be inadvertently mixed during this and other steps in your production process,
particularly while you are awaiting test results from spent sprout irrigation water (or in-process
sprout) testing. Maintaining the integrity of each production batch will minimize the potential for
cross-contamination and the amount of potentially affected product in the event of a positive
pathogen finding.

Packing/Packaging

Sprouts are usually manually placed into containers, including both “packing” and “packaging.”
Typically, finished sprouts are placed into containers at the sprout growing operation but may be
occasionally transported in bulk to another location to be packed and/or packaged.
•
•
•

•

•
•

You must use food-packing material that is adequate for its intended use, which includes
being (1) cleanable or designed for single use; and (2) unlikely to support growth or transfer
of bacteria (§ 112.116(a)).
If you reuse food-packing material (e.g., for bulk delivery of sprouts), you must take
adequate steps to ensure that FCSs are clean, such as by cleaning food-packing containers or
using a clean liner (§ 112.116(b)).
Food-packing materials must be stored and maintained to protect sprouts from being
contaminated with known or reasonably foreseeable hazards and to prevent those materials
from attracting and harboring pests (§ 112.123(b)(2)). For example, food-packing materials
should be stored in a clean, dry area, separate from seeds used for sprouting.
Your building must be suitable in size, construction, and design to facilitate maintenance and
sanitary operations for covered activities to reduce the potential for contamination of covered
produce or FCSs, including by separation of operations in which contamination is likely to
occur (§ 112.126(a)(1)(ii)). For example, you should pack and/or package finished sprouts in
an area separate from areas used for other activities such as seed storage, seed treatment, and
sprout production.
You must handle harvested sprouts in a manner that protects against contamination with
known or reasonably foreseeable hazards (§ 112.113).
You must ensure all tools and equipment used to pack sprouts, including FCSs such as
packing tables, are of adequate design, construction, and workmanship to enable them to be
adequately cleaned and properly maintained (§ 112.123(a)).
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Storage and Distribution

When you store finished sprouts, you should arrange product to allow good air circulation and rapid
cooling. Because sprouts are still respiring, they can generate heat, even in a cold room. Small
containers and good air circulation help prevent “hot spots” in a batch of sprouts that may result due
to heat generated by the still living sprouts. You should maintain the cold chain as much as possible
when staging product to prepare for loading delivery trucks.
Vehicles that you use to transport sprouts must be adequately clean before use and adequate for use
in transporting sprouts to minimize the risk that vehicles/equipment used during transportation
becomes a potential source of contamination (§ 112.125).

IV. Buildings, Tools and Equipment
Maintaining an environment that promotes the hygienic production of sprouts and minimizes the
potential for cross-contamination is essential to food safety. Proper construction of buildings helps
protect against potential sources of external contaminants (e.g., airborne contamination and pests)
that may compromise the safety of food. Pest control and effective sanitation will help minimize the
transfer of microbial hazards within the operation.
Subpart L (Equipment, Tools, Buildings, and Sanitation) of the Produce Safety Rule establishes
standards to prevent equipment, tools and buildings, and inadequate sanitation, from contaminating
produce. This section of the Rule includes requirements for toilet and hand-washing facilities, and
appropriate storage, maintenance, and cleaning of equipment and tools. There are also sproutspecific requirements relating to buildings, tools, and equipment in § 112.143(a) and (b).

Requirements for Buildings

Sprout production (growing, harvesting, packing, and holding) must be conducted in a fully enclosed
building (§112.143(a)). Such buildings are subject to the requirements of Subpart L (§ 112.122).
Sprout operations should take particular note of the following:
•

You must take those measures reasonably necessary to protect covered produce, FCSs, and
food-packing materials from contamination by pests in buildings, including routine
monitoring for pests as necessary and appropriate (§ 112.128(a)). In addition, for fullyenclosed buildings as required for sprout production, you must take measures to exclude
pests from your buildings (§ 112.128(b)).
o For example, doors of sprout operations should be tight fitting and kept closed when
not in use. Windows of sprout operations should be properly fitted and kept closed at
all times unless screened. Unprotected openings to the outside should be blocked or
repaired to prevent entry of pests.
o In addition, you should routinely monitor storage areas (e.g., for seed, tools and
equipment), sprout production areas, as well as packing, and holding areas for
evidence of pests. For example, you should evaluate your operation, focusing on the
perimeters of the building, look for unprotected openings through which rodents
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•

could enter, potential harborage sites as well as other signs of potential contamination
(e.g., stains, insects, feces (rodent pellets), urine, or foreign material). You should
consider using a black light to examine for signs of rodent urine. We recommend
you develop and implement procedures for pest control (e.g., setting traps) and/or
work with a private company specializing in pest control.
Building size, construction, and design must be suitable to facilitate maintenance and sanitary
operations for covered activities to reduce the potential for contamination of sprouts or FCSs
with known or reasonably foreseeable hazards (§ 112.126(a)(1)).
o For example, the internal surfaces of buildings and fittings, such as ceilings, walls,
floors, cooling units, and light fixtures, should be durable, nonabsorbent, and easily
cleanable. The use of wood, sheet rock and other absorbent materials should be
minimized, even for non-food-contact surfaces, if these surfaces cannot be adequately
maintained, cleaned and sanitized so that they do not become a source of
contamination for sprouts or FCSs.
Your building must provide sufficient space for placement of equipment and storage of
materials (§ 112.126(a)(1)(i)).
o For example, you should ensure enough space is available to allow easy access to
equipment, such as sprout growing units, for cleaning, sanitizing and maintenance
activities. Sufficient space should exist for employees to perform their job tasks in a
way that does not result in injury or contamination of product. For example, an area
should not be too small to accommodate the tasks being performed. As another
example, spare equipment or food-packing material should not block easy access to
facilities that employees need to do their jobs adequately, such as hand washing sinks
or sinks used to wash tools and equipment. This situation could result in
contamination of food or FCSs.
The potential for contamination must be reduced by effective design including the separation
of operations in which contamination is likely to occur, by one or more of the following
means: location, time, partition, enclosed systems, or other effective means (§
112.126(a)(1)(ii)).
o For example, seed storage, seed treatment, sprout storage and chemical storage each
should be located in a separate room or location. In addition, packing and/or
packaging activities should be conducted in a separate room or area from where
sprout production occurs.
You must provide adequate drainage in all areas where normal operations release or
discharge water or other liquid waste on the ground or floor of the building (§ 112.126(a)(2)).
o Floors should be sloped towards trapped drains with covers to minimize the
accumulation of standing water and presence of low spots where water may pool.
Stagnant water accumulated on floors can harbor pathogens, especially Listeria
monocytogenes (Ref. 15). Minimizing the accumulation of standing water is
particularly important for sprout operations where large quantities of water are used
during production.
You must implement measures to prevent contamination of sprouts and FCSs in your
buildings, as appropriate, considering the potential for such contamination through: floors,
walls, ceilings, fixtures, ducts, or pipes; and drip or condensate (§ 112.126(b)).
o For example, to comply with this provision, you should consider whether the
occurrence of drip or condensate in your sprout production building presents a
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•

potential for contamination of your sprouts or FCSs and take measures to minimize or
prevent that potential for contamination. Such measures include:
 Keeping buildings in good repair in order to prevent leakage of rainwater into
the walls or ceilings of buildings, and preventing any drip or condensate from
overhead pipes or ceilings from dripping onto sprouts or food-contact
surfaces.
 Adequately and regularly cleaning fixtures, ducts or pipes inside the building
where covered activities occur.
 Considering placement of growing units with respect to potential routes of
contamination, such as splash from the floor, and taking appropriate steps to
minimize the potential for contamination of sprouts and FCSs (as discussed
above (see Section III (General Sprout Production))).
 Monitoring cold rooms used to cool finished sprouts for drip or condensate
(e.g., from the ceiling over exposed sprouts) and taking appropriate steps to
minimize the potential for contamination of sprouts and FCSs (as discussed
above (see Section III (General Sprout Production))).
We recommend that you consider providing designated areas and/or separate rooms in your
building(s) for employees taking breaks. Providing such areas or rooms helps ensure that
personnel comply with certain requirements to use hygienic practices while on duty (e.g., not
eating, chewing gum, or using tobacco products in an area used for a covered activity (§§
112.32(a) and (b)(6))).

B.
•

Toilet and Hand Washing Facilities

You must provide personnel with adequate, readily-accessible toilet facilities that are
designed, located, and maintained to prevent contamination of covered produce, FCSs, and
areas within your operation used for growing, harvesting, packing or holding sprouts, water
sources, and water distribution systems with human waste (§§ 112.129(a) and (b)(1)). Toilet
facilities must be directly accessible for servicing, must be serviced and cleaned at a
frequency sufficient to ensure suitability of use, must be kept supplied with toilet paper, and
must provide for the sanitary disposal of waste and toilet paper (§§ 112.129(b)(2) and (3)).
o Sprout operations are required to grow, harvest, pack, and hold sprouts in a fullyenclosed building (§ 112.143(a)), and such buildings are subject to Subpart L,
including the requirement in § 112.129 for adequate, readily accessible toilet
facilities. This means that sprout operations must provide personnel with adequate,
readily accessible toilet facilities during all times in which they are in production (i.e.,
during all covered activities, including any growing, harvesting, packing, and holding
of sprouts). This also means that sprout operations must provide a hand-washing
station in sufficiently close proximity to toilet facilities to make it practical for
persons who use the toilet facility to wash their hands at all times in which sprout
operations are in production (§ 112.129(c)).
o Portable toilets may be used, provided they meet all applicable requirements. In
particular, if you use portable toilets, you should consider their location with respect
to meeting relevant requirements for accessibility for servicing (§ 112.129(b)(2)), and
being readily accessible to personnel when they are conducting covered activities (§
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112.129(a)). For example, the service vehicle should be able to enter your property
and maneuver as close as necessary to the portable toilet to service the unit.
o Toilets should not leak onto the floor. Clogged, leaking, or broken toilets should be
repaired immediately (see §§ 112.129(b)(3) and 112.131(c)).
Sprout operations must provide a hand-washing station that is in sufficiently close proximity
to toilet facilities to make it practical for persons who use the toilet facility to wash their
hands (§ 112.129(c)). Hand-washing stations must also be adequate and readily accessible to
workers during sprout growing, harvesting, packing, and holding (§ 112.130(a)).
o Hand-washing stations should be strategically located within the operation to
facilitate their use at key times, such as when entering sprout production and
packaging areas.
Your hand-washing facilities must be furnished with: soap (or other effective surfactant);
running water that satisfies the requirements of § 112.44(a) for water used to wash hands; and
adequate drying devices (such as single service towels, sanitary towel service, or electric
hand dryers) (§112.130(b)). You must not use antiseptic hand rubs (i.e., hand sanitizers) as a
substitute for soap (or other effective surfactant) and water (§ 112.130(d)).
o While you must not use hand sanitizers as a substitute for soap (or other effective
surfactant) and water, you may consider having hand sanitizer dispensers, aerosol
spray devices, or hand-dip bowls of solution available in addition to hand washing
stations.

Plumbing Systems for Water

The plumbing system within your sprout operation must be of an adequate size and design and be
adequately installed and maintained to distribute water under pressure as needed, in sufficient
quantities, in all areas where used for covered activities, for sanitary operations, or for hand-washing
and toilet facilities (§ 112.133(a)).
In addition, the plumbing must be of an adequate size and design and be adequately installed and
maintained to properly convey sewage and liquid disposable waste, and avoid being a source of
contamination to covered produce, FCSs, areas used for a covered activity, or agricultural water
sources (§§ 112.133(b) and (c)).
The plumbing system must not allow backflow from or cross-connections between piping systems
that discharge wastewater or sewage and piping systems that carry water used for sprout production,
for sanitary operations or for use in hand-washing facilities (§ 112.133(d)). Practices such as leaving
open-ended hoses on the floor of your sprout operation or submerged in tanks of liquid should be
avoided because of the potential for water from the floor or tank to back siphon and contaminate your
water system. We recommend that you refer to the U.S. Environmental Protection Agency’s (EPA’s)
Cross-Connection Control Manual regarding situations that may lead to contamination through crossconnections and backflow, and the devices and procedures you can use to prevent such
contamination (Ref.16).

Sewage and Waste Management

You must dispose of sewage into an adequate sewage or septic system, or through other adequate
means (§ 112.131(a)). You must maintain sewage and septic systems in a manner that prevents
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contamination of sprouts, FCSs, areas used for a covered activity, agricultural water sources and
agricultural water distribution systems with known or reasonably foreseeable hazards (§ 112.131(b)).
See also §§ 112.129(b)(1) and (3); 112.130(c); and 112.131(c) and (d) regarding disposal of waste
from toilet facilities, hand-washing facilities, leakages or spills, and after significant events such as
flooding or an earthquake.
You must convey, store, and dispose of trash, litter and waste in a way that minimizes the potential
for trash, litter, or waste to attract or harbor pests and protects against contamination of sprouts,
FCSs, areas used for sprout production, agricultural water sources, and agricultural water distribution
systems (§ 112.132(a)), and you must adequately operate systems for waste treatment and disposal so
that they do not constitute a potential source of contamination in areas used for a covered activity (§
112.132(b)). For example, we recommend that waste be carried out of, but not through, sprout
production areas when sprouts are exposed to minimize the risk of contamination of sprouts.

Equipment and Tools

Equipment and tools subject to the requirements of Subpart L are those that are intended to, or likely
to, contact covered produce; and those instruments or controls used to measure, regulate, or record
conditions to control or prevent the growth of microorganisms of public health significance.
Examples include implements, cooling equipment, palletizing equipment, and equipment used to
store or convey harvested covered produce (such as containers, bins, food-packing material, dump
tanks, flumes, and vehicles or other equipment used for transport that are intended to, or likely to,
contact covered produce) (§ 112.121).
•

You must use equipment and tools that are of adequate design, construction, and
workmanship to enable them to be adequately cleaned and properly maintained (§ 112.123(a)
and (c)). You must install, store, and maintain equipment and tools in a way that will
facilitate cleaning of the equipment and all adjacent spaces, protect against contamination,
and prevent attraction and harborage of pests (§ 112.123(b) and (c)).
o Equipment breakdown and broken or damaged tools and equipment can interfere with
the efficient running of your operation and can result in hazards to your employees
and food safety risks associated with your products. Areas that commonly need
attention in a sprout operation are cracked or worn belts and conveyors, chipped or
cracked guards, and cracked, chipped or worn equipment, including growing units.
Damaged or rough surfaces are difficult to adequately clean and sanitize. You should
repair or replace any equipment and FCSs that are rusted, pitted or otherwise
damaged.
o Inaccessible or hard-to-clean places may provide harborage or growth sites for
microorganisms.
o Seeds, sprouts, hands, or gloves that come into contact with dirty surfaces can be
contaminated with pathogenic microorganisms. Even if tools and equipment are
adequately constructed, inadequate cleaning and sanitizing of the tools and equipment
can lead to contamination. See also Section V (Cleaning and Sanitizing).
o Appropriate practices for storing and maintaining equipment and tools can protect
against contamination and reduce the potential for attracting or harboring pests,
which can carry human pathogens. Pest harborage by equipment not only can
contaminate the equipment; it can also increase the prevalence of pests near a
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building, and provide a place for them to live and breed. Sprout operations should
store equipment and tools in a fully enclosed building to minimize the potential for
contamination.

Cleaning and Sanitizing

Cleaning and sanitizing are different, and important steps that are critical to the safety of your
finished sprouts. This section discusses cleaning and sanitizing frequencies, recordkeeping and the
development of Sanitation Standard Operating Procedures (SSOP), how cleaning and sanitizing
differ, verification activities, and corrective actions to take in response to suspected or known
contamination.

Frequency of Cleaning and Sanitizing

Section 112.123(d)(1) is a general requirement that applies to all covered farms, and requires you to
inspect, maintain, clean and, when necessary and appropriate, sanitize all FCSs of equipment and
tools used in covered activities as frequently as reasonably necessary to protect against contamination
of covered produce. For operations growing sprouts covered by Subpart M, we determined that it is
“necessary and appropriate” to sanitize all such food contact surfaces used to grow, harvest, pack, or
hold sprouts after cleaning them and therefore we specifically require both cleaning and sanitizing
for such food contact surfaces prior to contact with sprouts or seeds used to grow sprouts, as reflected
in § 112.143(b). “Food contact surfaces” means “those surfaces that contact human food and those
surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the food
ordinarily occurs during the normal course of operations. ‘Food contact surfaces’ includes food
contact surfaces of equipment and tools used during harvest, packing, and holding” (§ 112.3). “Food
contact surfaces” also includes food contact surfaces of equipment and tools used in growing covered
produce, including sprouts (see, e.g., §§ 112.123(d)(1) and 112.143(b)). In a sprouting operation,
food contact surfaces include, for example, trays or drums used for sprouting; interior surfaces of
containers used for seed rinsing, seed treatment, and pre-germination seed soaking; and counters that
come into contact with sprouts during packing and/or packaging (See Section III (General Sprout
Production)).
In general, we recommend cleaning and sanitizing of food contact surfaces used in sprout operations
at least daily to meet the requirements of §§ 112.123(d)(1) and 112.143(b). For example, you should
clean and sanitize all food contact surfaces in the production environment at the end of each
production day. Appropriate frequency of cleaning and sanitizing may vary based on specific
practices; for example, you should incorporate a cleaning and sanitizing step for food-contact
surfaces between each different production batch of sprouts (e.g., when more than one batch will
contact the same FCSs on the same day). Cleaning and sanitizing between production batches of
sprouts will minimize the potential for cross-contamination, and also facilitate corrective actions in
the event that a positive pathogen (or indicator organism) test result is obtained (e.g., from a spent
sprout irrigation water, sprouts, and/or environmental sample) (See Section VIII (Sampling and
Testing of Spent Sprout Irrigation Water or In-Process Sprouts) and Section IX (Environmental
Monitoring)). As another example, you should clean and sanitize FCSs prior to resuming production
after more than a day of those food-contact surfaces not being used (in which case your cleaning and
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sanitizing of those surfaces would occur less frequently than daily because they are not being used
daily). Surfaces that are used continuously for more than a day, such as bins or drums that contain
sprouts during germination and growth periods lasting more than a day, do not need to be cleaned on
a daily basis while they continuously contain or otherwise contact only one production batch of
growing sprouts. We consider such uses to be a single, continuous instance of contact. The rule
requires that the FCSs be cleaned and sanitized “before contact.”
Additionally, you must maintain and clean all non-FCSs of equipment and tools subject to Subpart L
and used during harvesting, packing, and holding as frequently as reasonably necessary to protect
against contamination of sprouts (§ 112.123(d)(2)). While the rule does not require sanitizing of
non-FCSs, we recommend that sprout operations sanitize even non-FCSs on the same schedule as we
recommend for cleaning those surfaces because of the particularly high-risk nature of sprout
production. We recommend cleaning and sanitizing all non-food-contact surfaces in accordance with
the frequencies in Table 1 below. We recommend that initial sanitizing, of any surface, occur
immediately following completion of cleaning, and then be repeated as necessary (e.g., re-sanitizing
in the morning after cleaning and sanitizing the night before).

The recommendations in the following table are adapted from a 1999 publication by Tompkin et
al. (Ref. 17). If the results of environmental monitoring, spent sprout irrigation water, or product
testing indicate a food safety concern, you should consider increasing the frequency of cleaning
and sanitizing as part of an overall corrective action plan.
Table 1. Recommended Frequency of Cleaning and Sanitizing
Frequency of Cleaning and Sanitizinga

Surface, Area, or Equipment
Drains and floors

Daily

Pallets

Daily

Waste containers

Daily

Cleaning tools (e.g., mops, brushes)

Daily

Surfaces that have a greater potential to become
a source of L. monocytogenes contamination
(e.g., surfaces likely to be touched by employees
who touch product or food-contact surfaces
during operations, or areas where there may be a
build-up of moisture or product residue)

Daily

Condensate drip pans

Monthly

Motor housings, external surfaces of enclosed
processing systems

Monthly

Overhead piping, ceilings and wallsb

Semi-annually

Freezers (e.g., spiral, blast, tunnel) containing
exposed RTE foodsc

Semi-annually
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Frequency of Cleaning and Sanitizinga

Surface, Area, or Equipment

Interiors of Ice Makers
Semi-annually
a
Since production environments vary, it may be appropriate to increase cleaning frequencies
depending on the specific circumstances of the product area.
b
We recommend that that you clean and sanitize some walls and ceilings (e.g., those in close
proximity to a production line) at the same time as the production equipment (e.g., daily).
c
If the manufacturer of the equipment recommends cleaning on a more frequent basis, we
recommend that you increase this frequency to match the recommendations of the manufacturer.

Sanitation Standard Operating Procedures (SSOPs) and Recordkeeping

Sprout operations should create and manage one or more Sanitation Standard Operating Procedure(s)
(SSOP). A SSOP is a document which describes sanitation procedures, schedules, and needed
materials, tools, and chemicals for specific cleaning and sanitizing tasks. Sprout operations may
have several SSOPs describing various tasks throughout the production environment. Each piece of
equipment as well as the production environment itself should be considered when developing
SSOPs. While not required under the Produce Safety Rule, SSOPs promote consistency between
applications as well as proper and complete applications of procedures by different workers. The
following details should be included in each SSOP and periodically reviewed by management:
• For what piece(s) of equipment or area(s) of the production environment the SSOP was
written.
• Who is responsible for the cleaning and sanitizing tasks.
• When each task is to be completed.
• What tools and chemicals (for both cleaning and sanitizing) are needed.
• How the chemicals are to be prepared.
• How the chemicals are to be used and what precautions need to be taken.
• How to properly clean and sanitize the piece(s) of equipment or work area(s).
You must establish and keep records of the date and method of cleaning and sanitizing of equipment
used during growing operations for sprouts and all covered harvesting, packing, or holding activities
(§ 112.140(b)). If you have an SSOP, these records should document the performance of the steps
outlined in the SSOP, for example using a checklist. Maintaining records of the performed activities
not only helps a firm ensure activities are appropriately performed, but also serves as documentation
to show auditors or inspectors, as necessary, that the activities were properly performed.

Cleaning

Cleaning refers to the practice of removing visible organic material and other debris from surfaces.
When cleaning and sanitizing is required, you must properly clean surfaces prior to sanitizing
because many sanitizers will not be effective unless food and dirt have been removed from the
surface first (see definition of “sanitize” in § 112.3, “to adequately treat cleaned surfaces …”
(emphasis added)).
Cleaning procedures should have set frequencies established in a sprout operation’s SSOPs (see
discussion above). Your cleaning procedures should be established in light of the results of
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sanitation verification activities, environmental monitoring results (see Section IX (Environmental
Monitoring)), surface materials (e.g., stainless steel, plastic, concrete), and the general effectiveness
of your cleaning agent(s).
To properly clean your equipment, tools, or other surfaces, you should:
1. Prepare the area by removing or appropriately covering food items, electrical equipment, and
food-packing materials.
2. If necessary, remove items from the surfaces to be cleaned (including tools, pieces of food,
organic material, or other debris) and disassemble equipment to expose surfaces to
subsequent cleaning and sanitizing activities.
3. For wet cleaning of food-contact surfaces, rinse the equipment with water that meets the
microbial criterion described in § 112.44(a).
4. Wash equipment with an effective cleaning agent/detergent, using concentrations, contact
times, and other directions stated on the label.
5. Physically scrub equipment using appropriate tools.
6. Rinse with water if necessary. Water that contacts food-contact surfaces must meet the
microbial criterion described in § 112.44(a).
Factors that influence the effectiveness of cleaning procedures include, but are not limited to, the
following:
•
•
•
•
•

How well organic matter, sprouts, and other debris is removed from the equipment, through
physical removal and/or rinsing.
The type and strength of the cleaning agent/detergent.
The surface material (e.g., plastic, stainless steel, concrete, etc.) to be cleaned and its
condition. You should consider the surface material to be cleaned when selecting cleaning
agents/detergents.
Contact time of the cleaning agent/detergent with the surface(s) being cleaned.
The duration and force of physical scrubbing.

Mops, brushes and other equipment used for cleaning and sanitizing should also be durable and
replaced immediately if damaged, cracked, or worn, to prevent the colonization of those tools by
microorganisms of public health concern. This equipment should also be stored appropriately, and
be cleaned and sanitized as needed.

Sanitizing

The Produce Safety Rule defines “sanitize” to mean “to adequately treat cleaned surfaces by a
process that is effective in destroying vegetative cells of microorganisms of public health
significance, and in substantially reducing numbers of other undesirable microorganisms, but without
adversely affecting the product or its safety for the consumer” (§ 112.3). When cleaning and
sanitizing is required, you must properly clean surfaces prior to sanitizing because many sanitizers
will not be effective unless food and dirt have been removed from the surface first. Sanitizing
surfaces is usually achieved through chemical means.

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The following should be considered when developing your SSOPs and when sanitizing your
equipment or production environment:
•
•
•
•

The surfaces should be cleaned as described above.
Verification activities, described below, should be conducted to evaluate the effectiveness of
your cleaning and sanitizing activities.
Sanitizing agents may be harmful to employees. Proper precautions should be taken when
such chemicals are used.
Chemical sanitizing agents must be used according to label directions in accordance with the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The following should be considered when selecting sanitizing agents:
•
•
•
•
•

Employee safety.
The material of the surface that is to be sanitized.
Characteristics of water (e.g., hardness, pH, temperature) used to prepare the sanitizing agent.
The compatibility of the sanitizing agent with the cleaning chemical(s).
Possible impact on the sprouts.

Consulting with cleaning and/or sanitizing agent suppliers will help you select the products that are
best suited for your operation.

Verification of Cleaning and Sanitizing

Effective cleaning and sanitizing is dependent on numerous factors; individuals that are responsible
for cleaning and sanitizing should consider what activities can be controlled to reduce sanitation
variability. The concentration of the sanitizing agent used is a key factor that directly correlates to its
effectiveness. Verification of chemical concentrations should be done with appropriate test kits and,
if analytical instruments are used to measure or regulate sanitizer efficacy, they must be accurate and
precise as necessary and appropriate in keeping with their purpose (§ 112.124(a)), adequately
maintained (§ 112.124(b)), and adequate in number for their designated use (§ 112.124(c)).
We recommend that sprout operations conduct verification sampling of recently cleaned and
sanitized surfaces to monitor overall sanitation effectiveness. We recommend that you use at least
one, or more, of the various available methods to verify the effectiveness of your cleaning and
sanitizing procedures. Some of these tests, which include bioluminescence, adenosine triphosphate
(ATP), and protein-based technologies, provide rapid results and allow for follow-up or intensified
cleaning and sanitizing activities if results are above established thresholds. Another option is to
quantify aerobic plate counts (APC) of a surface to directly monitor viable microbial populations, the
results of which could also be used to indicate where to target sampling of Listeria spp. or L.
monocytogenes as part of environmental monitoring. However, it is critical to understand that none
of these tests is an appropriate substitute for environmental monitoring of Listeria spp. or L.
monocytogenes as required for sprout operations by § 112.145 (See Section IX (Environmental
Monitoring)).

Cleaning and Sanitizing Conducted in Response to Suspected or Known
Contamination
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Cleaning and sanitizing is required as a corrective action measure if:
1. Sprouts or sprout irrigation water test positive for the pathogens E. coli O157:H7,
Salmonella, or any pathogens meeting the criteria in § 112.144(c). In such a situation, you
must clean and sanitize the affected surfaces and surrounding areas (§ 112.148(c)).
2. Listeria spp. or L. monocytogenes is detected in the growing, harvesting, packing, or holding
environment. In such a situation, you must clean and sanitize the affected surfaces and
surrounding areas (§ 112.146(b)).
In addition to the cleaning and sanitizing required as corrective action measures in § 112.146(b) and
§ 112.148(c), we recommend that you undertake intensified cleaning and sanitizing activities in
response to any occurrence of known or suspected contamination of your sprouts, seeds used for
sprouting, or locations in your operation (e.g., tools, equipment, other surfaces). In such situations
(for example, if your environmental monitoring cleaning verification testing yields a second Listeria
spp. positive result on the same FCS (see Section IX (Environmental Monitoring))), the following
actions should be considered as means of performing “intensified” cleaning and sanitizing:
•
•
•
•
•
•
•

Dismantling equipment further than described in the SSOP, if you have one, or further than
your normal practice.
Intensified (e.g., more vigorous, longer time) scrubbing of surfaces where positive samples
were found (if applicable) or where product residue accumulates.
Identifying, cleaning, and sanitizing possible harborage sites and evaluating possible crosscontamination routes.
Removing and soaking of equipment parts in an appropriate sanitizing agent overnight.
Increased frequency of cleaning and sanitizing activities for all surfaces that are not already
cleaned or sanitized daily.
Heat treatment of equipment or parts.
Replacement or repair of tools, equipment, or production operation surfaces.

As previously mentioned, the use of an EPA-registered cleaning or sanitizing chemical in any way
that is inconsistent with its labeling (e.g., preparing a higher concentration than specified on the
label) is a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Additionally, exposure to these chemicals may be hazardous to employees and may increase the
likelihood of damage to the equipment.
Additional information on corrective action measures required and/or recommended in response
either to positive pathogen results in spent sprout irrigation water or sprouts (§ 112.148), or to
findings of Listeria spp. or Listeria monocytogenes (§ 112.146) are discussed in Section VIII
(Sampling and Testing of Spent Sprout Irrigation Water or In-Process Sprouts) and Section IX
(Environmental Monitoring).
In addition to the cleaning and sanitizing specifically required by the Produce Safety Rule, it is
important to note that detection of any foodborne pathogens in samples of seed, spent sprout
irrigation water or sprouts, or in environmental samples from food- or non-food-contact surfaces in
the production operation (e.g., positive pathogen results from voluntary testing conducted in addition
to required testing) should also result in previously unscheduled cleaning and sanitizing of affected
food- and non-food-contact surfaces. Similarly, involvement of a sprout operation in a foodborne
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illness outbreak, observations of filth, or other signs of possible contamination should result in
previously unscheduled cleaning and sanitizing. You should also consider conducting previously
unscheduled cleaning and sanitizing activities if you know or have reason to believe that a lot of
seeds may be contaminated with a pathogen (in addition to the requirements you must fulfill in such
situations, set forth in § 112.142(b))(See Section VII (Seeds for Sprouting)).

VI. Agricultural Water in Sprout Operations
In the Produce Safety Rule, we define “agricultural water” as “water used in covered activities on
covered produce where water is intended to, or is likely to, contact covered produce or food contact
surfaces, including water used in growing activities (including irrigation water applied using direct
water application methods, water used for preparing crop sprays, and water used for growing sprouts)
and in harvesting, packing, and holding activities (including water used for washing or cooling
harvested produce and water used for preventing dehydration of covered produce)” (§ 112.3).
Several uses of water typical to sprouting operations meet the definition of “agricultural water,”
including water used to irrigate sprouts; to prepare ice that will contact sprouts; and to contact food
contact surfaces (including water used to prepare seed treatments, or to rinse, wash, or soak seeds
prior to sprouting). “Food contact surfaces” means “those surfaces that contact human food and
those surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the
food ordinarily occurs during the normal course of operations. ‘Food contact surfaces’ includes food
contact surfaces of equipment and tools used during harvest, packing, and holding” (§ 112.3). “Food
contact surfaces” also includes food contact surfaces of equipment and tools used in growing covered
produce, including sprouts (see, e.g., §§ 112.123(d)(1) and 112.143(b)). In a sprouting operation,
food contact surfaces include, for example, trays or drums used for sprouting; interior surfaces of
containers used for seed rinsing, seed treatment, and pre-germination seed soaking; and counters that
come into contact with sprouts during packing and/or packaging (See Section III (General Sprout
Production)). Therefore, all water used in a sprout operation to contact such surfaces meets the
definition of “agricultural water,” including, as mentioned above, water used to prepare seed
treatments or to rinse, wash, or soak seeds prior to sprouting.
Not all water uses meet the definition of “agricultural water.” For example, water used to wash the
exterior of a sprout operation’s delivery vehicle is not “agricultural water” (assuming that the vehicle
exterior is not used in a way that would make it fit the definition of a “food contact surface”).
This section of the guidance is intended to help operations growing sprouts covered under Subpart M
comply with the agricultural water requirements of the Produce Safety Rule. Here, we provide a
limited discussion of certain provisions of Part 112 related to agricultural water as they relate to
sprout production, most notably the requirement that agricultural water must be safe and of adequate
sanitary quality for its intended use (§ 112.41); the numerical microbial quality criterion that is
relevant to sprouting operations (§ 112.44(a)); and the related requirements for agricultural water
testing frequency (§ 112.46).

Numerical Microbial Quality Criterion for Agricultural Water Used in a
Sprouting Operation (§ 112.44(a))
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Certain uses of “agricultural water” (including sprout irrigation water) are subject to a microbial
water quality requirement of no detectable generic E. coli per 100 ml (see § 112.44(a)), and all water
supplied to hand-washing facilities at sprouting operations is required to meet the same standard (see
§ 112.130(a) and (b)(2); see also § 112.143(a)). We are not aware of any uses of water common in
sprouting operations that are intended to or likely to contact food or food contact surfaces that are not
subject to this microbial quality requirement. The no detectable generic E. coli per 100 ml microbial
quality criterion applies to water that is:
•
•

•
•

Used as sprout irrigation water (§ 112.44(a)(1));
Applied in any manner that directly contacts covered produce during or after harvest
activities (for example, water that is applied to covered produce for washing or cooling
activities, and water that is applied to harvested crops to prevent dehydration before cooling),
including when used to make ice that directly contacts covered produce during or after
harvest activities (§ 112.44(a)(2));
Used to contact food contact surfaces, or to make ice that will contact food contact surfaces(§
112.44(a)(3)); and
Used for washing hands during and after harvest activities (§ 112.44(a)(4)) and all water
supplied to hand-washing facilities at sprouting operations, including water used for handwashing during growing activities (see § 112.130(a) and (b)(2); see also § 112.143(a)).

As discussed above, many uses of agricultural water in sprouting operations contact food contact
surfaces, and such uses are subject to this microbial quality criterion (§ 112.44(a)). “Food contact
surfaces” as defined in § 112.3 includes (as stated in the definition) food contact surfaces of
equipment and tools used in harvesting, packing, and holding covered produce; but it also includes
such surfaces of tools and equipment used in growing covered produce, including sprouts (see, e.g.,
§§ 112.123(d)(1) and 112.143(b)). One important difference between the application of the Produce
Safety Rule to sprouts as compared to other types of covered produce are the different microbial
water quality requirements that apply to water used during growing. While we apply the most
stringent microbial water quality criterion to water used in growing of sprouts (§ 112.44(a)), we
apply less stringent microbial water quality criteria to water used during growing of non-sprout
covered produce (§ 112.44(b)), and further limit the application of that criteria to only such water
applied using a “direct water application method,” as that term is defined in § 112.3. We defined
“direct water application method” to include water uses that are intended to, or likely to, contact
covered produce or food contact surfaces. Thus, with respect to water used during growing:
•

•

The less stringent microbial water quality criteria in § 112.44(b) apply to water applied to
non-sprout covered produce during growing using a “direct water application method,” which
includes water applied to food contact surfaces of tools and equipment used on non-sprout
covered produce during the growing stage. We do not interpret § 112.44(a)(3) to also apply
the more stringent water quality criterion to the same food contact surfaces when they are
used in growing non-sprout covered produce, but only to food contact surfaces used during
the later stages of harvesting, packing, and holding of non-sprout covered produce.
On the other hand, the more stringent microbial water quality criterion in § 112.44(a) applies
to all agricultural water used to irrigate sprouts (§ 112.44(a)(1)), and to all agricultural water
used to contact food contact surfaces of tools and equipment used during growing,
harvesting, packing, and holding sprouts (§ 112.44(a)(3)).
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Similarly, the rule applies more stringent requirements for hand-washing water to sprout operations
during growing as compared to operations growing covered produce other than sprouts. For sprout
operations, § 112.143(a) requires that growing (as well as harvesting, packing, and holding) take
place in a fully-enclosed building. Sections 112.130(a) and (b)(2) require that, for growing that takes
place in a fully-enclosed building, adequate and readily accessible hand-washing facilities must be
provided, furnished with water that satisfies the § 112.44(a) microbial quality criterion.
As discussed above, in a sprouting operation, “food contact surfaces” include, for example, trays or
drums used for sprouting; interior surfaces of containers used for seed rinsing, seed treatment, and
pre-germination seed soaking; and counters that come into contact with sprouts during packing
and/or packaging. While seeds used to grow sprouts are not themselves “covered produce,” seeds for
sprouting are considered “food” under Section 201(f) of FD&C Act and as defined in § 112.3.
Requirements relating to “food contact surfaces” in Part 112 apply not only to surfaces that contact
(or drain onto, or otherwise transfer onto) sprouts themselves but also seeds used to grow sprouts.
Water used to contact seeds prior to sprouting also necessarily contacts food contact surfaces that
contact, drain onto, or otherwise transfer onto those seeds, and therefore must meet the § 112.44(a)
microbial quality criterion (§ 112.44(a)(3)). For example, this includes water used to rinse seeds to
remove dirt or debris, water used to prepare seed treatments, water used for post-treatment rinsing of
seeds, and water used for a pre-germination soak of seeds.

Agricultural Water Systems and How the Source Type and Treatment Status
Affect Relevant Requirements

Sprout operations will need to identify the type(s) of agricultural water source(s) used in their
operation (e.g., ground water, water from a public water supply) and are required to inspect and
adequately maintain their agricultural water sources and distribution systems (§ 112.42). Under §
112.42(a), sprout operations are required to inspect all of their agricultural water systems to the
extent they are under their control (including water sources, water distribution systems, facilities, and
equipment), to identify conditions that are reasonably likely to introduce known or reasonably
foreseeable hazards into or onto covered produce or food-contact surfaces in light of their covered
produce, practices, and conditions. The specific known or potential hazards that may be associated
with your operation and food, in relation to your agricultural water, will likely vary dependent on
your specific agricultural water source(s), water distribution system(s), practices at your operation,
and your covered produce.
In addition, once you identify uses of water in your operation that meet the definition of agricultural
water, the water sources you use should be evaluated to determine which requirements of Subpart E
are applicable. As explained above, we are not aware of any uses of water common in sprouting
operations that are intended to or likely to contact food or food contact surfaces (and therefore, that
fit the definition of “agricultural water”) that are not subject to the microbial quality requirement in §
112.44(a). Therefore, we consider it likely that all “agricultural water” uses in a sprouting operation
are subject to § 112.44(a), and our discussion below focuses on § 112.44(a) and related provisions.
Untreated surface water may not be used for § 112.44(a) purposes, including for sprout irrigation
water (see § 112.44(a)). The definition of “surface water” appears in § 112.3 and includes, for
example, water from rivers.
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Untreated ground water may be used for § 112.44(a) purposes. The definition of “ground water”
appears in § 112.3 and includes, for example, water from wells that does not meet the definition of
“surface water” (e.g., wells that are not influenced by surface water). In addition to all other
applicable requirements of Subpart E that apply to agricultural water as a general matter, if you use
untreated ground water for § 112.44(a) purposes in a sprouting operation, you must:
•

•

Sample and test water from each untreated ground water source used for such purposes, at the
frequency established in the rule (§ 112.46(c); see also Section VI.E. below), and in
compliance with the methodology requirements established for both sampling and testing in
the rule (§ 112.47(b), 112.151; see also Section VI.E. below);
If the microbial quality criterion (no detectable generic E. coli in 100 mL) is not met,
immediately discontinue using water from the affected water source and/or distribution
system for any § 112.44(a) purpose, and take appropriate corrective measures before using
the affected water source and/or distribution system again for any such purpose (§ 112.45(a));
Maintain records related to agricultural water testing, corrective actions, and test
methodology as required under §§ 112.50(b)(2), (6), and (9).

Treated water (i.e., water that a sprouting operation treats) may be used for §112.44(a) purposes.
This is true regardless of the source from which the water was taken. For example, water from a
surface water source may be treated in accordance with § 112.43 and used for a § 112.44(a) purpose.
Section 112.44(a) says “you must not use untreated surface water for any of these purposes”. If
water has been treated in accordance with the requirements of § 112.43, it is “treated” water (not
“untreated”). Water that has been treated in accordance with the requirements of § 112.43 is not
required to be tested to ensure compliance with the microbial quality criterion (§ 112.46(a)(3)); In
addition to all other applicable requirements of Subpart E that apply to agricultural water as a general
matter, if you use treated water for § 112.44(a) purposes in a sprouting operation, you must:
•

•

Comply with all applicable requirements for treating water (e.g., the treatment must be
effective to make the water meet the no detectable generic E. coli per 100 mL microbial
quality criterion (§ 112.43(a)(1)), delivered in a manner that ensures it consistently meets that
criterion (§ 112.43(a)(2)), and must be monitored at a frequency adequate to ensure it
consistently meets that criterion (§ 112.43(b)); and
Maintain records related to such treatment (§ 112.50(b)(4)).

Water from a public water system or supply, as described in § 112.46(a)(1) and § 112.46(a)(2), may
be used for §112.44(a) purposes. Such water is not required to be tested to ensure compliance with
the microbial quality criterion (§§ 112.46(a)(1) and (2)). In addition to all other applicable
requirements of Subpart E that apply to agricultural water as a general matter, if you use water from a
public water system or supply for § 112.44(a) purposes in a sprouting operation, you must:
•

Maintain annual documentation of the results or certificates of compliance from the public
water system or supply that demonstrate that the water meets the microbial quality criterion
of § 112.44(a), i.e., no detectable generic E. coli per 100 ml (§ 112.50(b)(7)).

The exceptions from the testing requirements for water received from a public water system (as in §
112.46(a)(1)) or a public water supply (as in § 112.46(a)(2)) apply only when such water is not held
under your control in a way that meets the definitions of “ground water” or “surface water” before
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you use it as agricultural water. See the definitions of “ground water” and “surface water” in §
112.3.
If you hold water received from a public water system or public water supply in a surface water
capacity (e.g., holding it in an uncovered tank outdoors), then the water is exposed to potential
contamination in a manner similar to other surface water sources, such that it becomes a “surface
water” source as applicable. The prohibition on using untreated surface water for § 112.44(a) uses
prohibits use of such water as agricultural water in a sprouting operation.
If you hold water received from a public water system or public water supply in a ground water
capacity (e.g., through recharging a well), the water is exposed to potential contamination in a
manner similar to other ground water sources, such that it becomes a “ground water” source, as
applicable, and the testing requirements in § 112.46(c) (and related requirements discussed above)
applicable to untreated ground water will apply.

Safe and of Adequate Sanitary Quality (§ 112.41)

In addition to the specific numerical microbial water quality criterion in § 112.44(a) that applies to
sprout operations as discussed above, we have established a general agricultural water quality
requirement.
The requirement in § 112.41 (that all agricultural water must be safe and of adequate sanitary quality
for its intended use) applies to all agricultural water, including uses for sprout production. The
principle of “safe and of adequate sanitary quality for its intended use” contains elements related both
to the attributes of the source water used and the activity or practice related to the use of the
agricultural water. The way in which agricultural water is used can affect the risk of contamination
of produce. This requirement is a general standard of agricultural water quality applicable to all
covered activities in which agricultural water is intended to or likely to contact covered produce or
food-contact surfaces. For example, where the intended use is sprout irrigation, agricultural water
which exceeds the microbial quality criterion of § 112.44(a) would also fail to meet the requirement
in § 112.41 that agricultural water must be safe and of adequate sanitary quality for its intended use.
Although a test result indicating the agricultural water does not meet the applicable microbial water
quality requirement in § 112.44(a) demonstrates that the water is not safe or of adequate sanitary
quality for those specified uses, the converse is not necessarily true. That is, agricultural water that
meets the § 112.44(a) microbial quality criterion may not be safe or of adequate sanitary quality, for
example, if pathogenic organisms are present.
Sprout operations must inspect and adequately maintain the water distribution system and sources of
agricultural water used in the operation (see § 112.42). These activities may lead a sprout operation
to discover information giving them reason to believe that their agricultural water is not safe or of
adequate sanitary quality for its intended use. For example, a sprout operation might inspect a well it
uses as a source of untreated ground water for sprout irrigation in compliance with § 112.42 and find
a dead animal in the well. The sprout operation in this example now has reason to believe that the
agricultural water from that well is not safe or of adequate sanitary quality for its intended use.
If you have determined, or have reason to believe, that your agricultural water source is not safe or of
adequate sanitary quality for its intended use as required by § 112.41, you must immediately
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discontinue that use(s), and before you may use the agricultural water source and/or distribution
system again for that use(s), you must take appropriate corrective actions as set forth in § 112.45(a).

Reuse of Sprout Irrigation Water

We define a “production batch” of sprouts as “all sprouts that are started at the same time in a single
growing unit (e.g., a single drum or bin, or a single rack of trays that are connected to each other),
whether or not the sprouts are grown from a single lot of seed (including, for example, when multiple
types of seeds are grown within a single growing unit)” (§ 112.3). This definition is intended to treat
as a production batch product that is exposed to the same conditions during sprouting, such as
multiple seed types grown in a common drum or multiple trays in a single rack that may be exposed
to water that has contacted other product in the same growing unit. The example of a “single
growing unit” as “a single rack of trays that are connected to each other” refers to a single rack of
trays for which irrigation water is shared across the trays, exposing the sprouts grown in that rack of
trays to the same conditions (the same irrigation water).
We recommend against using the same water to irrigate multiple production batches of sprouts (e.g.,
applying spent water from batch 1 to irrigate batch 2) without any form of water management (e.g.,
treatment) in between batches. The conditions that are used to produce sprouts allow
microorganisms, including those of public health significance, to grow. Using spent sprout irrigation
water from one production batch of sprouts to irrigate another production batch of sprouts can lead to
cross contamination between batches, multiplying the amount of product potentially exposed to any
contamination that may be present. Moreover, depending on the circumstances, such water may not
be safe and of adequate sanitary quality for its intended use, in which case the use would be
prohibited by § 112.41.
Separate from the requirements for agricultural water under Subpart E, we note that the requirements
in Subpart M for testing spent sprout irrigation water for Salmonella spp., E. coli O157:H7 (and any
other pathogen meeting the requirements of § 112.144(c)) apply to each individual production batch
of sprouts (§ 112.147). Re-using spent sprout irrigation water from one production batch of sprouts
to irrigate another production batch of sprouts does not relieve covered sprout operations of the need
to conduct required testing under § 112.147 for spent sprout irrigation water from each individual
production batch of sprouts (see Section VIII (Sampling and Testing of Spent Sprout Irrigation Water
or In-Process Sprouts)).
Similarly, we also recommend that sprout operations not reuse spent sprout irrigation water to
irrigate a single production batch of sprouts over time without any form of water management (e.g.,
treatment) in between uses. Reusing spent sprout irrigation water for subsequent irrigation of the
same growing unit on the same production batch of sprouts over time could reintroduce any
pathogens present in the water into the growing sprouts. Any pathogens that may be present in the
reused spent sprout irrigation water could then multiply to higher numbers during sprouting. For
“stationary” growing units in particular, this practice can also spread contamination that might have
otherwise been localized to one area of the growing unit (i.e., a “hot spot”) throughout the entire
production batch of sprouts. Moreover, depending on the circumstances, such water may not be safe
and of adequate sanitary quality for its intended use, in which case the use would be prohibited by §
112.41.
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Agricultural Water Testing Frequency, Sampling, and Test Methods

Covered sprout operations are required to test their agricultural water source(s) to ensure compliance
with the microbial quality criterion in § 112.44(a) if they use untreated ground water as agricultural
water (see Section VI.B above). In this circumstance, sprout operations are initially required to test
each such water source a minimum of four times throughout the growing season or over a period of
one year (§112.46(c)). If all four of the initial samples tested meet the microbial quality criterion in §
112.44(a), you may test once annually thereafter. You must resume testing at least four times per
growing season or year if any annual test fails to meet the microbial quality criterion in § 112.44(a).
Section 112.46(c) requires that all such samples be collected to be representative of the intended
use(s). By “representative of the intended use(s)” we mean collected from a location, and at a time,
such that the sample can reasonably be expected to represent the quality of the agricultural water
when it is used for the intended use(s).
With respect to timing, the timing of your sample collection should be reasonably related to the
timing of your agricultural water use(s) such that the sample can reasonably be expected to represent
the quality of the water when it is used. For example, a sprout operation that uses untreated ground
water for agricultural water uses only from April through August of each year should take its samples
during the part of the year that it is in production (April – August) so that the samples are
representative of the intended use(s). A sprout operation should assess its production schedule to
determine an appropriate sampling scheme for collecting the four initial samples.
With respect to location, sampling at the point of your actual use is ideal (e.g., sampling where water
comes out of a faucet or hose in your building and enters your sprout growing unit to be used for
irrigation water). You may also sample at other points along the water distribution system, from the
water source itself to the point of use, as long as there is no reasonably likely point of contamination
in the water distribution system between your chosen sampling point and the point of use, such that
the sample can reasonably be expected to represent the quality of the water when it is used. For
example, if untreated ground water is drawn from a well that is not under your control, you might
choose to collect samples from a point that is under your control, such as sampling from a valve on a
pipe at the edge of your property line. As another example, if the well is under your control, you
may choose to collect samples from the well head. In either case, such samples can be considered
“representative of the intended use(s)” (with respect to the location of the samples), provided that
there is no reasonably likely point of contamination in the water distribution system between your
chosen sampling point and the point of use, such that the sample can reasonably be expected to
represent the quality of the water when it is used. In compliance with § 112.42(a), you are required
to conduct an inspection of the agricultural water system, to the extent under your control, to identify
(among other things) reasonably likely points of contamination. This inspection is required at the
beginning of a growing season, as appropriate, but at least annually. This inspection should assist
you in selecting your sampling points by helping you determine what sampling locations are, or are
not, representative of your intended use(s).
Agricultural water samples to be tested for compliance with the § 112.44(a) microbial quality
criterion must be collected aseptically in accordance with § 112.47(b). Using the right materials and
equipment is particularly important to ensure the sample collection is conducted aseptically as
required under § 112.47(b). You must use sterile equipment and tools when collecting samples
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aseptically. Note that cleaning and sanitizing of sampling equipment is not equivalent to sterilization
(See Appendix 1 on Aseptic Sampling).
Agricultural water samples must be analyzed for compliance with the § 112.44(a) microbial quality
criterion using a method as set forth in § 112.151 (§ 112.47(b)). We reviewed EPA approved test
methods for water, and determined that EPA Method 1603 is appropriate for testing water quality for
this purpose (§ 112.151(a)).
However, we recognize that other scientifically valid analytical methods may be available or may
become available in the future. Therefore, we provide flexibility for covered farms to use any other
scientifically valid analytical method that is at least equivalent to the prescribed analytical method
(i.e., EPA Method 1603) in accuracy, precision, and sensitivity (§ 112.151(b)(1)). Any scientifically
valid method can be used, provided you ensure that the method is at least equivalent to the prescribed
analytical method in accuracy, sensitivity, and precision in detecting the relevant organism or
indicator (i.e., generic E. coli) in the relevant sample matrix (i.e., ground water). Covered farms are
not required to notify us or submit information about such methods of analysis for FDA’s review or
approval prior to use.

You should choose a laboratory that is qualified to test agricultural water for generic E. coli.
Testing is typically contracted to a third-party testing laboratory. Testing may also be performed
by a sprout operation’s own laboratory (e.g., an operation’s own “in-house” laboratory).
You should use a laboratory that employs scientifically valid laboratory methods and procedures that
can provide reliable, accurate test results. A laboratory conducting the tests on which you rely might
be, but is not required to be, accredited. Using an accredited laboratory (e.g., a laboratory accredited
to International Organization for Standardization (ISO) Standard 17025) is one way to have
confidence that a laboratory will provide reliable, accurate rest results. Regardless of which
laboratory you use, testing must be done using a method as set forth in § 112.151.
F.

Post-Harvest Water Management

Section 112.48(a) requires you to manage the water used during harvest, packing, and holding
activities for covered produce, including sprouts, as necessary, including by establishing and
following water-change schedules for re-circulated water to maintain its safety and adequate sanitary
quality and minimize the potential for contamination of covered produce and food-contact surfaces
with known or reasonably foreseeable hazards. Section 112.48(b) requires you to visually monitor
the quality of water that you use during harvest, packing, and holding activities for covered produce
(for example, water used for washing covered produce in dump tanks, flumes, or wash tanks, and
water used for cooling covered produce in hydrocoolers) for buildup of organic material. In addition,
under § 112.44(a), agricultural water applied in any manner that directly contacts covered produce
during or after harvest activities is required to meet the no detectable generic E. coli in 100 mL
microbial quality criterion. This requirement applies to the water as it is being added to a dump tank,
flume, or wash tank.

•

For example, in a sprout operation, these requirements apply to water used for washing and
cooling of sprouts. You must visually monitor the quality of water for buildup of organic
material (such as hulls and plant debris). If multiple production batches of sprouts use the
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•

same post-harvest water, we recommend that you visually check the quality of water prior to
adding each new production batch of sprouts.
We recommend that you change water used for post-harvest washes of sprouts as needed to
minimize the potential for cross-contamination. Your visual monitoring of the water should
provide you with relevant information. For example, you should change the water when you
observe buildup of organic material (this is likely to mean that you should change the water
multiple times a day), and/or between each production batch of sprouts).
In addition to changing post-harvest wash water for sprouts as needed, you should also
consider using a water treatment system as part of managing your post-harvest water. We
also recommend that such treatments, their delivery, and monitoring, follow the provisions in
§ 112.43.

VII. Seeds for Sprouting
The requirements in § 112.142 are directed at sprout operations to reduce the likelihood that seeds
serve as a vehicle for introducing contamination in sprouts. Specifically, under § 112.142(a), you
must take measures reasonably necessary to prevent the introduction of known or reasonably
foreseeable hazards into or onto seeds that you will use for sprouting. You must visually examine
seeds, and packaging used to ship seeds, for signs of potential contamination with known or
reasonably foreseeable hazards (§ 112.142(d)). You must take certain actions if you know or have
reason to believe a lot of seeds is contaminated with a pathogen (§§ 112.142(b)(1) and (2) (except in
a few specified circumstances as described in § 112.142(c)). Finally, you must use only seeds for
sprouting that have been treated using a scientifically valid method to reduce microorganisms of
public health significance (§ 112.142(e)). The seed treatment may be applied at your operation
and/or you may rely on prior treatment by another party, provided certain requirements are met (§
112.142(e)(2)).
This section of the guidance provides recommendations to help you comply with these requirements
for receiving, storing, and treating seeds for sprouting. As previously mentioned, throughout this
guidance, for the ease of the reader, we often refer collectively to everything sprouted to produce
sprouts for human consumption, including beans, simply as “seeds.” In the Rule, we used the phrase
“seeds or beans” to remove any potential confusion as to whether beans for sprouting were included.
References to “seeds” in this guidance should not be read to exclude other things that are sprouted to
produce sprouts for human consumption, such as beans.

Seed Receiving, Handling and Storage

Studies indicate that contaminated seed is the likely source of most sprout-related outbreaks (Ref. 2).
Seed contamination can occur at the seed farm, seed conditioner, seed supplier, or at the sprout
operation. The sprout growing process involves many opportunities for contamination in or on a few
seeds to spread through the entire sprout production batch.
Only a small portion of seed produced in the United States is destined for sprouting, while most is
used as planting stock to produce forages for livestock or for planting to grow human food (Ref. 2).
Although FDA encourages sprout operations to purchase seeds grown under Good Agricultural
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Practices (GAPs), this does not always occur. Therefore, some seeds are grown, milled, and/or
stored under conditions where contamination is likely to occur. Seed may become contaminated by
potential sources of fecal contamination, such as contaminated water, use of inadequately treated or
raw manure as fertilizer, contamination from wild or domesticated animals, or inadequate worker
hygiene. These conditions may contribute to the presence of human pathogens on seed for sprouting.
During harvest, seeds may also be exposed to a significant amount of dirt and debris. Localized
contamination may be spread throughout the harvested seed lot due to poor equipment sanitation
and/or inadequate worker hygiene. The subsequent steps of sorting, cleaning, storing, and packaging
of seeds at seed mills may further spread contamination, especially if GAPs are not followed.
Damage to the seeds may also contribute to the overall safety of the seeds; such damage may occur
inadvertently or deliberately (i.e., scarification). Cracks, crevices, and other types of damage to
seeds may facilitate the internalization of pathogens into seeds and aggravate contamination by
making it difficult to remove pathogens during subsequent treatment and handling (Ref. 2).
Post-harvest processing, handling, shipping, and storage of seeds also pose unique safety issues.
During these steps, seeds from multiple lots of different origins may be mixed together, providing
opportunity for cross contamination to occur, and complicating any necessary later traceback (Ref.
2). In many cases, the decision whether to direct seed to cultivation of other crops or to sprouting is
not made until after the seeds are harvested. Therefore, the seed grower may not know if the seeds
will be sold for sprouting, and may have little incentive to follow GAPs. We are aware that some
sprout seed suppliers seek assurances from the seed grower and handler that seeds were produced
under GAPs and handled according to food safety best practices throughout harvesting, conditioning,
storage, and transportation. Sprout operations can request this information from the entity which sells
their seeds. While not requirements of the Produce Safety Rule, we recommend these practices as
prudent when sourcing the seeds used for sprouting.

Seed receiving by a sprout operation

Because of the role contaminated seeds have played in numerous sprout-associated outbreaks, we
recommend that you take all the steps you reasonably can take to ensure you are buying and using
quality seeds for the sprouts you grow. As mentioned above, seed can become contaminated at any
point along the supply chain. We recommend that seeds for sprouting be grown under GAPs and that
they be conditioned and stored under sanitary conditions. Knowing your seed supplier(s) and
establishing specifications for the seeds you receive (such as being grown under GAPs and handled
under sanitary conditions during storage and distribution or transport) can help improve the safety of
the seeds you receive. Specifications also provide standards against which you can assess the
acceptability of the seeds you receive for the production of finished sprouts.
Once seeds arrive at your operation, you should verify that the transport vehicle was clean and
sanitary. You should also check the seed tag, package labeling and other documentation to ensure
the seeds are what you ordered, that they meet any specifications you may have established with your
seed supplier (such as microbial testing for pathogens or prior seed treatment if requested), and that
any information or documentation that you may plan to keep for your own records (such as
documentation of the seed lot number, or of prior treatment of seed) has been provided.

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We recommend you develop a seed receiving program setting out the standard operating procedures
(SOPs) you follow to receive and inspect seed upon receipt and the criteria you use in determining
whether to accept a shipment. As discussed above, we also recommend you establish specifications
in sourcing seeds to ensure only seeds that have been produced and handled in accordance with
GAPs are introduced to the sprouting environment. An example of a seed receiving and inspection
checklist can be found in the next section (Section VII.A.2. Visual Inspection of Seeds and Their
Packaging). Your seed receiving program should include specific procedures to handle any issues
identified while inspecting a shipment. Personnel who receive shipments of seeds should be trained
to inspect the incoming product and identify any concerns. Before receiving incoming seeds, you
should ensure they are from a known supplier and match the information on the purchase order. If a
shipment does not meet your pre-specified requirements, you should evaluate the deviation and,
based on your criteria for accepting seeds, determine whether the safety of the seed may be
compromised and whether the lot should be rejected.

Visual inspection of seeds and their packaging

Under the Produce Safety Rule, you must visually examine seeds, and packaging used to ship seeds,
for signs of potential contamination with known or reasonably foreseeable hazards (§ 112.142(d)).
Each bag should be examined for physical damage (e.g., holes from rodents) and signs of
contamination (e.g., stains, insects, feces, urine, or foreign material) upon arrival. This can be as
simple as using a black light to examine seed packaging for signs of rodent urine, and using a hand
held magnifying glass to examine seeds for small bits of rodent pellets, excessive dirt and debris, or
excessive damage. As mentioned above, damage to seeds can provide nooks and crannies for
pathogens to lodge in and make any treatment to reduce pathogens less effective.
A seed receiving and inspection checklist should include:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•

Verify Shipping information (e.g., truck conditions, shipping protection)
Verify supplier name and address on packages to see if they match those on purchase order
Verify date of shipping and amount
Obtain and verify seed specifications (e.g., seed type, code or lot number, origin, harvest
date, and conformance with GAPs)
Verify lot information (e.g., original lot size, trace-back information)
Check condition and size of bags
Inspect for evidence of tampering
Inspect for evidence of water damage
Note any strange or foul odor
Visually inspect for presence of insect, bird, or rodent droppings
Inspect for vermin urine using a black light
Check for damaged or moldy packages
Open one or several bags of seed and inspect for cracked or chipped seeds and the presence
of foreign materials in the seeds (e.g., mud balls, sticks, or glass)
Check seed testing record, if available, including lot number tested, name of laboratory, test
results, and details of tests performed (e.g., test method used, information to support
scientific validity of test method, date tested)
Check seed treatment record, if available
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•

•

Check letters of guarantee, certificates of conformance, or certificates of analysis, if
applicable (e.g., contractual agreements or statements from your seed supplier attesting to
whether the seeds were grown under GAPs, tested for human pathogens, or if a seed
treatment was applied)
Note any lots rejected due to evidence of contamination or for other reasons

This visual exam of seeds and their packaging upon receipt is one of the first steps you should take at
your operation to reduce the chance of seeds serving as a source of contamination in the sprouts you
produce. If you observe obvious signs of seed damage or contamination upon receipt, you should
report the information to the seed grower, distributor, supplier, or other entity from whom you
received the seed and return the shipment to the supplier, if you conclude the contamination occurred
prior to the seed arriving at your sprout operation. If you have reason to believe the contamination
occurred at your own sprout operation, you should evaluate your practices and conditions and
consider how best to prevent recurrence of the problem. This evaluation may lead you to identify
new measures you should take to prevent the introduction of hazards into seeds at your operation in
compliance with § 112.142(a). In both scenarios, you should also discontinue use of the affected part
of the seed lot, conduct intensified cleaning and sanitizing of any surfaces that may have become
contaminated (see Section V (Cleaning and Sanitizing)), and take any other actions necessary to
prevent reoccurrence of contamination.
In the event that your visual examination of seeds identifies contamination, you might consider, in
lieu of discontinuing use of the affected part of the seed lot, treating the affected part of the seed lot
with a process that is reasonably certain to achieve destruction or elimination of the most resistant
microorganisms of public health significance that are likely to occur in the seeds (we understand that
some in the industry may refer to such treatments as a “pasteurization step”). However, we note that
processes that meet this description are not currently commonly used in the sprouting industry. Such
processes are far more robust than seed treatments described in § 112.142(e), which typically only
reduce microorganisms of public health significance, rather than eliminate or destroy them. We do
not recommend relying on a seed treatment that does not eliminate or destroy pathogens as an
appropriate response to visual observations suggesting contamination of seed. For more information,
please see the seed treatment section (Section VII.B) of this document below.

Seed testing

Because microbial contamination in seeds, if present, is often at low population levels and not
uniformly distributed throughout a seed lot, such contamination is often difficult to detect (Ref. 2). If
you or your seed supplier tests a lot of seeds for pathogens, you should be aware that the absence of a
positive test result for pathogens does not mean that the lot of seeds is necessarily pathogen-free. We
consider testing spent sprout irrigation water (or in-process sprouts) from each production batch of
sprouts (see discussion in Section VIII. (Sampling and Testing of Spent Sprout Irrigation Water or
In-Process Sprouts) to be a much more reliable indicator than testing seed to determine whether the
sprouts, and the seeds used to produce the batch, are contaminated.
The Produce Safety Rule does not require microbial testing of seeds for sprouting by you or your
supplier. However, if you choose to conduct seed testing, we recommend that you develop and
implement a written sampling plan for collecting a representative sample, collect the sample
aseptically, and test the sample using a scientifically valid method. In addition, we recommend you
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develop, as part of such a plan, specific corrective actions that you will take in the event of a positive
test result. A positive test result for pathogen indicates that the lot of seeds is contaminated. In such a
case, you must take certain actions under § 112.142(b), including discontinuing use of that seed lot
for sprout production, except as provided for in certain limited circumstances in § 112.142(c).
One such circumstance is if you treat the lot of seeds with a process that is reasonably certain to
achieve destruction or elimination of the most resistant microorganisms of public health significance
that are likely to occur in the seeds (§ 112.142(c)(1)). We understand that some in the industry may
refer to such treatments as a “pasteurization step.” We note that processes that meet the description
in § 112.142(c)(1) are not currently commonly used in the sprouting industry. Such processes are far
more robust than seed treatments described in § 112.142(e), which typically only reduce
microorganisms of public health significance, rather than eliminate or destroy them. For more
information, see the seed treatment section (Section VII.B) of this document below. If you choose to
conduct such a treatment on your seed lot so that you may use those seeds for sprouting, we note that
you must still comply with the requirement in § 112.142(b)(2) to report the positive test result to your
seed grower, distributor, or supplier.
You are not required to take the steps set forth in § 112.142(b)(1) and (2) if you later reasonably
determine, through appropriate follow-up actions, that the lot of seeds is not the source of
contamination. We consider that there are very few circumstances in which § 112.142(c)(2) would
be applicable in the event there has been a positive pathogen test result in an incoming lot of seed,
however. It is also important to note that if a positive pathogen test result is obtained from a seed lot,
re-testing a new sample from the same seed lot and obtaining a negative result does not negate the
previous positive test result. In such a case, required follow-up actions must still be taken. If you
choose to test your seeds, or to have them tested, you or your supplier should follow a sampling plan
that includes collecting a sufficiently large amount of seeds from throughout the lot to increase the
chances of the sample actually reflecting seed throughout the lot and of detecting pathogens if they
are present.

Seed storage

Seeds can become contaminated during storage. Under the Produce Safety Rule, you must take
measures reasonably necessary to prevent the introduction of known or reasonably foreseeable
hazards into or onto seeds that you will use for sprouting (§ 112.142(a)).
Seeds you use for sprouting should be handled and stored in a manner that will prevent damage and
contamination. As mentioned in Section I of this guidance (Introduction), the Produce Safety Rule
does not address chemical or physical hazards. However, you have a responsibility to ensure that
your sprouts are not adulterated or misbranded under the FD&C Act and are in compliance with all
applicable laws. You should take whatever steps are necessary to also ensure your seeds do not
become contaminated with physical or chemical hazards.
Many pests are attracted to seeds, and these pests can serve as a source of, or vector for, spreading
contamination, especially when seeds are in storage. In order to prevent the introduction of known or
reasonably foreseeable hazards into or onto seeds that will be used for sprouting as required under §
112.142(a), you should store seeds in a protected manner. Your seed storage area should be clean,
dry, protected against pests and separate from the rest of your sprout operation. Your seed storage
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area should be an area dedicated for that use, and should not be used for sprout production or to store
equipment or other items such as personal items (see also § 112.126(a)(1)(ii), and Section IV
(Buildings, Tools and Equipment)). It should be inside a building of sound construction and in good
repair (see also §§ 112.143(a), 112.126, and Section IV (Buildings, Tools and Equipment)). You
should store seeds off the floor, away from walls and in proper storage conditions to prevent bacterial
growth and to facilitate pest control inspection. You should regularly inspect seed packaging,
containers, and the surrounding area to monitor for evidence of pests and you should have a pest
control program in place (see also § 112.128, and Section IV (Buildings, Tools and Equipment)).
You should store seed at an appropriate temperature and take steps to maintain proper humidity
levels.
Once the original seed packaging is opened, remaining seed should be stored in closed containers
with tight-fitting lids or otherwise protected from contamination. If you use containers other than
original packaging to hold seeds, these containers should be emptied, and their food contact surfaces
must be cleaned and sanitized prior to use (See § 112.143(b)). We recommend that they also be
cleaned and sanitized between uses (See Section IV (Buildings, Tools and Equipment) and Section V
(Cleaning and Sanitizing)).
Containers should also be labeled to maintain the identity of the seed lot and to indicate whether the
seeds have received prior treatment by a grower, supplier or distributor.
For seeds that have received prior treatment by the seed grower, distributor, or supplier, it is
important that you store these seeds under conditions that will prevent them from becoming
contaminated in compliance with § 112.142(a), particularly if you do not plan to re-treat the seeds
prior to sprouting. We recommend that seeds that received prior treatment be stored separately from
untreated seeds, in airtight, containers/packages that are as small as practicable to minimize the
number of times any particular container/package is opened and closed to remove seed from that
container (because each such event presents the possibility of contamination). If you reuse
containers/packaging, you must ensure that food contact surfaces on these containers are cleaned and
sanitized before contact with seeds used to grow sprouts (§ 112.143(b)). We recommend that you
also clean and sanitize their food contact surfaces in between each use.

Seed Treatment

Research indicates that seed contamination, when it occurs, may be at low levels, intermittent, or
unequally distributed within seed lots. However, even low levels of human pathogens on seed for
sprouting are a concern, due to the ideal growth conditions present during sprouting. There is some
evidence that sprout operations associated with outbreaks often did not apply seed treatments
correctly, consistently, or at all (Ref. 2). While treating seeds used for sprouting does not guarantee
pathogen-free sprouts, seed treatment has been shown to reduce the percentage of contaminated
batches (Ref. 18, Ref. 19, Ref. 20, Ref. 21, Ref. 22). Therefore, seed treatment is a critical part of a
multi-hurdle approach to reduce the public health risks associated with sprouts.
The Produce Safety Rule requires that the seeds you use to grow sprouts be treated using a
scientifically valid method to reduce microorganisms of public health significance (§ 112.142(e)).
We use the term “scientifically valid” to mean an approach that is based on scientific information,
data, or results published in, for example, scientific journals, references, textbooks, or proprietary
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research. To meet the seed treatment requirement, you must adopt one of the following two
approaches:
•
•

Treat seeds that will be used to grow sprouts using a scientifically valid method to reduce
microorganisms of public health significance (§ 112.142(e)(1)), or
Rely on prior treatment of seeds conducted by a grower, distributor, or supplier of the seeds
(whether to fulfill this requirement completely or for the purpose of considering such prior
treatment when applying appropriate additional treatment of the seeds at the covered farm
immediately before sprouting), provided that you obtain documentation (such as a Certificate
of Conformance) from the grower, distributor, or supplier that: (i) The prior treatment was
conducted using a scientifically valid method to reduce microorganisms of public health
significance; and (ii) The treated seeds were handled and packaged following the treatment in
a manner that minimizes the potential for contamination (§ 112.142(e)(2)).
1.

Choosing a seed treatment

A successful seed treatment should reduce microbial pathogens while preserving seed viability,
germination, and vigor. Seed types can vary in sensitivity to antimicrobial agents and other types of
treatments, which can affect treatment efficacy and how well the seeds germinate and grow after
treatment. The varying surface features of different types of seeds can influence how well a
treatment can access and inactivate pathogens on or in the seed. Therefore, an antimicrobial
treatment that is effective for one type of seed may not be as appropriate for other types.
When reviewing the options available for seed treatment, especially if you plan to treat seeds at your
operation (as opposed to, or in addition to, purchasing pre-treated seeds), you should consider the
feasibility of correctly applying the treatment at your operation. For example, irradiation 2 is an
option for seed treatment to reduce microorganisms of public health significance that may not be
feasible for a sprout operation to apply on-site. In addition, hot water treatments have been
demonstrated to reduce pathogens on seeds by more than 5 log CFU/g in one study (Ref. 23) and to
undetectable levels in another (Ref. 24). However, these treatments can require use of equipment
such as industrial-sized hot water pasteurization machines (Ref. 25) that might be cost prohibitive for
a small sprout operation.
Nothing in part 112 requires or authorizes farms to take measures in conflict with existing federal,
State, or local regulations. We expect any seed treatment that is used to be applied in accordance
with all applicable federal, State, tribal, or local requirements. For example, in compliance with
FIFRA, pesticide chemicals used as seed treatments must be registered with the EPA and labeled for
2

21 CFR § 179.26(b)(10) allows seed for sprouting to be treated with ionizing radiation up to a maximum dose of 8
kGy We note that the codified language in the regulation states “seeds,” but for the purposes of the regulation, the
FDA recognizes that beans for sprouting (e.g., mung bean seeds used for sprouting) would also be included. For
information about the use of non-ionizing sources of radiation (such as UV light, radio frequency, microwaves, and
pulsed light) we refer the reader to 21 CFR Part § 179 more generally. We note that while seeds that have been
treated with ionizing radiation must be labeled with a radura symbol along with either the statement “Treated with
radiation” or the statement “Treated by irradiation,” sprouts that are grown using irradiated seeds need not be so
labeled where the sprouts themselves have not been irradiated (see 21 CFR § 179.26(c)(2); 65 FR 64605, at 64606-7
(Oct. 30, 2000)).

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use to reduce microorganisms of public health significance on seeds for sprouting. Unlike pesticide
chemicals, pest control devices that work by physical means (e.g., heat) and are classified by EPA as
“pesticide devices” do not require registration by EPA under FIFRA (Ref. 26). Sources of radiation
used to treat food are considered food additives under the law and require an authorizing regulation
by the FDA. Note also that some States require registration of pesticide devices, and we refer you to
the appropriate State pesticide regulatory agency for more information on a particular State’s
requirements related to pest control devices (Ref. 27).
Rather than establishing a specific type or method of seed treatment that you must use to treat seeds,
the Produce Safety Rule allows the use of any scientifically valid method to reduce microorganisms
of public health significance on seeds that you use to grow sprouts (§ 112.142(e)). This approach
provides flexibility in choosing a seed treatment. In choosing a treatment(s) appropriate to your
operation and sprouts, and in compliance with the Produce Safety Rule, there are a number of things
to consider. In this guidance, we highlight certain treatments that have been studied in the literature
and discuss important considerations related to using certain treatments.
Known seed treatment methods include those that work by chemical means (liquid or gas), physical
means, or a combination of these. Based on a review of available literature, physical and
combination style treatments have been reported to be the most effective for removing pathogens
from seeds for sprouting. Physical treatments, such as heat (dry heat or hot water), high pressure,
and ionizing radiation (herein referred to as “irradiation”) are reported to have better penetration
characteristics for reaching bacteria on microscopically rough surfaces as well as the interior of the
seed as compared to chemical treatments (Ref. 28). In some studies, physical treatments have been
reported to achieve a 5-log or greater reduction in pathogens on seeds (Ref. 25, Ref. 28, Ref. 29, Ref.
30). Combination methods applying two or more methods sequentially or simultaneously may be
more effective than using a single treatment alone. Examples of such combination treatments
include: Chemical plus heat; irradiation plus dry heat; and high pressure plus dry heat. Literature
suggests many combination treatments may be able to achieve 5-log or greater reduction in
pathogens on seeds (Ref. 25, Ref. 28, Ref. 29, Ref. 30, Ref. 31, Ref. 32).
As mentioned above, chemical pesticides used as seed treatments must be registered with the EPA
and labeled to reduce microorganisms of public health significance on seeds for sprouting in
compliance with FIFRA. Previous studies suggest the following chemicals, when used at appropriate
concentrations, may be able to achieve at least a 3-log reduction of pathogens. We note, however,
that such treatments require EPA approval and registration under FIFRA before they may be used for
such purposes: Acidified sodium chlorite (Ref. 33), calcium hydroxide (Ref. 34), calcium
hypochlorite 3 (Ref. 28), caprylic acid (Ref. 35), gaseous acetic acid (Ref. 36), (Ref. 37), hydrogen
peroxide (Ref. 34, Ref. 38), lactic acid (Ref. 32), monocaprylin (Ref. 35), oxalic acid (Ref. 32), and
phytic acid (Ref. 32). Moreover, we note that this is not intended to be an exhaustive list.

Seed treatment efficacy

In our prior sprouts guidances, we cited a 20,000 ppm calcium hypochlorite treatment as an
example of a seed treatment. The EPA registration for this treatment has since been updated and we
refer readers to EPA for further information.
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Many seed treatments reduce, but do not eliminate or destroy, microorganisms of public health
significance that may be present on the seeds. Pathogens that are not eliminated by seed treatment
could potentially be amplified during the sprouting process; therefore, seed treatment prior to
sprouting is a key component of the multi-hurdle risk reduction framework established in the
Produce Safety Rule.
We recommend sprout operations use the most efficacious seed treatment available to reduce the
presence of microorganisms of public health significance on seeds for sprouting, with primary
consideration given to reduction of Salmonella spp. and E. coli O157:H7. We are aware of several
existing treatments that have been reported to achieve a 4 or 5-log (or greater) reduction of
microorganisms of public health significance on seeds for sprouting, when used under the parameters
specified in the literature (Ref. 25, Ref. 28, Ref. 29, Ref. 30):
•
•
•

Heat, including dry heat and hot water (Ref. 39)
High pressure
Irradiation + Dry heat

Certain chemical treatments, including gaseous acetic acid, lactic acid, phytic acid, oxalic acid, and
sodium hypochlorite have also been reported to achieve a 4 or 5-log (or greater) reduction in
microorganisms of public health significance on seeds for sprouting (Ref. 28, Ref. 32); we note,
however, that such treatments require EPA approval and registration under FIFRA before they may
be used for such purposes. We refer readers to EPA for further information. Information regarding
current EPA registered pesticide products is available on EPA’s Web site at:
https://iaspub.epa.gov/apex/pesticides/f?p=PPLS:1.
A prudent sprout operation would not rely only on a treatment that achieves a low level of reduction
if other, more effective, treatments are available. We understand that a 3-log reduction is the
minimum level of reduction of pathogens the EPA will consider to register an antimicrobial
treatment that includes a public health claim on seeds. Using the most efficacious seed treatments
available is expected to greatly reduce the likelihood of producing contaminated sprouts. As an
additional benefit to sprout operations, doing so is also expected to help minimize the time and
resources you invest in producing a batch of sprouts that is later determined to be contaminated
through routine testing required under § 112.147 (and which must be discarded as a result, as
required under § 112.148).

a. Other considerations when evaluating seed treatment efficacy
The validity and efficacy of any treatment is dependent on the specific parameters used, e.g., seed
type, treatment concentration, treatment time, temperature, pressure, or radiation dose. Sprout
operations should carefully monitor these and other variables that impact the overall efficacy of the
treatment, including, for example, for most chemical treatments, the seed-to-treatment solution ratio
and pre- and post-treatment rinsing. If you are utilizing a seed treatment described in scientific
literature, you should take into account the parameters used in the study and determine whether they
are compatible with how you will be applying the treatment at your operation. For example, if the
treatment you are considering has only been tested on alfalfa seeds, and you plan to use the treatment
on mung beans, you should not assume that the treatment will be equally efficacious at reducing
microorganisms of public health significance on mung beans. Additionally, you should pay attention
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to any special equipment that is used to apply the seed treatment as it is described in the literature.
For example, hot water seed treatment using a seed pasteurizing system (Ref. 25) would not be
equivalent to boiling seeds in hot water on a kitchen stove, because the seed treatment machine has
built in temperature control mechanisms that are validated, self-correcting, and time-controlled while
a kitchen stove does not.
To ensure seed treatments are consistently applied correctly, if you treat seeds at your sprout
operation, you should develop a written seed treatment Standard Operating Procedure (SOP). The
SOP should include: objectives, methods used, who is responsible for each task, materials needed,
treatment procedures, parameters to be measured or monitored, and relevant records to be made (in
compliance with the requirements of § 112.150(b)(1) and otherwise). All plans should be tailored to
what is actually done in your operation.

Using pre-treated seeds

There are several seed treatment methods that can be effectively applied by a grower, handler, or
distributor of seeds such that, when followed by good handling and packaging practices, they can
eliminate the need for you to treat seeds at your operations immediately before sprouting. However,
using pre-treated seeds does not preclude you from treating the seeds again at your own operation.
The availability of various options for seed treatment (e.g., by you, your seed supplier, or both) has
several benefits, including increased flexibility for you and increased availability of treatment options
that may be cost-prohibitive to some small sprout operations. We encourage sprout operations who
choose this option to purchase seeds that have been treated with the most efficacious method
available.
We note that sprout operations who choose to purchase seeds that have been pre-treated with ionizing
radiation should be aware that if those same seeds are to be treated again with ionizing radiation, the
cumulative dose must not exceed the maximum dose as indicated in § 179.26(b)(10).
If you choose to rely, in whole or in part, on using pre-treated seeds, you must obtain documentation
from your seed supplier that the treatment was conducted using a scientifically valid method to
reduce microorganisms of public health significance (§ 112.142(e)(2)(i)) and that the treated seeds
were handled and packaged, following the treatment, in a manner that minimizes the potential for
contamination (§ 112.142(e)(2)(ii)). We recommend that you obtain documents of this type from
your supplier that are specific to each lot of seeds you receive from that supplier. One such type of
document you may obtain is a Certificate of Conformance. Such a certificate (or other forms of
documentation used for this purpose) should include documentation of the scientifically valid method
used to treat the seeds, the level of log reduction achieved, the type of seeds used for any validation
study that may have been done, and the pathogens targeted. We also recommend that if water was
used to prepare treatments for the seeds, you should obtain documentation or assurances from your
supplier that the water used for treating seeds meets the microbial quality criteria in § 112.44(a) (0
detectible generic E. Coli in 100 mL water).

Proprietary treatments

The Produce Safety Rule does not prohibit the use of proprietary seed treatments (e.g., treatments
developed based on a firm’s own scientific research not published in scientific literature). However,
we expect any seed treatment that is used to be applied in accordance with all applicable federal,
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State, tribal, or local requirements. If you (or your seed supplier) use a proprietary treatment, then
we expect you (or the party who applies the treatment) to take all necessary steps to ensure that it is
in compliance with all relevant laws, including the FIFRA, if applicable, and that the treatment is
effective in reducing pathogens on seeds. If you rely on treatment conducted by a seed supplier, you
must obtain documentation (such as a Certificate of Conformance) from that supplier that the
treatment was conducted using a scientifically valid method to reduce microorganisms of public
health significance (§§ 112.142(e)(2)(i) and 112.150(b)(1)). We recommend that in such
circumstances, you ask your seed supplier for a written explanation of the treatment parameters that
were applied, and the basis for the conclusion that the treatment is scientifically valid. In the event of
an investigation or inspection of your sprout operation, we may ask to review the science supporting
the seed treatment(s) you rely on, including proprietary treatment(s), to ensure it is scientifically
valid.

Additional considerations for treating seeds for sprouting

If you treat seeds for sprouting at your sprout operation, you should take steps to ensure that the seed
treatment(s) is applied correctly and that the treatment of seeds does not result in contamination of
food or food contact surfaces.
Seed treatment should take place in a clean location, separate from areas used for storage for seeds
and areas used for sprout germination and packing (See also § 112.126(a)(1)(ii) and Section IV
(Buildings, Tools and Equipment)). You must visually examine seeds, and packaging used to ship
seeds, for signs of potential contamination (§ 112.142(d)). As discussed in Section VII.A.2 above,
we recommend that you do this upon the seeds’ arrival at your operation. We also recommend that,
if you have stored the seeds for any length of time after their arrival at your operation and prior to
sprouting, before bringing seeds into the treatment area, you should re-inspect bags of seeds for signs
of contamination. Before you treat seeds, any containers or utensils that will come into contact with
the seeds as part of the treatment process must be cleaned and sanitized (§ 112.143(b)).

a. Employee practices
Employees who conduct seed treatment at your operation should receive appropriate training for the
job, and should be supervised in a manner that ensures that they follow the established treatment
procedures (e.g., label instructions, SOPs).

b. Pre-germination seed rinse and soak
Seeds are typically rinsed before treatment. While the Produce Safety Rule does not require pretreatment rinsing, we recommend that seeds be rinsed thoroughly before treatment to reduce
microorganisms of public health significance, to remove dirt, and to increase the efficiency of the
treatment. If you do rinse seeds before treatment, you should repeat the rinsing process with new
water until most of the dirt is removed and rinse water runs clear. We also recommend that you
conduct your rinse in such a way as to maximize seed surface contact with water (e.g., by mixing or
agitating). If a surfactant is used to help remove soil and debris during seed rinsing, it should be
rinsed out completely before the next step.
Soaking causes seeds to swell and softens hulls to allow the sprout to grow out of the seed.
Depending on your production practices and the type of seeds you use, a pre-germination soak may
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be necessary to improve germination. Pre-germination soaking is not required by the Produce Safety
Rule.
If you do rinse or soak seeds, water used for these purposes must meet the microbial quality criterion
in § 112.44(a) (i.e., no detectable generic Escherichia coli (E. coli) in 100 milliliters (mL) of water),
and related requirements elsewhere in Subpart E, because such water contacts FCSs (surfaces of the
rinse or soak container that also contact seeds used for sprouting) during the covered activity of
growing covered produce (sprouts) (See § 112.44(a)(3)); see also Section VI. (Agricultural Water in
Sprout Operations)). This includes water used for any additional post-soaking rinses of seeds that
you may conduct, for example, to remove residues generated during soaking.
In addition, if you do rinse or soak seeds, you must clean and sanitize the FCSs of your tools and
equipment before they contact the seeds (§ 112.143(b); see also Section V. (Cleaning and
Sanitizing)). These are FCSs used during the covered activity of growing covered produce (sprouts).
In addition, if you do rinse or soak seeds, you must take any other measures that are reasonably
necessary to prevent the introduction of known or reasonably foreseeable hazards into or onto the
seeds during that process (§ 112.142(a)).
We recommend that sprout operations not rinse or soak large quantities of seed together, but instead,
to minimize the possibility of cross-contamination, rinse or soak in a single container only the
amount of seed that will be used in a single production batch of sprouts. Containers used to rinse or
soak seeds should be large enough to allow thorough mixing without splashing. Personnel should
either wear a new pair of disposable or clean reusable gloves, or have clean hands, when pouring
seeds into the container. We recommend that you change the water each time you change the seeds
you are rinsing or soaking (e.g., for the seeds for each new production batch of sprouts).

c. Chemical seed treatment
If applying a chemical seed treatment, you should use clean, appropriately labeled containers when
mixing the treatment chemicals to the desired concentration, and the treatment should be prepared
correctly to ensure the chemical is present at the desired concentration. You should determine the
volume of chemical needed based on the weight of the seeds to be treated. You should refer to the
chemical label instructions to calculate the amount of chemical needed to achieve the desired
concentration and volume of the treatment solution. If water is used, you should use a scale to weigh
dry chemicals, and then add them to a container that already contains the appropriate amount of
water. Water used for mixing such solutions must meet the microbial quality criterion in § 112.44(a)
(see Section III.A (General Sprout Production)). The solution should be stirred to mix it completely
and dissolve all solids. After mixing, you should verify the treatment solution concentration
according to the label directions, since the concentration can impact treatment effectiveness.
Once the chemical treatment is prepared, you should carefully combine it with the seeds. You should
agitate the seeds and the chemical treatment at the correct temperature and for the appropriate
amount of time according to any seed treatment SOP you may have established, and the chemical’s
label instructions. It is important to use the correct amount of treatment for a known quantity of
seeds; too much seed and/or too little chemical will decrease the effectiveness of the treatment. The
same batch of seed treatment solution should not be used on seeds used to produce more than one
production batch of sprouts; you should prepare a new treatment before each application. For
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chemical treatments prepared as a solution, you should drain the chemical solution and dispose of it
according to label directions and all applicable federal, state, and local requirements after completing
the treatment. You should rinse seeds thoroughly to remove any residual treatment if necessary.

Corrective Actions for Seeds That May Be Contaminated With a Pathogen

If you learn that a lot of seeds has been associated with foodborne illness, or if you learn that a lot of
seeds may be contaminated with a pathogen based on microbial test results (including that required
under § 112.144(b)), you have certain duties with respect to that seed lot and sprouts grown from that
seed lot under § 112.142(b).
Section 112.142(b) requires that in such circumstances, except as provided in § 112.142(c), you must
discontinue use of all seeds from that lot for sprout production (§112.142(b)(1)), must ensure that
sprouts grown from that lot of seeds do not enter commerce (§112.142(b)(1)), and must report the
information to the seed grower, distributor, supplier, or other entity from whom the seed was
purchased (§112.142(b)(2)).
It is important for you to report the findings to the entity (seed grower, distributor, or supplier) that
supplied the seeds, so that entity could then take appropriate follow-up actions. These actions
include informing other buyers of the suspected lot of seeds regarding the contamination, destroying
or diverting any remaining seeds to non-food uses, and/or investigating the potential source of
contamination, as necessary. Additionally, the seed grower, distributor, or supplier may be required
to submit a report to the Reportable Food Registry (RFR), which requires food facilities to report
certain information to the FDA when there is a reasonable probability that the use of, or exposure to,
an article of food will cause serious adverse health consequences or death to humans or animals.
Depending on the circumstances, it may also be appropriate to recall sprouts that have already
entered commerce that were produced from the affected seed lot. Any sprouts that are adulterated
should be voluntarily recalled.
When your belief that a lot of seeds may be contaminated is based only on microbial test results, you
would not have to take the steps described in §112.142(b)(1) (discontinue use of the suspect lot of
seeds and ensure sprouts made from them do not enter commerce) if you treat the suspect lot with a
process that is reasonably certain to achieve destruction or elimination of the most resistant
microorganisms of public health significance that are likely to occur in the seeds (§112.142(c)(1)).
This option exists to allow sprout operations flexibility in responding to a finding that would
otherwise mean they would have to discontinue use of the seeds and to encourage future innovation
in seed treatment processes. Processes that meet the description in §112.142(c)(1) are not, at this
time, commonly used in the sprouting industry. Such processes are far more robust than seed
treatments described in §112.142(e), which typically only reduce microorganisms of public health
significance, rather than eliminate or destroy them. If a sprout operation opts to use irradiation to
meet the requirements of § 112.142(c)(1), it is essential to use a level of irradiation that is reasonably
certain to achieve destruction or elimination of the most resistant microorganisms of public health
significance that are likely to be in the seeds (we note that not all levels of irradiation can achieve
this).
Moreover, when the reason for believing the lot of seeds may be contaminated is based only on
microbial test results, if you reasonably determine, through appropriate follow-up actions, that the lot
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of seeds is not the source of contamination, you do not have to take the steps in § 112.142(b)(1) or
(2). That is, you are not required to discontinue use of that seed lot and ensure that sprouts grown
from that lot do not enter commerce (§ 112.142(b)(1)), nor do you need to inform the seed grower,
distributor or supplier of the positive test result (§ 112.142(b)(2)). However, we expect that the
situations in which you could take follow-up actions that would be adequate to reasonably determine
that the lot of seeds was not the source of contamination are not extensive. Two examples of
scenarios in which we believe such a determination might be appropriate are described below.
Examples of Possible Scenarios and Follow-Up Corrective Actions
1. Seed lot A is recalled by the seed supplier due to contamination with Salmonella while an
operation has sprouting in process with that seed lot. The sprout operation immediately stops
production of sprouts using seed lot A, disposes of the sprouts and returns unused seed to the
distributor. The sprout operation cleans the equipment and starts using the same equipment
to grow another batch of sprouts using seed lot B. Seed lot B was purchased from a different
seed supplier that sources their seed from a different farm compared to seed lot A. Spent
sprout irrigation water from the next production batch of sprouts using seed lot B then tests
positive for Salmonella, and follow-up sample analysis shows this to be the same Salmonella
serotype that was identified as contaminating seed lot A. The sprout operation discovers that
cleaning and sanitizing protocols were not followed properly following sprout production
using seed lot A, and swabs the equipment and finds a matching Salmonella serotype on the
equipment that had been used to sprout both seed lots A and B. After adequately and
thoroughly re-cleaning and sanitizing the equipment and re-testing food contact surfaces for
Salmonella with negative results, the sprout operation starts a new production batch of
sprouts using seed lot B as a follow-up action to the positive test result to determine whether
seed lot B may also be contaminated. The second time, all spent sprout irrigation water tests
from seed lot B sprouts come back negative. In this circumstance, the sprout operator could
reasonably conclude that seed lot A had contaminated the equipment, which was not initially
adequately cleaned and sanitized and therefore contaminated the first batch of sprouts
produced from seed lot B. If the farm is following appropriate follow-up sanitation
procedures, and spent sprout irrigation water from seed lot B is no longer testing positive for
Salmonella, under these circumstances the farm may reasonably conclude that seed lot B was
not the source of contamination that generated the positive test result when testing spent
sprout irrigation water from seed lot B sprouts. We note that in general a negative test for
seeds or spent sprout irrigation water would not, by itself, be enough evidence that seed lot B
was not contaminated. However, in this example, the seed supplier’s Salmonella serotype
result from seed lot A that matches serotype found in the positive spent sprout irrigation
water sample and the swab from equipment used to sprout seed lot B, combined with the
different supplier and farm source for seed lot B as compared to seed lot A, improper
cleaning and sanitizing of equipment, negative subsequent test results, and the intervening
improvements in cleaning procedures, supports the conclusion that the positive spent sprout
irrigation water sample from sprouts made with seed lot B was most likely due to
contamination of shared production equipment with seed lot A.
2. A sprout operation mixes two seed lots (lot A and B) together to result in a mixed sprout
product for which the spent sprout irrigation water tests positive for Salmonella. The sprout
operation could sprout each seed lot individually. If upon follow-up serotype sample
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analysis, spent sprout irrigation water from only one seed lot (lot A) tests positive for
Salmonella matching the original positive, the sprout operation could reasonably determine
that seed lot A was the source of the Salmonella positive in spent sprout irrigation water from
the mixed seed sprouts. The sprout operation would be required to discontinue use of all
seeds from the affected seed lot for sprout production (unless it treats the seed lot in
accordance with § 112.142(b)(1)), ensure that sprouts grown from that seed lot do not enter
into commerce, and report the information to the grower, distributor, supplier, or other entity
from whom the farm received the seeds, in compliance with § 112.142(b). Under §
112.142(c), the sprout operation could continue to use seed lot B, provided there were no
subsequent positive test results and no information suggesting association of that seed lot
with foodborne illness.
In the event that your sprouts are associated with foodborne illness, you are required to discontinue
use of all seeds from the affected lot for sprout production and ensure that sprouts grown from that
lot of seeds do not enter commerce (§ 112.142(b)(1)), and you must report the information (i.e.,
association of the seed lot with illness) to your grower, distributor, supplier, or other entity from
whom you received that seed lot (§ 112.142(b)(2)). We are not aware of actions that a sprout
operation could take to demonstrate that the lot of seeds was not the source of contamination
following an outbreak of foodborne illness. The sprout operation, along with regulators, may make a
determination that the farm’s seeds were not associated with a foodborne illness outbreak, but it is
unlikely that the sprout operation would have adequate information and records (e.g.,
epidemiological data and traceback information) to make that determination independently.
Therefore, the Produce Safety Rule does not provide a similar option to § 112.142(c) applicable in
instances where there is knowledge or reason to believe that a lot of seeds has been associated with
foodborne illness, and, therefore, in such circumstances you must take the actions required in §§
112.142(b)(1) and (2).
We restate, as a summary, different scenarios regarding corrective actions for seeds that may be
contaminated with a pathogen below.
Scenario 1:
•
•

A lot of seeds is associated with foodborne illness (e.g., you learn that a lot of seeds is
implicated in an outbreak); or
A lot of seeds is recalled by the supplier, grower, distributor, or other entity because of
possible contamination with a pathogen (i.e., you learn of a recall of a lot of seeds due to
association with foodborne illness or positive microbial test results)

Required Actions:
•
•
•

Discontinue use of all seeds from that lot for sprout production (§ 112.142(b)(1)).
Ensure that sprouts grown from that lot of seeds at the sprout operation do not enter
commerce (§ 112.142(b)(1)).
Report the information (association with illness or positive microbial test results) to the seed
grower, distributor, supplier, or other entity from whom you received the seeds (§
112.142(b)(2)).

Additional Actions:
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•
•
•

We recommend that you return the affected lot of seeds to the supplier, grower, distributor, or
other entity from which they were purchased.
We recommend that you clean and sanitize the affected surfaces (i.e., those that may have
contacted the seeds that were associated with illness) and surrounding areas, and perform any
other actions necessary to prevent reoccurrence of the contamination.
Depending on the circumstances, it may be appropriate to recall sprouts that have already
entered commerce that were produced from the affected seed lot. Any sprouts that are
adulterated should be voluntarily recalled.

Scenario 2:
•

Positive microbial test result finding a pathogen in seeds.

Required Actions:
•

Except as provided by § 112.142(c):
o Discontinue use of all seeds from the affected lot for sprout production (§
112.142(b)(1));
o Ensure that sprouts grown from the affected lot of seeds do not enter commerce (§
112.142(b)(1)); and
o Report the information (microbial test findings) to the seed grower, distributor,
supplier, or other entity from whom you received the seeds (§ 112.142(b)(2)).

Additional Actions:
•

•

We recommend that you return the affected lot of seeds to the supplier, grower, distributor, or
other entity from which they were purchased, or, as provided in § 112.142(c)(1), you have
the option to treat the lot of seeds with a process that is reasonably certain to achieve
destruction or elimination of the most resistant microorganisms of public health significance
that are likely to occur in the seeds (may be referred to as a “pasteurization step”). However,
we note that processes that meet this description are not currently commonly used in the
sprouting industry. Such processes are far more robust than seed treatments described in
§112.142(e), which typically only reduce microorganisms of public health significance,
rather than eliminate or destroy pathogens. If you treat the affected lot of seeds with a
process described in § 112.142(c)(1), you are not required to take the steps described in §
112.142(b)(1). You are still required to report the information about the positive test result to
your supplier under § 112.142(b)(2).
As provided in § 112.142(c)(2), if you reasonably determine, through appropriate follow-up
actions, that the lot of seeds was not the source of contamination, you are not required to take
the steps described in §§ 112.142(b)(1) and (2). We note, however, that it is unlikely
§112.142(c)(2) could be satisfied in the event of a positive seed pathogen test result.
Depending on the circumstances, it may also be appropriate to recall sprouts that have
already entered commerce that were produced from the affected seed lot. Any sprouts that
are adulterated should be voluntarily recalled.

Scenario 3:
•

Positive microbial test result finding a pathogen in spent sprout irrigation water or sprouts
(i.e., positive results from pathogen testing required under § 112.144(b); see also Section VIII
(Sampling and Testing of Spent Sprout Irrigation Water or In-Process Sprouts)
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Actions Required:
•

Except as provided by § 112.142(c):
o Discontinue use of all seeds from the affected lot for sprout production (§§
112.142(b)(1); 112.148(b));
o Ensure that sprouts grown from the affected lot of seeds do not enter commerce (§§
112.142(b)(1); 112.148(b)); and
o Report the information (microbial test findings) to the seed grower, distributor,
supplier, or other entity from whom you received the seeds (§§ 112.142(b)(2);
112.148(b)).

•

Take appropriate action to prevent any food that is adulterated under section 402 of the
FDCA from entering into commerce (§ 112.148(a));
Clean and sanitize the affected surfaces and surrounding areas (§ 112.148(c)); and
Perform any other actions necessary to prevent reoccurrence of the contamination (§
112.148(d)).

•
•

Additional Actions:
•

•
•

•

We recommend that you return the affected lot of seeds to the supplier, grower, distributor, or
other entity from which they were purchased, or, as provided in § 112.142(c)(1), you have
the option to treat the lot of seeds with a process that is reasonably certain to achieve
destruction or elimination of the most resistant microorganisms of public health significance
that are likely to occur in the seeds (may be referred to as a “pasteurization step”). However,
we note that processes that meet this description are not currently commonly used in the
sprouting industry. Such processes are far more robust than seed treatments described in
§112.142(e), which typically only reduce microorganisms of public health significance,
rather than eliminate or destroy pathogens. If you treat the affected lot of seeds with a
process described in § 112.142(c)(1), you are not required to take the steps described in §
112.142(b)(1). You are still required to report the information about the positive test result to
your supplier under § 112.142(b)(2).
You should also conduct an assessment to determine whether or not the seed lot(s) used was
the source of the contamination.
As provided in § 112.142(c)(2), if you reasonably determine, through appropriate follow-up
actions, that the lot of seeds was not the source of contamination, you are not required to take
the steps described in §§ 112.142(b)(1) and (2). We expect, however, that the situations in
which you could take follow-up actions that would be adequate to make a reasonable
determination that the lot of seeds was not the source of the contamination are not extensive.
See examples discussed above.
Depending on the circumstances, it may also be appropriate to recall sprouts that have
already entered commerce that were produced from the affected seed lot. Any sprouts that
are adulterated should be voluntarily recalled.

Recordkeeping

We recommend that you establish and keep sufficient records to allow you to maintain the lot
identity of the seeds you receive and the sprouts you produce, by which we mean that you should be
able to determine which seed lot was used to grow each production batch of sprouts, and which
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container(s) of seed belong to one lot in the event that corrective actions need to be taken. For each
seed lot, your records should allow you to determine the identity of the supplier, variety, date of
receipt, batch or lot number of the seed that you received (including all identifying numbers assigned
to the seed, both by the supplier and by your operation, if different), and the date(s) that you used the
seed from that lot for sprouting. This will facilitate trace back to your seed supplier and (when
possible) to the seed grower as needed. Maintaining records that provide traceability by connecting
each production batch of sprouts to the lot of seeds used to grow them can help minimize the scope
of product potentially affected in the event of a problem with a particular production batch of sprouts
or a particular lot of seeds. We recommend that you maintain such records related to each lot of
seeds for at least two years after the last use of the seed lot.
When receiving seeds, you should make sure each bag of seeds (or other container) is clearly marked
in a way that allows you to maintain the identity of the seed lot, and if received bags or containers are
not already so marked, you should mark them as needed.
A seed receiving log documenting seed lot receipt and inspection will help you document your seed
receiving procedures and facilitate an effective trace-back if necessary. We recommend you use a
seed receiving and inspection checklist (see Section VII.A.2 (Visual Inspection of Seeds and their
Packaging)) in part to help you generate useful records such as those described here. We recommend
that, for all incoming seed shipments, you record and/or otherwise maintain the information in your
seed receiving and inspection checklist in writing.
If the sprout operation is providing the required treatment of seeds used for sprouting (§
112.142(e)(1)), documentation of this treatment is required (§112.150(b)(1)). Like all records
required by the Produce Safety Rule, seed treatment records must comply with all applicable
requirements for records in Subpart O of Part 112 (see Section X (Recordkeeping)). For example,
they must:
•

•
•
•
•

include actual values and observations obtained during monitoring (§ 112.161(a)(1)(ii)) (i.e.,
observations of treatment conditions and key parameters monitored during preparation and
application of treatments (e.g., chemical composition, heating temperature, equipment used,
concentration or strength of treatment, treatment time, pH of the treatment solution,
agitation));
include the date and time of the activity documented (§ 112.161(a)(1)(v)) (i.e., the date and
time the treatment was applied);
be created at the time an activity is performed or observed (§112.161(a)(2)) (i.e., they must
be created at the time of the treatment, not before or afterward);
be dated, and signed or initialed, by the person who performed the activity documented (§
112.161(a)(4)) (i.e., by the person applying the treatment); and
be reviewed, dated, and signed, within a reasonable time after the records are made, by a
supervisor or responsible party (§ 112.161(b)).

The following information should also be maintained in seed treatment records:
•
•
•

Type of seeds treated
Seed lot number
Type of treatment (i.e., chemical, heat)
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•
•
•

References to the scientific data supporting the method
Printed name of person applying treatment
Printed name of reviewing supervisor or responsible party

If you are relying on prior treatment of seeds by someone in the supply chain prior to your operation
(e.g., a grower, distributor, or supplier of seeds) (§ 112.142(e)(2)), whether to fulfill the treatment
requirement completely or for the purpose of considering such prior treatment when applying
appropriate additional treatment at your operation, you must obtain documentation (such as a
Certificate of Conformance) from the grower, distributor, or supplier seeds that the treatment was
conducted using a scientifically valid method to reduce microorganisms of public health significance
(§ 112.142(e)(2)(i)) and that the treated seeds were handled and packaged, following the treatment, in
a manner that minimizes the potential for contamination (§ 112.142(e)(2)(ii)) (See also §
112.150(b)(1)). We recommend that you obtain documents of this type from your supplier that are
specific to each lot of seeds you receive from that supplier. Certificates of Conformance (or other
forms of documentation used for this purpose) should include documentation of the scientifically
valid method used to treat the seeds, the level of log reduction achieved, the type of seeds used for
any validation study that may have been done, and the pathogens targeted. We also recommend that
if water was used to treat the seeds, you should obtain documentation or assurances from your
supplier that the water used for treatment meets the microbial quality criteria in § 112.44(a) (0
detectible generic E. Coli in 100 mL water).
Sprout operations also must maintain documentation of certain corrective actions (see §
112.150(b)(6)). Required corrective actions that relate particularly to seeds (the topic of this section),
as discussed in Section VII.C. (Corrective Actions for Seeds that May be Contaminated with a
Pathogen), include those taken in accordance with §§ 112.142(b) and (c) (i.e., required actions if you
know or have reason to believe that a lot of seeds may be contaminated with a pathogen), and
112.148 (i.e., additional required actions where your knowledge or reason to believe that the lot of
seeds is contaminated came from required spent sprout irrigation water or sprout pathogen testing
pursuant to § 112.144(b)). With respect to records you keep to document any of these corrective
actions:
•

•
•
•

You must make a record of the date and time at which you performed each activity (e.g.,
returning the affected seed lot to a supplier, destroying sprouts grown from the affected seed
lot, reporting information to your seed supplier, treating seeds with a process reasonably
certain to achieve destruction or elimination in seeds of the most resistant microorganisms of
public health significance, or conducting follow up actions to investigate the potential source
of the contamination) (§ 112.161(a)(1)(v)).
You must make such records of each such activity at the time the activity is performed (§
112.161(a)(2)).
Such records must be dated, and signed or initialed, by the person who performed the activity
documented (§ 112.161(a)(4))
Such records must be reviewed, dated, and signed, within a reasonable time after the records
are made, by a supervisor or responsible party (§ 112.161(b)).

Specifically, if you treat the affected lot of seeds with a process that is reasonably certain to achieve
destruction or elimination in seeds of the most resistant microorganisms of public health significance,
the records you keep to document this action for purposes of §§ 112.142(c)(1) and 112.150(b)(6)
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must include the same content required for records documenting routine seed treatment under §§
112.142(e)(1) and 112.150(b)(1) (see above in this same section). We also recommend that such
records also include the same additional content that we recommend for records documenting routine
seed treatment (see above in this same section).
With respect to records you keep to document follow up actions taken in accordance with §
112.142(c)(2), we recommend including as much detail as practical in your records (e.g., regarding
the scope of your evaluation, any deficiencies found, and all relevant actions taken).

VIII. Sampling and Testing of Spent Sprout Irrigation Water (or
In-Process Sprouts)
Microbial testing of spent sprout irrigation water (or in-process sprouts) is an important part of a
multi-hurdle approach to ensure contaminated sprouts do not enter the marketplace. Under §
112.144(b), you must either test spent sprout irrigation water from each production batch of sprouts
for E. coli O157:H7 and Salmonella species and any pathogens meeting the criteria in § 112.144(c)
or, if testing spent sprout irrigation water is not practicable (for example, soil-grown sprouts
harvested with roots or for hydroponically grown sprouts that use very little water), you must test
each production batch of sprouts at the in-process stage (i.e., while sprouts are still growing).
Under § 112.144(c) the Produce Safety Rule requires testing of other pathogens in addition to E. coli
O157:H7 and Salmonella when the following conditions are met: (1) testing for the pathogen is
reasonably necessary to minimize the risk of serious adverse health consequences or death from the
use of or exposure to sprouts; and (2) a scientifically valid test method for the pathogen is available
to detect the pathogen in spent sprout irrigation water (or sprouts). If both conditions are met for a
particular pathogen such that testing would be required, we intend to issue additional guidance to
inform stakeholders.
This section of the guidance provides recommendations to help you comply with the requirements
related to sampling and testing spent sprout irrigation water (or in-process sprouts), including
establishing and implementing a written sampling plan (§ 112.147), collecting samples using an
aseptic technique (§ 112.147(b)), preventing each production batch of sprouts from entering
commerce until test results are received (§ 112.147(b)), testing samples in accordance with required
methods (§§ 112.147(b) and 112.153), and developing and implementing corrective actions to be
followed in the event that the sample(s) of spent sprout irrigation water or sprouts test positive for a
pathogen (§ 112.147(c)). Recommendations related to recordkeeping requirements for sampling and
testing of spent sprout irrigation water (or in-process sprouts) are also discussed (§ 112.150).

Developing a Sampling Plan

Under § 112.147(a), you must establish and implement a written sampling plan that identifies the
number and location of samples (of spent sprout irrigation water or in-process sprouts) to be
collected for each production batch of sprouts to ensure that the collected samples are representative
of the production batch when testing for contamination. In addition, under § 112.147(b), in
accordance with the written sampling plan, you must aseptically collect samples of spent sprout
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irrigation water or sprouts, and test the collected samples for pathogens using a method as set forth in
§ 112.153. You must not allow the production batch of sprouts to enter into commerce unless the
results of the testing of spent sprout irrigation water or sprouts are negative for E. coli O157:H7,
Salmonella species, and, if applicable, a pathogen meeting the criteria in § 112.144(c). Also, under §
112.147(c), your written sampling plan must include a corrective action plan that at a minimum,
describes the actions you are required to take under § 112.148, and details when and how you will
accomplish those actions, if the samples of spent sprout irrigation water or sprouts test positive for E.
coli O157:H7, Salmonella species, or a pathogen meeting the criteria in § 112.144(c).
The written sampling plan:
1. Should specify whether you are testing spent sprout irrigation water or, alternatively, inprocess sprouts (i.e., while the sprouts are still growing). If the latter, you should explain why
testing spent sprout irrigation water is not practicable. For example, we recognize testing
spent sprout irrigation water is not practicable for soil-grown sprouts harvested with roots
and for hydroponically grown sprouts that use very little water;
2. Should specify that the collected samples are to be tested for Salmonella spp. and E. coli
O157:H7 (as well any other pathogens, if applicable, in accordance with § 112.144(c));
3. Should identify the specific test method by which collected samples will be tested for
relevant pathogens (you are required to use a method as set forth in § 112.153);
4. Should indicate the person(nel) (name or title) in your sprout operation who is (are)
responsible for sample collection, as well as any specific training and/or qualifications that
the sample collector(s) should possess;
5. Must specify the specific location(s) in your sprout operation where samples are to be
collected (§ 112.147(a)). If your sample collection location differs, for example, depending
on the type of growing unit or irrigation practices used, you should describe any such
differences. We also recommend including a diagram of the different growing units at your
operation, and indicating the points of sample collection in your sampling plan;
6. Should indicate the timing during the growth cycle of sprouts when samples of spent sprout
irrigation water (or in-process sprouts) are to be collected and any differences in sampling
time for specific sprout types or growing practices.
7. Must specify the number of samples of spent sprout irrigation water (or in-process sprouts) to
be collected from each production batch of sprouts (§ 112.147(a)). You should also note any
differences in the number of samples based on the type of growing unit or irrigation
practices, as well as the number of sub-samples, as applicable;
8. Should indicate the volume of spent sprout irrigation water (or in-process sprouts) to be
collected for each sample;
9. Should specify that samples must be collected aseptically (§ 112.147(b)). The sampling plan
should also describe your procedure(s) for aseptic collection of spent sprout irrigation water
or in-process sprout samples. You may need to describe more than one procedure for aseptic
sample collection, depending on the types of sprouts you grow and the growing practices in
your operation;
10. Should include information about sampling tools and materials necessary for aseptic sample
collection following your procedures, as well as any other instructions necessary to ensure
that samples adequately represent each production batch of sprouts;
11. Should indicate your procedures for delivering or shipping collected samples to the testing
laboratory (and if applicable, how to schedule sample pick-up), including identifying the
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12.

13.

14.
15.

16.

specific laboratory(ies) that you use (e.g., name, address, contact information), any forms that
should be completed, sample labeling procedures, and storage considerations;
Should specify that the production batch of sprouts must not enter into commerce until results
of the testing are obtained and those results are negative for E. coli O157:H7 and Salmonella
spp. (as well as, if applicable, any other pathogens in accordance with § 112.144(c)) (§
112.147(b)). The sampling plan should also describe your specific procedure(s) for ensuring
that this requirement is satisfied for each production batch of sprouts;
Must include a corrective action plan, as required under § 112.147(c), which describes the
specific corrective actions you must take in response to a positive test result (§112.148), and
provides details of how and when you will accomplish those actions. You should either
include your cleaning and sanitizing procedures, or reference your SSOP, in your corrective
action plan to describe how you will accomplish the required cleaning and sanitizing
corrective actions (§ 112.148(c));
Should indicate the person(nel) (name or title) in your sprout operation who is (are)
responsible for implementing the corrective action plan in response to a positive test result;
Should describe the records that you will make and maintain for each sample of spent sprout
irrigation water or sprouts, and identify the person(nel) (name or title) in your sprout
operation who is (are) responsible for completing and maintaining the records; and
Should indicate any additional considerations for spent sprout irrigation (or in-process
sprouts) sampling and testing as appropriate for your operation (e.g., growing unit type,
irrigation practices, and sprouting cycle).

We recommend you develop your written sampling plan taking into account the specific growing and
irrigation practices at your operation. We recommend that you periodically review your written
sampling plan, particularly in light of any changes in production practices or conditions that may
impact your sample collection procedures
In the following section, we provide additional recommendations on how to develop and implement
your written sampling plan in six key areas: (1) Collecting and shipping samples, (2) Preventing a
production batch of sprouts from entering commerce while test results are pending, 3) Choosing a
laboratory and test method, (4) Interpreting results, (5) Developing a corrective action plan (and
taking relevant corrective actions), and (6) Preparing and keeping records. We also provide certain
recommendations regarding other pathogen testing you may choose to do on spent sprout irrigation
water, in-process sprouts, or finished sprouts in addition to the required testing discussed elsewhere
in this section.

Collecting and Shipping Samples
1.

Preparing for sample collection

You should assess the configuration of your growing units, water outlets, and product distribution
within the growing unit to determine how to collect a sample that adequately represents the
production batch of sprouts. Your assessment may lead you to make changes to your sprout
production area, for example relocating growing units to allow ready access for representative
sampling.

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The person(s) that perform sample collection of spent sprout irrigation water (or in-process sprouts)
should be identified in your written sampling plan, at least by title. Sample collection may be
performed by, for example, employees or contracted personnel. If you determine that training is
needed to perform sample collection, then this should be specified in the sampling plan and records
should indicate that training was successfully completed. Samples must be collected aseptically in
accordance with § 112.147(b) and, therefore, training in aseptic techniques may be useful.
•

•
•
•
•
•
•

Sterile sample containers, labeled with relevant information, including production batch
number and identifying information for your sprouts and your sprouting operation
o For spent sprout irrigation water samples, 1-liter sterile containers (e.g., plastic cups)
should be used instead of bags, because bags can leak or spill liquid samples;
o For in-process sprout samples, individual containers (e.g., cups or bags) should be
used for each sub-sample;
Sterile sampling equipment (e.g., cups or tongs);
Single-use gloves;
Cleaned countertop or other surface;
Clean cooler with ice packs dedicated to sample storage;
Neutralizing agent (if collecting samples of spent sprout irrigation water that is chlorinated,
see below); and
Any forms or records to be completed.

If your sprout operation uses chlorinated water for irrigation, there is likely to be residual chlorine in
the spent sprout irrigation water. To neutralize the effect of any residual chlorine on test results, you
should add an appropriate amount of neutralizing agent (e.g., 100 mg/L of sodium thiosulphate) in
the sampling bottle prior to collecting the sample in that bottle.
Using the right materials and equipment is particularly important to ensure the sample collection is
conducted aseptically as required under § 112.147(b). You must use sterile equipment and tools to
collect samples aseptically. Cleaning and sanitizing is not equivalent to sterilization (See Appendix 1
on Aseptic Sampling).

Collecting the sample

If samples are improperly collected or mishandled, or collected in a manner such that samples are not
representative, the test results may not accurately reflect the potential for contamination in that
production batch of sprouts. Therefore, it is important to establish sample collection procedures and
implement them uniformly.

a. Identifying the production batch of sprouts
Under § 112.144(b), you must sample and test spent sprout irrigation water (or sprouts) from each
“production batch of sprouts” at your operation. A production batch of sprouts is defined as “all
sprouts that are started at the same time in a single growing unit (e.g., a single drum or bin, or a
single rack of trays that are connected to each other), whether or not the sprouts are grown from a
single lot of seed (including, for example, when multiple types of seeds are grown in a single
growing unit)” (§ 112.3). This definition of a “production batch of sprouts” is intended to treat as
one batch product that is exposed to the same conditions during sprouting. For example, when
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multiple seed types are started at one time and used to grow sprouts in a common drum, the mixed
sprouts grown together in the drum are a single production batch of sprouts. As another example,
when a rack of connected trays is used to grow sprouts started at the same time in way that exposes
sprouts in some trays to water that has contacted sprouts in other trays (for example, if the water
drips through upper trays of sprouts on the rack down into lower trays of sprouts on the rack), the
sprouts in the rack of connected trays (the growing unit) are a single production batch of sprouts. If,
however, the connected trays of sprouts in such a rack were started at two different time points, there
would be two different production batches of sprouts in that single growing unit, based on the two
different start times, for which two samples and tests (one from each production batch of sprouts)
would be required. As another example, two separate growing units of sprouts would be two
production batches of sprouts, even if the sprouts in them were started at the same time, because a
“production batch of sprouts” is limited to a single growing unit. If you have two drums of sprouts,
these are two separate growing units, even if they contain sprouts started at the same time. You must
not pool samples from multiple growing units for purposes of testing spent sprout irrigation water (or
in-process sprouts). “Pooling” refers to the practice of combining samples from multiple growing
units to create one sample for testing. You must separately sample and test each production batch of
sprouts.
If you start growing sprouts in one growing unit and then transfer them to different growing units
during sprouting, multiplying the number of growing units, you should collect your samples (of spent
sprout irrigation water, or in-process sprouts) from the growing unit(s) where the sprouts are held at
your predetermined time of sample collection (see Section VIII.B.2.b.ii below, When to Collect the
Sample). In this scenario, the production batches should be determined based on the growing unit(s)
that contain the sprouts at the pre-determined time of sample collection. For example, if alfalfa
sprouts started together in growing unit A are transferred to growing units B and C after 36 hours of
sprouting, and your predetermined sampling time is 48 hours into sprouting, sample collection should
occur from growing units B and C since that is where the sprouts will be contained at 48 hours into
sprouting, and you should sample and test growing units B and C separately, as two production
batches. On the other hand, if your predetermined sampling time is 24 hours into sprouting, sample
collection should occur from growing unit A, which you should treat as a single production batch. In
some cases, collecting a representative sample of spent sprout irrigation water may be more
challenging after the transfer (e.g., collecting necessary volume), which may lead you to adjust your
production practices (e.g., delaying transfer).
A production batch of sprouts is not be confused with a lot of seeds. Seed lot numbers are typically
assigned by seed suppliers. The seed lot number may appear on seed packages, or on seed shipment
records. The seed lot number allows both the seed supplier and the sprout operation to track seeds,
and we recommend that sprout operations keep sufficient records to connect their test results and
corrective actions to specific seed lots whenever possible. It is typical for a single seed lot to be used
to produce multiple production batches of sprouts. In addition, it is also common for multiple seed
lots to be mixed to produce a single production batch of sprouts.

b. Collecting a representative sample
As provided in § 112.147, you must establish and implement a written sampling plan to ensure that
the collected samples are representative of the production batch when testing for contamination.
Collecting samples that are “representative,” in the context of microbiological testing, means that the
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samples, to the extent possible, accurately reflect the potential for contamination in the larger
production batch of sprouts. One indicator of the extent to which the samples of spent sprout
irrigation water or in-process sprouts are representative of the production batch is the degree to which
the samples “cover” the production batch, i.e., the proportion of the batch of sprouts that has come
into contact with the spent sprout irrigation water from which the sample is taken, or the degree to
which the sample of in-process sprouts has been collected from different physical locations across
the production batch. The greater the coverage of the production batch of sprouts, the more
representative the sample. In order to collect a representative sample of spent sprout irrigation water
or sprouts, you may need to, for example, increase the number of sub-samples or the total amount of
sample you collect. Below, we discuss certain growing conditions and irrigation practices, their
potential impact on sample collection, and recommendations for obtaining a representative sample.

What to sample

You must collect a sample of spent sprout irrigation water or sprouts from each production batch of
sprouts (§ 112.144(b)). Only when testing spent sprout irrigation water is not practicable, for
example, soil-grown sprouts harvested with roots or for hydroponically grown sprouts that use very
little water, you must test each production batch of sprouts at the in-process stage (i.e., while sprouts
are still growing) under § 112.144(b)(2). This does not preclude, however, additional voluntary
testing (e.g., testing finished product sprouts for specific pathogens) you may choose to do in
addition to the required sampling and testing under § 112.144(b).

ii.

When to collect the sample

The optimal time for sample collection is when pathogen levels are likely to be at their highest, to
maximize the likelihood of detecting pathogens. The optimal time for sample collection may vary
depending on the type of sprouts you produce, or on your sprouting practices.
Current research indicates that for alfalfa sprouts, pathogen levels peak approximately 48 hours from
the start of the sprouting process. Pathogen levels will not necessarily increase after 48 hours and
may decline slightly (Ref. 40). However, if you are sprouting seeds that have a longer growth cycle
compared to alfalfa sprouts, it may take longer for the germinating seeds to reach the conditions that
will encourage the growth of pathogens, if present. Optimal timing of sample collection may be
sooner for sprouts that have a shorter growth cycle compared to alfalfa sprouts.
Based on the available science, as a general matter we recommend that you collect samples as close
to 48 hours from the start of sprouting as practicable. If the complete sprouting process for a given
sprout type takes fewer than 48 hours, we recommend you collect samples as close to 48 hours as
practicable even if that is towards the end of the growing cycle. If you pre-soak the seeds (i.e.,
soaking them in water for a short time before transferring them to growing units for sprouting), we
recommend that you include the pre-soak time in your calculations.
If you wish to explore the optimal timing for sample collection in your sprouting operation (e.g.,
unique considerations based on sprout types, seed treatment, and/or production practices at your
operation), we recommend collecting the spent sprout irrigation water (or in-process sprouts) at 24
hour-intervals and sending the samples to a laboratory to test the Aerobic Plate Count (APC) (also
known as Total Plate Count, TPC). The Aerobic Plate Count is used to measure populations of
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microorganisms in a sample, and can help determine the point in the sprouting process at which the
highest levels of bacteria (including pathogens) are detected (Ref. 41).
We also recommend that, to the extent possible, you collect samples of spent sprout irrigation water
at the start of your irrigation cycle rather than towards the end of the cycle. Pathogens that may be
present in the production batch of sprouts are likely to be at their highest levels at the beginning of
the irrigation cycle and will continue to decrease through the end of the irrigation cycle. Therefore,
collecting samples at the start of irrigation is likely to maximize the probability of detecting
pathogens if they are present.
In instances where irrigation cycles are not frequent (e.g., many hours pass between each irrigation
cycle) or where irrigation is not otherwise occurring at the optimal sampling time, irrigation water
may be added specifically for sample collection to facilitate collecting your sample at the optimal
time. If adding irrigation water specifically for sample collection, you should do this as close to the
start of the next regular irrigation cycle as possible to allow time for pathogens that may be present in
the production batch of sprouts to grow after the end of your last irrigation cycle. If it is
impracticable to add irrigation water for collecting a sample of spent sprout irrigation water (e.g., for
sprouts grown using very little water), you may instead sample in-process sprouts before the start of
the next irrigation cycle (§ 112.144(b)(2)).

iii.

How much and how many samples to collect

If testing spent sprout irrigation water, you should collect at least one sample of 1.5 liters of water
(about 3 pints or 1.6 quart) from each production batch of sprouts. It may be advisable for this
sample to be made up of multiple subsamples, depending on whether your growing unit has a single
drainage point or multiple drainage points (see VIII.B.2.b.iv, “Where to Collect Sample,” below). As
a general matter, when sub-sampling is advisable, we recommend that you collect at least 30 subsamples (Ref. 41a, Ref. 41b).
If testing in-process sprouts, we recommend that you collect at least thirty (30) 50-gram sub-samples
of sprouts for a total of at least 1500 grams (about 52.91 ounces or 3.31 pounds) from each
production batch of sprouts.
However, you should also consider circumstances specific to your sprout operation or production
practices and adjust your sampling as needed to ensure you obtain samples representative of the
production batch of sprouts. The number of different microorganisms for which you are testing can
also affect the volume of sample necessary for testing.

(1) Large production batches of sprouts
If the level (percentage) of contamination with pathogens and the sample size tested are held
constant, the amount of potentially contaminated finished product that may escape detection through
sampling and testing increases with the size of the production batch (Ref. 42). In addition, the fact
that distribution of contamination in any given production batch is likely to be heterogeneous makes
it difficult to ensure that your test results accurately represent the potential for contamination in the
production batch, especially for production batches that are particularly large (Ref. 42a). Because of
these concerns, we recommend that you collect additional samples of spent sprout irrigation water (or
in-process sprouts) from particularly large production batches, and test those samples separately, to
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provide a comparable level of control over the volume of potentially contaminated product that may
escape detection during production of large production batches as compared to small production
batches. We developed these recommendations by establishing a threshold amount of potentially
contaminated product that might escape detection at a level that is three times the amount that might
escape detection for a batch of typical size with a single sample and test. We recommend additional
samples and tests for batch sizes where that threshold amount would otherwise be exceeded because
of the large size of the batch (Ref. 42). For example, if your single production batch will consist of
greater than 2400 lbs. of finished sprouts, we recommend that you collect two samples (of at least 1.5
liters each, for a total of 3 liters collected) of spent sprout irrigation water from that production batch
and test each sample separately. If sampling in-process sprouts from a production batch of the same
size, we recommend that you collect two samples (each totaling at least 1500 g, each made up of 30
(50 g) subsamples, for a total of 3000 g and 60 (50 g) subsamples collected), and test each sample
separately (Ref. 42). If your production batch is greater than 10,500 lbs. of finished sprouts, we
recommend that you collect three samples (of at least 1.5 liters each, for a total of 4.5 liters collected)
of spent sprout irrigation water from that production batch and test each sample separately. Similarly
if sampling in-process sprouts from a production batch of the same size, you should collect a total of
3 samples (each at least 1500 g, each made up of 30 (50 g) subsamples for a total of 4500 g and 90
(50 g) subsamples collected) (Ref. 42).

(2) High volumes of irrigation water/high flow rates
Larger volumes of irrigation water and/or higher rates of irrigation flow (e.g., as often used for mung
bean sprouts grown in bins, such that a 1.5 liter container is likely to overflow immediately at the
normal flow rate) can dilute any pathogen that may be present in the water, making collecting a
representative sample of spent sprout irrigation water more difficult and therefore making it less
likely that a pathogen that is present will be detected. We recommend that sprout operations using
large volumes of water and/or high rates of flow either temporarily decrease the volume of water
and/or flow rate through a growing unit during spent sprout irrigation water sampling; or add water
to the growing unit at a lower volume/flow rate between regular irrigation cycles for the specific
purpose of collecting a sample.

(3) Low volumes of irrigation water/low flow rates
Conversely, operations using lower volumes of irrigation water and/or rates of irrigation flow, such
as misting, may find collecting a sufficient amount of irrigation as a sample water (e.g., collecting at
least the recommended 1.5 liter) more challenging. We recommend that such operations, to the
extent possible, either temporarily increase the volume of water and/or flow rate through a growing
unit during spent sprout irrigation water sampling; or add water to the growing unit at a higher
volume/flow rate immediately prior to the regular irrigation cycle for the specific purpose of
collecting a sample. We recommend that you consider whether either of these options is practicable
for your operation before deciding to sample in-process sprouts rather than spent sprout irrigation
water. If, however, sampling spent sprout irrigation water is not practicable under the circumstances,
you may instead sample in-process sprouts (§ 112.144(b)(2)).

iv.

Where to collect sample

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For samples of spent sprout irrigation water, you should assess the configuration of your growing
units, the flow of irrigation water, outlets of water exiting the growing unit, and product distribution
within the growing unit to determine how and where to best collect a representative sample. Sprouts
that are not mixed during growing (e.g., in racks of trays, bins, or tanks) can result in a more
heterogeneous (i.e., uneven) spread of pathogens in spent sprout irrigation water than sprouts that are
mixed during growing (e.g., in a rotating drum). A growing unit may have a single or multiple points
for collection of spent sprout irrigation water dependent on the type of the growing unit. If your
sprout growing unit has a trough or other common point where water drains from the growing unit
(e.g., the low point of the front of a rotating drum), you should collect the entire spent sprout
irrigation water sample (we recommend at least 1.5 liter) at that point. Because this spent sprout
irrigation water has flowed through the entire growing unit of sprouts, collection at this point is likely
to be representative, even if your sprouts are not mixed during growing. If the growing unit has
multiple points of drainage (e.g., a single rack of connected trays or a large bin for growing mung
bean sprouts), you should collect partial samples (sub-samples) from these different points of
drainage to ensure the combined sample is representative, especially if your sprouts are not mixed
during growing. In such cases, you should collect a minimum of 30 sub-samples of approximately
equal volume from various drainage points (e.g., by moving your sample container around to
different drainage locations). The 30 sub-samples should, together, comprise your sample of at least
1.5 liter (total) of spent sprout irrigation water.
To collect samples of in-process sprouts, we recommend that you collect at least thirty (30) 50-gram
sub-samples from multiple locations in the growing unit, for a total of at least 1,500 grams from each
production batch.

How to collect your sample

You must collect samples aseptically, as required under § 112.147(b). In Appendix 1 of this
document, we provide specific recommendations on aseptic sampling procedures.

Preparing the sample for shipping, and shipping the sample for testing

Prior to and during delivery or shipping to a laboratory, samples should be held at an appropriate
temperature, preferably between 0 and 4.4 ºC (between 32 and 40 ºF). Sealed coolant packs should
be used in lieu of ice, as needed during delivery or shipment, to avoid the possibility of melting ice
contaminating the sample. Samples should not be frozen. The samples should be shipped to the
laboratory within 24 hours from the time of sample collection, and analyzed promptly. A delay of
more than 24 hours between sample collection and the lab’s receipt of spent sprout irrigation water or
sprout samples may make the test results inaccurate (Ref. 43).
Prior to sending the samples to a laboratory for testing, you should check to verify that your samples
are clearly identified with the production batch number and other identifying information for your
sprouts and your sprouting operation. You should specify the microorganisms for testing on any
laboratory forms.

Preventing Production Batches of Sprouts from Entering Commerce

Under § 112.147(b), you must not allow the production batch of sprouts to enter commerce unless
the results of the testing of the spent sprout irrigation water or sprouts are negative for E. coli
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O157:H7, Salmonella spp., and, if applicable, any additional pathogen test required under §
112.144(c).
While awaiting test results, you may move the production batch of sprouts from the growing area to
another physical location, such as a holding or storage area in your sprouting operation, or an off-site
storage location. However, you may not sell it or offer it for sale to another entity during this time.
You should establish and implement procedures to ensure that production batches do not enter
commerce until negative test results are obtained for all required pathogen tests.
Establishing and using unique production batch numbers or other identifiers can help ensure
implementation of these procedures. For example, the production batch number or other identifier
should be written clearly and prominently on the sample(s) sent to the testing laboratory and on
containers used for the sprouts at your operation (or otherwise displayed on or in association with the
sprouts while at your operation).

Choosing a Test Method

In accordance with § 112.153(a), spent sprout irrigation water (or in-process sprouts) from each
production batch must be tested for E. coli O157:H7 and Salmonella species using either the method
of analysis described in “Testing methodologies for E. coli O157:H7 and Salmonella species in spent
sprout irrigation water (or sprouts)” (currently available at
http://www.fda.gov/downloads/Food/FoodScienceResearch/LaboratoryMethods/UCM467055.pdf) 4
(§ 112.153(a)(1)); or a scientifically valid method that is at least equivalent to this method in
accuracy, precision, and sensitivity (§ 112.153(a)(2)). For any other pathogen(s) meeting the criteria
in § 112.144(c), you are required to use a scientifically valid method (§ 112.153(b)).
If you use a method to test for E. coli O157:H7 and/or Salmonella species other than the one in §
112.153(a)(1), it must be a scientifically valid method that is at least equivalent to the method in §
112.153(a)(1) in accuracy, precision, and sensitivity, as required under § 112.153(a)(2). We use the
term “scientifically valid” to mean an approach that is based on scientific information, data, or results
published in, for example, scientific journals, references, text books, or proprietary research.
Although you are not required to notify or submit information to FDA prior to using such alternate
method, you must establish and keep records of any such alternate methods that you use (§
112.150(b)(5)). Such records should include detailed analytical procedures, results and/or data from
validation studies showing equivalence of the alternate method to the reference method, and any
other relevant information supporting the use of the alternate method.
We recommend use of methods validated through a collaborative study (currently available at
http://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM298730.pdf) 5, for example per
4

Because websites are subject to change, it is possible that this specific website address will change. If you cannot
access this document at that website, alternative websites where you currently can access this document include
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm114664.htm, http://www.fda.gov/Food/Fo
odScienceResearch/LaboratoryMethods/default.htm, and http://www.fda.gov/fsma. Alternatively, you can search on
part or all of the title of the method, in the search box on FDA’s Web site at http://www.fda.gov, or using a
generally available search engine.
5
Alternative websites where you can currently access this document include:
http://www.fda.gov/ScienceResearch/FieldScience/ucm273423.htm and http://www.fda.gov/fsma. Alternatively,

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AOAC Appendix J or ISO 16140:2016. Alternate methods should be validated for E. coli O157:H7
or Salmonella spp. against FDA’s reference method (§ 112.153(a)(1)) in spent sprout irrigation water
and/or sprouts, as applicable, and demonstrated to meet the requirements for alternate methods in §
112.153(a)(2) (i.e., demonstrated to be at least equivalent to the reference method in accuracy,
precision, and sensitivity). Methods validated by third party methods validation organizations such
as AOAC Official Methods of Analysis (OMA), MicroVal, and AFNOR (Association Française de
Normalisation) may meet the requirements in § 112.153(a)(2), however, FDA does not automatically
consider methods validated by third party organizations such as the listed organizations to be
equivalent. Information on alternate methods reviewed by FDA and found to be equivalent will be
made available on our website, such as at such as at http://www.fda.gov/fsma,
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm114664.htm, and
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/default.htm.

Interpreting Test Results

Testing for E. coli O157:H7 and Salmonella species in spent sprout irrigation water or sprouts using
the FDA reference method (§ 112.153(a)(1)) can yield one of two results:
•
•

A confirmed positive result, which is obtained when screening procedures yield a
presumptive positive result that is followed by confirmatory steps demonstrating the presence
of E. coli O157:H7 or Salmonella species,; or
A negative result, which can be obtained if either:
o Screening procedures do not yield a presumptive positive result; or
o Confirmatory steps after a presumptive positive do not result in confirmation of the
presence of E. coli O157:H7 or Salmonella species.

Confirmatory steps that are part of FDA’s reference method are conducted on the same culture
enrichment as the screening procedures used at the beginning of the analysis. To comply with the
requirements of §§ 112.144(b), 112.147, and 112.153 for testing spent sprout irrigation water or inprocess sprouts, if you receive a presumptive positive result from screening procedures, you must
conduct confirmatory steps and may not stop the analysis at the presumptive positive result.
You cannot “test your way to safety” by collecting and testing additional samples of spent sprout
irrigation water or sprouts from the same production batch if your first test yields a confirmed
positive result. A negative test result in additional samples does not negate a previous positive test
result. Consider any confirmed positive result to be valid (even if subsequent tests on the original
sample or other samples collected from the production batch of sprouts are negative), absent other
circumstances clearly demonstrating the inaccuracy of the first test result (e.g., reported issue at the
laboratory, such as cross-contamination).
Sprouts must not be allowed to enter commerce unless the results of the testing of spent sprout
irrigation water or sprouts are negative for E. coli O157:H7, Salmonella spp., and, if applicable,
any additional pathogens meeting the criteria in § 112.144(c) (§ 112.147(b)). If you obtain a
negative result (of either type described above) for all relevant pathogens, your obligation under §
you can search on part or all of the title of the method, in the search box on FDA’s Web site at http://www.fda.gov,
or using a generally available search engine.

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112.147(b) to prevent the batch from entering commerce has been satisfied. Once you have all such
negative test results for a given production batch of sprouts, it would be reasonable to allow that
production batch to enter commerce, provided there is no other reason for concern (e.g., there is no
concern about potential contamination of your production environment with L. monocytogenes based
on which you should continue to prevent the batch from entering commerce; see Section IX
(Environmental Monitoring)).

Choosing a Laboratory

You should choose a laboratory that is qualified to test spent sprout irrigation water (and/or inprocess sprouts, as applicable) for E. coli O157:H7, Salmonella species, and any pathogens meeting
the criteria in § 112.144(c). Testing is typically contracted to a third-party testing laboratory.
Testing may also be performed by a sprout operation’s own laboratory (e.g., an operation’s own “inhouse” laboratory). You should use a laboratory that employs scientifically valid laboratory methods
and procedures that can provide reliable, accurate test results. A laboratory conducting the tests on
which you rely might be, but is not required to be, accredited. Using an accredited laboratory (e.g., a
laboratory accredited to International Organization for Standardization (ISO) Standard 17025) is one
way to have confidence that a laboratory will provide reliable, accurate rest results. Regardless of
which laboratory you use, testing must be done using a method as set forth in § 112.153.

Developing a Corrective Action Plan and Taking Corrective Actions

Your written sampling plan must include a corrective action plan that, at a minimum, requires you to
take the actions in § 112.148 (listed below), and details when and how you will accomplish those
actions, if the samples of spent sprout irrigation water or sprouts test positive for E. coli O157:H7,
Salmonella species, or a pathogen meeting the criteria in § 112.144(c) (§ 112.147(c)). Under §
112.148, you must, at a minimum, take these actions if your samples of spent sprout irrigation water
or sprouts test positive for E. coli O157:H7, Salmonella species, or a pathogen meeting the criteria in
§ 112.144(c):
•
•

•
•

Take appropriate action to prevent any food that is adulterated under section 402 of the
Federal Food, Drug and Cosmetic Act from entering into commerce (§ 112.148(a));
Take the steps required in § 112.142(b) with respect to the lot of seeds used to grow the
affected production batch of sprouts (except as allowed under § 112.142(c)) (§ 112.148(b))
(see Section VII.C (Corrective Actions for Seeds that May be Contaminated with a Pathogen)
of this document):
Clean and sanitize the affected surfaces and surrounding areas (§ 112.148(c));
Perform any other actions necessary to prevent recurrence of the contamination (§
112.148(d)).

Your corrective action plan must detail when and how you will accomplish these actions. Having a
correction action plan in place at your operation will help ensure that corrective actions are taken
quickly in response to positive findings of pathogens in spent sprout irrigation water or sprouts. The
plan should include:
•

procedures for identifying the contaminated production batch of sprouts (for example, using
the production batch number information associated with the positive test results), and
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•
•

•

destroying the contaminated production batch of sprouts; as well as steps necessary to ensure
any contaminated food does not enter commerce;
procedures for identifying affected food contact surfaces and surrounding areas, and for
cleaning and sanitizing affected surfaces and areas;
procedures for appropriate handling of the lot of seeds corresponding to the contaminated
production batch of sprouts (i.e., procedures for discontinuing the use of that lot of seeds,
ensuring that sprouts grown from that lot of seeds do not enter commerce, and reporting
positive test findings to the seed grower, distributor, supplier, or other relevant entity, as
required in § 112.142(b). Alternatively, procedures for any follow-up actions you intend to
take as provided in § 112.142(c)(2); and/or if you decide to treat that lot of seeds as provided
in § 112.142(c)(1), procedures for appropriate handling of the lot of seeds prior to, during,
and after treatment) (see Section VII.C (Corrective Actions for Seeds that May be
Contaminated with a Pathogen) of this document for additional information on these
provisions); and
any specific steps that are necessary to prevent recurrence of the contamination, considering
the conditions and practices in your sprout operation.

One required corrective action is to take appropriate action to prevent any food that is adulterated
under section 402 of the FD&C Act from entering into commerce (§ 112.148(a)). This requires you
to prevent the contaminated production batch of sprouts from entering commerce (see also §
112.147(b)). In addition, you should also determine (for example, through review of your production
and sanitation records) the potential for other foods produced at your operation to have become
adulterated due to cross-contamination from the contaminated production batch of sprouts, its spent
sprout irrigation water, or its associated seed lot(s). If any other food has become adulterated, you
must take appropriate action to prevent it from entering into commerce. For example, if you
packaged another food item (e.g. tofu) on the same food-contact surface as the contaminated
production batch of sprouts without intervening cleaning and sanitizing and the food has therefore
become adulterated, § 112.148(a) requires that you take appropriate action to prevent that food from
entering commerce. For example, you could destroy that food. You should take special care when
handling contaminated sprouts (or other food), water, and equipment to avoid accidental exposure of
other food, food contact surfaces, and other parts of the production environment to pathogen(s).
Another required corrective action is to clean and sanitize the affected surfaces and surrounding areas
(§ 112.148(c)). You should evaluate your operation for the potential for the affected production
batch of sprouts to have contaminated other objects and production areas (both food and non-food
contact surfaces). Anything in your sprout operation that has come into contact with the
contaminated sprout production batch (e.g., packaging areas, cold storage, or harvest containers), its
spent sprout irrigation water (e.g., drums, trays, bins, buckets, tools and other sprouting equipment,
sampling/testing equipment, and other surfaces, such as floors, drains, walls, and tables), or the
associated lot(s) of seeds (e.g., containers used to store and treat seeds) should be treated as an
affected surface. These surfaces, and the areas surrounding them, could potentially contaminate
other food, including subsequent batches of sprouts at your operation, without effective cleaning and
sanitizing. As part of your evaluation, you should review your production records to identify both
food-contact and non-food contact surfaces that may have come in contact with the contaminated
production batch of sprouts, its spent sprout irrigation water, or its associated seed lot(s), and review
your cleaning and sanitation records to determine when those surfaces were last cleaned and
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sanitized. We recommend you conduct intensified cleaning and sanitizing of affected surfaces and
areas surrounding them (see Section V (Cleaning and Sanitizing)) in response to the known
contamination event.
In addition, you must take any other actions necessary to prevent recurrence of contamination (§
112.148(d). Examples of such corrective actions that may be appropriate include:
•
•

•

Re-evaluating your seed treatment protocol and procedures against current scientific
information;
Retraining your employees to ensure accurate and proper implementation of your seed
treatment protocol, seed handling procedures, visual examination of seed and packaging, and
any other relevant controls. For example, if you have repeated positive pathogen test results
in spent sprout irrigation water or in-process sprouts, we recommend that you observe your
employees as they implement your sprout production process (and/or specific procedures,
such as those related to seed receipt or seed treatment) to determine if there are any
deficiencies;
Re-evaluating your seed sourcing. For example, if you have multiple positive pathogen test
results in spent sprout irrigation water or in-process sprouts that are associated with different
lots of seeds obtained from the same seed supplier, we recommend that you re-evaluate
whether you should continue using that seed supplier; and
Re-evaluating your cleaning and sanitizing procedures and, as needed, retraining employees
on appropriate practices. For example, if you obtain repeated positive pathogen test results
from spent sprout irrigation water or in-process sprouts from different production batches
grown from different seed lots that shared the same growing unit or food contact surface, you
should re-evaluate your cleaning and sanitizing procedures and the manner in which your
employees are implementing those procedures.

Recordkeeping

You must establish and keep certain records to satisfy the requirements of the Produce Safety Rule.
For more information on the recordkeeping requirements, see the Recordkeeping Section of this
Guidance. Section 112.150(b)(3) to (b)(6) describe records that you must establish and maintain
related to sampling and testing of spent sprout irrigation water (or in-process sprouts) and
corresponding corrective actions. Specifically, you must prepare and keep these records:
1. Your written sampling plan, which includes your corrective action plan, for each
production batch of sprouts (§ 112.150(b)(3)).
2. Records of any analytical methods you use in lieu of the methods that are incorporated by
reference in § 112.153(a)(1) to test for E. coli O157:H7 or Salmonella species (§
112.150(b)(5)). Such records should include analytical procedures, as well as information
relevant to the determination of the scientific validity of the alternate method; If you use the
method listed in § 112.153(a)(1), keeping records of your use of this test method, although
not required, would be helpful to demonstrate compliance. In addition, if you test spent
sprout irrigation water (or in-process sprouts) for any other pathogen(s) meeting the criteria
in § 112.144(c), you should keep records of the scientifically valid test method you used for
such testing.
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3. Documentation of the results of all required analytical tests (§ 112.150(b)(4)).

The results of all required analytical tests conducted either by a third-party or in-house
laboratory must be documented. Records of required pathogen test results for spent sprout
irrigation water (or sprouts) must include the following information, in accordance with §
112.161(a)(1):
•
•
•
•
•

The name and location of your operation;
Actual values and observations obtained (e.g., test results);
An adequate description of covered produce applicable to the record (e.g., production
batch number);
Location of the growing area from which the sample was collected (e.g., growing unit
information); and
Date and time of activity documented (e.g., information about date and time of
sample collection, and sample receipt and analysis by the testing lab).

In addition, such records must be dated, and signed or initialed by the person who performed
the activity documented (e.g., the individual who conducted sample analysis) as required
under § 112.161(a)(4). Also, as required under § 112.161(b), these records must be
reviewed, dated, and signed, within a reasonable time after the records are made, by a
supervisor or responsible party.
4. Records of procedures for preventing production batches of sprouts from entering
commerce. We also recommend that you maintain records of your procedures for preventing
production batches of sprouts from entering commerce unless required spent sprout irrigation
water (or in-process sprout) pathogen test results are negative. For example, in conjunction
with your test results, you should document the date you received each test result and either
the date the sprouts were released into commerce following a negative test result, or the date
of your corrective actions with respect to the contaminated batch following a positive result
(see also § 112.150(b)(6), discussed below).
5. Records of corrective actions (§ 112.150(b)(6)). You must maintain documentation of
corrective actions taken in accordance with § 112.148, which requires you to take certain
follow-up actions if samples of spent sprout irrigation water (or sprouts) test positive for
pathogens. To implement this requirement you should establish a system that allows you to
accurately identify a production batch of sprouts and associated seed lot number with the
results of spent sprout irrigation water (or sprouts) testing samples, and corresponding
corrective actions taken for a positive test result. In addition to the required corrective action
records, we recommend that you also document additional information describing the event,
such as the results of any evaluation or comprehensive investigation you may conduct, and
identification of food and food contact surfaces potentially affected by the contamination.
Corrective action records must include documentation of the following:
•
•

Documentation of your disposition of contaminated production batches of sprouts
(i.e., the manner in which you chose to prevent them from entering into commerce),
as well as the disposition of any other adulterated food (§ 112.148(a)).
Documentation of steps you took with respect to the lot of seeds associated with the
affected production batch of sprouts, in accordance with§ 112.142(b) (except as
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•
•

allowed under §112.142(c)) (§ 112.148(b)). (For more information about these
records, see Section VII.D (Seeds for Sprouting – Recordkeeping) of this document.)
Documentation of cleaning and sanitizing of the affected surfaces and surrounding
areas (we recommend that you include your cleaning and sanitizing procedures and
any verification of cleaning and sanitizing you may perform) (§ 112.148(c)).
Documentation of any other actions you took to prevent reoccurrence of the
contamination (e.g., re-training of your employees, re-evaluating your cleaning and
sanitizing procedures; re-evaluating your seed treatment protocol; and/or reevaluating your seed sourcing, as applicable) (§ 112.148(d)).

Records of corrective actions must include the following information, in accordance with §
112.161(a)(1):
•
•
•
•
•

The name and location of your operation;
Actual values and observations obtained, when applicable (e.g., values and
observations obtained in any verification of cleaning and sanitizing you may conduct
such as post-cleaning and sanitizing ATP test results );
An adequate description of covered produce applicable to the record (e.g., affected
sprout production batch number );
The location of a specific growing area or other area applicable to the record, when
applicable (e.g., location or other identifiers for growing units and other surfaces
cleaned and sanitized as corrective actions); and
Date and time of the activity documented (e.g., information about when and where
cleaning and sanitizing corrective actions were performed; information about when
any employee re-training corrective action was conducted).

In addition, such records must be dated, and signed or initialed by the person who performed
the activity documented (e.g., the individual who reported positive test findings to the seed
supplier; the individual who took steps to ensure contaminated production batch of sprouts
did not enter commerce) as required under § 112.161(a)(4). Also, as required under §
112.161(b), these records must be reviewed, dated, and signed within a reasonable time after
the records are made, by a supervisor or responsible party.

Additional Voluntary Testing

We understand that some sprout operations may voluntarily conduct additional pathogen tests on
spent sprout irrigation water, in-process sprouts, or finished sprouts in addition to the required testing
discussed elsewhere in this section.
For any such voluntary testing, if test results identify pathogens, we recommend that you take the
same corrective actions as those required for a positive test result for E. coli O157:H7 or Salmonella
species in spent sprout irrigation water (or in-process sprouts). We recommend that you establish a
recordkeeping system that allows you to associate such voluntary pathogen test results with the
related production batch of sprouts, the related seed lot number(s) and any corrective actions taken in
response to a positive test result. Note that specific recommendations on testing of finished product
for L. monocytogenes are described in Section IX. (Environmental Monitoring).

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IX. Environmental Monitoring
This section of the guidance is intended to help sprout operations comply with the requirements of
the Produce Safety Rule for environmental monitoring of the sprout growing, harvesting, packing,
and holding environment by sampling and testing environmental samples for Listeria species (spp.)
or Listeria monocytogenes (L. monocytogenes). For the purposes of this guidance, environmental
samples are samples collected from a surface or area of the growing, harvesting, packing, and
holding environment in an operation for the purpose of testing the surface or area for the presence of
Listeria spp. or L. monocytogenes in accordance with the requirements of §§ 112.144(a) and
112.145. To accomplish this, you must establish and implement a written environmental monitoring
plan that is designed to identify L. monocytogenes if it is present in the growing, harvesting, packing,
or holding environment (§ 112.145(a)). As part of your environmental monitoring plan, you must
also develop a sampling plan (§ 112.145(c)) that includes how often, when, and where you will
sample the environment and the test microorganism (Listeria spp. or L. monocytogenes).
Environmental samples must be collected aseptically and tested using a method as set forth in §
112.152 (§ 112.145(d)).
The written environmental monitoring plan must also include a corrective action plan that, at a
minimum, requires you to take the actions in § 112.146, and details when and how you will
accomplish those actions, if the growing, harvesting, packing, or holding environment tests positive
for Listeria spp. or L. monocytogenes (§ 112.145(e)). Section 112.146 describes the corrective
actions that you must take if the growing, harvesting, packing, or holding environment tests positive
for Listeria spp. or L. monocytogenes, which include:
•
•
•
•
•
•

Conducting additional testing of surfaces and areas surrounding the area where Listeria
species or L. monocytogenes was detected to evaluate the extent of the problem (§
112.146(a)) (we refer to this type of testing in this document as “exploratory testing”),
Cleaning and sanitizing the affected surfaces and surrounding areas (§ 112.146(b)),
Conducting additional sampling and testing to determine whether the Listeria spp. or L.
monocytogenes has been eliminated (§ 112.146(c)) (we refer to this type of testing in this
document as “cleaning verification testing”),
Conducting finished product testing when appropriate (§ 112.146(d)),
Performing any other actions necessary to prevent recurrence of the contamination (§
112.146(e)), and
Taking appropriate action to prevent any food that is adulterated under section 402 of the
FD&C Act from entering into commerce (§ 112.146(f)).

Principles for Developing an Environmental Monitoring Plan

L. monocytogenes has been identified as the target pathogenic microorganism of concern for
environmental monitoring in a sprout operation. There are several species of Listeria but L.
monocytogenes is the primary species known to cause disease in humans. This pathogen is among
the leading causes of death from foodborne illness in the United States, and predominantly affects the
most susceptible populations, including older adults, pregnant women, newborns and those with
weakened immune systems (Ref. 44, Ref. 45, Ref. 46, Ref. 47). Once L. monocytogenes becomes
established in an operation, it can serve as a source of repeated product contamination and potentially
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lead to foodborne illness outbreaks (Ref. 48). A number of outbreaks and recalls involving sprouts
have occurred due to contamination with L. monocytogenes (Ref. 3, Ref. 4, Ref. 49).
L. monocytogenes is widespread in the environment. It is found in soil, water, sewage, and decaying
vegetation (Ref. 50, Ref. 51, Ref. 52, Ref. 53). It can be readily isolated from humans, domestic
animals, raw agricultural commodities, and food processing environments (particularly cool, damp
areas). L. monocytogenes can multiply slowly at refrigeration temperatures, thereby challenging an
important defense against proliferation of foodborne pathogens, refrigeration (Ref. 54, Ref. 55, Ref.
56, Ref. 57, Ref. 58). L. monocytogenes will grow faster at warmer temperatures. While L.
monocytogenes may occasionally be found almost anywhere in a sprout production environment, it is
most likely to become established in areas and on surfaces that are not only wet, but are relatively
undisturbed and that may trap organic material. These include drains, cooling units, drip pans,
condensation on walls or ceilings, and areas that are difficult to access or difficult to clean (e.g., weld
seams, metal cracks, and rollers). L. monocytogenes is known to form biofilms (i.e., communities of
microbes embedded in an organic polymer matrix, adhering to a surface) on food contact surfaces
(FCSs) and non-food contact surfaces and, as a result, persists on these surfaces despite aggressive
cleaning and sanitizing (Ref. 59). “Food contact surfaces” as defined in § 112.3 includes (as stated in
the definition) food contact surfaces of equipment and tools used in harvesting, packing, and holding
covered produce; but it also includes such surfaces of tools and equipment used in growing covered
produce, including sprouts (see, e.g., §§ 112.123(d)(1) and 112.143(b)). The term “non-food contact
surfaces” (Non-FCSs) refers to any surfaces that, under normal operating procedures, do not contact
either food or food-contact surfaces. Non-FCSs may include equipment, vents, fixtures, drains,
walls, floors, and employee clothing, shoes, and accessories. Once L. monocytogenes has established
a niche, it may persist in the environment for long periods of time, serving as a potential source of
repeated contamination, until and unless the niche is identified and eliminated (Ref. 58, Ref. 60).
The goals of an environmental monitoring program should be to:
•
•
•

Find L. monocytogenes and harborage sites if present in your operation;
Ensure that corrective actions have eliminated L. monocytogenes and harborage sites when
found in your operation; and
Verify the effectiveness of your control programs for L. monocytogenes.

The Written Environmental Monitoring Plan

Section 112.144(a) requires you to test the growing, harvesting, packing, and holding environment
for Listeria species or L. monocytogenes in accordance with the requirements of § 112.145. Section
112.145(a) requires that you develop a written environmental monitoring plan that is designed to
identify L. monocytogenes if it is present in the growing, harvesting, packing or holding environment.
In order to identify L. monocytogenes if it is present, § 112.145(b) requires that you direct your plan
to sampling and testing for L. monocytogenes or Listeria species. Your written environmental
monitoring plan must also include a sampling plan (§ 112.145(c)). You must collect samples
aseptically and test them using a method as set forth in § 112.152 (§ 112.145(d)). Finally, your
environmental monitoring plan must include a corrective action plan that, at a minimum, requires
you to take the actions in § 112.146, and details when and how you will accomplish those actions, if
the growing, harvesting, packing, or holding environment tests positive for Listeria species or L.
monocytogenes (§ 112.145(e)).
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We recommend that you periodically review and assess your written environmental monitoring plan
and update the plan as needed in response to new information or corrective actions that have been
taken (e.g., if new equipment has been purchased, new product lines have been added, significant
changes have been made to production flow, or new sampling locations have been identified).
In the sections below, we describe in more detail the components of the environmental monitoring
plan.

Developing a Sampling Plan

As part of your environmental monitoring plan, you must have a written sampling plan. Your written
sampling plan:
•
•
•
•

•
•
•
•
•
•

Must specify what you will test collected samples for (i.e., Listeria species or L.
monocytogenes) (§ 112.145(c)(1)) (we refer to this microorganism as the “test
microorganism” in the remainder of this document);
Should identify the specific test method by which collected samples will be tested for the test
microorganism (you are required to use a method as set forth in § 112.152);
Should identify the person(s) responsible for sample collection in your operation and any
specific training that the person(s) should have;
Must specify the number and location of sample collection sites, which must include
appropriate FCS sites and non-FCS sites of equipment and other surfaces within the growing,
harvesting, packing, and holding environment (§ 112.145(c)(3)). You should include a list of
all identified FCS and non-FCS sites in your plan, along with a description of whether the
number and location of your sample collection sites will result in sampling from all identified
sites within a specified time period or a representative subset of all identified sites;
Must specify the frequency of sample collection, which must be no less than monthly (§
112.145(c)(2);
Must specify at what point during production you will collect the samples (§ 112.145(c)(2));
Should specify the requirement of § 112.145(d) that samples must be collected aseptically.
Your plan should include procedures for aseptic sample collection, including appropriate
materials and steps to prepare for sample collection.
Should specify the sample collection method used (e.g., sponge v. swab sampling, whether
any samples will be composited) and sample sizes to be collected at the various sample
collection sites;
Should identify the laboratory you are using to conduct the testing; and
Should identify the records you will keep for each sample collected, including the
documentation of the results of your analytical tests and actions you take in accordance with
§ 112.146.

Testing for Listeria spp. or L. monocytogenes

Your sampling plan must specify what you will test collected samples for (i.e., Listeria spp. or L.
monocytogenes) (§ 112.145(c)(1)). The purpose of environmental monitoring is to verify the
adequacy, or lack thereof, of cleaning and sanitizing practices through monitoring for the presence of
pathogens in the environment and, if pathogens are present, to eliminate or minimize their presence
and prevent transfer of pathogens to food-contact surfaces or to sprouts where they might cause
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illness. Testing for either the pathogen directly (L. monocytogenes) or an indicator organism
(Listeria spp.) facilitates accomplishing these objectives. An indicator organism is indicative that the
food has been exposed to conditions that pose an increased risk for contamination of the food with a
pathogen or that the food has been exposed to conditions under which a pathogen can increase (Ref.
61). Therefore, if you test for Listeria spp., you should eliminate Listeria spp. regardless of whether
it is L. monocytogenes, and except in certain circumstances described further below (such as when
product testing of sprouts is appropriate as a corrective action), this guidance does not recommend
determining whether identified Listeria spp. is L. monocytogenes. For these reasons, we recommend
that you primarily test your production environment for Listeria spp. rather than L. monocytogenes,
except in certain circumstances described further below.
Testing for Listeria spp. will detect multiple species of Listeria, including L. monocytogenes. A
positive test result for the presence of Listeria spp. on an FCS or non-FCS indicates the potential for
contamination of that surface with L. monocytogenes and suggests that conditions are suitable for
survival and/or growth of L. monocytogenes. A positive test result for the presence of Listeria spp.
on an FCS or a non-FCS does not establish the presence of L. monocytogenes on that surface.
When testing product (e.g., as part of corrective actions), we recommend testing for L.
monocytogenes rather than for Listeria spp. because of the risk to public health from L.
monocytogenes in food. If you choose to test food for Listeria spp. and find it to be positive, we
recommend you determine whether the Listeria spp. is L. monocytogenes or treat the food as if it
were contaminated with L. monocytogenes.

Person(s) Collecting Samples

The person(s) that perform sample collection should be identified in your sampling plan, at least by
title. Sample collection may be performed by, for example, employees or contracted personnel. For a
larger operation, we recommend you assemble a trained Sampling Team to undertake this activity. If
you determine that training is needed to perform sample collection, then this should be specified in
the sampling plan and records should indicate that training was successfully completed. Samples
must be collected aseptically in accordance with § 112.145(d) and, therefore, training in aseptic
techniques may be useful.

Establishing Sample Collection Locations and Frequency
1.

Identifying sample collection locations

You should take a risk-based approach in determining where to sample and test the environment for
the presence of Listeria spp. or L. monocytogenes. This can be accomplished by characterizing the
areas in your operation according to the potential for product contamination. One way of doing this
is to characterize your operation in terms of a zone system. Zone designations for surfaces or areas
reflect how close those surfaces or areas are to a ready-to-eat food (such as sprouts), and the risk the
surfaces or areas pose to food if the surfaces or areas are contaminated with L. monocytogenes. For
example, you could characterize your operation with four zones as shown in Table 2.

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Table 2. Example of Four Sampling Zones in a Sprout Operation
Zones

Description

Examples

Zone 1

Food-Contact Surfaces

Utensils, table surfaces, rotary drums,
growing bins or trays, washing tubs,
spinner/dryer, packaging and conveyors,
hoppers

Zone 2

Non-food-contact surfaces in close
proximity to food and food-contact surfaces

Equipment housing or framework, and
some walls, floors, ceilings or drains in the
immediate vicinity of FCSs

Zone 3

More remote non-food-contact surfaces that
are in or near the production areas and
could lead to contamination of zones 1 and
2

Forklifts, hand trucks and carts that move
within the operation, and some walls, floors
or drains not in the immediate vicinity of
FCSs

Zone 4

Non-food-contact surfaces, remote areas
outside of the production area, from which
environmental pathogens can be introduced
into the production environment

Locker rooms, cafeterias, and hallways
outside the production area or outside areas
where raw materials or finished products
are stored or transported

Establishing a zone system is not a requirement under the Produce Safety Rule, but doing so is
helpful in designing an environmental monitoring plan and determining frequency for sampling
different surfaces in different areas. If you do not establish a zone-based system, you should
otherwise characterize areas where you will collect environmental samples according to potential for
contamination and, at a minimum, you should distinguish between FCSs and non-FCSs.

2.
sites

Number of food contact surface and non-food contact surface sampling

You must specify sample collection sites in your sampling plan, and this must include both FCS and
non-FCS sites (§ 112.145(c)(3)). You should make an extensive list of FCS and non-FCS sites for
potential sampling and include this list as part of your sampling plan. For examples of FCS and nonFCS sampling sites, see Appendix 3 – Potential Sources of L. monocytogenes for Sampling in a
Sprout Operation.
We also recommend that you describe or assign identifiers to each of your sample sites in your
sampling plan, particularly if your operation has more than one possible location that could meet a
site description. For example, if you have three rotary drum growing units, you should consider
assigning unique identifiers (e.g., Growing Unit A, Growing Unit B) to facilitate sample collection
and to be able to associate test results with the correct sample site in order to take appropriate
corrective actions. In addition, you should consider developing a diagram of your operation which
identifies the FCSs and non-FCSs that have been identified as sampling sites.
To determine the appropriate number of FCS and non-FCS sites to sample, you should consider the
size of your operation (e.g., square footage), operation features, equipment design, product flow, the
production methods used to produce the sprouts, and previous sampling results (if any). The number
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of sampling sites must be sufficient to determine whether measures are effective (i.e., to verify the
implementation and effectiveness of sanitation measures for controlling the presence of L.
monocytogenes in the sprout production environment by finding Listeria spp. or L. monocytogenes if
it remains in the sprouting operation after routine cleaning and sanitizing procedures) (§
112.145(c)(3)). We recommend you select a number of sampling locations from the list of FCS and
non-FCS sampling sites to sample at a specified frequency, so that the plan rotates through different
sites over time and all sites get tested within a defined time period. If you are using a zone system,
we recommend that the number of sampling sites be higher in zones 1 and 2 because of the greater
risk of sprout contamination if L. monocytogenes is present in these zones.
While larger sprout operations will likely have more sampling sites than smaller operations, even the
smallest sprout growers should collect samples from at least 5 sites of FCS and 5 sites of non-FCS
from each production area (e.g., each growing room) per sampling event.
As discussed in Section IX.A, L. monocytogenes is widespread in the environment, has been isolated
from sprout production environments, and has been shown to persist in equipment and the production
environment in harborage sites. As a result, even when an operation is cleaning and sanitizing
effectively, you should expect that there will be occasional positives in environmental samples
collected from your operation. As also discussed in Section IX.A, the goals of an environmental
monitoring program should be to find L. monocytogenes and harborage sites if present in your
operation; ensure that corrective actions have eliminated L. monocytogenes and harborage sites when
found in your operation; and verify the effectiveness of your control programs for L. monocytogenes.
If you consistently see negative test results on the sites you are sampling, we recommend that you
revise your environmental monitoring procedures to add, substitute, or both add and substitute other
sites in your plan for sample collection and testing to ensure you are not missing a possible source of
contamination.

Identifying sampling frequency

Your sampling plan must specify how often you will collect environmental samples, which must be
no less than monthly (§ 112.145(c)(2)). Frequency of sampling should be based on risk and depends
on the size and complexity of your operation. Your sampling plan should describe whether you will
collect samples from all sample sites identified as part of the extensive list of potential sampling sites
or from a representative subset of FCS and non-FCS during each sampling event. If you sample and
test a representative set of sites (rather than all sites) each month, we recommend that your written
sampling plan be designed so that all sites that you have identified in your extensive list of potential
sampling sites are tested within a predetermined interval appropriate to your operation (e.g.,
quarterly).
If you are testing a representative subset of FCS and non-FCS sites during each sampling event,
different surfaces should be assigned different frequencies/priorities for sampling based on risk, with
FCSs and certain non-FCSs (i.e., zone 2) being most frequently tested and non-FCSs further from the
production area being least frequently tested (the zone system helps with this type of planning).
Sampling Frequency Example #1:
You evaluate your operation and identify 90 potential sites for sampling (30 FCS, 60 non-FCS), of
which a representative number will be sampled monthly. There are various ways to achieve this.
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•
•
•
•

You might determine, for example, that all FCS sites will be tested at least bi-monthly and all
non-FCS sites will be tested at least quarterly.
In such a case you could choose to, for example, collect 35 monthly samples (from 15 FCS
and 20 non-FCS sites) at one sampling event (e.g., first of every month).
Alternatively, for example, you could choose to collect a certain proportion of those samples
every week, for a total of 35 samples collected over the course of the month (e.g., 5-10
samples each week).
You could not wait, however, for the end of each quarter to collect all 90 samples (e.g.,
sampling January 1 and then waiting until April 1 to sample all 90 sites again) as this practice
would not meet the monthly minimum sampling frequency requirement (§ 112.145(c)(2)).

Sampling Frequency Example #2:
You establish a 4-zone system that prioritizes sampling from Zones 1 and 2. There are various ways
to achieve this.
•
•
•

You might determine, for example, that all FCS sites will be tested at least once a month and
all non-FCS sites will be tested at least quarterly.
In such a case you could choose to, for example, specify sample collection from specific FCS
sites at least once every week, such that all FCS sites in the operation are tested at least once
each month.
As part of such an approach, you might choose to, for example, specify sample collection
from representative sets of non-FCS sites every two weeks for zone 2 sites and monthly for
zone 3 and 4 sites, such that all non-FCS sites identified in your monitoring plan are tested at
least once each quarter.

Timing of Sample Collection

Your sampling plan must specify the point(s) during production at which environmental samples will
be collected (§ 112.145(c)(2)). We recommend you collect environmental samples several hours into
production (e.g., 3 to 4 hours), and preferably towards the end of production, just prior to cleanup.
Collecting your samples toward the end of production allows L. monocytogenes (if present) to work
its way out of harborage sites and into the environment where it can more easily be detected.
Environmental samples should not be taken immediately after surfaces have been sanitized, as the
sanitizer may affect the test results. In addition, environmental samples for identifying L.
monocytogenes should not be confused with other types of samples collected for verification of
cleaning and sanitizing, which are typically collected immediately after sanitizing (e.g., ATP hygiene
monitoring involves the use of a device called a luminometer to measure the combined total ATP of
organic material (food residues and microbial populations) collected from a swabbed surface). See
discussion on verification of cleaning and sanitizing in Section V (Cleaning and Sanitizing) of this
guidance for more information.

Sample Collection and Shipping

Your sampling plan should specify the sampling method you will use and details of your sample
collection procedures. Use of appropriate materials and equipment is particularly important to ensure
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the sample collection is conducted aseptically, as required under § 112.145(d). For more details on
Aseptic Sampling, see Appendix 1. Information on sampling methods and sample collection can be
found in Appendix 2 (Recommended Procedures for Collecting Environmental Samples).
Prior to and during delivery or shipping to a laboratory, samples should be kept refrigerated. Sealed
coolant packs should be used in lieu of ice, as needed during delivery or shipment, to avoid the
possibility of melting ice contaminating the sample. Samples should not be frozen. Samples should
be shipped to the laboratory within 24 hours after sample collection. We recommend that the
maximum timeframe between environmental sampling and analysis of the sample at an external or
internal pathogen testing laboratory be 48 hours.
Prior to sending the samples to a laboratory for testing, you should check to verify that your samples
are clearly identified with all necessary information about the samples and your sprouting operation.
You should specify the microorganism for testing on any laboratory forms.

Testing
1.

Test methods for Listeria spp. or L. monocytogenes

In accordance with § 112.152, the growing, harvesting, packing, and holding environment must be
tested for Listeria spp. or L. monocytogenes using “Testing Methodology for Listeria species or L.
monocytogenes in Environmental Samples” (currently available at
http://www.fda.gov/downloads/Food/FoodScienceResearch/LaboratoryMethods/UCM467056.pdf 6(
§ 112.152(a))) or a scientifically valid method that is at least equivalent to FDA’s method in
accuracy, precision, and sensitivity (§ 112.152(b)).
A common technique is to combine several samples and analyze the mixture (which is referred to as
a “composite”). We do not recommend compositing samples from FCS sites.
If you test sprouts for Listeria monocytogenes as part of your Corrective Actions, we recommend that
you use the procedures described in FDA’s Bacteriological Analytical Manual Online (BAM),
Chapter 10 – “Listeria monocytogenes,” “Detection and Enumeration of Listeria monocytogenes in
Foods” (currently available at:
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071400.htm) 7 for preparing
food samples and testing them for the presence of L. monocytogenes.

Because websites are subject to change, it is possible that this specific website address will change. If you cannot
access this document at that website, alternative websites where you currently can access this document include
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm114664.htm, http://www.fda.gov/Food/Fo
odScienceResearch/LaboratoryMethods/default.htm, and http://www.fda.gov/fsma. Alternatively, you can search on
part or all of the title of the method, in the search box on FDA’s Web site at http://www.fda.gov, or using a
generally available search engine.
7
Because websites are subject to change, it is possible that this specific website address will change. If you cannot
access this document at that website, alternative websites where you currently can access this document include
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm114664.htm, http://www.fda.gov/Food/Fo
odScienceResearch/LaboratoryMethods/default.htm, and http://www.fda.gov/fsma. Alternatively, you can search on

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Alternate methods under § 112.152(b)

If you plan to use a test method other than the one in § 112.152(a) to test the growing, harvesting,
packing, and holding environment for Listeria spp. or L. monocytogenes, it must be a scientifically
valid method that is at least equivalent to the method in § 112.152(a) in accuracy, precision, and
sensitivity, as required under § 112.152(b). We use the term “scientifically valid” to mean an
approach that is based on scientific information, data, or results published in, for example, scientific
journals, references, text books, or proprietary research. Although you are not required to notify or
submit information to FDA prior to using such alternate method, you must establish and keep records
of any such alternate methods that you use (§ 112.150(b)(5)). Such records should include detailed
analytical procedures, results and/or data from validation studies showing equivalence of the
alternate method to the reference method, and any other relevant information supporting the use of
the alternate method.
We recommend use of methods validated through a collaborative study, (currently available at
http://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM298730.pdf) 8, for example per
AOAC Appendix J or ISO 16140:2016. Alternate methods should be validated for Listeria spp. or L.
monocytogenes against FDA’s reference method (§ 112.152(a)) in environmental samples, and
demonstrated to meet the requirements for alternate methods in § 112.152(b) (i.e., demonstrated to be
at least equivalent to the reference method in accuracy, precision, and sensitivity). Methods
validated by third party methods validation organizations such as AOAC Official Methods of
Analysis (OMA), MicroVal, and AFNOR (Association Française de Normalisation) may meet the
requirements in § 112.152(b); however, FDA does not automatically consider methods validated by
third party organizations such as the listed organizations to be equivalent. Information on alternate
methods reviewed by FDA and found to be equivalent will be made available on our website, such as
at such as at http://www.fda.gov/fsma,
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm114664.htm, and
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/default.htm.

Interpreting test results

Testing for Listeria spp. or L. monocytogenes in environmental samples using the FDA reference
method (§ 112.152(a)) can yield one of the following results:
•

A positive result for Listeria spp., which for purposes of the FDA reference method, means
finding the presence of typical colonies on a Listeria specific agar (i.e., completing Steps I.AI.F in the FDA reference method with respect to Listeria) 9.

part or all of the title of the method, in the search box on FDA’s Web site at http://www.fda.gov, or using a
generally available search engine.
8
Alternative websites where you can currently access this document include:
http://www.fda.gov/ScienceResearch/FieldScience/ucm273423.htm and http://www.fda.gov/fsma. Alternatively,
you can search on part or all of the title of the method, in the search box on FDA’s Web site at http://www.fda.gov,
or using a generally available search engine.
9
The FDA reference method provides options for testing for both Listeria spp. and L. monocytogenes. They are
described in the reference method in parallel, such that, for example, step I.E.1 describes part of the procedure for
testing for L. monocytogenes while step I.E.2 describes part of the procedure for testing for Listeria spp. Thus, a

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•

•

A positive result for L. monocytogenes, which can be obtained if a positive result for Listeria
spp., or a presumptive positive result for L. monocytogenes, is followed by confirmatory
steps that result in a confirmed L. monocytogenes cultural isolate (i.e., completing Step I.I in
the FDA reference method).
Two types of negative results can be obtained:
o Listeria specific agars do not yield a positive result for Listeria spp., indicating a
negative finding for Listeria spp.; or
o Additional confirmatory steps after a positive result for Listeria spp. or a presumptive
positive result for L. monocytogenes does not result in confirmation of the presence
of L. monocytogenes, indicating that while Listeria spp. were found, L.
monocytogenes was not found.

You are required to specify the test microorganism (Listeria spp. or L. monocytogenes) in your
sampling plan (§ 112.145(c)(1)). If you choose to establish a sampling plan that specifies testing for
Listeria spp. as we recommend, you are not required to perform confirmatory testing for L.
monocytogenes after obtaining a positive test result for Listeria spp., although you may voluntarily
choose to do so.
If your plan specifies that you will test for Listeria spp. and you conduct testing using the FDA
reference method (Recommended approach):
•
•
•
•

a positive result for Listeria spp. triggers the requirement to take corrective actions under §
112.146;
a negative result for Listeria spp. does not trigger the requirement to take corrective actions
under § 112.146;
if you voluntarily choose to perform confirmatory testing for L. monocytogenes on an
environmental sample that yields a positive result for Listeria spp., a positive result for L.
monocytogenes also triggers the requirement to take corrective actions under § 112.146; and
if you voluntarily choose to perform confirmatory testing for L. monocytogenes on an
environmental sample that yields a positive result for Listeria spp., a negative result for L.
monocytogenes does not trigger the requirement to take corrective actions under § 112.146,
but your positive result for Listeria spp. already triggered that requirement and the L.
monocytogenes negative does not affect that outcome.

If your plan specifies that you will test for L. monocytogenes and you conduct testing using the FDA
reference method:
•
•

a positive result for Listeria spp. triggers the requirement to take corrective actions under §
112.146, and you must continue with confirmatory testing to identify L. monocytogenes as
provided in your sampling plan;
a negative result for Listeria spp. does not trigger the requirement to take corrective actions
under § 112.146;

“positive result for Listeria spp.” refers to completion of the reference method up to step I.F (or G, if applicable)
including all steps relevant to Listeria spp.

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•
•

a positive result for L. monocytogenes triggers the requirement to take corrective actions
under § 112.146; and
a negative result for L. monocytogenes does not trigger the requirement to take corrective
actions under § 112.146, but your positive result for Listeria spp. already triggered that
requirement and the L. monocytogenes negative does not affect that outcome.

Laboratory that conducts testing

You should choose a laboratory that is qualified to test environmental samples for Listeria spp. or L.
monocytogenes (whichever you are testing for). Testing is typically contracted to a third-party
testing laboratory. Testing may also be performed by a sprout operation’s own laboratory (e.g., an
operation’s own “in-house” laboratory). You should use a laboratory that employs scientifically
valid laboratory methods and procedures that can provide reliable, accurate test results. A laboratory
conducting the tests on which you rely might be, but is not required to be, accredited. Using an
accredited laboratory (e.g., a laboratory accredited to International Organization for Standardization
(ISO) Standard 17025) is one way to have confidence that a laboratory will provide reliable, accurate
rest results. Regardless of which laboratory you use, testing must be done using a method as set forth
in § 112.152.

Developing a Corrective Action Plan and Taking Corrective Actions

Your written environmental monitoring plan must also include a corrective action plan that, at a
minimum, requires you to take the actions in § 112.146, and details when and how you will
accomplish those actions, if the growing, harvesting, packing, or holding environment tests positive
for Listeria spp. or L. monocytogenes (§ 112.145(e)). Section 112.146 describes the corrective
actions that you must take if the growing, harvesting, packing, or holding environment tests positive
for Listeria spp. or L. monocytogenes.

Corrective action plan

Your corrective action plan must detail when and how you will accomplish the actions in § 112.146
when required. Having a corrective action plan in place at your operation will help ensure that
corrective actions are taken quickly in response to a finding of Listeria spp. or L. monocytogenes in
the environment. Your corrective action plan:
•

•
•
•

Must specify how and when you will conduct additional testing of surfaces and areas
surrounding the area where the positive test result was detected to evaluate the extent of the
problem, including the potential for Listeria spp. or L. monocytogenes to have become
established in a niche (§ 112.146(a)) (“exploratory testing”);
Must specify how and when you will clean and sanitize the affected surfaces and surrounding
areas (§ 112.146(b));
Must specify how and when you will conduct additional sampling and testing to determine
whether the Listeria spp. or L. monocytogenes has been eliminated (§ 112.146(c)) (“cleaning
verification testing”);
Must specify when and how you will conduct finished product testing when appropriate (§
112.146(d));
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•

•
•

Must indicate that you will perform any other actions necessary to prevent recurrence of the
contamination (§ 112.146(e)) and should specify what some of those actions may be. For
example, you should specify additional steps you will take to determine the source and route
of contamination if your cleaning verification testing yields positive results for Listeria spp.
or L. monocytogenes;
Must specify when and how you will take appropriate action to prevent any food that is
adulterated under section 402 of the FD&C Act from entering into commerce (§ 112.146(f));
and
Should identify the person(s) responsible for corrective actions in your operation and any
specific training that the person(s) should have.

Implementing corrective actions

We recommend that you consider your corrective actions based on whether or not you detected
Listeria spp. or L. monocytogenes and whether or not you detected the organism on an FCS or a nonFCS site (see Table 3 - Corrective Actions when Listeria species is found in an environmental
sample). In the sections below and in Figure 2 (Examples of Non-FCS* testing and follow-up
activities for zone 2) and Figure 3 (Example of FCS* testing and follow-up activities), we describe
corrective action steps based on the combination of organism and location.

a. Corrective actions if you detect Listeria spp. on a non-food-contact
surface
We describe appropriate corrective actions for a positive test result for Listeria spp. from an
environmental sample collected during your routine sampling of a non-FCS site in this section. These
steps are also summarized in Figure 2 (Examples of Non-FCS* testing and follow up activities for
Zone 2). We focus on corrective actions for positives in zone 2, which are in close proximity to food
and food contact surfaces. You must also take corrective actions as required by § 112.146 if a
positive result(s) is obtained in Zones 3 or 4. Corrective actions for non-FCS positives in Zones 3
and 4 may be less rigorous than those for non-FCS positives in Zone 2 provided that all relevant
requirements are met. For example, after obtaining a positive test result in Zone 3 or 4, you must
conduct additional testing (referred to below as “exploratory testing,” see Section IX.J.2.a.i) of
surfaces and areas surrounding the area where Listeria species or L. monocytogenes was detected (§
112.146(a)). However, it would be reasonable to take fewer exploratory samples after a positive in
Zone 3 or 4 compared to a positive test result in Zone 2, especially for Zone 4 positives, as these
have a lower potential to contaminate food or food contact surfaces. You must clean and sanitize the
affected surfaces and surrounding areas (§ 112.146(b)), however the cleaning and sanitizing
conducted might be less aggressive for a positive in Zone 3 or 4 compared to cleaning and sanitizing
for a positive in Zone 2. You must then conduct additional sampling and testing (referred to below as
“cleaning verification testing,” see section IX.J.2.a.i) to determine whether the Listeria species or L.
monocytogenes has been eliminated (§ 112.146(c)), however it would be reasonable to take fewer
samples as a follow-up for a positive in Zone 3 or 4 compared to Zone 2. Finished product testing is
less likely to be necessary in response to a positive in Zone 3 or 4 compared to a positive in Zone 2.
Recommendations in section IX.J.2.a.i below regarding 112.146(e) would still apply to a Zone 3 or 4
positive, and would depend on the number of positives identified during follow up testing.
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The discussion in this section relates only to positive environmental samples on non-FCSs. If you
obtain a positive environmental sample (e.g., Listeria spp.) on an FCS during any of the various
types of follow-up testing to an original positive on a non-FCS (i.e., exploratory testing, cleaning
verification testing, or intensified testing), you should immediately switch to taking corrective
actions appropriate to finding positives on FCSs in section IX.J.2.b. below.

Non-FCS Listeria spp. positive (1st positive)

You should examine the area surrounding the site of the positive test result in all directions for
potential sources of Listeria spp. as described in Appendix 3 (Potential Sources of L. monocytogenes
for Sampling in a Sprout Operation) of this guidance. You should pay particular attention to possible
niches that allow harborage of L. monocytogenes.
Exploratory testing: You must conduct additional testing of surfaces and areas surrounding the area
where Listeria spp. was detected to evaluate the extent of the problem, including the potential for
Listeria spp. or L. monocytogenes to have become established in a niche (§ 112.146(a)).
•

•

•
•

•

Exploratory testing provides you with information about the extent of the problem
represented by the initial positive test result (e.g., whether the presence of Listeria spp. or L.
monocytogenes is isolated or more extensive). The results of exploratory testing should be
used to inform your cleaning and sanitizing (see below, § 112.146(b)). In addition, if you
receive any positive results from your exploratory testing, you should consider conducting
intensified cleaning and sanitizing and intensified sampling and testing (discussed below as a
recommended response to a 2nd positive).
If the original positive test result is from a composite sample, you should either first conduct
additional follow-up testing to identify the specific non-FCS that is contaminated with
Listeria spp. or, alternatively, conduct your exploratory testing as if each non-FCS site
represented by the composite is positive (i.e., conduct exploratory testing of surfaces and
areas surrounding all of the sites represented by the composite).
The exploratory testing samples should include at least 3 to 5 samples from surrounding FCS
and non-FCS sites in close proximity to the positive site.
Exploratory Testing While in Production: If you receive a positive result for a routine
individual sample for a non-FCS site while you are in production (e.g., you are either still
growing the production batch of sprouts that was growing when you took your routine
samples, or you have started another production batch of sprouts), you should conduct
exploratory sampling and testing during that production cycle, provided that you are at least 3
hours into the production cycle.
Exploratory Testing When Not in Production: If you receive a positive result for a routine
sample for a non-FCS site when you are not in production (e.g., the growing unit has already
been cleaned and sanitized from the prior production batch of sprouts and you have not
started the next production batch), you should conduct exploratory sampling and testing at
least 3 hours into the production of the next batch.

Cleaning and sanitizing: You must clean and sanitize the affected surfaces and surrounding areas (§
112.146(b)).

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•

•

You must conduct additional cleaning and sanitizing of the site from which the positive
sample was taken, as well as from the surrounding areas, including both FCS and non-FCS
(whether or not you have already conducted routine cleaning and sanitizing of these
surfaces). You should consider the results of your exploratory testing in determining what
locations should be cleaned and sanitized, and how the cleaning and sanitizing should be
conducted. The site of the initial positive result and the sites of any additional positive
results found during exploratory testing should all be cleaned and sanitized.
You should also consider verifying the efficacy of your cleaning and sanitizing using
additional methods beyond the required testing (§ 112.146(c)) before your next production
run (e.g., ATP testing). See Section V (Cleaning and Sanitizing).

Cleaning verification testing: You must conduct additional sampling and testing to determine
whether the Listeria species has been eliminated (§ 112.146(c)).
•
•
•

Timing: You may conduct your cleaning verification testing at the same time as your next
regularly scheduled environmental sampling event.
If all your cleaning verification tests are negative, you should resume routine environmental
monitoring. We recommend that you target these surfaces where positives have previously
been found for sampling and testing during your next routine environmental sampling event.
If your cleaning verification tests identify another positive result at the site of the initial
positive or in any of that site’s surrounding areas, this should lead you to take further steps
(see below).

ii.
Non-FCS Listeria spp. positive from cleaning verification testing
(2nd positive)
Intensified cleaning and sanitizing: If any of the cleaning verification samples from the initial
positive site or areas around it are positive for Listeria spp., we recommend that, as an action to
prevent recurrence of the contamination (§ 112.146(e)), you perform intensified cleaning and
sanitizing in the affected areas. Intensified cleaning and sanitizing includes sanitation measures that
are performed in addition to normal sanitation procedures and are escalated in response to continued
findings of positive samples. Intensified cleaning and sanitizing can include increasing the frequency
of cleaning and sanitizing for certain pieces of equipment and breaking down the equipment into its
parts for further cleaning. (See Section V (Cleaning and Sanitizing)).
•

We also recommend that you conduct another round of sampling and testing at this stage,
both to verify the effectiveness of your intensified cleaning and sanitizing, and to look for
possible harborage sites in the affected area (see below). Thus, to look for possible
harborage sites, you should sample and test areas of the equipment exposed by disassembly
prior to cleaning and sanitizing the equipment.

Intensified testing: If any of the cleaning verification samples from the initial positive site or areas
around it are positive for Listeria spp., we also recommend that, as an action to prevent recurrence of
the contamination (§ 112.146(e)), you conduct another round of sampling and testing at this stage
(“intensified testing”), both to verify the effectiveness of your intensified cleaning and sanitizing, and
to look for possible harborage sites in the affected area.
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•

•

The follow-up samples should include at least 3 to 5 samples including the initial positive
site, surrounding positive sites identified in cleaning verification testing, and surrounding
FCS and non-FCS sites in close proximity to any positive sites. As appropriate, equipment
should be disassembled during follow-up testing and exposed areas should be sampled and
tested, ideally before such areas are cleaned and sanitized (see above) to help identify
possible harborage sites.
If your intensified sampling and testing results are all negative, you should return to routine
environmental monitoring. We recommend that you target these surfaces where positives
have previously been found for sampling and testing during your next routine environmental
sampling event. If you find another positive result at the site of the initial positive or in any
of that site’s surrounding areas, this should lead you to take further steps (see below).

iii.
Any intensified sampling test Listeria spp. positive (3rd or
subsequent positive)
Additional activities/Comprehensive investigation: If your intensified sampling and testing results in
an additional positive sample(s), as an action to prevent recurrence of the contamination (§
112.146(e)) we recommend that, you conduct additional activities to determine the source and route
of contamination, including activities involved in a comprehensive investigation as discussed in
section IX.J.2.b.i. These actions could vary depending on the risk that an FCS or food could become
contaminated from the positive non-FCS site. Examples of such actions include escalating
mitigation efforts to identify and eliminate the Listeria spp. source, and considering consultation with
a Listeria control expert.
The example in Figure 2 addresses testing and follow-up actions for specific positive finding of
Listeria spp. on a Zone 2 non-FCS during one sampling period. Detecting Listeria spp. at several
non-FCS sampling locations during the same sampling period could indicate that your routine
sanitation procedures are inadequate, and could indicate that the Listeria spp. has become established
in one or more harborages in Zone 2. In such situations, the risk associated with cross contamination
from a contaminated a Zone 2 non-FCS site to FCS (Zone 1) or food increases as the number of
contaminated Zone 2 non-FCS sites increases. When several Zone 2 non-FCS site positives are
detected during one sampling period, we recommend that you review your written sanitation
procedures to identify and implement more effective routine sanitation procedures and escalate your
corrective actions until the situation is resolved.

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Figure 2. Example of Non-FCS* Testing and Follow-Up Activities for Zone 2.

b. Corrective actions if you detect Listeria spp. on a food-contact surface
We describe appropriate corrective actions for a positive test result for Listeria spp. from an
environmental sample collected during your routine sampling of an FCS site in this section. These
steps are also summarized in Figure 3 (Example of FCS* testing and follow-up activities).

FCS Listeria spp. positive (1st positive)

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You should examine the area surrounding the site of the positive test result in all directions for
potential sources of Listeria spp. as described in Appendix 2 (Potential Sources of L.
monocytogenes for Sampling in a Sprout Operation) of this guidance. You should pay particular
attention to possible niches that allow harborage of L. monocytogenes.
Exploratory testing: You must conduct additional testing of surfaces and areas surrounding the area
where Listeria species was detected to evaluate the extent of the problem, including the potential for
Listeria species or L. monocytogenes to have become established in a niche (§ 112.146(a)).
•

•

Exploratory testing provides you with information about the extent of the problem
represented by the initial positive test result (e.g., whether the presence of Listeria spp. or L.
monocytogenes is isolated or more extensive). The results of exploratory testing should be
used to inform your cleaning and sanitizing (see below, § 112.146(b)). In addition, if you
receive any positive results from your exploratory testing, you should consider conducting
intensified cleaning and sanitizing and intensified sampling and testing (discussed below as a
recommended response to a 2nd positive).
You should conduct exploratory sampling and testing of sites that represent a potential source
of the FCS contamination identified by your initial positive FCS result. Conduct exploratory
sampling and testing upstream (i.e., locations in the operation that the product contacts earlier
in the product flow) from the positive FCS in the production area to help identify a source of
contamination.
While in Production: If you receive a positive result for a routine individual sample for an
FCS site while you are in production (e.g., you are either still growing the production batch
of sprouts that was growing when you took your routine samples, or you have started another
production batch of sprouts), you should conduct exploratory sampling and testing during
that production cycle, provided that you are at least 3 hours into the production cycle.
When Not in Production: If you receive a positive result for a routine sample for an FCS site
when you are not in production (e.g., the growing unit has already been cleaned and sanitized
from the prior production batch of sprouts and you have not started the next production
batch), you should conduct exploratory sampling and testing at least 3 hours into the
production of the next batch.

Cleaning and sanitizing: You must clean and sanitize the affected surfaces and surrounding areas (§
112.146(b)).
•

•

You must conduct additional cleaning and sanitizing of the site where the positive sample
was taken, as well as from the surrounding areas, including both FCSs and non-FCSs
(whether or not you have already conducted routine cleaning and sanitizing of these
surfaces). You should consider the results of your exploratory testing in determining what
locations should be cleaned and sanitized, and how the cleaning and sanitizing should be
conducted. The site of the initial positive result and the sites of any additional positive
results found during exploratory testing should all be cleaned and sanitized.
You should also consider verifying the efficacy of your cleaning and sanitizing using
additional methods beyond the required testing (§ 112.146(c)) before your next production
run (e.g., ATP testing); See Section V (Cleaning and Sanitizing).
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Cleaning verification testing: You must conduct additional sampling and testing to determine
whether the Listeria spp. has been eliminated (§ 112.146(c)).
•
•
•

Comprehensive investigation: Following a positive finding of Listeria spp. on an FCS, as an action to
prevent recurrence of the contamination (§ 112.146(e)), you should conduct a comprehensive
investigation to identify and mitigate Listeria sources, and modify procedures where appropriate.
You may need to stop production at your sprout operation in order to conduct the comprehensive
investigation. Such an investigation could involve:
•
•
•
•

Checking maintenance records for modifications or repairs to major equipment;
Interviewing and observing sanitation, maintenance, and production employees to determine
whether appropriate procedures are being followed;
Reviewing production, maintenance, and sanitation procedures to determine whether to
modify the procedures to prevent contamination, and then making those modifications
identified by the review; and
Reviewing traffic patterns, equipment layout, and adherence to employee hygiene
procedures.

Based on the comprehensive investigation described above, you may find there are additional actions
you need to take to prevent recurrence of the contamination (§ 112.146(e)). The following are
examples of potential actions you should consider:
•
•

Check maintenance records for modifications or repairs to major equipment or any other
significant changes in production practices; and
Correct any identified problems (e.g., re-train personnel, revise sanitation procedures, repair
equipment, update maintenance program).

ii.
FCS Listeria spp. positive from cleaning verification test (2nd
positive)
Three production days of intensified cleaning and sanitizing: If any of the cleaning verification
samples from the initial positive site or areas around it are positive for Listeria spp., we recommend
that, as an action to prevent recurrence of the contamination (§ 112.146(e)), you perform intensified
cleaning and sanitizing in the affected areas for the next three production days. Intensified cleaning
and sanitizing includes sanitation measures that are performed in addition to normal sanitation
procedures and are escalated in response to continued findings of positive samples. Intensified
cleaning and sanitizing can include increasing the frequency of cleaning and sanitizing for certain
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pieces of equipment and breaking down the equipment into its parts for further cleaning. (See Section
V (Cleaning and Sanitizing)).
•

We also recommend that you conduct three additional rounds of sampling and testing at this
stage, both to verify the effectiveness of your intensified cleaning and sanitizing, and to look
for possible harborage sites in the affected area (see below). Thus, to look for possible
harborage sites, you should sample and test areas of the equipment exposed by disassembly
prior to cleaning and sanitizing the equipment.

Three production days of intensified testing: If any of the cleaning verification samples from the
initial positive site or areas around it are positive for Listeria spp., we also recommend that, as an
action to prevent recurrence of the contamination (§ 112.146(e)), you conduct three additional rounds
of sampling and testing at this stage (“intensified testing”), for the next three production days both to
verify the effectiveness of your intensified cleaning and sanitizing, and to look for possible harborage
sites in the affected area.
•

Each round of follow-up samples should include at least 3 to 5 samples including the initial
positive site, surrounding positive sites identified in cleaning verification testing, and
surrounding FCS and non-FCS sites in close proximity to any positive sites. As appropriate,
equipment should be disassembled during follow-up testing and exposed areas should be
sampled and tested, ideally before such areas are cleaned and sanitized (see above) to help
identify possible harborage sites.

Finished product testing and other product actions: You must conduct finished product testing when
appropriate (§ 112.146(d)). In the circumstances described here, where you have identified a second
FCS positive result:
•

•

You should test the production batch of sprouts from the production day associated with the
second positive for Listeria spp. on the FCS. You should test the sprouts for L.
monocytogenes using a statistically-based sampling protocol and analytical methods that will
provide an appropriate level of confidence in these results (e.g., 95% confidence that you will
detect L. monocytogenes in the sample if present). While these test results are pending, and
while you are taking the other steps recommended in this section (i.e., three production days
of intensified cleaning and sanitizing, three production days of intensified sampling and
testing, receiving results from such testing, conducting a comprehensive investigation), you
should not allow the production batch of sprouts to enter commerce.
You should also prevent the production batches of sprouts from the second and third
production days from entering commerce while you are taking the other steps recommended
in this section (three production days of intensified cleaning and sanitizing, three production
days of intensified sampling and testing, receiving results from such testing, and conducting a
comprehensive investigation).

Comprehensive investigation: Following a positive finding of Listeria spp. on an FCS, as an action to
prevent recurrence of the contamination (§ 112.146(e)), you should conduct a comprehensive
investigation to identify and mitigate Listeria sources, and modify procedures where appropriate.
You may need to stop production at your sprout operation in order to conduct the comprehensive
investigation. For more information on comprehensive investigations, see section IX.J.2.b.i above.
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Negative Results from Intensified Testing and Finished Product Testing: If all results from your
three production days of intensified testing are negative, and your finished product testing is also
negative, you should return to routine environmental monitoring. It would be reasonable to allow all
three production days’ worth of sprouts to enter commerce at this point, provided there is no other
reason for concern (e.g., other testing requirements in § 112.147 have been satisfied for these
batches). We recommend that you target these surfaces where positives have previously been found
for sampling and testing during your next routine environmental sampling event.
Positive Results from Intensified Testing and/or Finished Product Testing: If any of the intensified
testing results, or product testing results, are positive, this should lead you to take further steps (see
below).

iii.
Product L. monocytogenes positive and/or any intensified sampling
test Listeria spp. positive (3rd or subsequent positive)
Stop production and investigate: If your intensified sampling and testing again detects Listeria spp.
on an FCS and/or a non-FCS site, and/or you detect L. monocytogenes in your product (third or
subsequent positive), you should assume that you have a harborage site. As an action to prevent
recurrence of the contamination (§ 112.146(e)), you should stop production, destroy and/or consider
recalling any potentially contaminated sprouts (or other food) (see “Product Actions” below) and
consult food safety experts familiar with troubleshooting L. monocytogenes contamination problems
in operations to conduct a comprehensive investigation and make recommendations for appropriate
actions to take based upon that investigation.
Product Actions: You must take appropriate action to prevent any food that is adulterated under
section 402 of the FD&C Act from entering into commerce (§ 112.146(f)).
•

•

If your production batch of sprouts tests positive for L. monocytogenes, § 112.146(f) requires
you to prevent it from entering into commerce. We recommend that you destroy any such
production batch. If you have held batches of sprouts from your two subsequent production
days, you should consider the possibility that those production batches may also be
adulterated, depending on the circumstances. If those batches are adulterated, § 112.146(f)
requires you to prevent them from entering into commerce. Moreover, we recommend that
you destroy any such batches in light of the positive finding of L. monocytogenes in the first
batch, combined with the earlier positive findings in your environment.
If any of the samples from the three production days of intensified sampling and testing of
FCS and non-FCS sites for Listeria spp. is positive, you should consider the possibility that
the production batches representing all three of those days of production may also be
adulterated, depending on the circumstances. If the batches are adulterated, § 112.146(f)
requires you to prevent them from entering into commerce. Moreover, we recommend that
you destroy any such batches in light of all of the positive findings in your environment.
In both of these circumstances, you should also evaluate whether any other production
batches of sprouts (either at your operation or in distribution) should be recalled or destroyed.

Returning to production: After all of these corrective actions have been taken and production begins
again, you should take action to prevent your new production batches of sprouts from entering
commerce until further steps are taken. We recommend that you test each production batch of
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sprouts, and conduct intensified sampling and testing on each production day, until you have three
consecutive days of negative test results for FCSs, non-FCSs, and sprouts.

c. Additional considerations for if you detect Listeria spp. on a food-contact
surface with continuous contact with sprouts that are being mixed (e.g., rotary
drum growing units)
If you obtain a positive for Listeria spp. from an FCS with continuous contact with sprouts that are
also being mixed (e.g., FCS from a rotary drum growing unit), there is a heightened risk that your
sprouts may be contaminated with L. monocytogenes (as compared to finding Listeria spp. on FCSs
that do not continuously contact sprouts while they are also being mixed, such as surfaces of
stationary tray growing units). As a result, we recommend that you take additional corrective actions
in response to such a finding, beyond those already discussed above.
If you receive notification of a positive test result for Listeria spp. from an environmental sample
from an FCS collected during your routine sampling (i.e., a first environmental positive from such a
site), you should take all corrective actions described above and should also take action to prevent the
production batch of sprouts associated with the positive sample site (i.e., the production batch of
sprouts that was grown in the rotary drum where the positive Listeria spp. was identified and any
other potentially affected product) from entering commerce while you take the following steps:
•

•

Conduct exploratory testing as described above (§ 112.146(a)). If your exploratory testing
yields additional positives for Listeria spp., you should conduct intensified cleaning and
sanitizing, and intensified testing, for three consecutive production days (as described above
as a recommended response to a 2nd positive on an FCS site). If any of your intensified
testing yields a positive result, you should proceed to the corrective actions recommended
above for a 3rd positive on an FCS site.
Further analyze the sample that was positive for Listeria spp. to determine whether the
Listeria identified is L. monocytogenes. If you determine the sample is positive for L.
monocytogenes, § 112.146(f) requires you to take appropriate action to prevent the
production batch of sprouts grown in the affected rotary drum from entering commerce. We
recommend that you destroy any such product.
If all of your intensified testing of the environment for Listeria spp. for 3 consecutive
production days, and L. monocytogenes finished product testing is negative, it would be
reasonable at that time to allow the production batch of sprouts grown in the rotary drum at
issue to enter commerce, and to return to routine sampling and testing.

The example in Figure 3 addresses testing and follow-up actions for specific positive finding of
Listeria spp. on an FCS during one sampling period. Detecting Listeria spp. at several FCS sampling
locations during the same sampling period could indicate that your routine sanitation procedures are
inadequate, and could indicate that the Listeria spp. has become established in one or more harborage
sites. In such situations, the risk associated with cross contamination from contaminated FCS sites to
food increases as the number of contaminated FCS sites increases. When several FCS site positives
are detected during one sampling period, we recommend that you immediately review your written
sanitation procedures to identify and implement more effective routine sanitation procedures,
escalate your corrective actions, and identify and eliminate the Listeria spp. source(s).
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If you find Listeria spp. on FCS sites in the same general area on multiple occasions, we recommend
that you evaluate why this area continues to be a source of positive results and take actions to
eliminate the contamination, such as by determining the efficacy of your sanitation procedures and
modifying them as necessary.

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Figure 3. Example of FCS* Testing and Follow-Up Activities

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Table 3. Corrective Actions when Listeria Species is Found in an Environmental Sample
Non-FCS
Routine
sampling
positive #1

•

Exploratory testing (§
112.146(a))

•

Clean and sanitize area of
positive(s) (§ 112.146(b))

•

Cleaning verification
testing (may be during next
routine sampling event) (§
112.146(c))

•

Cleaning
verification
sampling
positive #2

FCS

•

*If exploratory testing
yields positives, consider
moving to recommended
corrective actions for
positive #2 below.

Intensified cleaning and
sanitizing (including
disassembly of equipment)
(§ 112.146(e))
Intensified sampling and
testing (§ 112.146(e))

100

•

Exploratory testing (§ 112.146(a))

•

Clean and sanitize area of positive(s)
(§ 112.146(b))

•

Cleaning verification testing (may be
during next routine sampling event)
(§ 112.146(c))

•

Comprehensive investigation (§
112.146(e))

•

*If exploratory testing yields
positives, consider moving to
recommended corrective actions for
positive #2 below.

•

*For continuous contact/mixing FCS
positives, see additional
recommendations in J.2.c of this
document.

•

Intensified cleaning and sanitizing
(including disassembly of equipment)
(§ 112.146(e))

•

Intensified sampling and testing (§
112.146(e))

•

Test product and prevent it from
entering commerce (§ 112.146(d))

•

Comprehensive investigation (§
112.146(e))

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Non-FCS
Intensified
sampling
positive #3

•

FCS

Additional activities to
determine source(s) and
route(s) of contamination (§
112.146(e))

•

Stop production and consult experts
for comprehensive investigation (§
112.146(e))

•

Intensified cleaning and sanitizing
(escalated, e.g., steam equipment) (§
112.146(e))

•

Intensified sampling and testing (§
112.146(e))

•

Resume production, preventing entry
of product into commerce and
product testing until 3 consecutive
days of product, FCSs, and non-FCSs
are negative (§ 112.146(e))

d. Corrective actions if you detect Listeria monocytogenes on a food-contact
or non-food contact surface
In general, we expect that sprout operations will test FCS and non-FCS sites for Listeria spp. rather
than L. monocytogenes. There is likely minimal value in determining whether Listeria spp. is L.
monocytogenes because, typically, you should focus on eliminating the Listeria spp. regardless of
whether it is L. monocytogenes. However, in certain cases you should consider conducting further
tests to determine whether the Listeria spp. positive in your environmental samples is L.
monocytogenes. One example of such a situation is described above in section IX.J.2.c for
continuous contact/mixing FCS positives.
If you detect L. monocytogenes on an FCS, § 112.146(f) requires to you take appropriate action to
prevent any food that is adulterated under section 402 of the FD&C Act from entering into
commerce. Depending on the circumstances, you may have production batches of sprouts that are
adulterated under section 402(a)(4) of the FD&C Act because of their association with the affected
FCS location. We recommend that you destroy any potentially affected production batch of sprouts
(or other food) associated with the contaminated FCS (as part of a recall, if applicable) and follow
procedures outlined above (see “returning to production” in discussion of recommended corrective
actions for a 3rd positive on an FCS).

Voluntary Periodic Sampling and Testing of Sprouts

Periodic sampling and testing of sprouts that you produce can provide a historical reference of
baseline performance for your operation and verify the adequacy of your control of L.
monocytogenes over time. We recommend that you establish and implement written procedures for
periodic sampling and testing finished sprouts for the presence of L. monocytogenes. We
recommend that you test food products for L. monocytogenes rather than for Listeria spp. because of
the risk to public health from L. monocytogenes in food. If you choose to test food for Listeria spp.
and find it to be positive, we recommend you determine whether the Listeria spp. is L.
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monocytogenes or treat the food as if it were contaminated with L. monocytogenes. We recommend
that you take action to prevent all product that is represented by the sprouts you test from entering
commerce while results are pending (e.g., the full production batch and any other food produced
during the same period from cleanup to cleanup). We recommend that your written procedures
include the frequency of this sampling (e.g., monthly, quarterly) and the sampling plan to ensure the
sample collected is representative of the production batch of sprouts. The ideal frequency of
sampling and sampling plan should also reflect factors such as any relevant customer requirements
and the frequency of detection of Listeria spp. in your environmental samples. Note that
recommendations pertaining to voluntary testing for other pathogens besides L. monocytogenes (in
addition to the required testing in § 112.144(b)) in spent sprout irrigation water, in-process sprouts,
or finished sprouts are discussed in Section VIII (Sampling and Testing of Spent Sprout Irrigation
Water or In-Process Sprouts).

Analysis of Data for Trends

To make the best use of the data that you collect through your environmental monitoring program,
we recommend that you analyze the data (e.g., sample results, corrective actions, findings from
comprehensive investigations) from your environmental monitoring program over time for trends
that can help you to continuously improve sanitation conditions in your operation by reducing the
percentage of overall positive environmental samples in your operation. This trend analysis could
provide evidence that L. monocytogenes in your operation is not being controlled (e.g., if a resident
strain has become established in a niche environment) so that you can take steps to control it.
Examples of trends that could indicate that L. monocytogenes in your plant is not being controlled
are:
•
•
•

Finding Listeria in the same area on multiple but non-consecutive sampling occasions (e.g.,
positive one week and negative the next, appearing to be isolated positives);
An increase in the percentage of overall positives in the establishment; and
Increases in positive environmental samples in particular sites or areas.

Even if you have taken appropriate corrective actions for individual positive results from a particular
area, the continued finding of Listeria spp. positives in that area over time may indicate a continuing
problem such as an unidentified harborage site. If your analysis of data indicates a potential
problem, such as an increased incidence of Listeria species in your operation, you should conduct a
more complete investigation to determine if further actions are warranted and take appropriate
corrective actions to reduce the incidence of Listeria species in your operation. We recommend that
you establish and maintain a record of any trend analysis that you conduct. The trend analysis may
also lead you to update your written environmental monitoring plan.

Recordkeeping

Section 112.150 describes records that you must establish and maintain related to sprouts. For more
information on the recordkeeping requirements, see the Section X (Recordkeeping). Specifically,
you must establish and maintain the following records related to environmental monitoring:
•

Your written environmental monitoring plan, including your sampling plan and corrective
action plan, in accordance with the requirements of § 112.145 (§ 112.150(b)(2));
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•

Documentation of the results of all analytical tests (§ 112.150(b)(4)). The results of all
analytical tests must be documented, regardless of whether they were conducted by your own
(e.g., in-house) laboratories or third-party laboratories. Records of environmental monitoring
tests must include the following information, in accordance with § 112.161(a)(1):
o The name and location of your operation;
o Actual values and observations obtained;
o An adequate description of covered produce applicable to the record (e.g., production
batch number of sprouts in production at the time of the environmental sample);
o Location of the growing area or other area(s) applicable to the record (e.g.,
identification of each sampling site, including whether it is an FCS or non-FCS site);
and
o Date and time of the activity documented (e.g., date/time of sample collection, and
sample receipt and analysis by the testing lab).

•

Records of any analytical methods you use in lieu of the methods that are incorporated by
reference in § 112.152(a) (§ 112.150(b)(5)). Such records should include analytical
procedures, as well as information relevant to the determination of the scientific validity of
the alternate method. If you use the method listed in § 112.152(a), keeping records of your
use of this test method, although not required, would be helpful to demonstrate compliance;
and
Documentation of corrective actions you take in accordance with § 112.146 (§
112.150(b)(6)). Records of corrective actions must include the following information, in
accordance with § 112.161(a)(1):
o The name and location of your operation;
o Actual values and observations obtained (e.g., observations and information related to
a comprehensive investigation following repeated Listeria spp. positives on an FCS,
such as the food and food contact surfaces potentially affected by the contamination
event);
o An adequate description of covered produce applicable to the record (e.g., production
batch number of sprouts in production at the time of the corrective action);
o Location of a growing area or other area(s) applicable to the record (e.g.,
identification of locations sampled for follow-up testing or intensified cleaning and
sanitizing); and
o Date and time of the activity documented (e.g., date/time of follow-up testing or
intensified cleaning and sanitizing).

In addition, such records must be dated, and signed or initialed by the person who performed the
activity documented (e.g., the individual who performed the corrective action) as required under
§ 112.161(a)(4). Also, as required under § 112.161(b), these records must be reviewed, dated,
and signed, within a reasonable time after the records are made, by a supervisor or responsible
party.
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Recordkeeping

Records are an essential component of safely growing, harvesting, packing, and holding food,
including sprouts. Records can be used to ascertain safety of products, monitor storage conditions,
document good agricultural practices, and track receipt and distribution of product(s). Records also
offer written evidence that operational processes are being properly followed and are under control.
They may also be used to help determine the cause of underlying problems in the event of an
outbreak or recall.
In this section, we provide a brief overview of certain aspects of the recordkeeping requirements in
the Produce Safety Rule for sprout operations covered by Subpart M.

Recordkeeping Overview
1.

General requirements

Except as otherwise specified, the requirements of Subpart O apply to all records that are required
under the Produce Safety Rule. All required records must include, as applicable and unless otherwise
specified:
•
•
•
•
•

The name and location of your sprout operation (§ 112.161(a)(1)(i));
Actual values and observations obtained during monitoring (§ 112.161(a)(1)(ii));
An adequate description (such as the commodity name, or the specific variety or brand name
of a commodity, and, when available, any lot number or other identifier) of covered produce
applicable to the record (§ 112.161(a)(1)(iii));
The location of a growing area or other area (for example, a specific packing shed) applicable
to the record (§ 112.161(a)(1)(iv)); and
The date and time of the activity documented (§ 112.161(a)(1)(v)).

Required records must also:
•
•
•

Be created at the time an activity is performed or observed (§ 112.161(a)(2));
Be accurate, legible, and indelible (§ 112.161(a)(3)); and
Be dated, and signed or initialed by the person who performed the activity documented (§
112.161(a)(4)).

Actual Values and Observations
Section 112.161(a)(1)(ii) requires records to include, as applicable, the actual values and
observations obtained during monitoring. “Actual values and observations” means: (a) the value or
observation, as applicable, itself is written, e.g., 96°F; and (b) truthful information is recorded. For
example, if a batch of sprouts tests positive for Salmonella, a person must not write on the test results
that the sample of spent sprout irrigation water was negative for Salmonella. Observation records
can take many forms, including photographs. For example, if you are documenting a repair you are
conducting, we recommend taking pictures before and after the repair.

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Date and Time
As applicable, the date and time of the documented activity must be written on the records as
required under § 112.161(a)(1)(v). This information not only shows when something happened, it
can also help demonstrate that an operation consistently followed its written plans and procedures.
Records must also be created at the time that an activity is performed or observed under §
112.161(a)(2). You must not pre-fill records, nor rely on your memory to write down the
information later.
Adequate Description of Covered Produce Applicable to the Record
An adequate description of covered produce applicable to the record is required under §
112.161(a)(1)(iii). For sprouts, an adequate description of covered produce should include the
product name (including the commodity/product name, or the specific variety or brand name) and
any number or other identifier that your operation uses to identify the product. We recommend that
you assign a unique identifier for each individual production batch of sprouts (as that term is defined
in § 112.3 and relates to various requirements in Subpart M, such as the spent sprout irrigation water
or sprout testing required for each production batch of sprouts under § 112.144(b)). Using unique
production batch numbers and including them on all applicable records helps enable a sprout
operation to track any production batch internally and through distribution in the event there is a
problem with a production batch of sprouts. If you use additional identification systems (e.g., for
product that has been packaged for sale), then you should be able to link the information used in
those additional identification systems to each associated production batch of sprouts. For
example, you may combine product from Production Batch “A” with Production Batch “B”
during packaging, and assign an additional identifier (e.g., #1234) to the final packaged product.
In this example, you should be able to (e.g., through records or a coding scheme) use the
additional identifier (#1234) to identify each production batch that is a component of the final
product (i.e., Production Batches A and B).
For each production batch of sprouts, we also recommend that you keep records of the following
information, as applicable:
•
•
•
•
•
•

The seed lot number(s) for the seeds used to grow the production batch of sprouts (so that the
seeds that were used to grow each production batch of sprouts can be easily and reliably
identified in the event of a problem);
Container size/type;
Date packaged;
Number of units packaged;
Holding area; and
Any other comments and information that may be useful in the event of a problem.

We also recommend that, for records of seed treatments that you perform at your operation to reduce
microorganisms of public health significance (§§ 112.142(e)(1) and 112.150(b)(1)), you include a
description of the seeds to which the record relates. Such a description should include the type of
seeds treated, and the seed lot number (see also Section VII.D (Seeds for Sprouting – Recordkeeping)
of this guidance for more information on seed treatment records).
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Location of growing area or other area applicable to the record
As applicable, the location of the growing area or other area applicable to the record must be
included in the record under § 112.161(a)(1)(iv). For example, a sprout operation’s growing area
could be the specific sprouting room in which a batch of sprouts is grown. Other areas applicable to
the batch record could include the designated seed treatment area, or a particular packing line used
for that batch of sprouts. If you have diagrams of your sprout operation, it is desirable for the
locations on the records to match the descriptions in your diagrams, as appropriate.
Accuracy, Legibility, Indelibility
Required records must be accurate, legible, and indelible under § 112.161(a)(3). If mistakes are made
on a record, they should be marked through with a single line and initialed and dated by the person
making the correction. The correct information should be written adjacent to it. The person
correcting the record should not write over existing information, obscure it by scratching it out, or
use liquid correction fluid. While handwriting styles may vary, the information on a required record
must be legible so that company officials and regulatory agencies, as appropriate, can review it.
Information must be written in an indelible manner, e.g., written in ink, so that it cannot be erased.
Dated, and Signed or Initialed by the Person Who Performed the Activity
The individual who performed the activity documented is required to date, and sign or initial the
required record under § 112.161(a)(4). Examples of individuals who perform the activity requiring a
record include the person inspecting the agricultural water system (for records required under §
112.50(b)(1)), a worker sanitizing equipment used for growing sprouts (for records required under §
112.140(b)(1)), or a laboratory analyst testing sprout spent sprout irrigation water samples for
microbiological contamination (for records required under § 112.150(b)(4)).

Duplication not required

Section 112.163(a) provides that you are not required to duplicate any existing records if those
records contain all of the required information and satisfy the requirements of the Produce Safety
Rule. Similarly, if you have records containing some but not all of the required information, §
112.163(b) provides you the flexibility to keep any new information required either separately or
combined with your existing records, even where the formats for each record may not be the same.

Record retention and availability

Required records must be kept for at least 2 years past the date the record was created (§
112.164(a)(1)).
Records that relate to the general adequacy of equipment or processes or records that relate to
analyses, sampling or action plans being used by a farm, including the results of scientific studies,
tests, and evaluations, must be retained at the sprout operation for at least 2 years after the use of
such equipment or processes, or records related to analyses, sampling, or action plans, is
discontinued (§ 112.164(b)). Examples of such records for a sprout operation include: the written
sampling plan for spent sprout irrigation water or sprouts including the corrective action plan (§§
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112.147(a) and (c); 112.150(b)(3)), and the written environmental monitoring plan including the
corrective action plan (§§ 112.145(a) and (e); 112.150(b)(2)).
For sprout operations that are eligible for the qualified exemption in accordance with § 112.5,
records that you rely on during the 3-year period preceding the applicable calendar year to satisfy the
criteria for a qualified exemption, in accordance with §§ 112.5 and 112.7, must be retained as long as
necessary to support your exemption status during the applicable calendar year (§ 112.164(a)(2)).
In addition, you must have all required records readily available and accessible during the retention
period for inspection and copying by FDA upon oral or written request, except that you have 24
hours to obtain records you keep offsite and make them available and accessible to us for inspection
and copying (§ 112.166(a)). Offsite storage of required records is permissible, provided such records
can be retrieved and provided onsite within 24 hours of request for official review (§ 112.162(a)).
Electronic records are considered to be onsite at your farm if they are accessible from an onsite
location at your farm (§ 112.162(b)).

Format

As required by § 112.165, you must keep records as: (1) original records; (2) true copies; or (3)
electronic records. “True copies” include, for example, photocopies, pictures, scanned copies,
microfilm, microfiche or other accurate reproductions of the original records. True copies of records
should be of sufficient quality to detect whether the original record was changed in a manner that
obscured the original entry (e.g., through the use of liquid correction fluid). “Electronic records” are
subject to the same requirements under the Produce Safety Rule as paper records. We are not
requiring electronic records, nor are we specifying the form or format of the records that must be
established and maintained except as otherwise set forth in Subpart O (e.g., certain content is
required when applicable as discussed in Section X.A.1 above). To satisfy the requirements of the
produce safety regulation, paper or electronic records or a combination of the two may be used.
Records that are established or maintained to satisfy the requirements of part 112 and that meet the
definition of electronic records in § 11.3(b)(6) are exempt from the requirements of part 11
(Electronic Records; Electronic Signatures). Records that satisfy the requirements of part 112, but
that also are required under other applicable statutory provisions or regulations, remain subject to
part 11 (§ 112.165(c)).
Although part 11 does not apply, except for records otherwise subject to part 11 (as provided in §
112.165(c)), covered sprout operations should take appropriate measures to ensure that electronic
records are trustworthy, reliable, and generally equivalent to paper records and handwritten
signatures executed on paper. Also, as noted above, electronic records are subject to the same
requirements in part 112 as paper records, including requirements for making records available and
accessible to FDA (§ 112.166) and retention requirements (§ 112.164).

Sprouts-Specific Record Requirements

The following recordkeeping requirements apply to growing, harvesting, packing, and holding of
sprouts covered by Subpart M.

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Records related to seed treatment: Section 112.150(b)(1) requires that you establish and
keep documentation of your treatment of seeds to reduce microorganisms of public health
significance in the seeds, at your farm; or alternatively, documentation (such as a Certificate
of Conformance) from your seed supplier that seeds are treated to reduce microorganisms of
public health significance and are appropriately handled and packaged following the
treatment, in accordance with the requirements of § 112.142(e).
o See section VII.D of this guidance for discussion of required and recommended
content for these records.
Written environmental monitoring plan, including corrective action plan: Section
112.150(b)(2) requires sprout operations to establish and keep a written environmental
monitoring plan, in accordance with § 112.145, which is designed to identify Listeria
monocytogenes if it is present in the growing, harvesting, packing, or holding environment.
Your environmental monitoring plan must be directed to sampling and testing for either
Listeria species or L. monocytogenes and your written environmental monitoring plan must
include a sampling plan and a corrective action plan, including actions described in §
112.146.
o See Section IX (Environmental Monitoring) of this guidance for discussion of
required and recommended content for these records.
Written sampling plan for testing spent sprout irrigation water (or, where that is not
practicable, sprouts) from each production batch of sprouts, including corrective action
plan: Section 112.150(b)(3) requires that you establish and keep a written sampling plan for
each production batch of sprouts, in accordance with § 112.147(a) and (c). Your corrective
action plan must, at a minimum, require you to take the actions in § 112.148, and detail when
and how you will accomplish those actions, if the samples of spent sprout irrigation water or
sprouts test positive for E. coli O157:H7, Salmonella spp., or a pathogen meeting the criteria
in § 112.144(c).
o See Section VIII (Sampling and Testing of Spent Sprout Irrigation Water or InProcess Sprouts) of this guidance for discussion of required and recommended
content for these records.
Documentation of analytical test results for all testing done under Subpart M: Section
112.150(b)(4) requires records of all analytical tests conducted for purposes of compliance
with subpart M. This includes, e.g., records of test results from:
o Environmental testing for Listeria spp. or L. monocytogenes under §§ 112.144(a) and
112.145;
o Testing spent sprout irrigation water (or sprouts) from each production batch of
sprouts for E. coli O157:H7, Salmonella spp., and any pathogen meeting the criteria
in § 112.144(c) under §§ 112.144(b) and 112.147;
o Any additional testing conducted if you detect Listeria spp. or L. monocytogenes in
the environment under § 112.146 (a), (c), (d), and (e) (see also § 112.150(b)(6)
below);
o Any additional testing conducted if you detect E. coli O157:H7, Salmonella spp., or
any pathogen meeting the criteria in § 112.144(c) in spent sprout irrigation water or
sprouts under § 112.148(d) (see also § 112.150(b)(6) below); and
o Any testing conducted as part of follow-up actions related to suspected contamination
of a seed lot with a pathogen under § 112.142(c)(2) (see also § 112.150(b)(6) below).
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Documentation of analytical methods used in lieu of those incorporated by reference in
the rule for sprout-specific testing requirements: Section 112.150(b)(5) requires sprout
operations to establish and keep documentation of any analytical methods used in lieu of the
methods for both environmental testing and sprout production batch testing that are
incorporated by reference in §§ 112.152 and 112.153.
o In the event that other pathogens meet the criteria in § 112.144(c), thereby requiring
you to test spent sprout irrigation water or sprouts for such pathogens using a
scientifically valid method (§§ 112.144(b) and 112.153(b)), we recommend that you
establish and maintain a record of the method used for such testing.
Corrective action records: Section 112.150(b)(6) requires records of corrective actions
conducted in accordance with the requirements of §§ 112.142(b) and (c), 112.146, and
112.148:
o See Section VII.D (Seeds for Sprouting – Recordkeeping) of this guidance for
discussion of required and recommended content for records related to corrective
actions for possible contamination of a seed lot (§§ 112.142(b) and (c))
o See Section IX (Environmental Monitoring) of this guidance for discussion of
required and recommended content for records related to corrective actions if the
growing, harvesting, packing, or holding environment tests positive for Listeria
species or L. monocytogenes (§ 112.146).
o See Section VIII (Sampling and Testing of Spent Sprout Irrigation Water or InProcess Sprouts) of this guidance for discussion of required and recommended
content for records related to corrective actions if samples of spent sprout irrigation
water or sprouts test positive for E. coli O157:H7, Salmonella spp., or a pathogen
meeting the criteria in § 112.144(c) (§ 112.148).

Other Required Records

The records required under the Produce Safety Rule are dependent, in part, on the nature of practices
and procedures related to the covered activities in your operation, and are listed under the applicable
sections of part 112, including in Subparts A, C, E, F, L, and M (i.e., §§ 112.2(b)(4), 112.7, 112.30,
112.50, 112.60, 112.140, and 112.150). Required records that are specific to sprout operations are
discussed above in Section X.B (records required under § 112.150 for sprouts subject to subpart M).
Records required under other subparts of the Produce Safety Rule that may be relevant to sprout
operations are identified briefly below.
•

•

Records relating to commercial processing exemption: Section 112.2 requires farms
relying on the exemption for produce that receives commercial processing that adequately
reduces the presence of microorganisms of public health significance to establish and
maintain documentation of their required disclosures to customers and annual written
assurances obtained from customers.
Records relating to eligibility for qualified exemption: Section 112.7 requires farms
eligible for the qualified exemption in accordance with § 112.5 to establish and keep
adequate records necessary to demonstrate that the farm satisfies the criteria for a qualified
exemption (e.g., dated sales receipts), including a written record reflecting that the owner,
operator, or agent in charge of the farm has performed an annual review and verification of
the farm’s continued eligibility for the qualified exemption.
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Training records: Section 112.30 requires you to establish and keep records of training that
document required training of personnel, including the date of training, topics covered, and
the persons(s) trained.
• Records related to agricultural water:
o Section 112.50(b)(1) requires you to establish and keep records of your agricultural
water system inspection findings in accordance with the requirements of § 112.42(a).
o
Section 112.50(b)(2) requires documentation of the results of all analytical tests
conducted on agricultural water for purposes of compliance with Subpart E.
o Section 112.50(b)(3) requires documentation of scientific data or information relied
on to support the adequacy of a method used to satisfy the requirements of §§
112.43(a)(1) and (a)(2) for treating agricultural water. All covered farms that treat
their water to achieve a water quality requirement in the Produce Safety Rule are
required to keep these records of the science supporting their agricultural water
treatment method(s).
o Section 112.50(b)(4) requires documentation of results of monitoring water treatment
under § 112.43(b). All covered farms that treat their water to achieve a water quality
requirement in the Produce Safety Rule are required to keep these records of the
results of their water treatment monitoring.
o Section 112.50(b)(6) requires you to establish and keep documentation of actions you
take when your agricultural water does not meet the water quality requirements in the
Produce Safety Rule in accordance with § 112.45. For example, if you determine that
water you use for a purpose listed in § 112.44(a) does not meet the microbial quality
criterion established in that section, § 112.45(a) provides that you must take certain
steps as a result, and § 112.50(b)(6) requires you to keep records documenting the
steps that you took.
o Section 112.50(b)(7) requires annual documentation of the results or certificates of
compliance from a Public Water System required under § 112.46(a)(1) or (a)(2), if
applicable. All covered farms that rely on the exemption from agricultural water
testing requirements for water furnished by a public water system or public water
supply are required to keep these records demonstrating that the water supplied by the
public entities meets relevant requirements.
o Section 112.50(b)(9) requires you to establish and keep documentation of any
analytical methods that you choose to use for agricultural water testing in lieu of the
method that is incorporated by reference in § 112.151(a).
Records related to biological soil amendments of animal origin: Section 112.60 requires you
to establish and keep certain documentation relating to any treated biological soil amendments of
animal origin (BSAAO) you use (e.g., substrates). The required records differ based on whether
treatment was conducted by the sprout operation or by a third party. For a treated BSAAO
supplied by a third party, you are required to establish and keep documentation (such as a
Certificate of Conformance) at least annually that the process used to treat the BSAAO is a
scientifically valid process that has been carried out with appropriate process monitoring, and
that the BSAAO has been handled, conveyed, and stored in a manner and location to minimize
the risk of contamination by an untreated or in process BSAAO (§ 112.60(b)(1)). For a treated
BSAAO you produce for your own covered farm(s), you are required to establish and keep
documentation that process controls were achieved (§ 112.60(b)(2)).
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Records of cleaning and sanitizing: Section 112.140 requires you to establish and keep
documentation of the date and method of cleaning and sanitizing of equipment subject to subpart
L used in growing, harvesting, packing, or holding sprouts.

Supervisory Review of Records

Certain required records must be reviewed, dated, and signed by a supervisor or a responsible party
within a reasonable time after the records are created (§ 112.161(b)). These records include:

•
•
•
•
•
•
•
•
•
•

As applicable, records related to eligibility for the qualified exemption (§ 112.7(b));
Records related to required training of personnel (§ 112.30(b)(2));
As applicable, documentation of the results of all agricultural water testing (§ 112.50(b)(2));
As applicable, documentation of the results of water treatment monitoring (§ 112.50(b)(4));
As applicable, documentation of actions you take in when your agricultural water does not
meet the water quality requirements in the Produce Safety Rule (§112.50(b)(6));
As applicable, for a treated biological soil amendment of animal origin you produce for your
own covered farm(s), documentation that process controls were achieved (§ 112.60(b)(2));
Documentation of cleaning and sanitizing of equipment (§§ 112.140(b)(1) and (2));
Records related to seed treatment (§ 112.150(b)(1)).
Documentation of analytical test results for all sprout-specific testing done under Subpart M
(§ 112.150(b)(4));
As applicable, documentation of sprout-specific corrective actions you take under Subpart M
(§ 112.150(b)(6)).

The person reviewing records should ensure that they were completed accurately and in a timely
manner, consider whether the records suggest any problems that need to be corrected, and institute
any corresponding corrective actions as necessary. The person reviewing records should also look
for any trend that could lead to problems in the future if not adequately addressed, and institute
preventive measures as necessary.
Reviewing records can be tedious, particularly since a reviewer may be looking at similar records
day after day. It can be a challenge to remain focused when reviewing records and not to skim over
them with a quick glance. We recommend that you select a time to review records when you are able
to focus without interruption. If more than one supervisor or responsible person is qualified to
review records, you may find it helpful to rotate the review of different types of records among these
reviewers, or to rotate review shifts, so that reviewers do not have to review the same records
repeatedly or for long time periods. This rotation may help in reviewing records with a “fresh” pair
of eyes.

XI. Appendices
A.

Appendix 1. Aseptic Sampling
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You must aseptically collect environmental samples (§ 112.145(d)) and samples of spent sprout
irrigation water or sprouts (§ 112.147(b)). If you are required to test your agricultural water (§§
112.44(a), 112.46(c)), you must aseptically collect water samples as well (§ 112.47(b)). Aseptic
sampling is a sampling technique used to assure that the microbial load of a sample is not affected by
the sampling method and/or the sample collector does not contaminate the source from which the
sample is collected (including cross-contamination between sample sites). The use of sterile
sampling implements and containers and a prescribed sampling method defines aseptic sampling
(See 80 FR 74450 and references cited therein). Collected samples should also be handled in a
manner to ensure samples are not contaminated during storage or during transportation to the
laboratory.
Sterile Equipment

The requirements in §§ 112.47(b),112.145(d) and 112.147(b) to collect samples “aseptically” mean
that you must use sterile sampling equipment to collect the required samples. Note that “sterile” is
not equivalent to “clean and sanitized.” Sterilization achieves a higher standard than cleaning and
sanitizing. “Sterilization” refers to a validated process used to render a product free of all forms of
viable microorganisms. In many cases, thermal methods, such as steam, are used to achieve
sterilization (See Liquid Chemical Sterilization)(Ref. 62). “Sterile” refers to the end point achieved
by a sterilizing process. You may purchase pre-packaged sterilized tools/equipment to use in
sampling, or you may use (and re-use) tools and equipment for sampling that have been properly
sterilized, such as in an autoclave or a dry heat oven. An autoclave machine is a device that sterilizes
laboratory instruments and equipment by using highly pressurized saturated steam to effectively kill
microorganisms. If you decide to use an autoclave, any responsible personnel should receive
adequate training prior to the use of the autoclave. When used properly, autoclaves are safe and
highly effective to sterilize sample containers or sampling equipment (e.g., cups or tongs) and can be
cost-effective. Sampling equipment, such as one-piece stainless steel, forceps, spatulas, and sample
containers, may be sterilized using an autoclave (steam heat), for example, at 121 °C (250 °F) for 30
minutes at 15 psi, or for heat-resistant, dry materials in a dry-heat oven, for example, at 140 °C (284
°F) for 3 hours (Ref. 63). If you choose to use an autoclave, you should follow the instructions
provided by the manufacturer to ensure that sterilizing of sampling tools and equipment is effective.
If you choose to sterilize your own sampling tools and equipment, you should package them after
sterilization in a manner to prevent contamination post-sterilization (e.g., wrap them with aluminum
foil), and should only open their packaging immediately prior to use.
We recommend that you include your plans regarding use of sterilized sampling equipment in your
written sampling plan for spent sprout irrigation water (or sprouts) (see Section VIII (Spent Sprout
Irrigation Water or In-Process Sprouts)) and your written environmental monitoring plan (see Section
IX (Environmental Monitoring)).
General Aseptic Sample Collection Procedures

The requirements in §§ 112.47(b), 112.145(d), and 112.147(b) to collect samples “aseptically” also
mean that, in addition to using sterile equipment for sampling, you must use a sampling method that
does not affect the microbial load of the sample collected and does not contaminate the source from
which the sample is collected. We recommend that you include your procedures for aseptic
technique in your written sampling plan for spent sprout irrigation water (or sprouts) (see Section
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VIII (Spent Sprout Irrigation Water or In-Process Sprouts)) and your written environmental
monitoring plan (see Section IX (Environmental Monitoring)). We recommend the following aseptic
techniques, which are generally applicable to any kind of sampling:
1. For activities in fully enclosed buildings, a sample collector should wear a clean lab coat,
single-use gloves, and a hair net to ensure he or she does not contaminate the samples.
2. Hands should be washed immediately before sampling, and prior to putting on disposable
clean gloves. Gloves should be put on in a manner that does not contaminate the outside of
the glove. Gloves should be properly disposed of after use.
3. To prevent cross contamination, gloves should be changed between samples. In addition,
you should change gloves if you touch any surfaces other than the sample sites such as
garbage, drains, or the floor.
4. Hands should be kept away from mouth, nose, eyes, and face while collecting samples. Try
not to cough or sneeze into the samples, and if you do, discard the affected sample(s).
5. Sampling instruments should be protected from contamination at all times before and during
use. Either use them only once or sterilize them in between uses, so each sample will be
taken by fresh and sterile utensils. Sampling equipment and samples moving between the
sampling site and the sample container should not be passed over the remaining pre-sterilized
instruments.
6. The type of sample containers used (e.g., bags, tubes, cups, flasks) should depend on the type
of sample collected. You should use containers that are dry, leak-proof, wide-mouthed, and
of a size suitable for the type of sample collected.
• The container should be properly labeled, such as with a marked strip of masking
tape, prior to sampling to identify the sample information, such as the sample
production batch, time, and the date of sampling. You should not use a felt pen
directly on plastic containers because the ink might penetrate the container. The
container should be opened only sufficiently to collect the sample directly in the
container, and then immediately closed and sealed.
• Containers such as plastic jars or metal cans that are leak-proof may be hermetically
sealed.
• If collecting samples in a container with a lid, the lid should not be placed on a
counter.
• Whenever possible, avoid using glass containers, which may break and contaminate
the sample, the source from which the sample was taken, and/or covered produce,
including sprouts.
7. Sample containers for water samples (i.e., agricultural water and spent sprout irrigation
water) should not be overfilled, and you should leave an air space of 1 to 2 inches at the top
to prevent overflow.
8. For samples collected indoors, samples and sampling equipment should not be exposed to
unfiltered air currents. When opening sterile sampling containers, you should work rapidly,
open sterile sampling containers only to admit the sample and close it immediately.
9. You should not touch inside the sterile sample container, lip or lid. You should not allow
fingers or anything except the sample to contact the inside of the sample container.
10. You should not use a sample container that has fallen on the floor.
11. You should not expose covered produce, including sprouts or food contact surfaces to
samples or hands after sampling. You must wash hands with soap and water following
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sample collection, because sampling is a time when hands may have become contaminated in
manner reasonably likely to lead to contamination of covered produce (§ 112.32(b)(3)(vi)).
12. Samples should be delivered to the laboratory promptly.
13. Spent sprout irrigation water (or in-process sprouts) should be kept at an appropriate
temperature, preferably at 0 to 4.4 °C (32 to 40 °F). Sealed coolant packs, rather than ice,
should be used to avoid contamination from melting ice.
Collection Procedures – Environmental Sampling
For environmental sampling of food and non-food contact surfaces for Listeria spp. or Listeria
monocytogenes, more specifically, we recommend the following aseptic techniques in addition to the
general techniques (discussed in Section XI.A immediately above).
1. You should wash and sanitize hands to the mid-forearm. Aseptically place a glove on the
hand used for swabbing.
If sponge sampling:
2. Using the ungloved hand, open the bag containing the sponge on a stick by pulling off the
clear perforated strip at the top of the bag.
3. Pull apart the white tabs to open the mouth of the bag.
4. Aseptically pour 9-10 ml of sterile Dey-Engley (D/E) or other neutralizing broth into the bag
to hydrate the sponge, being careful not to contaminate the broth or sponge during the
transfer.
5. Close the bag and evenly moisten sponges by hand massage.
6. Position the sponge so that the handle is sticking out of the bag and close the bag around the
stick.
7. Through the bag, squeeze the excess broth gently out of the sponge. Do not let your hand go
past the thumb stop on the stick.
8. Carefully take the sponge-stick out of the bag by grasping the stick and swab the area
selected using firm and even pressure. Be careful to maintain sanitary conditions when
sampling. Do not let your hand go past the thumb stop on the handle.
9. Swab between 4 inches by 4 inches up to 12 inches by 12 inches square of food contact or
environmental surface area. If collecting from surfaces with visible residue (e.g., dust, dirt,
buildup of organic material), we recommend increasing the number of sponges and collecting
from a smaller surface area for each sponge to improve the likelihood of detection.
10. Swab the chosen area using firm and even pressure:
• Sponge vertically (approximately 10 times); then
• Flip the sponge and use the other side to swab horizontally (approximately 10 times);
• Then move the sponge diagonally, using the same surface side as you used for
horizontal (approximately 10 times).
11. Open the bag and insert the sponge portion into the bag.
12. Grip the sponge through the bag and bend the stick of the sponge back and forth with slight
force, while gripping the sponge through the bag. The stick should break easily within the
sponge (do not break the stick at the thumb stop). Discard the broken stick. If the stick is
sticking out above the sponge, discard this sample.
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13. Squeeze as much air out of the bag as possible and fold the top of the bag down at least 3
times until it is folded all the way down to the sponge. Fold in the tabs to lock the fold in
place.
14. Label the bag with the date and location of the sample.
15. Take each new sample following the same steps in 1) – 14), starting by changing the glove on
the gloved hand between samples.
16. When all samples have been taken and prepared for shipping or delivery, ship the samples or
deliver them to the laboratory as soon as possible for analysis. Keep the samples in a
refrigerator if not ready to be shipped to the lab.
If swab sampling:
2. Using the ungloved hand, open the tube containing the swab.
3. Aseptically pour 9-10 ml of sterile D/E or other neutralizing broth into the tube to hydrate the
swab or use sampling swabs that are already pre-moistened in 9-10 ml of D/E broth. If the
D/E broth is not purple, discard the tube.
4. Close the cab of the tube and wait until the swab is moistened.
5. Carefully take the swab out of the tube and swab the area selected using firm and even
pressure. Be careful to maintain sanitary conditions when sampling.
6. Swab at least 1 inch by 1 inch square of food contact or environmental surface area.
7. Swab the chosen area using firm and even pressure:
• Sponge vertically (approximately 10 times); then
• Flip the sponge and use the other side to swab horizontally (approximately 10 times);
• Then move the sponge diagonally, using the same surface side as you used for
horizontal (approximately 10 times).
8. Do not touch the outside of the opening and insert the swab portion into the tube.
9. Close the cap of the tube.
10. Label the bag with the date and location of the sample.
11. Take each new sample following the same steps in 1) – 10), starting by changing the glove on
the gloved hand between samples.
12. When all samples have been taken and prepared for shipping or delivery, ship the sample or
deliver it to the laboratory as soon as possible for analysis. Keep the sample in a refrigerator
if not ready to be shipped to the lab.

Appendix 2. Recommended Procedures for Collecting Environmental
Samples

Laboratory analysis of samples should only be conducted by persons with appropriate
microbiological training or experience. Listeria monocytogenes infection can cause serious
illness and death, including fetal death. We recommend that pregnant women and persons who
are immunocompromised because of illness, medication, or advanced age avoid working with
this organism. Contaminated equipment and media should be sterilized before disposal or reuse.
Preparing for Sample Collection
You should assess the configuration of your sprout growing, harvesting, packing and holding
environment, to determine how best to collect environmental samples. Based on your assessment,
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you may determine that it is necessary to make changes to your sprout production area; for example,
relocating growing units to gain easier access to surfaces for sampling.
To prepare for sample collection, you should assemble the materials necessary for aseptic sample
collection and shipping, which may include:
•
•
•
•
•
•
•
•
•
•
•
•

Gloves
Sponges (non-microbiocidal, sterile)
Plastic bags (sterile) to hold sponges (e.g., lab blender bag)
Swabs (cotton tipped applicators; non-microbiocidal and sterile)
Sterile containers (with lids) to hold swabs (e.g., screw-capped or snap-capped plastic tubes),
or sterile commercial swab-container devices with neutralizing broth
Scissors (sterile)
Plastic container to hold 100 ml (sterile)
Bottles (with lids) to hold 100 ml (sterile)
Dey-Engley (D/E) neutralizing broth (commercially available, or prepared according to a
formula) (sterile)
Cleaned working surface (e.g. counter top or rolling cart)
Cooler with ice packs
Any forms or records that need to be completed

See Appendix 1: Aseptic Sampling for specific information on aseptic techniques. Aseptic sampling
technique, including use of sterile equipment and media, is required under § 112.145(d).
Collecting Samples from Surfaces (Including Both Food-Contact Surfaces and Non-FoodContact Surfaces)
The two most common methods to collect samples are “surface sponging” and “swabbing.” Another
method used for sampling difficult to clean areas is liquid rinse samples. In general, the preferred
method of sampling is surface sponging, but swabs may be more appropriate for small or hard-toaccess surfaces.
In general, the preferred method of sampling is surface sponging, but certain areas could be more
appropriately sampled using a swab (e.g., head screws, small water collection points, screw holes,
threaded surfaces or interior corners of equipment) or rinse method. The sample size of each site
should be consistent with the testing methodology and the sample collection method being used. The
recommended sample size for swabs is generally smaller (e.g., 1 inch by 1 inch) compared to
sponges (e.g., 4 inches by 4 inches up to 12 inches by 12 inches). However, if collecting from
surfaces with visible residue (e.g., dust, dirt, buildup of organic material), we recommend increasing
the number of sponges and collecting from a smaller surface area for each sponge to improve the
likelihood of detection.
We recommend that you wear sterile gloves. For wet surfaces, you should wipe and absorb moisture
and wet product and residue with the sponge. For dry surfaces, you should wipe the sample site area
with a sponge or swab moistened with D/E broth. You should use a systematic technique that swabs
in multiple directions as also described in “Testing Methodology for Listeria species or L.
monocytogenes in Environmental Samples” (currently available at
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http://www.fda.gov/downloads/Food/FoodScienceResearch/LaboratoryMethods/UCM467056.pdf) 10.
You should add more buffer if necessary.
Samples should be properly identified, packaged with ice packs and shipped refrigerated within 24
hours after sampling. We recommend that the maximum time frame between shipping and receipt at
an external or internal pathogen testing laboratory be within 48 hours. Samples should not be frozen.
Collecting Rinse Samples
To collect samples using a rinse technique, you should add small pieces from equipment (such as
screws, nuts or gaskets) directly to the bag containing D/E broth and hand massage the bag for
sufficient time to remove soil and residues (approximately 1 minute). Then you must aseptically
remove the items from the bag and subject the broth to analysis.
In some situations involving small cracks and crevices, it may help to use a plastic bulb transfer
pipette. You should use tubes containing 10 mL sterile D/E broth in this procedure. You should pull
the D/E broth into the pipette bulb and transfer the D/E broth to the crack or crevice, and then you
should pull it back into the bulb. You should repeat this several times to thoroughly rinse the crack
or crevice. Then you must use aseptic procedures when transferring the D/E broth to a sterile
container for further analysis (§ 112.145(d)).
Collecting Liquid Samples (Including Floor Drain Effluents)
We recommend that you use a sterile beaker or similar container to collect 110 + 5 ml of liquids,
where possible, such as drainage effluents, standing water, melt water from thawed processing ice,
and vacuum or drip pan condensate. We recommend that you immediately transfer the collected
sample into a sterile screw-capped bottle and then chill and store the bottle at 5 degrees C (41
degrees F), including during transport to the testing laboratory.
Compositing Samples Collected from Sponges or Swabs
A common technique is to combine analytical portions from several samples and analyze the mixture
of the portions (which is referred to as a “composite”). A typical composite scheme is to composite
up to 5 sponges or swabs. We do not recommend compositing more than 5 sponges or swabs, and we
do not recommend compositing samples from FCSs.
Preparing Samples Collected from Liquids
For larger samples (e.g., 100 mL or greater), we recommend that you filter 100 ml of the collected
liquid through one or more sterile 0.45 micron pore-diameter filters as soon as possible after sample
collection. If particulate content is high (e.g., judging from the sample turbidity), we recommend
10

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that you pass the liquid through a sterile glass pre-filter before the 0.45 micron filter. You should
rinse the retentate on the filter plus any pre-filter with 5-10 ml of D/E broth to remove any residual
inhibitory substances. If necessary, you should excise the filters from the funnel devices, using
sterile scalpels. You should put each filter and the pre-filter, if any, in a sterile bag (if you will use a
Stomacher) or in a sterile container (such as a blender jar, if you use a blender). You should add 225
mL of UVM broth, and follow procedures in “Testing Methodology for Listeria species of L.
monocytogenes in Environmental Samples” (version 1, Oct 2015) (currently available at:
http://www.fda.gov/downloads/Food/FoodScienceResearch/LaboratoryMethods/UCM467056.pdf 11)
beginning with incubation of the primary enrichment.
For small volumes of liquid samples, we recommend that you add the liquid sample to 225 mL of
UVM broth, and follow procedures in “Testing Methodology for Listeria species of L.
monocytogenes in Environmental Samples” (version 1, Oct 2015) beginning with incubation of the
primary enrichment.
Note: If composites are made from the filters, you should cut the filter and any pre-filter in half using
sterile instruments. You should use one half of each filter to form a composite and retain the other
half at 5 degrees C (41 degrees F) as a reserve for analysis if the composite is positive for Listeria
spp.
Sample Analysis
See “Testing Methodology for Listeria species of L. monocytogenes in Environmental Samples”
(version 1, Oct 2015) for testing the samples.

Appendix 3. Potential Sources of L. monocytogenes for Sampling in a Sprout
Operation

This table provides examples of possible food contact and non-food contact surfaces for use in
developing a Listeria environmental monitoring program. The list is not all-inclusive. This list
could be further sub-divided to establish a four zone system for an operation.

Table 4. Potential Sources of L. monocytogenes in a Sprout Operation
Category
A. Contact surfaces for sprouts

•
•
•
•

Potential Sources of L. monocytogenes
Fibrous and porous-type conveyor belts
Interior of drums, carts, crates, containers, bins, tubs
and baskets
Utensils
Gloves

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Category
B. Surfaces that generally do not
contact sprouts

C. Sprout Operation Environment

•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•

Potential Sources of L. monocytogenes
Cracked hoses
Hollow rollers for conveyances
Equipment framework
Wet, rusting, or hollow framework
Open bearings within equipment
Condensate drip pans
Motor housings
Maintenance tools (e.g., wrenches and screw drivers)
Forklifts, hand trucks, trolleys, and racks
On/off switches
Vacuum cleaners and floor scrubbers
Trash cans and other such ancillary items
Tools for cleaning equipment (e.g., brushes and
scouring pads)
Aprons
Floors, walls and drains
Ceilings, overhead structures, and catwalks
Wash areas (e.g., sinks), condensate, and standing
water
Wet insulation in walls or around pipes and cooling
units
Rubber seals around doors, especially in coolers
Contents of vacuum cleaners

XII. References
We have placed the following references on display in the Division of Dockets Management, Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at
that location between 9 a.m. and 4 p.m., Monday through Friday. We have verified the website
addresses, but we are not responsible for any subsequent changes to websites after this document
publishes in the Federal Register.
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119

Contains Nonbinding Recommendations
Draft-Not for Implementation

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121

Contains Nonbinding Recommendations
Draft-Not for Implementation

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122

Contains Nonbinding Recommendations
Draft-Not for Implementation

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125

File Type	application/pdf
File Title	Guidance for Industry: Sprouts
Author	FDA/CFSAN
File Modified	2019-05-23
File Created	2017-01-13