Draft Guidance for Industry: Standards 
for the Growing, Harvesting, Packing, 
and Holding of Sprouts for Human 
Consumption 
 
This guidance is being distributed for comment purposes only.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 FDA considers your comment on this guidance before we begin work on the final version of 
the guidance, submit either electronic or written comments on the draft guidance within 180 days 
of publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane,  
rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number  
FDA-2017-D-0175 listed in the notice of availability that publishes in the Federal Register.  
 
For questions regarding this draft document contact FDAs Technical Assistance Network by 
submitting your question at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-
technical-assistance-network-tan. 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
 
September 2023  
    Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Table of Contents 
 
I. Introduction ............................................................................................................................... 3 
II. Background .............................................................................................................................. 5 
A.  Other FDA Efforts Related to Sprouts ................................................................................. 5 
B.  Coverage of the Produce Safety Rule .................................................................................. 6 
C.  Coverage of Subpart M ........................................................................................................ 8 
D.  Compliance Dates for Sprouts ........................................................................................... 11 
E.  General Sprout Production ................................................................................................. 11 
III. Personnel Qualifications, Training, and Hygienic Practices ............................................ 12 
A.  Training Conducted to Implement Subpart M ................................................................... 15 
1. Training and supervision of personnel who conduct cleaning and sanitizing activities ... 16 
2. Training and supervision of personnel who handle seed .................................................. 17 
3. Training and supervision of personnel who conduct testing of spent sprout irrigation 
water or sprouts ..................................................................................................................... 18 
4. Training and supervision of personnel who conduct environmental monitoring .............. 19 
IV. Equipment, Tools, and Buildings ........................................................................................ 20 
A.  Requirements for Buildings ............................................................................................... 20 
B.  Pest Control ........................................................................................................................ 24 
C.  Toilet and Hand-Washing Facilities .................................................................................. 25 
D.  Plumbing Systems .............................................................................................................. 26 
E.  Sewage and Waste Management ....................................................................................... 27 
F.  Equipment and Tools ......................................................................................................... 29 
V. Sampling and Testing of Spent Sprout Irrigation Water (or In-Process Sprouts) ........... 31 
A.  Developing a Sampling Plan .............................................................................................. 32 
B.  Collecting and Shipping Samples ...................................................................................... 34 
1. Preparing for sample collection ........................................................................................ 34 
2. Collecting the sample ........................................................................................................ 35 
3. Preparing and shipping the sample ................................................................................... 42 
C.  Preventing a Production Batch of Sprouts from Entering Commerce while Test Results 
are Pending ................................................................................................................................ 42 
D.  Additional Voluntary Testing ............................................................................................ 42 
E.  Choosing a Laboratory ....................................................................................................... 43 
F.  Choosing a Test Method .................................................................................................... 44 
G.  Developing a Corrective Action Plan and Implementing Corrective Actions ................... 46 
1. Developing a corrective action plan ................................................................................. 46 
2. Taking corrective actions .................................................................................................. 47 
3. Documenting your corrective actions................................................................................ 49 
VI. References ............................................................................................................................. 49 
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Draft Guidance for Industry: Standards 
for the Growing, Harvesting, Packing, 
and Holding of Sprouts for Human 
Consumption 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administrations (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 FDAs Technical Assistance Network by submitting your question at 
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-technical-assistance-
network-tan.  
 
I. Introduction  
This draft guidance is intended for those persons (you) who grow, harvest, pack and/or hold 
sprouts covered by Subpart M of our final rule, published in the Federal Register (80 FR 74353) 
on November 27, 2015, entitled, Standards for the Growing, Harvesting, Packing, and Holding 
of Produce for Human Consumption (the Produce Safety Rule or the Rule).  
The Produce Safety Rule established 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)). The Rule focuses on certain conditions 
and practices identified as common routes of 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 
common routes of microbial contamination, including: agricultural water; biological soil 
amendments of animal origin; worker health and hygiene; equipment, tools, buildings and 
sanitation; and domesticated and wild animals.  
Sprouts represent a distinct food safety concern because the conditions under which sprouts are 
produced (i.e., temperature, water activity, pH and available nutrients) are also ideal for the 
growth of pathogens, if present (Ref. 2). Between 1996 and 2020 in the United States, FDA 
observed 52 reported outbreaks of foodborne illness associated with sprouts. Together, it is 
estimated that these outbreaks resulted in at least 2700 cases of illness, 200 hospitalizations, and 
three deaths (Ref. 3, Ref. 4, Ref. 5, Ref. 6, Ref. 7, and Ref. 8). During this timeframe, sprouts 
have been associated with outbreaks of several different pathogens, including Salmonella spp., 
Listeria monocytogenes, E. coli O157:H7, and several types of non-O157:H7 pathogenic E. coli 
(i.e., E. coli O157:NM (H-), E. coli O104:H4, E. coli O26, E. coli O121, E. coli O103) (Ref. 9 and 
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Ref. 10). In foodborne illness outbreaks associated with sprouts where the source of 
contamination was identified, epidemiological investigations often identify the most likely source 
of contamination as seeds used for sprouting (Ref. 2 and Ref. 11). However, poor sanitation and 
unhygienic practices at the sprout operation have also contributed to the contamination of sprouts 
(Ref. 2, Ref. 6, Ref. 12, Ref. 13, and Ref. 14). 
Because the distinctive practices and conditions for growing sprouts present unique risks, we 
established sprout-specific requirements in Subpart M (Sprouts) of the Produce Safety Rule. 
Subpart M of the Rule builds on sprout production practices similar to areas covered in our 1999 
Sprout Guidances (discussed further below, now withdrawn). 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. 
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 farms that grow, harvest, pack or hold sprouts are referred to in this guidance as sprout 
operations, or you. Produce that is covered by the Rule is referred to as covered produce.   
Neither the Produce Safety Rule nor this draft guidance document is directed to growing, 
conditioning, or distributing seed for sprouting 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. 15 and Ref. 16), 
everyone in the sprout supply chain has a responsibility to help ensure food safety. FDA has also 
issued the final guidance document regarding good agricultural practices for seed for sprouting, 
entitled Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting: 
Guidance for Industry (Ref. 17). 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 Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.  301 et 
seq.) and are produced in compliance with all applicable laws and regulations. Under section 
402(a)(1) of the FD&C Act, a food is adulterated if it bears or contains any added poisonous or 
deleterious substance which may render it injurious to health, and such substances may include or 
otherwise result from physical and chemical (including radiological) contamination. 
This draft guidance provides our current thinking and recommendations to assist sprout operations 
subject to the Produce Safety Rule primarily in complying with the sprout-specific requirements 
in Subpart M, specifically the requirements related to sampling and testing spent sprout irrigation 
water or in-process sprouts. This draft guidance accompanies the final guidance, Guidance for 
Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human 
Consumption (Ref. 18), which discusses other requirements of Subpart M (e.g., seed treatment, 
environmental monitoring), which are covered in the finalized sections (Ref. 18). FDA is issuing 
this draft guidance to receive comments on revised sections of a currently issued draft guidance 
entitled Compliance with and Recommendations for Implementation of the Standards for the 
Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout 
Operations (January 23, 2017). After reviewing comments and incorporating any changes, FDA 
will combine the subjects discussed into this guidance into a single final guidance, as appropriate. 
This draft guidance also briefly discusses certain requirements (in Subpart L of the Rule relating 
to Equipment, Tools, Buildings, and Sanitation) of particular relevance to a sprout operation. In 
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addition, this draft 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. In the 
development of this draft guidance, we particularly considered industry and international 
documents related to food safety and hygienic production of sprouts (Ref. 19, Ref. 20, and Ref. 
21). We have incorporated aspects of these documents that are consistent with our laws, 
regulations, and existing policies. 
Some of the material in this draft guidance relates to regulatory requirements of the Produce 
Safety Rule that are also covered in the draft Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption: Guidance for Industry (general produce 
compliance and implementation draft guidance (83 FR 53196) issued in October 2018) (Ref. 22). 
At the present time, the material on these overlapping topics (e.g., training, equipment, tools, and 
buildings) is consistent between these two draft guidance documents.  This draft guidance focuses 
specifically on insights drawn from FDAs experience with sprout operations, such as from 
inspections and sprout-associated foodborne illness outbreak investigations, and elaborates on 
how the broader training, equipment, tools, and buildings standards in part 112 could apply to and 
be implemented in a sprout operation.  
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys 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 Agency guidances means that something is suggested or recommended, but not 
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 operations) that 
sprouts had 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 the sprout 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 sprout industry and academia, to develop an educational video 
series entitled, Safer Processing of Sprouts (Ref. 23). In addition, we have provided technical 
assistance to the Illinois Institute of Technologys Institute for Food Safety and Health (IIT IFSH) 
Sprout Safety Taskforce in developing their US Sprout Industry Production Best Practices (Ref. 
20). 
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We also have been working with the Sprout Safety Alliance (SSA), a public-private partnership, 
since 2012 to develop a standardized curriculum and training and outreach programs for 
stakeholders in the sprout industry to enhance the industrys understanding and implementation of 
the requirements of the Produce Safety Rule, and of best practices for improving sprout safety 
(Ref. 24, Ref. 25, and Ref. 26). The SSA is composed of representatives from the sprout industry, 
retailers,  academia, and federal, state, and local food safety agencies. The SSA is funded by a 
grant from FDA to IIT IFSH. 
B.  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 into any State or territory of the United States, the 
District of Columbia, or the Commonwealth of Puerto Rico. Covered farms (i.e., those 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 exclusions, 
exemptions and limitations on which farms are covered farms (see  112.4). For example, 
sprout operations, for which, on a rolling basis, the average annual monetary value of produce 
sold during the previous 3-year period, adjusted for inflation, is less than or equal to $25,000 are 
not covered by this regulation ( 112.4(a)). See https://www.fda.gov/food/food-safety-
modernization-act-fsma/fsma-inflation-adjusted-cut-offs for information on FDA Food Safety 
Modernization Act (FSMA) inflation adjusted cut-offs. See also Standards for Produce Safety, 
Coverage and Exemptions/Exclusions for 21 Part 112, available at 
https://www.fda.gov/media/94332/download to assist you in determining which provisions of the 
Produce Safety Rule, if any, apply to you. 
Sprouts are produce as we defined that term in the Produce Safety Rule (see  112.3). Sprouts are 
also RACs when they are in their raw or natural state (see  112.3 and section 201(r) of the FD&C 
Act, defining raw agricultural commodity as 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)). An example of a processed food made using sprouts is sprouted 
seed butter. This 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. Rather, it means that the Produce Safety Rule only applies 
during the time that the sprouts are RACs. Other requirements, such as those in 21 CFR Part 117, 
may apply to any manufacturing/processing of the sprout RACs into processed food, depending 
on the circumstances. 
Sprouts do not qualify for the exemption from the Produce Safety Rule in  112.2(a)(1) for 
produce that is rarely consumed raw. This provision contains a list of produce commodities (such 
as potatoes) for which we have analyzed dietary consumption patterns and determined such 
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commodities 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), if 
they will receive 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 
requires covered farms to establish and maintain certain documentation and disclosures set forth 
in  112.2(b)(2)-(3): 1) disclosures to customers; and 2) annual written assurances obtained from 
customers. Sprouts that receive commercial processing (e.g., canned, shelf-stable mung bean 
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.1 We note that simply 
drying/dehydrating sprouts may not adequately reduce the presence of microorganisms of public 
health significance (Ref. 27 and Ref. 28) and therefore would not make them eligible to receive 
the commercial processing exemption from the Rule. 
Some sprout operations may be eligible for a qualified exemption and associated modified 
requirements in a calendar year if, during the previous 3-year period preceding the applicable 
calendar year, the average annual monetary value of the food (as defined in  112.3) the sprout 
operation sold directly to qualified end-users (as defined in  112.3) during such period exceeded 
the average annual monetary value of the food the sprout operation sold to all other buyers during 
that period; and the average annual monetary value of all food (as defined in  112.3) the sprout 
operation sold during the 3-year period preceding the applicable calendar year was less than 
$500,000, adjusted for inflation. (FDA makes available the updated inflation-adjusted figures at 
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-inflation-adjusted-cut-offs.)   
Section 112.6(b) describes the modified requirements applicable to a qualified exempt operation 
(e.g., labeling). Section 112.7 requires the sprout operation eligible for the qualified exemption, 
provided for in  112.5, to establish and keep adequate records necessary to demonstrate that the 
sprout operation 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 sprout 
 
1 In the Federal Register of January 5, 2018 (83 FR 598), we published a notification of availability of a guidance 
document titled Policy Regarding Certain Entities Subject to the Good Manufacturing Practice and Preventive 
Controls, Produce Safety, and/or Foreign Supplier Verification Programs. In that guidance document, we stated 
that we intend to exercise enforcement discretion regarding certain written assurance requirements, including those 
in 21 CFR part 112 (the Produce Safety Rule). We intend to exercise such discretion until we can complete a 
rulemaking process to consider options for the assurance requirements. https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/guidance-industry-policy-regarding-certain-entities-subject-current-
good-manufacturing-practice-and. See also the Federal Register of March 14, 2022 (87 FR 14169), in which we 
published a notification of availability of a guidance document titled Current Good Manufacturing Practice and 
Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety 
Regulations: Enforcement Policy Regarding Certain Provisions.  In that guidance document, we restated our intent 
to exercise enforcement discretion with respect to the Produce Safety Rule assurance requirements, as previously 
indicated in the 2018 guidance document described immediately above. https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/guidance-industry-current-good-manufacturing-practice-and-
preventive-controls-foreign-supplier.  
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operation has performed an annual review and verification of the sprout operations continued 
eligibility for the qualified exemption. 
C.  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 a growth medium in your operation, in addition to all other relevant 
requirements of the Produce Safety Rule, you must comply with the applicable requirements in 21 
CFR part 112, Subpart F (Biological Soil Amendments of Animal Origin and Human Waste). We 
discuss the requirements of Subpart F in the draft compliance and implementation guidance (Ref. 
22). We recognize that sprout operations may sell certain soil- or substrate-grown sprout types, 
such as wheatgrass, in a tray used for growing, with the soil/substrate and root intact, to 
commercial entities, including facilities that are required to register with FDA under section 415 
of the FD&C Act, restaurants, retail food establishments, and non-profit food establishments. In 
such cases, the operation that has harvested the sprouts with the roots and these sprouts are 
ordinarily subject to Subpart M (see  112.141). However, we understand that, in some cases, 
such sprouts may then be cut above the soil and/or substrate line at the commercial entity 
immediately before use or sale to the consumer. When a sprout operation sells sprouts with the 
roots intact in soil or substrate, and the commercial entity that receives them 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 
commercial entity stating that the sprouts will be cut above the soil or substrate line before use 
(see also Section VII.C.1 in the finalized sections (Ref. 18)).  
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. The 
standards in Subpart M may be useful to sprout operations that produce soil- or substrate-grown 
sprouts that are harvested above the soil or substrate line that voluntarily choose to follow these 
standards, in addition to complying with the required provisions of all other subparts in the 
Produce Safety Rule. 
We are aware that certain sprouts are grown hydroponically in trays, and then harvested without 
the root at either the sprout operation or by the customer. As we previously stated in the preamble 
to the final rule (80 FR 74353 at 74497, comment/response 364), all hydroponically grown 
sprouts are subject to the requirements of Subpart M. Under typical conditions for growing 
hydroponic sprouts, water circulates between sprouts in the same growing unit, such that any 
pathogens present in the seed or introduced during sprouting can spread throughout the 
production lot of sprouts (Ref. 2, Ref. 29, and Ref. 30) .  
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We are also aware of certain products marketed using descriptions such as activated seeds, 
sprouted seeds/briefly sprouted seeds, or sprouted nuts/briefly sprouted nuts (e.g., sprouted 
almonds, sprouted cashews, sprouted chia seeds, and sprouted pumpkin seeds). They are produced 
by soaking seeds, beans, or nuts in water for a brief period of time (e.g., 4-48 hours) to induce 
nutritional and textural changes in the seed, bean, or nut (e.g., to break down antinutrients that 
reduce the bioavailability of vitamins, minerals and other nutrients) and then drying the seeds, 
beans, or nuts (Ref. 31 and Ref. 32). Although soaking could begin the germination process, 
soaking would stop before the cotyledons (i.e., seed leaves) and roots are visible (Ref. 31). 
Because the seeds, beans, or nuts are no longer in their raw or natural state, and because the intent 
of the soaking is to induce nutritional and textural changes in the seed rather than to grow a 
produce RAC, we consider these products to be processed food rather than RACs. (See the 
definition of RAC in section 201(r) of the FD&C Act.) Foods described using terms such as 
activated seeds, sprouted seeds/briefly seeds/briefly sprouted seeds, or sprouted nuts/briefly 
sprouted nuts that were subsequently dried and used in manufactured foods without a process that 
adequately reduces microorganisms of public health significance have been involved in recent 
foodborne illness outbreaks and other contamination events (Ref. 33 and Ref. 34). We consider 
that such products typically are subject to the requirements of the Preventive Controls for Human 
Food Rule (21 CFR part 117). The controls such as those described in Subpart M of the Produce 
Safety Rule may be an effective option to control the food safety hazards introduced by the 
soaking step and may be appropriate for the product, depending upon the specific circumstances 
(e.g., the availability of other controls, the nature of subsequent manufacturing steps) as the 
soaking step associated with these products likely presents a similar risk to the soaking and 
irrigation steps associated with traditional sprouts (Ref. 35), and, as previously stated, simply 
drying/dehydrating the soaked sprouts may not adequately reduce the presence of microorganisms 
of public health significance (Ref. 27 and Ref. 28). However, we acknowledge that certain seeds 
or nuts may be sprouted into a traditional sprout which would then be subject to the requirements 
of the Produce Safety Rule. 
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., IIT IFSH Sprout 
Taskforce US Sprout Industry Production Best Practices document (Ref. 20), Food Safety 
Australia New Zealand (FSANZ) standards for sprouts (Ref. 36). 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 (i.e., 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. Unlike sprouts 
covered by Subpart M, microgreens are 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. 37). However, microgreens are considered covered produce for 
the purposes of the Produce Safety Rule and, unless exempt or excluded under the provisions in 
Subpart A, microgreens are subject to the other subparts of the Produce Safety Rule (80 FR 74353 
at 74497, comment/response 363).  
The following figure provides factors to consider when determining whether sprouts are subject to 
the sprout-specific requirements of Subpart M of the Produce Safety Rule.  
 
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Figure 1. Determining Coverage under Subpart M of the Produce Safety Rule 
 
 
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Note that throughout this guidance, for the ease of the reader, we often refer collectively to 
everything, including beans, sprouted to produce sprouts for human consumption 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 be read 
to  include things other than seeds that are sprouted to produce sprouts for human consumption, 
such as beans.  
In addition, the definition of produce includes sprouts irrespective of seed source (see  112.3). 
We consider sprouts to be a distinct category of produce that includes many different varieties 
(e.g., alfalfa, mung). Sprouts (i.e., alfalfa, mung and soybean sprouts) were evaluated to determine 
whether they are rarely consumed raw, and therefore exempt from the Produce Safety Rule (see 
80 FR 74353 at 74392, comment/response 68). Sprouts did not meet the threshold criteria for the 
rarely consumed raw exemption and are therefore considered covered produce. The mature plant 
and/or the seeds used to grow sprouts may or may not fall under the definition of produce. For 
example, wheatgrass sprouts and soybean sprouts have long been considered sprouts by the food 
industry and FDA and are covered produce under the Produce Safety Rule. However, for both 
wheat and soybeans, the mature crops are considered food grains, which do not fall under the 
definition of produce, and are not subject to the Produce Safety Rule. Sprouts may also be 
produced from seeds of produce that is considered to be rarely consumed raw, such as beet or 
pumpkin sprouts. While the mature produce may be rarely consumed raw, and therefore exempt 
from the Produce Safety Rule, the sprouts produced from the seeds of these crops are still covered 
produce under the Produce Safety Rule because we consider sprouts to be a distinct commodity 
from the mature form, and sprouts have not met the threshold criteria for the rarely consumed raw 
exemption.  
D.  Compliance Dates for Sprouts 
Sprout operations covered by the Produce Safety Rule and subject to Subpart M must be in 
compliance with all applicable provisions of the Produce Safety Rule at this time. The extended 
compliance dates provided for covered farms producing other produce commodities to comply 
with the agricultural water requirements of Subpart E do not apply to the production of sprouts 
subject to Subpart M. Sprout operations eligible for the qualified exemption from the Produce 
Safety Rule are also expected to be in compliance with the applicable modified requirements at 
this time.  
The same compliance dates that apply to all other covered produce apply to sprouts that are not 
subject to Subpart M but are otherwise subject to the Produce Safety Rule (i.e., soil- or substrate-
grown sprouts harvested without their roots). 
E.  General Sprout Production 
This section discusses common production practices for growing, harvesting, packing, packaging 
and holding of sprouted seeds. Later sections of this guidance describe the requirements of the 
Produce Safety Rule and provide recommendations for sprout operations in conducting the 
different steps in sprout production.  
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Typically, sprout production consists broadly of the steps depicted in Figure 2. 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.  
Figure 2. 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 Spent Sprout Irrigation Water 
(or in-process sprouts)  Harvest Wash/Drain Sprouts Bulk Cool/Spin Dry  Pack 
and/or Package  Cooling & Storage Distribution 
III. Personnel Qualifications, Training, and Hygienic Practices 
This section will help you understand qualifications and training requirements related to Subpart 
M and introduces concepts related to health and hygiene.  
We provide additional guidance on training and health and hygiene in the draft guidance titled, 
Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption (Ref. 38), including recommendations to help you: 
  Evaluate personnels assigned duties and identify personnel subject to the qualifications 
and training requirements; 
  Evaluate whether personnel have the necessary qualifications to perform their assigned 
duties; 
  Provide training at frequencies necessary to comply with Produce Safety Rule 
Requirements; 
  Determine how to provide easily understandable training; 
  Understand minimum training content for required training; 
  Understand additional training for persons who conduct harvest activities; 
  Understand training requirements for supervisors and responsible parties; 
  Understand requirements for supervision to ensure compliance; and 
  Determine required records for training. 
Subpart C of the Produce Safety Rule includes requirements for qualifications and training 
directed at personnel who handle or contact covered produce, including sprouts, or food contact 
surfaces (FCSs). While  112.22(a) does not explicitly state that it applies to personnel who 
contact FCSs, FDA interprets that section to apply to such individuals, in part because such 
personnel are specifically included in  112.21 (Ref. 38).  
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Employees who handle (contact) covered produce or FCSs during covered activities, or who 
supervise the conduct of such activities, at your operation must have a combination of education, 
training, and experience necessary to perform the persons assigned duties in a manner that 
ensures compliance with the Produce Safety Rule ( 112.21(b)). All personnel who handle 
covered produce or FCSs, or those who are engaged in the supervision thereof (including 
temporary, part time, seasonal and contracted) must receive adequate training as appropriate to the 
persons duties, upon hiring, and periodically thereafter, at least once annually ( 112.21(a)). In 
addition, training must be conducted in a manner that is easily understood by personnel being 
trained ( 112.21(c)). For example, if English is not the primary language for personnel in your 
operation, you should provide training in the language they customarily speak. Training should be 
provided at the appropriate educational level. Training must be repeated as necessary and 
appropriate in light of observations or information indicating the personnel are not meeting 
standards established by FDA in Subparts C through O of the Produce Safety Rule ( 112.21(d)). 
For example, if a supervisor observes that an employee is not collecting spent sprout irrigation 
water in accordance with your written sampling plan, the supervisor must retrain the employee on 
spent sprout irrigation water sample collection.  
To identify which of your personnel, including supervisors, are subject to the qualifications and 
training requirements, you should review the assigned duties of your personnel, and observe how 
they perform those duties (i.e., whether they handle or contact covered produce, including sprouts, 
or FCSs, or are engaged in the supervision thereof). It is important that you consider the breadth 
of activities at your operation that are covered by the Produce Safety Rule, and how they are 
performed. This will enable you to identify which personnel contact covered produce or FCSs. 
Examples of activities in which personnel likely handle covered produce or FCSs include:  
  Applying seed treatment (since the container in which the seeds are treated is an FCS); 
  Soaking seeds (since the container in which the seeds are soaked is an FCS); 
  Collecting spent sprout irrigation water, in-process sprouts, agricultural water or 
environmental monitoring samples;  
  Placing seeds into the growing unit; 
  Harvesting and washing sprouts; 
  Packing sprouts; 
  Receiving seed and performing a visual inspection for signs of contamination; 
  Handling containers used to pack and distribute sprouts or tools and equipment that 
contact sprouts; 
  Cleaning and maintaining equipment and tools that contact sprouts; and 
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  Performing corrective actions in response to a positive sample finding or outbreak of 
foodborne illness, for example, recognizing sprouts that may be adulterated or conducting 
intensified cleaning and sanitizing in response to a contamination event. 
Subpart C of the Produce Safety Rule also describes the minimum training requirements for 
personnel. All personnel who handle or contact covered produce, including sprouts, or FCSs 
during covered activities or supervise the conduct of such activities must receive training that 
includes all of the following ( 112.22(a)): 
  Principles of food hygiene and food safety; 
  The importance of health and personal hygiene for all personnel and visitors, including 
recognizing symptoms of a health condition that is reasonably likely to result in 
contamination of covered produce or FCSs with microorganisms of public health 
significance; and 
  The standards as established by FDA in Subparts C through O of part 112 that are 
applicable to the employees job responsibilities.  
Persons who conduct harvest activities for covered produce must receive additional training that 
includes the following ( 112.22(b)): 
  Recognizing covered produce that must not be harvested, including covered produce that 
may be contaminated with known or reasonably foreseeable hazards; 
  Inspecting harvest containers and equipment to ensure that they are functioning properly, 
clean and maintained so as not to become a source of contamination of covered produce 
with known or reasonably foreseeable hazards; and 
  Correcting problems with harvest containers or equipment or reporting such problems to 
the supervisor (or other responsible party) as appropriate to the persons job 
responsibilities. 
For example, harvest personnel must be trained to inspect bins that are used to hold harvested 
sprouts and to understand the requirement that bins must be cleaned and sanitized prior to contact 
with sprouts (( 112.22(a)(3), 112.22(b)(2)), 112.143(b)). Harvest personnel should be trained to 
be aware of actions during harvesting that can lead to contamination of FCSs and covered 
produce (e.g., stepping on the FCSs of a growing bin to harvest sprouts, or reaching an arm with a 
visibly soiled sleeve into a rotating drum to harvest sprouts).  
In addition, at a minimum, at least one supervisor or responsible party for your sprout operation 
must have successfully completed food safety training at least equivalent to that received under a 
standardized curriculum recognized as adequate by the FDA ( 112.22(c)). Attending training 
based on the standardized sprout curriculum developed by the Sprouts Safety Alliance (SSA) is 
one way to meet this requirement. We recommend that at least one supervisor or responsible party 
take the SSA course to meet the requirement in  112.22(c). You may use other training 
programs, provided the training is equivalent to the standardized sprout curriculum. The 
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standardized sprout curriculum covers fundamental food safety topics as they relate to sprouts and 
the requirements of the Produce Safety Rule, including an introduction to produce safety, sprouts 
specific requirements (e.g., spent irrigation water testing and seed treatment), worker health and 
hygiene, worker training, agricultural water, sanitation and recordkeeping.   
You could choose to have more than one supervisor, or other personnel, complete this training.  
For example, if your sprout operation has several supervisors who are responsible for ensuring 
that your operations adhere to the requirements of the Produce Safety Rule (see  112.23), you 
could charge each of these supervisors with completing the standardized curriculum or equivalent 
training. We also encourage you to have those who complete the standardized curriculum training 
(or equivalent) share what they learned with other personnel at your sprout operation. 
If you also conduct covered activities on non-sprout covered produce, at least one supervisor or 
responsible party for your sprout operation must have successfully completed food safety training 
at least equivalent to that received under standardized curriculum recognized as adequate by the 
FDA for produce other than sprouts ( 112.22(c)). The Produce Safety Alliance (PSA) developed 
the standardized curriculum, which covers additional topics relevant to non-sprout produce 
operations, such as wildlife, domesticated animals, produce handling, and land use. We have 
recognized the standardized curriculum developed by the PSA as the standardized curriculum 
referenced in  112.22(c). If you also conduct activities that are subject to the Current Good 
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food 
requirements in 21 CFR part 117, for example, if you conduct manufacturing and processing of 
food in addition to growing sprouts, additional qualifications and training requirements may 
apply. See 21 CFR 117.4 for additional information on these requirements.  
Subpart D includes the specific requirements for Health and Hygiene, including measures that 
must be taken to prevent ill workers from contaminating sprouts with microorganisms of public 
health significance, hygienic practices that must be used, and measures you must take to prevent 
visitors from contaminating sprouts and FCSs. We provide additional guidance on training, health 
and hygiene in the guidance titled, Draft Guidance for Industry: Standards for the Growing, 
Harvesting, Packing, and Holding of Produce for Human Consumption (Ref. 38). Training which 
covers the requirements of Subpart D must be provided to all personnel who handle or contact 
covered produce, including sprouts, or FCSs, during covered activities or supervise such activities 
( 112.22(a)(3)). Furthermore,  112.32(a) specifically requires all personnel who work in a 
sprout operation to use hygienic practices while on duty to the extent necessary to protect against 
contamination. In a sprout operation, this requirement applies to personnel who handle sprouts, 
seeds for sprouting or FCSs, including personnel who enter, but may not be assigned to, 
production or storage areas, such as personnel with shipping, delivery or other duties. 
A.  Training Conducted to Implement Subpart M 
All personnel who handle (contact) covered produce or FCSs, or who supervise those personnel, 
must have a combination of education, training, and experience necessary to perform the persons 
assigned duties in a manner that ensures compliance with the Produce Safety Rule (see  
112.21(b)). Additionally, all personnel who handle (contact) covered produce or FCSs during 
covered activities, or who supervise the conduct of such activities, must receive training on food 
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safety, personal hygiene, and the standards of the Produce Safety Rule (subparts C through O of 
part 112), as applicable to their job responsibilities (see 112.22).  
1.  Training and supervision of personnel who conduct cleaning and sanitizing 
activities 
At your sprout operation, employee(s) responsible for cleaning and sanitizing, as well as their 
supervisors, must receive training on the following topics, as applicable to their job 
responsibilities: 
  Cleaning and sanitizing of FCSs used to grow, harvest, pack, or hold sprouts before contact 
with sprouts or seeds or beans used to grow sprouts ( 112.143(b)). The following topics 
may be required for training, for example: 
  How to properly clean and sanitize (e.g., steps involved, what tools and chemicals 
o
are needed, how to prepare chemicals); 
  Considerations unique to individual pieces of equipment (e.g., if disassembly is 
o
necessary); 
  How to identify an FCS and the frequency of cleaning and sanitizing for FCS; 
o
  Activities to verify effectiveness of cleaning and sanitizing; and 
o
  How employee actions while cleaning and sanitizing equipment (e.g., dragging a 
o
hose from the floor across an FCS, or using a high-pressure hose on the floor next 
to an FCS) can lead to contamination of FCSs and covered produce. 
  Maintaining and cleaning all non-FCSs of equipment and tools used during harvesting, 
packing, and holding of sprouts ( 112.123(d)(2)). The following topics may be required 
for training, for example: 
  How to properly clean and maintain non-FCS (e.g., steps involved, what tools and 
o
chemicals are needed, how to prepare chemicals); 
  Considerations unique to individual pieces of equipment (e.g., if disassembly is 
o
necessary); and 
  How to identify a non-FCS, and frequency of cleaning and maintenance for non-
o
FCS. 
  Ensuring equipment and tools are installed and maintained to facilitate cleaning of the 
equipment and of all adjacent spaces ( 112.123(b)(1)); 
  Managing the quality of water used in cleaning and sanitizing activities ( 112.44(a)(3); 
  Performing intensified cleaning and sanitizing in response to suspected or known 
contamination ( 112.146(b) and 112.148(c)); and 
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  Establishing and maintaining records that relate to cleaning and sanitizing ( 112.22(a)(3) 
and 112.140(b)(1)).  
You must assign or identify personnel to supervise (or otherwise be responsible for) your 
operation to ensure compliance with the requirements of the Produce Safety Rule ( 112.23), 
including those related to cleaning and sanitizing. For more information about cleaning and 
sanitizing, see also Section III (Cleaning and Sanitizing) in the finalized sections (Ref. 18). 
2.  Training and supervision of personnel who handle seed 
At your sprout operation, employee(s) responsible for handling seed, as well as their supervisors, 
must receive training on the following topics, as applicable to their job responsibilities: 
  Preventing contamination in seeds ( 112.142(a)) (e.g., during storage; while rinsing, 
soaking or growing; and preventing recontamination of seed that has been treated). The 
following topic may be required for training, for example: 
  Seed sourcing considerations, for example the conditions that could result in seed 
o
becoming contaminated with pathogens prior to it arriving at your operation. 
  Seed receiving and performing a visual inspection for signs of contamination ( 
112.142(d)); 
  Applying seed treatment ( 112.142(e)(1)) and/or ensuring prior treatment by another 
entity meets the Produce Safety Rule requirements ( 112.142(e)(2));  
  If applying seed treatment at your sprout operation, personnel must be trained on how to 
apply seed treatment correctly (e.g., according to the label instructions at appropriate 
concentrations), how to monitor seed treatment, and materials needed ( 112.142(e)(1));  
  Managing the quality of water used to contact seeds ( 112.44(a)); 
  The cleaning and sanitizing requirements for FCS that contact seeds or sprouts ( 
112.143(b)); 
  Performing corrective actions in response to seed that is known or believed to be 
contaminated as required under  112.142 (discontinuing use of seed lot and contacting 
seed supplier, or treating seed to comply with  112.142(c)(1)); and  
  Establishing and maintaining records that relate to seed, and records related to corrective 
actions ( 112.22(a)(3); 112.150(b)(1) and (b)(6)). The following topic may be required 
for training, for example: 
  Maintaining the identity of a seed lot during rinses, treatment, and growing.  
o
You must assign or identify personnel to supervise (or otherwise be responsible for) your 
operation to ensure compliance with the requirements of the Produce Safety Rule ( 112.23), 
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including those related to handling seed. For more information about handling seeds for sprouting, 
see also Section V (Seeds for Sprouting) in the finalized sections (Ref. 18). 
3.  Training and supervision of personnel who conduct testing of spent sprout 
irrigation water or sprouts 
At your sprout operation, employee(s) responsible for spent sprout irrigation water (or in-process 
sprouts) testing, as well as their supervisors, must receive training on the following topics, as 
applicable to their job responsibilities: 
  Definition of production batch of sprouts (112.3);  
  Implementing the written sampling plan ( 112.147(a)), specifically how to collect a 
representative sample (location for collecting a sample, number of samples). The 
following topic may be required for training, for example: 
  Reviewing and updating the written sampling plan (e.g., after changes to the 
o
operation). 
  Aseptic sample collection ( 112.147(b)). The following topics may be required for 
training, for example: 
  Gathering materials and tools necessary for sample collection;  
o
  Understanding the sample volume to be collected and timing of sample collection; 
o
and  
  Preparing samples for shipment (if conducted by a third-party laboratory). 
o
  Not allowing a production batch of sprouts to enter commerce until test results are 
received ( 112.147(b)). The following topic may be required for training, for example: 
  Maintaining the identity of the seed lot and production batch during growing, 
o
sample collection, interpreting results, and taking corrective actions.  
  Methods to test samples for pathogens (if testing in-house) in compliance with  112.153; 
  Performing corrective actions in response to a positive sample finding (i.e., taking action 
to prevent adulterated food from entering commerce, discontinuing use of seed, 
contacting the seed supplier, cleaning and sanitizing the affected areas ( 112.148)). The 
following topic may be required for training, for example: 
  Interpreting test results. 
o
  Establishing and maintaining records related to testing spent sprout irrigation water or in-
process sprouts, and records related to corrective actions ( 112.22(a)(3); 112.150(b)(4) 
and (b)(6)).   
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You must assign or identify personnel to supervise (or otherwise be responsible for) your 
operation to ensure compliance with the requirements of the Produce Safety Rule ( 112.23), 
including those related to spent sprout irrigation water or sprouts sampling and testing activities. 
For more information about spent sprout irrigation water or in-process sprouts testing, see also 
Section V (Sampling and Testing of Spent Sprout Irrigation Water (or In-Process Sprouts)) in this 
document. 
4.  Training and supervision of personnel who conduct environmental 
monitoring  
At your sprout operation, employee(s) responsible for implementing your environmental 
monitoring plan, as well as their supervisors, must receive training on the following topics, as 
applicable to their job responsibilities: 
  Implementing the environmental monitoring plan ( 112.145(a)), specifically, the 
microorganisms for which samples will be tested (Listeria spp. or L. monocytogenes), 
number and location of sample collection sites, frequency of sample collection, point in 
production for sample collection. The following topics may be required for training, for 
example: 
  Reviewing/updating the written sampling plan (e.g., after changes to the 
o
operation); and  
  How to identify an FCS and non-FCS, as well as Zone 1, 2, 3 or 4 if you use the 
o
zone concept. 
  Aseptic sample collection ( 112.145(d)). The following topics may be required for 
training, for example:  
  Gathering materials and tools necessary for sample collection; 
o
  Understanding how to collect a sample (e.g., sponge or swab sampling) and 
o
sample sizes to be collected at the various sample collection sites; 
  Understanding how to conduct composite sampling (if applicable); and   
o
  Preparing samples for shipment (if conducted by a third-party laboratory). 
o
  Methods to test samples for pathogens or indicator organisms (if testing in-house) in 
compliance with  112.152; 
  Performing corrective actions in response to a positive sample finding (i.e., conducting 
additional testing of nearby surfaces, cleaning and sanitizing the affected and surrounding 
areas, conducting additional sampling and testing, conducting finished product testing 
when appropriate, conducting intensified cleaning and sanitizing if that is part of your 
corrective actions, and taking action to prevent adulterated food from entering commerce 
( 112.146)). The following topic may be required for training, for example: 
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  Interpreting test results.  
o
  Establishing and maintaining records related to testing, and records related to corrective 
actions ( 112.22(a)(3); 112.150(b)(4) and (b)(6)).  
You must assign or identify personnel to supervise (or otherwise be responsible for) your 
operation to ensure compliance with the requirements of the Produce Safety Rule ( 112.23), 
including those related to environmental monitoring. For more information about environmental 
monitoring, see also Section VI (Environmental Monitoring) in the finalized sections (Ref. 18).   
IV. Equipment, Tools, and Buildings 
Maintaining an environment that promotes the hygienic production of sprouts and minimizes the 
potential for cross-contamination is essential to food safety. Proper design, size, and construction 
of buildings 1) help protect against potential sources of external contaminants (e.g., airborne 
contamination and pests) that may compromise the safety of your sprouts and 2) facilitate 
maintenance and sanitary operations to minimize the potential for cross-contamination. Proper 
design, construction, installation, storage and maintenance of equipment and tools is necessary to 
facilitate their cleaning and sanitizing, as well as to minimize the potential for harborage and 
growth of pathogens on equipment and tools. Effective pest control and properly constructed and 
maintained sanitary facilities (e.g., properly functioning toilets, waste systems, and handwashing 
facilities) will help minimize the introduction and transfer of microbial hazards within your 
operation. 
Subpart L (Equipment, Tools, Buildings, and Sanitation) of the Produce Safety Rule establishes 
standards to prevent equipment, tools and buildings from contaminating produce, including 
sprouts. This subpart of the Rule includes requirements for building design and construction, pest 
control, toilet and hand-washing facilities, plumbing systems, waste management, and design, 
construction, storage, maintenance, and cleaning of equipment and tools. There are also sprout-
specific requirements within Subpart M relating to buildings, tools, and equipment, in  
112.143(a) and (b). The following section provides guidance on these topics for sprout operations, 
except that the cleaning and sanitizing provisions of Subpart L and Subpart M ( 112.143(b)) are 
discussed separately, in Section III (Cleaning and Sanitizing) in the finalized sections (Ref. 18). 
A.  Requirements for Buildings 
You must conduct sprout production (growing, harvesting, packing, and holding) in a fully-
enclosed building (112.143(a)). Such buildings are subject to the requirements of Subpart L ( 
112.122). The activities that must occur in a fully-enclosed building include seed storage and 
treatment. Storage sheds, buildings, or other structures used to store food contact surfaces (FCSs) 
(such as harvest containers and food-packing materials) are also subject to the requirements of 
Subpart L (112.122(b)). Sprout operations should take particular note of the following: 
  Fully-enclosed building means a structure confined with walls and a ceiling, and may 
have openings such as windows, doors (including warehouse doors), or air intake vents. 
All covered activities related to sprout production (e.g., seed storage, treatment, growing, 
and holding of sprouts) must occur within a fully-enclosed building. To ensure your 
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building is fully-enclosed:  
  Doors should be tight fitting and kept closed when not in use. Weather stripping 
o
around the doors should not contain gaps that show entry of light when the door is 
closed. 
  Windows should be properly fitted and kept closed at all times, unless screened. 
o
Air intake vents should be equipped with close-fitting screens or filters. Screens 
should not be damaged, ripped or torn. Unprotected (e.g., unscreened) openings to 
the outside should be blocked or repaired.  
  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)).  
Specifically, your building must provide sufficient space for placement of equipment and 
storage of materials ( 112.126(a)(1)(i)). 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 contamination of product. For 
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.  
  To assess whether a building is suitable in size, you should consider: 
o
  The types of activities that occur within the building; 
  The volume and frequency of activity within the building; 
  The number, size and placement of equipment and tools used or stored 
within the building; and 
  The number of people (e.g., personnel, supervisors, contractors, visitors) 
using the building at any given time.   
  Buildings should have enough space for covered activities to be conducted 
o
without contact between non-FCSs and either seeds, sprouts or FCSs; such non-
FCSs include the floor, waste or other potential sources of contamination. For 
example: 
  There should be adequate space to store bins or other equipment that 
contact sprouts off the floor, particularly for bins that are FCSs and have 
been cleaned and sanitized; 
There should be sufficient space between sprout growing units to avoid 
water from cleaning of one growing unit to splash onto sprouts or FCSs of 
another growing unit; and  
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There should be enough space available to allow easy access to 
equipment, such as sprout growing units, for cleaning, sanitizing and 
maintenance  activities. 
  The internal surfaces (e.g., ceilings, walls, floors) of buildings and the surfaces of 
o
fittings (including cooling units, light fixtures), even if non-FCSs, should be 
durable, nonabsorbent, and easily cleanable, to the extent necessary to minimize 
the potential for contamination of sprouts and FCSs, giving consideration to the 
way in which these surfaces will be cleaned (e.g., wet cleaning, dry cleaning, see 
Section III (Cleaning and Sanitizing) in the finalized sections (Ref. 18)). Any 
cracks or damage to ceilings, walls, and floors should be repaired to facilitate 
cleaning of those surfaces and to minimize the potential for harborage of 
environmental pathogens. For example: 
  The use of wood, sheetrock, and other absorbent materials should be 
minimized, even for non-FCSs, if these surfaces cannot be adequately 
maintained for their intended use, or if use of these materials will interfere 
with appropriate cleaning and, when necessary and appropriate, sanitizing, 
so that they do not become a source of contamination for sprouts or FCSs. 
For example, we do not recommend the floors, walls or ceilings be made 
of wood or sheetrock in a wet environment, such as the sprout germinating 
and growing room; 
  Where catwalks are installed over sprouts, FCSs or seeds for sprouting, 
they should be constructed of solid surface materials with kick plates, they 
should have catch trays installed beneath them, or the product should be 
protected from drippage by covers or other barriers. Personnel should not 
walk above unprotected product and FCSs; 
  If you have a drop ceiling in a fully-enclosed building, the building should 
be constructed in a way that allows access to the space between the roof 
and the drop ceiling for maintenance and sanitary operations, such as pest 
control activities; and 
  Air intakes should be designed to be adequately maintained and cleaned, 
and not be located near potential sources of contamination. 
  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)). For example:   
  The following areas should be separated from each other unless the potential for 
o
cross-contamination between them has been otherwise adequately addressed: 1) 
seed receiving and storage; 2) seed treatment; 3) seed soaking, sprout 
germination, and growing; 4) sprout packing, packaging, cooling, and storage; 
and 5) microbiological analysis (i.e., for samples analyzed at an in-house 
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laboratory) (Ref. 39); 
  You should consider providing designated areas and/or separate rooms in your 
o
building(s) for employees to take breaks. Providing such areas or rooms helps 
ensure that personnel comply with requirements that they 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))). 
  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)). For example: 
  Any rooms where activities involving water, such as cleaning and sanitizing, are 
o
conducted should be appropriately drained and graded, e.g., cold storage rooms, 
seed treatment areas, seed soaking, sprout germinating and growing rooms, 
bathrooms, and post-harvest washing areas;  
  Such floors should be sloped towards trapped drains with covers to minimize the 
o
accumulation of standing water. The presence of low spots, where water may 
pool, should be minimized. Stagnant water accumulated on floors can harbor 
pathogens, especially Listeria monocytogenes (Ref. 40). 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)). For 
example: 
  You should keep buildings (e.g., roofs, walls) in good repair in order to prevent 
o
leakage of rainwater into production areas, which can bring with it contaminants 
from outside the building; 
  You must handle harvested sprouts in a manner that protects against 
o
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. You should not distribute for 
human consumption any sprouts that have dropped to the floor, as the floor can 
serve as a source of contaminants such as Listeria monocytogenes. 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 should consider whether the occurrence of drip or condensate in your sprout 
o
production building presents a potential for contamination of your sprouts or 
FCSs and take measures to minimize or prevent that potential from occurring. 
Such measures include: 
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  Installing and maintaining fixtures, ducts, pipes, and overhead structures 
to prevent or minimize drips and condensate onto product, seed for 
sprouting, or FCSs, and adequately and regularly cleaning these fixtures; 
  Utilizing refrigeration drip pans so that water is drained and disposed of 
away from sprouts and FCSs;  
  Monitoring sprout germinating and growing rooms, cold rooms used to 
cool or hold finished sprouts, and other rooms susceptible to accumulation 
of condensate, for drips and condensate (e.g., from the ceiling over 
exposed sprouts), taking appropriate steps to protect the product when 
drips or condensate are found, and taking corrective action to ensure that 
any contaminated sprouts are not distributed; and 
  If condensation is a problem that you cannot otherwise correct in your 
sprout operation, you might consider installing drip guards to collect 
and/or divert condensate that might otherwise contact sprouts, seeds for 
sprouting or FCSs. 
B.  Pest Control  
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)). Further, for fully-enclosed buildings, you must 
take measures to exclude  pests from your buildings ( 112.128(b)). 
You are required to conduct all covered activities related to sprout production within a fully-
enclosed building (see section above on  112.143(a)) and 112.122 on fully-enclosed buildings). 
Conducting your sprout operation within a fully-enclosed building helps ensure that pests are 
excluded. 
  As part of a pest control program, you should: 
  Inspect for and remove any potential harborage sites and food or water sources 
o
(e.g., spilled seed); 
  Inspect for potential entry points for pests. You should look for unprotected 
o
openings through doors or windows as well as elsewhere around the perimeter of 
your buildings, through which rodents, birds, insects and other pests can enter. 
You should take measures to close any unprotected openings; 
  Implement procedures on a routine schedule to eliminate the presence of pests 
o
(e.g., setting traps) and/or work with a private company specializing in pest 
control; and 
  Routinely monitor storage areas (e.g., storage of seeds, packaging materials, tools, 
o
and equipment), sprout production areas, waste storage areas, and packing and 
holding areas for evidence of pests and other signs of vermin activity that could 
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lead to contamination of sprouts (e.g., stains, insects, feces (e.g., rodent pellets), 
urine, or foreign material). You should consider using a black light to examine for 
signs of rodent urine as part of routine monitoring. 
In addition, you must properly store and maintain equipment and tools to prevent them from 
attracting and harboring pests (see discussion below on storage of equipment and tools) 
(112.123(b)(2)).  
C.  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 sprouts, FCSs, and  areas used for a covered 
activity, agricultural water sources, and agricultural 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)).  
You are required to grow, harvest, pack, and hold sprouts in a fully-enclosed building ( 
112.143(a)), and such buildings are subject to Subpart L, including the requirement in  112.129.  
  Portable toilets may be used, provided they meet all applicable requirements. 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 (112.129(a)). Service vehicles should be able to enter your 
property and maneuver as close as necessary to the portable toilet to service the unit, to 
prevent spillage of sewage during servicing; 
  Toilets must not leak onto the floor because, for example, personnel movement can result 
in transfer of contaminants to production areas of your operation. Clogged, leaking, or 
broken toilets should be repaired immediately (see  112.129(b)(3) and 112.131(c)); 
  You 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)). Toilet use provides a direct means for hands to become contaminated with 
pathogens. Hand-washing after toilet use protects against the transfer of pathogens from 
hands to sprouts, seeds for sprouting, and FCSs; 
  Hand-washing stations must also be adequate and readily accessible to workers during 
sprout growing, harvesting, packing, and holding ( 112.130(a)). Hand-washing stations 
should be strategically located within your operation to facilitate their use at key times for 
employees, such as when they enter sprout production and packaging areas, after their 
breaks, when their hands become soiled after contact with insanitary objects, and after 
bathroom use; 
  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; 
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and adequate drying devices (such as single service towels, sanitary towel service, or 
electric hand dryers) (112.130(b));   
  You must provide for appropriate disposal of waste (for example, waste water and used 
single-service towels) associated with a hand-washing facility and take appropriate 
measures to prevent waste water from a handwashing facility from contaminating 
covered produce, FCSs, areas used for a covered activity, agricultural water sources, and 
agricultural water distribution systems with known or reasonably foreseeable hazards ( 
112.130(c)); and  
  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)). Antiseptic hand rubs may be used 
after proper hand-washing and drying in accordance with 112.32(b)(3), as the antiseptic 
hand rub can serve as an additional measure in reducing the number of bacteria on hands 
relatively free of grease, soil, and other material.   
D.  Plumbing Systems 
Your plumbing system 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)). Inadequate water pressure and volume could impact your ability to perform your 
operations in a sanitary manner. For example, low water pressure could compromise your ability 
to properly clean your FCSs or to provide water to multiple handwashing facilities at the same 
time. You should evaluate the adequacy of your plumbing systems, considering such factors as 
volume and frequency of water use. 
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)). You should establish procedures on how to inspect your 
plumbing system periodically and identify any conditions that could result in it becoming a source 
of contamination. Your procedures should include the frequency of these inspections, the 
personnel involved, and those conditions that should be reported to you, a supervisor, or other 
responsible party for corrective action. If you observe the potential for contamination, you should 
take appropriate measures to prevent the plumbing from becoming a source of contamination, as 
soon as possible. For example, you could remove dead-end piping when it is detected or 
periodically flush these lines to remove any residue. 
The plumbing system must not allow backflow from, or cross-connections between, piping 
systems  that discharge waste water 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)). A cross-
connection is a connection between a water source or distribution pipe (e.g., drinking water, water 
used for hand-washing, water used for cooling sprouts) and a liquid waste pipe (e.g., sink drain, 
sewage line, floor drain line). Unless adequate backflow prevention is implemented (e.g., air gap, 
installation/maintenance of an adequate backflow prevention device), a cross-connection can 
result in backflow, the undesirable reversal of the flow against the normal waterline pressure (e.g., 
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from a sewage line to the water line supplying a hand-washing station). To avoid such conditions, 
you should, for example: 
  Inspect all water supply piping to determine where appropriate backflow prevention 
devices are needed, whether they have been installed, and if absent, install such devices. 
The appropriate device for any cross-connections in your operation is dependent on your 
plumbing system, how the water is used, and the level of risk associated with 
contamination; 
  Use hoses in a manner that prevents backflow. Hoses that are connected to water lines 
under pressure could become sources of contamination to the water supply if an 
unintentional, temporary cross-connection is created. For example, if you leave an open-
ended hose on the floor in pooled water or submerged in a tank of water, backflow can 
occur if a pressure differential develops, reversing the flow of water in the hose. This 
backflow could result in contamination of the water supply. Hoses should be stored off 
the floor on a designated holder and should have an adequate backflow prevention device 
installed upstream; and 
  We recommend that you refer to the U.S. Environmental Protection Agencys (EPAs) 
Cross-Connection Control Manual regarding situations that may lead to contamination 
through cross-connections and backflow, and the devices and procedures you can use to 
prevent such contamination (Ref. 41). 
E.  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 
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)). For example: 
   Your sewage system, including a system that services portable toilets, should securely 
contain or securely transport sewage and liquid waste away from locations where you 
conduct covered activities; and 
  If you use a septic system, the tank should be properly sealed, in good working order, and 
free from damage. The inlet and outlet plumbing also should be in good working order 
and free from damage, and the drain field should be properly functioning, with no visible 
leakage at the surface. 
You must manage and dispose of leakages or spills of human waste in a manner that prevents 
contamination of covered produce, and prevents or minimizes contamination of FCSs, areas used 
for a covered activity, agricultural water sources, or agricultural water distribution systems. ( 
112.131(c)). 
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 In the event of a sewage spill or leak, you should contact your local public health or waste 
management authorities for assistance in complying with their regulations for sewage disposal. 
Management of a human waste spill or leak should include: 
  Containing the spill or leak; 
  Preventing your personnel from entering the affected area; 
  Evaluating any potential impacts to covered produce, FCSs, covered activity areas, or 
agricultural water sources or distribution systems; 
  Removing and disposing of the spill or leakage contents; 
  Disposing of any contaminated sprouts; 
  Cleaning and sanitizing any contaminated FCSs; and 
  Repairing or replacing any faulty sewage system components. 
After a significant event (such as flooding or an earthquake) that could negatively impact a 
sewage or septic system, you must take appropriate steps to ensure that sewage and septic systems 
continue to operate in a manner that does not contaminate covered produce, FCSs, areas used for 
a covered activity, agricultural water sources or agricultural water systems ( 112.131(d)). 
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)). For example: 
  Waste should be carried out of, but not through, sprout production areas to minimize the 
risk of contamination of sprouts and FCSs. Your operation should be arranged so that 
waste from other areas is not conveyed through sprout growing/production areas; 
  We recommend that waste containers be kept closed with tight fitting lids to minimize the 
attraction of pests. In addition, waste containers should be routinely monitored and 
emptied, and storage areas for waste should be monitored for pests as part of your pest 
control program; and  
  Storage of waste should be in areas that are easily accessible, but at the same time will 
not serve as a source of contamination for workers, production areas, seeds and sprouts, 
and FCSs. 
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)). 
You should establish frequencies to collect waste (including sprouts that drop on the floor during 
harvesting or packing activities). You should be aware of containers, equipment and personnel 
involved in transferring waste from sprout production areas to waste storage and treatment areas 
and implement practices to prevent contamination of sprouts, seeds for sprouting and food contact 
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surfaces by these objects and personnel. You should maintain outdoor waste storage containers, 
such as dumpsters, and areas near these containers to minimize the potential for their serving as a 
source of contamination.  
If you treat plant-based biological material (e.g., waste sprouts) by composting prior to disposal, 
you should do so in a manner that minimizes contamination of sprouts, seeds, and FCSs and does 
not attract pests (e.g., consider the placement of the compost pile and the process of aerating the 
pile and checking temperatures). If you use such biological material in the production of soil-
grown sprouts or non-sprout produce, you must take measures reasonably necessary to prevent the 
introduction of known or reasonably foreseeable hazards (see  112.11). If your compost that is 
used in the production of sprouts or other covered produce includes materials of animal origin, it 
is considered a biological soil amendment of animal origins (BSAAO) and the requirements of 
Subpart F apply. 
F.  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 of equipment include growing units, irrigation systems, cooling 
equipment, equipment used to store or convey harvested sprouts (such as containers, bins, food-
packing material), wash tanks, balances, packing tables, forklifts, and vehicles or other equipment 
used for transport that are intended to, or likely to, contact covered produce ( 112.121). Further 
examples of tools used at a sprout operation include harvesting rakes, shovels, thermometers, or 
instruments to measure sanitizer concentration. 
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). Seams on FCSs of 
equipment and tools that you use must be either smoothly bonded, or maintained to minimize 
accumulation of dirt, filth, food particles and organic material and thus minimize the opportunity 
for harborage or growth of microorganisms (112.123(c)). 
  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. You should properly repair (e.g., such that it can be adequately 
cleaned) or replace tools or equipment that is rusted, pitted, or otherwise damaged; 
  Inaccessible or hard-to-clean components of equipment may provide harborage sites for 
pathogens that can lead to contamination of your sprouts. You should evaluate equipment 
to identify any areas that may be inaccessible or hard-to-clean. If any such areas are 
identified, you should evaluate the potential risk associated with the areas that are 
inaccessible for cleaning and sanitizing, and consider: 
  Moving the equipment to a new location that allows easier access; 
o
  Purchasing cleaning tools and products to facilitate access to those hard-to-clean 
o
areas (e.g., extendable brushes); 
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  Reassembling equipment in a new layout that facilitates access for cleaning and 
o
sanitizing; and    
  Replacing that equipment entirely.  
o
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)). For example: 
  When installing equipment, you should elevate growing units (e.g., trays) or other 
containers used to hold sprouts (e.g., dewatering centrifuge) off the floor at a sufficient 
height to ensure that splash off the floor (e.g., from production, cleaning) does not 
contaminate the sprouts or FCSs of the equipment;  
  Equipment should not be installed or stored so close to a wall that employees cannot 
clean the equipment and the wall, perform environmental monitoring between the 
equipment and the wall, or monitor for pests between the equipment and the wall; 
  All sprout production equipment and tools must be stored within a fully-enclosed 
building, even when not in use (e.g., long-term storage); 
  You should consider the storage of tools and equipment (such as shovels, stackable bins, 
and perforated spinning baskets) with respect to potential routes of contamination, such 
as splash  from the floor or overhead condensate. For example, you might use wall 
mounted racks or clean pallets for short-term storage (e.g., during employee break times), 
especially in areas where water accumulates, to ensure that FCSs of tools and equipment 
do not contact the floor;  
  Pest harborage in stored equipment can lead to contamination of FCSs and give pests 
ready access to sprout production areas and exposed product. You should thoroughly 
clean and dry any equipment before storage and remove any pieces of food or other 
organic material to minimize attraction of pests. You should also ensure storage areas for 
equipment are covered as part of your pest control program (e.g., monitored for pests). 
See section IV.B. (Pest Control) for more information.   
If you use equipment such as pallets, forklifts, tractors, and vehicles, such that they are intended 
to, or likely to, contact sprouts, you must do so in a manner that minimizes the potential for 
contamination of sprouts or FCSs with known or reasonably foreseeable hazards ( 112.123(e)). 
Instruments or controls you use to measure, regulate, or record temperatures, hydrogen-ion 
concentration (pH), sanitizer efficacy or other conditions, in order to control or prevent the growth 
of microorganisms of public health significance, must be accurate and precise as necessary and 
appropriate in keeping with their purpose; adequately maintained; and adequate in number for 
their designated uses ( 112.124). Examples of such instruments in a sprout operation include 
thermometers (e.g., to record the temperature of sprouts, cold storage rooms) and meters for 
measuring pH or sanitizer concentration (e.g., to monitor seed treatment or sanitizer efficacy). 
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You should follow the manufacturers instructions on proper care, calibration, and maintenance of 
these instruments to ensure the instrument is providing accurate and precise readings.  
Sprouts are usually manually placed into containers, including in the process of both packing 
and packaging. Typically, finished sprouts are placed into finished product containers at the 
sprout growing operation, but occasionally may be transported in bulk to another location. To 
minimize the risk that such containers will serve as a source of contamination:  
  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 and sanitized ( 112.116(b) and 
112.143(b));   
  Equipment and tools, including food-packing material, 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; and  
  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. Hot spots can facilitate the growth of any pathogens present in the sprouts.  
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.  Vehicles/equipment 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 become a potential source of contamination ( 112.125) 
You should maintain the cold chain as much as possible when staging product to prepare for 
loading to delivery trucks. State and local regulations may require temperature control upon 
receipt by a retail establishment for the safety of the sprouts. 
V. 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. Section 
112.144(b) requires that you 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 hydroponically grown sprouts that use very little water), test each 
production batch of sprouts at the in-process stage (i.e., while sprouts are still growing). 
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Section 112.144(c) requires testing of other pathogens in addition to E. coli O157:H7 and 
Salmonella species 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). We intend to issue 
additional guidance to inform you if both conditions are met for a particular pathogen such that 
testing would be required (80 FR 74353 at 74504, comment/response 375). 
In this section of the guidance we provide recommendations to help you comply with the 
requirements related to sampling and testing spent sprout irrigation water (or in-process sprouts), 
including developing a sampling plan ( 112.147), collecting and shipping samples ( 
112.147(b)), preventing a production batch of sprouts from entering commerce while the results 
of the testing are pending ( 112.147(b)), choosing a test method ( 112.147(b) and 112.153), 
interpreting test results, choosing a laboratory, and developing a corrective action plan and 
implementing corrective actions ( 112.147(c)). Section III (Personnel Qualifications, Training, 
and Hygienic Practices) of this guidance above also provides recommendation to help you comply 
with the requirements on training and supervision of personnel who conduct testing of spent 
sprout irrigation water (or in-process sprouts) ( 112.21(b)). We also discuss additional voluntary 
testing you may choose to conduct.  
A.  Developing a Sampling Plan 
Section 112.147(a) requires that you 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,  
112.147(b) requires that, in accordance with your written sampling plan, you aseptically collect 
samples of spent sprout irrigation water or sprouts and test the collected samples for pathogens 
using a method set forth in  112.153. You must not allow the production batch of sprouts to enter 
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,  112.147(c) requires that your written sampling plan 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 must: 
  Specify whether you are testing spent sprout irrigation water or, alternatively, in-process 
sprouts (i.e., while the sprouts are still growing). For example, we recognize testing 
spent sprout irrigation water may not be practicable for soil-grown sprouts harvested with 
roots and  for hydroponically grown sprouts that use very little water; 
  Specify the 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 
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differences. You may find it useful to include a diagram of the different growing units at 
your operation, and indicate the points of sample collection in the diagram; 
  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)); and 
  Include a corrective action plan, as required by  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 
reference or include your cleaning and sanitizing policies and procedures in your 
corrective action plan to describe how you will accomplish the required cleaning and 
sanitizing corrective actions ( 112.148 (c)). 
While not required by the Produce Safety Rule, we further recommend that the written sampling 
plan: 
  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)); 
  Identify the specific test method by which collected samples will be tested for  relevant 
pathogens. (You are required to use a scientifically valid method that conforms to the 
requirements in  112.153); 
  Indicate the person(s) (name or title) in your sprout operation (or contracted personnel, 
including from a laboratory) who is (are) responsible for sample collection, as well as any 
specific training and/or qualifications that the sample collector(s) should possess (see 
discussion on  112.22(a)(3) in Section III. A. 3 (Training and Supervision of Personnel 
Who Conduct Testing of Spent Sprout Irrigation Water or Sprouts));  
  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; 
  Indicate the volume of spent sprout irrigation water (or in-process sprouts) to be 
collected for each sample; 
  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 (see Appendix 1 (Aseptic Sampling) in the finalized 
sections (Ref. 18));   
  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; 
  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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specific laboratory(ies) that you use (e.g., name, address, contact information), any forms 
that should be completed, sample labeling procedures, and storage and transport 
considerations (e.g., holding samples at 4C); 
  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)), as 
required by  112.147(b). The sampling plan should also describe your specific 
procedure(s) for ensuring that  112.147(b) is satisfied for each production batch of 
sprouts; 
  Indicate the person(s) (name or title) in your sprout operation who is (are)  responsible for 
implementing the corrective action plan in response to a positive test result; and  
  Indicate any additional considerations for spent sprout irrigation (or in-process sprouts) 
sampling and testing appropriate for your operation (e.g., growing unit type, irrigation 
practices, and sprouting cycle). 
You should develop your written sampling plan taking into account the specific growing and 
irrigation practices at your operation. For example, you should note any differences in your 
sampling practices based on the type of sprouts, growing unit or irrigation practices, as applicable. 
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. 
B.  Collecting and Shipping Samples 
1.  Preparing for sample collection 
You should assess the configuration of your growing units, their water outlets, and product 
distribution and placement within the growing units 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 provide ready 
access for representative sampling. 
Sample collection may be performed by employees or contracted personnel. Samples must be 
collected aseptically, in accordance with  112.147(b), and, therefore, training in aseptic 
techniques is recommended for the sample collector(s) (see discussion on  112.22(a)(3) in 
Section III. A. 3 (Training and Supervision of Personnel Who Conduct Testing of Spent Sprout 
Irrigation Water or Sprouts). 
The following materials and practices are recommended for aseptic sampling of spent sprout 
irrigation water or in-process sprouts:  
  Sterile sample containers, labeled with relevant information, including the production 
batch number and name of your sprouting operation: 
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  For spent sprout irrigation water samples, sterile containers (e.g., sterile plastic 
o
cups intended for sample collection) should be used. We note that bags can leak 
or spill liquid samples; 
  For in-process sprout samples, individual containers (e.g., cups or bags) should be 
o
used for each subsample; 
  Sterile sampling equipment (e.g., tongs); 
  Single-use gloves; 
  Cleaning and sanitizing of the countertop or other work surface used for holding the 
sampling supplies and packaging the sample; 
  Clean cooler and ice packs dedicated to sample storage; 
  A neutralizing agent (if collecting samples of spent sprout irrigation water that is 
chlorinated, see discussion below); and 
  Preparation of appropriate forms or records that include information about the samples 
being collected (i.e., spent sprout irrigation water or in-process sprouts), production batch 
number, date and time of collection, person collecting the sample etc. (Although not 
required by the Produce Safety Rule, we recommend preparation of such forms to 
effectively manage and document your spent irrigation water and sprout testing 
activities.)  
If you use chlorinated water for irrigation, there is likely to be residual chlorine in the spent sprout 
irrigation water. Residual free chlorine in a water sample can inactivate pathogens that may be 
present (Ref. 42 and Ref. 43) and therefore impact your ability to detect pathogens in spent sprout 
irrigation water if they are present. If there could be any detectable residual chlorine in your spent 
sprout irrigation water, you should add an appropriate amount of neutralizing agent to the 
sampling bottle prior to collecting the sample to neutralize the residual chlorines effect on the test 
results. For example, if you use chlorinated irrigation water from a municipal water source and 
choose not to test for residual free chlorine in the municipal water or spent sprout irrigation water, 
you should add a neutralizing agent (e.g., 100 mg sodium thiosulphate per L of spent sprout 
irrigation water) to the sampling bottle. However, the method of neutralizing the treatment may be 
different depending on treatments applied.     
Using appropriate materials and equipment is particularly important to ensure that the sample is 
collected aseptically, as required by  112.147(b). You must use sterile equipment and tools to 
collect samples aseptically. Cleaning and sanitizing are not equivalent to sterilization (See 
Appendix 1 on Aseptic Sampling in the finalized sections (Ref. 18)). 
2.  Collecting the sample 
If samples are collected improperly or in a manner such that they are not representative, or if the 
samples are mishandled (e.g., during storage or transport), then the test results may not accurately 
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reflect the potential for contamination in the related production batch of sprouts. Therefore, it is 
important to establish appropriate sample collection procedures and implement them uniformly. 
a.  Identifying the production batch of sprouts 
Section 112.144(b) requires you to sample and test spent sprout irrigation water (or sprouts) from 
each production batch of sprouts. 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). We note that this definition links a production batch of sprouts to a single growing unit, 
not a single irrigation line. 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 
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 that are started at the same time in such a 
way that exposes some sprouts 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 
times, they would be two different production batches of sprouts in that single growing unit, for 
which two samples and tests (one from each production batch of sprouts) would be required. As 
another example, sprouts in two separate growing units (e.g., drums) of sprouts would be separate 
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. 
You must not pool samples from multiple growing units for purposes of testing spent sprout 
irrigation water (or  in-process sprouts). Pooling in this context 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 ( 112.144(b)). 
If you start growing sprouts in one growing unit and then transfer them to different growing units 
during sprouting, thereby increasing 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 V. B. 2. d 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 after the start of sprouting, and you should sample 
and test growing units B and C separately, as two separate production batches. On the other hand, 
if your predetermined sampling time is 24 hours after the start of sprouting, sample collection 
should occur from growing unit A, and you should treat the sprouts in growing units B and C 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). 
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A production batch of sprouts does not usually correlate with a lot of seeds. 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. 
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 you to track seeds. Although not required by the Produce Safety Rule we recommend that you 
keep sufficient records to connect your test results and corrective actions to specific seed lots 
whenever possible. In addition, FDA published a rule to establish additional traceability 
recordkeeping requirements (beyond what is already required in existing regulations) for persons 
who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the 
Food Traceability List. The rule will affect some sprout operations. For further information, see 
Food Traceability List at https://www.fda.gov/food/food-safety-modernization-act-fsma/food-
traceability-list.  
b.  Collecting a representative sample 
Section 112.147 requires that you 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 samples, to the extent possible, accurately reflect the potential for contamination in the entire 
production batch of sprouts. 
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) are those growing units that do not mix, or agitate, 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., contamination hot spots) (Ref. 30). The other category (mixed) 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., 
contamination hot spots are less likely, and contamination, if it occurs, is more likely to be 
widespread throughout the production batch of sprouts) due to the mixing that occurs during 
growing (Ref. 30). For these reasons, collecting a representative spent sprout irrigation water 
sample can be more challenging from stationary growing units (particularly those with multiple 
drain  points) than from mixed growing units. For a stationary growing unit, you may need to take 
multiple subsamples from various locations (e.g., drains for spent sprout irrigation water) in the 
growing unit for the sample to be representative.  
The effectiveness of spent sprout irrigation water (or in-process sprouts) testing depends on 
having a sample that represents the entire production batch. For example, if you are testing the 
sprouts themselves, this means collecting subsamples from different physical locations across the 
production batch. When you are testing spent sprout irrigation water, the greater the degree to 
which the sample is taken from spent irrigation water that has covered (i.e., passed over, 
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interacted with) the entire batch of sprouts, the more representative the sample. To come as close 
as possible to achieving complete coverage (i.e., 100% representative of the production batch), 
you may need to increase the number of subsamples you collect. 
A 2018 quantitative risk assessment conducted by the FDA (Ref. 44) describes the importance of 
collecting a representative sample. The researchers assessed the risk of salmonellosis associated 
with the consumption of alfalfa sprouts and evaluated the public health impact of seed treatment 
and spent sprout irrigation water testing for Salmonella cells during production. Given the model 
parameters, data, and assumptions, if there were not any interventions, the assessment estimates 
that there would be 76,000 (95% confidence interval (CI) 15,400-248,000) cases of salmonellosis 
every year tied to the consumption of contaminated sprouts. 
The risk assessment looked at the impact of mitigation strategies, such as spent sprout irrigation 
water testing, on the predicted numbers of cases of salmonellosis. The predicted effectiveness of 
testing was highly influenced by the degree to which the sampled spent sprout irrigation water 
covered the production batch.  For example, FDA researchers estimated that if the coverage was 
complete (100% representative of the production batch), spent sprout irrigation water testing 
would detect 86% of the contaminated production batches, assuming that spent sprout irrigation 
water from every production batch was sampled for testing.  By contrast, if the sampled spent 
sprout irrigation water contacted 20% of the production batch, FDA researchers estimated that 
only 43% of the contaminated batches would be detected. 
It is important to recognize that even with proper spent sprout irrigation water testing (100% 
coverage), you may miss 14% of the contaminated production batches of sprouts. Because only a 
proportion of the cells present in a contaminated production batch of sprouts are transferred to 
irrigation water during sampling and only 1.5 liters is tested, it is possible that spent sprout 
irrigation water testing will not detect all the contaminated production batches (Ref. 44). 
Nonetheless, we consider microbial testing of spent sprout irrigation water to be a critical part of 
the multi-hurdle approach, combined with seed treatment, to ensure contaminated sprouts do not 
enter the marketplace.  
Among the interventions the researchers evaluated, the model predicted to have the greatest 
public health impact was a 5-log seed treatment combined with spent sprout irrigation water 
testing with 100% coverage. Together, they would result in an estimated 99.9994% reduction in 
the number of salmonellosis cases per year  essentially 1 case every two to three years (0.45 
(95% CI 0.10-1.5)) (see Section V.B (Seed Treatment) of the finalized sections (Ref. 18)). 
Below, we discuss certain growing conditions and irrigation practices, their potential impact on 
the representativeness of a sample, and recommendations for obtaining a representative sample.  
c.  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, with soil-grown sprouts harvested with roots or hydroponically grown sprouts that use 
very little water, are you permitted to instead test each production batch of sprouts at the in-
process stage (i.e., while sprouts are still growing) ( 112.144(b)(2)). This does not prevent you 
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from performing additional voluntary testing (e.g., testing finished product sprouts for specific 
pathogens) in addition to the sampling and testing required by  112.144(b). 
d.  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 if they are present. The optimal time for sample 
collection may vary depending on the type of sprouts you produce, and 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. 45). 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 than 48 hours 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, even if that is towards the end of the 
growing cycle. If you conduct a pre-germination soak of 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-germination soak time in your calculations related to timing of sample collection. 
If you wish to explore the optimal timing for sample collection in your sprouting operation (e.g., 
unique considerations based on sprout type, 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 microorganisms in a sample and can help determine the point in the sprouting process at which 
the highest levels of bacteria (including pathogens) are present (Ref. 46). You would then 
identify the point during growing at which the populations of microorganisms are highest, and 
sample spent sprout irrigation water at this time. 
In instances in which irrigation cycles are infrequent (e.g., many hours pass between each 
irrigation cycle) or in which irrigation otherwise does not occur at the optimal sampling time, you 
may add irrigation water specifically to facilitate sample collection so that you can collect your 
sample at the optimal time. 
e.  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 quarts) from each production batch of sprouts. It may be advisable for this 
sample to be made up of multiple subsamples, which are subsequently combined (i.e., combined 
volume of 1.5 liters), depending on whether your growing unit has a single drainage point or 
multiple drainage points (see Section V. B. 2. f (Where to Collect Samples) below). As a general 
matter, we recommend that you collect a subsample from every drainage point, up to 30 
subsamples (Ref. 47 and Ref. 48).  
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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. You should collect one sample of 1.5 liters of spent sprout 
irrigation water (or 1500 g of in-process sprouts) per production batch of sprouts irrespective of 
whether you are using the method in  112.153(a)(1) or using an alternate method as permitted 
under 112.153(a)(2).  
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 that are representative 
of the entire production batch of sprouts. The number of different microorganisms for which you 
are testing can also affect the volume of sample necessary for testing. If additional pathogen 
testing is required under  112.144(c), sample volume of spent sprout irrigation water or in-
process sprouts may need to be increased. 
Recent scientific advancements have also shown improvements in the ability to detect low levels 
of pathogens in water samples when using a concentration or filtration step (e.g., Moore Swab) 
(Ref. 49, Ref. 50, and Ref. 51). It may be worth considering the applicability of these methods for 
testing spent sprout irrigation water. 
i.  Large production batches of sprouts 
Even with the same level of contamination (i.e., percent of sprouts that are contaminated) and the 
same sample size, the potential for illness is greater from a larger production batch of sprouts than 
a smaller one (Ref. 52). This is true because the quantity (e.g., pounds) of contaminated product 
that can be missed with that sampling is larger with a larger lot, and because contamination is 
likely to be unevenly spread throughout the batch, particularly in stationary growing units, and 
even more so with larger production batches (Ref. 53). Because of these concerns, we recommend 
that you collect additional samples (beyond those recommended above) of spent sprout irrigation 
water (or in-process sprouts) from particularly large production batches and test those samples 
separately.  
Increasing the volume of spent sprout irrigation water tested increases the likelihood of detecting 
a pathogen (Ref. 44). For example, if your production batch consists 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) of spent sprout irrigation water from that production batch and test each sample 
separately. If you are instead sampling in-process sprouts from that production batch, we 
recommend that you collect two samples (each totaling at least 1500 g, each made up of thirty 50 
g subsamples, for a total of 3000 g and sixty 50 g subsamples) and test each sample separately 
(Ref. 52).  
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) of spent sprout irrigation 
water from that production batch and test each sample separately. Similarly, if you are instead 
sampling in-process sprouts from that production batch, you should collect a total of three 
samples (each at least 1500 g, each made up of thirty 50 g subsamples, for a total of 4500 g and 
ninety 50 g subsamples) (Ref. 52). 
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ii.  High volumes of irrigation water/high flow rates 
Use of large volumes of irrigation water and/or high rates of irrigation flow (e.g., as is often used 
for mung bean sprouts grown in bins), such that a sampling container is likely to overflow almost 
immediately at the normal flow rate can dilute any pathogens that may be present on the sprouts. 
That makes collecting a representative sample of spent sprout irrigation water more difficult, and 
therefore makes it less likely that any pathogens that are present will be detected. We recommend 
that if your irrigation system normally uses large volumes of water and/or high rates of flow, you 
temporarily decrease the volume of water and/or flow rate through the growing unit during spent 
sprout irrigation water sampling. 
iii.  Low volumes of irrigation water/low flow rates 
Conversely, if you use low volumes of irrigation water and/or rates of irrigation flow, such as in a 
misting system, you may find collecting a sufficient amount of irrigation water (e.g., collecting at 
least the recommended 1.5 liter) more challenging. In this case, we recommend that you, to the 
extent possible, either temporarily increase the volume of water and/or flow rate through the 
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. You should consider whether either of these options is practicable  for 
your operation before determining that you may instead sample in-process sprouts in accordance 
with  112.144(b)(2). 
f.  Where to collect samples 
You should assess the configuration of your growing  units, the flow of irrigation water, the 
location of water outlets from the growing unit, and product distribution and placement within the 
growing unit to determine how and where to best collect representative samples. Growing sprouts 
in a growing unit in which they are not mixed during growing (e.g., grown in racks of trays, bins, 
or tanks) can result in a more uneven distribution of pathogens in spent sprout irrigation water 
than growing sprouts in a growing unit that is mixed during growing (e.g., in a rotating drum).  
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 at that point. Because water at this point represents spent 
sprout irrigation water that has flowed through the entire growing unit of sprouts, collection at this 
point is likely to be representative. 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 (subsamples) from each of 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 up to 30 subsamples of approximately equal volume from the 
various drainage points (e.g., by moving your sample container around to different drainage 
locations). The subsamples may be combined and should, together, comprise your sample of at 
least 1.5 liter of spent sprout irrigation water.  
g.  How to collect your sample 
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You must collect samples aseptically ( 112.147(b)). In Appendix 1 of the finalized sections (Ref. 
18), we provide specific recommendations on aseptic sampling procedures.  
3.  Preparing and shipping the sample 
You should ship one sample of 1.5 liters of spent sprout irrigation water (or 1500 in-process 
sprouts) per production batch of sprouts to a laboratory for analysis, irrespective of whether you 
are using the method specified in the rule ( 112.153(a)(1)) or using an alternate method as 
permitted under  112.153(a)(2). Prior to and during delivery or shipment to a laboratory, you 
should hold your samples at an appropriate temperature, preferably between 0 and 4.4 oC 
(between 32 and 40 oF). You should use sealed coolant packs in lieu of ice, as needed during 
delivery or shipment, to avoid the possibility of melting ice contaminating the sample. You should 
not freeze the samples. You should ship the samples so that they are received by 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 labs receipt of spent sprout irrigation water or sprout 
samples may make the test results inaccurate (Ref. 54). 
Prior to sending the samples to a laboratory for testing, you should check to verify that your 
samples are clearly identified with the sprout production batch number and the name of your 
sprouting operation. You should specify the microorganisms for which the samples will be tested 
on any laboratory forms. 
C.  Preventing a Production Batch of Sprouts from Entering Commerce 
while Test Results are Pending  
Section 112.147(b) requires that you not allow a 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 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 of 
sprouts do not enter commerce until negative pathogen test results are obtained for all required 
pathogen tests. Establishing and using unique production batch numbers or other identifiers that 
can be linked to samples that are being tested can help ensure implementation of these procedures.  
D.  Additional Voluntary Testing 
We understand that some sprout operations may voluntarily conduct other 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, you should 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) (see Section V.G. (Developing a 
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Corrective Action Plan and Implementing Corrective Actions)). We recommend that you establish 
a 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 pathogen test result. 
 
E.  Choosing a Laboratory 
You should choose a laboratory that is qualified to test spent sprout irrigation water (and/or in-
process sprouts, as applicable) for E. coli O157:H7, Salmonella species, and any pathogens 
meeting the criteria in  112.144(c) using methods that meet the requirements of  112.153. 
Testing is typically contracted to a third-party testing laboratory, but you may perform the testing 
in your own in-house laboratory. If using a third-party testing laboratory, you should use a 
laboratory that employs scientifically valid laboratory methods  and procedures that can provide 
reliable, accurate test results. If you use an in-house laboratory, you may be able to complete 
the screening step of the test method but may need to send the enrichment broth out to a third-
party testing laboratory for confirmatory testing (if it cannot be conducted in-house). ( 
112.144(b), 112.147, and 112.153). 
If your laboratory utilizes a different method from the method listed in  112.153 (or an alternate 
method found to be equivalent by FDA available on our website) to test your samples of spent 
sprout irrigation water or in-process sprouts, we recommend you use the questions included in the 
decision tree for test methods requirements for Salmonella and E. coli O157:H7 in spent sprout 
irrigation water (or sprouts) (available at https://www.fda.gov/media/132369/download) to assist 
you in determining whether the method meets the requirements of  112.153. You should discuss 
the method with the laboratory to ensure the necessary sample volume will be tested for each 
pathogen. We recommend testing 750-mL of spent sprout irrigation water (or 750-g of in-process 
sprouts) for Salmonella spp., and 200-mL of spent sprout irrigation water (or 50-g of in-process 
sprouts) for E. coli O157:H7, irrespective of whether you are using the method described in  
112.153(a)(1) or an alternate method as permitted under  112.153(a)(2). The number of tests for 
each pathogen will depend on the test method being used. For example, if you use an alternate 
method to test for E. coli O157:H7 that has been validated for 25-mL, the lab should conduct 8 
tests (i.e., one test per 25-mL subsample, for a total sample volume of 200-mL). If the alternate 
method for E. coli O157:H7 has been validated for a higher sample volume (e.g., 100-mL of spent 
sprout irrigation water), you may be able to use a reduced number of tests (e.g., one test per 100-
mL subsample, or two tests total per 200-mL). 
If you conclude the laboratorys test methods do not meet the requirements of  112.153, you may 
consider requesting that the laboratory utilize a different method or select another laboratory to 
analyze your samples (see the next section, V. F. Choosing a Test Method, for more information). 
A laboratory conducting the tests required by 112.144(b) on which you rely might be, but is not 
required to be, accredited. Using an accredited laboratory (e.g., a laboratory accredited to 
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International Organization for Standardization (ISO) Standard 17025) is one way to have 
confidence that it will provide reliable, accurate test results.2 
F.  Choosing a Test Method 
Section 112.153(a) requires that you test spent sprout irrigation water (or in-process sprouts) from 
each production batch of sprouts 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 
https://www.fda.gov/media/94349/download)3 ( 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)). 
A decision tree for test methods requirements for Salmonella and E. coli O157:H7 in spent sprout 
irrigation water (or sprouts) is available at https://www.fda.gov/media/132369/download. For any 
other pathogen(s) meeting the criteria in  112.144(c), you are required to use a scientifically 
valid method ( 112.153(b)). 
We recommend that you have a discussion with your laboratory to select a method that meets the 
requirements of  112.153 to test your spent sprout irrigation water or in-process sprouts. It is the 
responsibility of the sprout operation (not the laboratory) to ensure that the appropriate test 
method is used.  
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 
research. Although you are not required to notify or submit information to FDA prior to using 
such an alternate  method, you must establish and keep records of any such alternate methods that 
you use ( 112.150(b)(5)) to test for E. coli O157:H7 or Salmonella species. Such records should 
include the 1) name and identification number of the method validated by a third-party methods 
validation organization, or 2) the detailed analytical procedures, and results 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. 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 (see  112.153(b)) (see Section VII.C.3 (Required Records for Spent Sprout Irrigation 
Water) in the finalized sections (Ref. 18)). 
 
2 By contrast, sprout operations must use a laboratory participating in the laboratory accreditation for analyses of 
foods (LAAF) program, as required by FSMA, for corrective action testing of environmental samples ( 112.146(a) 
and (c)) and finished product ( 112.146(d)). See https://www.fda.gov/food/food-safety-modernization-act-
fsma/fsma-final-rule-laboratory-accreditation-analyses-foods-laaf for more information. 
3 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 
https://www.fda.gov/food/science-research-food/laboratory-methods-food and https://www.fda.gov/food/guidance-
regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma. Alternatively, you can search on part 
or all of the title of the method, in the search box on FDAs Web site at https://www.fda.gov/ or using a generally 
available search engine. 
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We recommend use of methods validated through a collaborative study (such methods are 
currently available at https://www.fda.gov/media/83812/download)4, for example per AOAC 
Appendix J or ISO 16140-2:2016.  Alternate methods should be validated for E. coli O157:H7 in 
spent sprout irrigation water and/or sprouts, as applicable, against FDAs reference method ( 
112.153(a)(1)). Alternate methods should be validated for Salmonella spp. in sprouts against 
FDAs reference method ( 112.153(a)(1)). We recommend that alternate methods for Salmonella 
spp. in spent sprout irrigation water be validated against FDAs Bacteriological Analytical 
Manual (BAM) (Chapter 5, Section C.29: Salmonella), a method that was updated after the 
development of FDAs reference method and which is scientifically valid and at least equivalent 
to the method of analysis in  112.153(a)(1) in accuracy, precision, and sensitivity for this 
application.  All alternate methods must meet the requirements 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, or Association Francaise de Normalisation 
(AFNOR), 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 to our reference methods. Information on alternate methods reviewed by FDA and 
found to be equivalent will be made available on our website, such as at https://www.fda.gov/ and 
https://www.fda.gov/food/science-research-food/laboratory-methods-food. 
Section 112.150(b)(4) requires that you establish and keep records of all analytical tests 
conducted on spent sprout irrigation water or in-process sprouts for Salmonella spp., E. coli 
O157:H7, and any additional pathogen required under  112.144(c). The results must be 
documented whether they were conducted by a third-party or your own (e.g., in-house) 
laboratory. 
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: 
  Screening procedures do not yield a presumptive positive result; or 
  Confirmatory steps after a presumptive positive result do not result in confirmation of the 
presence of E. coli O157:H7 or Salmonella species. 
Confirmatory steps that are part of FDAs 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 
 
4 Alternative websites where you can currently access this document include: https://www.fda.gov/science-
research/field-science-and-laboratories/method-validation-guidelines 
and https://www.fda.gov/. Alternatively, you can search on part or all of the title of the method, in the search box on 
FDAs Web site at https://www.fda.gov/, or using a generally available search engine. 
45 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
in-process 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 should not attempt to 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 from the same production 
batch of sprouts does not negate a previous positive test result. You should 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 that the first test result was inaccurate (e.g., a reported issue at the 
laboratory, such as cross-contamination). If one test on a sample is confirmed positive, and then 
another test from that sample is negative, that may be because pathogens may not be evenly 
distributed within the sample. 
If you obtain a  negative result (of either type described above) for all relevant pathogens, your 
obligation under  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. 
G.  Developing a Corrective Action Plan and Implementing Corrective 
Actions 
1.  Developing a corrective action plan 
As required by  112.147(c), 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), if 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 V. C of the finalized sections (Corrective Actions for Seeds that 
May be Contaminated with a Pathogen) (Ref. 18)); 
  Clean and sanitize the affected surfaces and surrounding areas ( 112.148(c)); and  
  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 ( 
112.147(c)). Having a corrective action plan in place at your operation will help ensure that you 
take corrective actions quickly and consistently in response to positive findings of pathogens in 
spent sprout irrigation water or sprouts. The plan should include: 
46 
  Contains Nonbinding Recommendations 
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  Procedures for identifying a contaminated production batch of sprouts (for example, 
using the production batch number information associated with the positive test results), 
destroying the contaminated production batch of sprouts or diverting it to a non-food use, 
and ensuring any contaminated food does not enter commerce; 
  Procedures for identifying affected food contact surfaces (FCSs) and surrounding areas, 
and for cleaning and sanitizing those surfaces and areas; 
  Procedures for appropriate handling of the lot(s) of seeds corresponding to the 
contaminated production batch of sprouts (i.e., procedures for discontinuing the use of 
that (those) lot(s) of seeds, ensuring that sprouts grown from that (those) lot(s) 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 if that lot of seeds is not the source of 
contamination (e.g., the lot of seeds is not the source of the pathogen found in spent  
sprout irrigation water or sprouts), as required 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 V. C of the finalized 
sections (Corrective Actions for Seeds that May be Contaminated with a Pathogen) for 
additional information on these provisions (Ref. 18)); 
  Procedures for understanding the underlying cause of contamination (e.g., sources and 
routes of contamination) and/or contributing factors; and 
  Procedures for any specific steps that are necessary to address the underlying cause of 
contamination in order to prevent recurrence of the contamination, considering the 
conditions and practices in your sprout operation. 
2.  Taking corrective actions 
You should take special care when handling contaminated sprouts (or other food), water, and/or 
equipment to avoid accidental exposure of other food, FCSs, and other parts of the production 
environment to pathogen(s). 
You are required to prevent the contaminated production batch of sprouts from entering 
commerce (see   112.147(b) and 112.148(a)). You should 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). A food 
will be deemed to be adulterated if it has been prepared, packed, or held under insanitary 
conditions whereby it may have become contaminated with filth, or whereby it may have been 
rendered injurious to health. (Section 402(a)(4) of the FD&C Act). It is a prohibited act to 
introduce or deliver for introduction into interstate commerce any food that is adulterated (section 
301(a) of the FD&C Act). 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 FCS as was used for the contaminated production batch of sprouts without 
intervening cleaning and sanitizing, the food is adulterated and  112.148(a) requires that you take 
47 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
appropriate action to prevent that food from  entering commerce. One option would be to destroy 
the tofu.  
You should evaluate your operation for the potential for the affected production batch of sprouts 
to have contaminated other objects and production areas (both FCS and non-FCSs). Any surface 
in your sprout operation that has come into contact with the  contaminated production batch of 
sprouts (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 considered an affected surface. 
These surfaces, and the areas surrounding them, could potentially contaminate other food, 
including subsequent batches of sprouts, at your operation, if they are not effectively cleaned and 
sanitized. You should conduct intensified cleaning and sanitizing of all affected surfaces and 
areas surrounding them (see Section III (Cleaning and Sanitizing) in the finalized sections (Ref. 
18)) in response to the known  contamination event. As part of your evaluation, you should 
review your production records to identify FCS and non-FCSs that may have come into 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 sanitized.  
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 consistent implementation of your seed  treatment 
protocol, visual examination of seeds, seed handling procedures, and any other relevant 
controls. For example, you should observe your employees to determine if they are 
properly implementing your procedures and the requirements of the Produce Safety Rule. 
Section 112.21(d) requires that you repeat training as necessary and appropriate in light 
of observations or information indicating that personnel are not meeting standards 
established in the Produce Safety Rule; 
  Re-evaluating your seed sourcing. For example, you should re-evaluate whether you 
should continue using your current seed supplier; and 
  Re-evaluating your cleaning and sanitizing procedures and, as needed, retraining 
employees on appropriate cleaning and sanitizing practices. For example, 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 FCS could indicate a deficiency in your cleaning and sanitizing 
procedures and/or in the degree to which your employees are implementing those 
procedures. 
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  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
3.  Documenting your corrective actions 
Section  112.150(b)(6) requires that you establish and keep records of actions you take in 
accordance with  112.142(b) and (c) and 112.148. These records of corrective actions should 
include information describing the event, such as the results of any evaluation or comprehensive 
investigation you may conduct, and identification of the food and FCSs potentially affected by the 
contamination. They must include the following information: 
  Documentation of your disposition of contaminated production batches of sprouts, 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 ( 112.142(b) or (c) and 112.148(b)); 
  Documentation of cleaning and sanitizing of the affected surfaces and surrounding areas 
( 112.148(c)); and 
  Documentation of any other actions you took to prevent reoccurrence of the 
contamination ( 112.148(d)) (e.g., retraining of your employees (see  112.21(d)), re-
evaluating your cleaning and sanitizing procedures; re-evaluating your seed treatment 
protocol; and/or re-evaluating your seed sourcing, as applicable). 
VI. References 
The following references marked with an asterisk (*) are on display at the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852, 240-402-7500, and are available for viewing by interested persons between 9 a.m. and 4 
p.m., Monday through Friday; they also are available electronically at 
https://www.regulations.gov. References without asterisks are not on public display at 
https://www.regulations.gov because they have copyright restriction. Some may be available at 
the website address, if listed. References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of the date this document 
publishes in the Federal Register, but websites are subject to change over time. 
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Journal of Food Microbiology 52(3):123-153. 
Ref. 3. DLima, C., et al. Memorandum to the File: Produce Related Outbreaks and Illnesses, 
December 2011. Food and Drug Administration.* 
49 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Ref. 4. Merriweather, S., et al. Memorandum to the File: 2011-2014 Produce Related Outbreaks 
and Illnesses, May 2015. Food and Drug Administration.* 
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* 
50 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
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51 
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Draft-Not for Implementation 
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53 
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54