Guide to Minimize Food Safety Hazards 
of Fresh-cut Produce: Draft Guidance for 
Industry 
 
This guidance is being distributed for comment purposes only.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that FDA considers your comment on this draft guidance before we begin work on the final 
version of the guidance, submit either electronic or written comments on the draft guidance 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of the draft guidance.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-2018-D-3583 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 
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm. 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
 
October 2018    Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Table of Contents 
 
 
I.  Introduction 
II.  Background 
A.  Regulatory Framework 
B.  Outbreaks of Foodborne Illness Associated with Fresh-cut Produce 
C.  Factors That Can Lead to the Contamination of Fresh-cut Produce with Pathogens 
III.  How to Apply This Guidance to Your Operations Based on the Regulatory 
Framework That Applies to Your Food Establishment 
IV.  CGMP Requirements Regarding Personnel (21 CFR 117.10) 
A.  Disease Control 
B.  Cleanliness (Hygienic Practices) 
1.  Clothing 
2.  Washing Hands 
3.  Maintaining gloves 
4.  Eating, chewing gum, drinking beverages, and using tobacco products 
5.  Other requirements for cleanliness (hygienic practices) 
V.  CGMP Requirements Regarding Plant and Grounds (21 CFR 117.20) 
A.  Grounds 
B.  Plant Construction and Design 
VI.  CGMP Requirements Regarding Sanitary Operations (21 CFR 117.35) 
VII.  CGMP Requirements Regarding Sanitary Facilities and Controls (21 CFR 
117.37) 
A.  Water Supply 
B.  Plumbing 
C.  Toilet Facilities 
D.  Hand-Washing Facilities 
E.  Disposal of Sewage and Rubbish 
VIII.  CGMP Requirements Regarding Equipment and Utensils (21 CFR 117.40) 
IX.  CGMP Requirements Regarding Processes and Controls (21 CFR 117.80) 
A.  General Requirements Regarding Processes and Controls 
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B.  Raw Materials and Ingredients 
C.  Manufacturing Operations 
X.  CGMP Requirements Regarding Warehousing and Distribution (21 CFR 
117.93) and Defect Action Levels (21 CFR 117.110) 
A.  Warehousing and Distribution 
B.  Defect Action Levels 
XI.  CGMP Requirements for Holding and Distribution of Human Food By-
Products for Use as Animal Food (21 CFR 117.95) 
XII.  PCHF Requirements for a Food Safety Plan and for Reanalysis of a Food 
Safety Plan (21 CFR 117.126 and 117.170) 
A.  Requirements for a Food Safety Plan 
B.  Reanalysis of a Food Safety Plan 
XIII.  PCHF Requirements for a Hazard Analysis (21 CFR 117.130) 
XIV.  PCHF Requirements for Preventive Controls (21 CFR 117.135) 
A.  General Information about Preventive Controls 
B.  Process Controls 
C.  Food Allergen Controls 
D.  Sanitation Controls 
E.  Considering Potential Routes of Contamination 
XV.  PCHF Requirements for Preventive Control Management Components (21 
CFR 117.140) 
XVI. PCHF Requirements for a Supply-Chain Program (Part 117, Subpart G) and 
Example of a Supply-Chain Program in the Production of Fresh-cut Leafy 
Vegetables 
A.  Requirements of Subpart G 
B.  Example of Supplier Approval, Receiving and Verification Activities in the 
Production of Fresh-cut Leafy Vegetables 
XVII. Adding Sodium Hypochlorite as an Antimicrobial Substance to Wash Water 
as an Example of a Process Preventive Control in the Production of Fresh-
cut Leafy Vegetables 
A.  Introduction 
B.  Considerations to Keep in Mind when Adding an Antimicrobial Substance to 
Wash Water as a Process Preventive Control 
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1.  Regulatory status of sodium hypochlorite and other substances used to treat wash 
water in contact with fresh-cut leafy vegetables 
2.  What an antimicrobial substance in wash water does and does not do 
3.  How characteristics of the wash water can impact the effectiveness of an added 
antimicrobial substance 
C.  Understand the Potential Hazard 
D.  Validation of Sodium Hypochlorite as a Process Preventive Control in Wash 
Water 
1.  Choose the commodity that you will use for validation purposes 
2.  Identify the target pathogen for the validation study 
3.  Scientifically establish the minimum effective concentration of antimicrobial in the 
wash water 
4.  Identify the process parameters that you will use for the validation study 
5.  Conduct the validation study 
E.  Establish and Implement Monitoring Procedures 
1.  What to monitor 
2.  How to monitor and how often to monitor 
3.  Who performs the monitoring 
F.  Establish Corrective Action Procedures 
G.  Determine Verification Procedures 
H.  Establish and Maintain Records 
I.  Summary Process Control Chart for Adding Sodium Hypochlorite as an 
Antimicrobial Substance to Wash Water as an Example of a Process Preventive 
Control in the Production of Fresh-cut Leafy Vegetables 
XVIII. Requirements Applying to Records That Must Be Established and 
Maintained (Part 117, subpart F) 
XIX.  Training 
A.  Training Requirements Specified in Part 117, Subpart A 
B.  Required Training in the Principles of Food Hygiene and Food Safety 
C.  Examples of Training Topics Appropriate to Assigned Duties 
D.  Delivery of Training 
E.  Records of Training 
XX.  Glossary of Terms Used in This Guidance 
A.  Terms Defined in 21 CFR part 117 
B.  Terms Defined in 21 CFR part 112 
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C.  Terms Defined for Use in This Guidance 
XXI.  Abbreviations Used in This Document 
XXII.  References 
Appendix 1.  Example of a Sanitation Master Schedule 
Appendix 2.  Summary Process Control Chart for Adding Sodium Hypochlorite 
to Wash Water as an Example of a Process Preventive Control in the 
Production of Fresh-cut Leafy Vegetables 
Appendix 3.  Example of a Training Aid to Instruct Personnel on Adequate 
Handwashing Procedures 
Appendix 4.  Example of a Training Aid to Instruct Personnel Who Have 
Responsibility for Cleaning and Sanitizing 
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Guide to Minimize Food Safety Hazards 
of Fresh-cut Produce: Draft Guidance for 
1
Industry  
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (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/GuidanceRegulation/FSMA/ucm459719.htm. 
 
I.  Introduction 
This guidance is intended for those persons (you) who are subject to our regulation, in 21 CFR 
part 117 (part 117), entitled Current Good Manufacturing Practice, Hazard Analysis, and Risk 
Based Preventive Controls for Human Food and who manufacture, process, pack, or hold fresh-
cut produce. In this guidance, fresh-cut produce means any fresh fruit or vegetable or 
combination thereof that has been physically altered from its whole state after being harvested 
from the field (e.g., by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or 
tearing) without additional processing (such as blanching or cooking). Fresh-cut produce may or 
may not undergo a wash or other treatment before being packaged for use by the consumer or a 
retail food establishment. Fresh-cut produce can be a single commodity or two or more mixed in 
the same package, such as coleslaw or fruit salads, and sometimes called ready to use, pre-
cut, or value added produce.  Fresh-cut produce also does not include produce that has been 
processed by freezing, cooking, canning, or packing in a juice, syrup, or dressing.  
Fresh-cut produce can be ready-to-eat (RTE) or not ready-to-eat (NRTE)2. Examples of RTE 
fresh-cut produce include broccoli florets, cauliflower florets, cut celery stalks, cut melon, peeled 
baby carrots, riced cauliflower, salad mixes (raw vegetable salads), sectioned grapefruit, 
shredded cabbage, shredded lettuce, sliced bell peppers, sliced mushrooms, sliced pineapple, 
                                                 
1 This guidance has been prepared by the Office of Food Safety, Division of Produce Safety in the Center for Food 
Safety and Applied Nutrition at the U.S. Food and Drug Administration.  
2 Note that our 2008 guidance entitled Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and 
Vegetables only addressed RTE fresh-cut produce, because it described fresh-cut produce as not requiring 
additional preparation, processing, or cooking before consumption, with the possible exception of washing or the 
addition of salad dressing, seasoning, or other accompaniments. This guidance addresses NRTE fresh-cut produce in 
addition to RTE fresh-cut produce due to changes in the marketplace since we developed the 2008 guidance. 
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sliced tomatoes, and spiral-cut zucchini squash. Examples of NRTE fresh-cut produce include 
cubed butternut squash and cubed sweet potatoes. 
This guidance is intended for you regardless of whether:  
  You are only subject to the current good manufacturing practice requirements for human 
food in part 117 (CGMP requirements); or 
  You are subject to both the CGMP requirements and the requirements for hazard analysis 
and risk-based preventive controls for human food (the human food preventive controls 
requirements, or PCHF requirements).  
The purpose of this guidance is to help you comply with the CGMP requirements and PCHF 
requirements of part 117. For additional information on the CGMP requirements and the PCHF 
requirements, see section II.A. This guidance does not describe all requirements of part 117, but 
rather highlights those requirements that are most relevant to fresh-cut produce processing 
establishments. Because fresh-cut produce processing establishments, and the types of fresh-cut 
produce they produce, are diverse, the recommendations in this guidance will be most useful 
when you adapt these recommendations to the specific procedures, practices, and processes at 
your establishment.  
This guidance is not intended for farms that only grow, harvest, or pack raw agricultural 
commodities (RACs), including those farms that grow, harvest, or pack RACs in accordance 
with our regulation, in 21 CFR part 112 (the produce safety regulation), entitled Standards for 
the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. However, 
if you are a farm mixed-type facility (i.e., you are a farm, but also conduct activities outside the 
farm definition that require you to be registered as a food facility), this guidance applies to your 
fresh-cut processing activities.  
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidance documents describe our current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in FDA guidance means that something is suggested or 
recommended, but not specifically required. 
II.  Background  
A. Regulatory Framework 
Subparts A, B, and F of part 117 include CGMP requirements for manufacturing, processing, 
packing and holding human food. In particular, the CGMP requirements in subpart B (entitled 
Current Good Manufacturing Practice) address topics such as personnel, plant and grounds, 
equipment and utensils, sanitary operations and facilities, processes and controls, and 
warehousing and distribution. With few exceptions (such as for farms and activities of farm 
mixed-type facilities that fall within the definition of farm, and for establishments solely 
engaged in the holding and/or transportation of one or more RACs), the CGMP requirements in 
part 117 apply to all persons who manufacture, process, pack, or hold human food, including 
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fresh-cut produce.3 See Table 1 for a list of those CGMP requirements, in subpart B, discussed in 
this guidance.  
Table 1.CGMP Requirements of Subpart B Discussed in this Guidance 
Section  Description 
117.10  Personnel 
117.20  Plant and grounds 
117.35  Sanitary operations 
117.37  Sanitary facilities and controls 
117.40  Equipment and utensils 
117.80  Processes and controls 
117.93  Warehousing and distribution 
117.95  Holding and distribution of human food by-products for use as animal food 
117.110  Defect action levels 
 
Subparts A, C, D, E, F, and G of part 117 include the PCHF requirements for hazard analysis and 
risk-based preventive controls, for preventive control management components (i.e., monitoring, 
corrective actions and corrections, and verification), and for associated records. With some 
exceptions (e.g., for qualified facilities, such as facilities that are a very small business as 
defined in 21 CFR 117.3), the PCHF requirements apply to any food establishment that is 
required to register as a food facility under our regulation Registration of Food Facilities in 21 
CFR part 1, subpart H. See 21 CFR 117.5 for a complete list of exemptions from the PCHF 
requirements.  
This document discusses PCHF requirements that are in subparts C, F, and G. See Table 2 for a 
list of the PCHF requirements in subparts C, F, and G. 
Table 2.PCHF Requirements in Subparts C, F, and G 
Subpart  Section  Description 
C  117.126  Food safety plan 
C  117.130  Hazard analysis 
C  117.135  Preventive controls 
C  117.139  Recall plan 
C  117.140  Preventive control management components 
C  117.145  Monitoring 
C  117.150  Corrective actions and corrections 
C  117.155  Verification 
C  117.160  Validation 
C  117.165  Verification of implementation and effectiveness 
C  117.170  Reanalysis 
                                                 
3 Although not specified in part 117, we do not apply the CGMP requirements to restaurants and retail food 
establishments. 
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Subpart  Section  Description 
C  117.180  Requirements applicable to a preventive controls qualified 
individual and a qualified auditor 
C  117.190  Implementation records required for subpart C 
F  117.301  Requirements Applying to Records That Must Be Established and 
through  Maintained 
117.335 
G  117.405  Supply-Chain Program 
through 
117.475 
 
Although this guidance provides specific recommendations for complying with the PCHF 
requirements when manufacturing, processing, packing, or holding fresh-cut produce, we are 
developing a separate, comprehensive guidance to help all food facilities that are subject to 
PCHF requirements  not just fresh-cut processing facilities  comply with the PCHF 
requirements. See our guidance entitled Hazard Analysis and Risk-Based Preventive Controls 
for Human Food, currently available as draft guidance 4(Ref. 1). This document refers to that 
comprehensive guidance as the PCHF guidance.5 The PCHF guidance will include separate 
chapters directed to topics such as conducting a hazard analysis, identifying potential hazards, 
and preventive controls, including both general recommendations for preventive controls and 
specific recommendations for certain types of preventive controls (such as time/temperature 
controls, sanitation controls, and food allergen controls). The PCHF guidance also will include 
appendices that identify potential hazards for specific foods and provide forms, adapted from 
forms developed by the Food Safety Preventive Controls Alliance (FSPCA)6, which you can use 
to help you document your hazard analysis and preventive controls. This document often refers 
you to the PCHF guidance rather than repeat the comprehensive guidance that will be included in 
the PCHF guidance.  
See the Glossary in section XX for the following definitions: 
  Several terms that are defined in 21 CFR 117.3 and used in this guidance; 
  The term produce as defined in the produce safety regulation (21 CFR 112.3); and 
                                                 
4 When finalized, this guidance will represent the current thinking of FDA on this topic. 
5 The PCHF guidance is being developed as a series of chapters. In developing this guidance, we first will issue each 
chapter as draft guidance (i.e., not for implementation) and request public comment; we then will finalize each 
chapter after considering and incorporating the public comments as appropriate. The Table of Contents of the PCHF 
guidance provides the titles of the planned chapters. Over time, the status of each chapter will change from draft 
guidance to final guidance. For simplicity, in this guidance regarding fresh-cut produce we refer you to the PCHF 
guidance, and describe the information that the chapter will address, without distinguishing chapters that have 
not yet issued in draft, chapters that are draft guidance, and chapters that we have finalized.  
6 The FSPCA is a broad-based public-private alliance consisting of key industry, academic, and government 
stakeholders whose mission is to support safe food production by developing a nationwide core curriculum, training, 
and outreach programs to assist companies producing human and animal food in complying with FDA Food Safety 
Modernization Act (FSMA) requirements for hazard analysis and risk-based preventive controls. For additional 
information about FSPCA, see their website at https://www.ifsh.iit.edu/fspca. 
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  Some additional terms, not defined in part 117 or the produce safety regulation, that we 
use in this guidance.  
See section XXI for a table of abbreviations commonly used in this guidance. 
B. Outbreaks of Foodborne Illness Associated with Fresh-cut Produce 
In recent years, the market for fresh-cut produce has expanded dramatically due to consumer 
demand for fresh, healthy, and convenient foods (Ref. 2). Recent trends, such as spiralized 
vegetables (e.g., zucchini noodles or zoodles) will likely continue to increase the popularity of 
fresh-cut produce in the United States. However, a variety of produce commodities, including 
fresh-cut varieties, have also been associated with foodborne illness outbreaks. Because many 
types of fresh-cut produce are RTE foods that consumers eat without cooking that could destroy 
pathogens, preventive controls to significantly minimize or prevent the contamination of fresh-
cut produce with pathogens play a key role in food safety.  
FDA compiles and maintains data on reported outbreaks and illnesses associated with FDA-
regulated foods. Between 1996 and 2010, produce accounted for 23.3% of the total reported 
outbreaks and 42.3% of the total outbreak-related illnesses (78 FR 3504 at 3507, January 16, 
2013). Both domestic produce and imported produce were identified as vehicles in these 
outbreaks. Many factors play a role in the contamination of produce with pathogenic 
microorganisms, including worker health and hygiene, the quality of agricultural water, the use 
of animal manure and other materials of animal origin as fertilizer, growing and harvesting 
operations, and equipment and building sanitation (Ref. 3). One example of an outbreak 
associated with on-farm contamination is the 2006 multistate outbreak of E. coli O157:H7 
infections associated with consumption of fresh spinach that led to 199 illnesses, 102 
hospitalizations, and 3 deaths (Ref. 4). Follow-up investigation related to this outbreak indicated 
that initial contamination of the spinach occurred on-farm.  
Over the last few decades, illnesses linked to contamination of fresh-cut produce with pathogenic 
microorganisms have been reported in the United States (Ref. 5). Between 1996 and 2010, fresh-
cut fruits and vegetables accounted for 16.8% of the total produce-related outbreaks (78 FR 3504 
at 3507, January 16, 2013). From 2002 to 2017, there were 39 outbreaks of foodborne illness 
linked to the consumption of fresh-cut produce, resulting in approximately 3,432 illnesses, 643 
hospitalizations and 15 deaths (Ref. 6).  
Although produce can become contaminated before it reaches a fresh-cut processing 
establishment (e.g., at the grower, as was the case in the 2006 outbreak associated with spinach 
(Ref. 4), or at a packinghouse), the available evidence demonstrates that the practices or 
conditions at a fresh-cut processing establishment also can lead to contamination of fresh-cut 
produce. For example, a listeriosis outbreak caused by diced celery that had been contaminated 
with Listeria monocytogenes and then served in chicken salad prepared by a hospital in Texas 
was linked back to a fresh-cut processing establishment (Ref. 7). Investigators from the Texas 
State Department of Health and FDA noted structural defects as well as inadequate handling and 
cleaning of produce at the fresh-cut processing establishment that produced the diced celery. 
Investigators found the outbreak strain of L. monocytogenes in environmental samples collected 
from floors, surfaces, and equipment in every room of the plant. Environmental samples 
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collected on four subsequent visits to the establishment detected widespread and continuing 
presence of the outbreak strain in the plant. For a review of some other examples in which the 
practices or conditions at a fresh-cut processing establishment have led to contamination of 
fresh-cut produce, see Ref. 8. 
C. Factors That Can Lead to the Contamination of Fresh-cut Produce with 
Pathogens 
Several factors can lead to contamination of fresh-cut produce. For example: 
  As discussed in section II.B, produce can be contaminated on-farm (Ref. 4). When 
incoming produce is contaminated, processing produce into fresh-cut products increases 
the risk of bacterial growth and contamination by breaking the natural exterior barrier of 
the produce (Ref. 9). The release of plant cellular fluids when produce is chopped or 
shredded provides a nutritive medium in which pathogens, if present, can survive or grow 
(Ref. 9). Thus, if pathogens are present when the surface integrity of the fruit or vegetable 
is broken, pathogen growth can occur and contamination may spread.  
  Handling practices that are common at fresh-cut processing establishments, such as 
mixing large batches of fresh-cut produce, have the potential to spread contamination 
across a larger volume of product (Ref. 5).  
  During manufacturing/processing or packing, fresh-cut produce can be contaminated by 
an environmental pathogen such as L. monocytogenes or Salmonella spp. that is present 
in the food production environment (Ref. 7).7  
  The potential for pathogens to survive or grow is increased by the high moisture and 
nutrient content of fresh-cut fruits and vegetables and by the potential for temperature 
abuse during processing, storage, transport, and retail display (Ref. 9).  
III.  How to Apply This Guidance to Your Operations Based on the 
Regulatory Framework That Applies to Your Food Establishment  
In this guidance, we identify CGMP and PCHF requirements that are most relevant to fresh-cut 
processing establishments, and specific recommendations related to those requirements. CGMPs 
are sometimes described as prerequisite programs that would be in place at a food 
establishment to support and provide a foundation for preventive-based food safety systems (Ref. 
10). The CGMP and PCHF requirements are mutually supportive and reinforcing and, thus, you 
should consider your CGMPs and the role of those CGMPs in the food safety system as you 
conduct your hazard analysis and establish and implement preventive controls to address 
identified hazards. For example: 
  The CGMP requirements include requirements for sanitary operations (in 21 CFR 
117.35) and for using chemical, microbial, or extraneous-material testing procedures 
                                                 
7 See the discussion of environmental pathogens in section III. 
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where necessary to identify sanitation failures or possible allergen cross-contact and food 
contamination (in 21 CFR 117.80(a)(5)). The PCHF requirements include requirements 
for sanitation controls (in 21 CFR 117.135(c)(3)) and for environmental monitoring (in 
21 CFR 117.165(a)(3)) as a verification8 if contamination of an RTE food with an 
environmental pathogen is identified as a hazard requiring a preventive control. Thus, 
both CGMP and PCHF requirements apply with respect to sanitation operations in your 
fresh-cut processing establishment and with respect to testing to identify whether 
sanitation operations are effectively implemented.  
  The CGMP requirements include requirements for manufacturing operations, such as 
requirements to perform steps such as washing, peeling, trimming, cutting, and sorting 
and inspecting, so as to protect food against allergen cross-contact and against 
contamination (in 21 CFR 117.80(c)(10)). The PCHF requirements include requirements 
for process controls (in 21 CFR 117.135(c)(1)).  
In this guidance, we provide recommendations for how you can comply with certain CGMP and 
PCHF requirements during the manufacturing, processing, packing, and holding of fresh-cut 
produce. When discussing our recommendations for complying with CGMP requirements, we 
use terms such as control or control measure rather than the term preventive control, 
which is associated with PCHF requirements.  
In this guidance, we provide more detailed recommendations for implementing certain 
requirements of part 117 and fewer recommendations for implementing other requirements that 
are more self-explanatory. For example, in Appendix 1 we provide an example of a sanitation 
master schedule that you could use for conducting sanitary operations in accordance with the 
requirements for sanitary operations in 21 CFR 117.35. However, we do not provide specific 
recommendations for how to comply with the requirement (in 21 CFR 117.10(a)) that personnel 
be instructed to report certain health conditions to their supervisors, because this requirement is 
self-explanatory. Because this guidance does not repeat the full text of all requirements of part 
117, you should familiarize yourself with the complete requirements of part 117. You can access 
them on the Internet at the Electronic Code of Federal Regulations. 
Some PCHF requirements that are expressly directed to RTE foods apply to RTE fresh-cut 
produce. For example, the hazard evaluation required by 21 CFR 117.130 must include an 
evaluation of environmental pathogens whenever an RTE food is exposed to the environment 
prior to packaging and the packaged food does not receive a treatment or otherwise include a 
control measure (such as a formulation lethal to the pathogen) that would significantly minimize 
the pathogen (21 CFR 117.130(c)(1)(ii)). The definition of environmental pathogen identifies 
Listeria monocytogenes and Salmonella spp. as examples of environmental pathogens (21 CFR 
117.3). In addition, the PCHF requirements include requirements for environmental monitoring 
(in 21 CFR 117.165(a)(3)) as a verification of preventive controls if contamination of an RTE 
food with an environmental pathogen is identified as a hazard requiring a preventive control. For 
additional information about these requirements, see the PCHF guidance (Ref. 1). For additional 
                                                 
8 Although not specified in 21 CFR 117.165(a)(3), environmental monitoring as a verification activity is usually a 
verification of sanitation controls. 
 
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information on control of the environmental pathogen L. monocytogenes in RTE foods, see our 
draft guidance for the control of L. monocytogenes in RTE foods (the Listeria guidance) (Ref. 
11).9  
 
IV.  CGMP Requirements Regarding Personnel (21 CFR 117.10)  
The CGMP requirements regarding personnel specify the measures you must take to prevent 
personnel from contaminating fresh-cut produce, food contact surfaces (FCSs), or food-
packaging materials. The primary areas of focus of the CGMP requirements regarding personnel 
are disease control (21 CFR 117.10(a)) and cleanliness (i.e., hygienic practices) (21 CFR 
117.10(b)). Personnel include full-time and part-time employees, temporary or seasonal 
employees, and contract personnel.  
A. Disease Control 
The CGMP requirements for disease control specify that any person who, by medical 
examination or supervisory observation, is shown to have, or appears to have, illness, open 
lesion, including boils, sores, or infected wounds by which there is a reasonable possibility of 
food, FCSs, or food-packaging materials becoming contaminated, must be excluded from any 
operations which may be expected to result in such contamination until the condition is 
corrected, unless conditions such as open lesions, boils, and infected wounds are adequately 
covered (e.g., by an impermeable cover) (21 CFR 117.10(a)). In addition, personnel must be 
instructed to report certain health conditions to their supervisors (21 CFR 117.10(a)). The 
principal reason for excluding personnel with such conditions is to prevent foodborne illness 
from consumption of food that is contaminated with pathogenic microorganisms through transfer 
of the pathogenic microorganisms from personnel to the food being produced.  
Many symptoms (e.g., vomiting, diarrhea, abdominal cramps, fever, and jaundice) associated 
with illnesses that warrant exclusion from food production operations (particularly 
communicable illnesses) would be obvious to the affected personnel and symptoms such as 
lesions often would be obvious to supervisory personnel as well. You should take steps to ensure 
that all personnel are aware of the importance of reporting applicable illnesses and being 
excluded from operations or areas of the plant where they could contaminate food, FCSs, or 
food-packaging materials. One way to ensure that personnel are aware of this responsibility is 
through the required training in the principles of food hygiene and food safety, which includes 
the importance of employee health and personal hygiene (21 CFR 117.4). Production workers 
who are sick could be re-assigned to duties that are unlikely to lead to contamination of food, 
such as clerical duties. If an office worker who has job duties that include delivering paperwork 
to the production line is ill, another office worker could deliver the paperwork during the illness. 
                                                 
9 In January 2017, we issued the draft guidance entitled Control of Listeria monocytogenes in Ready-to-Eat Foods 
(Ref. 11) When finalized, this guidance will reflect FDAs current thinking on this topic.  In this document we 
simply refer to that guidance as the Listeria guidance, without specifying its status as draft guidance or final 
guidance. 
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A mechanic who is ill should not repair equipment with FCSs unless the FCSs will be thoroughly 
cleaned and sanitized after repair.  
Some individuals who are infected do not show symptoms (i.e., they are asymptomatic). In 
many cases, an asymptomatic individual can spread a communicable disease. If neither you nor 
the individual know that the individual has an asymptomatic infection, it is unlikely that the 
individual would be excluded from working in operations where the individual could 
contaminate food, FCSs, or food-packaging materials. If this happens, the hygienic practices 
required by 21 CFR 117.10(b) (particularly the requirements for handwashing and maintaining 
gloves) can help reduce the potential for an asymptomatic individual to contaminate food, FCSs, 
or food-packaging materials. See the discussion of hygienic practices in section IV.B. 
Supervisors have an important role in ensuring that employees are aware of, and report, 
applicable health conditions that warrant exclusion from food production operations and areas of 
the plant where food is processed or exposed. One way to ensure that supervisors are aware of 
this responsibility is through the required training in the principles of food hygiene and food 
safety, which includes the importance of employee health and personal hygiene (21 CFR 117.4). 
Supervisors should be aware that they should look for any obvious symptoms of an applicable 
health condition in personnel (e.g., if an employee makes frequent trips to the toilet facilities). 
Signage and visual aids, such as posters, can also serve to remind employees to report applicable 
health conditions. 
B. Cleanliness (Hygienic Practices) 
The CGMP requirements for cleanliness address hygienic practices such as wearing suitable 
outer garments, washing hands, maintaining gloves, wearing effective hair restraints, storing 
personal items, and confining activities such as eating food, chewing gum, drinking beverages, 
and using tobacco to areas other than areas where food may be exposed or where equipment or 
utensils are washed (21 CFR 117.10(b)). You should refer to 21 CFR 117.10(b) for the complete 
requirements for cleanliness. 
1.  Clothing 
Your personnel who handle food, FCSs, or food-packaging materials must wear suitable outer 
garments to protect against allergen cross-contact and against contamination of food, FCSs, or 
food-packaging materials (21 CFR 117.10(b)(1)). Examples of suitable outer garments include 
smocks, aprons, coveralls, hair nets, beard guards, and footwear covers. Strategies that you can 
use to avoid contamination of food, FCSs, or food-packaging materials through outer garments 
include wearing clothing and footwear that are dedicated for food processing operations, 
changing clothing and footwear as necessary and appropriate during food processing operations, 
and replacing outer garments when they become damaged or can otherwise no longer be cleaned.  
2.  Washing Hands  
The CGMP requirements specify that personnel who work in direct contact with food, FCSs, or 
food-packaging materials must wash their hands at the following times: before starting work, 
after each absence from the work station, or at any other time when the hands may have become 
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soiled or contaminated (21 CFR 117.10(b)(3)). Examples of times when hands can become 
contaminated are using the restroom, touching the nose or mouth (particularly after coughing or 
sneezing) or other skin, and contacting contaminated surfaces (e.g., unclean equipment, walls, 
floors, trash, objects (such as hoses, pallets, and the bottom of buckets) that have been in contact 
with the floor) and tools that do not contact food (e.g., brooms and shovels)). See Appendix 3 for 
an example of a training aid to instruct personnel on adequate handwashing procedures.  
3.  Maintaining gloves 
The CGMP requirements specify that gloves used in food handling must be maintained in an 
intact, clean, and sanitary condition (21 CFR 117.10 (b)(5)), but do not specify the types of 
gloves (e.g., disposable gloves or reusable gloves). Thus, you have flexibility to choose the type 
of gloves that work best for your operations. You should regularly evaluate the condition of 
reusable gloves to determine whether they should be cleaned or replaced (e.g., due to holes, tears 
or cracks). When determining an appropriate frequency for cleaning gloves, you should consider 
how the ways in which the gloves will be used impact the potential for the gloves to contaminate 
food, FCSs, and food-packaging materials.  
4.  Eating, chewing gum, drinking beverages, and using tobacco products 
The CGMP requirements specify that personnel must not eat, chew gum, drink beverages, or use 
tobacco products in an area in which food may be exposed or where equipment or utensils are 
washed (21 CFR 117.10 (b)(8)). You should confine these activities to designated areas (e.g. 
break rooms, designated smoking areas, and lunch rooms) and locate them at a sufficient 
distance from fresh-cut processing operations and FCSs so that spillage of partially consumed 
food, chewing gum, beverages, and tobacco products do not serve as a potential source of 
contamination to fresh-cut produce or FCSs. Locating these designated areas near hand-washing 
facilities may help to facilitate handwashing after consuming these products. Your supervisors 
should also observe that your personnel follow the required practices and be prepared to address 
observations of unhygienic practices. 
5.  Other requirements for cleanliness (hygienic practices) 
The CGMP requirements specify that you must take any other necessary precautions to protect 
against allergen cross-contact and against contamination of food, FCSs, or food-packaging 
materials with microorganisms or foreign substances (21 CFR 117.10 (b)(9)). We recommend 
that your procedures for addressing accidents in which personnel are injured include procedures 
to reduce the potential for bodily fluids to contaminate food, FCSs, or food-packaging materials. 
V.  CGMP Requirements Regarding Plant and Grounds (21 CFR 
117.20)  
The CGMP requirements regarding plant and grounds address measures to prevent plant and 
grounds from contaminating food, FCSs, or food-packaging materials.  
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A. Grounds  
The CGMP requirements regarding the grounds of a food processing plant specify methods for 
adequately maintaining grounds to protect against the contamination of food. For example: 
  If grounds are under the control of the plants operator, such methods address storage of 
equipment; removal of litter; maintenance of yards and parking lots; draining areas that 
may contribute contamination to food by seepage, foot-borne filth, or providing a 
breeding place for pests; and operating systems for waste treatment and disposal (21 CFR 
117.20(a)(1) through (4)). 
  If bordering grounds that are not under the operators control are not adequately 
maintained, the operator of the plant must exercise care in the plant by inspection, 
extermination, or other means to exclude pests, dirt, and filth that may be a source of 
food contamination (21 CFR 117.20(a)(5)). 
You should refer to 21 CFR 117.20(a) for the complete requirements.  
Examples of steps you can take to comply with the CGMP requirements regarding grounds 
include: 
  Adequately remove debris, unused equipment, and vegetation; and 
  Adequately drain grounds. 
B. Plant Construction and Design 
The CGMP requirements regarding plant construction and design specify that the plant must be 
suitable in size, construction, and design to facilitate maintenance and sanitary operations for 
food-production purposes (i.e., manufacturing, processing, packing, and holding). For example, 
the plant must: 
  Provide adequate space for such placement of equipment and storage of materials as is 
necessary for maintenance, sanitary operations, and the production of safe food (21 CFR 
117.20(b)(1));  
  Permit the taking of adequate precautions to reduce the potential for allergen cross-
contact and for contamination of food, FCSs, or food-packaging materials with 
microorganisms, chemicals, filth, and other extraneous material (21 CFR 117.20(b)(2)); 
  Be constructed in such a manner that floors, walls, and ceilings may be adequately 
cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, 
ducts and pipes does not contaminate food, FCSs, or food-packaging materials; and that 
aisles or working spaces are provided between equipment and walls and are adequately 
unobstructed and of adequate width to permit employees to perform their duties and to 
protect against contaminating food, FCSs, or food-packaging materials with clothing or 
personal contact (21 CFR 117.20(b)(4)); 
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  Provide adequate lighting and ventilation (21 CFR 117.20(b)(5) and (6)); and  
  Where necessary, provide adequate screening or other protection against pests (21 CFR 
117.20(b)(7)).   
You should refer to 21 CFR 117.20(b) for the complete requirements. You also should refer to 
our Listeria guidance (Ref. 11) for specific recommendations on plant construction and design to 
reduce the potential for contamination of fresh-cut produce with L. monocytogenes. 
Examples of steps you can take to comply with the CGMP requirements regarding plant 
construction and design include: 
  Locate the doors leading to the outside in an area other than in a processing area;  
  Close all exterior doors and entrances when not in use, and ensure an adequate seal when 
exterior doors and entrances are closed, to prevent entry by pests (Ref. 12);  
  Fit floor drains with seals and grates adequate to prevent pest entry;  
  Design product areas to have traffic patterns that separate intact RACs and finished 
product from each other using either linear product flow (intact RACs to finished 
product) or physical partition (Ref. 11). See Figure 3 in Ref. 13 for an example of product 
and personnel flow patterns in a fresh-cut processing plant and Appendix 3 in Ref. 11 for 
an example of air flow in a food processing plant;  
  Use positive air pressure in the fresh-cut processing area (Ref. 11 and Ref. 14); 
  Use construction material that is smooth (Ref. 15) and easily cleanable, such as stainless 
steel or plastic whenever practical for constructing food storage and processing areas to 
reduce the potential for microbial harborage that could lead to contamination of food. 
Alternatively, when doing so is not practical, give special attention to cleaning these 
surfaces as part of your sanitary operations; 
  Do not construct a floor flume transfer from the produce cooling and packing operation 
into or across an area housing fresh-cut produce operations whenever practical. If it is not 
practical to avoid such a floor flume transfer, we recommend that you use floor flumes 
with caution due to the potential for water aerosol contamination of the room air and 
nearby equipment surfaces; 
  Plumb flume water to a floor drain (rather than to the floor) with a backflow preventer 
(Ref. 16) if practical to do so. Alternatively, when doing so is not practical, give special 
attention to standing water (Ref. 11) as part of your sanitary operations; 
  Either do not construct trench drains, or equip trench drains for automatic flushing 
whenever practical, taking care to ensure that automatic flushing does not create aerosols 
that could contaminate food or FCSs. If you use trench drains and automatic flushing is 
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not practical, we recommend that you give special attention to the areas around the trench 
drains during your sanitary operations; and  
  When applicable, locate any microbiology laboratory as far away as practical from the 
processing area, because routine microbiological testing usually involves enrichment 
procedures that enable microorganisms to multiply before conducting analytical tests to 
detect them.  
During new construction or renovations, you should carefully consider the potential for L. 
monocytogenes to spread to areas in the plant where RTE foods, food contact surfaces, or food-
packaging materials will be exposed to the environment. For example, new construction and 
renovations could cause significant disruption to air patterns, walls, ceilings, or floors that 
ordinarily act as a barrier to reduce the potential for cross-contamination of food, food contact 
surfaces, non-food contact surfaces, or food-packaging materials. Actions you should take 
depend on the type of construction activity and the potential for contamination.  
The Listeria guidance (Ref. 11) includes comprehensive recommendations for the types of 
actions that you could take to reduce the potential for L. monocytogenes to contaminate food, 
FCSs, or food-packaging material in certain circumstances. Examples of such recommendations 
as they would apply to a fresh-cut produce processing establishment include: 
  Design and construct the plant so that walls, ceilings, windows, doors, floors, drains, and 
overhead fixtures (e.g., pipes, air vents, and lights) in areas where fresh-cut produce is 
processed or exposed are manufactured using materials that will prevent condensate 
buildup and resist deterioration when exposed to food or cleaning chemicals; when 
surfaces deteriorate, they can become hard-to-clean and result in contamination with, and 
harborage of, microorganisms;  
  Design and construct the roof so that it drains freely and does not leak;  
  Do not place windows that can be opened in areas where fresh-cut produce is processed 
or exposed (when practical); alternatively, you could use positive air pressure or other 
mitigation measures in fresh-cut processing areas with such windows; and 
  Avoid construction materials made of porous or absorbent materials, such as wood or 
foam, in areas where fresh-cut produce is processed or exposed and in other wet 
processing areas in the plant, to reduce the potential for harborage of Listeria 
monocytogenes.  
VI.  CGMP Requirements Regarding Sanitary Operations (21 CFR 
117.35)  
The CGMP requirements for sanitary operations address general maintenance, substances used in 
cleaning and sanitizing, storage of toxic materials, pest control, sanitation of FCSs, sanitation of 
non-FCSs, and storage and handling of cleaned portable equipment and utensils.  
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  The CGMP requirements for general maintenance specify that buildings, fixtures, and 
other physical facilities of the plant must be maintained in a clean and sanitary condition 
and kept in repair adequate to prevent food from becoming adulterated. Cleaning and 
sanitizing of utensils and equipment must be conducted in a manner that protects against 
allergen cross-contact and against contamination of food, FCSs, or food-packaging 
materials (21 CFR 117.35(a)).  
  The CGMP requirements for substances used in cleaning and sanitizing and for storage of 
toxic materials include limitations on the use and storage of toxic materials in a plant 
where food is processed or exposed (21 CFR 117.35(b)). 
  The CGMP requirements for pest control permit the use of pesticides to control pests in 
the plant only under precautions and restrictions that will protect against the 
contamination of food, FCSs, and food-packaging materials (21 CFR 117.35(c)). 
  The CGMP requirements for sanitation of FCSs specify that all FCSs, including utensils 
and food-contact surfaces of equipment, must be cleaned as frequently as necessary to 
protect against allergen cross-contact and against contamination of food and specifically 
address FCSs used for manufacturing/processing, packing, or holding low-moisture food; 
food contact-surfaces used in wet processing; and single-service articles (21 CFR 
117.35(d)).  
You should refer to 21 CFR 117.35 for the complete requirements. 
Examples of steps you can take to comply with the CGMP requirements regarding sanitary 
operation are:  
  Use a step-wise process for cleaning and sanitizing (e.g., Pre-clean (e.g., dry clean), Pre-
rinse, Soap and Scour, Post-Rinse, Prepare for Inspection, Pre-op Inspection, and Sanitize 
and Assemble) (Ref. 11);  
  Establish and implement a preventive maintenance program that is designed to minimize 
breakdowns and prevent contamination that could occur during repair of equipment. 
Examples of what a preventive maintenance program could address are schedules for 
examination and maintenance of equipment such as valves, gaskets, O-rings, pumps, 
screens, filters, hoists, and chiller plates. (If you establish your preventive maintenance 
program as a preventive control, you would include a written maintenance program in 
your food safety plan (21 CFR 117.126(b)(2) and 117.135(b))); 
  Clean and sanitize after maintenance repairs (Ref. 11);  
  Store chemicals used at the plant in a secure and designated area; 
  Review the cleanability of a surface prior to purchase and before installation; 
  Align the flow of equipment and tools at the plant with traffic patterns of people or, 
where applicable, with traffic patterns of tools and equipment used for cleaning and 
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sanitizing equipment (Ref. 17) before the tools or equipment are used across designated 
zones; 
  Establish adequate controls to maintain sanitary operations during construction; and 
  Arrange for pesticides to be applied only by persons who are qualified to do so by 
education, training, or experience (or a combination thereof). 
See Appendix 1 for an example of a master sanitation schedule for general maintenance in your 
plant. If you use this master sanitation schedule, we recommend that you tailor it to your 
operations as appropriate. For example, the frequency of cleaning could be more than, or less 
than, the frequency in the example master sanitation schedule depending on the specific 
characteristics of your plant and equipment.  
See the Listeria guidance (Ref. 11) for specific recommendations regarding sanitation programs 
to control Listeria monocytogenes.  
VII.  CGMP Requirements Regarding Sanitary Facilities and 
Controls (21 CFR 117.37)  
The CGMP requirements regarding sanitary facilities and controls address the water supply, 
plumbing, toilet and handwashing facilities, and disposal of sewage, rubbish, and offal.  
A. Water Supply 
The CGMP requirements for the water supply specify that the water supply must be adequate for 
the operations intended and must be derived from an adequate source. Any water that contacts 
food, FCSs, or food-packaging materials must be safe and of adequate sanitary quality. Running 
water at a suitable temperature, and under pressure as needed, must be provided in all areas 
where required for the processing of food, for the cleaning of equipment, utensils and food-
packaging materials, or for employee sanitary facilities (21 CFR 117.37(a)). 
Adequate water quality is critical in fresh-cut processing due to the potential for pathogen 
infiltration into cut or sliced produce and to the absence of a kill step (i.e., a processing step 
lethal to pathogens). To be adequate for use in a fresh-cut processing establishment, the water 
should be potable. 
B. Plumbing 
The CGMP requirements specify that plumbing must be of adequate size and design and 
adequately installed and maintained to provide functionality with respect to: the quantity of 
water carried throughout the plant; conveyance of sewage and liquid disposable waste from the 
plant; avoiding the potential for water to be a source of contamination to food, water supplies, 
equipment, or utensils, or for creating an unsanitary condition; adequate floor drainage; and 
providing that there be no backflow from, or cross-connection between, piping systems that 
discharge waste water or sewage and piping systems that carry water for food or food 
manufacturing (21 CFR 117.37(b)). 
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Examples of steps you can take to prevent water from becoming a source of contamination are: 
  Design properly sloping floors to drains (e.g., 1/4 inch per foot) to provide adequate 
drainage, and seal and keep drains in good repair;  
  Design floor drains to prevent the accumulation of water in or around the drains, and 
make drains accessible for cleaning. This is especially important in areas where floors are 
subject to a flooding-type of cleaning;  
  Construct trench drains for automatic flushing; 
  Use solid sanitizers (e.g., blocks or rings of quaternary ammonium compounds) to 
maintain drains to minimize the potential for them to be a source of contamination; 
  Design collection areas for waste stream water to prevent contamination of food and 
equipment; and 
  Design drains with sufficient capacity to be adequate to handle increased water flow due 
to increased production capacity without drain back-ups. 
C. Toilet Facilities 
The CGMP requirements for toilet facilities specify that each plant must provide employees with 
adequate, readily accessible toilet facilities. Toilet facilities must be kept clean and must not be a 
potential source of contamination of food, FCSs, or food-packaging materials (21 CFR 
117.37(d)).  
Examples of steps you can take to prevent toilet facilities from being a potential source of 
contamination are: 
  Provide self-closing doors and/or provide doors that do not open into areas where food is 
exposed to airborne contamination, except where alternative means have been taken to 
protect against such contamination (such as double doors or positive air-flow systems);  
  Ensure that toilet facilities are constructed and installed appropriately, including with 
adequate backflow prevention (Ref. 15); and  
  Ensure that toilet facilities are maintained and kept in good repair. 
D. Hand-Washing Facilities  
The CGMP requirements for handwashing facilities specify that each plant must provide hand-
washing facilities designed to ensure that an employees hands are not a source of contamination 
of food, FCSs, or food-packaging materials, by providing facilities that are adequate, convenient, 
and furnish running water at a suitable temperature (21 CFR 117.37(e)). 
Examples of steps you can take to provide adequate handwashing facilities are:  
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  Provide handwashing (and, where appropriate, hand-sanitizing) facilities at each location 
in the plant where good sanitary practices require employees to wash and/or sanitize their 
hands;  
  Provide effective hand-cleaning and sanitizing preparations and sanitary towel service or 
suitable drying devices;  
  Design and construct devices or fixtures (such as water control valves  e.g., knee, foot, 
or elbow faucet controls) to protect against recontamination of clean, sanitized hands;  
  Provide adequate supplies of soap, single service towels, and a covered waste receptacle; 
and  
  Ensure that handwashing facilities are maintained, cleaned, and kept in good repair. 
E. Disposal of Sewage and Rubbish 
The CGMP requirements for sanitary facilities and controls address disposal of sewage (21 CFR 
117.37(c)) and storage and disposal of rubbish to minimize the development of odor, minimize 
the potential for the waste to become an attractant and harborage or breeding place for pests, and 
protect against contamination of food, FCSs, food-packaging materials, water supplies, and 
ground surfaces (21 CFR 117.37(f)). 
The production of fresh-cut produce generates a large quantity of waste that can serve as food 
and shelter for pests. We recommend that you take this into account when designing your waste 
disposal system. We also recommend that you segregate all waste in designated areas, removed 
from food production areas, to minimize the potential that waste will attract pests to food 
production areas or will provide a harborage or breeding place for pests in food production areas.  
You should refer to 21 CFR 117.37 for the complete requirements.  
VIII. CGMP Requirements Regarding Equipment and Utensils (21 
CFR 117.40)  
The CGMP requirements regarding equipment and utensils address the design, construction, and 
maintenance of equipment and utensils. For example, the CGMP requirements in 21 CFR 
117.40(a)(1) through (3) specify that: 
All plant equipment and utensils used in manufacturing, processing, packing, or holding food 
must be: 
  So designed and of such material and workmanship as to be adequately cleanable;  
  Adequately maintained to protect against allergen cross-contact and contamination;  
  Designed, constructed, and used appropriately to avoid the adulteration of food with 
lubricants, fuel, metal fragments, contaminated water, or any other contaminants; and  
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  Installed so as to facilitate the cleaning and maintenance of the equipment and of adjacent 
spaces.  
In addition, the CGMP requirements in 21 CFR 117.40(a)(4) through (6) and (b) specify that:  
  FCSs must be corrosion-resistant when in contact with food;  
  FCSs must be made of nontoxic materials and designed to withstand the environment of 
their intended use and the action of food, and, if applicable, cleaning compounds, 
sanitizing agents, and cleaning procedures;  
  FCSs must be maintained to protect food from allergen cross-contact and from being 
contaminated by any source, including unlawful indirect food additives; and  
  Seams on FCSs must be smoothly bonded or maintained so as to minimize accumulation 
of food particles, dirt, and organic matter and thus minimize the opportunity for growth 
of microorganisms and allergen cross-contact.  
You should refer to 21 CFR 117.40 for the complete requirements. Examples of steps you can 
take to comply with these CGMP requirements are: 
  Design equipment and tools with surfaces that are smooth, non-absorbent, sealed, and 
sloped (e.g., without horizontal edges that would prevent drainage), where feasible, in 
order to drain freely; 
  Cover junctures in FCSs; 
  Use an equipment design standard to obtain information to enhance existing or new 
designs for equipment containing FCSs, such as the sanitary standards inventoried by 3-A 
Sanitary Standards, Inc.;10  
  Construct work surfaces such as tables, counters, and cutting boards with stainless steel, 
and with curved edges, when doing so is practical for your operation. Alternatively, you 
could give special attention to these surfaces through your sanitation practices (see 
section VI).  
  Sharpen any knives that you use frequently, and replace those knives that are damaged or 
cannot be maintained in a sanitary condition;  
  Inspect cutting blades and belts frequently during processing operations for damage, 
build-up of food residue, or cleaning needs; and  
  Take steps to ensure that ice machines or storage bins do not become a source of 
contamination of food, FCSs, or food-packaging material by ensuring that they are 
                                                 
10 3-A Sanitary Standards, Inc. is a non-profit association (representing equipment manufacturers, processors, 
regulatory sanitarians and other public health professionals) that has established an inventory of Sanitary Standards 
and Accepted Practices for dairy and food processing equipment and systems. 
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constructed of food-grade materials, examining their interiors to ensure that they are 
clean, avoiding cross-connections in ice machines, and not storing utensils (such as 
scoops or cups) in the same containers as the ice. 
The CGMP requirements specify that holding, conveying, and manufacturing systems must be of 
a design and construction that enables them to be maintained in an appropriate clean and sanitary 
condition (21 CFR 117.40(d)). We recommend that any conveyor belts you use be smooth belts 
rather than grip-tread or textured belts. Smooth conveyor belts are easier to clean than grid-tread 
or textured belts, which have indentations molded into their surfaces to provide greater 
adherence between the product and the belt. These indentations can serve as a source of 
significant bacterial contamination (Ref. 18). 
The CGMP requirements specify that each freezer and cold storage compartment used to store 
and hold food capable of supporting growth of microorganisms must be fitted with an indicating 
thermometer, temperature-measuring device, or temperature-recording device so installed as to 
show the temperature accurately within the compartment (21 CFR 117.40(e)). We recommend 
that you locate the device you use for this purpose in an area of the refrigerator compartment that 
is more likely to be warm (e.g. near the door, on the cooler/refrigerator wall). Although doing so 
may not reflect the temperature within the compartment as a whole, it could provide you with an 
early warning if there is a problem with the refrigeration compartment and the temperature 
begins to rise. 
Additionally, the CGMP requirements specify that instruments and controls used for measuring, 
regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control 
or prevent the growth of undesirable microorganisms in food must be accurate and precise and 
adequately maintained, and adequate in number for their designated uses (21 CFR 117.40(f)). 
Instruments and controls used to monitor wash water used in the production of fresh-cut produce 
are particularly relevant to fresh-cut processing establishments. (See the discussion in section 
XVII of the monitoring of the concentration of free chlorine when using added chlorine in the 
wash water as a process control in the production of fresh-cut leafy vegetables.) 
IX.  CGMP Requirements Regarding Processes and Controls (21 
CFR 117.80)  
A. General Requirements Regarding Processes and Controls 
The CGMP requirements regarding processes and controls establish general requirements in 21 
CFR 117.80(a). For example, the general CGMP requirements in this section specify that 
adequate precautions must be taken to ensure that production procedures do not contribute to 
allergen cross-contact and to contamination from any source and that chemical, microbial, or 
extraneous-material testing procedures be used where necessary to identify sanitation failures or 
possible allergen cross-contact and food contamination (21 CFR 117.80(a)(4) and (5)).  
You should refer to 21 CFR 117.80(a) for the complete requirements.  
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Examples of steps you can take to comply with the general CGMP requirements regarding 
processes and controls are:  
  Limit access to the plant and to its processing areas; and 
  Restrict the movement of lift trucks, bins, totes, maintenance tools, cleaning implements, 
clothing, and personnel from receiving and storage zones to processing and packaging 
areas.  
B. Raw Materials and Ingredients 
The CGMP requirements establish specific requirements for raw materials and other ingredients 
in 21 CFR 117.80(b). For example, the CGMP requirements in this section for raw materials and 
other ingredients address practices such as inspecting, segregating, and handling raw materials 
and other ingredients as necessary to ascertain that they are clean and suitable for processing into 
food, and washing or cleaning raw materials as necessary to remove soil or other contamination. 
Water used for washing, rinsing, or conveying food must be safe and of adequate sanitary 
quality. Water may be reused for washing, rinsing, or conveying food if it does not cause 
allergen cross-contact or increase the level of contamination of the food (21 CFR 117.80(b)(1)). 
You should refer to 21 CFR 117.80(b) for the complete requirements. Examples of steps you can 
take to comply with the CGMP requirements regarding raw materials and ingredients are:  
  Inspect delivery vehicles carrying fresh produce and food-packaging material for 
cleanliness; 
  Inspect incoming fresh produce for physical hazards (such as animal and plant debris, 
stones, metal, wood, and other foreign material (e.g., staples from boxes, wire and plastic 
strapping from boxes, nails, or wires from crates)), either visually or by using detectors 
(such as metal detectors) and removing such physical hazards; and 
  Visually inspect incoming fresh produce for damage, filth, and infestation and either trim 
it to remove any damaged, rotten, or moldy material or reject it. 
C. Manufacturing Operations 
The CGMP requirements in 21 CFR 117.80(c) for manufacturing operations address practices 
such as: 
  Maintaining equipment and utensils and food containers in an adequate condition through 
appropriate cleaning and sanitizing, as necessary, and, insofar as necessary, taking 
equipment apart for thorough cleaning (21 CFR 117.80(c)(1)); 
  Conducting all food manufacturing, processing, packing, and holding under such 
conditions and controls as are necessary to minimize the potential for the growth of 
microorganisms, allergen cross-contact, contamination of food, and deterioration of food 
(21 CFR 117.80(c)(2));  
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  Holding food that can support the rapid growth of undesirable microorganisms at 
temperatures that will prevent the food from becoming adulterated during manufacturing, 
processing, packing, and holding (21 CFR 117.80(c)(3));  
  Taking adequate measures to protect against the inclusion of metal or other extraneous 
material in food (21 CFR 117.80(c)(8)); and 
  Performing steps such as washing, peeling, trimming, cutting, and sorting and inspecting 
so as to protect food against allergen cross-contact and against contamination; food must 
be protected from contaminants that may drip, drain, or be drawn into the food (21 CFR 
117.80(c)(10)). 
You should refer to 21 CFR 117.80(c) for the complete requirements. 
Examples of steps you can take to comply with the CGMP requirements regarding processes and 
controls for manufacturing operations are:  
  Give special attention, through your sanitary operations, to cleaning procedures for 
containers (such as wooden bins) that cannot be sanitized;  
  Use equipment such as sieves, traps, magnets, and metal detectors to prevent inclusion of 
metal and extraneous material, or to detect metal if such contamination does occur; 
  Wash RACs and processed produce (e.g., using spray or submersion techniques) by 
procedures such as: 
  Conducting an initial wash to remove dirt and debris where practicable;  
o
  In wash steps subsequent to the initial wash to remove dirt and debris, using 
o
antimicrobial chemicals11 in wash water to minimize the potential for microbial 
contamination of processing water and subsequent cross-contamination of RACs and 
processed produce12; 
                                                 
11 See 21 CFR 173.315 (Chemicals used in washing or to assist in the peeling of fruits and vegetables) for examples 
of antimicrobial chemicals used in wash water to minimize the potential for microbial contamination of processing 
water and subsequent cross-contamination of RACs and processed produce. 
12 For a comprehensive discussion of factors to consider in the design and implementation of the use of 
antimicrobial substances as a process control in wash water, see section XVII. Section XVII provides 
recommendations specific to the design and implementation of adding sodium hypochlorite as an antimicrobial 
substance to wash water as an example of a process preventive control. Although section XVII is specifically 
directed to recommendations for compliance with the PCHF requirements for process preventive controls, the 
information in section XVII can help you to design and implement control measures that add an antimicrobial 
substance to wash water to comply with CGMP requirements. In addition, the information in section XVII can be 
generalized to help you design and implement control measures that use antimicrobial substances other than 
chlorine.  
 
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  Where water is reused in a series of processes, arranging water flow to be counter to 
o
the movement of produce through different operations, with the result that as produce 
is further processed, it is exposed to the cleanest water; 
  Minimizing the build-up of organic material in wash water - e.g., by filtering 
o
recirculating water or using an industrial screen to scoop plant material or other 
debris from tanks. 
  Hold fresh-cut produce under refrigeration conditions even if the fresh-cut produce is not 
a time/temperature control for safety (TCS) food.13 
X.  CGMP Requirements Regarding Warehousing and 
Distribution (21 CFR 117.93) and Defect Action Levels (21 CFR 
117.110) 
A. Warehousing and Distribution 
The CGMP requirements regarding warehousing and distribution specify that storage and 
transportation of food must be under conditions that will protect against allergen cross-contact 
and against biological, chemical (including radiological), and physical contamination of food, as 
well as against deterioration of the food and the container (21 CFR 117.93). As discussed in 
section IX, we recommend that you hold fresh-cut produce under refrigeration conditions even if 
the fresh-cut produce is not a TCS food.  
The regulation entitled Sanitary Transportation of Human and Animal Food (21 CFR part 1, 
subpart O; the Sanitary Transportation Rule) requires shippers, loaders, carriers by motor vehicle 
and rail vehicle, and receivers engaged in the transportation of certain foods in the United States 
to use sanitary transportation practices that ensure food is not made unsafe during transport. The 
Sanitary Transportation Rule applies to the receipt and shipment of foods that require 
temperature control for safety and foods that are not completely enclosed by a container, and 
therefore applies to the receipt and shipment of many types of fresh-cut produce. Regarding the 
transportation of fresh-cut produce by motor or rail vehicle in the United States, achieving 
compliance with the Sanitary Transportation Rule will also ensure compliance with the 
requirements of 21 CFR 117.93 for transporting food under conditions that will protect against 
allergen cross-contact and against biological, chemical, and physical contamination of food.  
However, compliance with the Sanitary Transportation Rule will not necessarily ensure 
compliance with the requirement of 21 CFR 117.93 to store food under conditions that will 
                                                 
13 TCS food means a food that requires time/temperature control for safety (TCS) to limit pathogenic 
microorganism growth or toxin formation. Due to the wide range of foods subject to part 117, FDA has not yet 
developed guidance with specific time/temperature recommendations for foods subject to part 117. We note that the 
FDA Food Code, which has been widely adopted in state laws, recommends holding most TCS foods at 41F (7C) 
or lower (Ref. 19). The discussion of TCS food in Annex 3 of the Food Code lists cut melons, cut tomatoes, and cut 
leafy greens as examples of TCS food because intrinsic factors (such as pH, water activity, or combinations of pH 
and water activity) are unable to control bacterial growth once pathogens are exposed to the cellular fluids and 
nutrients after cutting (Ref. 19).  
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protect against deterioration of the food and the container, because the Sanitary Transportation 
Rule does not address food storage. Also, the Sanitary Transportation Rule does not address 
deterioration of food and food containers during transportation, unless such deterioration creates 
a condition that causes the food to become unsafe. 
B. Defect Action Levels  
The CGMP requirements regarding defect action levels (21 CFR 117.110) specify that: 
  The manufacturer, processor, packer, and holder of food must utilize at all times quality 
control operations that reduce natural or unavoidable defects to the lowest level currently 
feasible; and 
  The mixing of a food containing defects at levels that render that food adulterated with 
another lot of food is not permitted and renders the final food adulterated, regardless of 
the defect level of the final food. 
Part 117 defines a defect action level as a level of a non-hazardous, naturally occurring, 
unavoidable defect at which FDA may regard a food product adulterated and subject to 
enforcement action under section 402(a)(3) of the FD&C Act (21 CFR 117.3). Examples of 
naturally occurring, unavoidable defects are insects, insect larvae, insect filth, mold, and rodent 
filth (Ref. 20).  
As discussed in the Defect Action Levels Handbook (Ref. 20), we set these action levels because 
it is economically impractical to grow, harvest, or process raw products that are completely free 
of non-hazardous, naturally occurring, unavoidable defects.  Even if we have an established 
defect action level for a given defect in a given food commodity, you should not assume that you 
should only maintain a level of defect in your product that is just below that level. The defect 
action levels do not represent an average of the defects that occur in food --the averages are 
actually much lower. The defect action levels represent limits at which we may regard the food 
product adulterated under section 402(a)(3) of the FD&C Act.  
For additional information on naturally occurring, unavoidable defects and defect action levels, 
see the Defect Levels Handbook (Ref. 20).  
XI.  CGMP Requirements for Holding and Distribution of Human 
Food By-Products for Use as Animal Food (21 CFR 117.95) 
It is not uncommon for human food manufacturers to send by-products to local farmers or animal 
food manufacturers for use as animal food. To address this practice, the CGMP requirements in 
21 CFR 117.95 specify that:  
  Human food by-products held for distribution as animal food without additional 
manufacturing or processing by the human food processor, as identified in 21 CFR 
507.12, must be held under conditions that will protect against contamination, including 
the following: 
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  Containers and equipment used to convey or hold human food by-products for use as 
o
animal food before distribution must be designed, constructed of appropriate material, 
cleaned as necessary, and maintained to protect against the contamination of human 
food by-products for use as animal food (21 CFR 117.95(a)(1));  
  Human food by-products for use as animal food held for distribution must be held in 
o
a way to protect against contamination from sources such as trash (21 CFR 
117.95(a)(2)); and  
  During holding, human food by-products for use as animal food must be accurately 
o
identified (21 CFR 117.95(a)(3)); 
  Labeling that identifies the by-product by the common or usual name must be affixed to 
or accompany human food by-products for use as animal food when distributed (21 CFR 
117.95(b)); and 
  Shipping containers (e.g., totes, drums, and tubs) and bulk vehicles used to distribute 
human food by-products for use as animal food must be examined prior to use to protect 
against contamination of the human food by-products for use as animal food from the 
container or vehicle when the facility is responsible for transporting the human food by-
products for use as animal food itself or arranges with a third party to transport the human 
food by-products for use as animal food (21 CFR 117.95(c)). 
FDA is developing guidance on the use of human food by-products in animal food, including 
diversion of human food products to animal food use. In 2016, FDA issued for public comment a 
draft guidance for industry entitled Human Food By-Products For Use As Animal Food (Ref. 
21 and 81 FR 58521, August 25, 2016). FDA issued additional guidance on certain 
manufacturing processing activities conducted on human food by-products in section III. D. 
(pages 19-20) of guidance for industry entitled Policy Regarding Certain Entities Subject to the 
Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign 
Supplier Verification Programs (Ref. 22 and 83 FR 598, January 5, 2018). If you intend to 
distribute human food products for use in animal food, we recommend that you consult these 
currently available guidance documents. 
XII.  PCHF Requirements for a Food Safety Plan and for Reanalysis 
of a Food Safety Plan (21 CFR 117.126 and 117.170)  
A. Requirements for a Food Safety Plan 
The PCHF requirements for a food safety plan specify that:  
  You must prepare, or have prepared, and implement a written food safety plan (21 CFR 
117.126(a)(1)); and  
  The food safety plan must be prepared, or its preparation overseen, by one or more 
preventive controls qualified individuals (PCQIs) (21 CFR 117.126(a)(2)).  
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The written food safety plan must include the following (21 CFR 117.126(b)(1) through (7)): 
  The written hazard analysis; 
  The written preventive controls; 
  The written supply-chain program; 
  The written recall plan;  
  The written procedures for monitoring the implementation of the preventive controls; 
  The written corrective action procedures; and 
  The written verification procedures. 
The food safety plan is a record that is subject to the recordkeeping requirements of part 117, 
subpart F (21 CFR 117.126(c)). See part 117, subpart F and section XVIII of this document for 
information about the recordkeeping requirements.  
A food safety plan consists of the primary documents in a preventive controls food safety system 
that provides a systematic approach to the identification of food safety hazards that must be 
controlled to prevent or minimize the likelihood of foodborne illness or injury. It contains a 
collection of written documents that describes activities that ensure the safety of food during 
manufacturing, processing, packing, and holding. Chapter I of the PCHF guidance (Ref. 1) will 
provide additional information about the food safety plan. 
There is no standardized or mandated format for documenting the food safety plan. However, the 
FSPCA has developed worksheets to help you do so. Additionally, we have released version 1.0 
of our Food Safety Plan Builder, a software program which may be useful in documenting the 
food safety plan. The detailed information is available on our web page entitled Food Safety 
Plan Builder (Ref. 23). 
B. Reanalysis of a Food Safety Plan 
The PCHF requirements for reanalysis of a food safety plan specify that: 
  You must conduct a reanalysis of the food safety plan as a whole at least once every 3 
years (21 CFR 117.170(a)); and 
  You must conduct a reanalysis of the food safety plan as a whole, or the applicable 
portion of the food safety plan, in any of the following circumstances (21 CFR 
117.170(b): 
  Whenever a significant change in the activities conducted at your facility creates a 
o
reasonable potential for a new hazard or creates a significant increase in a previously 
identified hazard; 
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  Whenever you become aware of new information about potential hazards associated 
o
with the food; 
  Whenever appropriate after an unanticipated food safety problem in accordance with 
o
21 CFR 117.150(b); or 
  Whenever you find that a preventive control, combination of preventive controls, or 
o
the food safety plan as a whole is ineffective. 
The reanalysis must be done or overseen by a preventive controls qualified individual (21 CFR 
117.170(e)). A food safety plan that is reanalyzed must be revised if the reanalysis reveals a 
reasonable potential for a new hazard or a significant increase in a previously identified hazard 
(21 CFR 117.170(d)). You must validate, as appropriate to the nature of the preventive control 
and its role in your food safety system, any additional preventive controls needed to address the 
hazard identified, within timeframes specified in 21 CFR 117.170(c).  
XIII. PCHF Requirements for a Hazard Analysis (21 CFR 117.130)  
Part 117 defines hazard as any biological, chemical (including radiological), or physical agent 
that has the potential to cause illness or injury (21 CFR 117.3) and requires that facilities subject 
to PCHF requirements conduct a hazard analysis (21 CFR 117.130). The PCHF requirements for 
hazard analysis specify that: 
  You must conduct a hazard analysis to identify and evaluate, based on experience, illness 
data, scientific reports, and other information, known or reasonably foreseeable hazards 
for each type of food manufactured, processed, packed, or held at your facility to 
determine whether there are any hazards requiring a preventive control. The hazard 
analysis must be written regardless of its outcome (21 CFR 117.130(a));  
  The hazard identification must consider known or reasonably foreseeable hazards that 
include biological, chemical, and physical hazards, as well as known or reasonably 
foreseeable hazards that may be present in the food because they occur naturally, they 
may be unintentionally introduced, or they may be intentionally introduced for purposes 
of economic gain (21 CFR 117.130(b)); 
  The hazard analysis must include an evaluation of the identified hazards to assess the 
severity of the illness or injury if the hazard were to occur and the probability that the 
hazard will occur in the absence of preventive controls, and include an evaluation of 
environmental pathogens whenever an RTE food is exposed to the environment prior to 
packaging and the packaged food does not receive a treatment or otherwise include a 
control measure (such as a formulation lethal to the pathogen) that would significantly 
minimize the pathogen (21 CFR 117.130(c)(1)); and 
  The hazard evaluation must consider the effect of several factors on the safety of the 
finished food for the intended consumer (e.g., the formulation of the food; the condition, 
function, and design of the facility and equipment; raw materials and other ingredients; 
and intended or reasonably foreseeable use) (21 CFR 117.130(c)(2)). 
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Appendix 1 of the PCHF guidance (Ref. 1) will provide information on potential biological, 
chemical, and physical hazards in several food categories. Within Appendix 1 of the PCHF 
guidance, Tables 1H, 2H, and 3H will provide information about potential biological, chemical, 
and physical hazards, respectively, in the category Fruits and Vegetables, including fresh-cut 
produce. For your convenience, Table 3 summarizes the information presented in the August 
2016 draft of the PCHF guidance. Because we could revise this information after considering 
public comments to the August 2016 draft of Appendix 1 and more recent scientific information, 
you should check our website for any additions or deletions to Tables 1H, 2H, and 3H after we 
finalize the PCHF guidance. For example, Appendix 1 in the draft PCHF guidance that we issued 
for public comment in August 2016 included Cyclospora as a potential biological hazard in 
frozen fruit (such as raspberries, melon, blueberries, sliced strawberries, and tropical fruit) but 
did not include Cyclospora as a potential biological hazard in fresh-cut vegetables or fruits. We 
are considering including Cyclospora as a potential biological hazard in fresh-cut vegetables and 
fruits in the PCHF guidance, and included Cyclospora in Table 3, in light of two outbreaks of 
foodborne illness associated with consumption of fresh-cut vegetables in 2018 (Ref. 24 and Ref. 
25). 
Table 3.--Potential Biological, Chemical, and Physical Hazards in Fresh-cut Produce 
(Adapted from the PCHF guidance (Ref. 1))  
Chemical  Physical 
Category   Biological hazards  Example Products 
hazards  hazards 
Refrigerated   Clostridium botulinum*  Pesticides  Metal   Leafy greens (Single 
fresh-cut   Pathogenic E. coli  and Mixed greens that 
vegetables 
 Salmonella spp.  have been chopped or 
 L. monocytogenes  otherwise processed) 
 Shigella spp.   Shredded Carrots 
 Staphylococcus aureus   Avocado Chunks 
 Giardia lamblia   Leafy green salad blends  
 Cyclospora**   Diced Onions  
 Bacterial growth and/or   Cut Tomatoes  
toxin lack of   Sliced Mushrooms 
time/temperature control 
 Bacterial growth and/or 
toxin formation due to 
reduced oxygen 
packaging 
 Recontamination with 
environmental pathogens  
Refrigerated   Pathogenic E. coli   Mycotoxin/  Metal   Mixed Fruit Salad  
fresh-cut fruits   Salmonella spp.  natural toxins   Packaged Single Fruits 
 L. monocytogenes   Pesticides   Cut Melon  
 Shigella spp.   Apple Slices  
 Cyclospora**   Cut Pineapples  
 Bacterial growth and/or   Cut Mango  
toxin lack of 
time/temperature control 
 Recontamination with 
environmental pathogens  
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* You should consider the potential for an enhanced risk from C. botulinum for products that are in a reduced 
oxygen environment.  
** Not included in Appendix 1 of the draft PCHF guidance issued for public comment in August 2016. 
 
You should refer to 21 CFR 117.130 for the complete requirements for hazard analysis. The 
following chapters and appendices in the PCHF guidance (Ref. 1) will provide additional 
information about conducting a hazard analysis: 
  Chapter 2: Conducting a Hazard Analysis;  
  Chapter 3: Potential Hazards Associated with the Manufacturing, Processing, Packing, 
and Holding of Human Food;  
  Appendix 1: Potential Hazards for Foods and Processes (Tables 1H, 2H, and 3H); and 
  Appendix 2: Food Safety Plan Forms. 
Chapter 2 and Appendix 2 of the PCHF guidance (Ref. 1) will discuss worksheets developed by 
the FSPCA for you to use in conducting a hazard analysis.  
XIV. PCHF Requirements for Preventive Controls (21 CFR 117.135)  
A. General Information about Preventive Controls 
Part 117 defines preventive controls as those risk-based, reasonably appropriate procedures, 
practices, and processes that a person knowledgeable about the safe manufacturing, processing, 
packing, or holding of food would employ to significantly minimize or prevent the hazards 
identified by the hazard analysis that are consistent with the current scientific understanding of 
safe food manufacturing, processing, packing, or holding at the time of the analysis.  
The PCHF requirements for preventive controls specify that: 
  You must identify and implement preventive controls to provide assurances that any 
hazards requiring a preventive control will be significantly minimized or prevented and 
the food manufactured, processed, packed, or held by your facility will not be adulterated 
under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C 
Act. Preventive controls include controls at critical control points (CCPs) (if there are any 
CCPs) and controls, other than those at CCPs, that are also appropriate for food safety. 
Preventive controls must be written (21 CFR 117.135(a) and (b)).  
  Preventive controls include process controls, food allergen controls, sanitation controls, 
supply-chain controls, a recall plan, and any other procedures, practices, and processes 
(such as hygiene training and other CGMPs) necessary to provide the assurances required 
by 21 CFR 117.135(a) (21 CFR 117.135(c)).  
You should refer to 21 CFR 117.135 for the complete requirements. 
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We are developing the following chapters and appendices to provide additional information 
about preventive controls in the PCHF guidance, including information that could be useful to 
processors of fresh-cut produce (Ref. 1): 
  Chapter 4: Preventive Controls;  
  Chapter 5: Application of Preventive Controls and Preventive Control Management 
Components; 
  Chapter 10: Sanitation Controls;  
  Chapter 11: Food Allergen Controls;  
  Chapter 12: Preventive Controls for Chemical Hazards;  
  Chapter 13: Preventive Controls for Physical Hazards;  
  Chapter 14: Recall Plans;  
  Chapter 15: Supply-Chain Program for Human Food Products; 
  Chapter 16: Validation of a Process Control; 
  Appendix 2: Food Safety Plan Forms;  
  Appendix 3: Bacterial Pathogen Growth and Inactivation; and 
  Appendix 4: Sanitation and Hygienic Zoning. 
We also are developing 4 chapters in the PCHF guidance to target specific types of process 
controls  i.e., use of heat treatments, time/temperature control, formulation control, and 
drying/dehydration as process controls. Among these chapters targeting specific types of process 
controls, the chapter most relevant to a fresh-cut processing operation will be Chapter 7: Use of 
Time/Temperature as a Process Control. 
You should refer to the applicable chapters of the PCHF guidance for comprehensive guidance 
on preventive controls as these chapters become available. In sections XIV.B through XIV.D of 
this document, we briefly discuss process controls, food allergen controls, and sanitation controls 
as those controls could apply to a fresh-cut operation. In section XVI of this document, we 
discuss supply-chain controls. In section XIV.E of this document, we discuss some types of 
preventive controls that can be useful to significantly minimize or prevent biological hazards that 
can be introduced through common routes of contamination. 
B. Process Controls 
Part 117 specifies requirements for process controls in 21 CFR 117.135(c)(1). Process controls 
include procedures, practices, and processes to ensure the control of parameters during 
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operations such as heat processing, acidifying, irradiating, and refrigerating foods. Process 
controls must include, as appropriate to the nature of the control and its role in your food safety 
system:  
  Parameters associated with the control of the hazard; and  
  The maximum or minimum value, or combination of values to which any biological, 
chemical, or physical parameter must be controlled to significantly minimize or prevent a 
hazard requiring a process control.  
See section XVII for a discussion of a process control commonly used in the production of fresh-
cut produce  i.e., use of an antimicrobial substance added to wash water. 
C. Food Allergen Controls 
Part 117 specifies requirements for food allergen controls in 21 CFR 117.135(c)(2). Food 
allergen controls include procedures, practices, and processes to control food allergens and must 
include those procedures, practices, and processes employed for:  
  Ensuring protection of food from allergen cross-contact, including during storage, 
handling, and use; and  
  Labeling the finished food, including ensuring that the finished food is not misbranded 
under section 403(w) of the FD&C Act.  
In a fresh-cut operation, allergen controls could be appropriate in foods such as salads and 
sandwiches, which could contain salad dressing that contains egg or milk or other food allergens 
(such as tree nuts)). 
D. Sanitation Controls 
Part 117 specifies requirements for sanitation controls in 21 CFR 117.135(c)(3). Sanitation 
controls include procedures, practices, and processes to ensure that your facility is maintained in 
a sanitary condition adequate to significantly minimize or prevent hazards such as environmental 
pathogens, biological hazards due to employee handling, and food allergen hazards, and must 
include, as appropriate to your facility and the food, procedures, practices, and processes for: 
  The cleanliness of FCSs, including food-contact surfaces of utensils and equipment; and  
  The prevention of allergen cross-contact and cross-contamination from insanitary objects 
and from personnel to food, food-packaging material, and other FCSs and from raw 
product to processed product.  
In most cases, RTE fresh-cut produce is exposed to the environment prior to packaging and the 
packaged RTE fresh-cut produce does not receive a treatment or otherwise include a control 
measure (such as a formulation lethal to an environmental pathogen) that would significantly 
minimize an environmental pathogen. In these circumstances, your hazard analysis for RTE 
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fresh-cut produce must include an evaluation of environmental pathogens (such as Salmonella 
spp. and L. monocytogenes) (21 CFR 117.130(c)(1)(ii)). 
  If your fresh-cut operation is a wet-processing operation (e.g., if you produce fresh-cut 
melons or leafy vegetables), and your hazard analysis identifies L. monocytogenes as a 
hazard requiring a preventive control, you should refer to our Listeria guidance (Ref. 11) 
for recommendations for sanitation controls and for environmental monitoring as 
verification of sanitation controls.  
  If your fresh-cut operation is a dry-processing operation (e.g., if you produce chopped 
nuts), and your hazard analysis identifies Salmonella spp. as a hazard requiring a 
preventive control, you may find it useful to follow industry recommendations for the 
control of environmental pathogens in low-moisture foods (Ref. 26).   
E. Considering Potential Routes of Contamination 
As discussed in section II.C, several factors can lead to contamination of fresh-cut produce with 
pathogens. In developing preventive controls to provide assurance that pathogens will be 
significantly minimized or prevented, we recommend that you consider these factors. For 
example: 
  You can reduce the potential for incoming produce to be a source of contamination 
through your supply-chain controls. See section XVI for a discussion of supply-chain 
controls. 
  You can significantly minimize or prevent the spreading of contamination across large 
volumes of product by adding an antimicrobial substance to water used to wash fresh-cut 
produce. See section XVII for an example of using an antimicrobial substance added to 
wash water.  
  You can significantly minimize or prevent the potential for contamination of fresh-cut 
produce by an environmental pathogen such as L. monocytogenes or Salmonella spp. 
through sanitation controls. If your fresh-cut operation is a wet-processing operation, see 
the Listeria guidance (Ref. 11) for recommendations for sanitation controls and for 
environmental monitoring as verification of sanitation controls. If your fresh-cut 
operation is a dry-processing operation, you may find it useful to follow industry 
recommendations for the control of environmental pathogens in low-moisture foods (Ref. 
26).  
  You can significantly minimize or prevent the survival or growth of pathogens during 
processing, storage, and transport by treating fresh-cut produce as TCS food. Chapter 7: 
Use of Time/Temperature as a Process Control in the PCHF guidance (Ref. 1) will 
provide recommendations for TCS food.   
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XV.  PCHF Requirements for Preventive Control Management 
Components (21 CFR 117.140)  
With some exceptions, the PCHF requirements in 21 CFR 117.140 specify that your preventive 
controls are subject to the following preventive control management components (PC 
management components) as appropriate to ensure the effectiveness of the preventive controls, 
taking into account the nature of the preventive control and its role in your food safety system: 
  Monitoring in accordance with 21 CFR 117.145;  
  Corrective actions and corrections in accordance with 21 CFR 117.150; and 
  Verification in accordance with 21 CFR 117.155. 
The exceptions are for the supply-chain program, which is subject to a subset of the PC 
management components (specified in 21 CFR 117.140(b)), and for the recall plan, which is not 
subject to any PC management components (21 CFR 117.140(c)).  
You should refer to 21 CFR 117.140 for the complete requirements for PC management 
components and to 21 CFR 117.3 for definitions of the terms monitor, correction, and 
verification. Chapter 5 of the PCHF guidance (Ref. 1) will provide additional information 
about PC Management Components. As with the process control chapters in the PCHF guidance, 
for this guidance we adapted the Process Control form developed by the FSPCA to present an 
example of a worksheet that you can use when applying the PC management components to the 
use of chlorine as a process control in wash water. See Appendix 2 in this guidance for that 
worksheet. 
See section XVII of this document for specific recommendations for how you could apply the 
PC management components when adding an antimicrobial substance as a process control in 
wash water. 
XVI. PCHF Requirements for a Supply-Chain Program (Part 117, 
Subpart G) and Example of a Supply-Chain Program in the 
Production of Fresh-cut Leafy Vegetables  
A. Requirements of Subpart G 
Subpart G of part 117 requires a receiving facility to establish and implement a risk-based 
supply-chain program for those raw materials and other ingredients for which the receiving 
facility has identified a hazard requiring a supply-chain-applied control (21 CFR 117.405 (a)(1)). 
Part 117 defines a receiving facility as a facility that is subject to subparts C and G of part 117 
and that manufactures/processes a raw material or other ingredient that it receives from a 
supplier (21 CFR 117.3). Part 117 defines a supplier as the establishment that 
manufactures/processes the food, raises the animal, or grows the food that is provided to a 
receiving facility without further manufacturing/processing by another establishment, except for 
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further manufacturing/processing that consists solely of the addition of labeling or similar 
activity of a de minimis nature (21 CFR 117.3).  
You are a receiving facility as that term is defined in 21 CFR 117.3. Your suppliers will be the 
farms that grow the produce that you use in your fresh-cut operations. In many cases, your 
suppliers will be subject to the produce safety regulation. An exception that is relevant to this 
guidance is when the RACs that you receive are designated as rarely consumed raw in 21 CFR 
112.2(a), and therefore exempt from the standards of the produce safety regulation.14 Examples 
of RACs that are designated as rarely consumed raw in the produce safety regulation are winter 
squash, sweet potatoes, and asparagus.  
If you are a processor of fresh-cut produce, you are a receiving facility even if you are a farm 
mixed-type facility because your business satisfies the criteria in the farm definition in 21 
CFR 1.227 for some of the activities that you conduct, but your business also satisfies the 
definition of facility in 21 CFR 1.227 for the manufacturing/processing activities that you 
conduct in the production of fresh-cut produce.  
Subpart G specifies: 
  The requirement to establish and implement a supply-chain program (21 CFR 117.405); 
  General requirements applicable to a supply-chain program (21 CFR 117.410); 
  Responsibilities of the receiving facility (21 CFR 117.415); 
  Requirements for using approved suppliers (21 CFR 117.420); 
  Requirements for determining appropriate supplier verification activities (including 
determining the frequency of conducting the activity) (21 CFR 117.425); 
  Requirements for conducting supplier verification activities for raw materials and other 
ingredients (21 CFR 117.430); 
  Requirements for an onsite audit (21 CFR 117.435); and 
  Requirements for records documenting the supply-chain program (21 CFR 117.475). 
You should refer to subpart G for the complete requirements. Chapter 15 of the PCHF guidance 
(Ref. 1) will contain comprehensive recommendations to help a receiving facility comply with 
the requirements of subpart G for establishing and implementing a supply-chain program for its 
suppliers. You should refer to Chapter 15 of the PCHF guidance for those comprehensive 
recommendations.  
                                                 
14 See subpart A of the produce safety regulation for additional information about the coverage of the produce safety 
regulation.  
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B. Example of Supplier Approval, Receiving and Verification Activities in 
the Production of Fresh-cut Leafy Vegetables 
The purpose of this example is to illustrate how you could establish and implement a supply-
chain program for the production of fresh-cut leafy vegetables if you are subject to PCHF 
requirements. Specifically, in this example we discuss a fresh-cut processing establishment that 
produces fresh-cut romaine lettuce and receives romaine lettuce from either of two domestic 
primary production farms that each grow, harvest, and pack a variety of leafy vegetables, 
including romaine lettuce. The growing, harvesting, and packing activities of the farms are 
subject to the produce safety regulation. The fresh-cut processing establishment purchases 
romaine lettuce directly from the farms, without going through a distributor. To comply with the 
requirements of subpart G, the fresh-cut processing establishment: 
  Considers the results of its hazard analysis, which identifies pathogenic bacteria (such as 
pathogenic E. coli and Salmonella spp.) as hazards requiring a preventive control. 
Consumption of fresh-cut romaine lettuce contaminated with such pathogenic bacteria 
can lead to severe adverse health consequences or death (Ref. 9). For such hazards, the 
appropriate supplier verification activity is an onsite audit of the supplier, and the audit 
must be conducted before using the raw material or other ingredient from the supplier and 
at least annually thereafter in most cases15 (21 CFR 117.430(b)(1)).  
  Conducts sampling and testing of romaine lettuce from each of the farmss under 
consideration as a supplier as a one-time supplier approval activity to verify that the 
farms procedures, processes, and practices during its growing, harvesting, and packing 
operations minimize the contamination of romaine lettuce. 
  Conducts the following activities, before first receiving romaine lettuce from the farm (as 
supplier approval activities) and on an annual basis thereafter (as ongoing supplier 
verification activities):16 
  An onsite audit, including an assessment of the farms procedures, processes, and 
o
practices during its growing, harvesting, and packing operations as related to 
compliance with the produce safety regulation (21 CFR 117.430(b)(1)); and 
  A review of FDAs Firm/Supplier Evaluation Resources Web page (Ref. 27) on the 
o
FSMA Data Search & Information Data Dashboard to consider information relevant 
to each farms compliance history, such as whether produce from the farm has been 
recalled due to food safety concerns (21 CFR 117.410(d)(1)(iii)(C)).  
  Establishes and follows written procedures for receiving the romaine lettuce, including: 
                                                 
15 See 21 CFR 117.430(b)(2) for exceptions to this requirement for an annual onsite audit. 
16 Part 117 provides flexibility for other entities in the supply chain to determine, conduct, or both determine and 
conduct supplier approval and verification activities, with some limitations. Because the example in this guidance 
specifies that the fresh-cut operation purchases the romaine lettuce directly from a farm, there are no other entities in 
the distribution chain, and the fresh-cut operation determines and conducts all supplier approval and verification 
activities. 
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  A checklist to document that the incoming romaine lettuce is received only from the 
o
two farms that have been approved as suppliers; and  
  Procedures for receiving romaine lettuce from other farms, on a temporary basis, 
o
when necessary and appropriate, and for reviewing the written results of an 
appropriate inspection of the temporary suppliers for compliance with the produce 
safety regulation as an appropriate verification activity before receiving romaine 
lettuce from those temporary suppliers.  
  To comply with 21 CFR 117.475, establishes and maintains records, including: 
  Its written supply-chain program (21 CFR 117.475(c)(1));  
o
  The names and contact information for each of the farms that it approved as its 
o
suppliers (21 CFR 117.475(c)(3));  
  Its written procedures for receiving romaine lettuce from each of the farms that it 
o
approved as its suppliers (21 CFR 117.475(c)(4));  
  The checklists documenting that the romaine lettuce was received from approved 
o
suppliers (21 CFR 117.475(c)(5));  
  An explanation of the reasons for determining its supplier approval and verification 
o
activities (21 CFR 117.475(c)(6));  
  The results of the onsite audit (21 CFR 117.475(c)(7));  
o
  The results of its annual search of our Firm/Supplier Evaluation Resources Web 
o
page (Ref. 27) on the FSMA Data Search & Information Data Dashboard for 
information relevant to supplier compliance (21 CFR 117.475(c)(10)); and  
  When applicable (e.g., when the results of an inspection are substituted for an onsite 
o
audit as an appropriate verification activity before receiving romaine lettuce from a 
temporary supplier), documentation of the results of an appropriate inspection of a 
farm that supplies romaine lettuce on a temporary basis (21 CFR 117.475(c)(15)). 
XVII.  Adding Sodium Hypochlorite as an Antimicrobial 
Substance to Wash Water as an Example of a Process Preventive 
Control in the Production of Fresh-cut Leafy Vegetables  
A. Introduction 
The purpose of this example is to illustrate how you could establish and implement a process 
preventive control and associated PC management components (i.e., monitoring, corrective 
actions and corrections, and verification activities (and their associated records)) to control 
biological hazards in wash water used during the production of fresh-cut produce. Specifically, 
in this example, we discuss a fresh-cut processor that washes fresh-cut romaine lettuce in a 
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recirculating water flume system with sodium hypochlorite added to wash water. The sodium 
hypochlorite acts as a source of the antimicrobial substance, hypochlorous acid, which functions 
as a process preventive control to significantly minimize or prevent the cross-contamination of 
fresh-cut leafy vegetables with biological hazards during washing.  
In this example, the processor washes fresh-cut romaine lettuce of various cut sizes (0.5 inches  
1.5 inches) in a single-stage chilled water flume using water from a municipal source. The 
processor adds liquid sodium hypochlorite and citric acid using an automated system in a 
recirculation tank to maintain a minimum free chlorine17 concentration of 20 ppm (10 ppm is the 
critical limit) and a pH of 6.0-7.5. Water automatically replenishes in the recirculation tank 
where particulates are removed by a separating screen. The conveyor feeding the product into the 
flume system stops automatically if the free chlorine concentration drops below the operating 
limit of 20 ppm. The processor verifies the free chlorine concentration and pH twice per shift 
using a titration test kit and a calibrated pH meter, respectively. The processor begins processing 
with new flume water every 8 hours or daily, whichever occurs first.  
In this section, we: 
  Use the term wash water to mean recirculated (not single-pass) water used to wash and 
convey fresh-cut leafy vegetables (e.g., flume or wash tanks); and 
  Focus the discussion of biological hazards on pathogens  i.e., microorganisms of public 
health significance. (See the definition of pathogen in 21 CFR 117.3.) Examples of 
pathogens relevant to the production of fresh-cut leafy vegetables are pathogenic 
Escherichia coli, Salmonella, and Listeria monocytogenes. 
See Table 4 for our recommendations if your fresh-cut products or procedures are different from 
the example we discuss in this section.  
 
Table 4. Recommendations If Your Fresh-cut Products or Washing Procedures Are 
Different from the Example 
If:  Then You Should Consider ...  However, ... 
You wash fresh-cut produce other than  Whether (and, if so, how) you could adapt the  N/A 
leafy vegetables in a recirculating water  recommendations in this section to your 
flume system   operations 
You wash fresh-cut produce using a  Whether adding an antimicrobial to the wash  The specific recommendations we 
wash system other than a recirculating  water could be an appropriate preventive  provide for PC management 
water flume system (e.g., a single-pass  control to significantly minimize pathogens  components (e.g., for validation 
spray system)  during the washing step and, if so, whether  and monitoring/verification) 
and how you could adapt the  generally apply only to a 
recommendations in this section to your  recirculating water flume system 
operations 
                                                 
17 Free chlorine (sometimes called free available chlorine or active free chlorine) is readily measured using 
commercially available sensors and is produced when sodium hypochlorite is added to water. Among other things, 
free chlorine consists of hypochlorite ions and hypochlorous acid.  
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If:  Then You Should Consider ...  However, ... 
You add an antimicrobial other than  Whether (and if so, how) you could adapt the  N/A 
sodium hypochlorite to your  recommendations in this section to your 
recirculating water flume system   operations 
You wash RACs before you process the  Whether adding an antimicrobial to the wash  The specific recommendations we 
RACs into fresh-cut produce, using  water could be an appropriate preventive  provide for PC management 
either a recirculating water flume  control to significantly minimize pathogens  components (e.g., for validation 
system or another wash system (e.g., a  during the washing step and, if so, whether  and monitoring/verification) 
single-pass spray system)   and how you could adapt the  generally apply only to a 
recommendations in this section to your  recirculating water flume system 
operations 
  
B. Considerations to Keep in Mind when Adding an Antimicrobial 
Substance to Wash Water as a Process Preventive Control  
1.  Regulatory status of sodium hypochlorite and other substances used to treat 
wash water in contact with fresh-cut leafy vegetables  
Any substance that is reasonably expected to become a component of food because of its 
intended use in wash water used during the production of fresh-cut produce (e.g., by migrating 
from the wash water into food) must be lawful under sections 402(a)(2)(C) and 409 of the FD&C 
Act, e.g., because the substance: 
  Is covered by a regulation, listed in 21 CFR, that provides for its safe use;  
  Satisfies the criteria (in 21 CFR 170.30) for eligibility for classification as generally 
recognized as safe (GRAS);  
  Is the subject of a prior sanction issued by FDA or the U.S. Department of Agriculture 
prior to September 6, 1958 (section 201(s)(4) of the FD&C Act; see the definition of 
prior sanction in 21 CFR 170.3(l));  
  Is covered by a Threshold of Regulation (TOR) exemption in accordance with 21 CFR 
170.39; or 
  Is covered by an effective Food Contact Substance Notification (FCN) (21 CFR part 170, 
subpart D). 
In this example, we discuss a fresh-cut processor that washes fresh-cut romaine lettuce in a 
recirculating water flume system with sodium hypochlorite added to wash water. Under our food 
additive regulation in 21 CFR 173.315, sodium hypochlorite may be safely used to wash fruits 
and vegetables in an amount no more than the minimum required to accomplish the intended 
technical effect. The label or labeling of the container of sodium hypochlorite must bear 
adequate use directions to ensure use in compliance with all provisions of the food additive 
regulation (21 CFR 173.315(d)(2)). The amount of sodium hypochlorite required to accomplish 
its intended effect for a particular application generally is determined by a validation study for 
that application. (See the discussion of validation in section XVII.D.)  
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Although this example uses sodium hypochlorite as the antimicrobial substance, there are other 
antimicrobial substances that you could use in place of sodium hypochlorite. For example: 
  Our food additive regulation in 21 CFR 173.325(g) authorizes the use of acidified sodium 
chlorite solutions, produced by mixing an aqueous solution of sodium chlorite with any 
GRAS acid, as an antimicrobial agent in the water applied to processed leafy vegetables; 
  Our food additive regulation in 21 CFR 173.300(b)(2) authorizes the use of chlorine 
dioxide for washing fruits and vegetables that are not RACs;   
  Our Inventory of Effective FCNs lists several FCNs for uses of hypochlorous acid or 
calcium hypochlorite in process water in contact with fruits and vegetables (available at 
https://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm);18 
and 
  Our food additive regulation in 21 CFR 173.315 lists other substances that we have 
authorized for use in washing fruits and vegetables under certain conditions specified in 
that regulation (i.e., polyacrylamide, potassium bromide, sodium n-alkylbenzene-
sulfonate, sodium dodecylbenzene-sulfonate, sodium 2 ethyl-hexyl sulfate, and sodium 
mono- and dimethyl naphthalene sulfonates).   
Regardless of which substance you use, you should check the authorizing regulation, FCN, or 
other documentation (e.g., if you are using a substance on the basis of a conclusion that the use 
of the substance satisfies GRAS criteria) to identify the applicable conditions for safe use of that 
substance. For additional information about the lawful use of food additives and GRAS 
substances, see the information available from our web page entitled Ingredients and 
Packaging (available at https://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm). 
For additional information about the regulation of antimicrobial substances, including 
circumstances in which an antimicrobial substance is regulated by the U.S. Environmental 
Protection Agency as a pesticide chemical, see our guidance entitled Guidance for Industry: 
Antimicrobial Food Additives (Ref. 28.). A decision tree form of that guidance, entitled 
Determining Regulatory Authority for Antimicrobial Substances, is available at 
https://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/RegulatoryAuthorityA
ntimicrobialSubstances/default.htm.      
2.  What an antimicrobial substance in wash water does and does not do 
Adding antimicrobial substances to wash water can help to significantly minimize or prevent 
pathogen cross-contamination during washing of leafy vegetables and conveying leafy 
vegetables in water-based systems such as flumes. Importantly, adding antimicrobial substances 
to wash water does not significantly minimize or prevent pathogens that may require a 
                                                 
18 Importantly, FCNs are effective only for the manufacturer identified in the Inventory of Effective FCNs and, thus, 
you would obtain an antimicrobial substance listed in the Inventory of Effective FCNs from the manufacturer listed 
for that antimicrobial source in the Inventory of Effective FCNs. In other words, if multiple manufacturers produce 
the same antimicrobial substance as a food contact substance for use in wash water, each manufacturer must obtain 
its own effective FCN for that source of antimicrobial for use in wash water (21 USC 348(h)(2)(C)). 
 
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preventive control at other stages of production, such as pathogens on incoming produce or in the 
production environment. You should control pathogens on incoming produce through your 
supply-chain program as discussed in section XVI. You should control pathogens in the 
production environment through your CGMPs (as discussed in sections IVXI), and sanitation 
preventive controls (as discussed in section XIV.D) that are verified with an environmental 
monitoring program (as discussed in section XIV.D).  
3.  How characteristics of the wash water can impact the effectiveness of an 
added antimicrobial substance 
The characteristics of your wash water are dynamic in that they are constantly changing during 
the wash process. These dynamic characteristics can impact the effectiveness of an added 
antimicrobial substance. Examples of these dynamic characteristics when sodium hypochlorite is 
added to wash water are pH, organic load, water temperature, product-to-water ratio, rate of 
water replenishment, and water agitation.  
The relative proportion of the most active component of free chlorine, hypochlorous acid, is 
dependent on pH and temperature; the proportion of hypochlorous acid is greatest at a pH 3 to 7. 
At low pH (i.e., pH lower than 6.0), you increase the likelihood of toxic chlorine gases forming. 
Free chlorine is generally more effective at higher temperatures than colder temperatures.  
Organic load refers to dissolved and suspended solids such as plant particles and exudates. 
Organic load will accumulate over time in recirculated water and consume free chlorine, thereby 
reducing its concentration and effectiveness. Factors such as product type, product cut size, 
product feed rate into the flume system, product-to-water ratio, rate of water replenishment, and 
water agitation can impact the organic load and, thus, the concentration and effectiveness of the 
free chlorine in your wash water. As discussed in section XVII.D, the worst case conditions for 
the organic load (i.e., the highest organic load) of your wash water play a role in your validation 
of the use of sodium hypochlorite added to wash water as a process preventive control.  
C. Understand the Potential Hazard 
Produce washing systems used in the production of fresh-cut leafy vegetables, if not properly 
managed, can facilitate the cross-contamination of uncontaminated produce with pathogens that 
are present on incoming raw leafy vegetables. Cross-contamination of the processed leafy 
vegetables can result from product-to-product contact, from contaminated particles that 
accumulate in the water as cut leafy vegetables are washed, or from the water itself (due to 
pathogens washed off contaminated raw leafy vegetables). Unless the pathogenic microbial load 
in recirculated water is effectively controlled by the addition of an antimicrobial substance, 
pathogens can persist in the re-circulated water and, thus, contaminate the next batch of leafy 
vegetables that is washed.  
The survival of pathogens in the wash water, and the potential for cross-contamination of fresh-
cut leafy vegetables during processing, depends on a number of factors such as the type of 
pathogen, the pathogen population size, the effectiveness and concentration of the antimicrobial 
substance, environmental/operating conditions such as organic load in the water, the pH and 
temperature of the water, product feed rate into the system, and water agitation. As discussed in 
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section XVII.D, factors such as these play a role in your validation of the use of sodium 
hypochlorite added to wash water as a process preventive control. 
D. Validation of Sodium Hypochlorite as a Process Preventive Control in 
Wash Water 
With few exceptions, the PCHF requirements specify that you must validate that the preventive 
controls are adequate to control the hazard as appropriate to the nature of the preventive control 
and its role in your food safety system. The validation of the preventive controls must be 
performed (or overseen) by a preventive controls qualified individual (PCQI) (21 CFR 117.160). 
For the definition of PCQI, see 21 CFR 117.3 and the Glossary in section XX.A.  
In this example, sodium hypochlorite added to wash water as a process preventive control is 
intended to significantly minimize or prevent the contamination of processed leafy vegetables 
with pathogens during washing. In the following discussion, we describe a hypothetical example 
of how a fresh-cut leafy green processor validated sodium hypochlorite added to wash water as a 
process preventive control. 
1.  Choose the commodity that you will use for validation purposes 
If you are validating a substance added to wash water as a process preventive control for multiple 
leafy vegetable commodities, you may choose a single commodity for the validation study rather 
than validate the process preventive control on all the commodities. How you choose the 
commodity depends on the information that you have about the commodity. Because the type 
and amount of soil on the surface of the commodity will affect the effectiveness of the process 
preventive control, one way to choose the commodity is to rely on information about the relative 
organic load associated with those commodities that you process if you have such information 
(i.e., selecting the commodity known to produce the highest levels of organic load in the water 
during processing).  Another way to choose the commodity is to select the commodity based on 
its association with outbreaks of foodborne illness, because contamination of fresh-cut produce 
with pathogens in the wash water has the potential to lead to foodborne illness. In this example, 
the PCQI chose romaine lettuce because it was the only commodity processed in the system 
being validated. 
2.  Identify the target pathogen for the validation study 
The target pathogen for validation of a process preventive control is a known or reasonably 
foreseeable pathogenic contaminant with the greatest resistance to that process control. The 
target pathogen can be commodity-specific or be based upon information specific to the region in 
which the produce was grown. In the example of romaine lettuce, the processors PCQI 
identified E. coli O157:H7 as the target pathogen due to a history of the organism in the region 
where the suppliers grow the lettuce, the history of outbreaks of E. coli O157:H7 infections 
linked to lettuce, and the severity of illness associated with E. coli O157:H7 infection.  
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3.  Scientifically establish the minimum effective concentration of antimicrobial 
in the wash water 
You should scientifically establish the minimum concentration of the active antimicrobial 
substance (in this example, free chlorine that results after adding sodium hypochlorite) that will 
be effective as a process preventive control, based either on the published scientific literature or 
your own scientific study.  
If you are conducting your own scientific study, you should determine the minimum effective 
concentration of your antimicrobial substance under the worst-case conditions using the washing 
equipment of your processing line, using a nonpathogenic surrogate organism that has similar or 
more robust survival capabilities under the conditions being evaluated than the target pathogen. 
Alternatively, you could determine the minimum effective concentration under the worst-case 
conditions identified for your processing line, using a laboratory-scale or pilot-scale processing 
line rather than your production processing line, using either a surrogate organism or the target 
pathogen. Although you should not introduce a pathogen to your production processing line even 
for a validation study (to eliminate the potential for residual pathogen to contaminate your 
product), residual pathogen that remains in a laboratory-scale or pilot-scale processing line after 
a validation study would not affect product, as long as you do not distribute food produced using 
your laboratory-scale or pilot-scale processing line.  
In this example, the PCQI identified a minimum concentration of 10 ppm free chlorine based on 
a published scientific study of the efficacy of sodium hypochlorite in significantly minimizing E. 
coli O157:H7 cross-contamination during washing of romaine lettuce (Ref. 29). In that study, 10 
ppm free chlorine was established as the minimum value for efficacy (i.e., the critical limit). A 
minimum concentration of 10 ppm free chlorine was also supported by other published scientific 
studies (Ref. 30 and Ref. 31). In this example, the processing line will stop automatically if the 
free chlorine concentration drops below a specified concentration, and the PCQI established an 
operating level of 25  5 ppm free chlorine and an operating limit of 20 ppm free chlorine for 
when the processing line will stop to limit the potential that the free chlorine concentration 
would drop below the critical limit of 10 ppm. If your processing line will not stop automatically 
if the free chlorine concentration drops below a specified concentration, you could establish the 
same operating level and operating limit, but you would be stopping the system manually.19   
4.  Identify the process parameters that you will use for the validation study  
Some features of your processing operation are permanent, such as dimensions of the flume. In 
this example, the single flume line is 10 feet (3 meters) long by 2.5 feet (0.75 meters) wide. 
When flowing through the flume, the water is 1.6 feet (0.5 meters) deep; there is only one 
operating flow rate. Because they do not change, these features are not processing parameters 
                                                 
19 If you will be stopping the system manually, you should use a continuous monitoring system that records the free 
chlorine concentration continuously. One option is to use a continuous monitoring system that sounds an alarm if the 
free chlorine concentration drops below a specified concentration. Another option is to do frequent, manual checks 
of the record produced by the continuous monitoring system  e.g., every 30 minutes or more frequently based on 
the results of your validation study.  
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within the meaning of 21 CFR 117.135(c)(1) and do not need further consideration for the 
validation study.  
Other features of your system are process parameters within the meaning of 21 CFR 
117.315(c)(1), and they can be either fixed or variable. For example, a product cut size can be 
fixed for a particular commodity, and as long as that cut size is never varied, it does not need to 
be considered further in the validation study. Other process parameters are variable, and the 
ranges of these parameters that are expected to occur during an acceptable product run must be 
understood for the validation study. For example, a fresh-cut operation might identify a range of 
product feed rates for different product commodities but would generally set their feed rate at a 
fixed point on a given day or batch of product. Other process parameters vary continually during 
the course of operation (e.g., water replenishment rate and sodium hypochlorite feed rate) and 
generally stay within a certain range. Other process parameters are set to not deviate outside a set 
range, such a pH and temperature. These parameters may vary within certain limits. Other 
features vary but generally change in one continuous direction, such as organic load which 
continually increases as product is fed into the system.  
For each variable process parameter, you should identify the range of values that could occur 
during processing and select the conditions under which you will perform your validation study. 
You can design the validation study using either a single operating condition or multiple 
operating conditions. However, the conditions you should assess in your study should address 
the reasonably foreseeable conditions that provide the greatest challenge to the effectiveness of 
the added antimicrobial substance. The conditions under which you perform your validation 
study will establish the operating conditions that are effective and define the limits for deviations 
that require corrective actions.  
The PCQI determined that there would be variability in free chlorine due to variability in product 
feed rate and romaine lettuce cut size, each having a direct impact on the accumulation rate and 
the maximum level of organic load in the flume water. The PCQI conducted a preliminary study 
and determined that the worst-case operating conditions (i.e., the rate where the organic load in 
the water accumulated most rapidly and to the highest level) were achieved by setting the speed 
of the conveyor feeding product into the shredder at the maximum speed used (6,600 
pounds/hour) and the smallest product cut size (0.5 inches). Under these operating conditions, 
during the course of a four-hour study, the PCQI observed that the organic load that accumulated 
in the water plateaued at a chemical oxygen demand20 of 2,100 mg O /L after two hours of 
2
processing. (This plateauing effect is likely a result of the separating screen and automated water 
replenishment system of this processing line.) During the four hours of processing, the PCQI 
observed that: 
  The temperature and pH of the water stayed within the operational settings (34  36F; 
pH 6.0  7.5); and 
                                                 
20 Chemical oxygen demand is an indirect but quantitative measurement of the amount of organic load in the 
water. 
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  The sodium hypochlorite feed rate was variable (i.e., dependent on free chlorine sensor 
readings). 
The PCQI determined that the concentration of free chlorine is the critical factor. Given these 
conditions for the variable process parameters identified during the preliminary study, what 
remained for the PCQI to determine was the placement of the sensor used for monitoring the free 
chlorine concentration. For the purpose of the validation study, the PCQI decided to measure 
several process parameters (i.e., pH, temperature, and organic load) in addition to free chlorine 
concentration to fully document the operating conditions of that study. 
5.  Conduct the validation study 
In this example, the output of the validation study is the location where free chlorine 
concentrations are consistently at the lowest level in the recirculating water system, including 
during the worst-case conditions. That location is where the processor will place the sensor that 
measures free chlorine during production. Although the operating level of 25  5 ppm free 
chlorine is what will be used during normal production of romaine lettuce in this flume line, the 
PCQI chose to conduct the study at the predetermined critical limit of 10 ppm. The PCQI 
adapted the validation procedure from a procedure published in the scientific literature (Ref. 30).  
The validation trial was repeated three times as follows:  
  The wash water system was mapped using calibrated antimicrobial sensors that measured 
free chlorine by positioning the sensors (as many as practical) in those positions in the 
water system where the free chlorine was likely to be at the lowest concentration during 
normal operation. Temperature and pH sensors were added in the same locations as the 
free chlorine sensors. Chemical oxygen demand (as the measure of organic load) was 
determined manually from samples collected from the flume tank. 
  The system was started with sodium hypochlorite being fed until all free chlorine sensors 
were reading at 10 ppm free chlorine. The fresh-cut lettuce was then fed into the system 
at the fastest rate and smallest cut size. It was expected that there would be variability in 
pH and temperature. 
  During the study, the readings from each free chlorine sensor were recorded on a 
continuous basis. To verify that the operating conditions were as intended, chemical 
oxygen demand of the flume water was monitored every 30 minutes of the study; pH and 
temperature were monitored continuously. 
  The system was run with product for one hour past the point where the data from the 
preliminary study demonstrated that the organic load would plateau. 
The output of the study was the identification of the sensor location(s) where free chlorine 
concentrations were consistently at the lowest levels during the course of the three individual 
trials. The PCQI identified a single position at the end of the flume as the location to place the 
sensor where it will monitor continuously when product is in the flume.   
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The conclusions of the validation study are limited to the conditions under which the trials were 
performed.  
E. Establish and Implement Monitoring Procedures 
Part 117 requires that, as appropriate to the nature of the preventive control and its role in your 
food safety system, you establish and implement written procedures, including the frequency 
with which they are to be performed, for monitoring the preventive control. You must monitor 
the preventive controls with adequate frequency to provide assurance that they are consistently 
performed (21 CFR 117.145).  
1.  What to monitor 
In this example, the processor monitors the concentration of free chlorine (minimum of 10 ppm 
based on the scientific literature, operating limit of 20 ppm). The PCQI determined that it was 
not necessary to monitor pH or temperature during production because the critical factor is free 
chlorine, which is monitored continuously, and changes in pH and temperature will be reflected 
in the concentration of free chlorine. 
2.  How to monitor and how often to monitor 
In this example, an automated sensor that is placed in the location(s) identified as being the 
mostly likely to have the lowest free chlorine concentration monitors the concentration of free 
chlorine continuously. The Quality Assurance (QA) Technician checks the reading on the 
automated sensor twice per shift and records the observed value in the process log. 
3.  Who performs the monitoring 
When a person (rather than a machine) is assigned to perform monitoring, that person must have 
the education, training, or experience (or a combination of these) necessary to perform the 
individuals assigned duties (21 CFR 117.4(b)(1)).  
In this example, a continuous monitoring free chlorine sensor measures the concentration of free 
chlorine in the wash water. The QA Technician checks the reading on the automated sensor and 
records the observed value in the process log.  
F. Establish Corrective Action Procedures 
Part 117 includes requirements for you to establish and implement corrective action procedures 
that must be taken if a preventive control is not properly implemented (21 CFR 117.150(a)(1)). 
The corrective action procedures must identify the steps you will take to ensure that appropriate 
action is taken to identify and correct a problem; appropriate action is taken, when necessary, to 
reduce the likelihood that the problem will recur; evaluate all affected food for safety; and 
prevent all affected food from entering into commerce, if you cannot ensure that the affected 
food is not adulterated or misbranded under the relevant provisions of the FD&C Act (21 CFR 
117.150(a)(2)). However, you do not need to take such corrective actions if you take action in a 
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timely manner to identify and correct a minor and isolated problem that does not directly impact 
product safety (i.e., make corrections) (21 CFR 117.150(c)(2)).  
Examples of corrective action procedures applicable to use of free chlorine as a process control 
in wash water include: 
  Empty the processing line and discard the product back to the last time the monitored 
parameters were within the critical limits. The discarded product is either destroyed or 
diverted to animal food (usually for animals other than pets)21; 
  Clean and sanitize all affected post-wash FCSs; 
  The PCQI takes steps to determine (if possible) what caused the free chlorine 
concentration to drop below the critical limit so that actions can be taken to prevent such 
occurrences from happening in the future; and 
  Replace non-functioning sensor(s), when applicable. 
In this example, the conveyor feeding the product into the flume system stops automatically if 
the free chlorine concentration drops below the operating limit of 20 ppm and the processor 
makes those adjustments necessary so that the free chlorine concentration again exceeds the 
operating limit of 20 ppm. Because the adjustment addresses a divergence from an operating 
limit, without a deviation from a critical limit, the actions taken as a result are not considered to 
be corrective actions within the meaning of 21 CFR 117.150(a)(2), even though the QA 
Technician notes all such adjustments in the process log. (See the definition of adjustment in 
the Glossary in section XX.B.) If the concentration of free chlorine drops below the critical limit 
of 10 ppm, the QA Technician takes corrective actions and notes that deviation from the critical 
limit as an exception record in the process log. 
G. Determine Verification Procedures 
Part 117 requires that verification activities include, as appropriate to the nature of the preventive 
control and its role in your food safety system: (1) Validation; (2) Verification that monitoring is 
being conducted; (3) Verification that appropriate decisions about corrective actions are being 
made; (4) Verification of implementation and effectiveness; and (5) Reanalysis (21 CFR 
117.155). For a discussion of validating sodium hypochlorite added to wash water as a process 
preventive control, see section XVII.D. 
Part 117 also requires that you verify that the preventive controls are consistently implemented 
and are effectively and significantly minimizing or preventing the hazards. To do so you must 
                                                 
21 As discussed in section XI, FDA is developing guidance on the use of human food by-products in animal food, 
including diversion of human food products to animal food use (Ref. 21). FDA issued additional guidance on certain 
manufacturing processing activities conducted on human food by-products in section III. D. (pages 19-20) of 
guidance for industry entitled Policy Regarding Certain Entities Subject to the Current Good Manufacturing 
Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs (Ref. 22 and 83 
FR 598, January 5, 2018). In determining whether it is appropriate to divert a food product to animal food use, we 
recommend that you consult these currently available guidance documents. 
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conduct activities that include the following, as appropriate to your facility, the food, and the 
nature of the preventive control and its role in your food safety system:  
  Calibration of process monitoring instruments and verification instruments (or checking 
them for accuracy) (21 CFR 117.165(a)(1));  
  Product testing, for a pathogen (or appropriate indicator organism) or other hazard (21 
CFR 117.165(a)(2));  
  Environmental monitoring, for an environmental pathogen or for an appropriate indicator 
organism, if contamination of a ready-to-eat food with an environmental pathogen is a 
hazard requiring a preventive control, by collecting and testing environmental samples 
(21 CFR 117.165(a)(3)); and 
  Review of certain records by (or under the oversight of) a PCQI, to ensure that the 
records are complete, the activities reflected in the records occurred in accordance with 
the food safety plan, the preventive controls are effective, and appropriate decisions were 
made about corrective actions (21 CFR 117.165(a)(4)).  
Part 117 also requires, as appropriate to your facility, the food, the nature of the preventive 
control, and the role of the preventive control in your food safety system, that you establish and 
implement written procedures for: (1) The method and frequency of calibrating process 
monitoring instruments and verification instruments (or checking them for accuracy); (2) Product 
testing; and (3) Environmental monitoring (21 CFR 117.165(b)). 
In this example, the PCQI determined that the verification activities for free chlorine as a process 
preventive control are as follows: 
  On a weekly basis, a QA Technician checks the accuracy of sensors used for monitoring 
free chlorine concentration and, if not accurate, has them recalibrated or replaced if they 
cannot be recalibrated; 
  Twice per shift, the QA Technician verifies the free chlorine concentration using a 
titration test kit and records the results in the process log; 
  Within a week of their creation, the PCQI reviews calibration records and initials and 
dates the records to document that verification review; 
  Within a week of their creation, the PCQI reviews process logs (sometimes called batch 
records) documenting the sensor readings observed by the QA Technician and the 
results of the verification titration tests for free chlorine and initials and dates the records 
to document that verification review; and 
  Within a week of a problem requiring a corrective action, the PCQI reviews the 
corrective action records and initials and dates the records to document that verification 
review.  
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We have previously discussed the limitations of product testing as verification of preventive 
controls (see 78 FR 3646 at 38193820, January 16, 2013 and Responses 516 and 517, 55908 at 
56059 - 56061, September 17, 2015).  
This example does not discuss verification activities that are not directly related to free chlorine 
as a process control in wash water. For example, this example does not discuss environmental 
monitoring for an environmental pathogen as verification of sanitation controls. Likewise, this 
example does not discuss corrective action procedures that could be associated with such 
verification activities. For additional information on environmental monitoring for an 
environmental pathogen as verification of sanitation controls, and corrective action procedures 
that could be associated with such verification activities, see our Listeria guidance (Ref. 11) and 
Chapter 10 in the PCHF guidance (Ref. 1). 
H. Establish and Maintain Records 
Part 117 requires that you document the preventive control management components as follows: 
(1) The monitoring of preventive controls in records that are subject to verification and records 
review; (2) all corrective actions (and, when appropriate, corrections) in records that are subject 
to verification and records review; and (3) all verification activities (21 CFR 117.145(b)-(c), 
117.150(d), and 117.155(b)). 
In this example, the fresh-cut processing establishment maintains the following records 
applicable to the use of sodium hypochlorite added to wash water as a process preventive 
control: 
  The scientific publications that identified 10 ppm as the minimum concentration of free 
chlorine to be effective as a process preventive control;  
  The results of the validation study; and 
  The following records that are initialed and dated by the PCQI to document review of the 
records:  
  Records of accuracy checks and calibration records for monitoring/measuring 
o
devices; 
  Process logs documenting free chlorine concentrations as observed by the QA 
o
Technician from the readings on the automated sensor; 
  Free chlorine titration test records; 
o
  Corrective action records; and 
o
  Records of any other verification activities conducted. 
o
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I.  Summary Process Control Chart for Adding Sodium Hypochlorite as 
an Antimicrobial Substance to Wash Water as an Example of a Process 
Preventive Control in the Production of Fresh-cut Leafy Vegetables 
See Appendix 2 for a summary of the application of PC management components for the 
example of adding sodium hypochlorite to wash water as a process preventive control in the 
production of a fresh-cut leafy vegetables using an adaptation of the FSPCAs Process Control 
Form (Form 2-C (Modified) from Appendix 2 of the PCHF guidance (Ref. 1)). 
XVIII. Requirements Applying to Records That Must Be 
Established and Maintained (Part 117, subpart F)  
Subpart F of part 117 establishes requirements applying to required records, including: 
  General requirements, such as for records to be accurate, indelible, and legible; contain 
the actual values and observations obtained during monitoring and, as appropriate, during 
verification activities; be created concurrently with performance of the activity 
documented; include the date and, when appropriate, the time of the activity documented; 
and include the signature or initials of the person performing the activity (21 CFR 
117.305);  
  Requirements for the food safety plan to be signed by the owner, operator, or agent in 
charge of the facility upon initial completion and upon any modification (21 CFR 
117.310);  
  Record retention requirements (21 CFR 117.315);  
  Requirements for official review (21 CFR 117.320); and  
  Provisions for use of existing records (21 CFR 117.330).  
You should refer to part 117, subpart F for the complete requirements. 
Because 21 CFR 117.305(c) specifies that records must be indelible, you should not erase a 
mistake or obscure a mistake by scratching it out or using liquid correction fluid.  
As an example of how to record an actual value, when monitoring temperature you should 
record the actual temperature that you measure (e.g., 37F) rather than simply state whether the 
measured temperature was within the acceptable operating range (e.g., < 41F). As another 
example, when monitoring the concentration of free chlorine in wash water, you should record 
the actual concentration observed (e.g., 12 ppm) rather simply state whether the measured free 
chlorine was within the acceptable operating range (e.g., > 20 ppm).   
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XIX. Training  
A. Training Requirements Specified in Part 117, Subpart A 
Part 117 specifies that each individual (including temporary and seasonal personnel) engaged in 
manufacturing, processing, packing, or holding food or in the supervision thereof must: 
  Be a qualified individual, i.e., have the education, training, or experience (or a 
combination thereof) necessary to manufacture, process, pack, or hold clean and safe 
food as appropriate to the individual's assigned duties (21 CFR 117.4(b)(1)); and 
  Receive training in the principles of food hygiene and food safety, including the 
importance of employee health and personal hygiene, as appropriate to the food, the 
operation, and the individual's assigned duties (21 CFR 117.4(b)(2)). 
Part 117 also specifies that responsibility for ensuring compliance by individuals with the 
requirements of part 117 must be clearly assigned to supervisory personnel who have the 
education, training, or experience (or a combination thereof) necessary to supervise the 
production of clean and safe food (21 CFR 117.4(c)). 
You should refer to 21 CFR 117.4(b) and (c) for the complete requirements.  
B. Required Training in the Principles of Food Hygiene and Food Safety 
We recommend that your training in the principles of food hygiene and food safety address the 
following topics: 
  The symptoms (e.g., vomiting, diarrhea, open lesions) of a health condition that presents 
a reasonable possibility of contamination of food, FCSs, or food-packaging materials and 
the individual responsibility of all personnel to report such a health condition to 
supervisory personnel;  
  The hygienic practices required by the CGMPs and the role of these hygienic practices as 
applied in your plant in the production of safe food, with an emphasis on the requirement 
to wash hands before starting work, after each absence from the work station, and at any 
other time when the hands may have become soiled or contaminated;  
  Sources of foodborne pathogens (e.g., pathogens on incoming produce; humans and their 
waste; animals and their waste); 
  Routes of contamination (e.g., pests that may contaminate fresh-cut produce with their 
excreta if they are not excluded from the produce; a worker with an open wound who 
handles fresh-cut produce, FCSs, or food-packaging materials; and the potential for 
cross-contamination (e.g., for contaminants on unclean equipment to transfer to FCSs that 
have already been cleaned or already are in use for production)); 
  How to recognize raw or processed produce that may have become contaminated; 
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  Preventive measures (i.e., taking measures to prevent or minimize contamination at those 
points where potential routes of contamination exist); and 
  Corrective measures (e.g., the types of steps you will take to identify and correct 
problems, reduce the likelihood that a problem will recur, evaluate affected fresh-cut 
produce for safety, and prevent fresh-cut produce from entering into commerce if you 
cannot ensure that it is not adulterated under section 402 of the FD&C Act). 
C. Examples of Training Topics Appropriate to Assigned Duties 
Part 117 provides flexibility for personnel to be qualified by a combination of education, 
training, and experience. The specific knowledge, skills, and abilities that personnel need to be a 
qualified individual to perform their assigned duties depend on the activities that they will 
conduct. See Table 5 for examples of training topics that could be appropriate for an individuals 
assigned duties.  
Table 5.--Examples of Training Topics Appropriate to an Individuals Assigned Duties 
Personnel Function  Training Topics 
Purchasing  Awareness of your supply-chain program requirements and the role of those 
requirements as a preventive control 
Receiving  Procedures for receipt, handling, and storage of raw produce to ensure that raw 
produce is appropriately stored before use in production 
Production operations  The control measures employed during production, including the preventive 
measures, monitoring and verification activities, corrective actions, and records 
applicable to each employees position 
Maintenance  Measures to prevent contamination of food and FCSs during maintenance 
operations 
Cleaning operations  The principles and methods required for effective cleaning and sanitizing, especially 
as those methods relate to food safety;  
How to properly disassemble and reassemble produce processing equipment so that 
thorough cleaning and sanitation of that equipment can take place; 
The proper use of sanitizing agents (sanitizers), and the storage of chemicals used 
for cleaning and sanitizing; and 
Specific steps for cleaning and sanitizing equipment and areas of the plant. 
Trash removal  The potential for cross-contamination when personnel transition from handling trash 
and waste containers to handling raw and processed produce and FCSs 
 
D. Delivery of Training 
You have flexibility to design and deliver training in a manner that suits your operations and 
enables your personnel to understand why food hygiene and food safety practices are important, 
what you expect of them, and when and how they should perform specific tasks. For example, 
you have flexibility with respect to: 
  The method of delivery  e.g., classroom training, online training, or hands-on training;  
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  The time allotted to a training session  e.g., short training sessions on specific topics or 
longer training sessions covering multiple training topics;  
  Supporting audiovisual materials  e.g., pictures, graphics, and portable visual aids used 
in specific training, and signs posted throughout the plant as a reminder of food hygiene 
and food safety practices on an ongoing basis; and 
  How to effectively communicate training to all personnel regardless of language  e.g., 
through use of multi-lingual signs.  
See Appendix 3 for an example of a training aid that could be used to instruct personnel on the 
proper technique to use in washing hands. 
See Appendix 4 for an example of a training aid that could be used to instruct personnel with 
responsibility for cleaning and sanitizing equipment and areas of the plant.  
For additional training resources, see the FSPCA website at https://www.ifsh.iit.edu/fspca.  
E. Records of Training 
You must establish and maintain records that document the required training in the principles of 
food hygiene and food safety (21 CFR 117.4(d)). For more information about establishing and 
maintaining records, see section XVIII. 
XX.  Glossary of Terms Used in This Guidance  
A. Terms Defined in 21 CFR part 117 
Adequate: That which is needed to accomplish the intended purpose in keeping with good public 
health practice. 
Allergen cross-contact: The unintentional incorporation of a food allergen into a food. 
Correction: An action to identify and correct a problem that occurred during the production of 
food, without other actions associated with a corrective action procedure (such as actions to 
reduce the likelihood that the problem will recur, evaluate all affected food for safety, and 
prevent affected food from entering commerce). 
Critical control point (CCP): A point, step, or procedure in a food process at which control can 
be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to 
an acceptable level. 
Defect action level: A level of a non-hazardous, naturally occurring, unavoidable defect at which 
FDA may regard a food product adulterated and subject to enforcement action under section 
402(a)(3) of the FD&C Act.  
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Environmental pathogen: A pathogen capable of surviving and persisting with the manufacturing 
processing, packing, or holding environment such that food may be contaminated and may result 
in foodborne illness if that food is consumed without treatment to significantly minimize the 
environmental pathogen. Examples of environmental pathogens include Listeria monocytogenes 
and Salmonella spp. but do not include the spores of pathogenic sporeforming bacteria. 
Facility: A domestic facility or foreign facility that is required to register under section 415 of the 
FD&C Act, in accordance with the requirements of 21 CFR part 1, subpart H. 
Food: Food as defined in section 201(f) of the FD&C Act and includes raw materials and 
ingredients. 
Food allergen: A major food allergen as defined in section 201(qq) of the FD&C Act.22  
Food-contact surfaces: Those surfaces that contact human food and those surfaces from which 
drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs 
during the normal course of operation. Food contact surfaces includes utensils and food-
contact surfaces of equipment. 
Hazard: Any biological, chemical (including radiological), or physical agent that has the 
potential to cause illness or injury.  
Hazard requiring a preventive control: A known or reasonably foreseeable hazard for which a 
person knowledgeable about the safe manufacturing, processing, packing, or holding of food 
would, based on the outcome of a hazard analysis (which includes the severity of the illness or 
injury if the hazard were to occur and the probability that the hazard will occur in the absence of 
preventive controls) establish one or more preventive controls to significantly minimize or 
prevent the hazard in a food and components to manage those controls (such as monitoring, 
corrections or corrective actions, verification, and records) as appropriate to the food, the facility 
and the nature of the preventive control and its role in the facilitys food safety system.  
Lot: The food produced during a period of time and identified by an establishments specific 
code. 
Known or reasonably foreseeable hazard: A potential biological, chemical (including 
radiological), or physical hazard that is known to be, or has the potential to be, associated with 
the facility or the food. 
Microorganisms: Yeast, molds, bacteria, viruses, protozoa, and microscopic parasites and 
includes species that are pathogens. The term undesirable microorganisms includes those 
microorganisms that are pathogens, that subject food to decomposition, that indicate that food is 
contaminated with filth, or that otherwise may cause food to be adulterated. 
                                                 
22 Section 201(qq) of the FD&C Act defines the term major food allergen to mean any of the following: Milk, 
egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, 
pecans, or walnuts), wheat, peanuts, and soybeans, or a food ingredient that contains protein derived from one of 
these foods, with certain exceptions with respect to highly refined oils. 
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Monitor: To conduct a planned sequence of observations or measurements to assess whether 
control measures are operating as intended.  
Pathogen: A microorganism of public health significance. 
Pest: Any objectionable animals or insects including birds, rodents, flies, and larvae. 
Plant: The building or structure or parts thereof, used for or in connection with the 
manufacturing, processing, packing, or holding of human food. 
Preventive controls: Those risk-based, reasonably appropriate procedures, practices, and 
processes that a person knowledgeable about the safe manufacturing, processing, packing, or 
holding of food would employ to significantly minimize or prevent the hazards identified under 
the hazard analysis that are consistent with the current scientific understanding of safe food 
manufacturing, processing, packing, or holding at the time of the analysis. 
Preventive controls qualified individual (PCQI): A qualified individual who has successfully 
completed training in the development and application of risk-based preventive controls at least 
equivalent to that received under a standardized curriculum recognized as adequate by FDA or is 
otherwise qualified through job experience to develop and apply a food safety system. 
Qualified auditor: A person who is a qualified individual as defined in part 117 and has technical 
expertise obtained through education, training, or experience (or a combination thereof) 
necessary to perform the auditing function as required by 21 CFR 117.180(c)(2). Examples of 
potential qualified auditors include: (1) A government employee, including a foreign government 
employee; and (2) An audit agent of a certification body that is accredited in accordance with 21 
CFR part 1, subpart M. 
Qualified facility: A facility (when including the sales by any subsidiary; affiliate; or subsidiaries 
or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) that is a 
very small business, or a facility to which both of the following apply: (1) During the 3-year 
period preceding the applicable calendar year, the average annual monetary value of the food 
manufactured, processed, packed or held at such facility that is sold directly to qualified end-
users (as defined in part 117) during such period exceeded the average annual monetary value of 
the food sold by such facility to all other purchasers; and (2) The average annual monetary value 
of all food sold during the 3-year period preceding the applicable calendar year was less than 
$500,000, adjusted for inflation. 
Qualified individual: A person who has the education, training, or experience (or a combination 
thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to 
the individuals assigned duties. A qualified individual may be, but is not required to be, an 
employee of the establishment. 
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Raw agricultural commodity (RAC): Has the meaning in section 201(r) of the FD&C Act.23 
Ready-to-eat (RTE) food: Any food that is normally eaten in its raw state or any other food, 
including a processed food, for which it is reasonably foreseeable that the food will be eaten 
without further processing that would significantly minimize biological hazards. 
Receiving facility: A facility that is subject to subparts C and G of part 117 and that 
manufactures/processes a raw material or other ingredient that it receives from a supplier. 
Sanitize: To adequately treat cleaned surfaces by a process that is effective in destroying 
vegetative cells of pathogens, and in substantially reducing numbers of other undesirable 
microorganisms, but without adversely affecting the product or its safety for the consumer. 
Significantly minimize: To reduce to an acceptable level, including to eliminate. 
Supplier: The establishment that manufactures/processes the food, raises the animal, or grows the 
food that is provided to a receiving facility without further manufacturing/processing by another 
establishment, except for further manufacturing/processing that consists solely of the addition of 
labeling or similar activity of a de minimis nature. 
Supply-chain-applied control: A preventive control for a hazard in a raw material or other 
ingredient when the hazard in the raw material or other ingredient is controlled before its receipt. 
Validation: Obtaining and evaluating scientific and technical evidence that a control measure, 
combination of control measures, or the food safety plan as a whole, when properly 
implemented, is capable of effectively controlling the identified hazards. 
Verification: The application of methods, procedures, tests and other evaluations, in addition to 
monitoring, to determine whether a control measure or combination of control measures is or has 
been operating as intended and to establish the validity of the food safety plan. 
Very small business: A business (including any subsidiaries and affiliates) averaging less than 
$1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable 
calendar year in sales of human food plus the market value of human food manufactured, 
processed, packed, or held without sale (e.g., held for a fee). 
B. Terms Defined in 21 CFR part 112  
Produce: Any fruit or vegetable (including mixes of intact fruits and vegetables) and includes 
mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs. A fruit is the 
edible reproductive body of a seed plant or tree nut (such as apple, orange, and almond) such that 
fruit means the harvestable or harvested part of a plant developed from a flower. A vegetable is 
the edible part of an herbaceous plant (such as cabbage or potato) or fleshy fruiting body of a 
fungus (such as white button or shiitake) grown for an edible part such that vegetable means the 
                                                 
23 Section 201(r) of the FD&C Act defines the term "raw agricultural commodity" to mean 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. 
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harvestable or harvested part of any plant or fungus whose fruit, fleshy fruiting bodies, seeds, 
roots, tubers, bulbs, stems, leaves, or flower parts are used as food and includes mushrooms, 
sprouts, and herbs (such as basil or cilantro). Produce does not include food grains meaning the 
small, hard fruits or seeds of arable crops, or the crops bearing these fruits or seeds, that are 
primarily grown and processed for use as meal, flour, baked goods, cereals and oils rather than 
for direct consumption as small, hard fruits or seeds (including cereal grains, pseudo cereals, 
oilseeds and other plants used in the same fashion). Examples of food grains include barley, 
dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds 
(e.g., cotton seed, flax seed, rapeseed, soybean, and sunflower seed). 
C. Terms Defined for Use in This Guidance 
Adjustment: An intervention that you take if you determine that there is a divergence from an 
operating limit, without a deviation from a critical limit. 
Critical limit: A maximum and/or minimum value to which a biological, chemical, or physical 
parameter must be controlled to prevent, eliminate or reduce to an acceptable level the 
occurrence of a food-safety hazard.  
Fresh-cut produce: Any fresh fruit or vegetable or combination thereof that has been physically 
altered from its whole state after being harvested from the field (e.g., by chopping, dicing, 
peeling, ricing, shredding, slicing, spiralizing, or tearing) without additional processing (such as 
blanching or cooking).  
Infiltration: Movement of water containing pathogenic microorganisms from the surface of 
produce into the internal tissues of the produce. 
Operating limits: Criteria that may be more stringent than critical limits and are established for 
reasons other than food safety. 
Preventive control management components (PC management components): Monitoring, 
corrective actions and corrections, and verification (with associated records) as required by 21 
CFR 117.140. 
Target pathogen: A known or reasonably foreseeable pathogenic contaminant with the greatest 
resistance to a process control that is being validated. 
XXI. Abbreviations Used in This Document  
Abbreviation  What It Means 
CFR  Code of Federal Regulations 
CGMP  Current good manufacturing practice 
FCN  Food Contact Substance Notification 
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Abbreviation  What It Means 
FCS  Food-contact surface 
FDA  U.S. Food and Drug Administration 
FD&C Act  Federal Food, Drug, and Cosmetic Act 
FSPCA  Food Safety Preventive Controls Alliance 
HACCP  Hazard Analysis and Critical Control Point 
N/A  Not applicable 
NRTE  Not ready-to-eat 
Part 117  Our regulation, established in 21 CFR 117, entitled Current 
Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Human Food 
PCHF  Preventive Controls for Human Food 
PCHF requirements,  Requirements, in subparts A, C, D, E, F, and G of 21 CFR part 
human food  117, to establish and implement hazard analysis and risk-based 
preventive controls  preventive controls for human food 
requirements 
PC management  Monitoring, corrective actions and corrections, and verification 
components  (with associated records) as required by 21 CFR 117.140 
Produce safety  Our regulation, established in 21 CFR part 112, entitled 
regulation  Standards for the Growing, Harvesting, Packing, and Holding 
of Produce for Human Consumption 
QA  Quality Assurance   
RAC  Raw agricultural commodity 
RTE  Ready-to-eat  
TCS  Time/temperature control for safety 
TCS food  A food that requires time/temperature control for safety to limit 
pathogenic microorganism growth or toxin formation. 
 
 
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XXII.    References  
Ref. 1. Food and Drug Administration. 2016. "Hazard Analysis and Risk-Based Preventive 
Controls for Human Food: Draft Guidance for Industry." Accessed January 4, 2018. 
(https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfo
rmation/UCM517610.pdf) 
Ref. 2. Duff and Phelps. 2016. "Food Retail Industry Insights." Accessed January 4, 2018. 
(https://www.duffandphelps.com/assets/pdfs/publications/mergers-and-acquisitions/industry-
insights/consumer/food-retail-industry-insights-2016.pdf) 
Ref. 3. Food and Drug Administration. 2015. "Final Qualitative Assessment of Risk to Public 
Health from on Farm Contamination of Produce." Accessed January 4, 2018. 
(https://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM4707
80.pdf) 
Ref. 4. Centers for Disease Control and Prevention. 2006. Multistate Outbreak of E. coli 
O157:H7 Infections Linked to Fresh Spinach (FINAL UPDATE). Accessed June 1, 2018. 
(https://www.cdc.gov/ecoli/2006/spinach-10-2006.html) 
Ref. 5. Harris, L.J., J.N. Farber, L.R. Beuchat, M.E. Parish, T.V. Suslow, E.H. Garrett, and F.F. 
Busta. 2003. "Outbreaks Associated with Fresh Produce: Incidence, Growth, and Survival of 
Pathogens in Fresh and Fresh-cut Produce," Comprehensive Reviews in Food Science and Food 
Safety. 2(s1):78-141. 
Ref. 6. Fatica, M.K., and D. Gubernot. "Memorandum of Record: Fresh-cut Produce Related 
Outbreak Data, November 2017." Food and Drug Administration. 
Ref. 7. Gaul, L.K., N.H. Farag, T. Shim, M.A. Kingsley, B.J. Silk, and E. Hyytia-Trees. 2012. 
"Hospital-Acquired Listeriosis Outbreak Caused by Contaminated Diced CeleryTexas, 2010," 
Clinical Infectious Diseases. 56(1):20-26. 
Ref. 8. Jung, Y., H. Jang, and K.R. Matthews. 2014. Effect of the Food Production Chain from 
Farm Practices to Vegetable Processing on Outbreak Incidence, Microbial Biotechnology. 
7:517-527. 
Ref. 9. Food and Agriculture Organization of the United Nations/World Health Organization. 
2008. "Microbiological Hazards in Fresh Leafy Vegetables and Herbs: Meeting Report." 
Microbiological Risk Assessment Series. Accessed January 4, 2018. (http://www.fao.org/3/a-
i0452e.pdf) 
Ref. 10. National Advisory Committee on Microbiological Criteria for Foods. 1998. "Hazard 
Analysis and Critical Control Point Principles and Application Guidelines," Journal of Food 
Protection. 61:12461259. 
Ref. 11. Food and Drug Administration. 2017. "Control of Listeria monocytogenes in Ready-to-
Eat Foods: Draft Guidance for Industry." Accessed January 4, 2018. 
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(https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfo
rmation/UCM535981.pdf) 
Ref. 12. Geiger, C.A., and C. Cox. 2012. "Pest Prevention by Design." Accessed January 4, 
2018. (https://sfenvironment.org/sites/default/files/fliers/files/final_ppbd_guidelines_12-5-
12.pdf) 
Ref. 13. International Fresh-cut Produce Association. 2001. Chapter 5: Sanitary Plant and 
Equipment Design. In Food Safety Guidelines for the Fresh-cut Produce Industry. p 63, 4th 
edition. 
Ref. 14. Wanniarachchi, W.N.C., R.A.R.C. Gopura, and H.K.G. Punchihewa. 2016. 
"Development of a Layout Model Suitable for the Food Processing Industry," Journal of 
Industrial Engineering. 2016:1-8. 
Ref. 15. Schmidt, R., and D.J. Erickson. 2005. "Sanitary Design and Construction of Food 
Processing and Handling Facilities," FSHN0408, Food Science and Human Nutrition 
Department, UF/IFAS Extension. Accessed January 4, 2018. (http://edis.ifas.ufl.edu/fs120) 
Ref. 16. U.S. Environmental Protection Agency. 2001. "Potential Cross Contamination Due to 
Cross-Connection and Back-flows and the Associated Health Risks." Accessed January 4, 2018. 
(https://www.epa.gov/sites/production/files/2015-
09/documents/2007_05_18_disinfection_tcr_issuepaper_tcr_crossconnection-backflow.pdf) 
Ref. 17. Garrett, E.H. 2009. Chapter 16: Plant Sanitation and Good Manufacturing Practices for 
Optimum Food Safety in Fresh-cut Produce. In Microbial Safety of Fresh Produce (Eds: X. Fan, 
B.A. Niemira, C.J. Doona, F.E. Feeherry, and R.B. Gravani), Wiley-Blackwell, Oxford, UK., pp 
307-320, doi: 10.1002/9781444319347. 
Ref. 18. Troller, J.A. 1993. Chapter 16: Equipment and Process Sanitation. 2nd ed, Sanitation in 
Food Processing. Academic Press, San Diego, CA. 
Ref. 19. Food and Drug Administration. 2017. "Food Code." Accessed April 16, 2018. 
(https://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/UC
M595140.pdf). 
Ref. 20. Food and Drug Administration. 2016. "Defect Levels Handbook." Accessed January 4, 
2018. 
(https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm05
6174.htm)  
Ref. 21. Food and Drug Administration. 2016. Human Food By-Products For Use As Animal 
Food: Draft Guidance for Industry #239. Accessed January 4, 2018. 
(https://www.fda.gov/downloads/animalveterinary/guidancecomplianceenforcement/guidancefor
industry/ucm499201.pdf) 
Ref. 22. Food and Drug Administration. 2018. Policy Regarding Certain Entities Subject to the 
Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign 
58 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Supplier Verification Programs: Guidance for Industry. Accessed April 19, 2018. 
(https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfo
rmation/UCM590661.pdf) 
Ref. 23. Food and Drug Administration. 2017. Food Safety Plan Builder. Accessed January 4, 
2018. (https://www.fda.gov/food/guidanceregulation/fsma/ucm539791.htm) 
Ref. 24. Centers for Disease Control and Prevention. 2018. Multistate Outbreak of 
Cyclosporiasis Linked to Fresh Express Salad Mix Sold at McDonalds Restaurants  United 
States, 2018: Final Update. Accessed October 10, 2018. 
(https://www.cdc.gov/parasites/cyclosporiasis/outbreaks/2018/b-071318/index.html) 
Ref. 25. Centers for Disease Control and Prevention. 2018. Multistate Outbreak of 
Cyclosporiasis Linked to Del Monte Fresh Produce Vegetable Trays  United States, 2018: 
Final Update. Accessed October 10, 2018. 
(https://www.cdc.gov/parasites/cyclosporiasis/outbreaks/2018/a-062018/index.html) 
Ref. 26. Grocery Manufacturers Association. 2009. "Control of Salmonella in Low-Moisture 
Foods." Accessed January 4, 2018. (http://www.gmaonline.org/downloads/technical-guidance-
and-tools/SalmonellaControlGuidance.pdf) 
Ref. 27. Food and Drug Administration. "Firm/Supplier Evaluation Resources." Accessed May 
30, 2018. (https://datadashboard.fda.gov/ora/fd/fser.htm) 
Ref. 28. Food and Drug Administration. 1999. Guidance for Industry: Antimicrobial Food 
Additives. Accessed May 31, 2018. 
(https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/uc
m077256.htm) 
Ref. 29. Luo, Y., X. Nou, Y. Yang, I. Alegre, E. Turnerm, H. Feng, M. Abadias, and W. 
Conway. 2011. "Determination of Free Chlorine Concentrations Needed to Prevent Escherichia 
coli O157:H7 Cross-contamination during Fresh-cut Produce Wash," Journal of Food 
Protection. 74(3):352-358. 
Ref. 30. Gombas, D., Y. Luo, J. Brennan, G. Shergill, R. Petran, R. Walsh, H. Hau, K. Khurana, 
B. Zomorodi, J. Rosen, R. Varley, and K. Deng. 2017. "Guidelines to Validate Control of Cross-
Contamination During Washing of Fresh-cut Leafy Vegetables," Journal of Food Protection. 
80(2):312-330. 
Ref. 31. Luo, Y., B. Zhou, S.V. Haute, X. Nou, B. Zhang, Z. Teng, E.R. Turner, Q. Wang, and 
P.D. Millner. 2018. "Association between Bacterial Survival and Free Chlorine Concentration 
during Commercial Fresh-cut Produce Wash Operation," Food Microbiology. 70:120-128. 
Ref. 32. Krysinski, E.P., L.J. Brown, and T.J. Marchisello. 1992. "Effect of Cleaners and 
Sanitizers on Listeria monocytogenes Attached to Product Contact Surfaces." Journal of Food 
Protection. 55(4):246-251. 
59 
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Ref. 33. Natishan, P.M., and W.E. Ogrady. 2014. "Chloride Ion Interactions with Oxide-
Covered Aluminum Leading to Pitting Corrosion: A Review," Journal of The Electrochemical 
Society. 161(9):C421-C432. 
Ref. 34. Carpentier, B., and O. Cerf. 2011. "Review - Persistence of Listeria monocytogenes in 
Food Industry Equipment and Premises," International Journal of Food Microbiology. 145(1):1-
8. 
Ref. 35. Cox, L.J., T. Kleiss, J.L. Cordier, C. Cordellana, P. Konkel, C. Pedrazzini, R. Beumer, 
and A. Siebenga. 1989. "Listeria spp. in Food Processing, Non-food and Domestic 
Environments," Food Microbiology. 6(1):49-61. 
Ref. 36. Tompkin, R.B., V.N. Scott, D.T. Bernard, W.H. Sveum, and K.S. Gombas. 1999. 
Guidelines to Prevent Post-processing Contamination from Listeria monocytogenes, Dairy, 
Food and Environmental Sanitation. 19(8):551-562. 
Ref. 37. Parker, A. 2007. "Effective Cleaning and Sanitizing Procedures." Joint Institute for 
Food Safety and Applied Nutrition. Accessed January 4, 2018. 
(http://jifsan.umd.edu/pdf/gaqps_en/Section9.Effective_Cleaning_and_Sanitizing_Procedures.pd
f) 
Ref. 38. Schmidt, R.H. 2005. "Basic Elements of a Sanitation Program for Food Processing and 
Food Handling ": FS15, Food Science and Human Nutrition Department, UF/IFAS Extension. 
Accessed January 4, 2018. (http://edis.ifas.ufl.edu/fs076)   
60 
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Appendix 1.  Example of a Sanitation Master Schedule  
The table in this Appendix is an example of a Sanitation Master Schedule for periodic 
infrastructure cleaning and periodic equipment cleaning. For each area to be cleaned, the 
example Master Sanitation Schedule lists the cleaning method, the tools used, the cleaning and 
sanitizing materials, and the frequency of cleaning and sanitizing. We developed this example 
sanitation master schedule from publications in the scientific literature (Ref. 32 through Ref. 36), 
publicly availably documents from academic institutions (Ref. 37 and Ref. 38), and our Listeria 
guidance (Ref. 11).  
The table in this Appendix is a resource for you to see at a glance what a Sanitation Master 
Schedule could address; how certain methods, tools, and cleaning and sanitizing materials could 
be used in specific areas of your plant; and how the frequency of cleaning and sanitizing could 
vary depending on the area. You have flexibility to use different methods, tools, cleaning and 
sanitizing materials, and frequency of cleaning.  
In selecting products for your sanitation program, you should carefully review the product label 
and other information from the manufacturer to determine whether the product is intended for 
use as a cleaning compound or as a sanitizer. One way to distinguish a cleaning compound from 
a sanitizer is to look for information about the effectiveness of the product against specific 
microorganisms. The oversight by the U.S. Environmental Protection Agency (EPA) of 
sanitizers used for FCSs and non-FCSs includes a registration process in which the label of the 
EPA-registered product lists the microorganisms for which the sanitizer is effective.   
When selecting a cleaning compound, you should consider the manufacturers information 
regarding the compatibility of the cleaning compound with the objects on which the compound 
will be used. 
When selecting a sanitizer, you should consider the manufacturers information regarding: 
  The intended use of the sanitizer e.g., for use on FCSs, non FCSs, or both;  
  The compatibility of the sanitizer with the objects on which the sanitizer will be used;  
  The impact of soil on the sanitizer efficacy;  
  The ability of the sanitizer to effectively penetrate the extracellular material of the 
biofilm; and 
  The efficacy of the sanitizer: 
  In significantly minimizing pathogens that are reasonably foreseeable for your food 
o
products; and  
  Under your conditions of use (e.g., concentration, temperature, pH, and water 
o
hardness). 
61 
  Contains Nonbinding Recommendations 
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Example of a Sanitation Master Schedule  
Cleaning/Sanitation  Cleaning and 
Area  Tools  Frequency 
Method  Sanitizing Materials 
Walls  Foam, brush, rinse  Soft nylon  Chlorine-Quaternary  Once/Month (walls 
brush and  ammonium ("quat")- adjacent to 
medium  based cleaner and  processing 
pressure hose  sanitize  equipment should 
(when  be cleaned daily) 
appropriate) 
Ceiling  Foam, brush, rinse  Nylon brush,  Chlorine-quat-based  Once/Month 
medium  cleaner and sanitize 
pressure 
machine 
Floors  Foam, scrub, rinse  Hard bristle  Chlorine-quat-based  Daily 
broom (not  cleaner and sanitize 
straw), floor 
scrubbers, low 
pressure hose 
Doors  Foam, scrub, rinse  Scouring pad  Chlorine-quat-based  Once/Week 
cleaner and sanitize 
Handwashing station  Foam, scrub, rinse  Scoring pad  Chlorine-quat-based  Daily  
cleaner and sanitize  
Pallet jacks/forklift  Foam, scrub, rinse  Nylon brushes  Chlorine-quat-based  Weekly 
(forks and wheels)  cleaner and sanitize 
Plastic curtains  Foam, scrub, rinse  Nylon brush or  Chlorine-quat-based  Once/Week 
scouring pad  cleaner and sanitize   (adjacent to 
processing 
equipment should 
be cleaned daily) 
Drains and covers  Foam, brush, rinse  Drain brush  Chlorine-quat-based  Daily 
cleaner and sanitize  
Evaporator plates of  Foam, brush, rinse  Nylon brush  Chlorine-quat-based  Quarterly if using 
cooling units  cleaner and sanitize   quaternary rings in 
the drip pans. 
Overhead pipes,  Foam, brush, rinse  Brush with  Chlorine-quat-based  Once/Month 
electrical conduits,  bucket, or med  cleaner and sanitize  
structural beams  water pressure  
Hoist fixtures  Foam, brush, rinse  Cleaning pad  Chlorine-quat-based  Once/Month 
cleaner and sanitize  
Light fixtures  Brush and rinse  Brush or wipes  Chlorine-quat-based  Monthly or as 
cleaner and sanitize   needed  
Platform standing  Foam, brush, rinse  Nylon brush   Chlorine-quat-based  Daily 
grids  cleaner and sanitize  
Waste, dumpster areas  Foam, brush, rinse  Nylon brush   Heavy duty  Weekly or as 
degreaser, Chlorine- needed 
quat-based cleaner 
and sanitize  
Employee break  Sweep, Wash and  Designated  Chlorine-quat-based  Frequently 
rooms/bathrooms  Sanitize  bathroom  cleaner and sanitize   throughout the day 
brushes and 
tools 
Shipping warehouse  Sweeping  Designated  Chlorine-quat-based  Daily 
  Broom and  cleaner and sanitize    
Foam, scrub, rinse  Brushes  Quarterly 
62 
  Contains Nonbinding Recommendations 
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Cleaning/Sanitation  Cleaning and 
Area  Tools  Frequency 
Method  Sanitizing Materials 
Maintenance areas  Sweeping  Designated  Degreasing agent  Daily 
  Broom and   
Scrub, rinse  brushes  Monthly 
Receiving warehouse  Sweeping   Designated  Chlorine-quat-based  Daily 
  Broom and  cleaner and sanitize    
Foam, scrub, rinse  Brushes  Quarterly 
Mezzanines above  Foam, brush, rinse  Brush  Chlorine-quat-based  Daily  
flumes and above filling  cleaner and sanitize  
product 
Production processing  Foam, scrub, rinse  Nylon brushes   Chlorine-quat-based  Daily  
area  cleaner and sanitize  
Bin dumpers  Foam, scrub, rinse  Nylon brushes  Chlorine-quat-based  Daily 
cleaner and sanitize    
Flumes  Empty flumes, foam,  Nylon brushes  Chlorine-quat-based  Daily 
scrub, rinse  cleaner and sanitize  
(Sanitizer air dry 
before re-filling 
flume) 
Chiller plates  Foam, scrub, rinse  Nylon brushes  Chlorine-quat-based  Daily 
cleaner and sanitize 
Spin dryers  Remove basket from  Nylon brushes  Chlorine-quat-based  Daily 
dryer, foam, scrub, rinse  cleaner and sanitize  
Spin dryer baskets  Empty basket, foam,  Nylon brushes  Chlorine-quat-based  Daily 
scrub, rinse  cleaner and sanitize  
Blades and cutters  Remove, foam, scrub,  Nylon brushes  Chlorine-quat-based  Daily or as needed 
rinse  cleaner and sanitize   to prevent cross-
contamination 
during processing 
Hoppers  Foam, scrub, rinse  Nylon brushes  Chlorine-quat-based  Daily 
cleaner and sanitize 
Product filling scales  Remove, foam, scrub,  Nylon brushes  Chlorine-quat-based  Daily 
rinse  cleaner and sanitize  
Forming tubes at the  Foam, scrub, rinse  Nylon brushes  Chlorine-quat-based  Daily 
filler  cleaner and sanitize  
Conveyor belts  Foam, scrub, rinse  Nylon brushes  Chlorine-quat-based  Daily 
  cleaner and sanitize    
Remove, foam, scrub,  Monthly 
rinse   
Food contact knives and  Foam, scrub, rinse  Nylon brushes  Chlorine-quat-based  Daily or as needed 
tools   cleaner and sanitize   to prevent cross-
contamination 
during processing  
Plastic bins/barrels  Foam, scrub, rinse  Nylon brushes  Chlorine-quat-based  Daily 
  cleaner and sanitize  
Injection pump hose  Wipe clean  Single use  Chlorine-quat-based  Daily 
wipes  cleaner and sanitize  
Leaker tanks  Empty, foam, scrub, rinse  Nylon brushes  Chlorine-quat-based  Daily 
  cleaner and sanitize  
 
 
63 
  Contains Nonbinding Recommendations 
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Appendix 2.  Summary Process Control Chart for Adding Sodium Hypochlorite to Wash 
Water as an Example of a Process Preventive Control in the Production of Fresh-cut Leafy 
Vegetables  
FORM 2-C (Modified)24 PROCESS CONTROLS 
PAGE _________ 
PRODUCTS:  Fresh-cut romaine lettuce__________________________________________________________________ 
PLANT NAME: _Fresh-cut Operation A______ADDRESS: _123 Main Street, Anytown, State, Zip____________________ 
ISSUE DATE: (mm/dd/yy)______12/15/17________SUPERSEDES: (mm/dd/yy)_____12/13/16______________________ 
PROCESS CONTROL STEP: _Chlorine added to wash water_________________________________________________ 
HAZARD(S): _E. coli O157:H7__________________________________________________________________________ 
 
Critical  What to  Frequency of  Who 
How to Monitor  Corrective Action/Correction  Verification  Records25 
Limits  Monitor  Monitoring  Monitors 
Minimum  Concentra-  Automated   Continuous   The   Empty the processing line and discard   Weekly calibration of   Accuracy checks and 
concentration  tion of free  sensor  (automated  automated  the product back to the last time the  sensors used for  calibration records 
of free  chlorine in   Visual  sensor)  sensor  monitored parameters were within the  monitoring free chlorine   Free chlorine titration 
chlorine is 10  the wash  observation of   Twice per   The QA  critical limits   Twice per shift  test records 
ppm  water  the reading on  shift (QA  Technician   Clean and sanitize all affected post- verification of free   Process logs 
the automated  Technician)  wash FCSs  chlorine concentration  documenting the 
sensor by the QA   The PCQI takes steps to determining  using a titration test kit  concentrations of free 
Technician  (if possible) what caused the free   Records review by  chlorine observed by 
chlorine concentration to drop below  PCQI within 7 days of  the QA Technician 
the critical limit so that actions can be  record creation (batch  from the readings on 
taken to prevent such occurrences  records documenting the  the automated sensor 
from happening in the future  free chlorine   Corrective action 
 Replace non-functioning sensor(s)  concentrations,  records 
when applicable  calibration of sensors, 
corrective action 
records) 
 
                                                 
24 Modified from Form 2-C in Appendix 2 to address a single process control step.  Form 2-C in Appendix 2 can be used to list multiple process control steps. 
25 Records include the date and initials of the PCQI (or designee) as verification. 
64 
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Appendix 3.  Example of a Training Aid to Instruct Personnel on 
Adequate Handwashing Procedures  
We recommend that you train your employees on how, when, and why they must adequately 
wash (and, when applicable, sanitize) their hands and exposed portions of their arms (e.g., before 
entering areas where fresh or fresh-cut produce is processed or exposed). Below, we provide an 
example of a training aid that you could use to train employees on adequate handwashing 
procedures.26  
Example Training Aid on Adequate Handwashing Procedure: 
Soap combined with scrubbing helps dislodge and remove dirt and germs. Wash your 
hands following the steps below before entering any area where produce is processed or 
exposed: 
  Step 1: Use soap and warm running water. 
  Step 2: Wet hands. 
  Step 3: Apply soap. 
  Step 4: Vigorously rub hands up to elbows for 20 seconds. 
  Step 5: Rinse Hands. 
  Step 6: Turn off running water with a paper towel, not bare hands. 
  Step 7: Dry hands with a paper towel or air dry. Do not share towels. 
 
 
 
 
   
                                                 
26 This training aid would be used during a demonstration of the 7 steps of how to wash hands. It can be modified as 
appropriate to the hand-washing facilities used in your plants, e.g., to be specific to the use of knee-operated 
controls. 
65 
  Contains Nonbinding Recommendations 
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Appendix 4.  Example of a Training Aid to Instruct Personnel 
Who Have Responsibility for Cleaning and Sanitizing  
 
[Insert one or more pictures of the equipment or infrastructure to be cleaned] 
  Tools [provide a list of tools that will be used to clean the equipment or infrastructure in 
the picture] 
  Hose 
o
  Brush (including color when applicable for color-coded brushes) 
o
  Other 
o
  Safety Requirements (As Applicable) 
  Goggles/safety glasses 
o
  Gloves 
o
  Sanitation Rain Suit 
o
  Other 
o
 
Cleaning chemicals and sanitizers  
Procedural Step  Explanation of the Actions to Be Performed 
Step 1  Explanation of how to Dry Clean this equipment 
Step 2  Explanation of how to Pre-Rinse this equipment 
Step 3  Explanation of how to Soap and Scour this equipment 
Step 4   Explanation of how to Post-Rinse this equipment  
Step 5  Explanation of how to Prepare this equipment for Inspection 
Step 6  Explanation of how to perform the Pre-Op Inspection on this equipment and explanation of an 
acceptable Pre-op Inspection. 
Step 7  Explanation of how to Sanitize this equipment including acceptable levels of sanitizer ppm 
concentration. 
 
 
66