Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
 
 Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human 
Consumption: Guidance for Industry  
 
Draft Guidance
 
This guidance is being distributed for comment purposes only. 
 
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to 
ensure that FDA considers your comment on this draft guidance before we begin work on the 
final version of the guidance, submit either electronic or written comments on the draft 
guidance within 180 days of publication in the Federal Register of the notice announcing the 
availability of the draft guidance.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-3631 listed 
in the notice of availability that publishes in the Federal Register.  
 
For questions regarding this draft document contact the Center for Food Safety and Applied 
Nutrition (CFSAN) at 240-402-1700. 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
October 2018 
 
 
 
 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human 
1
Consumption: Guidance for Industry  
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration's (FDA or we) on this topic.  It does not establish any rights for any person and is 
not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance as listed on the title page.  
Table of Contents 
I.  Introduction ......................................................................................................................... 5 
II.  Background ......................................................................................................................... 5 
Chapter 1: General Provisions (Subpart A) ........................................................................... 7 
1.  Produce ........................................................................................................................... 9 
2.  Raw Agricultural Commodity....................................................................................... 10 
3.  Covered Produce ........................................................................................................... 11 
  Rarely Consumed Raw ............................................................................................. 12 
  Personal Consumption and On-Farm Consumption ................................................. 13 
  Produce Eligible for Exemption by Commercial Processing that Adequately 
Reduces the Presence of Microorganisms of Public Health Significance ........................ 13 
4.  Covered Farms .............................................................................................................. 14 
  $25,000 Threshold .................................................................................................... 15 
  Qualified Exemption ................................................................................................. 18 
5.  Covered Activities ........................................................................................................ 25 
Chapter 2: Personnel Qualifications and Training (Subpart C) ........................................ 26 
1.  Evaluating Personnels Assigned Duties ...................................................................... 26 
2.  Qualifications Necessary to Perform Assigned Duties ................................................. 27 
3.  Training Frequency ....................................................................................................... 29 
4.  Easily Understandable Training .................................................................................... 30 
5.  Minimum Training Requirements................................................................................. 31 
  Food Hygiene and Food Safety ................................................................................. 32 
  Health and Personal Hygiene .................................................................................... 33 
                                                 
1 This draft 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. 
1  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Standards in Subparts C through O ........................................................................... 34 
6.  Additional Training for Persons Who Conduct Harvest Activities .............................. 35 
  Recognizing When Not to Harvest Covered Produce............................................... 36 
  Harvest Containers and Equipment .......................................................................... 36 
7.  Food Safety Training for a Supervisor or Responsible Party ....................................... 37 
8.  Supervision to Ensure Compliance ............................................................................... 38 
9.  Training Records ........................................................................................................... 38 
Chapter 3: Health and Hygiene (Subpart D) ....................................................................... 39 
1.  Measures to Prevent Ill or Infected Persons from Contaminating Covered Produce ... 39 
  Understanding Applicable Health Conditions .......................................................... 40 
  Self-identification of Applicable Health Conditions ................................................ 41 
  Role of Supervisors in Identifying Applicable Health Conditions ........................... 42 
  Addressing Reports of Applicable Health Conditions .............................................. 43 
  Response to Potential Contamination of Covered Produce or Food Contact Surfaces
  44 
2.  Hygienic Practices ........................................................................................................ 45 
  Personnel and Hygienic Practices ............................................................................. 46 
  Role of Supervisors in Ensuring Personnel Follow Hygienic Practices ................... 46 
  Required Hygienic Practices ..................................................................................... 47 
3.  Measures to Prevent Visitors from Contaminating Covered Produce and Food Contact 
Surfaces ................................................................................................................................. 54 
  Visitor Awareness of Policies and Procedures ......................................................... 55 
  Toilet and Hand-Washing Facilities ......................................................................... 56 
Chapter 4: Biological Soil Amendments of Animal Origin and Human Waste (Subpart 
F) ............................................................................................................................................... 57 
1.  Determine Whether your Soil Amendment is a BSAAO ............................................. 59 
2.  Determine Whether your BSAAO is Treated or Untreated ................................... 61 
  Treated BSAAO ........................................................................................................ 61 
  Untreated BSAAO .................................................................................................... 61 
3.  Determine the Appropriate Treatment Process and Associated Microbial Standard for 
your Treated BSAAO ........................................................................................................... 63 
  Validation Studies ..................................................................................................... 64 
  Processes to Treat BSAAOs ..................................................................................... 65 
4.  Determine How to Apply your BSAAO ....................................................................... 66 
  Untreated BSAAO .................................................................................................... 66 
  Treated BSAAO ........................................................................................................ 69 
5.  Determine the Requirements for Handling, Transporting, and Storing your BSAAO . 71 
6.  Determine What Records to Keep for your Treated BSAAO ....................................... 72 
Chapter 5: Domesticated and Wild Animals (Subpart I) ................................................... 74 
1.  Determining Reasonable Probability That Animals Will Contaminate Covered Produce
  75 
2.  Assessing Relevant Areas for Evidence of Potential Contamination of Covered 
Produce ................................................................................................................................. 77 
  Developing and Modifying Your Approach to Assessment ..................................... 77 
  Performing Monitoring Activities............................................................................. 79 
2  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
3.  Evaluating Significant Evidence of Potential Contamination of Covered Produce by 
Animals to Determine Whether Harvest Can Occur ............................................................. 79 
Chapter 6: Growing, Harvesting, Packing, and Holding Activities (Subpart K) ............. 82 
1.  Separation of Covered and Excluded Produce .............................................................. 82 
2.  Identifying and Not Harvesting Contaminated Covered Produce ................................ 85 
3.  Handling Harvested Covered Produce .......................................................................... 86 
4.  Dropped Covered Produce ............................................................................................ 87 
5.  Packaging Covered Produce ......................................................................................... 88 
6.  Food-Packing Material.................................................................................................. 89 
  Identifying Single-Use and Reusable Food-Packing Materials ................................ 90 
  Evaluating Your Practices and Food-Packing Materials .......................................... 91 
Chapter 7: Equipment, Tools, Buildings, and Sanitation (Subpart L) .............................. 93 
1.  Equipment and Tools .................................................................................................... 93 
  Identifying Equipment and Tools Intended or Likely to Contact Covered Produce 94 
  Design, Construction, and Workmanship ................................................................. 94 
  Installation and Maintenance .................................................................................... 95 
  Storage ...................................................................................................................... 96 
  Inspection .................................................................................................................. 97 
  Examples ................................................................................................................... 99 
  Cleaning and Sanitizing Equipment and Tools ....................................................... 103 
  Transport Equipment .............................................................................................. 110 
  Instruments and Controls ........................................................................................ 110 
2.  Buildings ..................................................................................................................... 113 
  Size, Construction, and Design ............................................................................... 113 
  Preventing Contamination, Including Floors, Walls, and Ceilings ........................ 115 
  Drainage .................................................................................................................. 116 
  Pest Control ............................................................................................................. 117 
  Domesticated Animals ............................................................................................ 118 
3.  Other Sanitation Measures .......................................................................................... 119 
  Animal Excreta and Litter from Domesticated Animals ........................................ 120 
  Toilet Facilities ....................................................................................................... 120 
  Hand-Washing Facilities ......................................................................................... 122 
  Sewage Systems ...................................................................................................... 125 
  Trash, Litter, and Waste .......................................................................................... 127 
  Plumbing ................................................................................................................. 129 
4.  Records ....................................................................................................................... 130 
Chapter 8: Records (Subpart O) ......................................................................................... 131 
1.  General Requirements for all Records ........................................................................ 131 
  Farm Name and Location........................................................................................ 132 
  Location of Growing or Activity Area.................................................................... 132 
  Adequate Description of Covered Produce............................................................. 133 
  Actual Values and Observations ............................................................................. 133 
  Created when Activity is Performed or Observed .................................................. 133 
  Date and Time ......................................................................................................... 133 
  Accurate, Legible, and Indelible ............................................................................. 134 
3  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Dated, and Signed or Initialed by the Person Who Performed the Activity ........... 134 
  Review by a Supervisor or Responsible Party ........................................................ 134 
2.  Records Storage .......................................................................................................... 136 
3.  Use of Existing Records.............................................................................................. 136 
4.  Records Retention ....................................................................................................... 137 
5.  Records Format ........................................................................................................... 137 
6.  Records Disclosure ..................................................................................................... 138 
7.  Specific Records Requirements .................................................................................. 138 
Chapter 9: Variances (Subpart P) ....................................................................................... 139 
1.  Entities Eligible to Submit a Variance Request .......................................................... 139 
2.  Grounds for a Variance ............................................................................................... 139 
3.  Information to Support a Request for a Variance ....................................................... 140 
4.  Process for Requesting a Variance ............................................................................. 141 
III.  References ....................................................................................................................... 142 
 
4  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
I.  Introduction 
In the Federal Register of November 27, 2015, we published a final rule titled Standards for the 
Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (80 FR 
74353) (Produce Safety Rule).  The Produce Safety Rule established science-based minimum 
standards for the safe growing, harvesting, packing, and holding of produce grown for human 
consumption and is part of our implementation of the FDA Food Safety Modernization Act 
(FSMA).  This draft guidance is intended to help the owner, operator, or agent in charge of a 
covered farm (i.e., you) to comply with the requirements of the Produce Safety Rule.    
FDA's guidance documents, including this draft guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required.  
II.  Background 
Produce is usually grown outdoors in soil, with influences from weather and other environmental 
factors, and often does not receive treatment after harvesting that adequately removes pathogens 
that can cause human illness (referred to in this draft guidance as microorganisms of public 
health significance).  Therefore, we place emphasis on preventive measures throughout growing, 
harvesting, packing, and holding produce to reduce the incidence of contamination of produce 
that can lead to foodborne illness.  
The Produce Safety Rule established science-based minimum standards for the safe growing, 
harvesting, packing, and holding of produce grown for human consumption.  The rule requires 
covered farms to take appropriate measures to minimize the risk of serious adverse health 
consequences or death from the use of, or exposure to, covered produce, including those 
measures reasonably necessary to prevent the introduction of known or reasonably foreseeable 
hazards into covered produce, and to provide reasonable assurances that the produce is not 
adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  (21 
CFR 112.11).  Requirements of the rule focus on major routes of contamination, including: health 
and hygiene; agricultural water; biological soil amendments of animal origin; domesticated and 
wild animals; equipment, tools, buildings and sanitation; and related topics that include 
personnel qualifications and training; growing, harvesting, packing, and holding activities; and 
sprouts.     
This draft guidance relates to compliance and implementation of the following subparts of the 
Produce Safety Rule:   
  Subpart AGeneral Provisions;  
  Subpart CPersonnel Qualifications and Training;  
  Subpart DHealth and Hygiene;  
  Subpart FBiological Soil Amendments of Animal Origin and Human Waste;  
  Subpart IDomesticated and Wild Animals;  
5  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Subpart KGrowing, Harvesting, Packing, and Holding Activities;  
  Subpart LEquipment, Tools, Buildings, and Sanitation;  
  Subpart ORecords; and  
  Subpart PVariances.   
In the Federal Register of January 23, 2017, we published a notification of availability of a draft 
guidance for industry titled, Compliance with and Recommendations for Implementation of the 
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human 
Consumption for Sprout Operations:  Guidance for Industry (82 FR 7751), which focuses on the 
portion of the Produce Safety Rule (subpart M) that deals with sprouts.  Sprout operations should 
note that this draft guidance addresses aspects of the Produce Safety Rule to which sprout 
operations may also be subject.   
At this time, we are not issuing draft guidance for the following: subpart QCompliance and 
Enforcement; and subpart RWithdrawal of Qualified Exemption.  In the future, we may issue 
additional draft guidance addressing subpart BGeneral Requirements related to alternatives, and 
subpart EAgricultural Water. 
This draft guidance provides our current thinking and recommendations to help you comply with 
the minimum standards of other subparts of the Produce Safety Rule.  In some places, we refer 
directly to specific requirements from the Produce Safety Rule, which we cite for reference.  We 
also provide recommendations, examples, clarification, and information to help you develop 
your own procedures, processes, and practices, because the Produce Safety Rule requirements 
generally include enough flexibility for you to put them in place in a way that best fits your 
operations.  In many instances, there may be several different approaches that all result in 
compliance with the requirements of the Produce Safety Rule.  In some cases, we provide 
examples to illustrate and describe potential ways to meet the requirements of the Produce Safety 
Rule.   Note that we cannot, nor have we attempted to, describe every possible scenario and 
solution.   
 
6  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Chapter 1: 
General Provisions (Subpart A) 
This chapter addresses the requirements of Produce Safety Rule Subpart AGeneral Provisions, 
which will help you to determine the applicability of the Produce Safety Rule to your farm and 
your produce.  The Produce Safety Rule applies equally to covered produce grown domestically 
and covered produce imported or offered for import into any state or territory of the United 
States, the District of Columbia, or the Commonwealth of Puerto Rico.  (21 CFR 112.1(a)).  In 
other words, covered produce grown internationally and imported is subject to applicable 
provisions of the Produce Safety Rule.    
Generally, the Produce Safety Rule applies when three conditions are present: covered produce, 
covered farm, and covered activity.  If you are a covered farm, you must comply with all 
applicable requirements of the Produce Safety Rule when conducting a covered activity on 
covered produce.  (21 CFR 112.4(a)).      
This chapter is divided into 5 sections:  
  Produce;  
  Raw agricultural commodity;  
  Covered produce;  
  Covered farms; and  
  Covered activities.   
This chapter will discuss each of these terms in sequence, and we recommend that you consider 
them in the order in which they are presented.  Each section is intended to help you determine 
which provisions of the Produce Safety Rule, if any, apply to you and the food you produce.   
In this chapter, we also discuss:  
  the threshold for farms not covered by the Produce Safety Rule (average annual value of 
produce sold during the previous 3-year period of $25,000 or less);  
  produce that is rarely consumed raw and therefore not covered by the Produce Safety 
Rule; 
  farms eligible for a qualified exemption; and  
  produce that is eligible for an exemption because it receives commercial processing that 
adequately reduces the presence of microorganisms of public health significance. 
The following is a figure to assist you in determining which provisions of the Produce Safety 
Rule, if any, apply to you and the food you produce.     
 
 
 
7  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Figure 1a.  Standards for Produce Safety:  Coverage and Exemptions 
   
8  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
1.  Produce 
In determining whether the Produce Safety Rule applies to your farm and the food you produce 
on your farm, you should first consider whether the food is produce.  Under the Produce Safety 
Rule, produce generally means any fruit or vegetable, and includes mushrooms, sprouts, 
peanuts, tree nuts, and herbs.  (See the full definition of produce at 21 CFR 112.3).  Fruit is 
further defined as the edible reproductive body of a seed plant or tree nut (such as apple, orange, 
or almond); stated another way, fruit means the harvestable or harvested part of a plant 
developed from a flower.  The Produce Safety Rule defines a vegetable as 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 mushroom) grown for an edible part; in other words, vegetable means the 
harvestable or harvested part of any herbaceous 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.  (See 21 CFR 112.3).   
Both produce and covered produce (see the section of this chapter titled Covered Produce) 
refer to the harvestable or harvested part of the crop.  That means that produce could include 
components of the harvestable or harvested part of the plant that are not edible to humans.  For 
example, based on our current understanding of the crops and practices in the tree nut industry, 
we consider the entire unit (nut or kernel, hull, and shell), the harvestable or harvested part of 
the crop.  The kernels that have been separated from the shell/hull (i.e., nut with no shell/hull) 
would also be considered produce.  The shells/hulls that have been separated from the kernel 
would not be produce as defined in 21 CFR 112.3. 
Once the harvestable or harvested part of the crop is present, produce is present.  Ripeness or 
maturity level does not matter.  For example, unripe apples while not normally eaten at that point 
in their production, are the harvestable and harvested part of the plant and are therefore 
produce, including while they are still growing on the tree. 
Produce that is not reasonably expected to be directed to a human food use is not subject to the 
requirements of the Produce Safety Rule.  For example, produce that is reasonably expected to 
be used for biofuels, clothing, or household products is not subject to the Produce Safety Rule.  
Produce that is reasonably expected to be used only as animal food is not subject to the 
requirements of the Produce Safety Rule.  Produce that is reasonably expected to be used only 
for propagation of a crop (e.g., seeds, bulbs) is not subject to the requirements of part 112 
(except to the extent the Produce Safety Rule addresses seed for sprouting).  If you grow, 
harvest, pack, or hold produce, some of which is reasonably expected to be directed to a human 
food use and some of which is not reasonably expected to be directed to a human food use, you 
could comply with the requirements of the Produce Safety Rule for all of the produce so that you 
retain the option to direct all of the produce to a human food use.   
There are many produce commodities, so we have included in this draft guidance examples in 
addition to the list provided in 21 CFR 112.1(b)(1): ackee; aronia; arrowhead; arrowroot; 
atemoya; butterbur; cactus; chipilin; crabapple; dragon fruit; fiddlehead; ginkgo nut; komatsuna; 
9  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
longan; loroco; lotus root; microgreens2; persimmon; pomegranate; pomelo; ramp; salsify; 
swamp cabbage; tamarillo; tea; ti plant; and ulluko.  Edible flowers such as nasturtiums, 
lavender, and squash blossoms are also produce. 
Produce does not include food grainsmeaning the small, hard fruits or seeds of arable crops, 
or the crops bearing these fruits or seedsthat are primarily grown and processed for use as meal, 
flour, baked goods, cereals, or 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).  (21 CFR 112.3).  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).   
Saps (e.g., agave, birch, maple, palm) do not fit the definition of produce and therefore are not 
subject to the Produce Safety Rule.  Algae (e.g., seaweed) is not produce and therefore also not 
subject to the Produce Safety Rule. 
2.  Raw Agricultural Commodity 
In determining whether the Produce Safety Rule applies to your farm and the food you produce 
on your farm, you should next consider whether the food you produce is a raw agricultural 
commodity.  Only food that is both a raw agricultural commodity (RAC) and produce is 
subject to the Produce Safety Rule.  (See 21 CFR 112.1(a) and 112.2(a)(3)).  RAC means 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.  (Section 201(r) of the FD&C Act (21 U.S.C. 
321(r)); (21 CFR 112.3)).   
RACs changed into processed food are no longer subject to the Produce Safety Rule in their 
transformed state because they are no longer a RAC.  It is important to understand this 
distinction, which is not always apparent.  Changing a RAC into a processed food involves 
changing the general state of the commodity, sometimes referred to as transformation of the 
RAC into a new or distinct commodity.  Processed foods are not subject to the Produce Safety 
Rule (See 21 CFR 112.2(a)(3)).    
As noted earlier, the distinction between a RAC and a processed food is easily apparent in some 
cases and not in others.  Below are examples that help demonstrate the distinction.   
Examples of activities that do not change a RAC into a processed food include:   
  Hydro-cooling;  
                                                 
2 Microgreens and sprouts are distinct commodities. Historically, the primary criterion FDA has used to distinguish 
between the two product categories has been the growth stage of the leaves (Ref. 221).  Sprouts are usually 
harvested when the cotyledons (or seed leaves) are still un- or under-developed and true leaves have not begun to 
emerge.  In contrast, microgreens reach a later stage of growth, typically associated with the emergence of true 
leaves.  Microgreens are also typically grown in soil or substrate and harvested above the soil or substrate line.  
Because microgreens are not sprouts, they are not subject to the requirements in subpart M.  However, microgreens 
are considered covered produce for the purposes of this rule and, unless exempt or excluded under the provisions 
in subpart A, microgreens and microgreen farms are subject to all other subparts of part 112.  (See 80 FR 74353 at 
74497 (Comment/Response 363)).   
10  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Refrigeration;  
  Removal of leaves, stems, and husks;  
  Washing; and 
  Activities designed only to isolate or separate the commodity from foreign objects or 
other parts of the plant.  
Examples of activities that change a RAC into a processed food include: 
  Chopping; 
  Cooking; 
  Cutting; 
  Homogenization; 
  Irradiation; and 
  Pasteurization. 
The following are more specific examples of the distinction between RACs and processed foods:  
  Whole heads of lettuce are a RAC; however, they are no longer a RAC once they are 
chopped into smaller pieces; chopped lettuce is a processed food; 
  Whole walnuts are a RAC; however, they are no longer RACs once they are ground into 
walnut butter; walnut butter is a processed food; 
  Fresh oranges are a RAC; however, they are no longer RACs once they are processed to 
produce orange juice; orange juice is a processed food; and 
  Fresh papayas are a RAC; however, they are no longer a RAC once they are irradiated, 
irradiated papayas are a processed food. 
The fact that a particular RAC will be made into processed food does not necessarily mean that 
the RAC is exempt from the Produce Safety Rule.  The Produce Safety Rule applies only during 
the time that the food is a RAC.   
3.  Covered Produce 
Not all produce that is also a raw agricultural commodity is subject to the provisions of the 
Produce Safety Rule.  In determining whether the Produce Safety Rule applies to your farm and 
the food you produce on your farm, you should next consider whether your produce is covered 
produce.  Covered produce is produce that is a raw agricultural commodity and within the 
scope of the Produce Safety Rule.  (21 CFR 112.1).  Produce is subject to the Produce Safety 
Rule unless it is not covered or is eligible for an exemption.  
Produce that is not covered under the Produce Safety Rule includes that which is: 
  Rarely consumed raw; 
  Produced for personal or on-farm consumption; or  
  Not a raw agricultural commodity.   
Additionally, some produce is eligible for exemption from the Produce Safety Rule under 21 
CFR 112.2(b) (i.e., commercial processing that adequately reduces the presence of 
11  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
microorganisms of public health significance: the commercial processing exemption).  We 
discuss these concepts in the subsequent subsections, except for Raw Agricultural 
Commodities which was covered in a previous section.  
  Rarely Consumed Raw 
Rarely consumed raw (RCR) produce includes those commodities that FDA determined are 
almost always eaten only after being cooked.  The following is a complete list of the produce 
designated as rarely consumed raw in 21 CFR 112.2(a)(1), and thus not subject to the 
provisions of the Produce Safety Rule:    
  Asparagus;  
  Black, great Northern, kidney, lima, navy, and pinto beans;  
  Garden beet (root and top);  
  Sugar beet;  
  Cashew;  
  Sour cherry;  
  Chickpea;  
  Cocoa bean;  
  Coffee bean;  
  Collard;  
  Sweet corn;  
  Cranberry;  
  Date;  
  Dill (seed and weed);  
  Eggplant;  
  Fig;  
  Ginger;  
  Hazelnut;  
  Horseradish;  
  Lentil;  
  Okra;  
  Peanut;  
  Pecan;  
  Peppermint;  
  Potato;  
  Pumpkin;  
  Winter squash;  
  Sweet potato; and  
  Water chestnut.  (21 CFR 112.2(a)(1)).  
For your produce to be RCR, you do not have to have knowledge or confirmation of the cooking 
process the produce receives, or where, how, or by whom it is performed.   
12  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
   Personal Consumption and On-Farm Consumption 
Produce that is produced by an individual for personal consumption, or produced for 
consumption on the farm on which it was produced or on another farm under the same 
management, is not subject to the Produce Safety Rule.  (21 CFR 112.2(a)(2)).  For example, if a 
covered farm grows covered produce, and separately grows produce for personal consumption in 
an owners personal home garden that is located on the farms property, the produce for personal 
consumption would not be covered by the Produce Safety Rule. 
  Produce Eligible for Exemption by Commercial Processing that Adequately 
Reduces the Presence of Microorganisms of Public Health Significance  
Produce that receives commercial processing that adequately reduces the presence of 
microorganisms of public health significance is eligible for exemption from most provisions of 
the Produce Safety Rule (commercial processing exemption).  To qualify for this exemption, 
your produce must meet all of the conditions in 21 CFR 112.2(b).  (21 CFR 112.2(b)).  We 
discuss each of these conditions in the following subsections: 
  Commercial processing; 
  Disclosure accompanying produce and affiliated records; and 
  Written assurances from your customers and affiliated records. 
Subpart AGeneral Provisions, and subpart QCompliance and Enforcement, of the Produce 
Safety Rule continue to apply to you and your exempt produce even if this commercial 
processing exemption applies.   
  Commercial Processing 
It is important to note that the commercial processing exemption is applicable only to the 
produce that will receive commercial processing that adequately reduces the presence of 
microorganisms of public health significance.  Examples of such commercial processing  
includes: processing in accordance with the requirements of the Low Acid Canned Foods 
Regulation (21 CFR part 113), the Acidified Foods Regulation (21 CFR part 114), and the Juice 
HACCP Regulation (21 CFR part 120); treating with a validated process to eliminate spore-
forming microorganisms (such as processing to produce tomato paste or shelf-stable tomatoes); 
and processing such as refining, distilling, or otherwise manufacturing/processing produce into 
products such as sugar, oil, spirits, wine, beer, or similar products.  Freezing processes and 
washing (such as in a flume or dump tank) are commercial processes that generally do not 
significantly reduce the presence of microorganisms (Ref. 3) (Ref. 8) (Ref. 9) (Ref. 61) (Ref. 90).  
In some cases, only a portion of a farms produce might be eligible for the commercial 
processing exemption.  For example, if you own or operate a covered farm that produces both 
tomatoes that will be processed into tomato paste, and tomatoes that will be sold into the fresh 
market (i.e., tomatoes that will not be processed into tomato paste), only the tomatoes that will be 
processed into tomato paste are eligible for the commercial processing exemption under 21 CFR 
112.2(b).   
13  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Disclosure Accompanying Produce and Affiliated Records 
For your otherwise covered produce to qualify for the commercial processing exemption, you 
must disclose, in documents accompanying the produce, in accordance with the practice of the 
trade, that the food is not processed to adequately reduce the presence of microorganisms of 
public health significance.  (21 CFR 112.2(b)(2)).  Visual examination of the food might not 
readily reveal whether commercial processing has already been applied, so providing the 
disclosure through documentation or labeling helps to inform an entity in the supply chain that 
such a control has not yet been applied.   
The requirements for the disclosure statement specify that the disclosure must be made in 
documents accompanying the produce, in accordance with the practice of the trade.  (21 CFR 
112.2(b)(2); See 21 CFR 112.2(b)(3)(ii)(A) and 112.2(b)(3)(ii)(B)(2)).  This allows for the 
disclosure statement to be provided using a wide variety of documents that accompany the food, 
such as labels, labeling, bills of lading, freight bills, shipment-specific certificates of analysis, 
and other documents or papers associated with the shipment that food safety personnel for the 
customer is likely to read.  For purposes of the requirements of the disclosure statement, you 
could, for example, use labeling that includes a disclosure statement, not processed to 
adequately reduce the presence of microorganisms of public health significance, and then direct 
the recipient to a website for additional information.  However, referencing a website in a 
document of the trade without including the disclosure statement in the document of the trade 
would not satisfy the requirement of 21 CFR 112.2(b)(2).   
You must maintain documentation of disclosures that you provide to your customers in 
accordance with the Produce Safety Rule subpart ORecords.  (21 CFR 112.2(b)(4)).  You could 
keep the necessary documentation in various forms; for example, you could keep a sample 
disclosure and a ledger of entries of shipments including the disclosures, or copies of labels with 
the disclosure for each shipment.  We provide additional draft guidance on general records 
requirements at Chapter 8: Subpart ORecords.  
  Written Assurance from your Customers and Affiliated Records 
In the Federal Register of January 5, 2018 (83 FR 598), we published a notification of 
availability of a guidance document titled Policy Regarding Certain Entities Subject to the 
Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier 
Verification Programs.  In that guidance document, we stated that we intend to exercise 
enforcement discretion regarding the written assurance requirements of 21 CFR part 112 (the 
Produce Safety Rule).  We intend to exercise such discretion until we can complete a rulemaking 
process to consider options for the assurance requirements.  
4.   Covered Farms   
With the exception of entities associated with the written assurances described in part 3.c.iii 
above, only covered farms are subject to the requirements of the Produce Safety Rule.3  
                                                 
3 As noted above, we have stated that we intend to exercise enforcement discretion related to the written assurances 
associated with the commercial processing exemption.   
14  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Covered farms as described in 21 CFR 112.4 are subject to all applicable requirements of the 
Produce Safety Rule.   
Some farms are not covered farms because they are under the $25,000 threshold that we discuss 
later in this section.  Some farms are eligible for a qualified exemption under 21 CFR 112.5 (21 
CFR 112.4(b)), which limits the provisions to which they are subject.  Qualified exemptions are 
explained later in this section. 
Covered farms include farms and farm mixed-type facilities as defined in 21 CFR 112.3.  A 
farm mixed-type facility is an establishment that is a farm, but that also conducts activities 
outside the farm definition that require the establishment to be registered as a food facility under 
section 415 of the FD&C Act.4   
Contract harvesters that only perform harvesting operations for a covered farm but do not sell the 
produce are performing a covered activity on behalf of the covered farm.  Those contract 
harvesters would not be a covered farm; the farm for which they perform the harvesting would 
be responsible for compliance with the requirements of the Produce Safety Rule with respect to 
harvesting.   
  $25,000 Threshold 
The Produce Safety Rule applies only to those farms or farm mixed-type facilities with more 
than $25,000 in average annual value of produce sold during the previous 3-year period.  (See 
21 CFR 112.4(a)).  To calculate whether your farm is above or below the $25,000 threshold: 
  Calculate the average annual monetary value of your gross produce sales; 
  Determine which years sales need to be considered:  
o
  For example, if 2018 is the applicable calendar year (i.e., for the year you 
seek to calculate whether your farm is above or below the $25,000 
threshold), you would need to calculate the average annual value of gross 
sales for produce that you sold in 2017, 2016, and 2015. 
  Include:  
o
  All produce sold, not just covered producesee the section of this chapter 
titled Produce; 
  Produce you purchased or otherwise obtained from another entity and then 
resold to your customers; 
  Produce you sold at farmers markets, to grocery stores, directly to 
consumers, or online;   
                                                 
4 Section 415 of the FD&C Act requires that any facility engaged in manufacturing, processing, packing, or holding 
food for consumption in the United States be registered with the Food and Drug Administration.  The term facility 
includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) 
that manufactures, processes, packs, or holds food.  Such term does not include: farms; restaurants; other retail food 
establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or 
fishing vessels (except such vessels engaged in processing as defined in 21 CFR 123.3(k)). 
15  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Produce sold by a third party on your behalf (such as when a cooperative 
that takes possession of your produce without taking ownership sells your 
produce and returns the proceeds to you after the sale); and 
  Retail sales, wholesale sales, intrastate sales, and interstate sales 
(including produce offered for import to the U.S. or exported from the 
U.S.). 
  Do not include:  
o
  Produce for which you did not receive payment of money or anything else 
of value in exchange for the produce (e.g., produce held without sale or 
produce donated or given away); 
  The value of produce from other entities when a third party sells produce 
on your behalf along with produce from other entities (for example, if a 
cooperative sells your produce along with produce for other farms does 
not take ownership of your produce and returns the proceeds to you after 
the sale, you should count only the proceeds from your produce, not any 
proceeds from the sale of produce for other entities).   
  Adjust the baseline for inflation. 
  Use a baseline year of 2011 (in other words, $25,000 in 2011).  
o
  The U.S. Bureau of Economic Analysis provides the federal calculation 
for inflation adjustments.   
  We provide and intend to update the current adjusted dollar value for the 
baseline on our Website 
(https://www.fda.gov/food/guidanceregulation/fsma/ucm554484.htm) as 
well. 
  Using a baseline year of 2011, $25,000, adjusted for inflation, is $26,608 for 
o
2015, $26,956 for 2016, and $27,433 for 2017, and the average 3-year value is 
$26,999 for 2015-2017 (all figures obtained from the FDA website).  
If your average annual value of produce sold during the previous 3-year period is $25,000 or 
less, adjusted for inflation with a baseline year of 2011, then your farm is not subject to the 
requirements of the Produce Safety Rule; you could find it useful to perform the calculation as 
soon as possible in a given calendar year.  
There may be circumstances where a farm does not have 3 calendar years of records, such as for 
new farms.  It would be reasonable for the farm to rely on a projected estimate of revenue (or 
market value) when it begins operations.  We would evaluate the credibility of the projection 
considering factors such as the farms number of employees.  After the farm has records for one 
or two preceding calendar years, it would be reasonable for the farm to make the calculation 
based on records it has (i.e., for one or two preceding calendar years) and we will accept records 
for the preceding one or two years as adequate in these circumstances.  
Following are examples to illustrate how these calculations should be performed: 
16  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Example 1a. 
  A farm is performing a calculation in 2018 to determine whether it meets the $25,000 
threshold.  The farm would use its sales data for the preceding three years: 2015, 2016, 
and 2017.  In those years, the farms sales consisted of: 
  2015: $100,000 in live cattle; $50,000 in soybeans; $20,000 in tomatoes; $1000 
o
in asparagus; 
  2016: $150,000 in live cattle; $25,000 in soybeans; $40,000 in tomatoes; $1500 
o
in asparagus; 
  2017: $150,000 in live cattle; $60,000 in dent-corn; $10,000 in tomatoes; $1000 
o
in asparagus; 
  The live cattle, soybeans, and dent-corn are not produce5 (see the section of this chapter 
titled Produce for information on this topic), so sales of these commodities are not 
included in the calculations; 
  The farm sells the tomatoes and asparagus to retail customers through its farm stand 
and sells some tomatoes to another farmer, who then sells them to a wholesaler.  While 
asparagus is not covered produce (because it is rarely consumed raw), both asparagus 
and tomatoes are produce, so sales of these commodities are included in the 
calculations.  Retail and wholesale sales count toward the $25,000 threshold, so all of 
the farms tomato and asparagus sales are included in the calculations; 
  Total produce sales for each year to be included in the calculations are: 
  2015: $21,000; 
o
  2016: $41,500; 
o
  2017: $11,000; 
o
  The three-year average of produce sales is the sum of $21,000 + $41,500 + $11,000, 
divided by 3 = $24,500; 
  The 2015-2017 three-year average of $25,000 adjusted for inflation (obtained from the 
FDA website) is $26,999;   
  $24,500 is less than $26,999, so the farm is not subject to the Produce Safety Rule.  
Example 1b. 
  A new farm began operations in 2016 and is performing a calculation in 2018 to 
determine whether it meets the $25,000 threshold.  The farm would use its sales data 
based on the records it has, in this example: 2016 and 2017.  In those years, the farms 
sales consisted of: 
  2016: $13,000 in spinach; $5,000 in kale; 
o
  2017: $20,000 in spinach; $10,000 in kale; $5,000 in basil; 
o
  The farm sells the spinach, kale, and basil to a wholesaler.  Spinach, kale, and basil are 
all produce (see the section of this chapter titled Produce for draft guidance on this 
topic), so sales of these commodities are included in the calculations.  The $20,000 in 
spinach sales in 2017 included $10,000 in resale of spinach that the farm purchased 
                                                 
5 In these examples, the soybeans are grown for biofuels and are therefore considered food grains rather than 
produce. 
17  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
from other farms in the area.  Such sales count toward the $25,000 threshold, so all the 
farms spinach sales are included in the calculations; 
  Total produce sales for each year to be included in the calculations are (the farm was 
not operating in 2015, so this farm has only two years of sales to average): 
  2016: $18,000; 
o
  2017: $35,000; 
o
  The two-year average of produce sales is the sum of $18,000 + $35,000 = $53,000, 
divided by 2 = $26,500; 
  The two-year average of $25,000 adjusted for inflation for 2016 and 2017 is $26,956 + 
$27,433 = $54,389 divided by 2 = $27,195 (2016 and 2017 inflation-adjusted figures 
obtained from the FDA website);   
  $26,500 is less than $27,195, so the farm is not subject to the Produce Safety Rule.   
  Qualified Exemption 
If you exceed the $25,000 threshold, you could still determine that you are eligible for a qualified 
exemption.  Determination of a qualified exemption is based on all food6 sales, not just produce 
sales.  Examples of food include livestock7; meat; dairy products such as milk; hay; grains; and 
wine; and other food (for humans or other animals). 
A farm is eligible for a qualified exemption if it meets the requirements of 21 CFR 112.5:  
1) the average annual monetary value of the food your farm sold directly to qualified end-
users (see criteria section below) must be greater than that sold to all other buyers during the 
same period; and  
2) the average annual monetary value of all food your farm sold during the preceding 3-
year period must be less than $500,000, as adjusted for inflation.  (See 21 CFR 112.5(a)).  
There are examples below that demonstrate how to calculate the criteria for eligibility for a 
qualified exemption.     
If your farm is eligible for a qualified exemption for an applicable calendar year, then modified 
requirements of the Produce Safety Rule apply (21 CFR 112.6, 112.7); therefore, you could find 
it useful to perform the calculation as soon as possible in a given calendar year.  Draft guidance 
on modified requirements is provided in the section of this chapter titled Modified 
Requirements for a Farm with a Qualified Exemption.  You must also analyze your sales every 
year to verify your continued eligibility for the exemption (21 CFR 112.7(b)).  
                                                 
6 Food is defined in 21 CFR 112.3.  The qualified exemption is based on sales of all food rather than on produce 
sales because the exemption is defined in the FSMA statute. 
7 Livestock and meat are both food within the definition of food in 21 CFR 112.3.  (See U.S. v. Tuente Livestock, 
888 F. Supp. 1416 (S.D. Ohio 1995) (FDA may interpret the term food to include live animals raised for food)).  
There are instances when live animals are sold for purposes other than for food, such as being sold as pets (e.g., 
dogs).  Food held without sale (including live animals raised for food on a farm) need not be counted for purposes of 
this calculation unless and until it is sold. 
18  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Criteria for Eligibility for a Qualified Exemption 
To be eligible for a qualified exemption in a given calendar year, you must meet both of the 
criteria below.  (21 CFR 112.5(a)). 
A.  Criterion 1: 3-Year Average Annual Food Sales Direct to Qualified 
End Users is Greater than to All Other Buyers 
During the 3-year period preceding the applicable calendar year, your farms average annual 
monetary value of food (as defined in 21 CFR 112.3) sold directly to qualified end-users (as 
defined in 21 CFR 112.3) must exceed the average annual monetary value of food sold to all 
other buyers during that period in order to be eligible for a qualified exemption.  (21 CFR 
112.5(a)(1)).    
A qualified end-user, with respect to food, is either:  
(1) The consumer of the food (where the term consumer does not include a business);   
  Consumers are qualified end-users, regardless of the consumers location 
relative to the farm.  
or 
(2) A restaurant or retail food establishment (as those terms are defined in 21 CFR 1.227) 
that is located in the same State or the same Indian reservation as the farm that produced 
the food, or not more than 275 miles away from such farm.   
  A restaurant is a facility that prepares and sells food directly to consumers for 
immediate consumption.  (See 21 CFR 1.227).  
  A retail food establishments primary function is to sell food directly to 
consumers.  (See 21 CFR 1.227).  Examples include roadside farm stands, 
meal kit services, grocery stores, convenience stores, and farmers markets 
that fit the definition.   
A sale conducted online or through mail-order can be considered a sale to a qualified end-user if 
the buyer is a consumer, or is a restaurant or retail food establishment that meets the location 
requirements.  For domestic farms, food sales to a restaurant or retail food establishment in a 
neighboring country (e.g., Canada, Mexico, or the Bahamas) that is within 275 miles of the farm 
represent sales to a qualified end-user.  The same would also be true for a farm in Mexico selling 
food to a restaurant or retail food establishment in the United States within 275 miles of the farm.   
Criterion 1 involves comparing the value of food sold directly to qualified end-users to the 
value of food sold via all other types of sales during the specified time period.  For example, 
direct sales to a restaurant or retail food establishment at an auction, where the auction serves as 
a venue for the sale of your produce but does not purchase the produce, can be counted as a sale 
to a qualified end-user if the restaurant or retail food establishment meets the location 
requirements.   
19  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
The following are examples to illustrate how the calculations for criterion 1 should be 
performed: 
Example 1c (note that this example is a modification of Example 1a above, with some of the 
factors changed for illustrative purposes). 
  A farm is performing a calculation in 2018 to determine whether it meets criterion 1.  
The farm would use its sales data for the preceding three years: 2015, 2016, and 2017.  
In those years the farms sales consisted of: 
  2015: $100,000 in live cattle; $50,000 in soybeans; $30,000 in tomatoes; $1000 
o
in asparagus; 
  2016: $150,000 in live cattle; $25,000 in soybeans; $40,000 in tomatoes; $1500 
o
in asparagus; 
  2017: $150,000 in live cattle; $60,000 in dent-corn; $40,000 in tomatoes; $1000 
o
in asparagus;  
  The live cattle, soybeans, dent-corn, tomatoes, and asparagus are all food, as described 
above, so sales of these commodities are included in the calculations; 
  The farm sells the asparagus and some tomatoes to retail customers through its farm 
stand and also sells some tomatoes to another farmer, who then sells them to a 
wholesaler.  Customers of the farm stand include consumers and the owners of three 
restaurants located in towns in the same and an adjoining state that are located between 
two and 15 miles from the farm.  Both consumers and the restaurants to which the farm 
sells meet the definition of qualified end user, as described above.  The farm sells the 
live cattle, soybeans, and dent-corn to a wholesaler; 
  Sales of tomatoes are further divided as follows: 
  2015: $20,000 to qualified end users; $10,000 to wholesaler; 
o
  2016: $20,000 to qualified end users; $20,000 to wholesaler; 
o
  2017: $20,000 to qualified end users; $20,000 to wholesaler; 
o
  To facilitate the calculation for criterion 1, the sales data can be displayed as follows: 
  2015: $21,000 to qualified end users ($20,000 tomatoes + $1000 asparagus); 
o
$160,000 to other buyers ($10,000 tomatoes + $100,000 live cattle + $50,000 
soybeans); 
  2016: $21,500 to qualified end users ($20,000 tomatoes + $1500 asparagus); 
o
$195,000 to other buyers ($20,000 tomatoes + $150,000 cattle + $25,000 
soybeans); 
  2017: $21,000 to qualified end users ($20,000 tomatoes + $1000 asparagus); 
o
$230,000 to other buyers ($20,000 tomatoes + $150,000 live cattle + $60,000 
dent-corn); 
  The three-year average of food sold to qualified end users is the sum of $21,000 + 
$21,500 + $21,000, divided by 3 = $21,167; 
  The three-year average of food sold to other buyers is the sum of $160,000 + $195,000 
+ $230,000, divided by 3 = $195,000;   
  $21,167 does not exceed $195,000, so the farm does not qualify for a qualified 
exemption.  
20  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Example 1d (note that this example is a modification of Example 1b above, with some of the 
factors changed for illustrative purposes). 
  A new farm is performing a calculation in 2018 to determine whether it meets criterion 
1.  The farm would use its sales data based on the records it has, in this example: 2016, 
and 2017.  In those years, the farms sales consisted of: 
  2016: $40,000 in spinach; $15,000 in kale; 
o
  2017: $75,000 in spinach; $12,000 in kale; $10,000 in basil; 
o
  The farm sells the spinach, kale, and basil at its farm stand and through two regional 
produce auctions.  Spinach, kale, and basil are all food as discussed above, so sales of 
these commodities are included in the calculations.  All the customers of the farm stand 
are consumers and are, therefore, qualified end users.  Sales through the auctions are 
direct to the customer; that is, the auctions do not take ownership of the food and then 
resell to the buyer.  Some of the buyers at the auctions are restaurants or retail grocers 
and some are wholesalers.  Most of the restaurants and retail grocers meet the criteria 
for qualified end user (i.e., located within the same state or not more than 275 miles 
from the farm), but some do not;   
  Sales of food are further divided as follows: 
  2016: $25,000 at farm stand (to consumers); $20,000 at auctions to qualified 
o
end users; $10,000 at auctions to other buyers; 
  2017: $30,000 at farm stand (to consumers); $30,000 at auctions to qualified 
o
end users; $37,000 at auctions to other buyers; 
  To facilitate the calculation for criteria 1, the sales data can be displayed as follows: 
  2016: $45,000 to qualified end users; $10,000 to other buyers; 
o
  2017: $60,000 to qualified end users; $37,000 to other buyers; 
o
  The average of food sold to qualified end users is the sum of $45,000 + $60,000, 
divided by 2 = $52,500; 
  The average of food sold to other buyers is the sum of $10,000 + $52,500, divided by 2 
= $23,500; 
  $35,000 exceeds $23,500, so the farm meets criterion 1 for a qualified exemption.  The 
farm would then need to determine whether it meets criterion 2. 
B.  Criterion 2: Less than $500,000 in 3-Year Average Annual Food 
Sales  
In order to be eligible for a qualified exemption, your farm also must satisfy the requirement in 
21 CFR 112.5(a)(2).  Under that subsection, your farms average annual monetary value of all 
food (as defined in 21 CFR 112.3) sold during the 3-year period preceding the applicable 
calendar year must be less than $500,000, adjusted for inflation.  (21 CFR 112.5(a)(2)).  The 
applicable calendar year for calculating the adjustment for inflation is 2011.  (21 CFR 112.5(b)).   
Criterion 2 is based on the value of all food sold.  To determine whether your farms average 
annual value of food sold is below (i.e., less than) the $500,000 threshold:  
21  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Calculate the average annual monetary value of your gross food sales during the three
year period preceding the applicable calendar year (i.e., for the year you seek to calculate 
whether your farm is eligible for the qualified exemption): 
  Determine which years sales need to be considered:  
o
  For example, if 2018 is the applicable calendar year, calculate the average 
amount of gross sales for all food that you sold in 2015, 2016, and 2017. 
  Include:  
o
  All food sales, not just produce;  
  Food that you purchased or otherwise obtained from another entity and 
then resold to your customers; 
  Food that you sold at farmers markets, to grocery stores, directly to 
consumers, or online; 
  Food sold by a third party on your behalf; and 
  Retail sales, wholesale sales, interstate sales (including produce offered 
for import to the U.S. or exported from the U.S.), and intrastate sales. 
  Do not include:  
o
  Food held without sale (including live animals raised for food on your 
farm); or 
  Food for which there is no payment of money or anything else of value 
received in exchange for the food (i.e., produce donated or given away).   
  Adjust the baseline for inflation: 
  Use a baseline year of 2011 (in other words, $500,000 in 2011).  
o
  The U.S. Bureau of Economic Analysis provides the federal calculation 
for inflation adjustments.   
  We provide and intend to update the current adjusted dollar value on our 
website 
(https://www.fda.gov/food/guidanceregulation/fsma/ucm554484.htm) as 
well. 
  Using a baseline year of 2011, $500,000, adjusted for inflation is $532,170 for 
o
2015, $539,121 for 2016, and $548,654 for 2017 and the average 3-year value 
adjusted for inflation for 2015-2017 is $539,982.   
If the average annual value during the previous 3-year period is equal to or less than $500,000, 
adjusted for inflation, with a baseline year of 2011, criterion 2 is satisfied.  You could find it 
useful to perform the calculation as early as possible in a given calendar year.   
The following are continuations of the above examples, to illustrate how the calculations for 
criterion 2 should be performed: 
Example 1c, continued (note it is included for illustrative purposes only; since this farm already 
determined that they do not meet criterion 1 for a qualified exemption, there would be no 
practical need for performing a calculation for criterion 2). 
  A farm is performing a calculation in 2018 to determine whether it meets criterion 2.  
The farm would use its sales data for the preceding three years: 2015, 2016, and 2017.  
In those years, the farms sales consisted of: 
22  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  2015: $100,000 in live cattle; $50,000 in soybeans; $30,000 in tomatoes; $1000 
o
in asparagus; 
  2016: $150,000 in live cattle; $25,000 in soybeans; $40,000 in tomatoes; $1500 
o
in asparagus; 
  2017: $150,000 in live cattle; $60,000 in dent-corn; $40,000 in tomatoes; $1000 
o
in asparagus; 
  The live cattle, soybeans, dent-corn, tomatoes, and asparagus are all food, as described 
above, so sales of these commodities are included in the calculations.  Annual sales of 
food total: 
  2015: $181,000; 
o
  2016: $216,500; 
o
  2017: $251,000; 
o
  The three-year average of food sold is the sum of $181,000 + $216,500 + $251,000, 
divided by 3 = $216,167; 
  The average three-year value adjusted for inflation (obtained from the FDA website) is 
$539,982;   
  $216,167 is less than $539,982, so the farm meets criterion 2 for a qualified exemption.   
Example 1d, continued. 
  A farm is performing a calculation in 2018 to determine whether it meets criterion 2.  
The farm would use its sales data based on the records it has, in this example:2016, and 
2017.  In those years, the farms sales consisted of: 
  2016: $40,000 in spinach; $15,000 in kale; 
o
  2017: $75,000 in spinach; $12,000 in kale; $10,000 in basil; 
o
  Spinach, kale, and basil are all food as discussed above, so sales of these commodities 
are included in the calculations.  Annual sales of food total: 
  2016: $55,000; 
o
  2017: $97,000;   
o
  The average of food sold is the sum of $55,000 + $97,000, divided by 2 = $76,000; 
  The baseline value adjusted for inflation for 2016 is $539,121 and for 2017 is $548,654 
(obtained from the FDA website) and the two-year average is $543,888;   
  $76,000 is less than $543,888, so the farm meets criterion 2 for a qualified exemption.  
Since this farm also met criterion 1 for a qualified exemption as illustrated above, the 
farm would qualify for a qualified exemption. 
  Records  
If you are eligible for a qualified exemption under 21 CFR 112.5, you must establish and keep 
adequate records necessary to demonstrate that you satisfy the criteria for a qualified exemption, 
including a written record reflecting that you have performed an annual review and verification 
that you continue to meet those criteria.  (21 CFR 112.7(b)).   
Receipts or ledgers of sales to your customers that show the value of the sale of food items and 
the location of the customer (for any customers that are restaurants or retail food establishments) 
are examples of records that could be used to document your eligibility for a qualified 
23  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
exemption.  In certain situations, such as a farmers market, if all sales are to consumers, keeping 
track of daily sales rather than individual sales could be sufficient.  If you already keep records 
for another purpose, you may use those records to document your eligibility for a qualified 
exemption if they also meet all applicable requirements of the Produce Safety Rule.  Records you 
establish and keep to demonstrate your farm is eligible for a qualified exemption must meet the 
requirements of 21 CFR 112.7.  
To document your annual review and verification of eligibility, you should make and keep a 
report for each calendar year that includes the following information:  
(1) Your total annual value of sales of food for each of the preceding three calendar years 
(e.g., $181,00, $216,500, $251,000 for Example 1c; and $0, $55,000, $97,000 for 
Example 1d); 
(2) The average of the three values from item (1) (e.g., $216,167 for Example 1c; and 
$50,677 for Example 1d);  
(3) The inflation-adjusted value of $500,000, where the baseline year is 2011, using the 
applicable calendar year adjustment value (e.g., $539,982 for Example 1c and 1d).  
This value should be higher than the value in item (2) for you to be eligible for the 
qualified exemption;  
(4) Your total annual value of sales of food to qualified end-users for each of the 
preceding three calendar years (e.g., $21,000, $21,500, $21,000 for Example 1c; and 
$0, $45,000, $60,000 for Example 1d);  
(5) The average of the three values from item (4) (e.g., $21,167 for Example 1c; and 
$35,000 for Example 1d);  
(6) Your total annual value of sales of food for each of the preceding three years to 
entities other than qualified end users (e.g., $160,000, $195,000, $230,000 for 
Example 1c; and $0, $10,000, $37,000 for Example 1d);  
(7) The average of the three values from item (6) (e.g., $195,000 for Example 1c; and 
$15,667 for Example 1d).  This value should be lower than the value in item (5) for 
you to be eligible for the qualified exemption); and  
(8) A statement that, based on this information, you have concluded that you meet or 
continue to meet the criteria for a qualified exemption. 
  Modified Requirements for a Farm with a Qualified Exemption 
If your farm is eligible for a qualified exemption, you are subject to the following modified 
requirements: 
(1) When a food packaging label is required on food that would otherwise be covered 
produce under the Federal Food, Drug, and Cosmetic Act or its implementing 
regulations, you must include prominently and conspicuously on the food packaging 
label the name and the complete business address of the farm where the produce was 
grown (21 CFR 112.6(b)(1)); and 
(2) When a food packaging label is not required on food that would otherwise be covered 
produce under the Federal Food, Drug, and Cosmetic Act, you must prominently and 
conspicuously display, at the point of purchase, the name and complete business 
address of the farm where the produce was grown on a label, poster, sign, placard, or 
24  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
documents delivered contemporaneously with the produce in the normal course of 
business, or, in the case of Internet sales, in an electronic notice (21 CFR 
112.6(b)(2)). 
The complete business address must include the street address or post office box, city, state, and 
zip code for domestic farms, and comparable full address information for foreign farms.  (21 
CFR 112.6(b)(3)). 
You are also subject to the requirements of the following Produce Safety Rule subparts:  
  Subpart A (General Requirements);  
  Subpart O (Records); 
  Subpart Q (Compliance and Enforcement); and 
  Subpart R (Withdrawal of Qualified Exemption). 
5.  Covered Activities 
Covered farms subject to the Produce Safety Rule must comply with all applicable requirements 
of the Produce Safety Rule when conducting a covered activity on covered produce.  (21 CFR 
112.4(a)).  Covered activity is defined at 21 CFR 112.3 and means growing, harvesting, 
packing, or holding covered produce, as well as certain other types of activities identified in the 
definition.  This means, for example, that if a covered farm grows, harvests, packs, or holds 
covered produce, it is required to comply with all applicable provisions of the Produce Safety 
Rule in the process of doing those things.   
For example, for a farm that composts biological soil amendments of animal origin to use in 
growing covered produce, the relevant provisions of the rule related to composting biological 
soil amendments of animal origin apply.  As another example, if a farm packs covered produce 
on a table, the relevant provisions of the Produce Safety Rule related to cleaning and sanitizing 
of the table apply. 
 
25  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Chapter 2: 
Personnel Qualifications and Training (Subpart C) 
Personnel can introduce contamination while handling covered produce or food contact surfaces.  
Some produce-related outbreaks and contamination events identified personnel health and 
hygiene practices on the farm (Ref. 70) (Ref. 138) and produce handling and storage practices as 
likely contributing factors to these events (Ref. 32) (Ref. 72).  Furthermore, a study of food-
related outbreaks found more than 800 instances where personnel practices were reported to be 
instrumental in or contributory to the outbreak (Ref. 65).     
All personnel should be qualified to perform their assigned duties, understand how their actions 
impact food safety, and understand the regulatory requirements that apply to their assigned duties 
(See 21 CFR 112.21(b) for specific requirements that apply to some personnel).  Training helps 
provide farm personnel, including supervisors and responsible parties, a knowledge base that 
promotes safe food handling practices, and should ultimately reduce the likelihood of foodborne 
illness attributable to food handling practices.    
This chapter will help you: 
  Evaluate personnels assigned duties and identify personnel subject to the 
qualifications and training requirements; 
  Evaluate whether personnel have the necessary qualifications to perform their 
assigned duties; 
  Provide training at frequencies necessary to comply with Produce Safety Rule 
requirements; 
  Determine how to provide easily understandable training; 
  Understand minimum training content for required training; 
  Understand additional training for persons who conduct harvest activities; 
  Understand training requirements for supervisors and responsible parties;  
  Understand requirements for supervision to ensure compliance; and 
  Determine required records for training. 
Where applicable, we recommend periodically evaluating your relevant personnel, procedures, 
processes, and practices to ensure that you consider the scope of your relevant activities or 
operations, your personnel and their assigned duties, and any changes that occurred and how they 
are affected by and relate to the requirements of the Produce Safety Rule.  During such 
evaluations, you should consider not only typical practices, but also those that occur infrequently 
or due to unusual circumstances, to account for the breadth of personnel, procedures, processes, 
and practices associated with a given activity.   
1.  Evaluating Personnels Assigned Duties  
All personnel who handle covered produce or food contact surfaces, or those who are engaged in 
the supervision thereof, are subject to specific requirements regarding qualifications and training.  
(See 21 CFR 112.21).  There are specific additional requirements for persons who conduct 
26  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
harvest activities for covered produce.  (21 CFR 112.22).  This includes full-time, permanent, 
temporary, part-time, seasonal, contracted, and all other relevant personnel.     
To identify your personnel subject to the qualifications and training requirements in subpart C, 
you should review the assigned duties and observe the performance of the duties of all your 
personnel, including supervisors.  All personnel who handle covered produce or food contact 
surfaces, or who are engaged in the supervision thereof, must: 
  receive adequate training (21 CFR 112.21(a)); and 
  have a combination of education, training, and experience necessary to perform their 
assigned duties in a manner that ensures compliance with the Produce Safety Rule.  (21 
CFR 112.21(b)).   
It is important that you consider the breadth of covered activities on your farm, and how they are 
performed, to determine whether personnel performing each activity contact covered produce or 
food contact surfaces.  Examples of activities where personnel handle covered produce or food 
contact surfaces include: harvesting covered produce by hand; sorting, grading, and packing 
covered produce; handling food contact surfaces of containers used to distribute covered 
produce; and cleaning and maintaining harvesting and packing equipment that directly contacts 
covered produce.  In some circumstances, activities such as receiving or shipping could also 
involve contact with covered produce or food contact surfaces, depending on your procedures for 
such activities.  Other personnel could be assigned to duties that do not involve contact with 
covered produce or food contact surfaces (e.g., removing trash, sweeping floors, maintaining 
restrooms, maintaining or repairing non-food contact surfaces of equipment, pest control, or 
operating forklifts and tractors).  However, if such personnel are expected to handle covered 
produce or food contact surfaces, even infrequently, or are engaged in the supervision thereof, 
they must receive adequate training and have a combination of education, training, and 
experience necessary to perform their assigned duties in a manner that ensures compliance with 
the Produce Safety Rule because they are handling covered produce or food contact surfaces.  
(See 21 CFR 112.21(a) and 21 CFR 112.21(b)).   
2.  Qualifications Necessary to Perform Assigned Duties 
All personnel who handle covered produce or food contact surfaces, or who are engaged in the 
supervision thereof, must have a combination of education, training, and experience necessary to 
perform the persons assigned duties in a manner that ensures compliance with the Produce 
Safety Rule.  (21 CFR 112.21(b)).  You should evaluate the assigned duties of your personnel, 
identify those who handle covered produce or food contact surfaces and their current level of 
training, education, and experience, to determine whether they are qualified to perform their 
assigned duties in a manner that ensures compliance with the Produce Safety Rule.  When 
assigning duties, you must ensure that the assigned personnel have the appropriate combination 
of education, training, and experience to perform their duties, or that they receive any additional 
education or training necessary to perform their duties.  (See 21 CFR 112.22(b)).  Depending on 
the job duties, this could include training in combination with education, or experience.  
An appropriate combination of education, training, and experience prepares these personnel to 
conduct the assigned duties in a manner that aligns with the requirements of the Produce Safety 
27  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Rule (such as the requirements described in subpart DHealth and Hygiene; subpart KGrowing, 
Harvesting, Packing, and Holding Activities; and subpart LEquipment, Tools, Buildings, and 
Sanitation).  These personnel should be able to apply their knowledge to perform their assigned 
duties.  For example, if you assign personnel to pack covered produce by hand, they should have, 
and be able to apply, knowledge including that related to: health conditions that could result in 
contamination of covered produce (e.g., their duty to report to a supervisor if they become ill 
with, for example, diarrhea); the appropriate level of personal cleanliness for their assigned 
duties; avoiding contact with animals other than working animals; proper hand-washing 
procedures; using food-packing materials that are adequate for their intended use; proper 
handling of harvested covered produce; and maintenance of food contact surfaces.     
The extent of education, training, and experience necessary is likely to vary among your 
personnel based on the level of responsibility and range of duties that you assign.  Your 
personnel could already possess valuable education and experience specific to particular 
assigned duties, which you could consider when evaluating their assigned duties and 
qualifications.  However, some personnel could need additional training or education to ensure 
they understand your food safety procedures based on the requirements of the Produce Safety 
Rule.  For example, you could assign one of your workers, who has worked on farms for a 
decade and has a good understanding of horticultural practices for your crops, to several 
activities that can impact food safety, including harvesting, cleaning packing equipment, and 
handling raw manure and treated biological soil amendments of animal origin (BSAAOs).  If the 
scope of the workers previous assigned duties and farming experience did not provide the 
worker with the level of food safety knowledge necessary to perform these new activities in a 
manner that prevents contamination of covered produce, you could determine that the worker 
needs additional food safety training, such as targeted training about cleaning and sanitizing 
practices, and provide or otherwise arrange for that training.   
You should evaluate your personnels current levels of training, education, and experience to 
determine which personnel you will assign to supervise personnel who handle covered produce 
or food contact surfaces.  Such supervisors should have sufficient knowledge of food safety and 
hygienic practices to ensure awareness of the requirements of the Produce Safety Rule among 
personnel and to effectively determine whether other personnel are conducting activities in a 
manner that complies with the Produce Safety Rule.  As an example, one way a farm could 
implement 21 CFR 112.31 (which requires you to take measures to prevent contamination of 
covered produce and food contact surfaces with microorganisms of public health significance 
from any person with an applicable health condition) is by assigning a specific individual to  
determine daily whether arriving harvest personnel exhibit symptoms of an applicable health 
condition, and to receive information from personnel about any symptoms or diagnoses of such 
conditions.  In such a circumstance, the assigned individual should have: 1) knowledge of the 
symptoms of concern (e.g., vomiting, diarrhea); 2) knowledge of your procedure for excluding or 
reassigning workers with applicable health conditions; and 3) the ability to implement your 
procedures based on the requirements of the Produce Safety Rule in that area.  You should also 
ensure those who supervise the handling of covered produce and food contact surfaces can 
recognize whether personnel, individually or collectively, need additional or more frequent 
training as necessary and appropriate in light of observations or information indicating that 
28  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
personnel are not meeting standards established by FDA in subparts C through O of the Produce 
Safety Rule.    
The extent of education, training, and experience needed for personnel who handle covered 
produce or food contact surfaces, and those engaged in the supervision thereof, could also 
depend on the specific characteristics or organization of your farm.  For example, a farm could 
have a single worker responsible for completing several diverse activities (such as harvesting 
produce, evaluating treatment of BSAAOs, and working in the packing area) that involve a 
broader range of training topics for that worker.  Conversely, a farm could have several 
personnel working together to accomplish the same task, such as harvesting covered produce, 
that involves focused training specific to that activity.  Understanding the extent of your 
personnels duties will help you identify and deliver appropriate training so that the personnel 
who handle covered produce or food contact surfaces, and those engaged in the supervision 
thereof, have the combination of education, training, and experience necessary to perform 
assigned duties in compliance with the Produce Safety Rule.   
3.  Training Frequency 
The personnel you identify as those who handle covered produce or food contact surfaces, and 
those who are engaged in the supervision thereof, must receive adequate training: 
  Upon hiring (21 CFR 112.21(a)); 
  Periodically thereafter, at least once annually (21 CFR 112.21(a)); and 
  As necessary and appropriate in light of observations or information indicating that 
personnel are not meeting standards established by FDA in the Produce Safety Rule 
subparts C through O (21 CFR 112.21(d)).     
By providing training upon hiring, you introduce personnel to your procedures and the 
requirements of the Produce Safety Rule applicable to their assigned duties before they handle 
covered produce or food contact surfaces.  Although you may hire personnel at different times 
throughout the year to perform various activities, training must occur before personnel begin 
duties that involve handling covered produce or food contact surfaces, regardless of when they 
are hired (See 21 CFR 112.21(a)).  For example, if you hire workers in December whose 
assigned duties consist of performing clerical work throughout the year, and harvesting covered 
produce from May to October, then as long as these workers duties do not entail handling 
covered produce or food contact surfaces until May, you could choose to delay their initial 
training until, for example, late April. 
You must also provide periodic refresher training at least once annually for personnel who 
handle covered produce or food contact surfaces, and those who are engaged in the supervision 
thereof.  (See 21 CFR 112.21(a)).  Such training helps reinforce your personnels continued 
awareness of their responsibility to follow food safety and hygiene principles, and the 
requirements of the Produce Safety Rule.  You have the flexibility to determine the appropriate 
timing and frequency for periodic refresher training, as long as it occurs at least once per year.  
Some issues that could influence your decision on timing and frequency include the type, 
number, and timing of crops, and the timing of hiring and initial training for individual workers.  
For example, if you use different personnel to grow and harvest covered produce, or if you have 
29  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
year-round production, and want to deliver training to smaller groups rather than all personnel at 
once, then staggered, periodic refresher training could more effectively ensure that all personnel 
receive the required training.  For another example, you could decide to conduct periodic 
refresher training more frequently than once a year (e.g., bi-annual or quarterly training 
sessions), before personnel begin certain covered activities, such as before the beginning of the 
growing season and again before the beginning of covered produce harvesting, particularly if 
your training focuses on specific topics or activities.   
You should provide personnel with the most up-to-date information, to the extent practical, from 
credible sources.  Academia, extension services, industry associations, and government agencies 
can be useful sources of information.  You should keep your procedures and training materials 
updated and consider conducting periodic refresher training when new or additional information 
becomes available, such as new information about practices that could contribute to foodborne 
illness, or new recommendations about minimizing contamination.  For example, a multi-state 
outbreak of Listeria monocytogenes associated with cantaloupe led to 143 hospitalizations and 
33 deaths in 2011 (Ref. 23).  As a result, both FDA and produce industry trade associations 
updated existing documents to provide information on how to minimize microbial contamination 
of cantaloupe.   
If you change your procedures (for example, as a result of new information about how to best 
prevent contamination of covered produce you grow), you should update your training materials 
to reflect your new procedures, and conduct refresher training for affected personnel.  
Furthermore, you must repeat training, as necessary and appropriate in light of observations or 
information indicating that personnel are not meeting standards established by FDA in subparts 
C through O of the Produce Safety Rule.  (21 CFR 112.21(d)).  Observations and information 
could be provided by, for example, supervisors, responsible parties, or other personnel.  When 
providing repeat training, you should determine whether certain training content needs to be 
adapted in order to emphasize the conditions and practices necessary based on the requirements 
of the Produce Safety Rule.  For example, if your harvest crew supervisor reports that harvest 
personnel are not consistently washing their hands after returning from breaks, you should 
evaluate the available observations and information related to the harvest personnels practices. 
You could determine that training is necessary for those personnel that are not meeting the 
requirements of subpart D of the Produce Safety Rule; you would then provide refresher training 
to those personnel.  This training should include information about the public health significance 
of proper hand-washing, your hand-washing procedures, and the requirements of the Produce 
Safety Rule regarding hand-washing.  The training could be coupled with a demonstration of 
hand-washing technique.   
4.  Easily Understandable Training 
Training must be conducted in a manner that is easily understood by personnel being trained.  
(21 CFR 112.21(c)).  You should provide training in the language that your personnel 
customarily speak.  Training should also be tailored to the educational level of your personnel, 
using terminology that is commonly used and avoiding terminology that is unnecessarily 
complex or easily misinterpreted.  Training materials can include easily understood pictorials or 
graphics of important concepts.  You should deliver information in a manner that your personnel 
30  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
can relate to their assigned duties and provide examples that are relevant to your farm.  You may 
need to repeat key learning points in successive sessions, such as for complex topics, practices, 
or procedures. 
Training sessions should be designed to effectively deliver the content.  Training can include 
formal, scheduled events or less structured spontaneous sessions (e.g., in response to a real-time 
observation of poor practices by a supervisor).  Training sessions can include several topics or 
can focus on information related to a specific topic or task.  In some cases, longer training 
sessions could be effective to provide more depth of information or provide personnel with time 
to focus on complex concepts.  Training conducted upon hiring or when introducing concepts to 
personnel that have limited knowledge or experience with food safety topics could be longer than 
other training sessions.  Furthermore, dedicated training sessions can also emphasize your 
commitment to implementing food safety procedures based on the requirements of the Produce 
Safety Rule.   
In some cases, training is most effective when it is provided in short sessions, focusing on a 
specific topic that targets a specific food safety concern among small groups of personnel with 
the same or similar duties (Ref. 101).  When practical, these targeted training sessions should be 
conducted at or near the applicable work area.  For example, you could train personnel that 
perform cleaning and sanitizing on treatment preparation near the area where these solutions are 
made.  In another example, you could train personnel that perform packing activities about 
proper handling and cleanliness of food-packing materials, such as fiberboard boxes and plastic 
totes near their workstation.   
Hands-on practice or demonstrations can show your personnel how to perform a specific job 
task, and provide opportunities for them to practice performing the task under supervision (Ref. 
14) (Ref. 57).  This allows your trainers to observe, discuss, and correct any poor practices 
exhibited during training sessions.  For example, to train your harvest personnel to recognize 
covered produce that must not be harvested, as required by 21 CFR 112.22(b)(1), you might 
provide demonstrations in which you show the personnel examples of covered produce they 
should not harvest (e.g., covered produce contaminated with animal excreta) to prepare them to 
look for and recognize certain conditions.  As another example, you could train personnel 
performing packing activities on inspection of food-packing materials (e.g., fiberboard boxes or 
plastic totes) by showing and discussing the condition of food packing containers and whether 
they could be contaminated with a known or reasonably foreseeable hazard.   
You should consider posting signs or visual aids promoting practices presented in training as an 
additional reminder for personnel and to reinforce training concepts.  You should include, as 
appropriate, multilingual versions, or pictorials or graphics.  If you choose to post signs, you 
should do so in areas as close as practical to where personnel perform the relevant activities. 
5.  Minimum Training Requirements 
At a minimum, all personnel who handle covered produce or food contact surfaces during 
covered activities or supervise the conduct of such activities must receive training described in 
21 CFR 112.22.  (21 CFR 112.22).  As stated above, 21 CFR 112.21(a) establishes a training 
requirement for certain personnel (that is, all personnel who handle (contact) covered produce 
31  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
or food contact surfaces, or who are engaged in the supervision thereof).  The Produce Safety 
Rule provides the minimum content that must be included in that required training at 21 CFR 
112.22.  While the section regarding training content (21 CFR 112.22) does not explicitly state 
that it applies to personnel who contact food contact surfaces, FDA interprets that section to 
apply to such individuals, and those engaged in the supervision thereof, as provided in the 
section establishing the training requirement (21 CFR 112.21(a)).  You should focus this training 
on the principles that will help personnel understand how to perform their duties in a way that 
aligns with the requirements of the Produce Safety Rule and how their actions can affect the 
safety of covered produce and food contact surfaces.  While not required by the Produce Safety 
Rule, you should train other personnel in the same or similar fashion, as appropriate in light of 
their duties.  An evaluation of assigned duties for all of your personnel who engage in covered 
activities (even if they do not handle covered produce or food contact surfaces), and their current 
level of training, education, and experience should help you identify additional personnel for 
whom it would be prudent to provide training and determine appropriate training for each 
individual or group.   
The topic areas addressed in 21 CFR 112.22(a)(1) and (2)food hygiene, food safety, and health 
and personal hygiene, and in 21 CFR 112.22(a)(3)the standards in subparts C through O of the 
Produce Safety Rule, represent the minimum topic areas you must cover during training for your 
personnel who handle covered produce and food contact surfaces during covered activities, and 
those who are engaged in the supervision thereof.   
It is important to provide personnel with an understanding of the potential routes of 
contamination of covered produce and food contact surfaces so that they can recognize how their 
own practices have the potential to result in contamination.  Your training program should also 
include your food safety procedures.  Your training programs can be designed to supplement 
your personnels prior education, training, and experience.  The Produce Safety Rule does not 
specify who can provide training.  You could choose to have qualified farm personnel or a third 
party conduct your training activities.  
  Food Hygiene and Food Safety 
Your training must explain the principles of food hygiene and food safety.  (21 CFR 
112.22(a)(1)).  This provides an overall framework for job performance that helps ensure 
compliance with the requirements of the Produce Safety Rule. 
To meet the minimum requirements of food hygiene and food safety training, your training 
topics should include: 
  Relevant sources of foodborne pathogens (e.g., humans and their waste; animals and their 
waste); 
  Routes of contamination (e.g., animals or pests that contaminate covered produce with 
their excreta; inadequately composted biological soil amendments of animal origin 
(BSAAOs) handled in a way that results in contact with covered produce during 
application; a worker with an applicable health condition who handles covered produce; 
environmental transfer (e.g., contaminated soil or water contacting covered produce); and 
32  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
potential for cross-contamination (e.g., unclean surfaces contacting clean surfaces and 
transferring contamination)); 
  Preventive measures (i.e., taking measures to minimize the potential for contamination at 
those points where potential routes of contamination exist); and 
  Corrective measures (e.g., identifying covered produce that has been exposed to the 
potential for contamination and taking steps reasonably necessary to prevent the 
introduction of known or reasonably foreseeable hazards and ensure that it is not 
distributed for consumption, if necessary). 
The content of your training should connect these principles to your personnels specific job 
duties.  If, for example, you are conducting training for personnel whose assigned duties include 
removing trash from the packing area and infrequent handling of covered produce and food 
contact surfaces, the training should explain that waste containers could be contaminated (e.g., 
by pests, animal fecal material tracked onto the floor of the packing area, or in the area of the 
dumpster) and the potential for cross-contamination when they transition from handling trash and 
waste containers to handling covered produce and food contact surfaces (e.g., helping other 
personnel move covered produce, and containers holding covered produce, on packing tables). 
The training should also explain how to recognize practices (e.g., using packing tables as a break 
space over lunch) that could result in cross-contamination of covered produce.  
  Health and Personal Hygiene 
Your training must explain the importance of health and personal hygiene for personnel and 
visitors; this training must include information on recognizing the symptoms of a health condition 
(e.g., vomiting, diarrhea, open lesions) that is reasonably likely to result in the contamination of 
covered produce or food contact surfaces.  (21 CFR 112.22(a)(2)).  Further, your training should 
ensure that personnel understand that they have a responsibility to take action to prevent 
contamination due to their own health (i.e., communicable illness) and hygienic practices.  For 
those who handle covered produce or food contact surfaces, or who are engaged in the 
supervision thereof, your training must also include the requirements of the Produce Safety Rule 
related to health and personal hygiene that are applicable to their job responsibilities.  (21 CFR 
112.22(a)(3); see the section of this chapter titled Standards in Subparts C through O.  Training 
topics for the applicable personnel regarding health and personal hygiene must include:  
  Recognizing and reporting, as necessary, applicable health conditions as outlined in 21 
CFR 112.31; and 
  Hygienic practices to minimize the potential of contamination to covered produce and 
food contact surfaces, including those outlined in 21 CFR 112.32(b). 
Draft guidance on personnel and visitor health and hygiene is provided in Chapter 3: Health and 
Hygiene (Subpart D).  
You should train all personnel who handle covered produce or food contact surfaces to recognize 
and respond when they encounter situations that present the potential for contamination of 
covered produce or food contact surfaces.  For example, if your workers assigned duties include 
handling raw manure as well as harvesting covered produce by hand, you should train them to 
know how their activities could result in cross-contamination between the raw manure and the 
33  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
covered produce.  Further, the training should include your procedures regarding personal 
hygienic practices.  Your training should include instructions to report to a supervisor or 
responsible individual any situations that the worker observes or becomes aware of that could 
result in contamination of covered produce or food contact surfaces. 
  Standards in Subparts C through O  
Training must cover the standards established by FDA in subparts C through O of the Produce 
Safety Rule that are applicable to the employees job responsibilities.  (21 CFR 112.22(a)(3)).  
You should develop or use training programs that ensure that your personnel understand the 
regulatory requirements that are applicable to their job responsibilities.  The standards in 
subparts C through O often involve action by your personnel that requires a specific 
understanding of certain practices and their impact on food safety, without which personnel may 
not meet the standards.  Demonstrations are one method to show personnel examples of 
appropriate or inappropriate practices.   
The following are a few examples that connect job responsibilities with job-specific training 
topics.  These examples are intended to illustrate concepts for certain types of job responsibilities 
and are not intended to be universally applicable.  Even if you have personnel with similar job 
responsibilities to those mentioned here, you should perform your own evaluation based on your 
farms specific practices and conditions. 
Example 2a.  For personnel who sort covered produce by hand after harvest, training: 
  must include the requirements of the Produce Safety Rule that are applicable to 
o
their dutiesincluding those in subpart DHealth and Hygiene, and subpart K
Growing, Harvesting, Packing, and Holding Activitiesthat relate to sorting 
covered produce (See 21 CFR 112.22(a)(3)). 
  should include your farms procedures related to sorting covered produce
o
including what to do with covered produce that is reasonably likely to be 
contaminated.  
  should include how the personnels actions while sorting covered produce can 
o
lead to contamination of food contact surfaces and covered produce (e.g., 
situations where cross-contamination could occur).  
 
Example 2b.  For personnel who clean and sanitize packing equipment with food contact 
surfaces, training: 
  must include the requirements of subpart LEquipment, Tools, Buildings, and 
o
Sanitationthat relate to equipment cleaning and sanitizing (See 21 CFR 
112.22(a)(3)). 
  should include your procedures related to equipment cleaning, including how to 
o
prepare the cleaning and sanitizing solutions. 
  should include how the personnels actions while cleaning the equipment (e.g., 
o
dragging a hose from the floor across a clean food contact surface) can lead to 
contamination of food contact surfaces.   
 
34  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Example 2c.  For personnel who harvest covered produce by hand, and manage 
biological soil amendments of animal origin (BSAAOs), including a treatment process 
and keeping records of process controls, training: 
  must include the requirements of the Produce Safety Rule that are applicable to 
o
their duties, including those in subpart CPersonnel Qualifications and Training 
that relate to those who harvest covered produce, subpart DHealth and Hygiene 
that relate to harvesting covered produce by hand, subpart FBiological Soil 
Amendments of Animal Origin and Human Waste that relate to preparing, 
handling, conveying, and storing BSAAOs and keeping records of the treatment 
process, subpart K(Growing, Harvesting, Packing, and Holding Activities that 
relate to harvesting covered produce, and subpart ORecords that relate to 
keeping records of process controls. 
  should include your procedures related to harvesting activities, managing 
o
untreated and treated BSAAOs, including your treatment procedures and 
recordkeeping system. 
  should include how the personnels actions while performing certain practices 
o
(e.g., handling raw manure and then handling a clean food contact surface) can 
lead to contamination of covered produce and food contact surfaces. 
 
Example 2d.  For personnel who supervise the pest control activities for your farm and do 
not contact covered produce or food contact surfaces, training: 
  should include the requirements of subpart LEquipment, Tools, Buildings, and 
o
Sanitation that relate to pest control.   
  should include your procedures related to pest control. 
o
  should include how the personnels activities while overseeing the pest control 
o
activities (e.g., handling traps and bait stations then contacting a clean food 
contact surface) can lead to contamination of food contact surfaces and covered 
produce. 
  should include how to recognize signs of pest infestation and animal excreta. 
o
  should include how pests can contaminate covered produce. 
o
6.  Additional Training for Persons Who Conduct Harvest Activities 
There are specific training requirements for personnel who conduct harvest activities for covered 
produce (21 CFR 112.21(b)), in addition to the previously discussed training requirements that 
apply to all personnel who handle covered produce or food contact surfaces.   
As part of this training, you should encourage your personnel to communicate with their 
supervisors or responsible parties, or directly with other personnel, if they observe harvesting 
practices that do not align with your procedures or the applicable requirements of the Produce 
Safety Rule.  Examples of such observations include harvesting covered produce visibly 
contaminated with animal excreta, harvesting dropped covered produce, or observing contact 
between cut surfaces of covered produce and the soil during or after harvest.  (Additional 
information on these observations is found in 21 CFR 112.83, in Chapter 5: Domesticated and 
Wild Animals (Subpart I), in 21 CFR 112.112 and 112.113, and in Chapter 6: Growing, 
Harvesting, Packing, and Holding Activities (Subpart K.)).   
35  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
You could use contracted or temporary personnel to perform certain activitiesfor example to 
perform harvesting activitiesbut you should ensure that all personnel, including contracted, 
part-time, and temporary personnel, meet all of the training requirements of subpart C.  For 
example, you could choose to rely on training that the company with whom you contract delivers 
to their harvesting crews to meet the requirements of subpart C.  You should evaluate the 
training content to ensure that it meets the Produce Safety Rule requirements and aligns with 
your procedures.  You may need to provide additional training to address any topics not covered 
by the contract companys training, for example, to ensure the harvest personnel are aware of 
your specific procedures.   
  Recognizing When Not to Harvest Covered Produce 
Persons who conduct harvest activities must be trained to recognize covered produce that must 
not be harvested.  (21 CFR 112.22(b)(1)).  This includes covered produce that may be 
contaminated, such as by animal excreta (see also draft guidance in Chapter 6: Growing, 
Harvesting, Packing, and Holding Activities (Subpart K), titled Identifying and Not Harvesting 
Contaminated Covered Produce.  The training should emphasize to personnel that identifying 
and not harvesting covered produce that may be contaminated is potentially the only opportunity 
to prevent that covered produce from reaching consumers.  Other personnel conducting activities 
that follow harvesting may not observe or be aware of the signs of possible contamination that 
harvest personnel are able to observe. 
You should evaluate your harvesting activities and add training content specific for harvest 
personnel, as applicable to your farms operations.  In particular, you should include the 
following training topics for personnel conducting harvesting activities: 
  Recognizing covered produce that is reasonably likely to be contaminated with a known 
or reasonably foreseeable hazard (e.g., excreta, bite marks, crop destruction) immediately 
prior to and during harvesting (see also discussion of 21 CFR 112.112 and draft guidance 
in Chapter 6: Growing, Harvesting, Packing, and Holding Activities (Subpart K), titled 
Identifying and Not Harvesting Contaminated Covered Produce); and 
  As applicable, recognizing specific growing areas from which covered produce possibly 
should not be harvested due to significant evidence of potential contamination from 
animals observed during the growing season (see also discussion of 21 CFR 112.83 and 
draft guidance in Chapter 5: Domesticated and Wild Animals (Subpart I), titled 
Evaluating Significant Evidence of Potential Contamination of Covered Produce by 
Animals to Determine Whether Harvest Can Occur). 
  Harvest Containers and Equipment 
Persons who conduct harvest activities for covered produce must receive training on inspecting 
harvest containers and equipment to ensure that they are functioning properly, clean, and 
maintained so as not to become a source of contamination of covered produce with known or 
reasonably foreseeable hazards.  (21 CFR 112.22(b)(2)).  Such persons must also receive training 
on correcting problems with harvest containers or equipment, or reporting such problems to a 
supervisor or other responsible party as appropriate to the persons job responsibilities.  (21 CFR 
36  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
112.22(b)(3)).  Covered produce is often hand-harvested or hand-packed, sometimes directly into 
consumer-ready containers, so it is important for personnel to understand the influence of these 
practices on food safety (Ref. 14) (Ref. 64).    
You should train personnel who harvest covered produce to visually assess harvest containers 
(e.g., food-packing materials, consumer-ready containers, and those from which the covered 
produce will be repacked) to determine whether they could serve as a source of contamination to 
the covered produce (see also Chapter 6: Growing, Harvesting, Packing, and Holding Activities 
(Subpart K), especially the discussion related to food-packing materials).   
Training should include: 
  Types of handling and practices that can contaminate food contact surfaces of 
harvesting containers (e.g., illustrations of a worker with an uncovered hand 
wound touching the food contact surface of a harvest container, or a worker 
stepping on the food contact surface of a harvest container, or animal excreta 
present on food contact surfaces); 
  How and when personnel should inspect harvest containers; 
  Conditions that personnel should look for during their inspections (e.g., visible 
animal excreta; organic material; residue; debris; evidence of pests or animals; or 
containers that are cracked, pitted, scored, or otherwise damaged in a way that 
promotes the growth or transfer of bacteria);  
  Conditions that indicate the containers should be discarded; and  
  Examples of damaged or unclean harvest containers to help illustrate when 
cleaning or repair is needed and when the containers should be discarded may be 
helpful. For example, displays or photos of several harvest containers in different 
stages of disrepair and an explanation of the expected corrections for each 
container or examples of harvest containers that should be cleaned prior to use 
may be helpful. 
7.  Food Safety Training for a Supervisor or Responsible Party 
At a minimum, at least one supervisor or responsible party for your farm must have successfully 
completed food safety training at least equivalent to that received under standardized curriculum 
recognized as adequate by the FDA.  (21 CFR 112.22(c)).  The standardized curriculum was 
developed by the Produce Safety Alliance (PSA), and is offered as one way to meet this 
requirement.  You may use other training programs as long as the training is equivalent to the 
standardized curriculum.  The standardized curriculum covers fundamental food safety topics as 
they relate to produce and the requirements of the Produce Safety Rule, including an introduction 
to produce safety, worker health and hygiene, training, wildlife and domesticated animals, land 
use, agricultural water, produce handling, and sanitation.    
You could choose to have additional supervisors, or other personnel, complete this training as 
well.  For example, if your farm has several supervisors who are responsible for ensuring that 
your operations adhere to the requirements of the Produce Safety Rule, you could direct each of 
these supervisors to complete the standardized or equivalent training.  We also encourage you to 
37  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
have those who complete the standardized curriculum training (or equivalent) share what they 
learned with other personnel on your farm, during your on-farm training or otherwise. 
8.  Supervision to Ensure Compliance 
You must assign or identify personnel to supervise (or otherwise be responsible for) your 
operations to ensure compliance with the requirements of the Produce Safety Rule.  (21 CFR 
112.23).  Such personnel can include full-time, permanent, temporary, part-time, seasonal, 
contracted, or other personnel you designate as responsible for ensuring that your activities 
comply with the requirements of the Produce Safety Rule.  Oversight by qualified personnel is 
essential to ensure compliance with the Produce Safety Rule.  These supervisors or responsible 
individuals should be able to evaluate whether other personnel are conducting activities in a 
manner based on the requirements of the Produce Safety Rule.  (See 21 CFR 112.23).  You 
should ensure that your responsible individuals or supervisors are aware of their role in 
recognizing and ensuring the correction of deviations from your food safety procedures and the 
requirements of the Produce Safety Rule.  They should know that if they notice that a worker is 
not adhering to a food safety protocol, they should ensure that the worker receives immediate 
corrective training (e.g., instructions).  For example, if a supervisor observes a worker harvesting 
covered produce with obvious animal excreta, the supervisor should show all harvest personnel 
the affected produce and remind personnel of why such produce must not be harvested (See 21 
CFR 112.112).  Your responsible individuals or supervisors also should recognize when 
individual deviations are recurring, or are more widespread among personnel, as this could signal 
a need to find a better way to convey the principles of the training materials to the personnel or 
to provide more frequent periodic refresher training. 
You should evaluate your operations and ensure that you have identified personnel to supervise 
or be responsible for each aspect of your operations that relates to a provision of the Produce 
Safety Rule.  You could find that you will need multiple individuals to fill this role but, in some 
cases, one individual could be able to perform all of the necessary duties to ensure compliance.  
These individuals can play an integral role in ensuring food safety and building a culture of food 
safety on your farm.    
9.  Training Records 
You must establish and keep records of training that document required training of personnel, 
including the date of training, topics covered, and the person(s) trained.  (21 CFR 112.30(b)).  
An example of a record that meets the training records requirements is an attendance sheet for a 
training session that includes the date of training, list of personnel in attendance, and list of 
topics covered (e.g., proper hand-washing).  The records requirement applies regardless of 
whether you, a supervisor, or a responsible individual, or another entity, provides the training.  If 
you employ contracted personnel, and you choose to rely on the training the contracted company 
(or a third-party service provider) provides, you should request training documentation from the 
contracted company or third-party service provider, and maintain the records to demonstrate 
compliance with the training requirements.  (See additional draft guidance related to general 
recordkeeping requirements provided in Chapter 8: Records (Subpart O)).   
38  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Chapter 3: 
Health and Hygiene (Subpart D) 
People can contaminate covered produce and food contact surfaces with pathogens by failing to 
maintain hygiene practices; thereby potentially impacting the health of those who consume the 
contaminated produce (Ref. 70) (Ref. 138).  Unhygienic practices exhibited by farm personnel 
have contributed to some produce-related outbreaks (Ref. 70) (Ref. 138).  Human skin and 
clothing can transfer contamination in a variety of ways, including when a person uses the 
restroom, contacts other parts of the body or contaminated surfaces (e.g., unclean surfaces, soil, 
floors, trash, animals), and then handles covered produce or food contact surfaces (Ref. 58) (Ref. 
81) (Ref. 116).  Health and hygiene practices of personnel and visitors are therefore directly 
relevant to produce safety.   
People can carry and transmit pathogens harbored on their skin and in their gastrointestinal and 
respiratory tracts.  Individuals have the potential to spread communicable illnesses even if they 
do not show symptoms (i.e., asymptomatic carriers) (Ref. 24) (Ref. 131) (Ref. 56).  
Asymptomatic carriers do not show symptoms because they either have not yet developed 
symptoms, symptoms never manifested, or their symptoms have resolved or subsided (Ref. 56) 
(Ref. 24) (Ref. 131).  These individuals might not be aware that they are an asymptomatic carrier 
with the potential to spread a communicable illness, and may not seek medical examination, 
receive a diagnosis, or treat their illness.  Therefore, hygienic practices are important in 
protecting covered produce and food contact surfaces from contamination by people who could 
transmit pathogens.   
The requirements of subpart D establish minimum requirements to reduce the likelihood that 
personnel and visitors will introduce contamination to covered produce or food contact surfaces.  
The areas of focus include: preventing ill or infected persons from contaminating covered 
produce; implementing hygienic practices to minimize the risk of contamination by personnel; 
and minimizing the risk of contamination by visitors.  Following these practices will help 
prevent contamination of covered produce or food contact surfaces from individuals with 
applicable health conditions (see the section of this chapter titled Understanding Applicable 
Health Conditions) or from unhygienic practices.   
Much of the responsibility to prevent contamination of covered produce and food contact 
surfaces through hygienic practices rests with your personnel; it is important for you to 
communicate that responsibility to your personnel.  The requirements and recommendations 
discussed in this chapter include not only actions directed at youthe owner, operator, or agent 
(as defined in 21 CFR 112.3)but also actions directed at your supervisors or responsible parties, 
and your personnel.  Personnel can include full-time, part-time, contracted, and seasonal 
personnel; volunteers; and paid or unpaid interns at your facility.   
1.  Measures to Prevent Ill or Infected Persons from Contaminating 
Covered Produce  
This section contains draft guidance on:  
 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Applicable health conditions;  
  The responsibility of personnel to recognize and report applicable health conditions to a 
supervisor or responsible party;  
  The role of supervisors and responsible parties in identifying applicable health 
conditions;  
  Addressing reports of applicable health conditions; and  
  Responding to potential contamination of covered produce or food contact surfaces.   
Among other requirements, 21 CFR 112.31 requires you to: 
  Exclude any person from working in any operations that may result in contamination of 
covered produce or food contact surfaces with microorganisms of public health 
significance when the person is shown to have, or appears to have, an applicable health 
condition, until the persons health condition no longer presents a risk to public health; 
and 
  Instruct personnel to notify their supervisor(s) or a responsible party if they have, or if 
there is a reasonable possibility that they have, an applicable health condition.  
You should also: 
  Ensure that you and your supervisors, responsible parties, and personnel can identify 
applicable health conditions; and 
  Ensure that your supervisors and responsible parties are aware of their responsibilities to: 
  Remind personnel to report applicable health conditions;  
o
  Evaluate whether personnel understand and report applicable health conditions;  
o
  Understand procedures to address reports of applicable health conditions; and  
o
  Know how to respond to potential contamination of covered produce or food 
o
contact surfaces. 
  Understanding Applicable Health Conditions  
You must take measures to prevent contamination of covered produce and food contact surfaces 
with microorganisms of public health significance from any person with an applicable health 
condition.  (21 CFR 112.31(a)).  This could include, for example, full-time, part-time, 
contracted, and seasonal personnel; volunteers; unpaid and paid interns; and/or visitors.  
Applicable health conditions include communicable illnesses that present a public health risk in 
the context of normal work duties.  The scientific evidence from outbreaks, surveys, and 
published literature establishes that human pathogens (e.g., Salmonella, pathogenic E. coli, 
Shigella, and Cyclospora) constitute a biological hazard with the potential to cause serious 
adverse health consequences or death, and result in the vast majority of foodborne illness known 
to be associated with produce consumption (Ref. 28) (Ref. 121).   
Signs and symptoms (Ref. 27) (Ref. 98) (Ref. 115) (Ref. 55) of applicable health conditions can 
include the following: 
  Vomiting; 
40  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Diarrhea; 
  Abdominal cramps; 
  Sore throat with fever; 
  Jaundice (yellowish discoloration of the skin or of parts of the eyes); and 
  Open wounds (e.g. wounds, boils, cuts, or sores). 
Keep in mind that in some instances some non-communicable conditions and diseases can cause 
symptoms (e.g., vomiting, diarrhea) similar to those caused by the communicable illnesses 
described above.  Applicable health conditions do not include conditions such as pregnancy, or 
non-communicable diseases such as cancer, diabetes, and high blood pressure.  You should 
encourage personnel to report relevant symptoms, such as vomiting or diarrhea, to supervisors or 
responsible parties, regardless of the underlying condition, and your procedures should specify 
how to respond to such reports.  For further draft guidance, see the section of this chapter titled 
Addressing Reports of Applicable Health Conditions. 
  Self-identification of Applicable Health Conditions 
You must instruct your personnel to notify their supervisors (or a responsible party) if they have, 
or if there is a reasonable possibility that they have, an applicable health condition.  (21 CFR 
112.31(b)(2)).  Your personnel could become aware by self-identification or medical 
examination that they have, or there is a reasonable possibility that they have, an applicable 
health condition.   
You should ensure that personnel who have the potential to contaminate covered produce or food 
contact surfaces can identify applicable health conditions.  Such personnel include those who 
handle covered produce and food contact surfaces, and those who interact with personnel who 
handle covered produce and food contact surfaces.     
As discussed in this draft guidance at Chapter 2: Personnel Qualifications and Training (Subpart 
C), personnel who handle covered produce or food contact surfaces must receive training in the 
importance of health and personal hygiene, including recognizing symptoms of a health 
condition that is reasonably likely to result in contamination.  (21 CFR 112.22(a)(2)).  Such 
personnel also must receive training that includes the requirements established in subpart D of 
the Produce Safety Rule that are applicable to their job responsibilities.  (See 21 CFR 
112.22(a)(3)).  This training is one way a farm can satisfy its obligation to instruct its personnel 
to notify their supervisors (or a responsible party) if they have, or if there is a reasonable 
possibility that they have, an applicable health condition.  (21 CFR 112.31(b)(2)).  You should, 
for example, in the training provided for those personnel that you assign to pack covered produce 
by hand, include training on applicable health conditions and the need to report to a supervisor or 
other responsible party any applicable health conditions that they might have.   
For those personnel not covered by the training requirements in 21 CFR 112.22(a)(2) and (3), 
you should evaluate their job duties to determine whether you should provide them with training 
that ensures that they are aware of health and hygiene topics that are applicable to their job 
duties; depending on the circumstances, these personnel could contaminate covered produce or 
food contact surfaces if they have an applicable health condition.  This includes personnel who 
do not handle covered produce or food contact surfaces themselves but interact with personnel 
41  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
who do.  For examples, see the section of this chapter titled Addressing Reports of Applicable 
Health Conditions.        
You have the flexibility to determine how to provide awareness of the requirements of 21 CFR 
112.31(b)(1) and (2) to your personnel.  For example, you could have all personnel attend 
training on this topic at the same time.  You also could, for example, provide separate training on 
health and hygienic practices for personnel who do not handle covered produce or food contact 
surfaces and for those who handle covered produce or food contact surfaces.  
To promote self-identification of applicable health conditions by personnel, you should: 
  Train all personnel who may contaminate covered produce or food contact surfaces (not 
just those subject to the training requirement in 21 CFR 112.22(a)) on applicable health 
conditions and how to identify them, including relevant symptoms and communicable 
illnesses of concern;   
  Encourage personnel to be aware of their direct contact with, or exposure to, individuals 
with symptoms of applicable health conditions (e.g., vomiting, diarrhea), including away 
from your farm and in their homes.8  Remind personnel that they could also become ill or 
could become an asymptomatic carrier (as described in this chapters introduction).  You 
should emphasize that if personnel have direct contact with or exposure to symptomatic 
individuals, they should pay careful attention to their hygienic practices (e.g., frequently 
wash hands).  If personnel do have such contact or exposure, they should carefully 
monitor their health for potential symptoms of an applicable health condition;  
  Provide your personnel with information on which supervisor or responsible party to 
notify if they have, or if there is a reasonable possibility that they have, an applicable 
health condition.  Remind personnel that if a medical provider diagnoses them with an 
applicable health condition, information from the medical provider about the time period 
during which the worker is likely to be contagious could be helpful to you in determining 
appropriate steps regarding exclusion from duties that involve covered produce or food 
contact surfaces;  
  Encourage personnel to prompt co-workers exhibiting symptoms of applicable health 
conditions to report their condition to a supervisor or responsible party; and 
  Consider using signs or visual aids (e.g., posters) to reinforce important concepts 
regarding health and hygiene. 
  Role of Supervisors in Identifying Applicable Health Conditions 
Communication between supervisors or other responsible parties and personnel plays an 
important role in ensuring that personnel continue to be aware of and report applicable health 
conditions.  You should ensure that supervisors and responsible parties are aware of their 
responsibilities regarding the health and personal hygiene requirements of the Produce Safety 
Rule.  (See 21 CFR 112.22(a)(2)).  For example, if you assign a supervisor to make a daily 
assessment of whether harvest personnel exhibit symptoms of an applicable health condition and 
                                                 
8 An investigation in 2008 of a Salmonella outbreak associated with cantaloupe found that farm personnel and their 
families had recently experienced gastrointestinal illness.  (Ref. 32).    
42  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
receive information from personnel about their awareness of such conditions (because personnel 
recognize the condition themselves or are made aware of a condition as a result of a medical 
examination), you should ensure that the supervisor can recognize applicable health conditions, 
including the signs and symptoms of concern (e.g., vomiting, diarrhea, frequently visiting the 
toilet facilities) and knows when and how to exclude or reassign affected workers from 
operations through which they could contaminate covered produce or food contact surfaces.  
Supervisors should periodically remind personnel to report any applicable health conditions or 
symptoms of concern they experience or observe in other personnel.   
  Addressing Reports of Applicable Health Conditions  
You must exclude any person from working in any operations that may result in contamination 
of covered produce or food contact surfaces with microorganisms of public health significance 
when the person (by medical examination, the persons acknowledgement, or observation) is 
shown to have, or appears to have, an applicable health condition, until the persons health 
condition no longer presents a risk to public health.  (21 CFR 112.31(b)(1)).  You should be 
aware that the measures to prevent contamination described in 21 CFR 112.31(a) apply to any 
person who is shown to have, or appears to have, an applicable health condition.  For example, 
if a mechanic who is contracted to repair non-food contact equipment located in your farms 
packing area, near where covered produce and food contact surfaces are exposed, could contact 
covered produce or food contact surfaces while repairing equipment, that contact can result in 
contamination if the mechanic has an applicable health condition.  As another example, an 
unpaid intern who assists personnel packing covered produce could perform tasks that could 
contaminate covered produce or food contact surfaces, such as bringing food packing materials 
with food contact surfaces to the packing area.   
When presented with a report of a worker with an applicable health condition, you or a 
supervisor (or a responsible party) should evaluate the workers applicable health condition and 
job duties to determine appropriate measures to prevent contamination of covered produce and 
food contact surfaces.  Depending on the workers specific condition, and the specific operations 
involved, such measures could include temporarily assigning the worker to other duties, 
temporarily excusing them from work, or allowing the worker to continue with their job duties 
after completing certain actions, such as bandaging a wound in a manner that prevents 
contamination.  For example, you must not permit a worker who reports currently experiencing 
episodes of vomiting to directly handle covered produce or food contact surfaces until their 
condition no longer presents a risk to public health, and you must exclude that worker from 
activities where the potential for contamination of covered produce or food contact surfaces 
exists through indirect contact (e.g., handling shared objects with other personnel who also 
contact the covered produce or food contact surfaces), until their condition no longer presents a 
risk to public health.  (See 21 CFR 112.31(b)(1)).   
The Produce Safety Rule does not require (or authorize) you to obtain medical records of your 
personnel to determine or verify their applicable health condition.  You and your supervisors and 
other responsible parties should keep worker reports of applicable health conditions confidential 
and address such reports as necessary to prevent contamination of covered produce or food 
contact surfaces.  Supervisors should not reprimand or otherwise penalize personnel based on a 
report of an applicable health condition. 
43  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
In some cases, it may be possible to temporarily reassign a worker with an applicable health 
condition to other tasks to prevent contamination of covered produce or food contact surfaces, 
such as clerical activities in areas away from covered activities or waste removal in areas where 
covered activities do not occur.  If a workers applicable health condition involves a wound, boil, 
cut, or sore that can be adequately covered to prevent it from becoming a source of 
contamination, you could allow the individual to handle covered produce or food contact 
surfaces after the worker covers the wound, boil, cut, or sore in a manner that prevents 
contamination.  Depending on the location of the wound, boil, cut, or sore, adequate covering 
could involve the use of an impermeable bandage, finger cot, or glove.  A supervisor or other 
responsible party should assess the covered wound to determine whether it no longer presents a 
public health risk before allowing a worker to handle covered produce or food contact surfaces.  
(See 21 CFR 112.31(b)(1)). 
You should develop procedures in advance to assist supervisors and other responsible parties in 
making decisions about excluding or reassigning workers with applicable health conditions and 
ensure these personnel are aware of your procedures.  These procedures could account for 
specific symptoms associated with applicable health conditions and categories of personnel 
based on scope of job duties to ensure that any reassignment prevents contamination of covered 
produce and food contact surfaces.  The FDA Food Code is a resource that provides information 
on potential approaches for addressing situations in which personnel have certain communicable 
illnesses or conditions that represent a public health risk when handling food (Ref. 55).  
  Response to Potential Contamination of Covered Produce or Food Contact Surfaces 
You must take appropriate measures to minimize the risk of serious adverse health consequences 
or death from the use of, or exposure to, covered produce, including those measures reasonably 
necessary to prevent the introduction of known or reasonably foreseeable hazards into covered 
produce, and to provide reasonable assurances that the produce is not adulterated under section 
402 of the FD&C Act because of such hazards.  (21 CFR 112.11).  For example, if you are aware 
that a person with an applicable health condition is likely to have contaminated covered produce 
or food contact surfaces, you must take appropriate measures to ensure that the affected produce 
is not distributed unless its safety can be reasonably assured, and to prevent contamination of 
additional covered produce.  (See 21 CFR 112.11).   
You should train supervisors and personnel who work in areas where covered activities occur on 
how to respond to situations where a person with an applicable health condition could 
contaminate covered produce.  When such a situation occurs, you should consider taking 
additional actions such as the following:  
  Isolating the areas of potential contamination and ceasing activities in the area until the 
incident has been addressed;  
  Isolating and holding covered produce that could have been contaminated until its safety 
can be evaluated;  
  Disposing of any covered produce that could have been contaminated unless its safety 
can be assured; and 
  Cleaning and sanitizing, or replacing affected surfaces in the area, as appropriate.   
44  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
For example, if a worker unexpectedly becomes ill during the work shift and vomits on covered 
produce on a packing belt, the worker should report the incident to a supervisor or responsible 
party.  The supervisor or responsible party should then ensure that activities in that area cease 
and must exclude the worker from working in any operations that may result in contamination of 
covered produce or food contact surfaces until the persons condition no longer presents a risk to 
public health (See 21 CFR 112.31(b)(1)).  A supervisor or other responsible party should also 
oversee the removal of the affected covered produce, and ensure other appropriate measures are 
performed, such as cleaning and sanitizing of the affected food contact surfaces.   
There could be occasions when you find that the requirements of 21 CFR 112.31 are not being 
met at your farm.  For example, if you learn that a supervisor did not adequately respond to a 
report of a worker with an applicable health condition and your farm consequently failed to 
exclude the worker from an operation that may result in contamination of covered produce or 
food contact surfaces while the workers condition presented a risk to public health, you should 
consider taking steps such as retraining that supervisor (or all supervisors) as necessary in 
accordance with 21 CFR 112.21(d).  In addition, under 21 CFR 112.11, you should consider, for 
example, whether to change your farms procedures for responding to reports of applicable 
health conditions. 
2.  Hygienic Practices 
This section contains draft guidance on the following: 
  Hygienic practices and the requirements for personnel who work in an operation in 
which covered produce or food contact surfaces are at risk of contamination with known 
or reasonably foreseeable hazards to use hygienic practices;  
  The role of supervisors in ensuring personnel adhere to hygienic practices; and  
  Specific hygienic practices required under 21 CFR 112.32(b).   
You should take the following steps to ensure your personnel are implementing required 
hygienic practices (21 CFR 112.32): 
  Ensure that applicable personnel are aware of the hygienic practices requirements of the 
Produce Safety Rule and can identify, and correct or report, unhygienic practices; 
  Identify job duties in which personnel are likely to encounter potential sources of 
contamination (e.g., handling of biological soil amendments of animal original 
(BSAAOs), animals, or waste) and, as appropriate, ensure that applicable personnel are 
aware of hygienic practices; 
  Ensure personnel are aware of procedures associated with minimum hygienic 
requirements of the Produce Safety Rule, including maintaining adequate personal 
cleanliness, avoiding contact with animals other than working animals, thorough hand-
washing, using gloves (if applicable), wearing jewelry, eating, chewing gum, and using 
tobacco products; and 
  Ensure your supervisors and responsible parties observe personnel and communicate with 
personnel about hygienic practices, and identify unhygienic practices that need to be 
addressed. 
45  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Personnel and Hygienic Practices 
Personnel who work in an operation in which covered produce or food contact surfaces are at 
risk of contamination with known or reasonably foreseeable hazards must use hygienic practices 
while on duty to the extent necessary to protect against such contamination.  (21 CFR 112.32(a)).  
This requirement is not limited only to personnel who handle covered produce and food contact 
surfaces, but also applies to others who work in the operation.  You should evaluate those 
covered activities where covered produce or food contact surfaces are at risk of contamination 
and ensure that your personnel are following hygienic practices to prevent contamination, 
adjusting your procedures as necessary.   
You should ensure that all personnel, including individuals whose job duties may not directly 
involve covered produce or food contact surfacessuch as office or loading dock staff who 
occasionally enter a packing area, use hygienic practices while on duty to the extent necessary to 
protect against contamination and understand how hygienic practices impact the safety of 
covered produce.  For example, at a farm that grows covered produce and raises livestock, even 
if specific personnel are designated to handle only livestock, if their duties are such that they 
occasionally enter areas where they could contact covered produce or food contact surfaces with 
footwear or clothing that contacted animal excreta, their clothing could transfer contamination to 
covered produce or food contact surfaces if the worker does not follow hygienic practices.   
You should identify personnel whose job duties are likely to involve interaction with potential 
sources of contamination (such as handling trash, raw manure, or animals).  You should consider 
how these personnel interact with or come into proximity with other personnel and with covered 
produce and food contact surfaces.  If you determine that the personnels interactions create a 
risk for contamination of covered produce or food contact surfaces, you should ensure that they 
are aware of (such as through training), and follow, hygienic practices to protect against such 
contamination.   
Personnel should understand the importance of consistently following hygienic practices to 
prevent contamination, and when hygienic practices are necessary.  Personnel should be able to 
identify and report unhygienic practices that they observe, and you should encourage them to do 
so.  In addition to training, you could use signs, visual aids (e.g., posters), and verbal reminders 
to re-enforce to personnel the importance of using hygienic practices.  For example, you could 
place signs or visual aids by the entrance to a common area, such as a packing area, reminding 
personnel to use hygienic practices, including those outlined in 21 CFR 112.32(b).    
  Role of Supervisors in Ensuring Personnel Follow Hygienic Practices 
You must assign or identify personnel to supervise (or otherwise be responsible for) your 
operations to ensure compliance with the requirements of the Produce Safety Rule.  (21 CFR 
112.23).  The supervisors or other responsible parties you assign should ensure that other 
personnel consistently follow hygienic practices on your farm.  Supervisors or responsible 
parties should observe and communicate with personnel who have the potential to contaminate 
covered produce or food contact surfaces about hygienic practices to ensure awareness and 
implementation.  Supervisors and responsible parties should be familiar with the regulatory 
requirements regarding health and hygienic practices as well as your procedures.   
46  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
You should instruct your supervisors and responsible parties to observe personnel when 
performing their job duties to determine whether personnel are following hygienic practices and 
to identify and respond to any unhygienic practices.  You must perform or assign additional 
training for the appropriate personnel, as necessary and appropriate, to correct those practices 
that do not meet the requirements established by FDA in subpart D of the Produce Safety Rule.  
(See 21 CFR 112.21(d)).  In addition, under 21 CFR 112.11, you should consider any other 
actions you may need to take to ensure compliance with the Produce Safety Rule.  For example, 
consider whether you should change your farms procedures for responding to reports of 
unhygienic practices.   
You should also ensure that supervisors are aware of your procedures and the applicable 
requirements of the Produce Safety Rule, which can be achieved as part of required training (See 
21 CFR 112.22(a)).  For example, if you assign a supervisor to oversee harvest activities in a 
field where covered produce is handled, the supervisor must receive training including the 
requirements of subpart D, such as adequate personal cleanliness and thorough hand-washing, 
that are relevant to the supervisors job responsibilities. (21 CFR 112.22(a)(3)). The supervisor 
should also understand your related procedures.  For supervisors and responsible parties not 
subject to the training requirements in 21 CFR 112.22(a), you should nonetheless provide 
training that ensures that they are aware of the regulatory requirements for health and hygiene 
that are applicable to their job duties. 
  Required Hygienic Practices 
Personnel who work in an operation in which covered produce or food contact surfaces are at 
risk of contamination with known or reasonably foreseeable hazards must use hygienic practices 
while on duty to the extent necessary to protect against such contamination. (21 CFR 112.32(a)). 
The hygienic practices that personnel use to satisfy the requirements of 21 CFR 112.32(a) when 
handling covered produce or food contact surfaces during a covered activity must include those 
provided in 21 CFR 112.32(b).  (21 CFR 112.32(b)).  These represent the minimum requirements 
for hygienic practices that all operations must apply.  In addition, you should evaluate your 
operations to identify situations, if any, when hygienic practices in addition to those required by 
21 CFR 112.32(b) are necessary to protect against contamination, as provided in 21 CFR 
112.32(a).     
  Maintaining Adequate Personal Cleanliness 
Your personnel who handle covered produce or food contact surfaces during a covered activity 
must maintain adequate personal cleanliness to protect against contamination of covered produce 
and food contact surfaces.  (21 CFR 112.32(b)(1)).  Exposed skin, outerwear (e.g., smocks, 
aprons, coveralls, hair nets, beard guards, and footwear covers), clothing, and footwear should be 
free of filth, debris, and other material, to the extent practical.  Outerwear, clothing, and footwear 
are likely to accumulate some organic material through the normal course of certain activities for 
some job duties.  You should identify job duties where the accumulation of soil, organic 
material, filth, or other debris or potential sources of contamination occurs, and ensure your 
personnel maintain adequate personal cleanliness when later performing other activities where 
they can transfer contamination to covered produce or food contact surfaces; this could happen, 
for example, if personnel handle waste and then clean the food contact surfaces of equipment.  
47  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
You could, for example, specify certain practices related to outerwear, clothing, and footwear for 
personnel performing these duties.  
There are several strategies that you can use to prevent outerwear, clothing, and footwear from 
contaminating covered produce and food contact surfaces.  Personnel who are wearing soiled 
clothing upon arrival at the farm could present a source of contamination.  Generally, clothing, 
footwear, and outer garments should be clean when beginning job duties involving covered 
produce or food contact surfaces.  You should instruct personnel to use clean outerwear, 
clothing, and footwear, and change or remove those items as necessary to prevent contamination 
of covered produce and food contact surfaces.  You could, for example, establish procedures for 
personnel to wear outer garments while handling covered produce or food contact surfaces and 
remove them before performing any activities where contamination could occur.  You could, for 
example, establish procedures for personnel to wear aprons while packaging covered produce, 
then remove and properly store the aprons when taking a break, and put them back on upon 
returning to packing.   
If you establish such procedures, personnel should have access to clean outer garments as 
needed, and your procedures should ensure that these outer garments are periodically cleaned 
and replaced when they become damaged or can no longer be cleaned.  A suitable schedule for 
replacing and cleaning outer garments depends on the conditions of their use.  You should 
designate a supervisor or responsible party to periodically assess the condition of outer garments 
to determine whether cleaning or replacement is warranted; and personnel should store outer 
garments that are used to prevent contamination of covered produce or food contact surfaces in a 
location and manner that protects them from contamination.  The storage area should be dry and 
protected from the surrounding environment and pests.  For example, if personnel wear different 
smocks when handling covered produce than those worn when handling waste containers, you 
should have separate designated areas for storing smocks worn by personnel when handling 
covered produce and for storing smocks worn by personnel when handling waste containers.   
Practices that support maintaining personal cleanliness also include regularly bathing and 
keeping fingernails trimmed to permit effective removal of material from under and around 
fingernails.  Generally, personnel should bandage all boils, cuts, and other wounds on exposed 
skin, including the hands and wrists.  If a worker has a boil, cut, or other wound on their hands, 
they should use an impermeable cover, such as a bandage, and wear a glove or finger cot as a 
secondary barrier to protect the covered produce and food contact surfaces (i.e., prevent 
contamination).  We provide additional draft guidance in the section of this chapter titled Using 
Gloves.   
  Avoiding Contact with Animals Other Than Working Animals 
Your personnel who handle covered produce or food contact surfaces during a covered activity 
must avoid contact with animals other than working animals, and take appropriate steps to 
minimize the likelihood of contamination of covered produce when in direct contact with 
working animals.  (21 CFR 112.32(b)(2)).  These personnel, while performing covered activities, 
should also avoid contact with animal fur, feathers, saliva, skin, and excreta, which can harbor 
pathogens (Ref. 22) (Ref. 33) (Ref. 37) (Ref. 104) (Ref. 111) (Ref. 122).  In some cases, 
proximity to animals can result in the transfer of contamination (Ref. 33) (Ref. 104) (Ref. 111) 
48  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
(Ref. 122), which could be without an individuals knowledge or awareness, such as when an 
animal brushes against a workers hands or clothing.  In the absence of hygienic practices after 
contact with animals, humans can transfer these pathogens from their hands or clothing to 
covered produce or food contact surfaces.  In some outbreaks, failure to maintain hygienic 
practices after human contact with animals were identified as likely contributing factors to the 
outbreaks (Ref. 33) (Ref. 111) (Ref. 122).  
Personnel should be aware of their proximity to animals.  Personnel must wash their hands as 
soon as practical after touching animals (21 CFR 112.32(b)(3)(v)), which we discuss in the 
section of this chapter titled Thorough Hand-washing.  Additionally, personnel should 
consider the need for other hygienic measures, such as changing clothing or footwear, or using 
clean outerwear, as discussed in the section of this chapter titled Maintaining Adequate Personal 
Cleanliness.     
FDA does not expect, suggest, or recommend that you remove animals from your farm.  If your 
farm uses working animals, you should determine which personnel interact with these animals 
and ensure that those personnel minimize the potential for contamination of covered produce and 
food contact surfaces.  There are several ways that you can minimize the risk of personnel 
transferring contamination from working animals to covered produce and food contact surfaces.  
You could, for example, ensure that personnel who have direct contact with working animals are 
not assigned to duties that involve direct contact with covered produce or food contact surfaces.  
As an example of this, you could instruct the individual designated to handle a horse pulling a 
harvest cart not to handle the covered produce or food contact surfaces, and assign other 
personnel to activities related to loading covered produce in the cart.  If you assign personnel to 
duties in which they contact both covered produce or food contact surfaces and working animals, 
those personnel must wash and dry their hands thoroughly in accordance with 21 CFR 
112.32(b)(3) as soon as practical after touching animals or any waste of animal origin (21 CFR 
112.32(b)(3)(iv)).  To minimize the potential for contamination, you could, for example, separate 
such personnels job duties in a way that they complete those duties that involve handling 
covered produce or food contact surfaces before those that involve handling animals during a 
given day.  For additional draft guidance on working animals see Chapter 7: Equipment, Tools, 
Buildings, and Sanitation (Subpart L), and Chapter 5: Domesticated and Wild Animals (Subpart 
I).   
Personnel to whom you assign job duties of handling covered produce or food contact surfaces 
and working animals should understand your practices and procedures to minimize the potential 
for contaminating covered produce and food contact surfaces after contact with animals based on 
the requirements of the Produce Safety Rule.  You should instruct your supervisors and other 
responsible parties on your practices and procedures for personnel to avoid contact with animals 
other than working animals.  You should direct supervisors or responsible parties, as applicable, 
to ensure that personnel consistently implement practices to avoid contact with animals other 
than working animals, and minimize the potential for contamination of covered produce after 
contact with animals. 
 
 
49  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Thorough Hand-washing 
There are specified times when personnel who handle covered produce or food contact surfaces 
must wash their hands thoroughly, including scrubbing with soap or other effective surfactant 
and running water, and then thoroughly dry their hands.  (21 CFR 112.32(b)(3)).  Examples of 
surfactants include soap and detergents.  
You may not use antiseptic hand rubs (i.e., hand sanitizers) as a substitute for soap and water.  
(21 CFR 112.130(d)).  The use of soap and water is an effective method to clean hands (Ref. 29) 
(Ref. 59) (Ref. 100) (Ref. 133).  Grease, soil, or other material present on hands in a work 
environment has been shown to reduce the effectiveness of hand sanitizers in eliminating 
microorganisms (Ref. 59) (Ref. 100).  Antiseptic hand rubs may be used after proper hand-
washing and drying in accordance with 21 CFR 112.32(b)(3), when the antiseptic hand rub 
serves as an additional measure in reducing the number of bacteria on hands relatively free of 
grease, soil, and other material.   
Personnel should be aware that the greatest concentration of microbes typically exists around and 
under the fingernails and this is the most difficult area of the hand to clean (Ref. 89) (Ref. 100).  
Fingernail brushes, if used properly, have been found to be effective tools in cleaning this area of 
the hand (Ref. 89) (Ref. 100).  Adequate hand drying devices include single-service towels (e.g., 
paper towels that are disposed of after each use), single-use towels provided by a sanitary towel 
service (i.e., a towel rental service that launders and delivers clean towels), and electric hand 
dryers.  (See 21 CFR 112.32(b)(3)).  Personnel should not use common or shared towels for 
drying hands (Ref. 2) (Ref. 69) (Ref. 133).   
Personnel who handle covered produce or food contact surfaces must wash their hands: 
  Before starting work.  (21 CFR 112.32(b)(3)(i)).  Personnel should wash their hands 
immediately before beginning activities in which they contact covered produce or food 
contact surfaces.  For example, a worker could arrive at work and complete activities that 
do not involve contact with covered produce or food contact surfaces (e.g., signing in on 
a timesheet) before handling covered produce or food contact surfaces.  They should 
perform these non-food contact activities and then thoroughly wash and dry their hands 
before beginning food contact activities.  
  Before putting on gloves.  (21 CFR 112.32(b)(3)(ii)).  Gloves could collect and transfer 
contamination from unwashed hands to covered produce.  Washing hands before putting 
on gloves could, for example, protect against contamination from ones hand to the 
gloves and then to covered produce or food contact surfaces that the gloves contact (Ref. 
133).  For this reason, the use of gloves is not a substitute for hand-washing as required 
by 21 CFR112.32(b)(3).  We provide further draft guidance on glove use in the section of 
this chapter titled Using Gloves.  
  After using the toilet.  (21 CFR 112.32(b)(3)(iii)).  Toilet use provides a direct means for 
hands to become contaminated with pathogens that a worker could shed.  Hand-washing 
after toilet use protects against the transfer of pathogens from hands to other surfaces.  
You could choose to emphasize the requirement to wash hands after using the toilet by 
50  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
placing at toilet facilities and hand-washing facilities signs and visual aids describing 
hand-washing methods.  You could consider placing hand-washing facilities in 
communal areas immediately outside of each toilet facility.  During growing activities 
that take place in a fully-enclosed building, and during covered harvesting, packing, or 
holding activities, you must provide a hand-washing station in sufficiently close 
proximity to toilet facilities to make it practical for persons who use the toilet facility to 
wash their hands.  (21 CFR 112.129(c)).  
  Upon return to the work station after any break or other absence from the work station.  
(21 CFR 112.32(b)(3)(iv)).  Absence from the work station includes, for example, taking 
a break to eat, drink, or use tobacco; leaving the work station to answer the telephone or 
accept a delivery; using the toilet; or changing job duties.  During absences, an 
individuals hands can become contaminated because they could contact unsanitary 
surfaces (e.g., surfaces of buildings, equipment, or other objects that are not designed or 
maintained for food contact; personal food and beverages; toilet facilities; or the workers 
mouth, nose, hair, or skin).  Hand-washing upon returning to the work station helps to 
protect against contamination of covered produce and food contact surfaces.  For 
example, if a worker packing chayote fruit stops to take a waste container to a dumpster 
for disposal, the worker must wash their hands before returning to their work station to 
continue packing chayote fruit.  (See 21 CFR 112.32(b)(3)(iv)).  
  As soon as practical after touching animals (including livestock and working animals), or 
any waste of animal origin.  (21 CFR 112.32(b)(3)(v)).  For example, if a worker handles 
a horse pulling a harvest cart, they must wash their hands before handling covered 
produce.  (See 21 CFR 112.32(b)(3)(v)).  We discuss contact with animals by personnel 
who handle covered produce or food contact surfaces in the section of this chapter titled 
Avoiding Contact with Animals Other Than Working Animals.  
  At any other time when the hands may have become contaminated in a manner that is 
reasonably likely to lead to contamination of covered produce with known or reasonably 
foreseeable hazards.  (21 CFR 112.32(b)(3)(vi)).  Your personnel should recognize 
situations when their hands may become contaminated and when they are required to 
wash their hands.  Examples of such situations include touching: surfaces of buildings, 
components of equipment and tools (e.g., control panels, wheels, handles), or other 
objects that are not designed or maintained for food contact, such as outside walls, the 
floor, or the ground; objects that have been in contact with the floor; tractors; vehicles; 
non-food contact tools (e.g., brooms, shovels); trash, dumpsters, or other waste 
containers; or the workers nose, mouth, hair, or skin.   
Training for your personnel who handle covered produce or food contact surfaces, or who are 
engaged in the supervision thereof, must include the hand-washing requirements associated with 
21 CFR 112.32(b)(3).  (See 21 CFR 112.22(a)(3)).  You should emphasize how to recognize 
potential sources of contamination and the requirement for personnel to wash their hands after 
handling such objects and before handling covered produce or food contact surfaces.  You 
should also train personnel to be conscientious of contact between their hands and their nose, 
mouth, hair, skin, and other parts of the body, which increases the potential to transfer 
contamination.   
51  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
You should direct your supervisors and other responsible parties, as applicable, to ensure that 
personnel consistently follow practices to wash their hands thoroughly.  Supervisors and other 
responsible parties should encourage and remind personnel to thoroughly wash and dry their 
hands in keeping with your procedures.  For example, supervisors or responsible parties could 
perform demonstrations, or provide verbal reminders, or provide signs and visual aids at hand-
washing facilities.   
  Using Gloves  
We are not requiring that your personnel use gloves or that gloves, when used, be of a certain 
type (e.g., disposable, cotton, leather, or other types).  However, if you choose to use gloves in 
handling covered produce or food contact surfaces, the gloves must be maintained in an intact 
and sanitary condition and replaced when they can no longer be so maintained.  (21 CFR 
112.32(b)(4)).  Gloves with holes, tears, or cracks are not in an intact and sanitary condition.  
Gloves should be clean when personnel using gloves begin job duties involving covered produce 
or food contact surfaces.  
You should evaluate activities that involve hand contact with covered produce or food contact 
surfaces, and determine whether personnel should use gloves.  Factors to consider in the 
development of your approach to glove use include: type of activity, glove type, likelihood for 
contamination of covered produce or food contact surfaces, frequency of glove use, glove 
storage, frequency of glove cleaning (if appropriate), and glove replacement (e.g., identifying 
and replacing gloves when they are no longer in an intact and sanitary condition).  
We recognize that different types of gloves, or no gloves, may be appropriate depending on the 
circumstances, and 21 CFR 112.32(b)(4) provides you with the flexibility to choose practices 
that are appropriate for your operations.  Furthermore, if you choose to use gloves for handling 
covered produce or food contact surfaces during covered activities, your personnel must follow 
the hand-washing requirements in 21 CFR 112.32(b)(3) before putting on gloves.  (See 21 CFR 
112.23(b)(3)(ii)).  
You should develop procedures for glove storage that personnel should follow when storing 
reusable gloves while not in use.  Gloves used for activities involving contact with covered 
produce or food contact surfaces should be stored separately from those used for other activities, 
especially those involving contact with potential sources of contamination (e.g., trash or 
manure).  For both short- and long-term storage, you should provide a clean, dry environment in 
which it is convenient for your personnel to leave the gloves and where the gloves are protected 
from contamination.  For longer periods of storage, gloves should be stored in a fully or 
partially-enclosed building, in a designated area that protects the gloves from contamination.  For 
example, a farm could provide a table for short-term storage of gloves near a field that is being 
harvested so that personnel who temporarily leave the field (e.g., to use the toilet) can place their 
reusable gloves on the table until they return to work.  At the end of the day, the farm could 
specify that personnel return the gloves to a certain work station in a fully enclosed barn where 
designated personnel examine, clean, and then store the gloves in a designated cabinet.   
You should develop a system to periodically assess the condition of both single-use and reusable 
gloves to determine when they need to be replaced or, in the case of reusable gloves, cleaned.  
52  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Single-use gloves are intended to be used once and disposed of when removed.  They should not 
be reused.  When determining an appropriate frequency for cleaning reusable gloves, you should 
consider how the gloves will be used and the potential for them to contaminate covered produce 
or food contact surfaces.  For example, reusable gloves that are used daily for harvest activities 
are likely to need more frequent cleaning than gloves that are used once a month to move pallets.   
You should ensure that gloves used for activities that involve handling covered produce or food 
contact surfaces are immediately replaced or otherwise appropriately addressed when holes, 
tears, or cracks appear.  Single-use gloves should be replaced, and reusable gloves cleaned, when 
they contact a potential source of contamination, when they are removed from the work station 
and not stored in an intact or sanitary condition (e.g., when the worker takes a break or uses the 
toilet without storing the gloves according to your procedures), and when the worker changes job 
duties.  Under some circumstances, it could be appropriate for you to instruct personnel to 
change gloves when they become visibly soiled or at a predetermined frequency, even if the 
gloves remain in good condition.  The frequency you specify (e.g., every two hours) should be 
based on the activity in which the gloves are used and the likelihood that they will cause 
contamination of covered produce or food contact surfaces.   
You should identify activities that involve glove use, if any, and the personnel involved in these 
activities.  These personnel should understand your procedures on the use of gloves.  Your 
personnel should understand that hygienic practices involve removing gloves when stopping or 
completing activities for which the gloves were intended. For example, if personnel wear 
reusable gloves when handling covered produce or food contact surfaces throughout the day, 
they should remove those gloves before taking breaks or handling the trash.  You should instruct 
your supervisors and other responsible parties on your practices and procedures for glove use.  
You should direct your supervisors and other responsible parties, as applicable, to ensure that 
other personnel follow appropriate practices for glove use.  Furthermore, supervisors and 
responsible parties should emphasize to personnel hygienic practices related to glove use.  You 
could also choose to use signs and visual aids to reinforce your practices.    
  Hand Jewelry 
Jewelry can serve as a harborage site for contamination (Ref. 46) (Ref. 142).  Hand jewelry such 
as rings, bracelets, and watches could collect soil or other materials and the construction of the 
jewelry could hinder routine cleaning (Ref. 46) (Ref. 114) (Ref. 133) (Ref. 142).  Personnel who 
handle covered produce or food contact surfaces must remove or cover hand jewelry that cannot 
be adequately cleaned and sanitized during periods in which covered produce is manipulated by 
hand.  (21 CFR 112.32(b)(5)).  You should identify the activities on your farm that involve 
manipulating covered produce by hand, which could include hand harvesting, post-harvest 
washing, sorting, and packing.  For these activities, you should determine an approach to hand 
jewelry that aligns with the requirements of 21 CFR 112.32(b)(5).  You could choose to specify, 
for example, that personnel remove or cover all hand jewelry when manipulating covered 
produce by hand, or you could determine, for example, that some hand jewelry can be adequately 
cleaned and sanitized and allow that type of jewelry to be worn uncovered when your personnel 
manipulate covered produce by hand.   
53  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Personnel who wear uncovered hand jewelry while manipulating covered produce by hand 
should clean around and under any hand jewelry to prevent the jewelry from harboring 
contamination.  Jewelry that cannot be cleaned and sanitized can be covered using gloves or 
sleeve guards, as appropriate.  Examples of hand jewelry that is unlikely to be adequately 
cleaned and sanitized include rings with adornments or embellishments, including stones and 
carving, as well as bracelets and watches (Ref. 47).  Note that tears can occur in gloves or other 
outer garments, particularly from jewelry with embellishments.  Personnel who use gloves 
should follow your procedures related to glove use, including replacing torn gloves.  We provide 
draft guidance on glove use in the section of this chapter titled Using Gloves.     
Your personnel, including supervisors and responsible parties, should understand your 
procedures related to jewelry.  You should instruct your supervisors and other responsible parties 
on your practices and procedures related to hand jewelry, and you should direct them to ensure 
that other personnel consistently follow your procedures related to hand jewelry.  You should 
instruct your supervisors and responsible parties to observe other personnel when performing 
their job duties to determine whether they are implementing these hygienic practices, and to 
identify any practices that need to be addressed.   
  Eating, Chewing Gum, and Using Tobacco Products 
Personnel must not eat, chew gum, or use tobacco products in an area used for a covered activity; 
drinking beverages is permitted in designated areas.  (21 CFR 112.32(b)(6)).  You should 
instruct your supervisors or responsible parties to observe personnel when performing their job 
duties to determine whether they are implementing these hygienic practices, and to identify any 
unhygienic practices that need to be addressed.   
You should visually assess areas where covered activities are performed to determine where to 
locate areas designated for beverages.  You should locate these designated areas at a sufficient 
distance from covered produce and food contact surfaces so as not to serve as potential sources 
of contamination to covered produce or food contact surfaces, such as by spillage of partially 
consumed beverages and by personnel drinking beverages (e.g., through hand to mouth contact 
or spittle).  Locating these designated areas near hand-washing facilities could help to facilitate 
hand-washing after breaks for beverage drinking.  (See 21 CFR 112.32(b)(3)(iv)). 
3.  Measures to Prevent Visitors from Contaminating Covered Produce 
and Food Contact Surfaces  
You must take certain measures to prevent visitors from contaminating your covered produce or 
food contact surfaces with microorganisms of public health significance.  (See 21 CFR 112.33).  
A visitor is any person (other than personnel) who enters your covered farm with your 
permission.  (21 CFR 112.3).  Visitors could include consumers, delivery personnel, vendors, or 
others who are touring, conducting business, or observing your farm.   
Visitors could enter areas where covered produce is grown, harvested, packed, or held, and 
where food contact surfaces are present.  As with personnel, visitors can transmit contamination 
to covered produce or food contact surfaces.  For example, an ill visitor experiencing diarrhea 
who does not thoroughly wash their hands after using the toilet could unknowingly transfer 
54  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
pathogens to covered produce or food contact surfaces when later handling blueberries or 
harvesting containers during a tour of a blueberry field.  
  Visitor Awareness of Policies and Procedures 
You must make visitors aware of policies and procedures to protect covered produce and food 
contact surfaces from contamination by people and take all steps reasonably necessary to ensure 
that visitors comply with such policies and procedures.  (21 CFR 112.33(a)).  In addition, 21 
CFR 112.31(a) requires you to take measures to prevent contamination of covered produce and 
food contact surfaces with microorganisms of public health significance from any person with an 
applicable health condition, including visitors.   
You should evaluate the different types of visitors on your farm and their interaction with 
covered produce and food contact surfaces, to determine appropriate approaches based on the 
requirements of 21 CFR 112.33.  You have the flexibility to determine how to make visitors 
aware of your policies and procedures to protect covered produce and food contact surfaces from 
contamination by people.  Depending on your farms operations, and the reasons that visitors 
typically come to your farm, it could be appropriate for you to develop procedures specific to 
different types of visitor activities.  You could, for example, specify in your policies and 
procedures that visitors or visibly ill visitors cannot access certain areas or operations (e.g., 
harvesting or packing).  You should inform visitors of how their health and hygienic practices 
while visiting your farm are important to protecting covered produce and food contact surfaces 
from contamination.  You could provide verbal, written, or graphic instructions, or use a 
combination of these.  If you use written or graphic instructions on signs or visual aids, these 
should be in strategic locations, such as near the entrance or fields designated for visitors at a 
pick your own farm operation.  You or your supervisors or other responsible parties should 
communicate the necessary information to visitors as soon as practical after their arrival at your 
farm.   
There are multiple ways for farms to comply with the requirements of 21 CFR 112.33, including 
the following examples:   
Example 3a:  A farm specifies that for visitors that are likely to contact or be in proximity 
to covered produce or food contact surfaces, a supervisor will explain at the beginning of 
the visit the importance of health and hygiene, including thorough hand-washing 
procedures, and the risk from ill or infected visitors with an applicable health condition 
contaminating covered produce or food contact surfaces; their applicable policies and 
procedures; and the location of visitor-accessible restrooms and hand-washing facilities.   
 
Example 3b:  A farm uses one approach to inform all visitors by placing signs stating 
their applicable health and hygiene policies and procedures and the location of visitor
accessible restrooms and hand-washing facilities.  The farm displays this information 
where visitors are likely to see and read it at the beginning of a visit, such as near the 
entrance of the farm, the visitor-accessible restroom, or areas that visitors access.  
 
55  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Example 3c:  A farm provides to all visitors handouts that provide their applicable health 
and hygiene policies and procedures, and the location of visitor-accessible restrooms and 
hand-washing facilities. 
  Toilet and Hand-Washing Facilities 
You must make toilet and hand-washing facilities accessible to visitors.  (21 CFR 112.33(b)).  
You are not required to provide separate toilet and hand-washing facilities for visitors.  Toilet 
facilities can include plumbed facilities or portable facilities.  Note, however, that the general 
requirements that apply to toilet facilities and hand-washing facilities are specified in 21 CFR 
112.129 and 112.130, respectively.  You should inform visitors of the location of toilet facilities 
and hand-washing facilities that are accessible to them. 
56  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Chapter 4: 
Biological Soil Amendments of Animal Origin and Human Waste 
(Subpart F) 
Any biological soil amendment of animal origin (BSAAO) has the potential to be a route of on-
farm contamination of produce (Ref. 73) (Ref. 75) (Ref. 74) (Ref. 84) (Ref. 110) (Ref. 117) (Ref. 
140) (Ref. 143).  The use of unsafe agricultural practices, particularly involving an untreated 
BSAAO, could lead to foodborne illness from the consumption of contaminated produce.9   
This chapter provides draft guidance related to Produce Safety Rule subpart FBiological Soil 
Amendments of Animal Origin and Human Waste.  Subpart F contains minimum standards for 
BSAAOs, including agricultural teas that are BSAAOs, and human waste to minimize the risk of 
contamination and help prevent adulteration10 of your covered produce when you use BSAAOs.  
You may not use human waste for growing covered produce, except sewage sludge biosolids 
used in accordance with the requirements of 40 CFR part 503, subpart D, or equivalent 
regulatory requirements.  (21 CFR 112.53).   
This chapter will help you: 
1.  Determine whether your soil amendment is a BSAAO; 
2.  Determine whether your BSAAO is treated or untreated; 
3.  Determine the appropriate treatment process and associated microbial standard for your 
treated BSAAO; 
4.  Determine how to apply your BSAAO; 
5.  Determine the requirements for handling, conveying, and storing your BSAAO; and 
6.  Determine what records to keep related to your treated BSAAO. 
Figure 4a is a figure to assist you in determining whether your soil amendment is a BSAAO 
and Figure 4b provides the application requirements and minimum application intervals to 
help you understand the applicable requirements for your farm.   
   
                                                 
9 For a more detailed and thorough discussion of the many types, uses, and utility of soil amendments, as well as 
human pathogens associated with untreated BSAAOs and how certain treatments may reduce their prevalence, 
please consult FDAs Qualitative Assessment of Risk (QAR).  (Ref. 54). 
10 Under Section 402 of the FD&C Act.  
57  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Figure 4a.  Determining Whether Your Soil Amendment is a BSAAO 
 
   
58  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Figure 4b.  Application Requirements and Minimum Application Intervals (21 CFR 112.56) 
 
1.  Determine Whether your Soil Amendment is a BSAAO 
You should first determine whether your soil amendment, including an agricultural tea, is a 
BSAAO.  You should refer to the definitions listed in the Produce Safety Rule (21 CFR 112.3) 
that apply to the provisions of subpart F, including the following: soil amendment (SA); 
biological soil amendment (BSA); biological soil amendment of animal origin (BSAAO); 
manure; agricultural tea; agricultural tea additive; pre-consumer vegetative waste; non-fecal 
animal byproduct; stabilized compost; table waste; sewage sludge biosolids; and yard trimmings.  
59  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Understanding the definitions in 21 CFR 112.3 will help you to accurately classify your soil 
amendment.  The following are defined terms from 21 CFR 112.3 that are most frequently used 
in this draft guidance:   
Soil amendment means any chemical, biological, or physical material (such as elemental 
fertilizers, stabilized compost, manure, non-fecal animal byproducts, peat moss, perlite, 
pre-consumer vegetative waste, sewage sludge biosolids, table waste, agricultural tea and 
yard trimmings) intentionally added to the soil to improve the chemical or physical 
condition of soil in relation to plant growth or to improve the capacity of the soil to hold 
water.  The term soil amendment also includes growth media that serve as the entire 
substrate during the growth of covered produce (such as mushrooms and some sprouts). 
Biological soil amendment means any soil amendment containing biological materials 
such as stabilized compost, manure, non-fecal animal byproducts, peat moss, pre-
consumer vegetative waste, sewage sludge biosolids, table waste, agricultural tea, or yard 
trimmings, alone or in combination.  
Biological soil amendment of animal origin means a biological soil amendment which 
consists, in whole or in part, of materials of animal origin, such as manure or non-fecal 
animal byproducts including animal mortalities, or table waste, alone or in combination.  
The term biological soil amendment of animal origin does not include any form of 
human waste.  
Agricultural tea means a water extract of biological materials (such as stabilized compost, 
manure, non-fecal animal byproducts, peat moss, pre-consumer vegetative waste, table 
waste, or yard trimmings), excluding any form of human waste, produced to transfer 
microbial biomass, fine particulate organic matter, and soluble chemical components into 
an aqueous phase.  Agricultural teas are held for longer than one hour before application.  
Agricultural teas are soil amendments for the purposes of the Produce Safety Rule. 
You can determine whether a soil amendment, including an agricultural tea, is a BSAAO by 
determining the nature of the materials (e.g., feedstocks or ingredients) used to prepare them.  
Examples of BSAAOs include the following: 
  Treated, stabilized compost (i.e., finished compost), compost ingredients, or intermediary 
composting materials that contain materials of animal origin; 
  Treated mushroom mulch (i.e., finished mulch), spent (i.e., used previously as a BSAAO) 
mushroom mulch, mushroom mulch ingredients or intermediary materials that contain 
materials of animal origin; 
  Manure (see 21 CFR 112.3); 
  Worm castings; 
  Animal bedding material (e.g., straw) that contains animal excreta; 
  Grass clippings known to include significant animal excreta; 
  Table waste (e.g., post-consumer waste, including components that are animal or plant in 
origin); 
60  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Non-fecal animal byproduct (i.e., solid waste (other than manure) that is animal in origin 
(such as meat, fat, dairy products, eggs, carcasses, blood meal, bone meal, fish meal, 
shellfish waste (such as crab, shrimp, and lobster waste), fish emulsions, and offal) and is 
generated by commercial, institutional, or agricultural operations) (21 CFR 112.3); and 
  Agricultural tea containing biological materials of animal origin. 
2.  Determine Whether your BSAAO is Treated or Untreated 
After you have determined that you are using a BSAAO (including an agricultural tea that is a 
BSAAO), you should determine whether your BSAAO is treated or untreated.  (See 21 CFR 
112.51).  The treatment status of your BSAAO determines what application restrictions of the 
Produce Safety Rule apply.   
  Treated BSAAO 
For BSAAOs, other than agricultural teas, your BSAAO is treated if it was processed to 
completion to adequately reduce microorganisms of public health significance in accordance 
with the requirements of 21 CFR 112.54.  (21 CFR 112.51(a)).  The rule does not require you or 
your supplier to conduct lot-by-lot microbial testing of treated BSAAOs.  If you want to consider 
a BSAAO to be treated, it must be processed to completion using a treatment process 
described in 21 CFR 112.54 that has been validated to meet the relevant microbial standard in 21 
CFR 112.55.  See the section of this chapter titled Determine the Appropriate Treatment 
Process and Associated Microbial Standard for Your Treated BSAAO for further draft guidance 
on treatment processes. 
An agricultural tea that is a BSAAO is treated if the biological materials of animal origin used 
to make the tea have been processed to completion in accordance with the requirements of 21 
CFR 112.54, and the water used to make the tea is not untreated surface water and has no 
detectable generic E. coli in 100 ml water.  (21 CFR 112.51(a)).  Agricultural teas cannot contain 
agricultural tea additives if they are to be considered treated for purposes of 21 CFR 112.51.  
(21 CFR 112.51(b)(5)).   
  Untreated BSAAO 
If a BSAAO is not treated in accordance with the requirements of 21 CFR 112.51(a), it is 
untreated.  A BSAAO other than an agricultural tea is untreated if it has not been processed to 
completion in accordance with the requirements of 21 CFR 112.54.  (21 CFR 112.51(b)).  An 
agricultural tea is untreated if the biological materials of animal origin used to make it have not 
been processed to completion in accordance with the requirements of 21 CFR 112.54, or the 
water used to make the tea is untreated surface water, or the water used to make the tea has 
detectable generic E. coli in 100 mL of water.  (21 CFR 112.51(b)).  Agricultural tea also is 
untreated if it was made with biological materials of animal origin that contain an agricultural 
tea additive.  (21 CFR 112.51(b)(5)).   
In addition, a BSAAO is untreated if any of the following conditions apply:  
  It is contaminated after treatment;  
61  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  It is combined with an untreated BSAAO component after treatment; or 
  It is composed, at least in part, of untreated waste that you know, or have reason to 
believe, is contaminated with a hazard or has been associated with foodborne illness (See 
21 CFR 112.51(b)). 
Examples of untreated BSAAOs include: 
  Bedding materials (e.g., untreated straw, hay, wood chips) containing horse feces that are 
not processed to completion in accordance with 21 CFR 112.54 (21 CFR 112.51(b)(1)); 
  Stockpiled or aged manure that is not processed to completion in accordance with 21 
CFR 112.54 (21 CFR 112.51(b)(1));  
  Cow manure, undergoing turned composting, that has been held at an inadequate 
temperature, for an insufficient number of days, or that has not been turned enough (i.e., 
that is not processed to completion in accordance with 21 CFR 112.54) (21 CFR 
112.51(b)(1)); 
  Treated BSAAO compost contacted by runoff from a pile of untreated cow manure after 
treatment was completed on the compost (21 CFR 112.51(b)(2) and 112.52(c)); 
  Treated BSAAO compost to which bedding materials containing horse feces were added 
after treatment was completed on the compost (21 CFR 112.51(b)(3)); 
  Treated BSAAO mushroom mulch collected after use (i.e., spent material) contaminated 
with animal excreta during storage; 
  Agricultural tea made from raw manure (21 CFR 112.51(b)(1));  
  Agricultural tea made from stockpiled or aged manure that was not processed to 
completion in accordance with 21 CFR 112.54 (21 CFR 112.51(b)(1)); 
  Agricultural tea made from treated BSAAO compost contacted by runoff from a pile of 
untreated cow manure after treatment was completed on the compost (21 CFR 
112.51(b)(2) and 112.52(c)); 
  Agricultural tea made from treated BSAAO compost to which bedding materials 
containing horse feces were added after treatment was completed on the compost (21 
CFR 112.51(b)(3)); 
  Agricultural tea made from treated BSAAO compost and either untreated surface water, 
or water with detectible generic E. coli in 100 ml of water (21 CFR 112.51(b)(1)); and 
  Agricultural tea made from treated BSAAO compost to which molasses has been added 
as an agricultural tea additive (21 CFR 112.51(b)(5)).   
You may manage an untreated BSAAO in several ways:  
  Using it as an untreated BSAAO to grow covered produce (in accordance with the 
application restrictions in 21 CFR 112.56(a)(1)); 
  Treating or re-treating it (in accordance with 21 CFR 112.51 and 21 CFR 112.54) to 
enable using it as a treated BSAAO to grow covered produce (in accordance with the 
application restrictions in 21 CFR 112.56(a)(2) or (3)); 
  Using it in a manner that is not subject to the requirements of 21 CFR Part 112 (e.g., 
using it to grow produce not covered by the Produce Safety Rule or a non-produce crop); 
or 
  Disposing of it in accordance with local, state, and federal requirements. 
62  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
3. Determine the Appropriate Treatment Process and Associated 
Microbial Standard for your Treated BSAAO 
The Produce Safety Rule establishes application restrictions (application methods and 
application intervals) for BSAAOs based on whether they are untreated or treated, and for those 
that are treated, based on the level of treatment.  (See 21 CFR 112.56).  Thus, the level of 
treatment you choose for a treated BSAAO will affect the application method you use for the 
BSAAO in growing covered produce.  See the section of this draft guidance titled Determine 
How to Apply Your BSAAO. 
There are two different levels of treatment (i.e., microbial standards) available for treated 
BSAAOs; they appear in 21 CFR 112.55(a) and (b).  The treatment level in 21CFR 112.55(a) is 
more stringent than the treatment level in 21 CFR 112.55(b).  The two microbial standards are 
listed below:   
  Figure 4d.  21 CFR 112.55(a) (linked to the treatment processes in 21 CFR 112.54(a)): 
For the microorganism -  The microbial standard is - 
Not detected using a method that can detect one colony forming unit 
  L. monocytogenes  (CFU) per 5 gram (or milliliter, if liquid is being sampled) analytical 
portion. 
Not detected using a method that can detect three most probable 
  Salmonella species  numbers (MPN) per 4 grams (or milliliter, if liquid is being 
sampled) of total solids. 
Not detected using a method that can detect 0.3 MPN per 1 gram (or 
  E. coli O157:H7 
milliliter, if liquid is being sampled) analytical portion. 
 
  Figure 4e.  21 CFR 112.55(b) (linked to the treatment processes in 21 CFR 112.54(b)): 
For the microorganism -  The microbial standard is - 
Not detected using a method that can detect three MPN per 4 grams 
  Salmonella species 
(or milliliter, if liquid is being sampled) of total solids. 
Less than 1,000 MPN per gram (or milliliter, if liquid is being 
  Fecal coliforms 
sampled) of total solids. 
 
63  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
There are various processes to treat BSAAOs.  The Produce Safety Rule describes acceptable 
treatment processes in 21 CFR 112.54(a) and (b) for the treatment of BSAAOs to be used for 
growing covered produce, provided that the resulting BSAAOs are applied in accordance with 
the applicable requirements of 21 CFR 112.56 (See 21 CFR 112.54).   
You have the flexibility to determine a treatment process for your BSAAO under 21 CFR 
112.54.  You can use a physical process (e.g., heat), a chemical process (e.g., high alkaline pH), 
a biological process (e.g., composting), or a combination of processes (Ref. 30) (Ref. 137).  A 
scientifically valid treatment process is an approach based on scientific information, data, or 
results, published in, for example, scientific journals, references, text books, or peer-reviewed 
literature, or contained in proprietary research.   
  Validation Studies 
Validation studies are used to demonstrate that treatment processes meet the applicable microbial 
standards.  A treatment process must be validated to satisfy one of the two microbial standards 
contained in 21 CFR 112.55.  (See 21 CFR 112.54).  The validation studies upon which you rely 
may use any analytical method if the testing methods meet the sensitivity requirements (i.e., 
detection threshold) specified in 21 CFR 112.55.  FDA does not expect farms to perform 
validation studies related to BSAAO treatment processes; however, farms should ensure that the 
treatment processes they use have been validated to meet the standards of the Produce Safety 
Rule.  You could, for example, work with technical assistance resources, such as your BSAAO 
suppliers, academia, extension services, and industry associations to assist you with evaluating 
validation studies and your practices. 
Two examples of scientifically valid, controlled biological (e.g., composting) treatment 
processes that meet the microbial standard in 21 CFR 112.55(b) are provided in 21 CFR 
112.54(b)(1) and (b)(2), so no further validation of these treatments is necessary.  Although 21 
CFR 112.54(b)(1) and (b)(2) provide two example processes that you may use to satisfy the 
microbial standard in 21 CFR 112.55(b).  These are not the only means of achieving composting 
treatments that meet the microbial standard in 21 CFR 112.55(b), and we do not discourage you 
from using other processes that meet the requirements of 21 CFR 112.54.   
Validation studies should: 
  Adequately examine the treatment process and its ability to consistently and predictably 
meet the required microbial standard;    
  Consider the types of materials that will be used;  
  Consider the density of the materials;  
  Consider the potential for non-homogeneous material;  
  Consider the amount of material to be treated; 
  Consider the relevant environmental conditions (e.g., temperature, humidity, and 
precipitation, as could be impacted by regional or seasonal influences); 
  Include multiple repetitions of microbial testing performed using a statistically valid 
sampling plan to verify that the treatment process will consistently produce a BSAAO 
that meets the microbial standard; and 
64  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Outline the parameters (e.g., time, temperature, pH, moisture, number and timing of 
turnings, carbon:nitrogen ratio) to be controlled, and the acceptable limits or ranges for 
those parameters, in order to achieve the microbial treatment levels. 
The body of validation data used should demonstrate that the selected parameters are likely to be 
effective under production conditions similar to those used at the treatment site. Materials that 
are non-homogeneous could contain particles that react differently (e.g., heat at different rates) 
during the process.  Pathogens could be insulated (i.e., protected) within denser BSAAO 
material, which means that less homogeneous materials could require more intense treatment to 
meet the microbial standard.  In some cases, pilot scale studies may not be indicative of 
biological responses at a larger production scale.  Process validation is critical to ensuring that a 
treatment process will consistently achieve the specified standards.   
  Processes to Treat BSAAOs 
You must ensure that the treatment is processed to completion (See 21 CFR 112.51).  You 
should: 
  Establish procedures to ensure delivery of the scientifically valid, controlled process 
throughout the BSAAO;   
  Administer the treatment process in a controlled manner to ensure that the treatment 
parameters (e.g., time, temperature, moisture content, pH) established during validation 
are achieved throughout the entirety of the BSAAO material;  
  Ensure that the BSAAO is sufficiently homogenized during the treatment process, as 
applicable (e.g., blending or turning a compost pile); and 
  Ensure that the treatment parameters are achieved in areas of the material where delivery 
of the process could be more challenging to achieve, such as the bottom or edges of the 
pile (e.g., adding a blanket of straw for insulation; appropriate number and placement of 
thermometers).      
With respect to processing the BSAAO to completion using the example of turned composting 
under 21 CFR 112.54(b)(2), consider that every compost pile has a unique size, shape, and 
material (i.e., feedstocks or ingredients) composition, all of which affects how the pile will 
generate and maintain heat.  For example, many compost windrows will reach 131F (55C) 
relatively quickly, at which time the operator will begin monitoring the days above this 
temperature toward meeting the fifteen days of exposure to 131F (55C) per 21 CFR 
112.54(b)(2).  The operator will typically manage both oxygen and nutrients via turning, and, in 
some situations, moisture, to maintain the 131F (55C) temperature for a total of 15 days.  
Turning the piles also serves the purpose of maximizing exposure of the compost material to the 
elevated temperatures.  To ensure exposure to the 131F (55C) temperature, specified in the 
example treatment provided in 21 CFR 112.54(b)(2), a minimum of 5 turnings are specified, but 
we do not specify a timeframe for each of the turns.  Certain factors, such as windrow size or 
shape, or material composition or density, could influence the appropriate timing for turning.   
The treatment processes provided in 21 CFR 112.54(b)(1) and (b)(2) include adequate curing as 
the final component.  Curing is defined at 21 CFR 112.3. Curing is an important and necessary 
step to produce treated, stabilized compost (Ref. 35) (Ref. 40).   
65  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
4.  Determine How to Apply your BSAAO 
The requirements for application of your BSAAO are linked to whether it is treated or untreated, 
and, when treated, based on the level of treatment it received.  (See 21 CFR 112.56).  To 
determine how to apply your BSAAO, you should consider the following factors:  
  Whether the BSAAO is treated or untreated; 
  If treated, the level of treatment the BSAAO received; 
  Based on the BSAAOs treatment status and level of treatment (if applicable), the 
resulting application restrictions provided by the Produce Safety Rule;  
  The application methods that you could use and the likelihood of contact between the 
BSAAO and the harvestable or harvested part of the crop (e.g., broadcast application 
usually results in contact with covered produce; some other methods, such as injection or 
manual application, are less likely to result in contact);  
  Practices you could use after application and the likelihood of contact between the 
BSAAO and the harvestable or harvested part of the crop (e.g., incorporation into the soil 
or application of plasticulture prior to planting usually reduces the likelihood of contact 
with covered produce that grows above the ground); 
  The type of covered produce (e.g., grows in the ground, grows low to the ground, grows 
high above the ground);  
  The maturity of the covered produce at the time of application (e.g., whether the 
harvestable or harvested part is present at time of application);  
  The location of growing area where the BSAAO is applied with respect to surrounding 
growing areas (e.g., covered produce in fields adjacent to a field where the BSAAO is 
applied); and  
  The environmental conditions that could impact movement of BSAAO particulates. 
We provide examples throughout this section to illustrate potential approaches for the application 
of BSAAOs given the requirements of 21 CFR 112.56; we also identify specific covered produce 
in these examples for illustrative purposes.  Even if you use similar practices for the specific 
covered produce mentioned in these examples, you should evaluate your farms specific 
conditions and practices, such as through a visual assessment, to determine compliance with the 
regulatory requirements.  
  Untreated BSAAO 
Untreated BSAAOs must be applied in one of two ways: 
  Application in a manner that does not contact covered produce during application 
and minimizes the potential for contact with covered produce after application; or  
  Application in a manner that does not contact covered produce during or after 
application.  (21 CFR 112.56(a)).  
The two methods of application are the same regarding contact with covered produce during 
application of the BSAAO.  These two application methods for untreated BSAAOs are different 
because the second type of application does not involve contact with covered produce after 
66  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
application of the BSAAO.  The minimum application interval (i.e., interval between application 
of the BSAAO and harvest) specified for each method of application is discussed in the section 
of this chapter titled Minimum Application Interval.   
  Contact with Covered Produce During Application 
Untreated BSAAOs must be applied in a manner that does not contact covered produce during 
application.  (See 21 CFR 112.56(a)(1)(i) and 21 CFR 112.56(a)(1)(ii)).  This means there is no 
intended or likely contact between the untreated BSAAO and the harvestable or harvested part of 
the crop during application.  Your evaluation of your farms practices should assist you in 
determining how to apply your BSAAO based on this requirement.  You should consider the 
factors listed in the introduction of this section to determine how to apply your untreated 
BSAAO. 
Some application methods result in BSAAOs contacting the covered produce during application, 
and therefore cannot be used to apply untreated BSAAOs when the harvestable or harvested part 
of the crop is present during application.  Certain methods, such as broadcast application with 
any crop or mechanical side-dressing with crops growing on or near the ground, result in contact 
between the untreated BSAAO and the harvestable or harvested part of the crop during 
application.   
Example 4a:  If a farm applies an untreated BSAAO using a broadcast spreader (i.e., 
application throughout the field) while the harvestable or harvested part of the crop is 
present, widespread contact between the BSAAO and the crop would occur during 
application.   
You must not place, spread, or spray the untreated BSAAO in such a way that it contacts the 
harvestable part of your covered produce during application.  (See 21 CFR 112.56).   
Example 4b:  If, for example, a farm manually applies (e.g., with a shovel) an untreated 
BSAAO to the soil used to grow a crop growing high above the ground (e.g., pistachios) 
when the harvestable or harvested part is present, the untreated BSAAO would not 
contact the pistachios during application when properly applied.   
  Contact with Covered Produce After Application 
You must apply untreated BSAAOs so that, after application of the BSAAO, either (1) the 
BSAAO does not contact covered produce, or (2) the potential for contact with covered produce 
has been minimized.  (See 21 CFR 112.56(a)).   
As discussed above (regarding contact during application), to meet the requirement that the 
BSAAO does not contact covered produce after application, there is no intended or likely contact 
between the BSAAO and covered produce during the relevant time period (in this case, after 
application).  In Example 4b, if the pistachios were harvested without dropping the pistachios to 
the ground and there was otherwise no contact between the pistachios and the ground during 
growing or harvesting, then contact between the untreated BSAAO and the harvestable or 
harvested part of the pistachios after application is not intended or likely (i.e., it meets the 
67  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
requirement that the BSAAO does not contact covered produce after application).  This is the 
case even if there was some remote potential for the BSAAO to contact the harvestable or 
harvested part of the covered produce (e.g., particles to be lifted by the wind to the height of the 
harvestable or harvested part of the pistachios after applying the BSAAO to the soil).  There is 
always a chance that some soil amendment could be present in dust such that it settles on 
covered produce; however, we do not believe at this time that this type of potential contact is 
significant enough to be considered intended or likely for purposes of 21 CFR 112.56.   
Minimize the potential for contact means there is no intended contact between the BSAAO and 
covered produce during the relevant time period, but some unintentional contact is likely due to 
incidental or environmental action.   
Example 4c.  If a farm applies untreated manure on top of the soil prior to planting a field 
of green beans, while there would be no intended contact between the untreated BSAAO 
and the harvestable or harvested part of the crop after application, some unintentional 
contact between the untreated manure and the harvestable or harvested part of the green 
beans could occur because the manure could be carried by splash to the green beans 
during heavy rains.  The farms procedures include that during growing, the green bean 
plants will be attached to stakes to assist in minimizing the potential for contact between 
the harvestable or harvest part of the crop and the BSAAO after application. 
Example 4d:  There would be no intended contact after application for an untreated 
agricultural tea applied pre-planting as a drench or spray onto the soil for growing 
cauliflower; however, some unintentional contact between the untreated BSAAO and the 
harvestable or harvested part of the cauliflower could occur as a result of splash during 
heavy rains between the BSAAO and the cauliflower after application.  In the farms 
evaluation of factors, the harvestable or harvested part of the cauliflower is not present 
until several weeks after application, the covered produce grows above the ground with 
surrounding outer leaves, and the farm determined that rain events are infrequent during 
the growing and harvesting seasons. 
In some cases, contact is both intentional and likely.   
Example 4e:  If a farm incorporates an untreated BSAAO into the soil immediately prior 
to planting for the production of a root crop, this would cause the untreated BSAAO to 
contact the root crop after application (e.g., during growing).  In this example, contact 
between the covered produce and the untreated BSAAO after application is both 
intentional and likely to occur and its application does not meet the requirements for 
untreated BSAAO under 21 CFR 112.56(a). 
  Minimum Application Interval  
The minimum application interval of an untreated BSAAO that is applied in a manner that does 
not contact covered produce during or after application is zero days.  (21 CFR 112.56(a)(1)(ii)).  
A minimum application interval of zero days means that harvesting of the covered produce can 
occur on the same day that the untreated BSAAO is applied.   
68  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
FDA has not determined the minimum application interval for untreated BSAAOs that are 
applied in a manner that does not contact covered produce during application and minimizes the 
potential for contact with covered produce after application.  FDA reserved the provision that 
provides the minimum application interval of untreated BSAAO that is applied in a manner that 
does not contact covered produce during application and minimizes the potential for contact with 
covered produce after application.  (21 CFR 112.56(a)(1)(i)).  As a result, the requirements for 
the minimum application interval for untreated BSAAOs under 21 CFR 112.56(a) do not differ 
as of the date of publication of this draft guidance.  We are deferring action on an application 
interval until we pursue certain steps, including a risk assessment and further research.   
We acknowledge that many organic growers currently employ the National Organic Program 
(NOP) standard of 90 days or 120 days, as specified in 7 CFR 205.203(c)(1), and we recognize 
that such growers will likely continue to use this standard for organic crop production.  We do 
not object to growers use of a 90 or 120 day application interval for untreated BSAAOs subject 
to 21 CFR 112.56(a)(1)(i).  We believe adherence to a 90 or 120 day application interval to be a 
prudent step toward minimizing the likelihood of contamination while the risk assessment and 
further research occur.   
  Treated BSAAO 
For BSAAOs that undergo treatment processes that meet the requirements of 21 CFR 112.54(a) 
(that is, they meet the more stringent level of treatment in the Produce Safety Rule), you may 
apply the treated BSAAO in any manner, and the minimum application interval is 0 days.  In 
other words, you do not need to apply the BSAAO in a manner that does not contact covered 
produce either during or after application of the BSAAO or that minimizes the potential for such 
contact.  Additionally, covered produce can be harvested immediately after application of the 
BSAAO.  (21 CFR 112.56(a)(3)).  If you apply your treated BSAAO agricultural tea as a soil 
amendment in a manner that is intended or likely to contact (e.g. through splash, spray or 
leeching) your covered produce during or after application, the BSAAO used to prepare it must 
be treated to meet the requirement of 21 CFR 112.54(a).  (See 21 CFR 112.56(a)(3)). 
For BSAAOs that undergo treatment processes that meet 21 CFR 112.54(b) (that is, they meet 
the less stringent level of treatment in the rule), you must apply the treated BSAAO in a manner 
that minimizes the potential for contact with covered produce during and after application; and 
the minimum application interval is 0 days, which means covered produce can be harvested 
immediately after this BSAAO is applied.  (21 CFR 112.56(a)(2)).   
Example 4f: A farm chooses to side-dress a leafy green crop with a treated BSAAO 
compost that meets 21 CFR 112.54(b) (a BSAAO treated to meet the less stringent level 
of treatment in the rule) along the base of planted crop rows, either by manual application 
or by using specialized equipment to target application to the soil (e.g., at the base of a 
raised bed), which results in minimizing the potential for contact of the treated compost 
with the crop.  In this example, after application of the treated BSAAO, some limited 
potential for contact between the untreated BSAAO and the leafy green crop exists due to 
incidental or environmental action, such as by splash during heavy rains, but such 
contact, nonetheless, is generally minimized.  The farm determines that rain events are 
69  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
infrequent during the growing and harvesting seasons, and the farms procedures include 
removal of outer leaves during harvest. 
Example 4g:  For a treated BSAAO agricultural tea that meets 21 CFR 112.51(a) and 
112.54(b)) if a farm applies the treated BSAAO agricultural tea by side-dressing the soil 
(via hand sprayer or soil drench) for broccoli plants prior to flowering, some limited 
potential for contact exists between the untreated BSAAO and the harvestable or 
harvested part of the broccoli after application by splash during heavy rains, but such 
contact, nonetheless, is generally minimized.  In the farms evaluation of factors, the 
broccoli grows above the ground with surrounding outer leaves, and the farm determines 
that rain events are infrequent during the growing and harvesting seasons.  
Some application methods for BSAAOs do not minimize the potential for contact with covered 
produce during application and therefore should not be used for BSAAOs unless they have been 
treated to meet the more stringent standard in the rule.  That is, they can be used for BSAAOs 
that meet 21 CFR 112.54(a) but not for BSAAOs that only meet the treatment requirements of 21 
CFR 112.54(b).   
Example 4h: If the farm in Example 4f instead applied the treated BSAAO using a 
broadcast spreader (i.e., application throughout the field) while the harvestable or 
harvested part of the crop was present, it could be reasonably expected that there would 
be widespread contact between the BSAAO and the harvestable or harvested part of the 
leafy greens during application (as well as after application).     
The following figure summarizes requirements of 21 CFR 112.55 and 112.56, as applicable, for 
treated BSAAOs.      
Figure 4f.  Microbial Standards and Application Requirements for Treated BSAAOs. 
BSAAO  BSAAO  BSAAO  BSAAO  BSAAO  BSAAO  BSAAO 
Treatment  Microbial  Microbial  Microbial  Microbial  Application  Application 
Process   Standards   Standards   Standards   Standards   (112.56)  (112.56) 
( 112.54)  ( 112.55)  ( 112.55)  ( 112.55)  ( 112.55) 
for  for  for  for    Minimum 
L. monocytogenes  Salmonella  E. coli O157:H7  Fecal Coliforms  Interval 
 
 112.54(a)  
Any manner 
Scientifically 
(no restrictions)   
Valid Treatment  Not detected1  Not detected2  Not detected3  Not Applicable  0 Days 
Process to meet  
( 112.56(a)(3)) 
112.55(a)5 
Minimizes 
 112.54(b)  
potential contact 
Scientifically  <1,000 MPN per 
during and after 
Valid Treatment  Not Applicable  Not detected2  Not Applicable  gram (total  0  Days 
application 
process to meet   solids)4 
112.55(b)6 
( 112.56(a)(2)) 
1  Using a method that can detect 1 CFU per 5 grams (or milliliter, if liquid is being sampled) analytical portion. 
70  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
2  Using a method that can detect 3MPN Salmonella species per 4 grams (or milliliter, if liquid is being sampled) of total 
solids. 
3  Using a method that can detect 0.3 MPN per 1 gram (or milliliter, if liquid is being sampled) analytical portion 
4  Per milliliter (if liquid is being sampled) of total solids (dry weight) 
5  See figure 4d. 
6  See figure 4e. 
5.  Determine the Requirements for Handling, Transporting, and Storing 
your BSAAO 
The requirements of 21 CFR 112.52 state how you must handle, convey, and store BSAAOs.  
You should carefully evaluate your handling, transport, and storage practices for your BSAAOs 
(both treated and untreated) for the potential to contaminate your growing areas, water sources, 
water distribution systems, other soil amendments (including treated BSAAOs), areas used for 
covered activities, covered produce, and food contact surfaces.  (See 21 CFR 112.52(a)).  During 
your evaluation, you should remember that untreated BSAAOs include incomplete or partially 
treated BSAAOs and re-contaminated BSAAOs. 
You should evaluate your storage practices and the location of your BSAAOs to determine 
whether they are managed in a way that they do not become a potential source of contamination.  
You should not store these materials in locations where runoff (e.g., from rain or intentionally-
added water) could cause contamination of covered produce growing, harvesting, packing, or 
holding areas, agricultural water sources, or other soil amendments.  You, for example, could 
address this concern through the implementation of runoff controls (e.g., buffer strips or 
catchment ditches to divert or absorb any runoff) or with physical containment systems (e.g., 
concrete block walls, soil berms, pits, or lagoons) to prevent runoff.   
You must handle, convey, and store any treated BSAAO in a manner and location that minimizes 
the risk of it becoming contaminated by untreated or in-process BSAAOs.  (21 CFR 112.52(b)).   
You should also take measures to reduce the potential for your stored, treated BSAAO to become 
contaminated from sources other than BSAAOs, such as from wildlife intrusion and runoff from 
adjacent land.  To minimize the risk of it becoming contaminated, you could consider selecting 
storage locations where the treated BSAAOs are unlikely to contact untreated BSAAOs, 
covering the treated BSAAO with a tarp when the location is not subject to runoff, or storing it in 
an enclosed building.  You should ensure that your personnel are aware of potential sources of 
contamination and periodically assess storage areas for sources of contamination.  If your treated 
BSAAO becomes contaminated, you must handle, convey, and store as if it were untreated.  (See 
21 CFR 112.52(c)). 
You should evaluate how you and your personnel use equipment and tools (e.g. shovels, front 
end loaders, windrow turners) for handling BSAAOs to minimize the risk of contamination from 
an untreated BSAAO to a treated BSAAO.  You should consider whether the equipment that you 
use to handle treated BSAAOs (including agricultural teas that are BSAAOs) are also used to 
handle untreated BSAAOs, which could result in contamination.  You should ensure that your 
personnel use practices that minimize the risk of this contamination.  For example, you could use 
dedicated equipment and tools for activities involving contact with treated BSAAOs, limiting 
their use only for contact with treated BSAAOs. You also, for example, could clean and sanitize 
equipment and tools previously used with untreated BSAAOs before use with treated BSAAOs.  
71  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Personnel who handle BSAAOs, supervisors, and responsible parties should understand the 
potential routes of contamination associated with BSAAOs, your practices and procedures, and 
how to take appropriate corrective measures when they observe conditions that could lead to 
contamination.  You should direct your supervisors or other responsible parties, as applicable, 
with ensuring that your personnel consistently implement practices and procedures related to 
BSAAOs based on the regulatory requirements.   
6.  Determine What Records to Keep for your Treated BSAAO 
For treated BSAAOs that you acquire from a third party, you are required to maintain 
documentation, at least annually, that (1) the process used by your supplier to treat the BSAAO 
is a scientifically valid process that has been carried out with appropriate process monitoring 
(e.g., monitoring of time/temperature, moisture content, and pH); and (2) the BSAAO has been 
handled, conveyed, and stored in a manner and location to minimize the risk of contamination by 
an untreated or in-process BSAAO.  (See 21 CFR 112.60(b)(1)).  One example of such 
documentation is a Certificate of Conformance, provided at least annually, that certifies that 
these conditions will be met.   
For example, a farm that receives a treated BSAAO from a third party could keep a record that 
includes a statement such as: A scientifically valid thermal treatment was applied and carried 
out with appropriate process monitoring to satisfy the microbial standard in 21 CFR 11.55(a).  
The BSAAO has been handled, conveyed, and stored in a manner and location to minimize the 
risk of contamination.  In addition, other information related to producing or managing the 
BSAAO, such as the BSAAO materials used, process parameters monitored and their results, and 
any applicable test results could be included.  
For a treated BSAAO that you produce for your own covered farm(s), you must establish and 
keep documentation that the process controls (for example, time, temperature, and turnings) were 
achieved.  (See 21 CFR 112.60(b)(2)).  You should evaluate your farms specific processes to 
determine the documentation necessary to comply with the requirements of 21 CFR 
112.60(b)(2).   
Such documentation for treated, turned compost could include, for example: 
  a log book that lists the following: the date that composting began; the nature of the 
materials(s) (e.g., a compost that contains raw cow manure);  
  the carbon:nitrogen ratio of the materials (e.g. 25-30:1); the temperature profile (date, 
time, and location of each temperature measurement);  
  the date and time of each turning event; the date and results of moisture content and pH 
determinations;  
  the date of any addition of water; the date insulation (if any) was added and the means of 
insulation (e.g., three-inch layer of straw over pile); and  
  the end date of the composting and curing processes.   
Note that this list is for illustrative purposes only, and would not be applicable in all cases.   
72  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
If, for example, a farm receives from a third party a treated BSAAO that will be subject to 
further treatment processes on the farm, the farm could choose to obtain from the third party 
documentation about the process used to treat those BSAAOs, and how they were handled, 
conveyed, and stored.  In this example, the farm must keep records for the treated BSAAO 
produced on their covered farm (21 CFR 112.60(b)(2)).  We provide additional draft guidance on 
general records requirements in Chapter 8: Records (Subpart O). 
 
73  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Chapter 5: 
Domesticated and Wild Animals (Subpart I) 
Domesticated and wild animals are sources of pathogens (Ref. 107) (Ref. 113) (Ref. 139) (Ref. 
143) that can transmit foodborne disease through the contamination of produce (Ref. 60) (Ref. 
77) (Ref. 86) (Ref. 90) (Ref. 117).  Even domesticated companion animals, such as dogs and 
cats, can carry pathogens that could be transferred to humans (Ref. 31) (Ref. 111), including 
Salmonella spp. (Ref. 6) (Ref. 129) and pathogenic strains of E. coli (Ref. 13) (Ref. 103).  
Furthermore, pathogens associated with animal sources (e.g., animal excreta) (Ref. 110) (Ref. 
113) (Ref. 141) can survive for prolonged periods of time in the environment where they are 
deposited, such as in soil and water (Ref. 109).  In this chapter, we use specific animals (e.g., 
cows, dogs, swine, birds, and deer) as examples to provide draft guidance on protecting covered 
produce from contamination by animals; the animals used in the examples are not the only 
animals that can be a potential source of contamination of covered produce. 
The Produce Safety Rule does not authorize the taking of threatened or endangered species as 
that term is defined by the Endangered Species Act (16 U.S.C. 1531-1544) (i.e., to harass, harm, 
pursue, hunt, shoot, wound, kill, trap, capture, collect, or to attempt to engage in any such 
conduct).  Further, the Produce Safety Rule does not require covered farms to take measures to 
exclude animals from outdoor growing areas, or to destroy animal habitat or otherwise clear farm 
borders around outdoor growing areas or drainages.  (21 CFR 112.84.)  We recognize and 
support the longstanding co-location of animals and plant food production systems in agriculture, 
and do not prohibit animals from covered farms. 
The requirements of subpart I are science-based minimum standards regarding the potential for 
domesticated or wild animals to contaminate covered produce, and are reasonably necessary to 
minimize the risk of serious adverse health consequences or death from covered produce.  These 
standards address the potential for biological hazards to be introduced by your own domesticated 
animals, by domesticated animals from a nearby area, or by wild animals.  The requirements of 
subpart I apply only when covered activities occur in outdoor areas or partially-enclosed 
buildings and when, under the circumstances, a reasonable probability exists that animals will 
contaminate covered produce; they do not apply when a covered activity takes place in fully-
enclosed buildings or to fish used in aquaculture operations.  (See 21 CFR 112.81.)   
This chapter will help you: 
1.  Determine whether, under the circumstances, there is a reasonable probability that 
animals will contaminate your covered produce; 
2.  Assess the relevant outdoor areas and partially-enclosed buildings (i.e., relevant areas) on 
your farm for evidence of potential contamination of covered produce by animals; and 
3.  Evaluate significant evidence of potential contamination of covered produce by animals 
to determine whether harvest can occur. 
There are other requirements of the Produce Safety Rule that relate to animals.  Draft guidance 
on those requirements can be found in the following chapters and sections of this document: 
74  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Chapter 3: Health and Hygiene (Subpart D) sections titled Avoiding Contact with 
Animals Other Than Working Animals and Thorough Hand-washing; 
  Chapter 6: Growing, Harvesting, Packing, and Holding Activities (Subpart K) section 
titled Identifying and Not Harvesting Contaminated Covered Produce; and 
  Chapter 7: Equipment, Tools, Buildings, and Sanitation (Subpart L) sections titled 
Domesticated Animals; Pest Control; and Animal Excreta and Litter from 
Domesticated Animals. 
1.  Determining Reasonable Probability That Animals Will Contaminate 
Covered Produce 
To determine whether subpart I applies to you, you should: 
  Identify outdoor areas and partially-enclosed buildings on your farm where covered 
activities occur during the growing season; and 
  Determine whether, under your specific circumstances, there is a reasonable probability 
that animals will contaminate covered produce in these identified outdoor areas or 
partially-enclosed buildings during the growing season.  (See 21 CFR 112.81and 
112.83.) 
You should evaluate your farms covered produce, conditions, and practices when determining 
the probability that animals will contaminate your covered produce in these areas.  This should 
include an evaluation of the types of animals that could contaminate your covered produce, 
based on: 
  Available historical observations of animals; and 
  Other information and factors (e.g., presence of animal attractants or habitats) that could 
influence animal presence on or near your farm. 
Wild and domesticated animals, including your own domesticated animals and those from a 
nearby area, could be sources of contamination for covered produce and food contact surfaces.  
Wild and domesticated animals on or near your farm include feral, grazing, and working animals 
(e.g., guard dogs), livestock, and pets.  You should consider the presence of animal attractants or 
habitats on or near your farm (e.g., water and food sources; discarded produce, brush, or waste 
piles; wooded areas; areas used for concentrated animal housing or holding, such as animal barns 
or feeding operations; and potential nesting areas) that influence the presence of animals.  You 
should also consider seasonal presence of animals on your farm, such as areas used for resting or 
feeding by large numbers of Canada geese or other birds along their migration routes.   
In your evaluation, you should also consider land features (e.g., topography), land use, and the 
presence of existing measures or structures on or near your farm that affect whether animals (or 
their waste) will be present on your farm.  This could include features that control runoff 
containing animal waste (e.g., ditches, mounds, diversion berms, vegetative buffer strips, or 
animal waste containment structures) or other structures that impact your relevant areas.  For 
example, if you have well-designed and maintained diversion berms that prevent cattle waste 
75  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
runoff from entering your covered produce field, there would not be a reasonable probability that 
runoff from the diverted animal waste will contaminate your covered produce in that field.   
FDA encourages the application of practices that enhance food safety and that are consistent with 
sustainable conservation.  We do not expect, suggest, or recommend that farms eliminate animals 
from outdoor growing areas.  Nor do we require the application of practices that may adversely 
affect wildlife, such as removal of habitat or wild animals from land adjacent to produce fields.  
If you determine that there is a reasonable probability that animals will contaminate your covered 
produce, you must assess the relevant areas used for a covered activity for evidence of potential 
contamination of covered produce as needed during the growing season.  (See 21 CFR 
112.83(b)(1)).       
The following examples illustrate how a farm could evaluate their covered produce, conditions, 
and practices to determine whether there is a reasonable probability that animals will 
contaminate covered produce.  These examples are intended to illustrate concepts and are not 
intended to be universally applicable.  Even if you have circumstances similar to those 
mentioned here, you should perform your own evaluation based on your farms specific practices 
and conditions. 
Example 5a:  If a farm determines that their growing areas in partially-enclosed shade 
houses for Swiss chard are not located near animal attractants or habitats, and there have 
been no observations of animals with the potential to contaminate covered produce in 
these houses, then there is no reasonable probability that animals will contaminate the 
Swiss chard.  
Example 5b:  If a farm determines that their outdoor growing areas for mustard greens 
are near a pond that is a habitat for water fowl, and the water fowl and their excreta are 
frequently observed in the outdoor mustard greens growing areas, then there is a 
reasonable probability that the water fowl will contaminate those mustard greens.   
You should periodically re-evaluate your farms conditions and practices.  Changes on or near 
your farm could impact the probability that animals will contaminate your covered produce.  
Certain temporary or unusual conditions could influence whether there is a reasonable 
probability that animals will contaminate your covered produce.  Construction or cultivation on 
or near your farm, or weather events (Ref. 102), such as heavy rains, droughts, or fires (Ref. 91), 
could alter animal movements or cause atypical or unanticipated animal presence.  For example, 
during a drought, nearby wild animals could be more likely to enter your farm to access areas 
where you hold water, or animals could change their movements to avoid flooded areas during 
periods of heavy rainfall.  If these events occur, you should determine whether the conditions on 
or near your farm have changed in a way that affects a previous determination of whether there is 
a reasonable probability that animals will contaminate your covered produce.   
We concluded that it is not necessary for farms to apply the requirements of subpart I to covered 
produce that grows completely underground because there will not be a reasonable probability of 
contamination by animals as a general matter because of the growth habit of such produce; 
however, covered produce that grows completely underground is subject to other requirements of 
the Produce Safety Rule, as applicable, including 21 CFR 112.112 that requires you to take all 
76  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
measures reasonably necessary to identify and, not harvest, covered produce that is reasonably 
likely to be contaminated with a known or reasonably foreseeable hazard.   
2.  Assessing Relevant Areas for Evidence of Potential Contamination of 
Covered Produce 
If you determine that there is a reasonable probability that animals will contaminate your covered 
produce, you must assess the relevant areas used for a covered activity for evidence of potential 
contamination of covered produce as needed during the growing season.  (See 21 CFR 
112.83(b)(1)).  You have the flexibility to assess the relevant areas based on your covered 
produce, your practices and conditions, and your observations and experience.  (See 21 CFR 
112.83(b)(1)).  You should develop an approach that will assist you in assessing relevant areas 
for evidence of potential contamination of covered produce.  Your approach to assessment could 
vary depending on the types of animals and other factors you identified in determining whether 
there is a reasonable probability that animals will contaminate your covered produce in each 
relevant area on your farm.   
In your approach to assessment, you should consider the following: 
  The personnel who are responsible for monitoring the relevant areas; 
  The timing and frequency of monitoring; and 
  The reporting of observations of evidence of potential contamination (i.e., how and 
when reporting occurs and to whom). 
The outcome of your monitoring activities will help you determine whether you need to take any 
additional action with respect to your covered produce. Additional action is discussed in the 
section of this chapter titled Evaluating Significant Evidence of Potential Contamination of 
Covered Produce by Animals to Determine Whether Harvest Can Occur.  
  Developing and Modifying Your Approach to Assessment 
You should periodically evaluate your approach to assessment and modify it as needed. There 
are several factors you should consider in developing and modifying your approach to 
assessment, including: 
  The types of animals that you determined have a reasonable probability of 
contaminating your covered produce; 
  The expected numbers of such animals (i.e., animal populations); 
  The expected frequency of animal activity (e.g., monthly, weekly);  
  The likely location of animal activity that impacts your relevant areas (e.g., 
nearby attractants or habitats); and 
  The expected time of day of animal activity (e.g., early morning, dusk).   
Factors that influence animal presence, such as the presence of animal attractants or habitats 
(e.g., standing water, discarded produce piles, wooded areas, potential nesting areas, and 
identified animal pathways) on or near the relevant areas on your farm, should inform where and 
how often you monitor these areas.  For example, if one of the growing areas you plan to monitor 
77  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
is directly adjacent to a wooded area, that growing area could be more prone to animal activity, 
especially along the wood line, and warrant more frequent monitoring than other growing areas 
that are not near animal attractants.   
You should monitor when animals are more likely to be present in your outdoor areas or 
partially-enclosed buildings, which may vary depending on the type of animal.  For example, if 
your farm is within an animal migratory path (e.g., Canada geese are present during certain times 
of the year), your monitoring should occur when the migratory animals are present (e.g., the 
Canada geese).   
You should consider the potential impact of weather events and other conditions as you evaluate 
your monitoring frequency for relevant areas on your farm, and make potential short-term 
adjustments as needed.  As previously noted, weather events, such as heavy rains, droughts, or 
fires could alter animal movements or cause atypical or unanticipated animal presence (Ref. 91) 
(Ref. 102).  For example, during a drought, if a supervisor observes an increased presence of 
animals and excreta during monitoring of growing areas near ponds located on the farm, then the 
farm should more frequently monitor the growing areas near ponds during the drought 
conditions.   
The following examples illustrate how a farm could assess relevant areas for evidence of 
potential contamination under 21 CFR 112.83(b)(1) after having made a determination that there 
is a reasonable probability that animals will contaminate covered produce.  These examples are 
intended to illustrate concepts and are not intended to be universally applicable.  Even if you 
have circumstances similar to those mentioned here, you should perform your own evaluation 
based on your farms specific practices and conditions. 
Example 5c:  A farms outdoor area used for growing basil is near a pond and a wooded 
area that the farm determines is a habitat for several types of wild animals. The farm 
personnel observe deer herds and ground squirrels on the farm around the growing areas 
throughout the growing season (i.e., more than several occasions), and the farm 
determines the growing areas are within animal movement pathways.  The farm must 
assess these areas for evidence of potential contamination.  (See 21 CFR 112.83(b)(1)).  
The farm should monitor the outdoor basil growing areas at least twice during the 
growing season. 
Example 5d:  A farms outdoor kale growing areas are located near a pond that the farm 
determines serves as a water source for deer and ducks, and ducks and their excreta are 
observed in the outdoor growing areas one to two times per month (e.g., less frequently 
than weekly observations) during the growing season when kale is present. The farm 
must assess these areas for evidence of potential contamination (See 21 CFR 
112.83(b)(1)).  The farm should monitor the outdoor kale growing areas at least monthly 
during the growing season.   
Example 5e:  A farms outdoor areas for growing blackberries are located near a barn that 
the farm determines attracts birds for nesting. Birds are frequently (at least weekly) 
observed in the outdoor growing areas for blackberries, and personnel observed excreta 
on blackberries near and during harvesting activities. The farm must assess the 
78  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
blackberry growing areas for evidence of potential contamination (See 21 CFR 
112.83(b)(1)).  The farm should monitor the outdoor blackberry growing areas at least 
weekly.   
  Performing Monitoring Activities 
You should determine which personnel will conduct monitoring and how they are to perform 
monitoring.  You could, for example, designate a single individual to perform all monitoring 
activities, or designate specific individuals to perform these job responsibilities in different areas.  
Depending upon your situation, you could assign personnel to perform multiple tasks.  For 
example, if you determine that there is a reasonable probability that animals will contaminate 
your strawberry field and that you need to assess for evidence of potential contamination weekly, 
you could direct your personnel who perform weekly weeding in a strawberry field to monitor 
for potential contamination of strawberries while they weed the field.  You should also ensure 
that personnel performing monitoring understand how to identify signs of potential 
contamination of covered produce by animals. 
Monitoring should include a visual examination for evidence of potential contamination of 
covered produce by animals in your relevant areas.  Examples of animal activity to consider 
when examining for evidence of potential contamination include the presence of significant 
numbers of animals, animal excreta, nests, and signs of pecking, feeding, rooting, trampling, 
grazing, or bedding.  For example, your personnel performing monitoring of partially-enclosed 
buildings could look for bird nesting and landing areas in overhead areas, such as the rafters, 
eaves, or roof. 
3.  Evaluating Significant Evidence of Potential Contamination of Covered Produce by 
Animals to Determine Whether Harvest Can Occur 
If there is significant evidence of potential contamination by animals, you must evaluate whether 
the covered produce can be harvested in accordance with the requirements of 21 CFR 112.112 
and take measures reasonably necessary during growing to assist you later during harvest when 
you must identify, and not harvest, covered produce that is reasonably likely to be contaminated 
with a known or reasonably foreseeable hazard.  (21 CFR 112.83(b)(2)).   
In determining whether evidence of potential contamination is significant, you should consider 
the extent of the evidence of potential contamination.  A single observation of a few animals 
immediately adjacent to covered produce usually does not represent significant evidence of 
potential contamination; however, multiple observations of this type reported over time could 
result in a determination of significant evidence of potential contamination, especially when 
coupled with observations of excreta on, or damage to, covered produce.  On the other hand, a 
single observation of a large number of animals near covered produce coupled with extensive 
animal excreta on or near covered produce or crop damage could be sufficient to lead you to 
determine that there is significant evidence of potential contamination of the affected covered 
produce.  
You must take measures reasonably necessary during growing to assist you later during harvest 
when you must identify, and not harvest, covered produce that is reasonably likely to be 
79  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
contaminated with a known or reasonably foreseeable hazard.  (See 21 CFR 112.83(b)(2)).  
Reasonably necessary measures could include, for example, designating a specific distance 
around the area where you found significant evidence of potential contamination during the 
growing season and preventing harvest in that entire area (e.g., a no harvest zone).  In some 
circumstances, you might identify significant evidence of potential contamination only in a 
certain portion of an outdoor area (e.g., a portion of a field rather than the entire field).  For 
example, if significant quantities of animal excreta are observed in a portion of a field, you could 
designate an area around each observation of animal excreta, or block off a single area that 
includes all observations of animal excreta to prevent transfer to covered produce, such as by 
runoff or splash.  The specific distance around the observations of animal excreta will likely vary 
by crop, the extent of potential contamination, and other factors.  Certain sources, such as 
academia, extension services, industry associations, and government agencies could provide 
information on this topic to assist in your determination of an effective no harvest perimeter or 
zone.  
The following examples use the principles discussed in this section to illustrate approaches for 
determining whether significant evidence of potential contamination by animals exists.  For 
illustrative purposes, we selected specific covered produce for these examples.  These examples 
are intended to illustrate concepts, and are not intended to be universally applicable.  Even if you 
have circumstances similar to those mentioned here, you should perform your own evaluation 
based on your farms specific practices and conditions. 
Examples of monitoring observations that likely are significant evidence of potential 
contamination: 
Example 5f.  Monitoring observations of a flock of geese, crop destruction, and animal 
excreta. 
A worker observes evidence that a flock of migrating geese has intruded on fields of 
lettuce.  The worker observes extensive crop damage (e.g., evidence of crop consumption 
and gnaw or bite marks) and extensive goose excreta on and near the lettuce, and reports 
these observations to a supervisor.  The supervisor determines that this represents 
significant evidence of potential contamination of the affected lettuce fields and 
determines that the covered produce in the affected fields cannot be harvested, in 
accordance with 21 CFR 112.112.  The farm must take measures reasonably necessary to 
assist later during harvest so that they can identify and not harvest the affected produce. 
In this case, the farms chosen approach is for the supervisor to mark the affected fields 
with red flags and to communicate to the appropriate personnel that the affected lettuce 
fields will not be harvested. 
Example 5g.  Monitoring observations of animal excreta. 
A worker observes trampled plants, evidence of animal feeding, and animal excreta on 
green beans in one field.  The worker reports to a supervisor this observation. Workers on 
the farm have previously observed raccoons and animal tracks in the same field.  The 
supervisor determines that these observations are significant evidence of potential 
contamination for the field of green beans.  The farm must take measures reasonably 
necessary to assist later during harvest so that they can identify and not harvest the 
affected produce. In this case, the farms chosen approach is for the supervisor to mark a 
80  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
portion of the field that includes all affected areas with flags to designate the portion of 
the field that will not be harvested and to communicate to the appropriate personnel that 
the designated portion of the field will not be harvested.  The supervisor also reminds 
personnel to watch for evidence of potential contamination during the harvesting of 
covered produce.   
Example 5h.  Monitoring observations of animal excreta. 
A worker identifies and reports several piles of dog excreta observed in several areas 
during a monthly monitoring event of a zucchini field.  The observations indicate that 
some of the dog excreta is fresh while some appears to have been present in the field for a 
longer time.  Some of the dog excreta contacted the zucchini.  The farm owner 
determines that this observation is significant evidence of potential contamination of a 
portion of the zucchini in the field.  The farm must take measures reasonably necessary to 
assist later during harvest so that they can identify and not harvest the affected produce. 
In this case, the farms chosen approach is for a designated worker to mark an area 
surrounding each observation of dog excreta with flags and to designate that these areas 
will not be harvested.  The farm owner communicates to the appropriate personnel that 
the flags identify areas that should not be harvested; a supervisor also reminds the 
personnel to watch for additional evidence of potential contamination during harvest 
activities.   
Examples of monitoring observations that likely are not significant evidence of potential 
contamination: 
Example 5i.  Observations of animal tracks in an outdoor growing area. 
During the growing season, a worker performing monitoring observes a few raccoon 
tracks in a recently planted field of green beans.  This observation was the only 
observation reported for that field of green beans during the growing season.  This 
contrasts with example 5g where in addition to the observation of animal tracks, there 
was also evidence of animal feeding, animal excreta, and trampled plants. 
Example 5j.  Observations of animal excreta. 
A worker reports that they saw several small piles of fresh dog excreta in a small area of 
a blueberry field two weeks prior to harvest.  The dog excreta did not directly contact the 
blueberries.  A supervisor confirms that a careful assessment of the entire blueberry field 
was conducted, but that no other observations of animal excreta or potential 
contamination of covered produce were observed in the field.  A supervisor also confirms 
that the worker removed the dog excreta from the growing area immediately after the 
observation occurred.   
81  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Chapter 6: 
Growing, Harvesting, Packing, and Holding Activities (Subpart K) 
Produce is susceptible to contamination during growing, harvesting, packing, and holding 
activities (Ref. 17) (Ref. 49) (Ref. 67) (Ref. 90).  Adhering to food safety practices during the 
day-to-day operations on your farm is critical to protecting covered produce (Ref. 17) (Ref. 34) 
(Ref. 67) (Ref. 90) (Ref. 99) (Ref. 121).  Where applicable, we recommend evaluating your 
relevant procedures, processes, and practices periodically to ensure that you consider the scope 
of your relevant activities or operations and any changes that occurred and how they are affected 
by and relate to the requirements of the Produce Safety Rule.  During such evaluations, you 
should consider not only typical practices, but also those that occur infrequently or due to 
unusual circumstances, to account for the breadth of procedures, processes, and practices 
associated with a given activity.    
This chapter provides draft guidance on the requirements of Produce Safety Rule subpart K
Growing, Harvesting, Packing, and Holding Activities.  This subpart is applicable to growing, 
harvesting, packing, and holding activities, including the transition points between those phases.  
The discussion is divided into: separation of covered and excluded produce; identifying and not 
harvesting contaminated covered produce; handling harvested covered produce; dropped covered 
produce; packaging covered produce; and food-packing material.   
1.  Separation of Covered and Excluded Produce 
We provide draft guidance on the distinction between covered and excluded produce in Chapter 
1: General Provisions (Subpart A) in the sections titled Covered Produce.  Depending on your 
farm layout, planting schedule, and growing and harvesting seasons, there could be times when 
you grow, harvest, pack, or hold multiple produce crops at the same time and in approximately 
the same location.  You should evaluate your farms activities and produce to determine whether 
you grow, harvest, pack, or hold both covered and excluded produce and how you handle any 
excluded produce; you should visually assess your farms activities to confirm your farms 
practices.   
If all of the following conditions are applicable to your farm: 
  You grow, harvest, pack, or hold covered produce;  
  You grow, harvest, pack, or hold produce that is not covered by the Produce Safety Rule 
(i.e., excluded produce in accordance with 21 CFR 112.2); and  
  The excluded produce is grown, harvested, packed, or held in a manner that is not in 
accordance with the Produce Safety Rule requirements (21 CFR 112.111); 
then you must take measures during covered activities to:  
  Keep covered produce separate from excluded produce (except when placed in the same 
container for distribution) (21 CFR 112.111(a)); and  
82  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Adequately clean and sanitize, as necessary, any food contact surfaces that contact 
excluded produce before using such food contact surfaces for covered activities on 
covered produce (21 CFR 112.111(b)).   
If you do not grow, harvest, pack, or hold both covered and excluded produce, or if you grow, 
harvest, pack, and hold your excluded produce in accordance with the provisions of the Produce 
Safety Rule, then the requirements of 21 CFR 112.111 are not applicable to your farm.   
Example 6a:  A farm grows, harvests, packs, or holds both radishes (covered produce) 
and beets (excluded produce) at the same time.   
  If the farm grows, harvests, packs, or holds both radishes (covered produce) and 
beets (excluded produce) at the same time, and if the farm grows, harvests, packs, 
or holds the beets in accordance with the Produce Safety Rule, then 21 CFR 
112.111 does not apply and the farm does not need to ensure that the two crops 
are separated during growing, harvesting, packing, and holding, and that you 
clean and sanitize, as necessary, any food contact surfaces that contact the beets 
before they contact the radishes.   
  However, if the farm grows, harvests, packs, or holds the beets (excluded 
produce) in a way that is not in accordance with the Produce Safety Rule 
requirements for covered produce (e.g., if the farm uses a biological soil 
amendment of animal origin (BSAAO) and does not follow the applicable 
requirements related to the BSAAO found in subpart F), then the farm must 
ensure that the two crops are separated during growing, harvesting, packing, and 
holding, and that the farm cleans and sanitizes, as necessary, any food contact 
surfaces that contact the beets before they contact the radishes, as applicable.  
(See 21 CFR 112.111(a) and (b)).     
You are not required to keep covered and excluded produce separate when you place them into 
the same container for distribution.  (21 CFR 112.111(a)).  For example, you are not restricted 
from selling items such as gift baskets or community supported agriculture (CSA) boxes that 
contain both covered and excluded produce, or other non-produce food items.  So, you could put 
the radishes and beets described in the second bullet of the example above together into a CSA 
box for distribution to your CSA customers. 
If you are subject to the provisions of 21 CFR 112.111, then you should evaluate your farms 
practices, including growing, harvesting, packing, and holding activities, to determine how to 
separate covered produce and excluded produce.  This can involve, for example, separation in 
location (i.e., physical space), separation in time, or a combination of both.  You should 
determine whether activities involving covered and excluded produce occur in the same location 
or at the same time, use the same equipment and tools, or involve the same personnel, because 
use of the same location, equipment, or personnel (Ref. 17) (Ref. 134) could necessitate changes 
to your practices or additional oversight in order maintain separation.   
You should identify the location (i.e., physical space) in which the covered and excluded 
produce will be grown, harvested, packed, and held.  You could, for example, choose to plant 
83  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
covered produce in a location that is physically separate from where you plant excluded produce.  
Similarly, you could, for example, choose to designate and maintain different holding and 
packing areas or buildings to ensure separation of covered and excluded produce.  Depending on 
your practices, other strategies could be effective in separating covered and excluded produce. 
You should also identify equipment and tools used during growing, harvesting, packing, and 
holding of excluded produce that are also used for covered produce.  You should pay particular 
attention to the food contact surfaces of equipment and tools (e.g., knives and harvest containers) 
that could contact excluded produce and then contact covered produce.  For example, you could 
assign separate equipment and tools to the growing and harvesting of covered and excluded 
produce; or you could establish procedures for cleaning and, as necessary, sanitizing equipment 
and tools used for excluded produce before using them for contact with covered produce (such 
cleaning, and as necessary, sanitizing, is required by 21 CFR 112.111(b) when the same tools are 
used in these circumstances, and more generally by 21 CFR 112.123(d)).  We provide draft 
guidance on cleaning and sanitizing in Chapter 7: Equipment, Tools, Buildings, and Sanitation 
(Subpart L).   
For packing and holding activities, you could schedule the packing of covered produce before 
the packing of excluded produce, using cleaned and, if necessary, sanitized equipment, tools, and 
containers for the covered produce.  Further, if you choose to pack or hold both covered produce 
and excluded produce (that is not grown, harvested, packed, or held in accordance with the 
Produce Safety Rule) at the same time, you could consider the following practices to minimize 
the risk of contamination of the covered produce: 
  Providing walls, other barriers, or space to separate covered and excluded produce;  
  Clearly marking packing or holding areas for excluded produce or covered produce;  
  Clearly marking or color-coding containers to minimize the risk of excluded produce 
containers being used for covered produce; and 
  Establishing procedures for personnel working in the excluded produce packing or 
holding areas to ensure separation of excluded produce and covered produce. 
You should instruct your supervisors and other responsible parties on your procedures for 
separation of covered and excluded produce.  Supervisors and other responsible parties should 
emphasize and remind personnel to maintain separation of covered and excluded produce based 
on the regulatory requirements.   
Personnel who handle covered produce or food contact surfaces, or who are engaged in the 
supervision thereof, must receive training related to the separation of excluded and covered 
produce, as applicable.  (See 21 CFR 112.22(a)(3)).  Personnel who contact food contact surfaces 
for cleaning and, when necessary, sanitizing activities, or who are engaged in the supervision 
thereof, must also be trained.  (See 21 CFR 112.22(a)(3)).  These personnel should understand 
your practices for maintaining separation of covered and excluded produce, preparing the 
cleaning and sanitizing solutions, when necessary; and when to perform such activities between 
handling of excluded and covered produce.  We provide further draft guidance on training in 
Chapter 2: Personnel Qualifications and Training (Subpart C). 
 
84  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
2.  Identifying and Not Harvesting Contaminated Covered Produce  
Immediately prior to and during harvest activities, you must take all measures reasonably 
necessary to identify, and not harvest, covered produce that is reasonably likely to be 
contaminated with a known or reasonably foreseeable hazard.  (See 21 CFR 112.112).  The 
requirements of 21 CFR 112.112 are intended to be flexible, to allow you to take steps 
appropriate for your situation based on those requirements.  In this section, we specifically 
discuss animal excreta as a potential source of contamination.  (See 21 CFR 112.112).  You 
should consider the possibility of other sources of contamination, such as flooding, that could be 
relevant to your particular growing and harvesting conditions, and address those as needed.   
Animal excreta represent a source of pathogens (Ref. 78) (Ref. 110) (Ref. 143).  Environmental 
investigations for certain outbreaks indicated that wild animal excreta were a source of 
pathogens linked to the outbreaks, and in some cases were observed in the fields near the time of 
harvest (Ref. 60) (Ref. 86) (Ref. 85).  Animal saliva, skin, fur, and feathers can also be a source 
of pathogens (Ref. 22) (Ref. 33) (Ref. 37) (Ref. 104) (Ref. 111) (Ref. 122).  FDA does not 
expect, suggest, or recommend that farms eliminate animals from outdoor growing areas.  
Instead, the Produce Safety Rule requires farms to take measures reasonably necessary to 
identify, and not harvest, covered produce that is reasonably likely to be contaminated with a 
known or reasonably foreseeable hazard.  This includes taking steps to identify and not harvest 
covered produce that is visibly contaminated with animal excreta.  At a minimum, your efforts 
must include a visual assessment of the growing area and all covered produce to be harvested, 
regardless of the harvest method.  (See 21 CFR 112.112).   
Signs that covered produce is reasonably likely to be contaminated with a known or reasonably 
foreseeable hazard include: 
  Excreta observed on the covered produce; 
  Excreta observed in an area where it is reasonably likely that it has contacted or will 
contact nearby covered produce during harvest (see also the discussion in Chapter 5: 
Domesticated and Wild Animals (Subpart I)); 
  Animal fur, hair, or feathers observed on the covered produce; and 
  Crop damage or destruction by animals (e.g., bite/gnaw marks; bent, uprooted, or 
trampled crops). 
The required visual assessment is most effective when it is performed as close in time before 
beginning harvesting as is practicable, under the circumstances of the farms operation, or during 
harvesting itself.  A visual assessment should involve designated personnel visually examining 
the entire designated harvest area, including areas that will be mechanically harvested.  For large 
areas that are mechanically harvested, you should designate personnel to visually assess sections 
of the growing area shortly before harvesting activities to identify areas where covered produce 
is reasonably likely to be contaminated with a known or reasonably foreseeable hazard.   
You must perform visual assessments of the ground above covered produce that is grown 
completely underground (e.g., carrots, radishes, jicama).  (See 21 CFR 112.112).  If, during your 
assessment of the growing area and of the underground covered produce during harvest, you see 
evidence of animal excreta on or surrounding the covered produce, you must not harvest that 
85  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
covered produce.  (See 21 CFR 112.112).  If animal excreta are present on the ground above 
such covered produce during harvest and would be likely to contaminate the covered produce or 
food contact surfaces of harvest equipment, you must not harvest from the affected area.  (See 21 
CFR 112.112).   
Harvest personnel must be trained to recognize covered produce that must not be harvested, 
including covered produce that may be contaminated with a known or reasonably foreseeable 
hazard.  (See 21 CFR 112.22(b)(1)).  You should also instruct your harvest personnel to alert 
nearby harvest personnel of observations of covered produce that is reasonably likely to be 
contaminated with a known or reasonably foreseeable hazard (e.g., visible animal excreta).  You 
should specify when personnel need to inform a supervisor or other responsible party of 
observations of covered produce that is reasonably likely to be contaminated with a known or 
reasonably foreseeable hazard so they can determine appropriate steps to ensure that affected 
covered produce in the surrounding area is also not harvested.   
Your procedures should include necessary actions when evidence of contamination, including 
visible animal excreta, is observed.  You should inform your supervisors and other responsible 
parties of the expected actions and direct them to ensure that these tasks are completed as 
needed.  You should take the following actions in response to observations of animal excreta, or 
other evidence of contamination: identify areas of covered produce that will not be harvested, 
such as by cordoning off or otherwise identifying the affected areas; and not harvesting covered 
produce that is reasonably likely to be contaminated with a known or reasonably foreseeable 
hazard.  For example, if during a visual assessment, a worker identifies several clusters of 
blackberries that have visible animal excreta on them, then you could, for example, use a visual 
marker, such as colored flags, to indicate that they are not to be harvested.  You should also 
assess whether any other blackberries near the blackberries with the visible contamination are 
reasonably likely to be contaminated and take appropriate steps.   
As mentioned in Chapter 5: Domesticated and Wild Animals (Subpart I), during the growing 
season, you or your personnel could observe significant evidence of potential contamination 
when you assess relevant areas required by 21 CFR 112.83(b)(2).  Based on those observations, 
you could conclude that some growing areas cannot be safely harvested.  If you reach such a 
conclusion, you must take measures reasonably necessary during growing to assist you later 
during harvest when you must identify, and not harvest, covered produce that is reasonably likely 
to be contaminated with a known or reasonably foreseeable hazard.  (See 21 CFR 112.112).  For 
example, you could designate a portion of a growing area, so that covered produce in that area is 
not harvested, as a result of your observations during the growing season.  During harvest, you 
must not harvest such covered produce.  (See 21 CFR 112.112).  
3.  Handling Harvested Covered Produce 
You must handle harvested covered produce during covered activities in a manner that protects 
against contamination with known or reasonably foreseeable hazards.  (21 CFR 112.113).   
Harvested covered produce is vulnerable to contamination, and handling practices can protect 
against contamination (Ref. 36) (Ref. 90).   
86  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
You should evaluate your practices during harvesting, packing, and holding, to identify 
conditions that could increase the likelihood of contamination.  You should consider the handling 
of covered produce by personnel during and after harvest, and the equipment, buildings, and 
tools used for covered activities during and after harvest.  Based on your evaluation, you should 
adjust existing, or implement new, practices to protect harvested covered produce from 
contamination during handling, as needed.  Practices to consider include: avoiding contact 
between the cut surfaces of covered produce and soil, and reducing damage to harvested covered 
produce to the extent practical; and packing and holding covered produce in a manner that 
minimizes the potential for contamination.   
You should establish procedures to ensure that harvesting, packing and holding practices protect 
against contamination of covered produce.  Personnel who handle covered produce or food 
contact surfaces, or who are engaged in the supervision thereof, must receive training related to 
handling harvested covered produce, as applicable.  (See 21 CFR 112.22(a)(3)).  These personnel 
should understand your practices to protect harvested covered produce.  Furthermore, personnel 
you assign to supervise or otherwise be responsible for your operations should ensure that other 
personnel consistently implement practices to protect harvested covered produce against 
contamination.  We provide further draft guidance on training in Chapter 2: Personnel 
Qualifications and Training (Subpart C).  
Contamination could be transferred to harvested covered produce when contact occurs between 
the covered produce, especially at cut surfaces, and the soil.  Preventing unnecessary contact 
could reduce the likelihood of pathogen transfer (Ref. 36) (Ref. 90).  For example, during lettuce 
harvest, you should place harvested lettuce heads that have been cut from the root on a clean 
surface while waiting for trimming, rather than placing them directly on the soil.    
Bruises, punctures, or other injuries to harvested covered produce create potential pathways for 
pathogens to contaminate the covered produce and multiply (Ref. 5) (Ref. 4) (Ref. 67).   
Personnel should understand which activities will likely result in damage.  You could consider 
practices to protect against contamination of harvested covered produce through damage, such as 
the following: 
  Ensuring harvest containers are free from rough edges or other rigid protrusions; 
  Avoiding rough handling when transferring covered produce from one container to 
another or to a different surface, such as a hopper, table, or belt; 
  Avoiding overfilling containers, which can crush or damage covered produce; 
  Ensuring that personnel use equipment and tools consistent with your procedures and in a 
way that minimizes damage to covered produce. 
4.  Dropped Covered Produce 
You must not distribute dropped covered produce.  (21 CFR 112.114).  Dropped covered 
produce is produce that drops to the ground before harvest and does not include: 
  Root crops that grow underground (such as carrots);  
  Crops that grow on the ground (such as cantaloupe); or  
87  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Produce that is intentionally dropped to the ground as part of harvesting (such as 
almonds).   (21 CFR 112.114).   
Covered produce is subject to the requirements in 21 CFR 112.114 unless it is specifically 
identified as not being included within the meaning of dropped covered produce as provided in 
21 CFR 112.114.  Some covered produce, like almonds, may be intentionally dropped to the 
ground as part of harvesting (e.g., by shaking the almond tree).  This type of harvesting generally 
occurs with produce that have an inedible, hard outer layer, and an edible, relatively durable 
inner layer.  However, most covered produce, including some with an inedible outer layer or rind 
and soft-fleshed, inner layer, can be damaged by the force of the impact when dropped to the 
ground.  For covered produce crops that typically are not dropped to the ground during harvest, 
some could nonetheless fall to the ground, often resulting in damage to or contamination of the 
covered produce.  This damage may not be visible for several days or weeks.  The damage could 
introduce or cause an increase of pathogens (Ref. 5) (Ref. 4).  For example, peaches that drop 
from the tree are likely to impact the ground with a force that can cause damage to the surface of 
the fruit and allow for the introduction of pathogens into the flesh of the fruit.  Produce that 
grows off the ground, such as peaches or tomatoes, and that drops to the ground before harvest is 
considered dropped covered produce, even if the produce is still attached to the plant when it 
contacts the ground.  You should establish procedures that ensure that you do not distribute 
dropped covered produce.   
Personnel who handle covered produce or food contact surfaces, or who are engaged in the 
supervision thereof, must receive training related to dropped covered produce, as applicable.  
(See 21 CFR 112.22(a)(3)).  You should train your harvest personnel, and personnel you assign 
to supervise or otherwise be responsible for your operations, to avoid harvesting dropped 
covered produce.  These personnel should understand your practices related to dropped covered 
produce.  Personnel who supervise harvesting, or other responsible parties, should ensure that 
personnel who conduct harvesting do not include dropped covered produce with covered produce 
that will be distributed.  Furthermore, personnel you assign to supervise or otherwise be 
responsible for your operations should ensure that other personnel consistently implement 
practices to not distribute dropped covered produce.  We provide further draft guidance on 
training in Chapter 2: Personnel Qualifications and Training (Subpart C).  
5.  Packaging Covered Produce 
You must package covered produce in a manner that prevents the formation of Clostridium 
botulinum toxin, if such toxin is a known or reasonably foreseeable hazard (such as for 
mushrooms).  (21 CFR 112.115).  Produce containing C. botulinum toxin could have no visual 
indication that toxin is present (i.e., it may not appear contaminated or spoiled), so prevention is 
essential (Ref. 26) (Ref. 127).  Mushrooms develop C. botulinum toxin when packaged under 
certain conditions (Ref. 62) (Ref. 127).  Modified atmosphere or other reduced-oxygen 
packaging of produce other than mushrooms could present a similar risk for botulinum toxin 
formation depending on factors including produce type and respiration rate, pH, water activity, 
temperature, oxygen concentrations, initial Cl. Botulinum spore levels, and the presence and 
types of other microflora (Ref. 50) (Ref. 62).  
88  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Most covered produce continues to respire (i.e., breathe) after it is packaged (Ref. 7) (Ref. 120).  
If the covered produce is packaged in an oxygen-impermeable film, the continued respiration can 
decrease the level of oxygen and increase the level of carbon dioxide within the package, 
creating conditions favorable for C. botulinum toxin formation (Ref. 67) (Ref. 127). The 
necessary time for toxin formation varies depending upon the temperature and other conditions.  
The minimum temperature for C. botulinum growth and toxin formation is 38F (3.3C) (Ref. 
76) (Ref. 118) (Ref. 123).    
If Clostridium botulinum toxin is a known or reasonably foreseeable hazard, and you package 
your covered produce, you must do so in a manner that prevents the formation of C. botulinum 
toxin.  (21 CFR 112.115)).  You should consider your practices and procedures as well as 
conditions that could occur during distribution, including temperature fluctuation and exceeding 
set holding temperatures.  Some measures for covered produce that could help prevent the 
formation of C. botulinum toxin when identified as a known or reasonably foreseeable hazard 
include:  
  Creating conditions that are less favorable for C. botulinum growth and toxin formation, 
such as using open, perforated, or otherwise oxygen-permeable packaging and packing 
materials, to allow for gas exchange (i.e., for atmospheric oxygen to replenish the oxygen 
used by covered produce respiration); 
  When conditions are more likely to favor C. botulinum growth and toxin formation: 
  Using antimicrobial compounds, or other treatments, that are effective to prevent 
o
the growth and toxin formation by C. botulinum;  
  Maintaining the temperature of the packaged covered produce below 38F 
o
(3.3C); and 
  Using time-temperature integrators (trackers) for covered produce to signal when 
o
a cumulative time-temperature combination that presents a risk for C. botulinum 
toxin formation is reached. 
6.  Food-Packing Material  
Farms typically place harvested covered produce in containers (i.e., food-packing materials) for 
various purposes, such as collecting, conveying, or distributing.  Some farms use containers to 
transport harvested covered produce from growing areas to packing areas, where the covered 
produce is then packed (or repacked) for distribution.  For example, food-packing materials 
include containers used to collect harvested covered produce (e.g., harvest bins, buckets, and 
totes) in growing areas and transport the covered produce to a packing or holding area.  In other 
instances, harvest containers, such as fiberboard boxes into which the covered produce is placed 
when harvested, could be the same containers in which covered produce is distributed (e.g., 
when covered produce is field-packed).  Food-packing materials also include food-packaging 
materials, a term that has long been used (such as in FDAs human food CGMP regulations in 
21 CFR part 117, subpart B (previously 21 CFR Part 110)) to generally refer to a container that 
directly contacts the food.   
When you use a food-packing material, it must be adequate for its intended use, which includes 
being: 
89  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Cleanable or designed for single use; and  
  Unlikely to support growth or transfer of bacteria.  (21 CFR 112.116(a)). 
You should take the following steps to help you determine whether foodpacking material is 
adequate for its intended use on your farm: 
  Identify the types of food-packing materials that you use, and determine whether each 
type is reusable or for single use; 
  Determine whether your food-packing materials are unlikely to support the growth or 
transfer of bacteria, taking into consideration your handling, maintenance, and storage 
practices; and 
  Determine whether reusable materials can be cleaned, taking into consideration your 
handling, maintenance, and storage practices. 
Food-packing materials (including food packaging materials) are subject to the provisions of 
both 21 CFR 112.116(a) (subpart K) and 21 CFR 112.123(a) (subpart L).  To minimize 
redundancy and help provide clarity in our draft guidance on food-packing materials, we provide 
draft guidance on the aspects of the materials themselves in this chapter.  We provide draft 
guidance on other regulatory requirements of the Produce Safety Rule related to food-packing 
materials, including maintenance, storage, and inspection, in the section of Chapter 7: 
Equipment, Tools, Buildings, and Sanitation (Subpart L), titled Equipment and Tools. 
Pathogens can become established in, grow in, or be transferred from materials that have cracks, 
pits, jagged edges, rough areas, score marks, or other damage; these conditions increase the 
potential for certain materials to introduce contamination to covered produce (Ref. 128) (Ref. 
130) (Ref. 134).  Both porous and non-porous materials can facilitate contamination if they are 
damaged or their surfaces are not intact (Ref. 10) (Ref. 20) (Ref. 83) (Ref. 92) (Ref. 124).    
  Identifying Single-Use and Reusable Food-Packing Materials 
To ensure that you use a food-packing material that is adequate for its intended use, you should 
first identify the types of food-packing materials you use and determine whether they are 
reusable or designed for single use.  Generally, single-use packing materials are nondurable (e.g., 
easily susceptible to damage), or not easily cleaned (e.g., bags that can be torn, fiberboard that 
loses integrity or disintegrates when contacted by water or cleaning solutions).  Examples of 
single-use food-packing materials include clamshells used for retail packaging of berries, and 
foam sleeves used to protect Asian pears from bruising during distribution.  You should not reuse 
food-packing materials that are designed for single use.  Although some single-use food-packing 
materials could be sufficiently sturdy for multiple uses, they may not be cleanable after use and, 
when reused, could then serve as a source of contamination or support bacterial growth or 
transfer (Ref. 10).  Generally, some materials, such as fiberboard or foam, may not be suitable to 
reuse as packing materials because they are likely to support the growth of bacteria or cannot be 
adequately cleaned because the structure of the material prevents removal of organic material 
and bacteria or traps moisture, or the materials could degrade during cleaning (Ref. 10) (Ref. 53) 
(Ref. 136).      
90  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Evaluating Your Practices and Food-Packing Materials   
You should periodically evaluate your practices, including handling, maintenance, and storage of 
your food-packing materials, to determine whether, under the conditions, your food-packing 
materials are adequate for its intended use, including being unlikely to support the growth or 
transfer of bacteria and whether your reusable packing materials are cleanable.  Your practices or 
use of food packing materials could change over time, and you should account for these changes 
as appropriate; periodic evaluations can assist you with ensuring that you consider any changes.  
You should consider several factors that influence whether food-packing materials are adequate 
for their intended use, including:  
  The type of the material (e.g., plastic, metal, wood, foam, cardboard);  
  The nature of the material (e.g., smooth, course, absorbent, porous, non-porous, 
o
or); and 
  The durability of the material (e.g., fragile, malleable, firm, sturdy); 
o
  The construction (e.g., solid, stapled, hollow components);  
  The food-packing material handling practices (i.e., how carefully they are handled during 
receiving, storage, and preparation for use); 
  The existing condition of the material (e.g., intact, damage, surface abrasions); 
  The characteristics of the covered produce for which the packing material is used (e.g., 
heavy, light, hard shell, soft skin, moist, dry); 
  How the covered produce is placed into the food-packing material (e.g., by hand or by 
machine and how that can impact the potential for damage to the food-packing material);  
  Use of single-use, clean liners in otherwise reusable food-packing materials;  
  The impact of sanitation procedures (i.e., the cleaning and, when necessary and 
appropriate, sanitizing process), treatments or chemicals used, and devices used on the 
food-packing material;  
  The storage conditions (e.g., outdoor vs. indoor); and 
  The maintenance practices (e.g., approaches to repair or replace worn or damaged 
components).  
The following are examples using the principles and recommendations discussed in this section 
to illustrate approaches to evaluating food-packing materials and their use based on the 
requirements of 21 CFR 112.116 and 21 CFR 112.123.  To minimize redundancy, concepts 
related to maintenance, storage, inspection, cleaning, and when necessary and appropriate, 
sanitizing, are discussed in examples found in the section of Chapter 7: Equipment, Tools, 
Buildings, and Sanitation (Subpart L), titled Equipment and Tools.  These examples are 
intended to illustrate concepts, and are not intended to be universally applicable.  For illustrative 
purposes, we identify specific covered produce in these examples.  Even if you use similar 
materials or practices for the specific covered produce mentioned here, you should perform your 
own evaluation based on your farms specific practices and conditions.   
a.  Example 6b: Plastic bags   
A farm uses plastic bags for field packing celery in the growing area for distribution to retail 
stores.  The farm evaluates the plastic bags and their use, and concludes the following:  
91  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  The bag material is primarily polyethylene, which is: 
  smooth and non-absorbent; and 
o
  fragile (e.g., can be torn) and malleable;  
o
  The bag construction does not include voids or seams that could trap organic material or 
bacteria;  
  The bags are received from the manufacturer in containers that protect them from 
damage, and the farms procedures confirm the bags are in sound condition upon receipt;  
  The bag handling practices typically do not result in damage prior to use; 
  During field packing, each bags condition is intact and the bags are not reused; 
  The celery has a firm surface that is usually dry; and 
  The bag is sufficiently durable to withstand the celery being placed by hand into the bag. 
 
The farm determines that the bags are suitable to distribute the celery and are a single-use food
packing material, and continues to periodically evaluate the use and handling of the bags. 
b.  Example 6c: Waximpregnated, corrugated fiberboard boxes  
A farm places honeydew into wax-impregnated, corrugated fiberboard boxes for distribution.  
The farm evaluates the waxed, corrugated fiberboard boxes and their use, and concludes the 
following:  
  The box material is wax-impregnated, corrugated fiberboard, which is: 
  smooth and porous, with the wax surfaces having some moisture resistance; and 
o
  fragile and malleable (e.g., can be bent, dented, or torn); 
o
  The box construction includes open seams that could trap organic material or bacteria;  
  The boxes are received from the manufacturer on shrink-wrapped pallets that protect 
them from damage, and the farms procedures confirm the boxes are in sound condition 
upon receipt;  
  The box handling practices typically do not result in damage prior to use; 
  During packing, each boxs condition is intact, and the boxes are not reused;  
  The honeydew has a firm surface that is usually dry; and 
  The boxes are sufficiently durable to withstand the honeydew being placed by hand into 
the box. 
The farm determines that the boxes are suitable to distribute the honeydew and are a single-use 
foodpacking material, and continues to periodically evaluate the use and handling of the boxes. 
 
92  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Chapter 7: 
Equipment, Tools, Buildings, and Sanitation (Subpart L) 
Maintaining sanitary conditions where covered activities occur is critical to prevent 
contamination of covered produce from the surrounding environment (including buildings, 
sanitation systems, equipment, and tools) (Ref. 16).  A lack of sanitation can promote harborage 
of pathogens in the environment, which can increase the likelihood of contamination of covered 
produce (Ref. 16) (Ref. 52) (Ref. 53) (Ref. 79) (Ref. 108).    
This chapter provides draft guidance on the requirements of subpart LEquipment, Tools, 
Buildings, and Sanitation.  The discussion is divided into sections on: equipment and tools; 
buildings; other sanitation measures; and records.  Where applicable, we recommend evaluating 
your relevant practices, procedures, and processes periodically to ensure that you consider the 
scope of your relevant activities or operations and any changes that occurred and how they are 
affected by and relate to your equipment, tools, buildings, and sanitation and the requirements of 
the Produce Safety Rule.  During such evaluations, you should consider not only typical 
practices, but also those that occur infrequently or due to unusual circumstances, to account for 
the breadth of procedures, processes, and practices associated with a given activity.    
1.  Equipment and Tools 
Farms use many types of equipment and tools.  Several factors affect the ability of equipment or 
tools to be adequately cleaned or properly maintained, including: the type of materials; the 
design, construction, or workmanship; wear or damage; and cleaning practices.  This section 
provides more detailed draft guidance related to these topics. 
In this chapter, we provide draft guidance related to equipment and tools that are intended to, or 
likely to, contact covered produce and those instruments or controls used to measure, regulate, or 
record conditions to control or prevent the growth of microorganisms of public health 
significance, as described in 21 CFR 112.121.  You should take the following steps based on the 
requirements of the Produce Safety Rule related to equipment and tools: 
  Identify equipment and tools on your farm that are intended to, or likely to, contact 
covered produce, including instruments and controls used to measure, regulate, or record 
conditions; 
  Evaluate the design, construction, workmanship, installation, and maintenance of these 
equipment and tools; 
  Evaluate your storage and maintenance practices and storage locations for these 
equipment and tools; 
  Establish procedures and schedules for cleaning, and, when necessary and appropriate, 
sanitizing, food contact surfaces of these equipment and tools;  
  Establish procedures and schedules to conduct inspections of these equipment and tools; 
  Evaluate your use of transport equipment with covered produce; and  
  Evaluate the accuracy, precision, maintenance and numbers of instruments and controls 
used to measure, regulate, or record conditions to control or prevent the growth of 
microorganisms of public health significance.   
93  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Identifying Equipment and Tools Intended or Likely to Contact Covered Produce 
You should visually assess your covered activities and your growing, harvesting, packing, and 
holding areas to identify the equipment and tools that are intended to, or likely to, contact your 
covered produce.  The way you handle covered produce while using equipment or tools, or vice 
versa, can affect whether contact is likely, as illustrated in the following examples:   
Example 7a:  If you pack covered produce on a stainless steel table permanently attached 
to a wall, you could find that the covered produce frequently contacts the surface of the 
wall.  In this case, you should consider both the table and the wall to be pieces of 
equipment that are intended or likely to contact covered produce.   
Example 7b:  If separate guards or shields placed near other equipment occasionally 
contact covered produce or produce rinse water spray routinely rebounds from the guard 
or shield to a food contact surface, you should identify these guards and shields as pieces 
of equipment that contact or are likely to contact covered produce.   
  Design, Construction, and Workmanship  
For equipment and tools subject to this subpart, you must use equipment and tools that are of 
adequate design, construction, and workmanship to enable them to be adequately cleaned and 
properly maintained.  (21 CFR 112.123(a)).  The considerations are the same whether you design 
your own equipment and tools, purchase them prefabricated, or repurpose them.   
Food-packing materials (including food packaging materials) are subject to the provisions of 21 
CFR 112.116(a) (Subpart K) and 21 CFR 112.123(a).  We provide draft guidance on the aspects 
of the materials themselves in the section of Chapter 6: Growing, Harvesting, Packing, and 
Holding Activities (Subpart K) titled Food-Packing Material.  We provide draft guidance on 
other regulatory requirements of the Produce Safety Rule related to food-packing materials in 
this section on Equipment and Tools. 
  Evaluating Materials 
You should evaluate the materials used to make your equipment and tools.  You should consider 
whether the materials from which they are constructed will affect whether they can be adequately 
cleaned or properly maintained under the conditions of their use and throughout the period of 
their use, considering: stress and strain during use; environmental conditions during use or 
storage (e.g., wet, humid, dry); and the process of, and treatments used during, cleaning and, 
when applicable, sanitizing.  Equipment and tools made of non-porous materials, such as 
stainless steel and food-grade plastic (e.g., PVC, nylon), could allow for a wider range of 
effective cleaning methods; whereas porous material, such as fabric, cardboard, foam, and 
carpet, can trap moisture, making it difficult to remove organic material and bacteria.  
We recommend that you use equipment and tools made from non-porous materials to the extent 
practical.  However, we understand that covered farms sometimes use porous materials such as 
wood, fabric, or foam when conducting covered activities.  If you choose to use equipment and 
tools made of these materials, the equipment and tools must be of adequate design, construction, 
94  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
and workmanship to enable them to be adequately cleaned and properly maintained.  (See 21 
CFR 112.123(a).  We provide further draft guidance on cleaning and sanitizing in of the section 
of this chapter titled Cleaning and Sanitizing Equipment and Tools.   
  Evaluating Design, Construction, Workmanship, and Seams 
You should evaluate the design, construction and workmanship of your equipment and tools, 
including whether the equipment and tools: 
  Allow for access to all the components for cleaning, maintenance, and, when appropriate, 
inspection; and 
  Limit the potential for moisture or organic material to accumulate on or within the 
components of the equipment or tool, and subsequently to drip or drain onto covered 
produce or spread contamination.   
For example, equipment and tools should not have openings to hollow areas that are not 
otherwise accessible for cleaning and maintenance.   
You could choose to seek more information from sources such as equipment manufacturers, 
academia, extension services, industry associations, and government agencies to assist you with 
this evaluation.   
Seams on food contact surfaces of equipment and tools that you use must be either smoothly 
bonded, or maintained to minimize accumulation of dirt, filth, food particles, and organic 
material and thus minimize the opportunity for harborage or growth of microorganisms.  (21 
CFR 112.123(c)).  The materials and surfaces of equipment and tools should not have pits, 
corrosion, cracks, crevices, partially open seams, poorly bonded welds, rough areas or other 
damage.  Such defects can allow for the accumulation of moisture and organic material and can 
harbor or transfer bacteria (Ref. 128) (Ref. 130) (Ref. 134).    
You should repair or replace any equipment or food contact surface that is damaged in a way that 
it can no longer be adequately cleaned or properly maintained.  (See 21 CFR 112.123(a)). 
  Installation and Maintenance 
Equipment and tools must be installed and maintained as to facilitate cleaning of the equipment 
and of all adjacent spaces.  (21 CFR 112.123(b)(1)).  You should evaluate the installation and 
maintenance of your equipment and tools, and you should visually assess your farms activities 
to confirm your practices.  You should consider the potential for installed equipment or tools to 
accumulate moisture, organic material, or other potential sources of contamination that could 
contact, drip or drain onto covered produce or food contact surfaces.  You should also consider 
the potential for surrounding surfaces to transfer moisture, organic material, or other potential 
sources of contamination onto covered produce or food contact surfaces of your equipment and 
tools.    
You should install equipment so that maintenance and cleaning personnel can easily access all 
food contact surfaces, protective coverings or barriers, equipment framework, any movable parts, 
95  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
and other relevant parts.  For example, parallel conveyor belt systems should be installed with 
enough space between the systems to allow personnel to easily access the lines to perform 
maintenance, cleaning, and production activities.  This should include access to the belts, the 
framework supporting the belts, any enclosed housings for electrical components, and the points 
at which the framework is secured.  Maintenance and cleaning personnel should also have access 
to adjacent spaces, such as the floors, walls, ceilings, and other equipment and tools in the 
immediate vicinity.  For example, if a conveyor belt system becomes loose and drags on the floor 
as it rotates, personnel should have access to repair or replace the conveyor belt system.  In this 
example, you or your personnel should also determine whether any damage occurred to the 
equipment or the floor, any necessary steps to clean and, when necessary and appropriate, 
sanitize the equipment and floor, and whether any other measures are necessary. 
The condition of your equipment and tools, including their surfaces, is likely to degrade over 
time due to age, wear, or damage.  Such degradation could result in cracks, crevices, pits, jagged 
edges, rough surfaces, score marks, and other conditions or damage that can allow the potential 
for contamination.  You should evaluate your inspection and maintenance practices to ensure that 
you periodically assess for, and correct, any defects as soon as they are identified.  You should 
repair or replace any equipment or tool that is damaged in a way that it can no longer be 
adequately cleaned or properly maintained.  (See 21 CFR 112.123(a)). 
In some instances, maintenance practices could include repair.  There are several options to 
address the condition of equipment and tools, including refinishing, resurfacing, or removing and 
replacing components to reestablish cleanable surfaces.  For example, re-welding or grinding 
rough seams can smooth the surface and re-establish cleanability.  In another example, a scored 
table top could be resurfaced or replaced. 
  Storage  
Equipment and tools (including food-packing materials) must be stored and maintained to protect 
covered produce from being contaminated with known or reasonably foreseeable hazards and to 
prevent the equipment and tools from attracting or harboring pests.  (21 CFR 112.123(b)(2)).  
You should evaluate your storage locations periodically to determine the potential for 
contamination of equipment and tools stored in them, and note their proximity to potential 
sources of contamination.  For example, storage areas or buildings located near tree lines could 
increase the potential of rodent infestation (Ref. 95) (Ref. 135), which could warrant different 
procedures to protect covered produce from being contaminated with known or reasonably 
foreseeable hazards. Storage areas, including outdoor storage areas and storage areas in partially-
enclosed buildings, can attract pests and serve as a harborage for pests (Ref. 95) (Ref. 135), 
especially if equipment and tools are stored for extended periods.  See the section of this chapter 
titled Pest Control for further draft guidance on the control of pests.   
You should establish procedures to ensure that equipment and tools (including food-packing 
materials) are stored in a manner based on the requirements of 21 CFR 112.123(b)(2).  For 
example, you could find that sorting equipment used for daily field packing during the season 
can be protected overnight (after cleaning, and sanitizing as necessary and appropriate, at the end 
of the production cycle) by storing it in a partially-enclosed building with a clean covering (e.g., 
a tarp) over the sorting equipment to protect it from pests such as birds, accumulating debris, and 
96  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
weather or other conditions.  However, you could determine the sorting equipment will not be 
protected from contamination from pests, such as rodents, if it is stored long-term in a partially-
enclosed building.  You could determine, for example, that these pieces of equipment should be 
stored long-term in a fully enclosed building, where rodents can be more easily controlled.   
Equipment and tools should be clean and dry before storage to minimize the attraction of pests 
and protect covered produce from being contaminated.  Additionally, you should close or cover 
any openings into the equipment or tools to reduce the potential for pests to enter (e.g., placing a 
tarp over food contact surfaces, capping openings of pipes to prevent birds or rodents from 
nesting) (Ref. 80).  You could determine that a deep cleaning, and sanitizing as necessary and 
appropriate, procedure (i.e., beyond routine procedures) is appropriate when removing certain 
equipment and tools from storage.  See more draft guidance on cleaning and sanitizing in the 
section of this chapter titled Cleaning and Sanitizing Equipment and Tools.   
Equipment and tools, including food-packing materials, must be protected, including during 
outdoor storage, from sources of contamination (See 21 CFR 112.123(b)(2), such as dust, dirt, 
and debris, or cleaned prior to use (See 21 CFR 112.123(d)).  You should periodically inspect 
your storage of equipment and tools, including food-packing materials, that are intended to, or 
likely to, contact covered produce to ensure they are protected from contamination and do not 
attract or harbor pests.  You should establish procedures for inspection of your storage areas, 
including the frequency of these inspections, the personnel involved, and conditions that should 
be reported to you, a supervisor, or responsible party.   
  Inspection 
You must inspect all food contact surfaces of equipment and tools (including food-packing 
materials) that are used in covered activities as frequently as reasonably necessary to protect 
against contamination of your covered produce.  (See 21 CFR 112.123(d)(1)).  You should also 
consider inspecting non-food contact surfaces of equipment and tools.  You could perform these 
inspections as independent activities or in conjunction with other activities, such as cleaning, 
sanitizing, or scheduled maintenance.  Periodic inspection of your equipment and tools can help 
you to identify signs of potential contamination (e.g., visible soil, food residue, grease, or other 
material) and determine whether maintenance, replacement, or cleaning, or sanitizing is 
necessary.   
You should establish and communicate procedures for inspecting equipment and tools (including 
food-packing materials), the frequency of these inspections, the personnel involved, and 
conditions that should be reported to you, a supervisor, or responsible party to determine 
appropriate steps to protect covered produce.  Personnel, to whom you assign the responsibility 
for the inspection of food contact surfaces of equipment and tools (including transport equipment 
and instruments and controls, discussed in other sections of this chapter), or who are engaged in 
the supervision thereof, should understand your procedures for performing inspections.  You 
should direct your supervisors or other responsible parties to ensure that your personnel are 
consistently inspecting equipment and tools in accordance with your procedures and making 
corrections as needed.  You should also establish procedures to communicate your expected 
practices when personnel observe unclean, damaged, or worn equipment and tools, including 
food-packing materials.  For example, personnel you assign to inspect food-packing materials 
97  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
and those who supervise or are otherwise responsible for your operations involving food-packing 
materials should recognize food-packing materials that can no longer be cleaned.  In this 
example, supervisors and other responsible parties should ensure that only food-packing 
materials adequate for their intended use are being used.  Your evaluation of your equipment, 
tools and practices can guide you in developing your inspection procedures.  
You should perform inspections after each cleaning activity and before using equipment and 
tools to ensure that the cleaning activity was effective in removing residue from previous 
activities and that the equipment and tools remain clean during periods of storage.  Inspections 
should include visually assessing for remaining residues, such as visible soil, food residue, 
grease, or other material.  In some instances, performing inspections on dry equipment and tools 
can make it easier for personnel to see remaining residues such as visible soil than if the 
inspection is performed when the surface is wet.  The visual assessment should include the 
entirety of the equipment or tool, including areas that are difficult to access or clean, such as the 
underside of equipment (which could require the use of lights or other visual aids).   
The frequency at which you inspect the condition of your equipment and tools (e.g., for pitting, 
cracking, damage, partially open seams, excessive wear that provides harborage areas for 
moisture, organic material, and pathogens) is dependent upon the nature of the equipment or tool 
and its use.  When determining your inspection frequency, you should consider factors including:  
  The materials used (e.g., the type, nature, and durability of metal, plastic, wood, or fabric 
materials);  
  The construction technique (e.g., the durability of welded or bolted construction);  
  The conditions of use, including impact, abrasion, characteristics of covered produced, 
such as weight, texture, hardness;  
  The cleaning process and treatments used (e.g., reactivity with the materials, abrasion 
from scrubbing or scraping);  
  The storage conditions of the equipment or tool (e.g., potential damage from outdoor or 
indoor storage); 
  The climate (e.g., high humidity could result in more rapid deterioration);   
  The age of the equipment and tools (i.e., wear and damage associated with age); and 
  How often the equipment and tools are used (i.e., wear and damage associated with use). 
Based on your evaluation of these factors, you could, for example, choose to establish different 
inspection frequencies for different types of equipment and tools.  For example, you could 
determine that you need to implement a more frequent inspection schedule, such as daily or 
weekly, for equipment or tools that are frequently used or are likely to become worn or damaged 
relatively quickly (e.g., those with materials such as fabrics or thin blades, or those that are used 
under intense conditions).  Or, for example, you could find that for equipment and tools that are 
of highly durable construction or receive infrequent or light use, you can inspect them less 
frequently (e.g., at the beginning of each growing season and monthly thereafter). 
You should inspect single-use food-packing materials upon receipt or immediately before use to 
protect against contamination of your covered produce.  Generally, if single-use or reusable food 
packing materials are stored in a way, or location, where there is a potential for contamination, 
98  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
they should be inspected before use.  For example, your procedures could specify that your 
personnel will inspect reusable harvest containers prior to use, identify and set aside unclean or 
damaged containers, and notify a supervisor or responsible party of any unclean or damaged 
containers.       
The outcomes of your inspections should guide your decisions about continued use of your 
equipment and tools.  You could determine that replacing certain equipment or tools or adjusting 
equipment or tool placement, storage practices, or maintenance, cleaning, or sanitizing practices 
is necessary to minimize the potential for contamination of covered produce and food contact 
surfaces.  For inspections performed after each cleaning activity and before using equipment and 
tools, you could find that additional steps are necessary prior to using the equipment or tools.   
  Examples 
The following examples use the principles and recommendations discussed so far in this chapter 
to illustrate how a farm could evaluate their equipment and tools, conditions and practices based 
on the requirements.  The approaches described may not be appropriate for every scenario based 
on a farms circumstances.  For illustrative purposes, we identified specific covered produce for 
these examples.  Even if you use similar practices for the specific covered produce mentioned 
here, you should perform your own evaluation based on your farms specific conditions and 
practices; there could be circumstances where your practices and conditions would lead you to a 
different determination than the outcomes in the examples.  In these examples the farm visually 
assesses and evaluates their procedures to determine whether the equipment and tools covered by 
subpart L that they use are of adequate design, construction, and workmanship to enable them to 
be adequately cleaned and properly maintained based on the requirements of 21 CFR 112.123(a).  
The farm also determines whether seams on food contact surfaces of these equipment and tools 
are either smoothly bonded or maintained to minimize accumulation of dirt, filth, food particles, 
and organic material and thus minimize the opportunity for harborage or growth of 
microorganisms based on the requirements of 21 CFR 112.123(c).  Further, in these examples, 
the farm determines whether the equipment and tools are stored and maintained to protect 
covered produce from being contaminated and to prevent them from attracting and harboring 
pests based on the requirements of 21 CFR 112.123(b)(2).  Finally, in these examples, the farm 
determines whether the food contact surfaces of the equipment and tools are inspected and 
maintained as frequently as reasonably necessary to protect against contamination of covered 
produce based on the requirements of 21 CFR 112.123(d)(1).  We discuss approaches to 
cleaning, and, when necessary and appropriate, sanitizing equipment and tools in the section of 
this chapter titled Cleaning and Sanitizing Equipment and Tools.  Your practices or procedures 
or use of your equipment or tools could change over time, and you should account for these 
changes as appropriate; periodic evaluations can assist you with ensuring that you consider any 
changes that occur.   
Examples of farm evaluations that do not lead to a change in equipment or tools, practices or 
procedures:   
 
Example 7c. Harvest trailer with a wooden floor for hauling watermelons.  
99  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
A farm uses a harvest trailer with a wooden floor to carry watermelons from the field to a 
packing area.  The farm observes that the harvest trailer typically remains dry during use, and 
that the watermelons remain intact, with very few observations of damage to the watermelons 
that could result in watermelon residue or liquid from the watermelons leaking onto the 
trailer.  The farms procedures specify that the harvest trailer is to be kept clean and dry, 
maintained (e.g., free from splinters and cracks), and stored in a way that protects it from 
moisture, damage, and contamination, such as in a covered storage shed or garage to 
minimize the potential for contamination.  The farm directs their personnel using the trailer 
to inspect it for cleanliness and damage both prior to use and after each load, to maintain the 
trailer, and to clean the trailer by removing organic material, debris, and other material as 
necessary.  Personnel ensure that they do not place moist or damaged watermelons into the 
trailer.  The farm determines that their procedures are consistently followed by personnel, 
continues to use the harvest trailer, and periodically evaluates their practices and procedures. 
Example 7d. Storage and inspection of plastic bags.  
A farm uses single-use plastic bags for packing celery in the growing area.  The farm 
evaluates their storage, inspection and handling practices for this material from the time of its 
receipt until it leaves the farm.  The farm receives the plastic bags in containers on a pallet.  
The farm stores and maintains the bags as received from the supplier in a fully enclosed 
building in a clean, dry environment until ready for use.  Any plastic bags that are not used at 
the completion of field packing are covered, transported and stored in a fully enclosed 
building on pallets.  When the farm is ready to use the material, the pallets are transported to 
the growing area, and the bags are inspected when they are loaded onto the packing 
equipment.  If they find any signs of potential contamination they do not use the bags and 
report the conditions to a supervisor or other responsible party.  Further, a supervisor or other 
responsible party inspects the storage area weekly.  The farm continues to periodically 
evaluate their practices and procedures. 
Example 7e. Storage and inspection of wax-impregnated corrugated fiberboard boxes 
stored in a partially-enclosed building. 
A farm packs honeydew inside a partially-enclosed building and uses single-use, waxed, 
corrugated fiberboard boxes.  The unformed fiberboard boxes are received and stored in 
shrink-wrap.  The farms procedures specify that the boxes are to be stored indoors in a 
clean, dry environment.  Additionally, they specify that, when in the packing area, the 
unformed and formed boxes are kept on a pallet in a clean, dry area, away from personnel 
and equipment traffic, that each pallet is unwrapped on an as-needed basis, and that any 
unused boxes are to be moved to the indoor storage area daily when packing activities 
conclude.  They also specify that personnel are to inspect the boxes for any signs of potential 
contamination, damage, or poor condition (e.g., moisture) prior to using them; and that if 
they find such evidence, they are not to use the boxes and are to report the conditions to a 
supervisor or other responsible party.  Further, they specify that a supervisor or other 
responsible party is to inspect the location where the boxes are kept in the packing area 
periodically during the day to ensure that personnel follow these practices, and that a 
supervisor or other responsible party is to inspect the packaging storage area weekly.  The 
farm continues to periodically evaluate their practices and procedures. 
100  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Example 7f. Storage and inspection of harvest containers stored outdoors. 
A farm uses reusable plastic harvest containers to transport and hold pears.  The containers 
are stored outdoors.  The farms procedures specify that the containers are to be cleaned prior 
to use.  They specify that the container storage area is to be inspected by a supervisor or other 
responsible party twice a week.  Also, they specify that personnel are to inspect the 
containers for cleanliness, damage, and poor condition immediately prior to use to protect the 
pears that contact them from contamination.  Further, they specify that when personnel 
observe damage to containers to the extent that they can no longer be properly cleaned, the 
containers should be discarded.  The farm continues to periodically evaluate their practices 
and procedures. 
Example 7g. Storage and inspection of harvest containers stored outdoors with temporary 
storage in the growing area. 
A farm uses reusable wood harvest containers to transport cabbage for packing and holding.  
The containers are removed from an outdoor long-term storage area and temporarily stored 
outdoors in a growing area for several days prior to harvest.  The farms procedures specify 
that the long-term container storage area and the storage areas in each growing area are to be 
inspected by a supervisor or other responsible party twice a week. The farms procedures 
specify that personnel are to clean and dry the containers as they are removed from long-term 
storage for use.  They also specify that personnel are to inspect the containers immediately 
prior to use for cleanliness, damage, and poor condition.  Further, they specify that unclean 
containers are to be set aside for re-cleaning or replacement, and that damaged containers 
that can no longer be properly cleaned should be repaired or discarded.  The farm continues 
to periodically evaluate their practices and procedures. 
Examples of farm evaluations leading to a change in equipment or tools, practices or 
procedures: 
Example 7h. Harvest trailer with wooden floor for hauling tomatoes. 
A farm uses a harvest trailer with a wooden floor to move tomatoes from the field to a 
packing area.  The farm observes that the tomatoes are frequently damaged during loading 
and transport such that tomato residue or liquid leaks onto the wooden floor of the trailer.  
The farm determines that the wooden floor with tomato residue is difficult to clean and is not 
a suitable food contact surface under the circumstances.  The farm changes their procedures 
to include placing a clean, durable, non-porous, food grade, single-use liner in the harvest 
trailer to minimize the potential for contamination of the tomatoes from the wooden floor of 
the trailer.  The farm directs their personnel using the trailer to inspect the trailer and liners 
for cleanliness and damage prior to use, to maintain the trailer and to change the single-use 
liners between each load.  The farm continues to periodically evaluate their practices and 
procedures. 
Example 7i. Harvest trailer with carpeting material on the floor for hauling cantaloupe.  
101  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
A farm uses carpeting material on a harvest trailer used to convey cantaloupe.  The farm 
observes that the carpeting material reduces product bruising but it also absorbs moisture and 
organic material that is difficult to remove.  The farm determines that they cannot perform 
proper cleaning to maintain the carpeting material in a manner that protects against 
contamination.  The farm removes the carpeting and uses materials that are of a design, 
construction, and workmanship that farm personnel can adequately clean and maintain.  
Depending on their circumstances, this could include using reusable materials, such as 
plastic, or single-use materials, such as foam or plastic, or a different vehicle.  The farm 
continues to periodically evaluate their practices and procedures. 
Example 7j. Table with a wooden food contact surface used to sort radishes.  
A farm sorts radishes using a sorting table with a wooden surface on a metal support system.  
Farm personnel wash the radishes before sorting.  While conducting its evaluation, the farm 
observes that the wooden surface of the table accumulates soil, residue, and moisture from 
the radishes during sorting, and the farmer determines that personnel cannot properly clean 
the wooden surface of the table manner that protects against contamination.  The farm 
replaces the wooden top of the sorting table with a food grade material top that is of adequate 
design, construction, and workmanship that farm personnel can adequately clean and 
maintain.  Depending on the circumstances, this could include stainless steel, plastic or other 
materials.  The farm continues to periodically evaluate their practices and procedures.   
Example 7k. Foam pads on equipment used to convey apples. 
A farm uses foam pads on equipment used to convey apples.  The foam pads contact the 
apples.  The farm observes that the foam pads are not designed for frequent removal from the 
equipment which allows for the accumulation of dirt and other organic material, and the 
porous nature of the material allows for the accumulation of organic material on and 
underneath the pads.  The farm determines that they cannot adequately clean the foam pads 
in a manner that protects against contamination given their equipment, conditions and 
practices.  The farm evaluates several options, including: 
  Replacing the foam pads as frequently as reasonably necessary to protect against 
contamination; 
  Removing the foam pads;  
  Adding a removable liner, such as a plastic liner, over the foam with adequate design, 
construction, and workmanship that personnel can adequately clean and maintain; 
  Replacing the foam pads with a food grade material with adequate design, construction, 
and workmanship that enables personnel to adequately clean and properly maintain, such as a 
different type of foam, plastic or other material; or 
  Replacing the equipment with that which has a design, construction, and workmanship 
that is more compatible with the farms operations. 
The farm could also choose to take a short-term approach, such as removing or replacing the 
pads, and develop a long-term plan to replace the equipment with that which has a design, 
construction, and workmanship that is more compatible with the farms operations.  The farm 
continues to periodically evaluate their practices and procedures. 
102  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Example 7l. Inspection of harvest containers stored outdoors with evidence of 
contamination. 
A farm uses reusable plastic harvest containers to transport nectarines to a holding area.  The 
containers are stored outdoors.  The farms procedures specify that personnel are to inspect 
the containers immediately prior to use for cleanliness, damage, and poor condition 
immediately prior to use to protect the nectarines that contacts them from contamination.  
The farm determines that the storage area is to be inspected by a supervisor or other 
responsible party twice a week.  A supervisor inspecting the storage area observes rodent 
excreta in some of the storage containers.  Based on the outcome of the supervisors 
inspection, the plastic harvest containers located in the area in which evidence of rodent 
infestation was observed are designated for cleaning and sanitizing or replacement, as 
appropriate.  The farm also determines whether other measures are necessary, such as 
increasing the frequency of inspection and changes to pest control measures. 
Example 7m. Foam pads in plastic bin containers to cushion cherries. 
During harvesting, a farm uses foam pads to cushion cherries in plastic containers, and the 
foam pads contact the cherries.  The farm observes that the pads become moist during 
refrigerated cooling, and the pads remain in place as the packing containers are transported to 
the packing area.  The farm determines they have limited information on the effectiveness of 
cleaning porous foam materials, and gathers information from the manufacturer of the foam 
pads and from technical assistance resources to assist in their determination of whether the 
pads are appropriate for use as a reusable material.  If the farm determines the foam pads can 
be cleaned and that, under their conditions of use, they are unlikely to support the growth of 
bacteria, then they could reuse the pads with appropriate cleaning.  If the farm determines 
that the foam pads are not cleanable, they must not reuse them.  (See 21 CFR 112.123).  If 
the farm determines that single-use of the pads is unlikely to support growth or transfer of 
bacteria, then they could choose to designate them for single-use. 
   Cleaning and Sanitizing Equipment and Tools 
Cleaning and sanitizing are different steps that are important to the safety of your covered 
produce.  Unsanitary equipment and tools can serve as a source of contamination for produce 
(Ref. 8) (Ref. 10) (Ref. 48) (Ref.108).  You must inspect, maintain, clean, and, when necessary 
and appropriate, sanitize all food contact surfaces of equipment and tools used in covered 
activities as frequently as reasonably necessary to protect against contamination of covered 
produce.  (21 CFR 112.123(d)(1)).  You also must maintain and clean all non-food contact 
surfaces of equipment and tools subject to subpart L used during harvesting, packing, and 
holding as frequently as reasonably necessary to protect against contamination of covered 
produce.  (21 CFR 112.123(d)(2).  You should evaluate your equipment and tools by taking the 
following steps: 
  Identify food contact surfaces and non-food-contact surfaces of equipment and tools; and 
103  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Determine cleaning practices, and, as necessary and appropriate, sanitizing practices for 
each type of equipment and tool, and the frequency at which you will perform these 
practices. 
  Identifying Food Contact Surfaces and Non-Food Contact 
Surfaces of Equipment and Tools  
In the section of this chapter titled Equipment and Tools, we recommend that you identify all 
equipment and tools on your farm that are intended or likely to contact covered produce.  For 
these equipment and tools, you should also identify their food contact surfaces and non-food 
contact surfaces.   
Food contact surfaces means those surfaces that contact human food and those surfaces from 
which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily 
occurs during the normal course of operations.  Food contact surfaces includes food contact 
surfaces of equipment and tools used during harvest, packing, and holding. (21 CFR 112.3).  
Food contact surfaces also includes food contact surfaces of equipment and tools used in 
growing covered produce (See 21 CFR 112.123(d)(1)). 
You should carefully evaluate your practices during covered activities to identify the food 
contact surfaces of your equipment and tools.  You should visually assess your covered activities 
to identify food contact surfaces during production activities.  Some food contact surfaces could 
not be easily identified when production activities are not occurring.  In particular, you should 
look for drainage, or other mechanisms of transfer (e.g., water splash) that occur.  In some cases, 
you could have the flexibility to adjust your practices to avoid surfaces being considered food 
contact surfaces (see Example 7o).  The following examples illustrate how a farm could evaluate 
their equipment and tools, practices and conditions to identify food contact surfaces and non-
food contact surfaces.  Even if you use similar equipment, tools or practices, you should perform 
your own evaluation based on your farms specific practices and conditions.  
Example 7n:  A farm observes that the fine mist of water from the nozzles of a spray bar over 
a conveyor belt containing covered produce contacts the bar itself, resulting in water dripping 
from the bar onto the covered produce; in this example, the farm should consider the spray 
bar a food contact surface.   
Example 7o:  A farm observes parsley protruding through openings in a plastic container that 
touches the table where the containers were placed, so the farm should consider the table a 
food contact surface.  The farm could start placing a removable plastic surface between the 
containers and the table so that the table is not the food contact surface.    
Example 7p:  A farm observes a conveyor belt system used to move turnips and determines 
that the conveyor belt and some support bars underneath that contact the conveyor belt are 
food contact surfaces.  The farm carefully evaluates the conveyor belt system to determine if 
other components are food contact surfaces, such as through drainage or other mechanisms of 
transfer.  The farm identifies other components of the system, including the legs of the 
support structure for the conveyor belt system and the housings for electrical components, are 
not food contact surfaces. 
104  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Cleaning and Sanitizing Procedures 
Once you have identified equipment and tools subject to subpart L, and the associated food 
contact surfaces, you should evaluate and determine appropriate cleaning practices and 
frequencies for food contact surfaces and non-food contact surfaces.  You must inspect, maintain 
and clean and, when necessary and appropriate, sanitize all food contact surfaces of equipment 
and tools used in covered activities, and maintain and clean all non-food contact surfaces of 
equipment and tools used during harvesting, packing, and holding, as frequently as reasonably 
necessary to protect against contamination of covered produce.  (21 CFR 112.123(d)(1) and (2)).  
Cleaning and sanitizing activities should be performed both on a scheduled, periodic basis and in 
response to identified problems or potential contamination.   
Periodically performing cleaning and sanitizing procedures, including deep cleaning and 
sanitizing procedures, can increase effective soil removal, biofilm prevention and removal, and 
pathogen inactivation (Ref. 18) (Ref. 38) (Ref. 83) (Ref. 134).  You should consider performing 
deep cleaning and sanitizing, as necessary and appropriate, procedures (i.e., beyond routine 
procedures) on a scheduled, periodic basis.  These procedures can involve additional or different 
activities, such as disassembling equipment for more targeted cleaning when your routine 
procedures involve cleaning the assembled equipment (Ref. 66) (Ref. 134).  It can also involve 
using a different sanitizing compound than is typically used during routine procedures, in order 
to impact a broader range of potential microorganisms (Ref. 15) (Ref. 18) (Ref. 83) (Ref. 93) 
(Ref. 134). 
Your cleaning methods should remove potential sources of contamination, including visible soil, 
food residue, grease, and other material.  Cleaning methods can be broadly divided into wet 
cleaning and dry cleaning.  Generally, wet cleaning is the most effective method to remove 
organic material (Ref. 15) (Ref. 82), and involves the use of water and cleaning solutions.  There 
are a variety of different cleaning agents you can choose based on your specific needs.  You 
should select a cleaning agent based on, for example, the structure of the items to be cleaned, and 
the nature of the potential contamination.  Some options could include general purpose cleaners, 
alkaline and chlorinated detergents, or acid and enzyme detergents (Ref. 83) (Ref. 97).  You 
could choose to work with technical assistance resources, such as cleaning and sanitation 
suppliers, academia, extension services, and industry associations to determine the most 
appropriate cleaning and sanitizing treatments for your operations. 
In some circumstances, dry cleaning could be preferable to wet cleaning, such as when covered 
produce with dry surfaces are handled in a dry, low moisture environment.  In certain situations, 
the introduction of water into the otherwise low moisture environment can increase the potential 
for growth of some pathogens that could be present; such pathogens would be unlikely to grow 
without the addition of water (Ref. 12) (Ref. 11) (Ref. 43).  Dry cleaning typically involves 
mechanical action for the removal of organic material and other residues.   
You should evaluate your production environment, covered produce, and equipment and tools 
you use to determine when you should sanitize and identify sanitizing methods appropriate for 
food contact surfaces of your equipment and tools.  Sanitize means to adequately treat cleaned 
surfaces by a process that is effective in destroying vegetative cells of microorganisms of public 
health significance, and in substantially reducing numbers of other undesirable microorganisms, 
105  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
but without adversely affecting the product or its safety for the consumer.  (21 CFR 112.3).  
Sanitizing can include the use of such substances as hypochlorite, chlorine dioxide, iodine, 
quaternary ammonium compounds, hot water, steam, dry heat, or ultraviolet light (Ref. 15) (Ref. 
39) (Ref. 93) (Ref. 119).     
You should consider the following list of factors that influence the effectiveness of cleaning 
procedures: 
  The pressure of water or air used during debris removal (e.g., pre-rinse and post-rinse 
for wet cleaning).  Overly low pressure could not effectively remove soil or debris from 
surfaces.  However, if you are using high pressure when cleaning, you should take care to 
not spread contamination from one surface (e.g., floors, floor drains) to another, which 
can occur through splashing or aerosolizing (Ref. 18) (Ref. 66) (Ref. 134). 
  The material (e.g., plastic, stainless steel, concrete) of the surface to be cleaned and the 
method of construction of the equipment and tools (e.g., solid welded, bolted for 
disassembly).  We provide draft guidance on equipment and tool construction and its 
effect on cleanability in the section of this chapter titled, Design, Construction, and 
Workmanship.  
  The force and duration of physical scrubbing.  Low rates of force applied or short 
amounts of time spent scrubbing equipment and tools could result in only partial removal 
of soil and debris.  On the other hand, overly aggressive or prolonged cleaning processes 
could damage equipment and tool surfaces, potentially resulting in surface scratches or 
other damage, which can serve as harborage sites for pathogens (Ref. 96) (Ref. 97) (Ref. 
125). 
  The type and concentration of the cleaning agent or detergent.  You should refer to the 
label directions and manufacturer instructions for your detergents and other cleaning 
agents to ensure you use a concentration and method effective for your use, including the 
type of soil, residue, or material targeted for removal.  
  The contact time of the cleaning solution with the surface being cleaned.  Shortened 
contact time could result in only partial removal of soil and debris (e.g., the cleaning 
agent could not be able to fully loosen the debris from the surface or could leave a film or 
residue on your equipment or tools) (Ref. 38) (Ref. 97) (Ref. 125).  
  The characteristics and quantity of the soil and debris on the surface being cleaned.  
Certain types of residues (e.g., oily or high protein) or large quantities of residues can 
impact the need to modify the other factors described above (e.g., use a highly alkaline 
detergent or a highly oxidizing cleaner for certain residues or increase contact time and 
physical scrubbing) (Ref. 97) (Ref. 125).  
When choosing a sanitizing treatment, if one is appropriate and necessary, you should consider 
the following factors that influence their effectiveness, including: 
106  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  The material of the surface to be sanitized.  Some sanitizers are incompatible with some 
materials (e.g., products containing chlorine could lead to the degradation of some 
materials) (Ref. 93) (Ref. 125) (Ref. 105);  
  The type, duration, application method, temperature and concentration of the sanitizing 
or antimicrobial treatment (Ref. 15) (Ref. 38). You should refer to the label directions 
and manufacturer instructions to ensure you use a concentration and method effective for 
your use;  
  The contact time of the sanitizing or antimicrobial treatment with the surface being 
treated.  Shortened contact time could cause incomplete treatment and excessive contact 
time could damage your equipment or tools (Ref. 38) (Ref. 125); and  
  Characteristics of the water you use to prepare the sanitizing agent.  The hardness (i.e., 
presence of minerals), pH, and temperature of your water could impact the effectiveness 
of the sanitizing agent and its compatibility with the surface being sanitized (Ref. 38) 
(Ref. 39) (Ref. 125) (Ref. 126). 
The following steps are an example of a typical wet cleaning and sanitizing procedure (Ref. 94) 
(Ref. 125); some steps could not be applicable to your operation or could be modified (Ref. 38) 
(Ref. 94): 
1.  Pre-Clean:  personnel use tools such as brushes, brooms, scrapers, and collection pans to 
remove heavy residue, plant material or debris from the equipment or tools.   
2.  Initial Rinse:  personnel rinse the equipment or tools with water to remove additional 
organic material and residue that was loosened during the pre-clean step; scrubbing could 
be necessary during this step. 
3.  Washing with Cleaning Agent and Mechanical Action: personnel apply a cleaning agent 
in one of several forms, such as by spray or foam; personnel should ensure full coverage 
of the relevant surface with the cleaning agent for the time and at the temperature 
specified by the cleaning agent manufacturer; small equipment or tools or components of 
these can be washed in sinks or tanks containing a solution of the cleaning agent; 
mechanical action (e.g. scrubbing) ordinarily should be applied, using tools such as 
brushes or scouring pads, in order to fully remove organic material and residues. 
4.  Post-Rinse: personnel apply water to remove loosened soil and debris along with the 
cleaning agent; after the post-rinse the equipment and tools could be allowed to dry prior 
to further activities.   
5.  Inspection:  personnel check the equipment or tools for any remaining soil or residue; 
additional draft guidance on equipment and tool inspection is found in the section of this 
chapter titled Inspection. 
6.  Sanitize: when necessary and appropriate, personnel apply antimicrobial treatments to 
clean, rinsed surfaces.  Sanitizing is generally not effective unless it is preceded by a 
107  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
cleaning step, because residual organic material can protect pathogens from the action of 
the sanitizing treatment (Ref. 94) (Ref. 38) (Ref. 39) (Ref. 82) (Ref. 93).  Antimicrobial 
treatments should be applied so that the treatment contacts all areas of the food contact 
surface.  Care should be taken to ensure contact of the treatment with hard to reach places 
(e.g., edges of interlocking conveyor systems, gears and sprockets that contact covered 
produce, and the undersides of guards, covers, and ceilings, from which moisture could 
drip or drain onto the covered produce).  This could be done by immersion (e.g., for small 
equipment and tools and their components), spraying, or flushing (e.g., for stationary 
equipment).    You should consult the labeled instructions provided by the supplier.  In 
some instances, antimicrobial treatments should be followed by rinsing.     
Dry cleaning typically involves a pre-cleaning step to remove heavy residue, plant material, and 
debris, followed by a dry-cleaning step using mechanical action to further remove organic 
material and residue.  Tools that are typically used for dry cleaning include vacuum systems, 
brushes, scrapers, and compressed air.  An inspection should also be performed after dry 
cleaning to evaluate the effectiveness of the cleaning process.  Generally, there are fewer options 
available for routine sanitizing of dry cleaned equipment and tools, and these may not be suitable 
for all circumstances.   
  Frequency of Cleaning and Sanitizing 
You should evaluate and establish cleaning frequencies for both food contact and non-food 
contact surfaces, as well as sanitizing frequencies for food contact surfaces, as necessary and 
appropriate.  You should schedule cleaning and sanitizing of equipment and tools with food 
contact surfaces after storage, after relevant production cycles (e.g., daily or between shifts), or 
as otherwise necessary to protect against contamination of covered produce.  In some cases, you 
could determine that cleaning for both the non-food contact surfaces and the food contact 
surfaces of equipment and tools should occur at the same frequency.   
The following are some factors that you should consider when determining the frequency of 
cleaning and, when necessary and appropriate, sanitizing: 
  Visual observations of the rate of accumulation of soil and debris;   
  Whether the surface is a food contact surface;  
  Whether the equipment or tools also are used for excluded produce (food contact surfaces 
of such equipment and tools must be adequately cleaned and sanitized, as necessary, 
before use on covered produce (21 CFR 112.111(b)); 
  The potential for contamination of the equipment or tool during use (e.g., more frequent 
cleaning and sanitizing could be necessary if a field-coring device regularly contacts the 
soil than if it is held away from the soil); 
  The duration of the production cycle (e.g., 8, 12, 16 hours); 
  Ambient temperature during use of the equipment and tools (the rate bacterial growth 
increases as temperature increases) (Ref. 38) (Ref. 126); 
  The ability of produce residues to support the growth of pathogens (most support growth, 
but the rate of growth can be influenced by differences in moisture, water activity, 
nutrients, and inhibitory substances) (Ref. 38) (Ref. 126); 
108  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  The design, construction, and workmanship of the equipment and tools (Ref. 38) (Ref. 
94) (Ref. 125) (Ref. 134) (e.g., more frequent cleaning and sanitizing could be necessary 
for a conveyor system with interlocking belt pieces compared to a system with a single-
piece, smooth belt because there could be a greater potential for accumulation of debris 
between the interlocking pieces); and  
  The results of any testing that you perform (e.g., results showing high levels of microbial 
indicator organisms could necessitate more frequent cleaning). 
You should consider the accumulation of soil, residue, or material during your covered activities 
and the potential for pathogen growth as you determine appropriate cleaning and sanitizing 
frequencies.  You could find it useful to schedule periodic deep cleaning and sanitizing, as 
necessary and appropriate, procedures (i.e., beyond routine procedures) at a reduced frequency in 
comparison to your routine procedures.  
You should consider performing a sanitizing step each time that you perform a complete wet 
cleaning procedure (e.g. steps 1-5 described in the section of this chapter titled Cleaning and 
Sanitizing Procedures) for equipment or tools.  The process of cleaning followed by sanitizing 
enhances microbial removal and inactivation (Ref. 38) (Ref. 83) (Ref. 93) (Ref. 94).   Further, 
depending on your established cleaning process, you could determine that performing a pre-clean 
step, or some portion of your cleaning procedures, should be performed at an increased 
frequency compared to that of the entire cleaning process to address heavy accumulation of 
residue (e.g., leaves, soil and other material) that could build up over the course of use.  For 
example, a farm conveys cucumbers into a packing area; the farms procedures could specify 
that the pre-cleaning step be performed at least twice during a production shift to control 
accumulation of mud, stems, and other debris, and that a complete wet cleaning cycle, including 
sanitizing, be performed at the end of each day.   
In some limited instances, you could determine that sanitizing food contact surfaces can occur at 
a reduced frequency compared to cleaning activities, particularly after dry cleaning.  For 
example, if a farm that shells and packs walnuts determines that the shelling area should remain 
dry, the farm could determine that the shelling equipment should be dry cleaned daily, using 
brushes and compressed air to remove organic material and residue; this avoids introducing 
moisture from wet cleaning, which could increase the potential for pathogen growth and transfer.  
Further, the farm could determine that prior to the beginning of covered activities each season, or 
at a specified frequency, the shelling equipment should be disassembled, moved to a location 
outside of the dry production environment, wet cleaned, and the food contact surfaces sanitized; 
after thorough drying, the equipment would be reassembled in the production area.   
You should also determine potential instances when cleaning and sanitizing of equipment or 
tools should occur outside your scheduled frequency.  You should ensure that cleaning and 
sanitizing of food contact surfaces and non-food contact surfaces of equipment and tools occurs 
immediately when you discover or suspect that they are potentially contaminated (e.g., after 
contact with human or animal excreta, contaminated water, contaminated produce, excluded 
produce, or contaminated hands).  For example, your procedures specify that a piece of 
equipment used for conveying gooseberries is cleaned and sanitized at the end of each 
production cycle; there could be circumstances where cleaning and, when necessary and 
appropriate, sanitizing the equipment must be performed before the scheduled time at the end of 
109  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
the production cycle, as reasonably necessary to protect against contamination.  (See 21 CFR 
112.123(d)(1)).  
  Transport Equipment 
If you use equipment such as pallets, forklifts, tractors, and vehicles such that they are intended 
to, or likely to, contact covered produce, you must do so in a manner that minimizes the potential 
for contamination of covered produce or food contact surfaces with known or reasonably 
foreseeable hazards.  (21 CFR 112.123(e)).  Equipment subject to subpart L that you use to 
transport covered produce must be adequately clean before use in transporting covered produce, 
and adequate for use in transporting covered produce.  (21 CFR 112.125).   
You should identify the equipment used to transport covered produce, which could include 
trucks.  If you determine that the transport equipment is not adequately clean, you could, for 
example, clean the equipment or choose to not use it.  You should pay particular attention to the 
surfaces that contact covered produce. 
  Instruments and Controls 
Instruments or controls you use to measure, regulate, or record temperatures, hydrogen-ion 
concentration (pH), sanitizer efficacy or other conditions, in order to control or prevent the 
growth of microorganisms of public health significance, must be: accurate and precise as 
necessary and appropriate in keeping with their purpose; adequately maintained; and adequate in 
number for their designated uses.  (21 CFR 112.124).  Examples of these instruments include pH 
meters or test strips; iodine test strips; chlorine test strips; oxidation-reduction potential meters; 
indicating thermometers; recording thermometers; thermocouples, and temperature actuated 
control valves.  These instruments could be used to measure or record such conditions as 
temperatures in composting piles; pH in composting piles; or the concentration of antimicrobial 
in a sanitizing solution. 
Personnel to whom you assign the responsibility for maintaining these instruments and controls, 
or who are engaged in the supervision thereof, should understand your procedures.  These 
personnel should understand the importance of accuracy and precision, and should ensure that 
accurate measurements are collected.  You should specify when personnel need to inform a 
supervisor or other responsible party of certain observations so they can determine appropriate 
steps.  You should direct supervisors or responsible parties, as applicable, to ensure that activities 
related to instruments and controls are conducted in accordance with your procedures and 
corrections are made as needed. 
  Accuracy and Precision 
The accuracy and precision of your instruments and controls help to ensure the efficacy of 
measures to control or prevent the growth of microorganisms of public health significance on 
your farm.  Accuracy is how close a devices displayed measurement compares to the true value.  
For example, if your thermometer displays a reading of 75.2F (24C) when placed in a 
container of water and the true temperature of the water is 85.2F (29C), your instrument is not 
very accurate.  Precision is the consistency among individual measurements displayed by an 
110  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
instrument under the same conditions.  For example, if you weighed a single watermelon 5 times 
on the same scale and the scale read 20.2 lbs., 18.9 lbs., 21.4 lbs., 19.5 lbs., and 22.8 lbs., the 
scale is not very precise.  Continuing with the first example, if your thermometer reads 75.2F 
(24C), 75.2F (24C), and 75.2F (24C) for three measurements of 84.2F (29C) water, the 
instrument is precise, but not accurate.  
You should evaluate your farms covered activities for which you use instruments or controls to 
measure, regulate, or record conditions to control or prevent the growth of microorganisms of 
public health significance.  The necessary degree of accuracy and precision for your instruments 
or controls varies depending on how they are used.  For example, an instrument that is both 
highly accurate and highly precise (e.g., within 2F (1C)) should be used when small variations 
can lead to the growth of pathogens, such as when using a thermometer to measure storage 
temperature in a cooler that contains mushrooms in oxygen impermeable packages.  In this 
example, the farm should target maintaining temperatures below 36F (2.2C) because a 
temperature above 38F (3.3C) during storage can result in the formation of Clostridium 
botulinum toxin (Ref. 76) (Ref. 118) (Ref. 123).   
As part of your maintenance activities, you should perform periodic accuracy checks to ensure 
that your instruments and controls are functioning properly.  In some cases, you can check the 
accuracy and precision of your instruments and controls yourself.  Generally, accuracy checks 
involve comparing an instruments displayed measurement against at least one true value.  In 
some instances, you could be able to account for minor, consistent deviations in instrument 
readings.  For example, if a farm uses a thermometer to check the temperature of turned compost 
under a process based on the example provided in 21 CFR 112.54(b)(2) to maintain aerobic 
conditions at a minimum of 131F (55C) for 15 days, and determines that the thermometer 
consistently reads within 4F of the true value during accuracy checks; the farm should account 
for this level of accuracy by targeting a temperature reading that is sufficiently high to ensure 
that it meets the target (e.g., maintain at least 135F (57C)).  You should adjust or replace any 
of your instruments or controls that do not meet your identified level of accuracy or precision.   
Documentation or manuals that typically accompany instruments and controls often contain 
information on the instruments accuracy.  You could, for example, contact the vendor or 
manufacturer directly to obtain additional information on the accuracy and precision of an 
instrument or control.  You could also choose, for example, to seek further information from 
technical assistance resources. 
You should establish a calibration schedule for all of the instruments and controls that you use to 
measure, regulate, or record temperatures, hydrogen-ion concentration (pH), sanitizer efficacy, 
or other conditions, to control or prevent the growth of microorganisms of public health 
significance.  You should replace instruments or controls that you cannot calibrate to the 
necessary level of accuracy or precision.  Many instrument and control vendors and 
manufacturers recommend periodically calibrating instruments, and can provide instructions and 
recommended frequencies for these procedures.   
Calibration involves comparing an instruments displayed measurement against multiple, true 
values, often using a known reference standard (e.g., National Institute of Science and 
Technology (NIST) traceable instrument or other recognized reference solutions or instruments) 
111  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
and a notation of the extent to which the measurement deviates from the standard.  You should 
use multiple true values, with at least one true value typical of the instruments use.  For 
example, pH probes are typically calibrated against two reference solutions, using at least one 
solution that reflects a value typically measured by the instrument when used.  As another 
example, if you are calibrating a thermometer that you typically use to measure temperatures of 
compost near 131F, you should use at least one calibration true value near 131F.  Calibration 
can also involve an adjustment to correct the accuracy deviation, depending on the instrument 
design.  For example, you can check a dial thermometer for accuracy by measuring the 
temperature it displays when placed in an ice slurry (32F (0C)) or boiling water, accounting for 
your elevation (e.g., 212F (100C) at sea level).  You could calibrate the thermometer by 
placing it and a NIST traceable instrument in an ice slurry and boiling water and comparing the 
temperature displayed by each.  You could then adjust your thermometer, if its design allows, to 
display a reading consistent with that of the NIST instrument.  If your thermometer cannot be 
adjusted, then you should account for the difference between the thermometer and the NIST 
traceable instrument when you use the thermometer.  You can calibrate your instruments and 
controls yourself or use a third-party, such as a manufacturer or contract laboratory.   
Calibration is important to ensure accurate results that are consistent over time.  Instrument wear 
or damage can result in changes in accuracy or precision.  The extent to which an instrument or 
control will maintain its accuracy and precision between calibrations depends on the type of 
instrument; instrument quality; frequency of use; use and storage environment (e.g., high 
humidity and temperature can affect some instruments and controls); and the way the instrument 
is used (e.g., rough handling can affect instruments and controls).  In some instances, you should 
periodically compare results against a more reliable instrument (e.g., periodic checks with a pH 
probe when typically using pH test strips), especially when there is potential for human error or 
judgement associated with qualitative results (e.g., color change in a pH test strip).  
You should maintain all instruments and controls according to the manufacturers 
recommendations.  Maintenance could include: performing start-up activities prior to taking 
measurements; performing instrument or control cleaning steps between measurements, such as 
flushing residual material from the instrument or control; and confirming expiration dates of the 
instruments, controls or associated materials.  Failure to maintain instruments can lead to 
inaccurate or imprecise readings.  For example, an expired test kit used to measure the 
concentration of sanitizing solution could provide an inaccurate measurement, possibly 
impacting the efficacy of your sanitizing procedures.  You should perform maintenance activities 
at appropriate frequencies to ensure that your instruments and controls function in the manner 
necessary to control or prevent the growth of pathogens.  For example, you should instruct your 
personnel to periodically check expiration dates, and not use expired instruments, test kits, test 
kit solutions, and instrument and control components. 
Storage methods could impact the functionality of some instruments and controls.  For example, 
the probe of a pH meter should not be stored in water, which can damage the probe and result in 
inaccurate readings.  Further, humidity or temperature can impact the accuracy of some test kits 
and reagents; these types of instruments or controls should be stored under climate-controlled 
conditions until use.   
 
112  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Adequate in Number 
You must have enough instruments on your farm to facilitate measurement (See 21 CFR 
112.124) and should have those instruments placed in appropriate locations to ensure control of 
your processes.  You should determine the appropriate number and appropriate placement of 
instruments and controls given the scale of your farms activities.  You should have sufficient 
numbers of instruments or controls conveniently located, so they are available when needed.  For 
example, if you perform treatment of biological soil amendments of animal origin (BSAAO), 
such as composting, at multiple sites of your farm, you should determine the number of 
thermometers necessary at each site so that your personnel can ensure that the compost meets 
any relevant temperature standards to comply with 21 CFR 112.54.  As another example, if you 
have multiple growing or packing locations on your farm, you should have enough test kits so 
that your personnel can check the strength of a sanitizing solution at all of those locations where 
testing is necessary.   
In some cases, you could need multiple instruments in order for them to be adequate in number 
for their designated uses.  For example, if you are composting a small biological soil amendment 
of animal origin (BSAAO) pile and monitoring the temperature, one thermometer placed near the 
bottom of the pile where temperature is more challenging to control could be sufficient.  
However, if you are composting large windrows, you could need multiple thermocouples placed 
throughout the pile at different depths to evaluate the overall temperature. 
2.  Buildings 
Buildings that are subject to subpart L of the Produce Safety Rule include any fully- or partially-
enclosed building used for covered activities, including minimal structures that have a roof but 
do not have any walls.  (21 CFR 112.122(a)).  Buildings that are subject to subpart L also include 
storage sheds, buildings, or other structures used to store food contact surfaces (such as harvest 
containers and foodpacking materials) (21 CFR 112.122(b)).  Such buildings could be 
permanent or temporary structures.  Partially-enclosed buildings typically have a roof, with one 
or more sides open to the natural environment while fully-enclosed buildings have walls on all 
sides, a floor, and a roof.  You should identify all fully- and partially-enclosed buildings on your 
farm that you use for a covered activity.  Buildings on your farm in which you do not perform 
covered activities, and which are, therefore, not covered by subpart L could include, for example: 
personal homes; grain silos; livestock barns; chicken coops; and stables.   
  Size, Construction, and Design 
Your buildings that are subject to subpart L must be suitable in size, construction, and design to 
facilitate maintenance and sanitary operations for covered activities to reduce the potential for 
contamination of covered produce or food contact surfaces with known or reasonably foreseeable 
hazards.  (21 CFR 112.126(a)(1)).  The buildings must:  
(i)  provide sufficient space for placement of equipment and storage of materials; and  
 
(ii) permit proper precautions to be taken to reduce the potential for contamination of 
covered produce, food contact surfaces, or packing materials by effective design 
113  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
including the separation of operations in which contamination is likely to occur, 
by one or more of the following means: location, time, partition, enclosed 
systems, or other effective means.  (See 21 CFR 112.126(a)(1)(i) and (ii)).   
What constitutes suitable size, construction, and design for a building largely depends on the 
buildings use for covered activities.  You should evaluate whether your identified buildings 
size, construction, and design are appropriate, considering the covered activities performed and 
operating conditions in each building.  You should consider factors such as drainage, ventilation, 
facilitation of pest control and whether there is sufficient space for free movement around any 
equipment.  For example, for a partially-enclosed building that a farm uses during the off season 
to store harvesting equipment that contacts covered produce, the farm should evaluate whether 
the building provides sufficient space for storage of the equipment and for maintenance of the 
building (e.g., pest control, removal of debris) to minimize the potential for contamination.   
You should ensure that the construction of your buildings facilitates the maintenance of sanitary 
conditions.  Windows, doors, and roofs of fully-enclosed buildings should prevent leaks and the 
entry of dirt, dust, debris, and pests.  Buildings should also allow access for examination and 
maintenance of equipment contained within the building and the building itself.  For example, if 
you choose to have a drop ceiling in a fully enclosed building used for packing, then the building 
should be constructed in a way that allows access to the space between the roof and the drop 
ceiling for maintenance and sanitary operations, such as pest control activities. 
Building materials and construction should be durable enough to withstand their use in order to 
reduce the potential for contamination.  You should evaluate your buildings materials and 
construction, and periodically visually assess your buildings.  For example, floors should be able 
to withstand expected foot traffic and movement of equipment and vehicles without becoming 
damaged and potentially harboring pathogens, and doors and walls should be durable enough to 
withstand typical impacts by personnel and transport equipment without becoming damaged or 
permitting pest entry.   
To ensure that the size and design of your buildings facilitates maintenance and sanitary 
operations, you should consider: the activities that occur within the building; the volume and 
frequency of activity within the building; the number, size, and placement of equipment and 
tools used or stored within the building; and the number of people (e.g., personnel, supervisors, 
visitors, contractors) using the building at any given time.  For a building to be suitable in size, it 
should have enough room for covered activities to be conducted without contact between 
covered produce or food contact surfaces and building materials, non-food contact surfaces, or 
clothing. 
When installing or placing equipment in your buildings, you should be aware of the area 
surrounding the equipment to ensure that personnel can easily perform inspections, maintenance, 
and cleaning and sanitizing activities.  See the subsection of this chapter titled Installation and 
Maintenance for further draft guidance on equipment placement.   
Example 7q:  A farm that uses a conveyor belt in a packinghouse should ensure that there is 
enough space between the conveyor equipment and the wall or adjacent equipment to allow 
personnel to easily access the entire length of the conveyor belt.  This should include access 
114  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
to: the conveyor belt; the support frame; the points at which the framework is secured to the 
floor of the building; and any surfaces that could contact, or from which water could drip or 
drain onto, covered produce or food contact surfaces.   
Example 7r:  In a fully enclosed building dedicated to packing covered produce, you should 
set up operations such that you can efficiently remove the trash without touching food 
contact surfaces.  
Example 7s:  If both clean and used harvest containers are stored in a partially-enclosed 
storage shed, the farm must ensure that there is enough space in the area to separate the 
containers to reduce the potential for contamination.  (See 21 CFR 112.126(a)(1)).  
There are multiple ways to ensure that building design separates your operations to reduce the 
potential for contamination. You can, for example, use careful layout and installation of 
equipment within buildings to reduce the potential for contamination, such as by installing 
physical barriers to separate activities, or dedicating areas to specific activities, with sufficient 
space or barriers between them.  For another example, the areas where covered produce are 
prepared for distribution (i.e., finished product) should not be immediately adjacent to areas 
where covered produce from the field are washed in a way that water splash could be transferred 
to the finished product.  When you identify the need to separate certain activities, you should 
ensure that personnel are aware of and understand your procedures that specify the separation to 
prevent contamination.   
  Preventing Contamination, Including Floors, Walls, and Ceilings 
You must implement measures to prevent contamination of your covered produce and food 
contact surfaces in your buildings, as appropriate, considering the potential for such 
contamination through floors, walls, ceilings, fixtures, ducts, or pipes; and drip or condensate.  
(21 CFR 112.126(b)).  Surfaces of buildings that are not adequately cleaned have the potential to 
become a source of contamination (Ref. 51) (Ref. 72).  You should evaluate your buildings and 
their components (e.g., floors, walls, ceilings, ducts, pipes, fixtures, drains), including periodic 
visual assessments.  You should repair or replace damaged or defective building components that 
have the potential to contaminate covered produce or food contact surfaces.  
Examples of measures that you should take, as appropriate, include: 
  Repairing piping systems that are leaking onto covered produce or food contact surfaces;  
  Repairing roofs, walls or floors with holes or cracks in them;  
  Protecting covered produce and food contact surfaces from condensate from ceilings and 
overhead pipes, or maintaining such surfaces in a sanitary condition if they are subject to 
the formation of condensation so that they do not serve as a source of contamination; 
  Protecting drains from becoming harborage sites for pathogens; 
  Cleaning and sanitizing building components as necessary to reduce the potential for 
contamination; and 
  If you use high pressure hoses in your cleaning activities, ensuring that water splash does 
not spread contaminants from floors, walls, ceilings, fixtures, ducts, or pipes to covered 
produce or food contact surfaces, or ensuring that maintenance, cleaning and sanitizing, if 
115  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
necessary and appropriate, procedures address such surfaces if they are subject to such 
water splash so that they do not serve as a source of contamination. 
Covered produce and food contact surfaces can be protected from dripping condensate using 
practices such as: routing condensate to drains, drip pans, or areas away from covered produce 
and food contact surfaces; not storing covered produce or food contact surfaces under or near 
areas identified as likely condensate areas or drip zones; covering covered produce and food 
contact surfaces to protect them from condensate; and controlling the humidity in your building 
(e.g., through ventilation) to minimize the formation of condensate.   
Ceilings, overhead pipes, walls, floors and drains can be maintained in a sanitary condition by 
ensuring that their surfaces are of a design, construction and workmanship such that they can be 
adequately cleaned and properly maintained (see the section of this chapter titled Design, 
Construction and Workmanship) and by cleaning, and, when necessary and appropriate, 
sanitizing them (see the section of this chapter titled Cleaning and Sanitizing Equipment and 
Tools).  In cases where condensate contacts your covered produce or food contact surfaces, you 
should consider the originating surface of the condensate a food contact surface, and you should 
evaluate whether measures to address any potentially contaminated covered produce or food 
contact surfaces are necessary.    
Floor drains are known to serve as harborage sites for Listeria monocytogenes (Ref. 19) (Ref. 
88), likely due to their cool, wet environment and the tendency for drain cleaning and sanitizing 
to be overlooked or inadequate (Ref. 19) (Ref. 87).  You should clean and sanitize drains in a 
way that that prevents harborage of contamination and minimizes the likelihood that water splash 
or aerosols will contact covered produce or food contact surfaces (e.g., cleaning drains after 
packing operations end and not using high pressure water rinsing).   
  Drainage 
You must provide adequate drainage in all areas where normal operations release or discharge 
water or other liquid waste on the ground or floor of the building.  (21 CFR 112.126(a)(2)).  The 
drainage system, including the drain grate, should accommodate the rate of release or discharge 
during peak operations.  Your buildings could need multiple drains to prevent standing water or 
slow drainage.    
We acknowledge the potential for small pools of water to temporarily form on the floor of 
buildings used for growing activities, and that pooling of water of this nature, which is temporary 
and could occur in the normal course of watering practices, is not reasonably likely to contribute 
to the contamination of covered produce.  We are not suggesting that it will always be possible to 
eliminate pooling.  Avoiding pooling by careful control of greenhouse watering practices with 
consideration to your drainage system is ideal; however, to the extent pooling could be inevitable 
or could sometimes occur, despite adequate drainage, we expect covered farms to take steps to 
protect covered produce from any contamination that could build in the pooled water. 
116  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Pest Control 
You must take those measures reasonably necessary to protect covered produce, food contact 
surfaces, and food-packing materials from contamination by pests in buildings, including routine 
monitoring for pests as necessary and appropriate.  (21 CFR 112.128(a)).  You should evaluate 
your buildings in which you perform covered activities to determine what measures are 
necessary. 
For fully-enclosed buildings, you must take measures to exclude pests from your buildings.  (21 
CFR 112.128(b)).  You should prevent pest entry (e.g., cover or repair holes in the building) and 
reduce pest attractants (e.g., debris for nesting, food scraps, pooled water) in such buildings and 
their immediately surrounding areas.  For partially-enclosed buildings, you must take measures 
to prevent pests from becoming established in your buildings (such as by use of screens or by 
monitoring for the presence of pests and removing them when present).  (21 CFR 112.128(c)).   
You should minimize pest attractants and harborage areas in and around your buildings, 
including accumulated litter and debris; food scraps; nesting material; unused equipment; waste 
storage; tall, dense foliage, weeds, and grass; and pooled water (see the section of this chapter 
titled Drainage).  You should visually assess potential points of entry and potential routes of 
pest movement.  Your first inspection can be used to guide your monitoring activities.  Your 
monitoring frequency (e.g., weekly, monthly, bi-monthly) should be based on several factors, 
including the potential for pest activity, environmental conditions, and the level of observed pest 
activity in or around your buildings.  Your monitoring could assist you in identifying areas of 
concern that you had not previously identified (e.g., you could identify a crack in the foundation, 
through which insects could enter, that developed after the previous inspection).   
During your monitoring activities, assigned personnel should look for pest attractants, points of 
pest entry, signs of pest activity, both inside and immediately outside of the building and, when 
found, attempt to identify the type of pest (e.g., bird, rodent, insect), and the extent of the 
activity.  Signs of pest activity might include the presence of the following: 
  Animal excreta (e.g., rodent pellets, bird droppings, urine);  
  Nests (e.g., bird, rodent); 
  Gnaw marks on materials or shredded materials (e.g., produce, packing materials, paper, 
plastic, wood); 
  Burrows, trails, or other evidence of pest movement (e.g., worn paths or grease marks), or 
tracks outside the building; 
  Insects (e.g., flies, larvae, ants) inside the building; and 
  Remains of dead pests. 
If you observe signs of pest activity, you should identify and address the contributing factors 
related to the pest activity.  You also should evaluate the potential for contamination of covered 
produce, food contact surfaces, and food-packing materials, and determine whether measures to 
address any potentially contaminated covered produce or food contact surfaces are necessary. 
If you identify pest infestation, 21 CFR 112.128(a) requires that you take those measures 
reasonably necessary to protect covered produce, food contact surfaces, and food-packing 
117  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
materials from contamination.  This can include strategies for their elimination or to prevent 
them from becoming established, such as installing: indoor rodent traps (e.g., catch-and-release 
traps, snap traps, glue boards); outdoor rodent traps and bait stations anchored to the perimeter of 
the building; insect glue boards; light traps; and electronic flying-insect killers.  These could be 
placed in areas of high pest activity, suspected points of entry, and nesting sites, but should be 
placed away from covered produce, food contact surfaces, and food-packing materials.  If you 
use pest traps or bait stations, you should check them periodically (e.g., weekly) for signs of 
activity, replace any that become lost or damaged, remove any dead pests, and replace any 
missing bait.  If you use pesticides, you should ensure that you use all pesticides and pesticide 
devices in accordance with all applicable Federal, state, and local laws.   
Personnel to whom you assign the responsibility of pest monitoring, or who are engaged in the 
supervision thereof, should understand your procedures related to pest control.  You should 
specify when personnel need to inform a supervisor or other responsible party of certain 
observations so they can determine appropriate steps.  You should direct supervisors or 
responsible parties, as appropriate, to ensure that activities related to pest control are conducted 
in accordance with your procedures and corrections are made as needed. 
  Domesticated Animals 
Domesticated animals could be present on your farm for a variety of reasons, including work 
(e.g., horses, mules), protection (e.g., guard dogs), and personal companionship (e.g., family 
pet).  However, domesticated animals can carry pathogens, such as Salmonella spp. (Ref. 6) 
(Ref. 110) (Ref. 129); and pathogenic strains of E. coli (Ref. 13) (Ref. 103) (Ref. 110) (Ref. 
143), and serve as sources of contamination of covered produce and food contact surfaces (Ref. 
71) (Ref. 77) (Ref. 78) (Ref. 90) (Ref. 117).  You must take reasonable precautions to prevent 
contamination of covered produce, food contact surfaces, and food-packing materials in fully-
enclosed buildings with known or reasonably foreseeable hazards from domesticated animals 
(e.g., cats, dogs, horses, chickens) by: (1) excluding domesticated animals from fully-enclosed 
buildings where covered produce, food contact surfaces, or food-packing materials are exposed; 
or (2) separating domesticated animals in a fully enclosed building from an area where a covered 
activity is conducted on covered produce by location, time, or partition.  (21 CFR 112.127(a)).  
You should refer to Chapter 5: Domesticated and Wild Animals (Subpart I) of this document for 
additional draft guidance on domesticated and wild animals related to outdoor areas and 
partially-enclosed buildings.    
You should evaluate the presence and purpose of the domesticated animals on your farm and 
visually assess their actions when determining reasonable precautions to prevent contamination 
in your fully enclosed buildings.  When excluding domesticated animals from buildings, you 
should keep all entryways, including windows and doors closed whenever it is not necessary for 
them to be open.  Windows should be screened to help prevent domesticated animal entry.  If 
you choose to satisfy the requirements of 21 CFR 112.127(a) through exclusion and there are 
times when entryways need to remain open, you should have a system in place to prevent 
domesticated animal entry.  For example, for those times when a loading dock door remains 
open, you could, for example, designate a worker assigned to that area to monitor and prevent 
entry of domesticated animals to the area, and to remove any that enter.  Alternatively, you 
118  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
could, for example, use gates or access limitation devices that domesticated animals are unable to 
maneuver (e.g., Dutch doors or gates that domesticated animals cannot jump over).   
In some instances, exclusion of domesticated animals from an entire, fully-enclosed building 
could be impractical, such as when the building has multiple rooms, only some of which are used 
for covered activities.  If you do not exclude domesticated animals from the entire building, you 
must separate them from areas where covered activities are conducted on covered produce by 
location, time, or partition (21 CFR 112.127 (a)(2)).  For example, you could allow animals to 
visit an administrative office that is separated by a wall that prevents access to the portion of the 
building in which packing activities occur.  For another example, in entryways to areas of the 
building in which covered activities are conducted on covered produce, self-closing doors can be 
used to prevent entrance of domesticated animals.  You also, for example, could separate 
portable equipment and tools that contact covered produce or food-packing materials by storing 
such equipment and tools in closed cabinets in rooms that domesticated animals can access. 
Finally, your procedures could permit domesticated animals in areas in which covered activities 
occur, at times when those activities are not taking place. In these instances, you should clean 
and, when necessary and appropriate, sanitize, exposed equipment, tools, floors, and walls of the 
room where the domesticated animals were present, before resuming use of the room for a 
covered activity.  See the section of this chapter titled Cleaning and Sanitizing Equipment and 
Tools for further draft guidance.   
Personnel who manage or interact with domesticated animals, or who are engaged in the 
supervision thereof, should understand your procedures related to reasonable precautions to 
prevent contamination of covered produce and food contact surfaces from domesticated animals 
in your fully enclosed buildings.  You should direct supervisors or responsible parties, as 
applicable, to ensure that personnel conduct activities in accordance with your procedures, and 
corrections are made as needed. 
Guard or guide (i.e., service) dogs could be allowed in some areas of a fully-enclosed building if 
the presence of the dog is unlikely to result in contamination of produce, food contact surfaces, 
or food-packing materials.  (21 CFR 112.127(b)).  Guard or guide dogs present in areas where 
covered produce, food contact surfaces, or food-packing materials are exposed should be under 
the control of a handler.  You should ensure that guard or guide dogs, including their fur, saliva, 
or skin, do not contact covered produce, food contact surfaces, or food-packing materials.  For 
example, you should not permit guard or guide dogs to: run throughout the building; jump onto 
equipment or tools that contact covered produce; contact the hands of personnel that contact 
covered produce; or contact covered produce.  You should inform guard and guide dog handlers 
of the potential for dogs to carry contamination into your buildings and ensure that they 
minimize the likelihood of the dogs becoming contaminated (e.g., contact with animal excreta) 
before entering your buildings.   
3.  Other Sanitation Measures 
The other sanitation provisions of the Produce Safety Rule (21 CFR 112.129 - 134) include the 
management of animal excreta and litter from domesticated animals, toilet facilities; hand-
washing facilities; sewage; trash, litter, and waste; and plumbing.    
119  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Animal Excreta and Litter from Domesticated Animals 
If you have domesticated animals, to prevent contamination of covered produce, food contact 
surfaces, areas used for a covered activity, agricultural water sources, or agricultural water 
distribution systems with animal waste, you must (1) adequately control their excreta and litter; 
and (2) maintain a system for control of animal excreta and litter.  (21 CFR 112.134). For 
example, you would comply with this provision by not locating manure piles adjacent to packing 
sheds in which covered produce is exposed. 
Draft guidance on related requirements is provided in: this chapter (related to 21 CFR 112.127); 
Chapter 5: Domesticated and Wild Animals (Subpart I) (related to 21 CFR 112.83); and Chapter 
6: Growing, Harvesting, Packing, and Holding Activities (Subpart K) (related to 21 CFR 
112.112).  Depending on the number and types of domesticated animals on your farm, there are 
different ways that you can manage the control of their excreta and litter.   
For domesticated animals under your control, you should identify the areas in which the animals 
are likely to produce excreta or litter (e.g., stalls, grazing pastures) and evaluate the potential for 
contamination, including through runoff and transfer via personnel footwear, of your covered 
produce, food contact surfaces, areas used for covered activities, agricultural water sources, or 
agricultural water distribution systems.  Additionally, you should evaluate how you store and 
transport their excreta or litter, and the potential for contamination from these activities.  You 
should house and pasture these animals, and store their excreta or litter downhill and away from 
areas of concern or by using berms, pits, or grading to contain runoff.  For companion or guard 
animals (e.g., dogs, cats) you could, for example, periodically inspect for excreta in the areas to 
which they have access, collecting and disposing of it in waste containers.   
  Toilet Facilities  
Human feces could contain pathogens in relatively high concentrations (Ref. 21) (Ref. 63) (Ref. 
40).  One of the most basic measures that you can take to prevent the transfer of pathogens from 
human feces to covered produce and food contact surfaces is to provide toilet facilities to collect 
and contain human feces and liquid waste.  Toilet facilities include portable toilets, outhouses, 
plumbed facilities, or other enclosed facilities where toilets are located.  
  Accessibility 
You must provide personnel with adequate, readily accessible toilet facilities, including toilet 
facilities readily accessible to growing areas during harvesting activities.  (21 CFR 112.129(a)).  
Note that 21 CFR 112.33(b) requires that you also make toilet and hand-washing facilities 
available to visitors; see Chapter 3: Health and Hygiene (Subpart D) of this document.  You 
should consider personnel and visitor activities and traffic throughout your growing, harvesting, 
packing, and holding areas to help you determine the appropriate number and locations of toilet 
facilities to efficiently accommodate the typical numbers of individuals accessing certain areas at 
the same time, such as at the beginning of work, or after a break.  You should evaluate your toilet 
facilities to determine whether they are easily accessible for personnel working in areas where 
covered activities occur, including during all harvesting activities.  You should ensure that toilet 
facilities are within a reasonable walking distance from covered activities (e.g., approximately 14 
120  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
mile or less).  You could, for example, consider placing toilet facilities near designated personnel 
break areas to facilitate their use.  You should ensure that personnel are aware of the locations of 
toilet facilities and know not to relieve themselves in the growing areas or in any area on your 
farm other than a toilet facility.   
  Design, Location, and Maintenance  
Toilet facilities must be designed, located, and maintained to prevent contamination of covered 
produce, food contact surfaces, areas used for a covered activity, water sources, and water 
distribution systems with human waste.  (21 CFR 112.129 (b)(1)).  You should evaluate your 
toilet facilities to ensure that they have proper drainage and that backflow devices do not leak 
sewage or liquid waste.  Toilet facilities, including portable toilet facilities, should securely 
contain or securely transport all sewage and liquid waste away from locations where covered 
activities occur.  For further draft guidance see the sections of this chapter titled Sewage 
Systems and Plumbing.   
Within fully or partially-enclosed buildings, your toilet facilities should be located and designed 
in a way that minimizes the potential for transferring contamination by persons entering and 
leaving the facilities.  For example, in a building used for both packing activities and office 
work, with the two areas separated, a toilet facility that is typically used by office and delivery 
personnel and visitors, in addition to packing personnel, ideally could have one entryway from 
the packing area and a separate entryway from the office area.  This arrangement would 
eliminate the need for office and delivery personnel and visitors to enter the packing area to use 
the toilet facilities.  You should consider toilet facilities as part of the overall size, construction, 
and design of your buildings.  See the subsection of this chapter titled Buildings  Size, 
Construction and Design.  
Runoff from toilet facilities has the potential to contaminate covered produce, soil, and irrigation 
water (Ref. 1) (Ref. 25).  The location of your toilet facilities should prevent contamination from 
human waste and should facilitate containment and cleaning of any accidental spills or leaks.  
For example, you could locate portable toilet facilities downhill from your growing area and 
away from your water sources; or, you could, for example, use berms or grades to help protect 
covered produce, areas where covered activities occur, and water sources and distribution 
systems from contamination from uphill toilet facilities.  
Your toilet facilities must be designed, located, and maintained to be directly accessible for 
servicing, be serviced and cleaned at a frequency sufficient to ensure suitability of use, and be 
kept supplied with toilet paper.  (21 CFR 112.129(b)(2)).  Sewage transport and other service 
vehicles should have clear access to your toilet facilities to ensure proper collection and disposal 
of human waste, minimizing the likelihood of spills or leakage.  You should maintain your toilet 
facilities in a sanitary condition.  You should establish monitoring, servicing, and cleaning 
procedures and schedules for toilet facilities.  You should monitor toilet facilities at a frequency 
that ensures that they remain sanitary and that they are supplied with toilet paper.  Your 
procedures should specify the frequency of these inspections, the personnel involved, and 
conditions that should be reported to you, a supervisor, or responsible party.  You should 
encourage personnel to report any observed deficiencies of the toilet facilities to their supervisor 
121  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
or other responsible party.  Tools and equipment used to clean toilet facilities should not be used 
to clean surfaces where covered activities are performed.   
Personnel to whom you assign the responsibility of maintaining toilet facilities, or who are 
engage in the supervision thereof, should understand your procedures.  You should direct the 
supervisors or other responsible parties, as applicable, to ensure that monitoring and other 
activities are conducted in accordance with your procedures, and corrections are made as needed. 
  Disposal of Waste and Toilet Paper 
Your toilet facilities must be designed, located, and maintained to provide for the sanitary 
disposal of waste and toilet paper.  (21 CFR 112.129(b)(3)).  Your toilet facilities should provide 
for the sanitary collection of human waste, either into a secure sewage collection system that is 
emptied as needed, or to a sewage transport system that moves it to an individual or municipal 
treatment system.  If your toilet or sewage transport system cannot accommodate toilet paper, 
you should keep waste containers with self-closing lids immediately adjacent to the toilet, such 
as receptacles with a sensor operated lid or other hands-free devices.  You should monitor these 
receptacles and empty them as necessary.   
  Hand-Washing Facilities 
Hand-washing is a key control measure in minimizing the potential for transferring 
contamination from human hands to covered produce and food contact surfaces (Ref. 100) (Ref. 
132).  All of the following requirements apply to hand-washing facilities:  
  You must provide your personnel with adequate, readily accessible hand-washing 
facilities during growing activities that take place in a fully-enclosed building, and during 
covered harvest, packing, or holding activities.  (21 CFR 112.130(a)).   
  During growing activities that take place in a fully-enclosed building, and during covered 
harvesting, packing, or holding activities, you must provide a hand-washing station in 
sufficiently close proximity to toilet facilities to make it practical for persons who use the 
toilet facility to wash their hands.  (21 CFR 112.129(c)).   
  You also must make toilet and handwashing facilities accessible to visitors.  (21 CFR 
112.33(b).  
These standards apply to both fully plumbed, stationary hand-washing facilities and portable 
units.   
  Adequate and Readily Accessible  
You should consider personnel and visitor activities and traffic throughout your growing, 
harvesting, packing, and holding areas to help you determine the appropriate number and 
locations of hand-washing facilities to efficiently accommodate the typical numbers of 
individuals accessing certain areas at the same time, such as at the beginning of work, or after a 
break.  You should evaluate your hand-washing facilities to determine whether they are easily 
accessible for personnel working in areas where covered activities occur, including during all 
harvesting activities and during growing activities that occur in fully-enclosed buildings.  
122  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
You should determine whether hand-washing facilities are located close to meal or break areas, 
or at or near points of entry to areas where covered activities occur.  Hand-washing facilities 
should ideally be available immediately outside or inside the entrance to packing areas.  Further, 
additional hand-washing facilities should be placed near where personnel work (i.e., near a 
sorting line), to ensure that personnel can easily access it if their hands become soiled or 
contaminated (e.g., frequent contact with a trash can).  The presence of hand-washing facilities at 
these and similar locations could promote their use by personnel.   
You should ensure that hand-washing facilities are in a location where they are accessible for 
servicing, maintenance or disposal activities.  Transport or other servicing vehicles or personnel 
should have clear access to hand-washing facilities to ensure sanitary collection and disposal of 
waste, including waste water, or other maintenance activities.  For portable hand-washing 
facilities, you could consider moving handwashing facilities from areas near where covered 
activities occur to a more remote location for waste water collection, cleaning, and servicing, 
rather than have these functions performed when the portable hand-washing facility is near 
covered activities.  You should ensure that whomever performs these activities is aware of your 
procedures. 
You must ensure that your hand-washing facilities are designed, maintained and managed to 
ensure sanitary conditions (See 21 CFR 112.130(a)).  You should establish monitoring, servicing 
and cleaning and sanitizing procedures and schedules for hand-washing facilities and perform 
these activities at a frequency that ensures that they remain sanitary.  You should consider the 
frequency of use for your hand-washing facilities to assist you in determining your frequency for 
cleaning and monitoring.  Your procedures should include the frequency of these inspections, the 
personnel involved, and conditions that should be reported to you, a supervisor, or other 
responsible party.  You should encourage personnel to report any observed deficiencies of the 
hand-washing facilities to their supervisor or other responsible party to ensure hand-washing 
facilities are continually maintained.  
To assist with maintaining sanitary conditions, you could consider installing hand-washing 
facility components that are automated or otherwise designed for hands-free use, such as faucets, 
soap dispensers, and paper towels dispensers that can be activated by motion sensors or by foot 
pedals.  This could help prevent your personnel from re-contaminating their clean hands by 
touching soiled faucet handles, or soap or paper towel dispensers.   
Personnel to whom you assign the responsibility of maintaining hand-washing facilities, or who 
are engaged in the supervision thereof, should understand your procedures.  You should direct 
the supervisors or other responsible parties, as applicable, to ensure that monitoring and other 
activities are conducted in accordance with your procedures, and corrections are made as needed. 
  Supplies 
Your hand-washing facilities must be supplied with soap (or other effective surfactant).  (21 CFR 
112.130 (b)(1)).  A surfactant is a substance that helps to remove dirt from hands.  You could not 
use an antiseptic hand rub as a substitute for soap (or other surfactant) and water.  (21 CFR 
112.130(d)).  However, you could provide hand sanitizers as an additional bactericidal measure 
123  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
for use after hand-washing with soap and water, and drying.  See draft guidance in the section of 
Chapter 3: Health and Hygiene (Subpart D) titled Thorough Hand-washing).  
You must furnish your hand-washing facilities with running water that satisfies the requirements 
of 21 CFR 112.44(a) for water used to wash hands (i.e., water must contain no detectable generic 
E. coli per 100 mL of water).  (21 CFR 112.130(b)(2)).  You could, for example, obtain running 
water from a fixed plumbing system or a portable unit that supplies and captures running water.   
Containers used to transport or store water for hand-washing should be emptied and thoroughly 
cleaned periodically.  You should not reuse hand-washing water that has not been treated, nor 
should you use communal, open containers of water for hand-washing. 
You must furnish hand-washing facilities with adequate drying devices.  (21 CFR 
112.130(b)(3)).  Examples of adequate drying devices include single-use disposable towels (e.g., 
paper towels), electric hand dryers, and cloth towels that are used only once and then laundered 
(e.g., using your own procedures or use a sanitary towel service).  Common or shared towels, or 
towels intended for multiple uses before laundering are not adequate drying devices for this 
purpose because repeated use of towels or use by multiple users can increase the potential for 
contamination.   
  Disposal of Waste for Hand-Washing Facilities 
You must provide for appropriate disposal of waste (e.g., waste water and used single-service 
towels) associated with a hand-washing facility and take appropriate measures to prevent waste 
water from a hand-washing facility from contaminating covered produce, food contact surfaces, 
areas used for a covered activity, agricultural water sources, and agricultural water distribution 
systems with known or reasonably foreseeable hazards.  (21 CFR 112.130(c)). 
  Single-Service Towels and Other Solid Hand-Washing Waste  
You should evaluate whether your solid hand-washing waste disposal systems contribute to 
contamination of covered produce, food contact surfaces, areas used for a covered activity, 
agricultural water sources, and agricultural water distribution systems.  Containers used for solid 
hand-washing waste (e.g., single-service towels) should be intact and free from damage, such as 
cracks, or should be lined with an intact liner (e.g., garbage bag).  You should develop 
procedures for the frequency that these containers should be emptied (e.g., based on frequency of 
use) so they do not serve as a source of contamination or pest attractant.  These containers should 
be covered to prevent the solid hand-washing waste from being transported (e.g., by wind, birds) 
to areas where covered activities occur.  You should cover waste containers in a way that also 
helps prevent potential contamination of hands (e.g., foot-operated or remote sensor-operated 
lids).  Containers used for solid hand-washing waste disposal should be located as close as 
practical to hand-washing facilities to maximize the likelihood that they will be used. 
  Liquid Hand-Washing Waste  
You should evaluate whether your liquid hand-washing waste disposal systems contribute to 
contamination of covered produce, food contact surfaces, areas used for covered activities, or 
agricultural water sources or distribution systems.  Your evaluation should include consideration 
124  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
of the surrounding area, such as topography and location of nearby water sources and covered 
activities because of the potential for runoff of liquid waste from hand-washing stations.  In 
plumbed hand-washing facilities, liquid waste typically drains into a plumbed waste system.  
Piping used to convey hand-washing liquid waste should be intact and free of leaks.  See the 
section of this chapter titled Plumbing for further draft guidance on waste water systems.   
If you use portable hand-washing facilities, the liquid waste should be collected in a manner that 
prevents contamination of covered produce, food contact surfaces, areas used for covered 
activities, or agricultural water sources or distribution systems.  For example, if a portable hand-
washing facility releases liquid waste onto the ground, the liquid could serve as a source of 
contamination.  Liquid hand-washing waste should be captured in a container that is intact and 
free from leaks; the container should be covered when it is not in use or when it is collected for 
disposal.  You should empty these containers as necessary (e.g., once they are filled to a certain 
point or at an established frequency based on use) and periodically clean them (e.g., at an 
established frequency based on use).  Liquid hand-washing waste containers should be emptied 
in a way that minimizes the potential for spillage.  If a third-party entity supplies and services 
your portable hand-washing facilities, you should ensure that the liquid waste containers are 
readily accessible to them and that they perform their activities in a manner that prevents 
contamination.  You should not locate portable hand-washing facilities near agricultural water 
sources or in a location from which spilled liquid hand-washing waste could contaminate areas 
associated with covered activities.  
  Sewage Systems 
Sanitary disposal of human waste greatly reduces the likelihood that it will serve as a source of 
contamination of covered produce, food contact surfaces, areas used for a covered activity, or 
agricultural water sources or distribution systems (Ref. 25) (Ref. 68).  Systems used to handle 
human waste include municipal sewage systems, individual septic systems, self-contained units, 
which could be portable, and any associated plumbing.  
  Use and Maintenance   
You must dispose of sewage into an adequate sewage or septic system or through other adequate 
means.  (21 CFR 112.131(a)).  You must maintain sewage and septic systems in a manner that 
prevents contamination of covered produce, food contact surfaces, areas used for a covered 
activity, agricultural water sources, and agricultural water distribution systems with known or 
reasonably foreseeable hazards.  (21 CFR 112.131(b)).  You should evaluate your sewage and 
associated plumbing systems (i.e., collection, containment, transport) based on these 
requirements.  Generally, sewage and septic systems in the U.S. are approved by local health 
authorities when installed, providing a level of assurance that their design is appropriate (e.g., the 
volume of water and organic material, including fecal material).  However, these systems can 
degrade over time (e.g., leaks, bypasses, damage, incomplete treatments), presenting the risk for 
contamination of surrounding soils and waters (Ref. 45) (Ref. 42).  Further, for systems that treat 
the sewage (e.g., septic systems), if your input volume or other characteristics exceed the design 
capacity, the system could not properly treat the sewage, potentially allowing pathogens to 
survive in the effluent.  
125  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
As part of your maintenance activities, you should periodically inspect your sewage systems, 
including those used for plumbed (e.g., sewer and septic systems) and non-plumbed (e.g., 
portable toilets, outhouses) toilet facilities.  You should have procedures for the frequency of 
these inspections, the personnel involved, and conditions that should be reported to you, a 
supervisor, or other responsible party.     
If you use a septic system, the tank should be properly sealed, in good working order, and free 
from damage.  The inlet and outlet plumbing should be in good working order and free from 
damage, and the drain field should be properly functioning, with no visible leakage at the 
surface.  If you use a septic system, you should have it pumped with sufficient frequency to 
prevent excess accumulation of solid human waste, which can result in premature septic system 
or drain field failure (Ref. 41) (Ref. 106).   
For portable toilet facilities, the waste retention tank should be structurally sound, not leak, and 
be constructed to prevent contamination and attraction of flies and other pests.  The tanks should 
remain closed to minimize the potential for contamination.  You should store these tanks in a 
way that protects them from damage that could result in leakage of human waste.  Storage 
containers should be accessible to facilitate collection and transport of sewage and liquid waste 
or other maintenance and servicing activities.  You should dispose of human waste from these 
tanks periodically (e.g., at an established frequency based on use) to prevent overflow.  You 
should ensure that the collection and disposal of human waste from your portable toilet facilities 
or outhouses is done in a manner that prevents spills.   
  Response to Leaks and Significant Events 
You must manage and dispose of leakages or spills of human waste in a manner that prevents 
contamination of covered produce, and prevents or minimizes contamination of food contact 
surfaces, areas used for a covered activity, agricultural water sources, or agricultural water 
distribution systems.  (21 CFR 112.131(c)).  
In the event of a sewage spill or leak, you should contact your local public health or waste 
management authorities for assistance in complying with their regulations for sewage disposal.  
Management of a human waste spill or leak could include:  
  Containing the spill or leak;  
  Preventing your personnel from entering the affected area;  
  Removing and disposing of the spill or leakage contents;  
  Disposing of any contaminated covered produce; 
  Cleaning and sanitizing any contaminated food contact surfaces;  
  Repairing or replacing any faulty sewage system components; and  
  Evaluating any potential impacts to growing area soil, food contact surfaces, covered 
activity areas, or agricultural water sources or distribution systems.   
Furthermore, if you know or have reason to believe that there is a sewer or septic system failure 
(e.g., soggy patches of land around your septic tank or drain field, slow draining sinks or drains, 
sewage odors, gurgling noises from the plumbing drain lines, or effluent backup coming from 
drains, sinks or toilets) (Ref. 41) (Ref. 44), you should immediately cease any water use that 
126  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
drains or transmits waste water into the affected sewage or septic system.  You should also 
determine the cause of the leak or spill and make any necessary repairs.  For example, if you find 
that the sewage system failure is the result of a sewer line that is burst, cracked, or penetrated, 
such as with tree roots, you should repair or replace the affected section.  You should verify that 
any actions corrected the problem before resuming use of the sewage or septic system.  In some 
instances, this might include having the system professionally inspected by a private firm or your 
local health authority.  
Sewage spills can occur in indoor facilities.  For example, if a toilet overflows onto the floor of a 
toilet facility that is accessed by personnel who work in areas where covered produce is exposed, 
you should immediately prevent access to the affected area until the spill can be removed and the 
area thoroughly cleaned and sanitized.  If your personnel access the area before it is cleaned, you 
should visually assess the potential that covered produce or food contact surfaces in adjoining 
areas have become contaminated.  You should ensure that your personnel and supervisors or 
other responsible parties understand your procedures for responding to a leak or spill of sewage.  
You should direct your supervisors or other responsible parties, as applicable, to ensure that 
actions taken to manage and dispose of leakages or spills of sewage are conducted in accordance 
with your procedures and corrections are made as needed. 
In addition, after a significant event, such as flooding or an earthquake, that could negatively 
impact your sewage or septic system, you must take appropriate steps to ensure that sewage and 
septic systems continue to operate in a manner that does not contaminate covered produce, food 
contact surfaces, areas used for a covered activity, agricultural water sources, or agricultural 
water distribution systems.  (21 CFR 112.131(d)).  After such an event, you should inspect your 
entire system to the extent that it is accessible to identify and correct any defects with the system.  
For example, you could find that an earthquake has damaged the intake or output baffles in your 
septic tanks; you should promptly repair these defects to prevent sewage, incomplete treatments, 
and premature drain field failure.  In another example, if you find that your septic systems drain 
field is failing due to flooding, you should wait for water levels to recede before resuming use of 
the system and evaluate the potential for the contamination of covered produce, food contact 
surfaces, areas used for a covered activity, agricultural water sources, or agricultural water 
distribution systems.   
When your inspection after a significant event indicates defects in your system, you should also 
consider whether you can continue to perform growing, harvesting, packing, and holding 
activities in a manner that complies with the Produce Safety Rule.  You should consider taking 
actions such as providing temporary, portable toilet and hand-washing facilities, and you should 
determine whether such actions would be adequate to prevent contamination (See 21 CFR 
112.131(a)).  There could be circumstances during which it is unsafe to continue growing, 
harvesting, packing, and holding covered produce, until the sewage system can be fully repaired 
(e.g., if water from your production activities and cleaning activities is directed to the sewage 
system). 
  Trash, Litter, and Waste  
For the control and disposal of trash, litter, and waste in areas used for covered activities, you 
must: 
127  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Convey, store, and dispose of trash, litter, and waste to:  
  Minimize its potential to attract or harbor pests (21 CFR 112.132(a)(1)); and 
o
  Protect against contamination of covered produce, food contact surfaces, areas 
o
used for a covered activity, agricultural water sources, and agricultural water 
distribution systems with known or reasonably foreseeable hazards (21 CFR 
112.132(a)(2)).   
  Adequately operate systems for waste treatment and disposal so that they do not 
constitute a potential source of contamination in areas used for a covered activity.  (21 
CFR 112.132(b)).   
You should evaluate your waste management system for compliance with these requirements, 
including:  
  Type and location of waste containers for collection or storage;  
  Frequency of waste collection and disposal; and  
  Maintenance of waste collection and storage areas.   
Personnel to whom you assign the responsibility of conveying, storing and disposing of trash, 
litter and waste, or who are engaged in the supervision thereof, should understand your 
procedures.  You should direct the supervisors or other responsible parties, as applicable, to 
ensure that activities are conducted in accordance with your procedures, and corrections are 
made as needed. 
You have the flexibility to select waste containers that you determine to be appropriate for your 
waste collection and storage activities.  However, you should ensure that waste containers are not 
prone to spills, leaks, or overflow.  Waste containers should be covered with tight-fitting lids 
when not in use, especially in outdoor areas or partially-enclosed buildings, to minimize the 
attraction of pests.  You should cover waste containers in a way that also helps prevent potential 
contamination of hands (e.g., foot-operated or remote sensor-operated lids).   
Waste containers should be readily available in areas where waste is typically generated (such as 
near sorting areas and personnel break areas) and positioned so that they are not likely to be 
overturned.  Their location should minimize the need for personnel who contact covered produce 
or food contact surfaces to have to adjust or relocate the containers during covered activities.  
Waste containers should accommodate the typical volumes of waste generated.   
You should establish an appropriate frequency for transferring waste from your waste collection 
containers to waste storage containers (e.g., dumpsters).  In establishing the frequency for 
transfer, you should consider the volume of waste collected and the nature of the waste.  Waste 
removal should be more frequent for waste material that is likely to serve as a source of 
contamination or attract pests.  For example, unlike some dry waste (e.g., damaged boxes or 
overwrap), discarded produce in areas where covered activities occur could be more likely to 
attract pests and contribute organic materials that promote bacterial growth, so waste collection 
in these areas should be more frequent.   
You should locate your waste storage containers (e.g., dumpsters) away from areas where 
covered produce or food contact surfaces are exposed.  You should consider the potential for 
128  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
runoff from these locations to areas you use for covered produce, food contact surfaces, areas 
used for a covered activity, agricultural water sources, and agricultural water distribution 
systems.  You could, for example, locate waste storage downhill from these areas or use berms 
or other grading to prevent runoff.  Your waste storage containers should always remain closed 
when not in immediate use.  Waste storage containers should be emptied in a manner and 
frequency that prevents waste from spilling or leaking.   
You should establish periodic cleaning, sanitizing, and maintenance schedules for your waste 
collection and storage containers, and equipment used to transport these items (e.g., forklifts) to 
minimize the potential of contamination.  Waste containers and equipment used to transport 
these items should be maintained, free from damage that facilitates leaks, and replaced as 
necessary.  Equipment used for waste disposal (e.g., conveyers) should be separated from 
covered produce and food contact surfaces and positioned in a way that minimizes the potential 
for their contamination.   
  Plumbing  
Plumbing must be of an adequate size and design and be adequately installed and maintained to: 
  Avoid being a source of contamination to covered produce, food contact surfaces, areas 
used for a covered activity, or agricultural water sources.  (21 CFR 112.133(c));   
  Distribute water under pressure as needed, in sufficient quantities, in all areas where used 
for covered activities, for sanitary operations, hand-washing, or toilet facilities.  (21 CFR 
112.133(a)); 
  Properly convey sewage and liquid disposable waste.  (21 CFR 112.133(b)); and 
  Not allow backflow from, or cross-connection between, piping systems that discharge 
waste water or sewage and piping systems that carry water used for a covered activity, for 
sanitary operations, or for use in hand-washing facilities.  (21 CFR 112.133(d)). 
 
Your plumbing system includes water lines and structures (e.g., faucets, toilets, pipes, collection 
and containment structures), and sewage lines and structures (e.g., pipes, collection and 
containment structures).  You should evaluate the adequacy of your plumbing systems 
considering such factors as volume of water and frequency of use.  You should periodically 
inspect your plumbing system and identify any conditions that could result in it becoming a 
source of contamination.  Your procedures should include the frequency of these inspections, the 
personnel involved, and conditions that should be reported to you, a supervisor, or other 
responsible party.  If you observe the potential for contamination, you should take appropriate 
measures to prevent the plumbing from becoming a source of contamination, as soon as possible.  
For example, you could remove dead-end piping or periodically flush these lines to remove any 
residue or other material. 
Inadequate water pressure and volume could impact your ability to perform your operations in a 
sanitary manner.  For example, low water pressure could compromise your ability to properly 
clean your food contact surfaces or to provide water to multiple hand-washing facilities at the 
same time.  
129  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Plumbing for sewage and liquid disposable waste should be intact and free from leaks to prevent 
contamination of surrounding areas (e.g., packing area floors, growing area soil, agricultural 
water sources and distribution systems, such as irrigation systems).  For additional draft guidance 
see the section of this chapter titled Sewage Systems. 
A cross-connection is a connection between a water source or distribution pipe (e.g., drinking 
water, water used for hand-washing, water used for cooling covered produce) and a liquid waste 
pipe (e.g., sink drain, sewage line, floor drain line).  Unless it is protected by a backflow 
prevention device, a cross-connection can result in backflow, the undesirable reversal of the flow 
against the normal waterline pressure (e.g., from a sewage line to the water line supplying a 
hand-washing station).  You should equip all water supply piping with backflow prevention 
devices to prevent contamination from cross-connections and backflow.   
Hoses should be used in a manner that prevents back-flow.  Hoses that are connected to water 
lines under pressure could become sources of contamination to the water supply if an 
unintentional, temporary cross-connection is created.  For example, if you leave an open-ended 
hose on the floor in pooled water or submerged in water, backflow can occur if a pressure 
differential develops, reversing the flow of water in the hose.  This backflow could result in 
contamination of the water supply.  Hoses should be stored off the floor on a designated holder. 
Drainage systems involving water contact with covered produce, such as from flumes or dump 
tanks, should flow into a floor drain with an air gap or with a backflow or back siphonage 
prevention device to prevent contamination of the flume system or dump tank if a backup occurs 
in the drainage system.     
4.  Records 
You must establish and keep documentation of the date and method of cleaning and sanitizing of 
equipment subject to subpart L used in (1) growing operations for sprouts; and (2) covered 
harvesting, packing, or holding activities.  (21 CFR 112.140).  Examples of such equipment and 
tools include harvesting tools, knives, implements, mechanical harvesters, waxing machinery, 
cooling equipment (including hydrocoolers), grading belts, sizing equipment, palletizing 
equipment, and equipment used to store or convey harvested covered produce (such as 
containers, bins, food-packing material, dump tanks, flumes, and vehicles or other equipment 
used for transport that are intended to, or likely to, contact covered produce).  An example of 
such a record would be a cleaning and sanitizing log for packing equipment that documents the 
date that cleaning or sanitizing was performed, and the method of cleaning or sanitizing (e.g., 
manual scrub with detergent and hot water).  The record should include the concentration of 
cleaning or sanitizing solutions (e.g., sanitized with 200 ppm chlorine spray).  You could, for 
example, develop records for groups of equipment that are cleaned and sanitized in the same way 
with the same cleaning and sanitizing solutions.  
Chapter 8: Records (Subpart O) provides draft guidance on the general records requirements that 
are applicable to these records. 
130  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Chapter 8: 
Records (Subpart O) 
This chapter provides draft guidance on the requirements of subpart ORecords.  Records are 
needed to keep track of measures directed at minimizing the risk of known or reasonably 
foreseeable hazards, to identify a pattern of problems that increase the risk of such hazards, and 
to facilitate verification and compliance with regulatory standards.  The records requirements 
will help you to comply with the requirements of the Produce Safety Rule and document, and 
FDA to determine, your compliance.  Additionally, records provide you, and FDA, with a view 
of the performance of your preventive measures over time.  
In this chapter, we provide draft guidance on the requirements of subpart O that apply to all 
required records under the Produce Safety Rule (21 CFR Part 112).  The specific records that 
your farm must keep depend, in part, on the requirements of the Produce Safety Rule that apply 
to your farm.  The requirements for specific records are listed in the applicable sections of the 
Produce Safety Rule: subparts A, B, C, E, F, L, and M (i.e., 21 CFR 112.2(b)(4), 112.7, 
112.12(c), 112.30, 112.60, 112.140, and 112.150).  (See also the subsection of this chapter titled 
Specific Records Requirements).  You should consult the chapters of this draft guidance 
related to subparts A, C, F, and L to ensure that you establish and maintain the specific records 
that those subparts require; subparts D, I, K, N, P, Q, and R do not require specific records.  We 
separately address specific records requirements for subpart MSprouts.  We also intend to 
separately provide draft guidance for the requirements of subparts BGeneral Requirements 
(specifically, Alternatives) and EAgricultural Water; and on specific records for these subparts.   
Subpart O describes the requirements for establishing and maintaining records, including: 
general requirements; records storage; use of existing records; records retention; records format; 
and records disclosure.  With a few exceptions, these requirements apply to all records the 
Produce Safety Rule requires.     
Personnel to whom you assign the responsibility of developing, creating, completing or 
reviewing records should understand your procedures.  You should direct supervisors or 
responsible parties, as applicable, to ensure that records are created and reviewed in accordance 
with your procedures and corrections are made as needed.  You could access templates for 
records from sources such as academia, extension services, and industry associations to assist 
you in creating a consistent approach. 
1.  General Requirements for all Records  
Except as otherwise specified, the requirements of subpart O apply to all records that are 
required under the Produce Safety Rule.  All required records must include, as applicable and 
unless otherwise specified:  
  The name and location of your farm (21 CFR 112.161(a)(1)(i));  
  Actual values and observations obtained during monitoring (21 CFR 
112.161(a)(1)(ii));  
131  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  An adequate description (such as the commodity name, or the specific variety or 
brand name of a commodity, and, when available, any lot number or other 
identifier) of covered produce applicable to the record (21 CFR 
112.161(a)(1)(iii));  
  The location of a growing area or other area (for example, a specific packing 
shed) applicable to the record (21 CFR 112.161(a)(1)(iv)); and  
  The date and time of the activity documented (21 CFR 112.161(a)(1)(v)).  
Required records must also:  
  Be created at the time an activity is performed or observed (21 CFR 
112.161(a)(2));  
  Be accurate, legible, and indelible (21 CFR 112.161(a)(3)); and  
  Be dated, and signed or initialed by the person who performed the activity 
documented (21 CFR 112.161(a)(4)). 
  Farm Name and Location 
Your required records must include, as applicable, the name and location of your farm.  (21 CFR 
112.161(a)(1)(i)).  This requirement ensures that your records are linked to your farm.  You 
should use the postal address or physical location (such as latitude or longitude) of the farm.  
You may choose to use documents pre-printed with your farm name and location to ensure that 
this information is captured on each of your records.  If your records include written information 
obtained from a third party (e.g., a report of analysis from a contract laboratory) and the 
information provided by the third party does not include certain required information (e.g., a 
customer number instead of your farms name and location), you can fulfill this requirement by 
supplementing the record with the additional required information, or including it on a new, 
attached record.  Additional draft guidance is provided in the section of this chapter titled Use 
of Existing Records. 
  Location of Growing or Activity Area 
Your required records must include, as applicable, the location of a growing area or other area 
applicable to the record.  (21 CFR 112.161(a)(1)(iv).  This requirement ensures that your records 
are linked to the specific growing areas, packing areas, or other areas of your farm that are 
relevant to the record.  Your personnel might create required records relative to several different 
areas on your farm.  You should therefore establish a system to accurately document the location 
applicable to the record, such as by using specific identifiers (e.g., field names or numbers; 
building names or numbers; or geographical markers) for the various areas on your farm.  For 
example, if a farm grows carrots in three separate fields and the records do not provide a specific 
identifier (e.g., name or number) for each field, the record would not be sufficiently specific to 
link the record to a specific field.  You should determine whether areas of your farm have 
existing specific location identifiers that you can use for your records or whether you need to 
create new identifiers.  If you already have farm maps with specific field, orchard, grove, or 
vineyard numbers, or other specific identifiers, for each site, you can record those identifiers on 
your records.  You may also choose to use street addresses or specific coordinates using a GPS 
or other mapping system.  
132  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Adequate Description of Covered Produce 
Your required records must include an adequate description of covered produce applicable to the 
record.  (21 CFR 112.161(a)(1)(iii)).  Descriptions should include the relevant commodity name, 
or the variety name or brand name, and any lot number or code that you use to identify the 
covered produce.  For example, if your farm grows different varieties of applesone variety in 
each of three orchardsthen your records for each orchard should, as appropriate, describe the 
covered produce grown in the relevant orchard: apples, Fuji; apples, Granny Smith; or 
apples, Golden Delicious.   
  Actual Values and Observations 
Your required records must include, as applicable, actual values and observations obtained 
during monitoring.  (21 CFR 112.161(a)(1)(ii)).  The records should include accurate values or 
observations from an instrument or a visual assessment by personnel, as applicable (e.g., a 
temperature reading of 96.2F from a thermometer, or a pH meter reading of 4.20).  Recording 
actual values and observations during monitoring is necessary to produce an accurate record.  
Records stating that monitoring measurements are satisfactory or unsatisfactory, without 
recording the actual times and observations (e.g., temperatures and turnings in treating biological 
soil amendments of animal origin) are vague and subject to varying interpretations and, thus, will 
not ensure that required measures have been taken or standards have been met.  In addition, it is 
not possible to discern a trend without actual measurement values. 
Furthermore, recordings of instrument readings must reflect the actual value displayed by the 
instrument, without rounding or generalization.  (See 21 CFR 112.161(a)(1)(ii)).  For example, if 
personnel conduct a pH measurement of composting manure and the reading is 6.56, the 
recorded value must be stated as 6.56, rather than pass or OK, or rather than being 
rounded to 7.0 or written as > 6 (greater than 6.0).  (See 21 CFR 112.161(a)(1)(ii)).   
  Created when Activity is Performed or Observed 
As applicable, your required records must be created at the time an activity is performed or 
observed.  (21 CFR 112.161(a)(2)).  This requirement ensures that the accuracy of recorded 
information is not impacted by human error, such as lapses in memory.  If an individual does not 
create the record at the time an activity is performed or observed, they could create an inaccurate 
record by forgetting the exact value observed, confusing values for multiple observations, or 
forgetting to create the record.  For example, if a worker is responsible for recording sanitizing 
activities that occur in a packing area, the worker should record each activity or observation, 
such as the pieces of equipment sanitized and the compounds and concentrations of treatments 
used, as it is performed.   
  Date and Time 
Your required records must include, as applicable, the date and time of the activity documented.  
(21 CFR 112.161(a)(1)(v)).  You should establish a procedure for personnel to use when 
recording dates to ensure consistency and clarity.  For example, you might set a procedure that 
personnel should record all dates in the format of MM-DD-YYYY.  Personnel should record 
133  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
times without rounding or generalization.  For example, if personnel take a measurement at 
1:03pm, they should record that time, not 1:00pm or 1:05pm.   
  Accurate, Legible, and Indelible 
Your required records must be accurate, legible, and indelible.  (21 CFR 112.161(a)(3)).  
Legibility is particularly important for records involving handwritten entries.  Indelibility is 
important to ensure that the original content has not been altered; therefore, records should not be 
erasable.  For example, an erasable white-board is not indelible.  If mistakes are made on a 
required record, your personnel should correct the original marking in a way that allows both the 
original content and the updated content to be read.  In other words, you should not mark over 
the original content in a way that prevents a person from reading the original content.  For 
example, if an incorrect value of 6.0 is written in permanent ink, the person who recorded that 
value should draw a single line through the 6.0, add the accurate value of 6.1, and write their 
initials and the date nearby.  For specific records listed in 21 CFR 112.161(b), a supervisor or 
responsible party reviewing records, when required by 21 CFR 112.161(b), should assess 
whether the record is legible.   
   Dated, and Signed or Initialed by the Person Who Performed the Activity 
The person who performed the activity documented must date, and sign or initial the record.  (21 
CFR 112.161(a)(4)).  This ensures that you can identify the individual who performed the 
activity recorded as well as the date the record was completed.  While this provision allows for 
the use of initials instead of a signature, there could be circumstances in which initials alone 
could be confusing.  For example, if you have multiple workers with the same initials (e.g., John 
Dab, Jane Dell, and Jennifer Doe), your procedures should direct those personnel to sign their 
full name or provide some additional identifier (e.g., JD1 or J. Dab or JWD) instead of 
using only their first and last initials.   
  Review by a Supervisor or Responsible Party 
A supervisor or responsible party must review, date, and sign the following records within a 
reasonable time after those records are created:  
  As applicable, records demonstrating eligibility for a qualified exemption under 21 CFR 
112.7(b);  
  As applicable, documentation that process controls were achieved for a treated biological 
soil amendment of animal origin you produce for you own covered farm(s), as required 
under 21 CFR 112.60(b)(2); 
134  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  Documentation of cleaning and sanitizing of equipment under 21 CFR 112.140(b)(1) and 
(2).  (21 CFR 112.161(b)).11  
When reviewing these records, the supervisor or responsible party should determine whether: 
  The records are complete, including whether personnel recorded their observations at the 
appropriate frequency for a given activity;  
  If any problems were recorded, those problems were addressed with appropriate 
corrective measures (for example, if a supervisor reviews a composting record and 
notices that a given temperature reading was below the necessary temperature for an 
effective treatment, the supervisor should confirm that the compost was either retreated 
or handled as untreated); and 
  Any necessary corrective measures are taken in a timely manner.  For example, if records 
indicate the need for a corrective measure to prevent distribution of an adulterated 
product, then a supervisor or other responsible party should confirm that the appropriate 
measure was performed.   
You should also review records to identify trends in recorded values or observations so that you 
can adjust before it is necessary to take corrective measures.  You should review records for any 
unexpected results.  For example, if a supervisor reviews a record of a sanitizer pH value, which 
they expect to be pH 6-7, and the recorded value is 4.2, the supervisor should follow-up with the 
worker who made the recording to determine whether there was a malfunction with the 
monitoring instrument, a difficulty by the worker in reading the instrument, a recording error 
(i.e., the record is not accurate), or some other problem. 
The supervisor or responsible party review must take place within a reasonable time after the 
records were created.  (See 21 CFR 112.161(b)).  In most instances, we believe that an 
appropriate time period for a supervisor or responsible party to review records is approximately 
one week after the record is created.  In some cases, you could find that a shorter or longer 
timeframe is appropriate.  You should adopt procedures regarding records review timeframes to 
ensure that supervisors and responsible parties consistently perform reviews within a reasonable 
timeframe to allow for any necessary follow-up actions.  For example, a reasonable timeframe 
should generally allow for covered produce or other items relevant to the record (such as 
equipment or biological soil amendments of animal origin) to be available so that you can take 
follow-up actions if needed.  
A detailed records review could become tedious, particularly when the various records include 
similar information.  You should ensure that supervisors and responsible parties review records 
at a time when they can focus on the records.  
When the owner or supervisor is both the person who performed the activity and the responsible 
party who reviews the record, the requirements in both 21 CFR 112.161(a)(4) and 112.161(b) are 
                                                 
11 The regulation at 21 CFR 112.161(b) also requires that a supervisor or responsible party review, date, and sign 
records required by 21 CFR 112.50(b)(2), (4), and (6), and 21 CFR 112.150(b)(1), (4), and (6), which are not 
addressed in this draft guidance.   
135  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
satisfied when that person signs and dates the record.  In this situation, the owner or responsible 
party should perform a thorough record review to evaluate the information in the record after the 
record includes all information required by the Produce Safety Rule (e.g., after that person 
records information such as the actual values and observations obtained during monitoring).   
2.  Records Storage 
You have the flexibility to store your records in a way that allows you to easily access them as 
necessary and to organize them consistent with your operating procedures.  You should evaluate 
how frequently you need to access your records and how you use them on your farm, and then 
develop a records management strategy that best fits your needs.  All records required under the 
Produce Safety Rule must be readily available and accessible to FDA.  (21 CFR 112.166). 
Required records must be stored either on the farm (i.e., onsite) or away from the farm (i.e., 
offsite).  (21 CFR 112.162).  Electronic records are considered onsite at your farm if they are 
accessible from an onsite location at your farm.  (21 CFR 112.162(b)).  If you have multiple 
growing sites for your farm, you could keep records at each site or consolidate all records from 
each growing site at a single site on your farm.  For example, if a farm has three growing sites 
and sometimes uses seasonally-rented fields, the farm could choose to store all its records at the 
farms main office, even if some of the records were completed at the three growing sites and the 
seasonally-rented fields.  As another example, the farm could store certain records for each 
growing site at that growing site while other records are stored at the farms main office. 
Offsite storage of records is permitted if such records can be retrieved and provided onsite within 
24 hours of request for official review.  (21 CFR 112.162(a)).  For example, your farm could 
generate some records that you need to easily access for a period of time, such as for one month 
or for a full growing season.  You could choose to transfer the records to a central storage 
location, which is not part of the farm, for longer-term storage after that initial time period has 
ended.  If those records are in an offsite storage location, they must be able to be retrieved and 
provided onsite within 24 hours of a request for official review.  (21 CFR 112.162(a)).   
3.  Use of Existing Records 
You may use existing records and information (e.g., documents or information that you have 
already developed and maintained during the normal course of your farms business, including 
records that are kept to comply with other Federal, State, or local regulations, or for any other 
reason) to comply with subpart O if those records contain all of the required information and 
satisfy the requirements of the Produce Safety Rule.  (See 21 CFR 112.163(a)).  It is not 
necessary for you to keep all of the required information in only one set of records, nor do you 
need to duplicate existing records, provided that, taken together, your records satisfy all of the 
applicable requirements of the Produce Safety Rule.  (See 21 CFR 112.163).  If existing records 
contain only some of the required information, you may keep additional information required for 
compliance with the Produce Safety Rule either separately or in combination with the existing 
records.  (21 CFR 112.163(b)).  If you maintain records required by another entity, and those 
records contain some of the information required by the Produce Safety Rule, you are not 
required to duplicate the overlapping components.  For example, your records must contain, as 
applicable, information such as the name and location of your farm (21 CFR 112.161(a)(1)(i)).  
136  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
If your records include written information obtained from a third party (e.g., a report of analysis 
from a contract laboratory) and the information provided by the third party does not include your 
farms name and location, you can fulfill this requirement by keeping your farms name and 
location recorded either separately or combined with the existing records. 
As another example, if you maintain records of your annual gross food sales as part of your 
documentation (in addition to your annual review record) to demonstrate that your farm meets 
the criteria for a qualified exemption from the Produce Safety Rule (21 CFR 112.7(b)), you 
could find that both your invoices and other financial records kept in the normal course of 
business provide the necessary information.  In this case, you would only need to keep one of 
these types of records (not both) to satisfy the requirement for documentation that your farm 
meets the criteria for the exemption (in addition to your annual review record), as long as the 
records you keep include all of the necessary information.   
4.  Records Retention 
You must keep records required by the Produce Safety Rule for at least 2 years past the date the 
record was created.  (21 CFR 112.164(a)(1)).  If you have a record with multiple entries, you 
should keep the record for 2 years past the date of the last recorded entry.  This could include 
records such as: training records required by 21 CFR 112.30(b); the process used to treat a 
biological soil amendment of animal origin that you produce, as required by 21 CFR 
112.60(b)(2); and the date and method of cleaning and sanitizing of equipment, as required by 21 
CFR 112.140(b)(2).   
You must also keep records that relate to the general adequacy of your equipment or processes, 
or records that relate to analyses, sampling, or action plans being used by your farm, including 
the results of scientific studies, tests, and evaluations, for at least 2 years after the use of such 
equipment or processes, or records related to analyses, sampling, or action plans, is discontinued.  
(21 CFR 112.164(b)).  Examples of such records include records that contain annual written 
assurances from your customers regarding produce that receives commercial processing (21 CFR 
112.2(b)(4)), if you keep such records because you rely on the exemption in 21 CFR 112.2.12  
If you rely on the qualified exemption in 21 CFR 112.5, you must keep records supporting your 
qualified exemption, in accordance with 21 CFR 112.5 and 112.7, as long as necessary to 
support your farms status during the applicable year.  (21 CFR 112.164(a)(2)).  This period 
could be as long as four years (i.e., the three previous years of financial records upon which you 
determined your eligibility for a qualified exemption and the current year for which the 
determination applies).   
5.  Records Format 
You have the flexibility to maintain your records as original records, true copies, or electronic 
records.  (21 CFR 112.165).  True copies include, for example, photocopies, pictures, scanned 
                                                 
12 As noted above, we have stated that we intend to exercise enforcement discretion related to the written assurances 
associated with the commercial processing exemption. 
137  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
copies, microfilm, microfiche, or any other accurate reproduction of the original record.  True 
copies of records should be of sufficient quality to reveal whether the original record was 
changed in a manner that obscured an original entry (e.g., by using liquid correction fluid).  
Electronic records are subject to the same requirements as paper records under the Produce 
Safety Rule.  You could use paper or electronic records, or a combination of the two, to satisfy 
the requirements of the Produce Safety Rule.  
6.  Records Disclosure 
Records obtained by FDA in accordance with the Produce Safety Rule are subject to the 
disclosure requirements under 21 CFR part 20.  (21 CFR 112.167).  This includes certain 
protection for confidential commercial information and trade secrets (See, e.g., 21 CFR 20.61).  
Our general policies, procedures, and practices relating to the protection of such information also 
apply to information received under the Produce Safety Rule. 
7.  Specific Records Requirements 
As noted above, subpart O describes how you must establish and maintain records the Produce 
Safety Rule requires.  You should refer to the following specific areas of the Produce Safety 
Rule and the relevant chapters of this draft guidance to determine what specific records you are 
required to keep that, with a few exceptions, are subject to the requirements of subpart O: 
  Subpart AGeneral Provisions: 
  Produce eligible for exemption based on receipt of commercial processing that 
o
adequately reduces the presence of microorganisms of public health significance 
(21 CFR 112.2(b)(4)); 
  Qualified Exemption (21 CFR 112.7); 
o
  Subpart CPersonnel Qualifications and Training; 
  Subpart FBiological Soil Amendments of Animal Origin and Human Waste; and 
  Subpart LEquipment, Tools, Buildings, and Sanitation.  
These specific records represent minimum standards; you could keep additional records related 
to practices on your farm to support minimizing the risk of contaminating covered produce.   
 
138  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Chapter 9: 
Variances (Subpart P) 
Subpart P of the Produce Safety Rule provides that a State, Federally-recognized tribe (tribe), 
or foreign country from which food is imported into the United States (foreign country) may 
request a variance from one or more requirements of subparts A through O of the rule, where the 
State, tribe, or foreign country determines that: 
  The variance is necessary in light of local growing conditions; and 
  The procedures, processes, and practices to be followed under the variance are 
reasonably likely to ensure that the produce is not adulterated under section 402 of the 
FD&C Act and to provide the same level of public health protection as the requirements 
of this part. (21 CFR 112.171).   
This chapter provides draft guidance on the requirements of subpart PVariances, and the 
procedures to request a variance.  In addition, this chapter provides draft guidance on how FDA 
intends to evaluate requests for a variance.  
1.  Entities Eligible to Submit a Variance Request 
The request for a variance must come from the competent authority (i.e., the regulatory authority 
for food safety) for a State, tribe, or foreign country.  (See 21 CFR 112.171 and 112.172).   
Entities that are not the regulatory authority for food safety, such as a state commodity 
commission, are not eligible to request a variance.  However, as discussed below, such groups 
(and others) may assist the competent authority in developing supporting information for the 
variance request. 
2.  Grounds for a Variance 
A competent authority (CA) may request a variance from one or more of the provisions of 
subparts A through O of the Produce Safety Rule.  (21 CFR 112.182).  Examples of some of the 
permissible types of variances are provided in 21 CFR 112.182.    
To request a variance, a CA must submit a petition under 21 CFR 10.30.  (21 CFR 112.172).  In 
addition to the requirements of 21 CFR 10.30, the Statement of Grounds of the CAs petition 
requesting a variance must provide a statement that the CA determined that:  
  The variance is necessary in light of local growing conditions;  
  The procedures, processes, and practices to be followed under the variance are reasonably 
likely to ensure that the produce is not adulterated under section 402 of the FD&C Act; and  
  The procedures, processes, and practices to be followed under the variance are reasonably 
likely to provide the same level of public health protection as the relevant requirements of the 
Produce Safety Rule.  (21 CFR 112.173(a)).   
The CA also must describe with particularity: 
139  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  The variance requested;  
  The persons to whom the variance would apply; and 
  The provision(s) of the Produce Safety Rule to which the variance would apply.  (21 CFR 
112.173(b)).   
Further, the CA must present information demonstrating:  
  That the procedures, processes, and practices to be followed under the variance are 
reasonably likely to ensure that the covered produce is not adulterated under section 402 of 
the FD&C Act; and  
  That the procedures, processes, and practices to be followed under the variance are 
reasonably likely to provide the same level of public health protection as the requirements of 
the Produce Safety Rule.  (21 CFR 112.173(c)). 
In evaluating whether a variance is necessary in light of local growing conditions, the CA 
might consider factors such as climate, soil, and geographical and environmental conditions in its 
particular region.  If particular controls (such as regional-specific practices, processes, or 
procedures) or oversight (such as regional produce marketing programs) are used, the nature of 
the oversight established could also be relevant to the CAs request.   
The petitions Statement of Grounds must describe with particularity the variance requested.  (21 
CFR 112.173(b)).  It must include the persons to whom the variance would apply and the 
provision(s) of the Produce Safety Rule to which the variance would apply.  (21 CFR 112.73(b)).  
Specifically, this includes what farms would be covered by the variance; the measures that farms 
covered by the variance would follow; and the provisions of the Produce Safety Rule for which 
those measures would be substituted.  The CA must also indicate the persons to which it requests 
that the variance apply.  (21 CFR 112.173(b)).  For example, the requested variance might apply 
to all persons in the CAs jurisdiction, or might be limited to a specific group in the jurisdiction.  
If the CAs proposed approach is based, at least in part, on climate, soil, or geographical or 
environmental conditions of a particular region within the CAs jurisdiction, the petition should 
describe those conditions and the boundaries of the specific region involved.    
3.  Information to Support a Request for a Variance  
The Statement of Grounds in a petition requesting a variance must present information 
demonstrating that the procedures, processes, and practices to be followed under the variance are 
reasonably likely to ensure that the produce is not adulterated under section 402 of the FD&C 
Act and to provide the same level of public health protection as the requirements of the Produce 
Safety Rule.  (21 CFR 112.173(c)).   
A CA should include relevant and scientifically-valid information or materials specific to the 
covered produce or covered activity to support the request for a variance from corresponding 
requirements established in the Produce Safety Rule, in accordance with the requirements of 21 
CFR 112.173(c).  It is likely that a CA will use several resources to gather the information 
necessary to support and describe its request for a variance.  A CA could develop the information 
itself, obtain it from scientific literature or a third party (such as a trade association or 
commodity board), or use some combination of resources to collect the necessary information.  
140  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
A CA could, for example, present in its petition information that came from an individual farm 
or group of farms, an importer or exporter, a trade or other industry association, academia, a 
private food safety entity, a consultant, or another stakeholder.  The scientific support for a 
variance could be developed, for example, through a broad effort involving farms, academia, 
extension services, industry associations, and government agencies.  Information that a CA uses 
does not need to be published in a peer-reviewed journal, although we encourage use of peer-
reviewed data and information.   
Although the types of data or information that a CA should submit in support of its petition for a 
variance vary widely depending upon the nature of the request, some examples include:  
  Information about the specific, local growing conditions, including crop, climate, soil, 
and geographical and environmental conditions of the region relevant to the request; 
  Information about the processes, procedures, or practices followed in the growing, 
harvesting, packing, or storing of covered produce in the region relevant to the request. 
4.  Process for Requesting a Variance  
To request a variance from one or more requirements of subparts A through O of the Produce 
Safety Rule, a CA must submit a petition to FDA under the procedures contained in 21 CFR 
10.30.  (21 CFR 112.172).  Subpart PVariances provides additional specific requirements for a 
petition for a variance.  We encourage competent authorities considering requesting a variance to 
participate in pre-submission consultations with FDA.   
A CA could also request that a variance requested by a petition submitted by another competent 
authority be applied to its similarly situated persons.  (See 21 CFR 112.177).  Similarly situated 
persons could include, for example, farms that operate under similar circumstances with similar 
procedures, processes, and practices as those covered by the other competent authoritys request 
for a variance.   
We encourage CAs to collaborate with other entities in the development of their petition 
requesting a variance, such as industry groups and other relevant stakeholders.  These entities 
could provide the CA with information to support certain aspects of the variance request or they 
could assist the CA in drafting the petition.  Additionally, if a CA is requesting a variance for 
farms within its jurisdiction that are similarly situated to those covered by a variance requested in 
a petition submitted by another CA, the requesting CA could find it useful to access scientific 
data and other information from that petition.    
We will presume that information submitted in a petition requesting a variance and comments 
submitted on such a petition, including a request that a variance be applied to its similarly 
situated persons, does not contain information exempt from public disclosure under 21 CFR part 
20, and will be made public as part of the docket associated with the request.  (21 CFR 112.174).     
141  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
III.  References  
We have placed the following references on display in the Dockets Management Staff, Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at 
that location between 9 a.m. and 4 p.m., Monday through Friday.  As of July 2018, FDA had 
verified the Web site address for the references it makes available as hyperlinks from the Internet 
copy of this draft guidance, but FDA is not responsible for any subsequent changes to Non-FDA 
Web site references after July 2018.  
1. A., Pachepsky Y., D. R. Shelton, J. E. T. McLain, J. Patel, and R.E. Mandrell. 2011. 
Irrigation Waters as a Source of Pathogenic Microorganisms in Produce, Advances in 
Agronomy 113:73-138. doi: 10.1016/b978-0-12-386473-4.00007-5. 
2. Ansari, A. A.,  S.V. Springthorpe, S.A. Sattar, W. Tostowaryk, and G.A. Wells. 1991. 
Comparison of cloth, paper, and warm air drying in eliminating viruses and bacteria 
from washed hands,  American Journal of Infectious Control. https://ac.els-
cdn.com/S0196655305802561/1-s2.0-S0196655305802561-main.pdf?_tid=fb7fc7fa-
2e2d-4327-bdce-
bdf94344ac21&acdnat=1531864393_304f7e17ab49fcea62371faa83ed2887.  
3. Archer, Douglas L. 2004. Freezing: an Underutilized Food Safety Technology? 
International Journal of Food Microbiology 90 (2):127-138. https://ac.els-
cdn.com/S0168160503002150/1-s2.0-S0168160503002150-main.pdf?_tid=9069a7d7-
47cf-41d6-845f-
af2453b81c86&acdnat=1531864808_c5f1f06ac8c122dc27d60b7483926ce9. 
4. Aruscavage, D.,  S. Miller, M.L. Lewis Ivey, K. Lee, and J.T. LeJeune. 2008. Physically and 
Biologically Damaged Lettuce Plants,  Journal of Food Protection 71 (12):2384-2388. 
https://doi.org/10.4315/0362-028X-71.12.2384. 
5. Aruscavage, D.,  K. Lee,  S. Miller, and J.T. LeJeune. 2006. Interactions Affecting the 
Proliferation and Control of Human Pathogens on Edible Plants,  Journal of Food 
Science 71 (8):R89 - R99. doi: 10.1111/j.1750-3841.2006.00157.x/full. 
6. Bagcigil, A.F., S. Ikiz, B. Dokuzeylu, B. Basaran, E. Or, and N.Y. Ozgur. 2007. Fecal 
shedding of Salmonella spp. in dogs,  Journal of Veterinary Medicine Science 69 (7): 
775-777. https://www.ncbi.nlm.nih.gov/pubmed/17675814. 
7. Becker, B. R., and B.A. Fricke. 1996. Transpiration and Respiration of Fruits and 
Vegetables, http://b.web.umkc.edu/beckerb/publications/chapters/trans_resp.pdf 
8. Beuchat, L. R. 1996. Pathogenic Microorganisms Associated with Fresh Produce.  Journal 
of Food Protection 59 (2):204-216. http://jfoodprotection.org/doi/pdf/10.4315/0362-
028X-59.2.204?code=fopr-site. 
9. Beuchat, L. R. 1999. Survival of Enterohemorrhagic Escherichia coli O157: H7 in Bovine 
Feces Applied to Lettuce and the Effectiveness of Chlorinated Water as a Disinfectant, 
Journal of Food Protection 62 (8):845-849. 
http://jfoodprotection.org/doi/pdf/10.4315/0362-028X-62.8.845?code=FOPR-site 
10. Beuchat, L. R. 2002. Ecological Factors Influencing Survival and Growth of Human 
Pathogens on Raw Fruits and Vegetables,  Microbes and Infection 4:413-423. 
http://www.sciencedirect.com/science/article/pii/S1286457902015551?via%3Dihub. 
 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
11. Beuchat, L. R.,  Komitopoulou, K,. Beckers, H.,  Betts, R.P., Bourdichon, F. Fanning, S., 
Joosten, H. M., and Ter Kuile, B. H. 2013, Low-water Activity Foods: Increased 
Concern as Vehicles of Foodborne Pathogens,  Journal of Food Protection 76 (1):150-
72. http://jfoodprotection.org/doi/pdf/10.4315/0362-028X.JFP-12-211. 
12. Beuchat, L. R. 2011. Persistence and Survival of Pathogens in Dry Foods and Dry Food 
Processing Environments. http://ilsi.eu/wp-content/uploads/sites/3/2016/06/Persistence-
and-survival-report.pdf  
13. Beutin, L., D. Geier, H. Steinruck, S. Zimmermann, and F. Scheutz. 1993. Prevalence and 
some properties of verotoxin (Shiga-like toxin)-producing Escherichia coli in seven 
different species of healthy domestic animals,  Journal of Clinical Microbiology 31 
(9):2483-2488. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC265781/pdf/jcm00021-
0249.pdf. 
14. Bihn, A.E., and Gravani B.R. 2006. Role of Good Agricultural Practices in Fruit and 
Vegetable Safety. In Microbiology of Fresh Produce. Washington, DC. 
15. Birkenhauer, E, and S. Neethirajan. 2015. Chapter 4-Prevention and Control of Biofilms in 
the Food Industry and Bio-Nanotechnology Approaches In Biofilms in the Food 
Environment, 84. United Kingdom: Wiley Blackwell. 
16. Brackett, R. E. 1992. Shelf Stability and Safety of Fresh Produce as Influenced by 
Sanitation and Disinfection,  Journal of Food Protection 55 (10):808-814. 
http://jfoodprotection.org/doi/pdf/10.4315/0362-028X-55.10.808?code=fopr-site. 
17. Brackett, R. E. 1999. Incidence, Contributing Factors, and Control of Bacterial Pathogens in 
Produce,  Postharvest Biology and Technology 15:305311. 
18. Carpentier, B., and O. Cerf. 1993. Biofilms and their Consequences, with Particular 
Reference to Hygiene in the Food Industry,  Journal of Applied Bacteriology 76:499-
511. 
19. Carpentier, B., and O. Cerf. 2011. Review--Persistence of Listeria monocytogenes in Food 
Industry Equipment and Premises,  Int J Food Microbiol 145 (1):1-8. http://ac.els-
cdn.com/S0168160511000122/1-s2.0-S0168160511000122-main.pdf?_tid=61797704-
9531-11e6-b8a0-
00000aab0f27&acdnat=1476795180_a46f84b8afc51230447883e4735c60. 
20. Carrasco, E., A. Morales-Rueda, and R.M. Garcia-Gimeno. 2011. Cross-contamination and 
recontamination by Salmonella in foods: A review,  Food Research International 45 
(2):545-556. doi: 10.1016/j.foodres.2011.11.004. 
21. Carrington, E. G. 2011. Evaluation of Sludge Treatments for Pathogen Reduction-Final 
Report.  European Commission DG Environment. 
22. Cason, J. A., A. Hinton, J. K. Northcutt, R. J. Buhr, D. K. Ingram, D. P. Smith, and N. A. 
Cox. 2007. Partitioning of External and Internal Bacteria Carried by Broiler Chickens 
before Processing,  Journal of Food Protection 70 (9):2056-2062. 
http://jfoodprotection.org/doi/pdf/10.4315/0362-028X-70.9.2056. 
23. CDC. 2012. Multistate Outbreak of Listeriosis Linked to Whole Cantaloupes from Jensen 
Farms, Colorado (Final update). https://www.cdc.gov/listeria/outbreaks/cantaloupes-
jensen-farms/index.html. 
24. CDC. 2012. Lesson 1: Principles of Epidemiology. Section 10. 
https://www.cdc.gov/ophss/csels/dsepd/ss1978/lesson1/section10.html 
25. CDC. 2015. Toilets and latrines. 
https://www.cdc.gov/healthywater/global/sanitation/toilets.html. 
143  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
26. CDC. 2017. Home Canning and Botulism. 
https://www.cdc.gov/features/homecanning/index.html. 
27. CDC. 2017. Symptoms and Sources of Food Poisoning. 
https://www.cdc.gov/foodsafety/symptoms.html. 
28. CDC. 2013. Surveillance of Foodborne Disease Outbreaks - United States, 1998-2008. 
MMWR Surveillance Summaries 62, 1-40. 
29. Charbonneau, D. L., J. M. Ponte, and B. A.  Kochanowski. 2000. A Method of Assessing 
the Efficacy of Hand Sanitizers: Use of Real Soil Encountered in the Food Service 
Industry,  Journal of Food Protection, 63 (4):495501. 
30. Chen, Z., and X. Jiang. 2014. Microbiological Safety of Chicken Litter or Chicken Litter-
Based Organic Fertilizers: A Review,  Agriculture 4 (1):1-29. doi: 
10.3390/agriculture4010001. 
31. Chomel, B., and B. Sun. 2011. Zoonoses in the Bedroom,  Emerging Infectious Diseases 
17 (2):167-172. doi: 10.3201/eid1702.101070. 
32. Crowley, C., J. Johanson, M. Mahovic, and S. Trujillo. 2012. Memorandum to the File-FDA 
Farm Investigations in Response to Outbreaks and Positive Sampling Findings for Use in 
Produce Rule Qualitative Risk Assessment: 2005-2008. In: FDA Farm Investigations in 
Response to Outbreaks and Positive Sampling Findings for Use in Produce Rule 
Qualitative Risk Assessment. 
33. Crump, J. A., A. C. Sulka, A. J. Langer, C. Schaben, A. S. Crielly, R. Gage, M. Baysinger, 
M. Moll, G. Withers, D. M. Toney, S. B. Hunter, R. M. Hoekstra, S. K. Wong, P. M. 
Griffin, and T. J. Van Gilder. 2002. An Outbreak of Escherichia coli O157:H7 
Infections among Visitors to a Dairy Farm,  New England Journal of Medicine 347 
(8):555-560. https://www.nejm.org/doi/10.1056/NEJMoa020524. 
34. D'Lima, C., K. Vierk., and Food and Drug Administration. 2011. Memorandum to the File - 
Produce Related Outbreaks and illnesses.  
35. Danon, M., I. H. Franke-Whittle, H. Insam, Y. Chen, and Y. Hadar. 2008. Molecular 
analysis of bacterial community succession during prolonged compost curing,  FEMS 
Microbiology Ecology 65 (1):133-44. doi: 10.1111/j.1574-6941.2008.00506.x. 
36. De Roever, C. D. 1998. Microbiological Safety Evaluations and Recommendations on Fresh 
Produce,  Food Control 9 (6):321-347. 
37. Doyle, M. P., and C. M. Erickson. 2011. Reducing the Carriage of Foodborne Pathogens in 
Livestock and Poultry, 85:960973. 
38. Dunsmore, D. G., A. Twomey, W. G. Whittlestone, and H. W.  Morgan. 1981. Design and 
Performance of Systems for Cleaning,  Journal of Food Protection 44 (3):220-240. 
39. Dvorak, G. 2008. Center for Food Security and Public Health 2008 Disinfection 101.. 
40. EPA. 2003. Control of Pathogens and Vector Attraction in Sewage Sludge In  
Environmental Regulations and Technology. 
41. EPA. 2005. A Homeowners Guide to Septic Systems. 
http://nepis.epa.gov/Exe/ZyPDF.cgi/200041E0.PDF?Dockey=200041E0.PDF. 
42. EPA. 2012. Case Studies of Individual and Clustered (Decentralized) Wastewater 
Management Programs.  https://www.epa.gov/sites/production/files/2015-
06/documents/decentralized-case-studies-2012.pdf. 
43. EPA. 2013. Moisture Control Guidance for Building Design, Construction and 
Maintenance. https://www.epa.gov/indoor-air-quality-iaq/moisture-control-guidance-
building-design-construction-and-maintenance-0. 
144  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
44. EPA. 2016. Septic Systems Guidance, Policy, and Regulations. 
https://www.epa.gov/septic/how-your-septic-system-works.  
45. EPA. 2017. Septic Systems Overview. https://www.epa.gov/septic/septic-systems-
overview. 
46. Fagernes, M. 2007. Impact of a Single Plain Finger Ring on the Bacterial Load on the 
Hands of Healthcare Workers,  Infection Control and Hospital Epidemiology 28 
(10):1191-5. 
47. Fagernes, M., and R. Nord. 2007. A study of microbial load of different types of finger rings 
worn by healthcare personnel,  VARD I NORDEN 27 (84):2124. 
48. FAO/WHO. 2008. Microbiological Hazards in Fresh Fruits and Vegetables Meeting 
Report.. 
49. FAO/WHO. 2008. Microbiological Hazards in Fresh Leafy Vegetables and Herbs Meeting 
Report.. 
50. Farber, J. N. , L. J.  Harris, M. E.  Parish, L. R.  Beuchat, T. V.  Suslow, J.R.  Gorney, E. H.  
Garrett, and F. F. Busta. 2003. Microbiological Safety of Controlled and Modified 
Atmosphere Packaging of Fresh and Fresh-Cut Produce,  Comprehensive Reviews in 
Food Science and Food Safety 2:142-160. 
51. FDA. 2011. Environmental Assessment: Factors Potentially Contributing to the 
Contamination of Fresh Whole Cantaloupe Implicated in a Multi-State Outbreak of 
Listeriosis. Last Modified September 20, 2015 Accessed June 19, 2015. 
http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm276247.htm. 
52. FDA. 2011. Environmental Assessment: Factors Potentially Contributing to the 
Contamination of Fresh Whole Cantaloupe Implicated in a Multi-State Outbreak of 
Listeriosis.. Last Modified September 20, 2015 Accessed June 19, 2015. 
http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm276247.htm. 
53. FDA. 2013. Environment Assessment: Factors Potentially Contributing to the 
Contamination of Fresh Whole Cantaloupe Implicated in a Multi-State Outbreak of 
Salmonellosis.. http://wayback.archive-
it.org/7993/20171114155057/https://www.fda.gov/Food/RecallsOutbreaksEmergencies/
Outbreaks/ucm341476.htm 
54. FDA. 2015. Final Qualitative Assessment of Risk to Public Health from On-Farm 
Contamination of Produce.. 
https://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UC
M470780.pdf 
55. FDA. 2017. Food Code 2017. Annex 3 Table 1a, 377. 
56. FDA. 2017. Food Code 2017. Chapter 1-2 Definitions, 3. 
57. Fleming, N., and C. Mills. 1992. Not Another Inventory, Rather a Catalyst for Reflection.. 
58. Flores, G. E., S. T. Bates, D. Knights, C. L. Lauber, J. Stombaugh, R. Knight, and N. Fierer. 
2011. Microbial Biogeography of Public Restroom Surfaces,  PLoS One 6 (11):e28132. 
doi: 10.1371/journal.pone.0028132. 
59. Foddai, A. C., I. R. Grant, and M. Dean. 2016. Efficacy of Instant Hand Sanitizers against 
Foodborne Pathogens Compared with Hand Washing with Soap and Water in Food 
Preparation Settings: A Systematic Review,  Journal of Food Protection 79 (6):1040-54. 
doi: 10.4315/0362-028X.JFP-15-492. 
145  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
60. Gardner, T. J., C.Fitzgerald, C. Xavier, R. Klein, J. Pruckler, S. Stroika, and J. B. 
McLaughlin. 2011. Outbreak of Campylobacteriosis Associated With Consumption of 
Raw Peas,  Clinical Infectious Diseases 53 (1):26-32. doi: 10.1093/cid/cir249. 
61. Gaukel, V. 2016. Cooling and Freezing of Foods, Reference Module in Food Science :1-3  
doi: 10.1016/b978-0-08-100596-5.03415-6. 
62. Gil, M. I., and M. V., Selma. 2005. Chapter 6- Overview of Hazards in Fresh-Cut Produce 
Production: Control and Management of Food Safety Hazards In Microbial Hazard 
Identification in Fresh Fruit and Vegetables. doi: 
https://doi.org/10.1002/0470007761.ch6. Hoboken, New Jersey. John Wiley and Sons, 
Inc. 
63. Gopinath, S., S. Carden, and D. Monack. 2012, Shedding light on Salmonella Carriers.  
Trends Microbiology 20 (7):320-7. 
https://www.sciencedirect.com/science/article/pii/S0966842X12000777. 
64. Gravani, R. B. 2010. Farm Worker Health and Hygiene.  Produce Safety Project Issue 
Brief. http://www.pewtrusts.org/~/media/assets/2009/pspworker1pdf.pdf. Accessed 11
292011. 
65. Greig, J.D., E.C.D. Todd, C.A. Bartleson, and B.S. Michaels. 2007. Outbreaks Where Food 
Workers Have Been Implicated in the Spread of Foodborne Disease. Part 1. Description 
of the Problem, Methods, and Agents Involved,  Journal of Food Protection 70:1752-
1761. 
66. Hammons, S. R., A. J. Etter, J. Wang, T. Wu, T. Ford, M. T. Howard, and H. F. Oliver. 2017. 
Evaluation of Third-Party Deep Cleaning as a Listeria monocytogenes Control Strategy 
in Retail Delis,  Journal of Food Protection 80 (11):1913 - 1923. 
67. Harris, L. J., J. N. Farber, L. R. Beuchat, M. E. Parish, T. V. Suslow, E. H. Garrett, and F. F. 
Busta. 2003. Chapter 3- 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 2:78-141. 
68. Howard. 2002. Chapter 4-Excreta Disposal In Healthy Villages: A guide for communities 
and community health workers.  
69. Huang, C., W. Ma, and S. Stack. 2012. The Hygienic Efficacy of Different Hand-drying 
methods: a review of the evidence,  Mayo Clinic 87 (8):791-8. doi: 
10.1016/j.mayocp.2012.02.019. 
70. Hutin , Yvan J.F., V. Pool , E. H. Cramer, O. V. Nainan, J. Weth, I.T. Williams, S. T. 
Goldstein, K. F. Gensheimer, B. P. Bell, C. N. Shapiro, M. J. Alter, and H. S. Margolis. 
1999. A Multistate, Foodborne Outbreak of Hepatitis A,  New England Journal of 
Medicine 340 (8):595-602. doi: 10.1056/nejm199902253400802. 
71. Ingham, S. C., J. A. Losinski, M. P. Andrews, J. E. Breuer, J. R. Breuer, M. T. Wood, and T. 
M. Wright. 2004. Escherichia coli Contamination of Vegetables Grown in Soils 
Fertilized with Noncomposted Bovine Manure: Garden-Scale Studies,  Applied and 
Environmental Microbiology 70 (11):6420-6427. 
72. Ingram, D.T., M.K. Fatica, and M. Mahovic. 2015. Memorandum to the File : FDA Farm 
Investigations in Response to Outbreaks and Positive Sample Findings: 2011-2014.. 
73. Islam, M., M.  Doyle, S. C. Phatak, P. Millner, and X. Jiang. 2004. Persistence of 
Enterohemorrhagic Escherichia coli O157:H7 in Soil and on Leaf Lettuce and Parsley 
Grown in Fields Treated with Contaminated Manure Composts or Irrigation Water,  
Journal of Food Protection, 67 (7):13651370. 
146  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
74. Islam, M., J. Morgan, M. P. Doyle, S. C. Phatak, P. Millner, and X. Jiang. 2004. Persistence 
of Salmonella Enterica Serovar Typhimurium on Lettuce and Parsley in Soils on Which 
They Were Grown in Fields Trated with Contaminated Manure Composts Irrigration 
Water,  Foodborne Pathogen and Disease 1 (1):27 - 35. 
75. Islam, M., M. P. Doyle, S. C. Phatak, P. Millner, and X. Jiang. 2005. Survival of 
Escherichia coli O157:H7 in soil and on carrots and onions grown in fields treated with 
contaminated manure composts or irrigation water,  Food Microbiology 22 (1):63-70. 
doi: 10.1016/j.fm.2004.04.007. 
76. Jay, J. M., M. J. Loessner, and D. A. Golden. 2005.  Chapter 24- Food Poisoning Caused by 
Gram-positive Sporeforming Bacteria in Modern Food Microbiology, 567  590. New 
York, New York. Springer. 
77. Jay, M. T., M. Cooley, D. Carychao, G. W. Wiscomb, R. A. Sweitzer, L. Crawford-Miksza, 
J. A. Farrar, D. K. Lau, J. OConnell, A. Millington, R. V. Asmundson, E. R. Atwill, and 
R. E. Mandrell. 2007. Escherichia coli O157:H7 in Feral Swine near Spinach Fields and 
Cattle, Central California Coast,  Emerging Infectious Disease 13 (12):1908-11. 
78. Jiang X, and Shepherd M. 2009. The Role of Manure and Compost in Produce Safety, In 
Microbial Safety of Fresh Produce, edited by Fan X, Niemira BA, Doona CJ, Feeherry 
FF and Gravani RB, 143-66. United Kingdom. IFT Press: Wiley-Blackwell. 
79. Kaneko, K. I., H. Hayashidani, K. Takahashi, Y. Shiraki, S. Limawongpranee, and M. 
Ogawa. 1999. Bacterial Contamination in the Environment of Food Factories Processing 
Ready-to-EatFresh Vegetables,  Journal of Food Protection 62 (7):800804. 
80. Kelley, L. 2013. Protect Irrigation Equipment From Winter Damage. Michigan State 
University Extension. 
http://msue.anr.msu.edu/news/protecting_irrigation_equipment_from_winter_damage. 
81. Kennedy, D. I., C. E. Enriquez, and C. P. Gerba. 2010. Enteric Bacterial Contamination of 
Public Restrooms,  CIRIscience:1-12. 
82. Kopper, G., S. Mirecki, I. S., Kljujev, V. B., Raicevic, B. T. Lalevic, J. Petrovic-Jovicic, S. 
Stojanovski, and D. Blazekovic-Dimovska. 2013. Chapter 23-Hygiene in Primary 
Production in Food Safety Management, 559-621. Waltham, Massachusetts. Academic 
Press. 
83. Krysinski, P. E., J. L. Brown, and J. T. Marchisello. 1992. Effect of Cleaners and Sanitizers 
on Listeria monocytogenes Attached to Product Contact surfaces,  Journal of Food 
Protection 55 (4):246-251. 
84. Kudva, I.T., K. Blanch, and C.J. Hovde. 1998. Analysis of Escherichia coli O157:H7 
Survival in Ovine or Bovine Manure and Manure Slurry,  Applied and Environmental 
Microbiology 64 (9):31663174. 
85. Kwan, L. S. P., C. Xavier, M. Santovenia, J. Pruckler, S. Stroika, K. Joyce, T. Gardner, I. P. 
Fields, J. McLaughlin, R. V. Tauxe, and C. Fitzgerald. 2014. Multilocus sequence 
typing confirms wild birds as the source of a camplylobacter outbreak associated with the 
consumption of raw peas,  Applied and Environmental Microbiology 80:4540  4546. 
86. Laidler, M. R., M. Tourdjman, G. L. Buser, T. Hostetler, K. K. Repp, R. Leman, M. 
Samadpour, and W. E. Keene. 2013. Escherichia coli O157:H7 Infections Associated 
With Consumption of Locally Grown Strawberries Contaminated by Deer,  Clinical 
Infectious Diseases 57 (8):1129-1134. doi: 10.1093/cid/cit468. 
87. Larsen, M.H., M. Dalmasso, H. Ingmer, S. Langsrud, M. Malakauskas, A. Mader, T. 
Mretr, S.M. Mozina, K. Rychli, M. Wagner, R. J. Wallace, J. Zentek, and K. Jordan. 
147  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
2014. Persistence of foodborne pathogens and their control in primary and secondary 
food production chains,  Food Control 44:92-109. doi: 10.1016/j.foodcont.2014.03.039. 
88. Leong, D., A. Alvarez-Ordonez, and K. Jordan. 2014. Monitoring occurrence and 
persistence of Listeria monocytogenes in foods and food processing environments in the 
Republic of Ireland,  Front Microbiol 5:436. doi: 10.3389/fmicb.2014.00436. 
89. Lin, C. M., F. M. Wu, H. K. Kim, M. P. Doyle, B.S. Michaels, and L. K. Williams. 2003. A 
Comparision of Hand Washing Techniques To Remove Escherichia cali and 
Caliciviruses under Natural or Artificial Fingernails,  Journal of Food Protection 66 
(12):2296-2301. 
90. Lynch, M. F., R. V. Tauxe, and C. W. Hedberg. 2009. The Growing Burden of Foodborne 
Outbreaks Due to Contaminated Fresh Produce: Risks and Opportunities.  Epidemiology 
and Infection 137 (3):307-315. doi: 10.1017/S0950268808001969. 
91. Lyon, L. J., H. M.; Huff, G. R.; Hooper, S. E.; Telfer, S.D.; Schreiner, and K. J.; Smith. 
2000. Wildland Fire in Ecosystems Effects of Fire on Fauna.  USDA Forest Service 
General Technical Report- RMRS-42 (1). 
92. Mafu, A. A., Denis, R., J. Goulet, and P. Magny. 1990. Attachment of Listeria 
Monocytogenes to Stainless Steel, Glass, Polypropylene, and Rubber Surfaces After 
Short Contact Times,  Journal of Food Protection 53 (9):742-746. 
93. Marriott, N., and R. B. Gravani. 2006. Chapter 10-Sanitizers In Principles of Food 
Sanitation, 165-189. New York, New York. Springer. 
94. Marriott, N., and R. B. Gravani. 2006. Chapter 19- Fruit and Vegetable Processing Plant 
Sanitation In Principles of Food Sanitation, 336-349. New York, New York. Springer. 
95. Marriott, N., and R. B. Gravani. 2006. Chapter 13- Pest Control In Principles of Food 
Sanitation, 235 - 255. New York, New York. Springer. 
96. Marriott, N., and R. B. Gravani. 2006. Chapter 11- Cleaning Compounds In Principles of 
Food Sanitation, 190-212. New York, New York. Springer. 
97. Marriott, N., and R. B. Gravani. 2006. Chapter 9- Cleaning Compounds In Principles of 
Food Sanitation, 141-164. New York, New York. Springer. 
98. Meng, J., M. Doyle, T. Zhao, and S. Zhao. 2007. Enterohemorrhagic Escherichia coli in 
Food,  Food Microbiology: Fundamentals and Frontiers:193- 213. 
99. Merriweather, S., T. C. Cloyd, C. Robinson, D. Gubernot, and Food and Drug 
Administration. 2015. Memorandum-Produce Related Outbreaks and Illnesses 2011 -
2014.. 
100. Michaels, B.S., and E.C.D. Todd. 2006. Chapter 5-Food Worker Personal Hygiene 
Requirements During Harvesting, Processing, and Packaging of Plant Products In 
Microbial Hazard Identification in Fresh Fruits and Vegetables, 115-153. Hoboken, NJ.  
John Wiley & Sons, Inc. 
101. Molloy, K., D. R. Moore, E. Sohoglu, and S. Amitay. 2012. Less is more: latent learning is 
maximized by shorter training sessions in auditory perceptual learning,  PLoS One 7 
(5):e36929. doi: 10.1371/journal.pone.0036929. 
102. Moore, T.T. 2011. Climate Change and Animal Migration,  Environmental Law 41:393-
405. 
103. Morato, E. P., L. Leomil, L. Beutin, G. Krause, R. A. Moura, and A. F. Pestana de Castro. 
2009. Domestic Cats Constitute a Natural Reservoir of Human Enteropathogenic 
Escherichia coli Types,  Zoonoses & Public Health 56 (5):229-237. doi: 10.1111/j.1863-
2378.2008.01190.x. 
148  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
104. NASPHV. 2011. Compendium of Measures to Prevent Disease Associated with Animals 
in Public Settings.  Recommendations and Reports 60 (4). 
105. Natishan, P. M., and W. E. O'Grady. 2014. Chloride Ion Interactions with Oxide-Covered 
Aluminum Leading to Pitting Corrosion: A Review,  Journal of the Electrochemical 
Society 161 (9):C421-C432. doi: 10.1149/2.1011409jes. 
106. National Environmental Services Center. 2004. Maintaining your Septic Systems  A 
guide for Homeowners,  Pipeline 15(4): 1-8. 
107. Nielsen, E. M., M. N. Skov, J. J. Madsen, J. Lodal, J. B. Jespersen, and D. L. Baggesen. 
2004. Verocytotoxin-producing Escherichia coli in wild birds and rodents in close 
proximity to farms,  Applied and Environmental Microbiology 70 (11):6944-7. doi: 
10.1128/AEM.70.11.6944-6947.2004. 
108. Parish, M. E. 1998. Coliforms, Escherichia coli and Salmonella Serovars Associated with a 
Citrus-Processing Facility Implicated in a Salmonellosis Outbreak,  Journal of Food 
Protection 61 (3):280-284. 
109. Park, Y., Y. Pachepsky, D. Shelton, J. Jeong, and G. Whelan. 2016. Survival of Manure-
borne and Fecal Coliforms in Soil: Temperature Dependence as Affected by Site-Specific 
Factors,  Journal of Environmental Quality 45 (3):949-57. doi: 
10.2134/jeq2015.08.0427. 
110. Pell, Alice N. 1997. Manure and Microbes: Public and Animal Health Problem?  Journal 
of Dairy Science 80 (10):2673-2681. doi: http://dx.doi.org/10.3168/jds.S0022-
0302(97)76227-1. 
111. Porter, J. D., C. Gaffney, D. Heymann, and W. Parkin. 1990. Food-borne outbreak of 
Giardia lamblia,  American Journal of Public Health 80 (10):1259-1260. 
112. QAR. 2015. Final Qualitative Assessment of Risk to Public Health from On-Farm 
Contamination of Produce. 
https://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UC
M470780.pdf. 
113. Renter, D. G., and J. M. Sargeant. 2002. Enterohemorrhagic Escherichia coli O157: 
Epidemiology and Ecology in Bovine Production Environments,  Animal Health 
Research Reviews 3 (2):83-94. doi: 10.1079/ahrr200245. 
114. Salisbury, D., P. Hutfilz, L. Treen, G. Bollin, and S. Gautam. 1997. The effect of rings on 
microbial load of health care workers hands,  American Journal of Infectious Control 
25:24-27. 
115. Scallan, Elaine, Patricia M. Griffin, Frederick J. Angulo, Robert V. Tauxe, and Robert M. 
Hoekstra. 2011. Foodborne Illness Acquired in the United StatesUnspecified Agents,  
Emerging Infectious Diseases 17 (1):16-22. doi: 10.3201/eid1701.P21101. 
116. Schlegelova, J., V. Babak, M. Holasova, L. Konstantinova, L. Necidova, F. Sisak, H. 
Vlokova, P. Roubal, and Z. Jaglic. 2010. Microbial Contamination after Sanitation of 
Food Contact Surfaces in Dairy and Meat Processing Plants,  Czech Journal of Food 
Science 28 (5):450-461. 
117. Schleh III, F. W., M. P. Lavigne, A. R. Bortolussi, C. A. Allen, E. V. Haldane, A. J. Wort, 
W. A. Hightower, E. S. Johnson, H. S. King, S. E. Nicholls, and V. C. Broome. 1983. 
Epidemic Listeriosis Evidence for Transmission by Food,  The New England Journal 
of Medicine 308 (4):203-206. 
118. Schmidt, H. R., R. V. Lechowich, and J. F. Folinazzo. 1961. Growth and Toxin Production 
by Type E Clostridium Botulinum Below 40F, Journal of Food Science 26(6):626-629. 
149  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
119. Silva, D. I., T. R. Careli, C. J. Lima, and J. N. Andrade. 2008. Effectiveness of Cleaning 
and Sanitizing Procedures in Controlling the Adherence of Pseudomonas fluorescens, 
Salmonella Enteritidis, and Staphylococcus aureus to domestic kitchen surfaces.  
Ciencia e Tecnologia de Alimentos. 
120. Silva, E. 2010. Respiration and Ethylene and their Relationship to Postharvest Handling in 
Wholesale Success: a Farmer's Guide to Selling, Postharvest Handling, and Packing 
produce (Midwest edition) in Family Farmed. http://www.familyfarmed.org/wp-
content/uploads/2010/07/WSmanual-12pgpreview.pdf 
121. Sivapalasingam, S., C. R. Friedman, L.  Cohen, and R. V. Tauxe. 2004. Fresh Produce: A 
Growing Cause of Outbreaks of Foodborne Illness in the United States, 1973 through 
1997,  Journal of Food Protection, 67 (10):23422353. 
122. Sivaramalingam, T., D. L.  Pearl, S. A. McEwen, D. Ojkic, and M. T.  Guerin. 2013. A 
temporal study of Salmonella serovars from fluff samples from poultry breeder hatcheries 
in Ontario between 1998 and 2008,  Canadian Journal of Veterinary Research, 77 
(1):1223. 
123. Skinner, G. E., and J. W. Larkin. 1998. Conservative Prediction of Time to Clostridium 
botulinum Toxin Formation for Use with Time-Temperature Indicators To Ensure the 
Safety of Foods,  Journal of Food Protection 61 (9 ):1154-1160. 
124. Soares, V. M., J. G. Pereira, C. Viana, T. B. Izidoro, S. Bersot Ldos, and J. P. Pinto. 2012. 
Transfer of Salmonella Enteritidis to four types of surfaces after cleaning procedures 
and cross-contamination to tomatoes,  Food Microbiology 30 (2):453-6. doi: 
10.1016/j.fm.2011.12.028. 
125. Stanfield, P. 2002. Chapter 10-Cleaning and Sanitizing a Food Plant In Food Plant 
Sanitation, 101-114. New York, New York. Marcel Dekker, Inc. 
126. Stanga, M.. 2010. Sanitation: Cleaning and Disinfection in the Food Industry. Italy. 
Wiley-VCH. 
127. Sugiyama, H., and K.H. Yang. 1975. Growth Potential of Clostridium botulinum in Fresh 
Mushrooms Packaged in Semipermeable Plastic Film,  Applied Microbiology 30 
(6):964-969. 
128. Tang, J. Y., M. Nishibuchi, Y. Nakaguchi, F. M. Ghazali, A. A. Saleha, and R. Son. 2011. 
Transfer of Campylobacter jejuni from raw to cooked chicken via wood and plastic 
cutting boards,  Letters in Applied Microbiology 52 (6):581-8. doi: 10.1111/j.1472-
765X.2011.03039.x. 
129. Taylor, D. J., and A. W. Philbey. 2010. Salmonella infections in garden birds and cats in a 
domestic environment,  Veterinary Record 167 (1):26-7. doi: 10.1136/vr.c3156. 
130. Tebbutt, G. M. 2010. Comparison of traditional and rapid methods for assessing the risk of 
bacterial cross-contamination from cutting boards,  International Journal of 
Environmental Health Research 9:67-74. 
131. Todd, E. C. D., J. D. Greig, C. A. Bartleson, and B.S. Michaels. 2008. Outbreaks Where 
Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 4. 
Infective Doses and Pathogen Carriage,  Journal of Food Protection, 71 (11):2339
2373. 
132. Todd, E.C.D., B.S. Michaels, D. Smith, J.D. Greig, and C.A. Bartleson. 2010. Outbreaks 
Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 9. 
Washing and Drying of Hands to Reduce Microbial Contamination,  Journal of Food 
Protection 73 (10):1937-1955. 
150  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
133. Todd, E.C.D., M. S. Barry, J. D. Greig, D. Smith, and C. A. Bartleson. 2010. Outbreaks 
where food workers have been implicated in the spread of foodborne disease. Part 8. 
Gloves as barriers to prevent contamination of food by workers,  Journal of Food 
Protection 73 ( 9 ):1762-1773. 
134. 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. 
135. UAP. Food manufacturing, processing and storage pest control. University of Arkansas 
publication AG1157. Edited by John D. Hopkins. 
136. Watson, A. J., D. Treadwell, A. S. Sargent, K. J. Brecht, and W. Pelletier. 2015. 
Postharvest Storage, Packaging and Handling of Specialty Crops: A Guide for Florida 
Small Farm Producers.  IFAS Extension University of Florida. 
137. Weil, J. D., C. N. Cutter, R. B. Beelman, and L. F. LaBorde. 2013. Inactivation of human 
pathogens during phase II composting of manure-based mushroom growth substrate,  
Journal of Food Protection 76 (8):1393-400. doi: 10.4315/0362-028X.JFP-12-508. 
138. Wheeler, C., T. M. Vogt , G. L. Armstrong, G. Vaughan, A. Weltman, O. V. Nainan, 
V.Dato, G. Xia, K. Waller, J. Amon, T. M. Lee, A. Highbaugh-Battle, C. Hembree, S. 
Evenson, M. A. Ruta, I. T. Williams, A. E. Fiore, and B. P. Bell. 2005. An Outbreak of 
Hepatitis A Associated with Green Onions,  New England Journal of Medicine 353 
(9):890-897. doi: 10.1056/NEJMoa050855. 
139. Whipp, S.C. 1994. Animals as a source of Escherichia coli pathogenic for human-beings.  
Journal of the American Veterinary Medical Association 204 (8):1168-1175. 
140. WHO. 2006. World Health Organization, & United Nations Environmental Programs. 
WHO Guidelines for the Safe Use of Wastewater, Excreta and Greywater,  Geneva, 
Switzerland. WHO Press. 
141. Yan, T., and M. J. Sadowsky. 2007. Determining Sources of Fecal Bacteria in 
Waterways,  Environ Monit Assess 129 (1-3):97-106. doi: 10.1007/s10661-006-9426-z. 
142. Yildirim, I., M. Ceyhan, A. B. Cengiz, A. Bagdat, C. Barin, T. Kutluk, and D. Gur. 2008. 
A Prospective Comparative Study of the Relationship between Different Types of Ring 
and Microbial Hand Colonization among Pediatric Intensive Care Unit Nurses,  
International Journal of Nursing Studies 45 (11):1572-6. doi: 
10.1016/j.ijnurstu.2008.02.010. 
143. Zhao, T., M. P. Doyle, J. Shere, and L. Garber. 1995. Prevalence of enterohemorrhagic 
Escherichia coli O157:H7 in a survey of dairy herds,  Applied and Environmental 
Microbiology 61 (4):1290-1293. 
 
151