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Program Manual

Harmonized GAP Audit Program

Policies and Procedures

July 2022
“SCI moving forward in the 21st Century using technology, innovation, and old-fashioned hard 

work” 

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Program Manual: Harmonized GAP Audit Program

Table of Contents

INTRODUCTION .......................................................................................................................... 1

GUIDE FOR ELECTRONIC USAGE........................................................................................... 1

BACKGROUND ............................................................................................................................ 2

History of the Produce GAPs Harmonized Initiative and Standards.............................................. 2

Governance of the Harmonized Standard....................................................................................... 3

USDA Produce GAPs Harmonized Audits..................................................................................... 3

AUDITOR INSTRUCTIONS......................................................................................................... 4

Additional Guidance for Conducting Audits.................................................................................. 4

Standards......................................................................................................................................... 4

Checklists........................................................................................................................................ 5

Auditee Information Section........................................................................................................... 5

Audit Information ........................................................................................................................... 7

A. Date and Time of the Audit............................................................................................ 7

B. Description of Operation................................................................................................ 8

C. Harvest Company Name (if applicable)......................................................................... 9

D. Other Contractors........................................................................................................... 9

E. Commodities Covered by Audit..................................................................................... 9

F. Commodities Produced During Audit............................................................................ 9

G. Total Acres Covered by Audit........................................................................................ 9

H. Total Square Feet Covered by Audit.............................................................................. 9

Auditor Information...................................................................................................................... 10

A. Field Office................................................................................................................... 10

B. Auditor Name(s)........................................................................................................... 10

C. Auditor Signature(s)..................................................................................................... 10

Audit Scope................................................................................................................................... 10

Other Information ......................................................................................................................... 10

A. Person(s) Interviewed................................................................................................... 10

B. Audit Requested By...................................................................................................... 11

C. Distribute Audit Report To* (if known)....................................................................... 11

Additional Comments................................................................................................................... 11

Internal Use Only.......................................................................................................................... 11

A. Reviewing Official Name............................................................................................. 12

B. Signature....................................................................................................................... 12

C. Date .............................................................................................................................. 12

D. Audit Results Meets USDA Acceptance Criteria......................................................... 12

Auditor Completion Instructions.................................................................................................. 12

A. Assessment Terms........................................................................................................ 12

B. Auditor Comments....................................................................................................... 13

C. Tallying the Audit ........................................................................................................ 13

D. Corrective Action Reports............................................................................................ 13

E. Submittal of the Audit Report for Review ................................................................... 13

Documents Required..................................................................................................................... 13

A. Policies and Procedures (WP)...................................................................................... 14

B. Record (R).................................................................................................................... 14
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C. Risk Assessment (A) .................................................................................................... 14

Auditee Information...................................................................................................................... 14

Audit Summary............................................................................................................................. 14

GENERAL GUIDANCE FOR ASSESSING REQUIREMENTS............................................... 15

Risk Assessments.......................................................................................................................... 15

Prevailing and Applicable Regulations......................................................................................... 15

Crop-Specific Guidance Expectations.......................................................................................... 16

Questionable Observations ........................................................................................................... 16

PROGRAM EXPECTATIONS.................................................................................................... 17

USDA Acceptance Criteria for the Produce GAPs Harmonized Food Safety Standard Audit.... 17

Meeting or Not Meeting Criteria .................................................................................................. 17

USDA ACCEPTANCE CRITERIA FOR THE HARMONIZED GAP PLUS+ AUDIT............ 18

Meeting or Not Meeting Criteria .................................................................................................. 18

GENERAL QUESTIONS............................................................................................................. 19

G-1 Management Responsibility .............................................................................................. 19

G-2 Food Safety Plan................................................................................................................ 23

G-3 Documentation and Recordkeeping................................................................................... 30

G-4 Worker Education and Training ........................................................................................ 35

G-5 Microbiological Sampling and Testing ............................................................................. 39

G-6 Traceability........................................................................................................................ 45

G-7 Recall Program .................................................................................................................. 50

G-8 Corrective Actions and Food Safety Incidents.................................................................. 53

G-9 Self-Audits......................................................................................................................... 57

G-10 Worker Health and Hygiene, and Toilet/Handwashing Facilities................................... 58

G-11 Waste Management ......................................................................................................... 88

G-12 Food Defense................................................................................................................... 90

G-13 Food Fraud....................................................................................................................... 94

FIELD OPERATIONS AND HARVESTING............................................................................. 98

Field Production............................................................................................................................ 98

F-1 Field History and Assessment............................................................................................ 98

F-2 Agricultural Chemicals/Plant Protection Products........................................................... 103

F-3 Water System Description................................................................................................ 117

F-4 Water System Risk Assessment ....................................................................................... 119

F-5 Water Management Plan .................................................................................................. 122

F-6 Animal Control................................................................................................................. 128

F-7 Soil Amendments............................................................................................................. 133

F-8 Vehicles, Equipment, Tools and Utensils ........................................................................ 139

Harvesting................................................................................................................................... 151

F-9 Preharvest Assessment ..................................................................................................... 151

F-10 Water/Ice Used in the Harvesting and Post-harvest Operations.................................... 153

F-11 Containers, Bins and Packaging Materials..................................................................... 160

F-12 Field Packaging Materials.............................................................................................. 164

F-13 Post-harvest Handling and Storage (Field Prior to Storage or Packinghouse) .............. 172

F-14 Equipment Sanitation & Maintenance ........................................................................... 175

POST-HARVEST OPERATIONS............................................................................................. 178

P-1 Product Sourcing.............................................................................................................. 178

P-2 Agricultural Chemicals .................................................................................................... 179
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P-3 Facility.............................................................................................................................. 182

P-4 Pest and Animal Control .................................................................................................. 191

P-5 Equipment, Tools and Utensils ........................................................................................ 195

P-6 Maintenance and Sanitation ............................................................................................. 201

P-7 Post-Harvest Water/Ice .................................................................................................... 218

P-8 Containers, Bins and Packaging....................................................................................... 230

P-9 Storage.............................................................................................................................. 239

P-10 Transportation (Packinghouse to Customer).................................................................. 249

USDA LOGO USE..................................................................................................................... 254

L-1 Food Safety Plan or Quality Manual................................................................................ 254

L-2 Traceability and Recall Program...................................................................................... 255

L-3 Approved Suppliers.......................................................................................................... 255

L-4 GAP & GHP Logo Approved Use................................................................................... 256

TOMATO AUDIT PROTOCOL................................................................................................ 258

OPEN-FIELD PRODUCTION AND HARVESTING .............................................................. 258

TOF-1 Management Responsibility........................................................................................ 258

TOF-2 Self-Audits.................................................................................................................. 259

TOF- 3 Field History and Pre-harvest Assessments............................................................... 260

TOF- 4 Workers Health/Hygiene and Toilet/Handwashing Facilities ................................... 263

TOF- 5 Pesticides.................................................................................................................... 268

TOF- 6 Water Used in Growing Activities............................................................................. 270

TOF- 7 Soil Amendments....................................................................................................... 272

TOF- 8 Sanitizing Agents Used During Harvest.................................................................... 274

TOF- 9 Product Containers..................................................................................................... 275

TOF-10 Field Packing of Tomatoes ....................................................................................... 279

PACKINGHOUSE ..................................................................................................................... 280

TPH-1 Management Responsibility........................................................................................ 280

TPH-2 Raw Material Sourcing ............................................................................................... 282

TPH-3 Traceability ................................................................................................................. 284

TPH-4 Self-Audits.................................................................................................................. 285

TPH-5 Product Containers and Packaging Materials............................................................. 286

TPH-6 Packinghouse Condition and Equipment.................................................................... 290

TPH-7 Worker Health/Hygiene and Toilet/Handwashing Facilities...................................... 295

TPH-8 Product Wash Water Management ............................................................................. 297

TPH-9 Quarantine or On-hold Materials................................................................................ 304

TPH-10 Tomato Rerunning Processes.................................................................................... 305

TPH-11 Food Defense Awareness.......................................................................................... 306

GREENHOUSE.......................................................................................................................... 307

TGH-1 Management Responsibility....................................................................................... 307

TGH-2 Recordkeeping and Traceability................................................................................. 308

A. Greenhouse Packing................................................................................................... 308

B. Packinghouse Packed Greenhouse Tomatoes ............................................................ 309

TGH-3 Self-Audit................................................................................................................... 311

TGH-4: Greenhouse............................................................................................................... 312

TGH-5 Worker Health/Hygiene and Toilet/Handwashing Facilities..................................... 314

TGH-6 Pesticides.................................................................................................................... 316

TGH-7 Water Used in Growing Activities............................................................................. 317
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TGH-8 Soil and Soil Amendments......................................................................................... 320

TGH-9 Sanitizing Agents Used During Harvest .................................................................... 323

TGH-10 Product Wash Water Management........................................................................... 326

TGH-11 Product Containers and Packaging Materials........................................................... 328

REPACKING AND DISTRIBUTION....................................................................................... 331

TPD-1 Management Responsibility........................................................................................ 331

TPD-2 Raw Material Sourcing ............................................................................................... 332

TPD-3 Traceability ................................................................................................................. 335

TPD-4 Self-Audits.................................................................................................................. 338

TPD-5 Product Containers and Packaging Materials............................................................. 339

A. Bins, Gondolas, Totes ................................................................................................ 339

B. Primary Packing Boxes.............................................................................................. 340

TPD-6 Packinghouse Condition and Equipment.................................................................... 343

A. General Building ........................................................................................................ 343

B. Facility and Equipment .............................................................................................. 344

TPD-7 Worker Health/Hygiene and Toilet/Handwashing Facilities...................................... 345

TPD-8 Product Wash Water Management ............................................................................. 345

TPD-9 Quarantine or On-hold Materials................................................................................ 348

TPD-10 Food Defense Awareness.......................................................................................... 348

GLOSSARY ............................................................................................................................... 350

REFERENCE LINKS................................................................................................................. 353

APPENDIX I – PRODUCE SAFETY RULE (PSR) ................................................................. 354

Subpart A: General Provisions ............................................................................................... 354

Subpart B: General Requirements .......................................................................................... 363

Subpart C: Personnel Qualifications and Training ................................................................. 363

Subpart D: Health and Hygiene .............................................................................................. 364

Subpart E: Agricultural Water................................................................................................ 366

Subpart F--Biological Soil Amendments of Animal Origin and Human Waste .................... 372

Subpart G--[Reserved]............................................................................................................ 376

Subpart H--[Reserved]............................................................................................................ 376

Subpart I--Domesticated and Wild Animals........................................................................... 376

Subpart J--[Reserved] ............................................................................................................. 376

Subpart K--Growing, Harvesting, Packing, and Holding Activities ...................................... 377

Subpart M--Sprouts................................................................................................................. 382

Subpart N--Analytical Methods.............................................................................................. 386

Subpart O--Records ................................................................................................................ 387

Subpart P--Variances.............................................................................................................. 389

Subpart Q--Compliance and Enforcement.............................................................................. 392

Subpart R--Withdrawal of Qualified Exemption.................................................................... 393

APPENDIX II – REQUIRED RECORDS FOR THE PRODUCE SAFETY RULE................. 399

APPENDIX III: DEPARTMENT OF LABOR- TITLE 29........................................................ 401

29 CFR 1910 - Occupational Safety and Health Standards........................................................ 401

1910 Subpart J – General Environmental Controls................................................................ 401

1910 Subpart K – Medical and First Aid................................................................................ 407

29 CFR 1928 Occupational Safety and Health Standards for Agriculture ................................. 408

1928 Subpart I – General Environmental Controls ................................................................ 408

APPENDIX IV: FDA & INDUSTRY GUIDANCE DOCUMENTS ........................................ 412
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FDA Guidance Documents..................................................................................................... 412

FDA Draft Guidance Documents ........................................................................................... 412

Industry Guidance in Collaboration with FDA....................................................................... 412

APPENDIX V: REQUIRED COMMENTS FOR AUDIT REPORTS ...................................... 413

APPENDIX VI: REFERENCES USED FOR MANUAL DEVELOPMENT........................... 419

APPENDIX VII: SUMMARY OF REFERENCE LINKS IN PROGRAM MANUAL............ 421
SCI Division Inspection Series Program Manual: Harmonized GAP Audit Program 

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INTRODUCTION

This manual is designed to help auditors interpret and apply the U.S. Department of Agriculture’s 

(USDA) Harmonized Good Agricultural Practices (GAP) and USDA Harmonized GAP Plus+ Audit 

standards and checklists. These instructions are in accordance with official Specialty Crops 

Inspection (SCI) Division policy. Please contact your immediate supervisor for any information not 

addressed in this manual. Additional auditor instructions are in the SCI Division Auditor Manual – 

General Requirements (In-Development). 

This manual contains links to various internal and external sources of information. Personnel 

without Internet or intranet access should contact their immediate supervisor for hard copies of 

documents as needed. 

SCI Division will review and maintain this manual to reflect current GAPs. Submit any 

recommended changes via email to the SCI Division’s Audit Services Branch at 

SCAudits@usda.gov. All updates will be shared with SCI Division auditors via the AIM update 

notification process. This publication supersedes previously issued auditing policies and 

instructions for the Produce GAPs Harmonized Food Safety Standards. 

GUIDE FOR ELECTRONIC USAGE 

The AIM system of instructional manuals is available electronically in Adobe Acrobat Portable 

Document Format (PDF) at the following intranet address: 

https://usdagcc.sharepoint.com/sites/ams/AMS-SCI/SitePages/Home.aspx. 

When accessed electronically, AIM materials have hyperlinks and hypertext (visible as underlined 

blue text) available to the PDF user. Clicking on a hyperlink takes the reader to a web site with 

information relating to the subject. Hypertext links the reader to a different page within the current 

manual, or a different manual, with information relating to the subject. For example, the hypertext 

in the Table of Contents allows a reader to go directly to the section of interest in the manual by 

clicking on the section title. 

PDF offers a variety of tools depending on the Adobe version the reader has. The newer the 

version, the more tools available. PDF documents are easily searchable for content within a 

document or within multiple documents. To learn about the variety of PDF search options: 

• Click on the “Help” tab on the top of any page in Adobe Acrobat, 

• Then click on the “Adobe Acrobat Help” bar, 

• Type the word “Search” in the “Search” box, and click on the “Search” button, 

• A series of options will become available, 

• Click on the “Access Search Features” link and follow the instructions for the type of search 

you are interested in.
SCI Division Inspection Series Program Manual: Harmonized GAP Audit Program 

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BACKGROUND

History of the Produce GAPs Harmonized Initiative and Standards

In 2009, the Produce GAPs Harmonization Initiative (GHI) was founded to create “one audit by any 

credible third party, acceptable to all buyers.” This initiative was led by a Steering Committee 

comprised of representatives of more than 30 major fresh produce buying companies, growers, and 

produce trade associations. The Initiative was designed to reduce the audit burden on the fruit and 

vegetable industry by developing “harmonized standards” acceptable to all parties that could be 

used to verify food safety practices for farm, harvest, packinghouse and storage/transportation 

operations for fresh produce. 

The Harmonized Standards were developed by a Technical Working Group (TWG) comprised of 

more than 150 volunteer technical experts in the areas of food safety, growing, and handling 

practices for a wide variety of crops and growing regions. The GHI TWG first compared the 13 

most commonly accepted fresh produce food safety standards: the California Leafy Greens 

Marketing Agreement (LGMA), Mushroom GAPs, SENASICA (Mexico’s agriculture ministry), 

Silliker, USDA, Tomato Food Safety Audit Protocol, Community Alliance with Family Farmers, 

California Strawberry Commission, the Association of Food and Drug Officials (AFDO) Model 

Code, AIB International, CanadaGAP, GlobalGAP, and Safe Quality Food (SQF) 1000. The 

comparison identified commonalities and select wording from each standard that best suited a 

common standard that would meet food safety needs. The TWG developed the Field Operations 

and Harvesting Harmonized Food Safety standard for all field operations and greenhouses, and the 

Post-harvest Harmonized Food Safety standard for growing operations with packing facilities 

onsite. The draft standards were tested by “pilot audits,” refined, and then finalized for use by audit 

organizations. 

The Harmonized Standards are based on the U.S. Food and Drug Administration’s (FDA) Guide to 

Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables. Neither the FDA guide 

nor the Produce GAPs Harmonized Audit Program apply to products that are processed. FDA 

considers raw produce that is peeled, cut, and/or chopped to be a processed food that is covered by 

FDA’s Current Good Manufacturing Practices (CGMP). Similarly, this audit program may not be 

used for processed produce, processed fruit and vegetable products (e.g., canned, dried, or frozen) 

or for other commodities regulated by FDA such as milk, dairy products, and shell eggs, which also 

are covered by FDA CGMP. Meat, poultry, and processed egg products are regulated by USDA’s 

Food Safety and Inspection Service (FSIS). The Agricultural Marketing Service (AMS) has no 

authority to assess conditions for these products. 

Specifically, the standards were designed to: 

• Achieve global recognition while being specifically applicable to North American 

operations, 

• Include requirements that:

o Are clearly defined,
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o Consider all microbiological, chemical, and physical hazards reasonably likely to 

occur.

o Are risk-based, science-based, attainable, auditable, and verifiable,

o Recognize and account for regional and crop-specific food safety needs, and 

o Are acceptable to most customers who require general produce food safety practices.

• Be scalable to fresh produce operations of all sizes,

• Be sufficiently non-prescriptive to allow for equivalent food safety practices,

• Be freely available for nonproprietary use by any producer, buyer, or auditor, and

• Be adaptable as science reveals better practices and limits.

Governance of the Harmonized Standard

The Harmonized Standards are “owned” by the fruit and vegetable industry through their 

participation on the GHI TWG. The GHI TWG is and will remain a volunteer organization of fresh 

produce stakeholders with open membership. The International Fresh Produce Association 

(International Fresh) serves as the secretariat and custodian of the standards for the benefit of the 

industry. The secretariat is responsible for maintaining standards policies, coordinating among 

support committees, communicating through the website, and serving as the point of contact for 

questions.

USDA, as a Harmonized Standard licensee, is required to use the International Fresh technical 

standard verbatim, with no changes in wording permitted. Licensees may include additional items 

in the audit, provided that those items are clearly marked, but they may not delete audit items. 

Requests to change the standards or the wording of the standards must be presented to the GHI 

TWG to undergo the established revision process.

The GHI TWG’s Calibration Committee is a subset group that provides real time responses to any 

questions about the standards and the development of official training materials.

USDA Produce GAPs Harmonized Audits

USDA has actively participated in the Harmonization Initiative since its inception, serving on both 

the GHI TWG and the Calibration Committee. In 2010, in response to a request from industry, 

USDA became actively involved in conducting a pilot program to audit to the Produce GAPs 

Harmonized Food Safety Standards. In 2011, USDA was one of the first organizations to provide 

Produce GAPs Harmonized Food Safety Standards audit services. In 2018, USDA aligned the 

Harmonized GAP audit services with the requirements of the FDA FSMA Produce Safety Rule. 
SCI Division Inspection Series Program Manual: Harmonized GAP Audit Program 

Effective Date: July 2022 Page 4 of 422

Additionally, in 2018, the USDA Harmonized GAP Plus+ Audit was created and was formally 

recognized for Technical Equivalence by the Global Food Safety Initiative (GFSI). In 2021, the 

Harmonized GAP Audit Services were updated to include addenda for the Tomato Audit Protocol. 

USDA Produce GAPs Harmonized audit services are provided to assess a company’s efforts to 

implement a food safety management system that uses a risk-based approach to minimize microbial 

contamination of fresh fruit, vegetables, and nuts. Audits are not a guarantee that covered products 

are free from microbial contamination; they indicate the operation has implemented and is 

following generally accepted food safety practices. 

USDA Produce GAPs Harmonized audit services are conducted by Federal or Federal-State 

licensed auditors. Audits occur on a scheduled basis at least once each year, with unannounced 

audits conducted according to instructions. 

AUDITOR INSTRUCTIONS

Additional Guidance for Conducting Audits

The SCI Division Auditor Manual – General Requirements (In Development) contains general 

instructions for conducting an audit or providing audit services. Additional guidance for procedures 

specific to conducting any of the USDA GAP or GHP audits is in current SCI Division AIM 

documents, including Instructions for the Corrective Action Process, and FPB 703 Fresh Products 

Branch Good Agricultural Practices and Good Handling Practices (GAP&GHP) Audit Appeals, 

Complaints and Dispute Process. This manual provides instructions that are specific to conducting 

Produce GAPs Harmonized Food Safety Standard audits. 

Standards

The GAP Harmonization Initiative provides audit standards for Field Operations and Harvesting as 

well as Post-harvest Operations. International Fresh also offers a combined standard. The official 

versions of these standards are posted on the International Fresh Produce GAPs Harmonization 

Initiative website at https://www.freshproduce.com/resources/food-safety/produce-gapsharmonized-audit-standard/ 

USDA incorporates the GAP Harmonization Initiative standards into the USDA Harmonized GAP 

and USDA Harmonized GAP Plus+ Audit programs standards (USDA Harmonized Standards). 

In addition to the requirements and their corresponding procedures, verifications, and corrective 

actions found in the GAP Harmonization Initiative standards, USDA has a designated 

documentation and mandatory question column in the USDA Harmonized Standards. Both USDA 

standards also include a Logo Use addendum and Tomato Audit Protocol addenda. The USDA 

Harmonized GAP Plus+ Audit Standard includes additional requirements to address the GFSI 

Technical Equivalence requirements.

In the USDA Harmonized Standards, the procedures provide guidance to the auditees on the 

components that should comprise their operation’s procedures. Each verification outlines what the 
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Effective Date: July 2022 Page 5 of 422

auditor should verify during the audit. When deficiencies are identified, the corrective action 

details the action that may be necessary. 

Checklists

There are two USDA checklists for the Harmonized GAP Audit Program: the USDA Harmonized 

GAP Audit checklist and the USDA Harmonized GAP Plus+ Audit checklist. The official copies of 

the USDA checklists are posted on the USDA Harmonized GAP Audit Program website at 

https://www.ams.usda.gov/services/auditing/gap-ghp/harmonized. Before conducting an audit, 

auditors must check the website to ensure that they have the latest version of the checklist(s).

Each checklist includes sections on Auditee Information, Audit Information, Auditor Information, 

Audit Scope, Other Information, Additional Comments, Internal Use Only, Auditor Completion 

Instructions, Auditee Information, USDA Acceptance Criteria, the Audit Summary, the body of the 

checklist for each standard, Duplication of Corrective Action Tab Instructions, and the Corrective 

Action Report. Instructions on how to use each section and guidance for auditors is included in 

subsequent sections of this manual.

Auditee Information Section

Provide the following information about each auditee in the Auditee Information section of each 

checklist.

A. Company Name 

Enter the legal business name the auditee wants listed on the USDA website, certificates, 

and any correspondence. The auditor must verify this information each year with the 

auditee. If the company does business under multiple names, you may include multiple 

names in this section. You also may use hyphenated names or names listed with a Doing 

Business As (DBA) designation. 

B. Audited Location Address 

Enter the physical location(s) at which the onsite audit takes place. If multiple sites are 

covered by the audit, record this information in the Additional Comments section of the 

checklist.

1. Global Positioning System (GPS) (Optional)

List the GPS coordinates of the physical audit location(s) if they are available or 

provided by the company. This section is optional, so if GPS coordinates cannot be 

determined, mark N/A. Use the Additional Comments section of the checklist if 

there is more information than will fit in the space provided.

2. Street
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List the physical street location of the audit site.

3. City, State, Zip

List the city, state, and zip code of the physical location being audited.

4. Multiple sites covered by this audit?

Check the Yes or No checkbox to designate if more than one site is covered by this 

audit. Use the Additional Comments section of the audit checklist to provide the 

further details of each audit site that will not fit in the Audited Location Address 

fields. List each site as designated by the auditee. For example, an auditee may 

designate a site by acreage blocks, site names, or crop production areas. An auditor 

may include a copy of a farm map or a list of audit sites provided by the auditee as 

long as the map or list is referenced in the audit report.

C. Mailing/Business Address

Use this section to list the mailing/business address for the company being audited. The 

auditor should verify this information with the auditee at each onsite audit.

1. Same as above

Check this box if the mailing address is the same as the audited location address 

listed above.

2. Street

List the mailing/business street address of the audit site.

3. City, State, Zip

List the city, state, and zip code of the mailing/business location being audited.

D. Federal Account Number

Must be established prior to scheduling the audit.

E. Company Contact

List the person the auditee designates as their main point of contact for the audit. This 

person may or may not be the company’s food safety manager.

F. Contact Title

List the job title of the person listed in the Company Contact section.
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G. Phone Number 

List the phone number of the person listed in the Company Contact section. If both office 

and cell phone numbers are given, list both phone numbers designating the type of phone for 

each number (cell or office).

H. Fax Number 

List the fax number of the person listed in the Company Contact section. 

I. E-Mail Address

List the e-mail address of the individual listed as the company contact. If additional e-mail 

addresses are provided, list them on this line as space permits or in the Additional 

Comments section. Be sure to include the name of the person associated with each e-mail 

address recorded.

J. Company uses USDA GAP&GHP Logo on packing or marketing materials? 

Select the Yes or No box to designate whether the company uses the USDA GAP&GHP 

logo on packing or marketing materials. If yes is selected, complete the USDA Logo Use 

Addendum of the audit checklist. A company must meet eligibility requirements and 

receive permission from the SCI Division in order to use the logo and complete a SC-652 

request for Logo Use Form. 

K. Is this company currently subject to the Produce Safety Rule (21 CFR Part 112)? 

Select the Yes or No box to designate whether the company is currently subject to the 

Produce Safety Rule (PSR). It is up to the operation to determine if they are subject to the 

Produce Safety Rule. If the auditee is subject to the Produce Safety Rule, the auditor will 

verify implementation of the PSR requirements when assessing compliance with the 

standard when applicable. 

Audit Information

Fill out the Audit Information section of the checklist to specify the following information about the 

audit. If additional space is needed, use the Additional Comments space on the audit report. 

A. Date and Time of the Audit 

Provide information that describes the onsite audit being conducted. Describe any offsite 

desk reviews of the company’s food safety plan or other paperwork performed in the 

Additional Comments section of the audit report. If the audit is stopped on the initial date 

and then restarted on a later date, then the auditor is required to document a reason. 
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Example scenario: An audit was conducted for two small neighboring farms. Both farms 

are managed under similar food safety plans by the same food safety 

manager. To streamline the audit process for both companies, the 

food safety manager asks the owners of each company to have the 

opening meeting, closing meeting and paperwork review conducted 

by the auditor at the same time. 

In this scenario, the Date and Time of the Audit section would be identical on the two 

reports. A comment explaining why the audit reports show the auditor at two places at the 

same time will clarify the situation.

Example comment: “This audit was conducted simultaneously with the neighboring farm. 

Both operations are managed by <<food safety manager name>>. 

The food safety manager asked, and both companies consented, to 

have the opening meeting, closing meeting, and paperwork review 

conducted together. The onsite audit for <<name of operation being 

audited>> was conducted between <<times>>.”

1. Beginning 

Date: List the date that onsite audit activities started (mm/dd/yyyy). If the audit is 

split into two different components, e.g., an initial visit for the farm and secondary 

visit for the harvest at a later date, list the date range of the initial visit.

Time: List the beginning time of onsite audit activities using standard time format. 

If an entire initial visit is recorded as in the example above, list the start and end time 

for that initial visit.

2. Ending 

Date: List the date the onsite audit activities concluded (mm/dd/yyyy). If the audit 

is split into two different components, e.g., initial visit for the farm and secondary 

visit for harvest at a later date, then the date range for the secondary visit may be 

listed here.

Time: List the concluding time of onsite audit activities. If an entire secondary visit 

is recorded as in the example above, list the start and end time for the secondary 

visit.

B. Description of Operation

List any information that further describes the operation being audited in this section. For 

example, “Operation is a 40-acre tomato farm in a suburban area surrounded primarily by 

housing developments. Operation primarily grows heirloom tomatoes for roadside market 

activities, and supplies product to several local restaurants.”
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C. Harvest Company Name (if applicable)

List the name of the harvest company if a separate contracted company is used to harvest the 

crop. If no outside harvest company is used, mark N/A. 

D. Other Contractors 

List any contractors used by the operation. This might include; portable toilet maintenance 

companies, pesticide applicators, or cooling unit maintenance companies. If no contractors 

are used, mark N/A. 

E. Commodities Covered by Audit 

It is not a requirement to perform a separate audit for every separate commodity grown on 

the farm, however operations may choose to do so if they so desire. USDA AMS policy 

allows diversified farming operations to cover all the commodities grown on the farm under 

the same audit subject to the following conditions: 

• All commodities covered by the audit must be declared during the initial audit and a 

list of the commodities submitted. The Food Safety Plan must address the various 

risks associated with all the commodities being audited. For instance, if a berry 

grower hand picks strawberries but mechanically harvests blueberries, the Food 

Safety Plan must address the potential risks and corrective actions associated with 

each of these activities.

• The auditor must have the opportunity to observe the crop(s) being grown and/or 

harvested during the initial audit or subsequent, unannounced verification visits.

F. Commodities Produced During Audit 

List all crops that are covered by the audit and are in operation at the time of the audit. A 

farm is considered “in operation” when fruits or vegetables are being grown, handled or 

harvested and activities such as thinning fruit, picking, harvesting, or field packing occur. It 

does not include activities such as pruning which occur when the fruits or vegetables are 

dormant or ground preparation such as plowing, discing or planting. A facility is “in 

operation” when any fruit or vegetable handling activity occurs such as sorting, packing, 

repacking, storing or transporting. 

G. Total Acres Covered by Audit 

List the total acres of the production area covered in the scope of the audit for the field 

locations. 

H. Total Square Feet Covered by Audit 
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List the total square footage of the packinghouse and the storage facilities covered in the 

scope of the audit. 

Auditor Information

Use this section to list information for all auditors and auditors-in-training who served on the audit 

team.

A. Field Office

List the name of the field office of the lead auditor.

B. Auditor Name(s)

List the full name of all auditors, auditors-in-training, evaluators, and observers who served 

on the audit team. The audit report shall clearly indicate the roles of all participants on an

audit, with the name of the lead auditor listed first. This applies for both an auditor or an 

auditor-in-training whose role is the lead auditor. When a lead auditor is an auditor-intraining, there must be a SCI Division auditor or evaluator listed as well. The role of 

everyone who was in attendance must be either listed in parenthesis following the name of 

the individual or in the list of the audit team.

Example 1: John Smith (AIT), John Q. Auditor (Evaluator) 

Example 2: Mary Smith (AIT), John Q. Auditor (Evaluator), Sam Stevens (Observer)

Example 3: Mary Smith, John Q. Auditor (Evaluator)

C. Auditor Signature(s)

“Signature on File” should be typed into the electronically submitted Excel workbook. The 

lead auditor is responsible for obtaining the signature of each member of the audit team and 

keeping the signed copy on file with the audit report in the local audit office. The lead 

auditor’s signature should appear first on the file copy. 

Audit Scope

Check all the boxes of the corresponding audit scope that pertains to the audit. For further 

instruction, refer to the GAP Audit Program Scope 

https://www.ams.usda.gov/sites/default/files/media/GAPProgramScope.pdf. 

Other Information

This section of the audit report contains the following pertinent audit information. 

A. Person(s) Interviewed
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Interviewing an appropriate number of people is necessary for the integrity of the audit. The 

number of people interviewed should be proportional to the size and scope of the operation. 

Record the first and last name of each person interviewed. 

Most workers use their legal names on official documents, while others may use a 

“nickname”. To ensure accuracy with the audit notes, comments, and operation’s records, 

the auditor must use the name the employee uses on all operational paperwork. This is 

critical in allowing the auditor to make additional accurate verification of other documents 

during the audit (such as training records).

There are many ways to obtain and verify the correct spelling of an employee’s name. An 

auditor may review the employee’s company identification or obtain the full name with 

correct spelling by reviewing worker’s training sign-in logs. The title of the employee does 

not need to be listed. 

B. Audit Requested By 

List the name of person requesting the audit report. This may or may not be the same as the 

company contact for the audit. For example, a buyer who is financially responsible for the 

audit may request the audit for one of its suppliers who is listed as the company contact.

C. Distribute Audit Report To* (if known)

List additional distribution instructions for the audit report, if any. Only upon written 

request from the auditee to the auditor can the audit report be distributed to another person, 

company, or entity. The request must specify that the report can be released to the third 

party. 

*It is not mandatory to supply the names of retail and food service buyers, but it is useful to 

know that information in the event the auditee asks USDA, in writing, to send a copy of the 

audit report directly to the buyer(s).

Additional Comments

An audit is a snapshot in time of the company being audited. While the checklist fields are 

designed to record as much information as possible about the audit, there often will be additional 

comments that will be very useful to anyone reading the audit report describing observations or 

circumstances of the audit. Use the Additional Comments section to record any information about 

the audit that does not have another designated place on the audit report, or for information that 

does not fit in the space the report allows for a given section. 

Internal Use Only

This section is for use of the Audit Services Branch only. 
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A. Reviewing Official Name

Show the name of the reviewing official who reviewed the audit report. 

B. Signature 

Place the signature of the reviewing official in this section. Electronic signatures may be 

used. 

C. Date

List the date the audit report is signed by the reviewing official.

D. Audit Results Meets USDA Acceptance Criteria

Check either Yes or No. This section refers only to the USDA Acceptance Criteria for the 

Produce GAPs Harmonized Food Safety Standard; it does not address meeting the Logo Use 

Addendum criteria in this checklist.

Auditor Completion Instructions

Assess all questions on the Produce GAPs Harmonized Food Safety Standard USDA checklists in 

accordance with the Verification Instructions in the Produce GAPs Harmonized Food Safety 

Standard, which you must have with you when performing audits. 

A. Assessment Terms

Assess all questions using one of the following: 

1. Compliant (C)

The operation meets the requirements of the Harmonized GAP Standard. 

2. Corrective Action Needed (CAN)

The operation does not meet the requirements of the Harmonized GAP Standard; 

however, the non-conformance is not considered to be an immediate food safety risk.

3. Immediate Action Required (IAR)

The operation does not meet the requirements of the Harmonized GAP Standard and 

the non-conformance is considered an imminent food safety risk. An imminent food 

safety risk is present when produce is grown, processed, packed, or held under 

conditions that promote or cause the produce to become contaminated. Examples of 

IARs include employees’ personal or hygienic practices that jeopardize the safety of 
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the produce, the presence or evidence of rodents or an excessive number of insects or 

pests.

4. Not Applicable (N/A)

The question is not applicable to the operation. 

B. Auditor Comments

Document all findings related to any question answered CAN or IAR in the Auditor 

Comment section of the checklist. You may document observations associated with any 

question on the checklist regardless of whether it is a non-conformity to clarify why a 

question was answered compliant. Write a comment for each question answered N/A 

explaining the rationale for that answer. In Appendix V, a table is provided to demonstrate 

required information the auditor must document in the comment section for certain 

requirements of the checklist.

C. Tallying the Audit

Once you finish the audit, fill out the score sheet (found in the Audit Summary) by 

recording the number of C, CAN, IAR, and N/As for each section of the audit. The 

electronic Excel checklist will tabulate this information automatically, but you must verify 

the Audit Summary is correct. Note the number of any question answered as CAN or IAR 

for each section in the last column of the Audit Summary section.

D. Corrective Action Reports

Fill out a Corrective Action Report for each question that was answered CAN or IAR. Refer 

to SCI Division current guidance on Corrective Action Reports for further instructions.

E. Submittal of the Audit Report for Review

Submit the Checklist (Excel file), the signed Agreement for Participation in Audit 

Verification Programs (SC-651), and the Request for Audit Services (SC-237A) to 

SCAudits@usda.gov in accordance with the guidelines in the SCI Division Auditor Manual 

(In Development). Ensure the most recent SC-651 is on file before or during the opening 

meeting for the audit. The auditee can use the same SC-651 each year if (1) they are using 

the most current version of the form; (2) the auditee has maintained good audit standing, (3) 

the operation’s address is accurate, (3) the release information remains unchanged (if 

applicable); and (4) the signature of the auditee’s current management is on file.

Documents Required

The auditing standards require verification of certain policies and procedures (WP), Risk 

Assessments (A) and records (R). To help auditors identify where documents (DOC) are required, 
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the Checklist includes a DOC column that designates the type of documentation to verify a WP, R, 

A or a combination. 

A. Policies and Procedures (WP)

A policy is high-level guidance that describes general goals and acceptable procedures for 

an organization. A procedure is a specified way to carry out an activity or process. Policies 

and procedures may be communicated in writing or orally. They only need to be written if 

the standard specifically states that requirement. Use interview techniques to verify that 

policies and procedures, whether communicated in writing or verbally, are implemented 

throughout the operation as specified.

B. Record (R)

A record is a document stating results achieved or providing evidence of activities 

performed. Records may include checklists, service records, billing forms, and water tests.

Records that show errors or deviations from the company’s procedures should be noted or 

copied and included in the audit report. Since such records will not likely support the 

requirement, assess the requirement as Corrective Action Needed or Immediate Action 

Required, depending on the severity of the non-conformity.

If you find evidence of falsified records any time during the audit, contact your immediate 

supervisor for further instructions. The auditor should take detailed notes of the observation 

and obtain a copy of the falsified document. Falsification of records is considered an 

egregious offense and will lead to an Immediate Action Required for the audit.

C. Risk Assessment (A)

A risk assessment is a process to identify potential hazards on a farm and/or in a 

packinghouse as well as the likelihood the hazards will impact the safety of fruits and 

vegetables. The findings of the risk assessment must be documented.

Auditee Information

This section of the Audit Checklist is designed to provide information to the auditee about the 

USDA Harmonized Standards and the USDA Produce GAPs Harmonized Audit program. It 

describes how to access and use the Standard and Checklist, and how to schedule an audit with 

USDA. You must be familiar with this section and may refer the auditee to this portion of the Audit 

Checklist when sharing information about the USDA Produce GAPs Harmonized Audit Program. 

Audit Summary

The Audit Summary shows the number of questions assessed as C, CAN, IAR, or N/A. The 

numbers are tabulated automatically in the electronic Excel checklists, however, upon completion 

of the audit, the auditor should verify them for accuracy to ensure that all questions were answered 
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and recorded properly. Auditor should list the requirement number for any assessed with CAN or 

IAR in the last column of the summary table.

The rest of this manual provides guidance on interpreting technical points and acceptance criteria.

There are also example scenarios that provide guidance on how to interpret various situations that

may be encountered.

GENERAL GUIDANCE FOR ASSESSING REQUIREMENTS

Risk Assessments

Risks must be assessed for potential physical, chemical, and biological hazards throughout the 

operation. Risk Assessments for the Produce GAPs Harmonized audit focus on food safety and 

must include:

• Identification of potential physical, chemical, and biological hazards;

• Analysis of any identified hazards;

• Control measures for identified hazards;

• Monitoring and verification of hazard mitigation; and

• Corrective and preventive actions to prevent additional hazards.

Prevailing and Applicable Regulations

The USDA Harmonized Standards can be applied in various countries and localities. The terms 

“prevailing regulation” and “applicable regulation” refer to regulations that apply specifically to the 

operation being audited, such as municipal, town, county, state, or Federal regulations. When these 

terms are used, you must be familiar with the regulations that apply to the auditee’s operation.

You may apply either the requirements in the standards or prevailing and applicable regulations;

apply whichever guidance is more stringent. For example, Requirement G-3.3 states that 

“Documentation shall be retained for a minimum period of two years, or as required by prevailing 

regulation.” If a state regulation requires retention of pesticide documentation for a minimum of 

three years, you would apply the three-year requirement. If a state regulation requires pesticide 

documentation must be kept for one year, you would apply the two-year requirement in the 

standard.

For many operations in the United States, the Food Safety Modernization Act (FSMA) Produce 

Safety Rule will be considered a prevailing regulation. Coverage and applicable sections of the rule 

are affected by the commodities produced and/or handled by an operation, the activities of the 

operation, sales, customers, and other factors. Operations are responsible for understanding if and 

how they are subject to the Produce Safety Rule.
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Crop-Specific Guidance Expectations 

The Harmonized Standards refer to current industry practices or current industry standards, which 

are practices or standards that are generally accepted and followed by members of a specific 

industry. SCI expects that producers will incorporate applicable industry practices and standards 

into their food safety plans, as appropriate, and auditors will reference applicable industry practices 

and standards when performing audits. 

You should be familiar with industry guidance reviewed by the FDA prior to conducting an audit. 

Please see Appendix IV: FDA & Industry Guidance Documents of this manual.

The auditee’s policies and practices may be based on FDA guidance, or new research or 

recommendations. Verify that any practice or policy that diverges from GAPs found in FDAreviewed guidance meets the requirements of the Harmonized Standard and has a credible basis, 

such as published studies that are peer reviewed and cooperative extension guidance. Most

importantly, you must observe implemented practices and policies to verify they minimize food 

safety hazards.

Questionable Observations

If you observe a questionable practice or policy during an audit: 

• Take thorough notes to document your observations; and 

• Contact your supervisor or the SCI Audit Services Branch (ASB) immediately if the practice 

or policy may be considered an IAR; or 

• Take thorough notes on the practice or policy if it is not one that may be considered an IAR 

and seek further guidance from your supervisor or ASB.

If you cannot decide whether a practice you see during an audit is an IAR, advise the auditee of the 

observations you documented and that you are seeking further guidance. 
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PROGRAM EXPECTATIONS

USDA Acceptance Criteria for the Produce GAPs Harmonized Food Safety Standard Audit

An operation must meet the following criteria to meet USDA acceptance criteria: 

1 No questions are assessed as an “IAR,” Immediate Action Required.

2 Falsification of records is considered an “IAR.”

3

Any applicable question marked with a ● in the MAN column must be 

assessed as "compliant".

4

Operation must have performed all risk assessments, designated with an 

"A" in the DOC column, in the Produce GAPs Harmonized Food Safety 

Standard.

5

If the auditee has been audited against the Produce GAPs Harmonized Food 

Safety Standard previously, the auditee must have addressed all associated 

CANs or IARs, following their established corrective action procedure.

6

In each major section (G, F, and P) of the audit, at least 80% of the 

questions not answered as "N/A" must be answered as compliant. 

Meeting or Not Meeting Criteria

If an operation meets the acceptance criteria as outlined above, the operation will receive a 

certificate stating its conformance to Produce GAPs Harmonized Food Safety Standard as well as 

being posted to the USDA website. Corrective action reports will still be supplied to the auditee for 

all non-conformances. 

If an operation does not meet the acceptance criteria as outlined above, a corrective action report 

form will be issued for each non-conformance noted on the audit. The operation has the 

opportunity to take measures in order to address the issue and schedule a new audit in order to show 

compliance to the acceptance criteria. 
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USDA ACCEPTANCE CRITERIA FOR THE HARMONIZED GAP PLUS+ AUDIT

An operation must meet the following criteria to meet USDA acceptance criteria: 

1 No questions are assessed as an “IAR,” Immediate Action Required.

2 Falsification of records is considered an “IAR.”

3

Any applicable question marked with a ● in the MAN column must be 

assessed as "compliant".

4

Operation must have performed all risk assessments, designated with an 

"A" in the DOC column, in the USDA Harmonized GAP Plus+ Standard.

5

If the auditee has been audited against the USDA Harmonized GAP Plus+ 

Standard or the Produce GAPs Harmonized Food Safety Standard 

previously, the auditee must have addressed all associated CANs or IARs, 

following their established corrective action procedure.

6

In each major section (G, F, and P) of the audit, at least 80% of the 

questions not answered as "N/A" must be answered as compliant. 

Meeting or Not Meeting Criteria

An operation that meets the acceptance criteria as outlined above, the operation will receive a 

certificate stating its conformance to the Harmonized Standard or USDA Harmonized GAPs Plus+ 

Standard as well as being posted to the USDA website. Corrective action reports will still be 

supplied to the auditee for all non-conformances.

If an operation does not meet the acceptance criteria as outlined above, a corrective action report 

form will be issued for each non-conformance noted on the audit. The operation has the 

opportunity to take measures in order to address the issue and schedule a new audit in order to show 

compliance to the acceptance criteria.
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GENERAL QUESTIONS

The questions in this section assess the operation’s Management Responsibility, Food Safety Plan

or Risk Assessment, Documentation and Recordkeeping, Worker Education and Training, Sampling 

and Testing, Traceability, Recall Program, Corrective Actions and Food Safety Incidents, and SelfAudits, Worker Health/Hygiene and Toilet/Handwashing Facilities, Waste Management, Food 

Defense, and Food Fraud. 

G-1 Management Responsibility 

Management must be committed to an operation’s food safety program. The following 

requirements address the essential elements of management responsibility:

Requirement G-1.1 A food safety policy shall be in place.

Procedure A written policy shall outline a commitment to food safety, in general 

terms, how it is implemented and how it is communicated to employees, 

and be signed by Senior Management.

Verification The auditor observes the food safety policy, observes that it is signed by 

Senior Management, and observes that it has been communicated to all 

employees in a manner that can be understood.

Corrective 

Action

The operation creates or revises the policy, or its communication to 

employees, to be in compliance.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

A food safety policy is the company’s written commitment to ensuring the safety of its product and 

a description of how that is accomplished. This policy must be signed by senior management. The 

Harmonized Standard doesn’t specify how often the food safety policy should be reviewed or 

revised, but the policy should accurately reflect current senior management and accurate, 

appropriate policy. If a company has a standard operating procedure (SOP) for updating its food 

safety policy, the food safety policy must be compliant with the SOP.

The food safety policy may be displayed or communicated in any way that can be demonstrated to 

be effective, including, being displayed in the front lobby in English and the predominant worker 

language, shared during annual training, or posted on an employee bulletin board. Throughout the 

audit, interview employees to verify that the food safety policy has been communicated effectively. 

All employees should be familiar with the food safety policy as appropriate for that employee’s 

responsibility. 

Example Scenarios 

Scenario 1: In reviewing an operation’s food safety policy, that was implemented/dated three years 

ago you review a SOP that states the food safety policy shall be updated yearly and/or as needed. 

Assessment: Corrective Action Needed
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Reason: The operation is not following their Standard Operating Procedure. 

Scenario 2: Operation presents their food safety policy which describes their commitment to 

ensure food safety, it is signed by senior management. The food safety policy is displayed in the 

employee break room and upon entry into the building (with sign in sheets for visitors, etc.) you 

conduct interviews throughout the audit with employees that are well versed on the food safety 

policy and procedures. 

Assessment: Compliant. 

Reason: Employees are able to accurately describe the company’s food safety policies and 

procedures showing they have been effectively communicated to and are knowledgeable on the 

subject. 

Requirement

G-1.1.a

The food safety policy shall include measurable objectives for meeting 

the safety needs of the products.

Procedure A written policy shall include measurable objectives, each of which is 

defined and includes a plan to achieve it. The plan must include the 

timeline in which the objective will be accomplished, who is responsible 

for ensuring it is accomplished, and how the progress of completion will 

be documented and verified.

Verification The auditor observes that the food safety policy contains measurable 

objectives and that the operation is progressing toward their completion.

Corrective 

Action

The operation adds or revises its measurable objectives.

Documents 

Required

Written Policy.

Mandatory

Expectation 

The operation must have measurable objectives for meeting the safety needs of their product in their 

food safety policy. These objectives must be defined and have a plan to achieve it. The plan must 

include: 1) a timeline in which the objective will be accomplished, 2) a designated individual or 

individuals who are responsible, and 3) an explanation of how the progress of completion will be 

documented and verified. 

Example Scenarios

Scenario 1: An auditee’s food safety plan contains the following objectives: 1) To provide safe 

food to customers and 2) To satisfy our customers. No additional information on the objectives is 

provided. 

Assessment: Corrective Action Needed

Reason: These objectives are not measurable. 

Scenario 2: An auditee’s food safety plan contains the following objectives: 1) To have zero 

product recalls or outbreaks associated with our products and 2) To respond to all customer 

complaints or feedback within 1 week of receipt. There is no documentation of their progress. 

Assessment: Corrective Action Needed. 
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Reason: Auditees must have a plan to verify and document progress towards their objectives. 

Requirement G-1.2. Management has designated individual(s) with roles, 

responsibilities and resources for food safety functions.

Procedure The food safety plan shall designate who has the responsibility and 

authority for food safety, including a provision for the absence of key 

personnel. Twenty-four hour contact information shall be available for 

these individuals in case of food safety emergencies. The organization’s 

senior management shall determine and provide, in a timely manner, the 

resources needed to implement and maintain the food safety plan.

Verification Auditor observes that the food safety plan has identified individual(s) 

for key food safety activities. Auditor verifies that procedures include 

provisions for when the identified individual is not present. Auditor 

observes whether senior management has provided the resources needed 

to implement and maintain the food safety plan.

Corrective 

Action

Operation identifies individual(s) for key food safety activities in the 

food safety plan. Operation identities actions to be taken when the 

identified individual(s) are not present. Senior Management commits 

resources needed to implement and maintain the food safety plan.

Documents 

Required

Written policy.

Mandatory ●

PSR 112.23

Expectation 

Operations must designate an individual(s) who is responsible for ensuring that its food safety 

program is being followed. Key personnel and 24-hour contact information must be included in the 

food safety plan and accessible to relevant employees. The auditor will interview the designee(s) to 

determine their knowledge of the program. Designees should be able to demonstrate procedures, 

show applicable records, and knowledgeably answer questions about the program for which they 

are responsible.

The auditor will include the name(s) of the individual(s) responsible for the Food Safety Plan with 

their roles/responsibilities in the comments. 

Example Scenario 

Scenario: There is no alternate designated for food safety. 

Assessment: The assessment will depend on whether the lack of an alternate affects effective 

implementation of the operation’s food safety plan. 

Reason: An operation that does not designate an alternate, thereby creating reasonable potential for 

food safety to be left unsupervised requires a corrective action. A small operation that designates 

only the owner and food safety manager, who are present to oversee all activity, but does not 

designate an alternate, would be compliant.

Produce Safety Rule 
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112.23: Operations must assign or identify personnel to supervise (or otherwise be responsible for) 

the operations to ensure compliance with the requirements of the Produce Safety rule.

Requirement G-1.2.a. The food safety plan outlines an organizational structure for at 

least those staff whose activities affect food safety.

Procedure The food safety plan defines and documents the job functions and 

responsibilities related to on farm activities of at least those staff whose 

activities affect food safety.

Verification Auditor observes documentation of job functions and responsibilities 

related to on farm food safety activities.

Corrective 

Action

The operation creates or revises the documentation of job functions and 

responsibilities related to on farm food safety activities.

Documents 

Required

Written policy.

Mandatory

Expectation 

The food safety plan must define an organizational structure that shows job functions and 

responsibilities of workers whose activities affect food safety within the company. For very small 

companies, an individual worker may be responsible for many job functions. 

Example Scenario 

Scenario: The auditee does not have an organizational chart, but instead provides a document 

which lists job titles and their roles in executing the food safety plan. 

Assessment: Compliant

Reason: Does not need to be an organizational chart, so long as roles and responsibilities are 

defined and documented for all employees who may affect food safety. 

Requirement G-1.3. There is a disciplinary policy for food safety violations.

Procedure There shall be a policy that establishes corrective actions for personnel 

who violate established food safety policies or procedures.

Verification Auditor observes the policy and checks for examples of enforcement.

Corrective 

Action

The operation creates or revises the policy, or its communication to 

employees, to be in compliance.

Documents 

Required

N/A.

Mandatory

Expectation 

The operation, whether part of a large farming corporation or a small family farm, must have a 

disciplinary policy for food safety violations that establishes corrective actions for personnel who 

violate established food safety policies or procedures. This policy does not have to be written, but it 

does need to be established, and effectively communicated to and understood by personnel. The 

corrective actions for personnel food safety violations are established by the operation and not the 

Harmonized Standard. The auditor will verify by interviews that employees are aware of and can 
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explain the company’s disciplinary policy for food safety violations. 

Example Scenarios

Scenario 1: Auditor reviews the food safety policy but does not see any documentation for a 

disciplinary policy. Employee interviews established that after 3 warnings or corrective actions 

relating to food safety, employee(s) would be dismissed. 

Assessment: Compliant 

Reason: Policy does not have to be written; however, it must be understood by employees. 

Scenario 2: Several employees of a large operation were interviewed. The interviews confirmed 

that employees were not made aware of a disciplinary policy.

Assessment: Corrective Action Needed

Reason: Although policy does not have to be written, policy needs to be established and 

communicated to and understood by personnel. 

G-2 Food Safety Plan 

The written Food Safety Plan is a critical component of every operation’s food safety program. The 

format of the Food Safety Plan is not specified in order to promote the writing of a plan that is 

customized to the operation. 
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Requirement G-2.1. There shall be a written Food Safety Plan. The plan shall cover 

the operation. The operation and products covered shall be defined.

Procedure The Food Safety Plan shall identify all locations of operation covered by 

the plan and shall identify physical, chemical, and biological hazards 

reasonably likely to occur and hazard control procedures, including 

monitoring, verification and recordkeeping, for all provisions covered by 

this audit.

Verification Auditor shall observe the Food Safety Plan and verify that the plan has 

considered potential biological, chemical and physical hazards and has 

identified preventive controls for hazards that may reasonably affect 

food safety.

Corrective 

Action

Operation develops or completes a Food Safety Plan for all locations of 

operation.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

The Food Safety Plan is a written document that outlines the company’s plan to identify, control, 

monitor, and verify the mitigation of potential food safety hazards. This includes physical, 

chemical, and biological hazards that are reasonably likely to affect food safety for water, soil 

amendments, field sanitation, production environment, and worker practices. 

The Food Safety Plan must identify locations, products, and activities of the operation. The plan 

will establish policies and procedures that will enable the operation to effectively prevent crosscontamination of produce from agricultural inputs, cleaning agents, or personnel who come directly 

or indirectly into contact with other sites, animals or produce throughout the operation. 

The plan must also include the operation’s recordkeeping requirements. 

The auditor will include the date and/or version of the current Food Safety Plan being audited in the 

comments. 

Example Scenarios 

Scenario 1: The Food Safety Plan is generic and does not consider the operation’s actual 

conditions and potential hazards. 

Assessment: Corrective Action Needed for lack of a specific plan; or Immediate Action Required 

if the conditions and potential hazards for that operation are imminent food safety hazards.

Reason: The plan must consider the operation’s actual conditions and procedures. 

Scenario 2: The Food Safety Plan is generic but considers all of the potential hazards reasonably 

likely to occur at the operation; procedures in the generic plan are being followed. 

Assessment: Compliant. 

Reason: The plan addresses all hazards for the operation and is consistent with procedures being 
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followed. 

Scenario 3: The operation’s Food Safety Plan is silent about hazards or states that there are no 

biological hazards likely to occur. 

Assessment: Corrective Action Needed or Immediate Action Required.

Reason: This contradicts current industry guidance. The operation’s contention that there are no 

hazards is insufficient unless it can provide evidence that its analysis is correct. “We’ve never had a 

problem” is not sufficient evidence.

Requirement G-2.2. The Food Safety Plan shall be reviewed at least annually.

Procedure Operation shall be responsible for reviewing their food safety plan at 

least annually, documenting the review procedure and revising the plan 

as necessary. Updated or revised on date shall be indicated.

Verification Auditor reviews last Food Safety Plan review.

Corrective 

Action

Operation reviews Food Safety Plan and documents review.

Documents 

Required

Record.

Mandatory

Expectation 

The operation must review its Food Safety Plan at least annually. If the operation has an SOP in 

place that requires more frequent reviews of the plan, verify that the plan is reviewed in accordance 

with the SOP. 

The auditor will include the date the Food Safety Plan was last reviewed in the comments. If Not 

Applicable is selected, include that the plan is less than a year old.

Example Scenarios 

Scenario 1: The operation’s Food Safety Plan does not have an effective or revised date.

Assessment: Corrective Action Needed. 

Reason: Standard requires that the Food Safety Plan must be reviewed at least annually and that 

“updated or revised on date shall be indicated.” 

Scenario 2: The operation’s Food Safety Plan is less than a year old.

Assessment: Not Applicable. 

Reason: Unless the operation has an SOP that specifies more frequent review, the operation only 

needs to review its plan annually. The Food Safety Plan must have been in place for a full year 

before it can be assessed for compliance to this requirement. Place a comment on the audit report 

indicating that the plan is less than a year old.
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Requirement G-2.2.a. The Food Safety Plan shall be reviewed in the event of any 

change which may affect food safety.

Procedure The documented food safety plan review shall include evidence of 

management’s commitment to establish, implement, maintain, and 

improve food safety and the organization's food safety culture. 

Elements of a food safety culture include but are not limited to 

communication about food safety policies and responsibilities, training, 

Employee feedback on food safety relate issues and performance 

measurement. Additionally, it shall ensure access to necessary resources 

to implement plan, including suitably qualified personnel. The plan must 

include a review of all supplier specifications.

Verification Auditor shall review documentation for food safety plan review in the 

event of any change which may affect food safety.

Corrective 

Action

Operation conducts a review of the food safety plan in the event of any 

change which may affect food safety, and provides documentation.

Documents 

Required

Record.

Mandatory ●

Expectation 

The plan must be reviewed at least annually. It shall also be reviewed in the event of any change 

which may affect food safety to ensure the hazards identified and any necessary controls continue to 

be accurate and appropriate for the operation in light of the changes. The plan shall be 

updated/revised as necessary based on this review. 

The documented Food Safety Plan review shall include evidence of management’s commitment to 

establish, implement, maintain, and improve food safety and the organization's food safety culture. 

Elements of a food safety culture include but are not limited to communication about food safety 

policies and responsibilities, training, employee feedback on food safety related issues and 

performance measurement. The auditor will verify through interviews and observations that 

workers performing their jobs share values, beliefs and similar mindsets and behaviors toward the 

importance of food safety in, across and throughout the organization. 

Example Scenarios 

Scenario 1: Operation had been manually monitoring chemical disinfectant concentration in flume 

water at a frequency specified in its Food Safety Plan. The operation manually added chemicals 

when levels dropped below a point specified in its Food Safety Plan. They recently switched to an 

automatic monitoring and injection system. Auditor observes that the operation’s Food Safety Plan

was last reviewed eight months ago.

Assessment: Corrective Action Needed

Reason: Food Safety Plan still reflects previous practices, not current practices or conditions. 

Scenario 2: Auditor observes that the operation recently expanded its product throughput by fifty 

percent, adding a new sorting line and packing line. However, the firm did not conduct a review of 

its Food Safety Plan based on these changes. Auditor asks the Food Safety Manager if they had 
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considered reviewing their plan. The manager said they considered it but didn’t think it was 

necessary because the building had adequate space to accommodate the new equipment and the 

equipment was similar to what they already had. Therefore, controls already in the plan are 

sufficient and the changes weren’t likely to affect food safety.

Assessment: Compliant 

Reason: In compliance. Changes not likely to affect food safety so no review needed. 

Requirement G-2.3. Operation has an Approved Supplier program for all incoming 

materials, including packaging.

Procedure Operation has and maintains a current list of approved raw material 

suppliers and service providers relevant to food safety. Approved 

Supplier program includes a procedure for accepting materials from 

alternate sources.

Verification Auditor verifies a list of raw material suppliers is maintained and 

current. Auditor verifies that all materials received from alternate 

sources has followed established procedure.

Corrective 

Action

Operation develops an Approved Supplier program and maintains 

current list. Operation develops a procedure for accepting materials 

from alternate sources. Operation ceases accepting or shipping 

materials from non-compliant suppliers.

Documents 

Required

Record.

Mandatory ●

Expectation 

Incoming materials include any materials purchased for use in production. This includes chemicals, 

produce, packaging material, labeling supplies, equipment used in the packing process, etc. 

The auditor will include the date of current approved supplier list in the comments.

Example Scenarios 

Scenario 1: An operation has a program in place for approving suppliers, which includes 

packaging materials, ingredients and cleaning chemicals, but the program is not written.

Assessment: Compliant for Harmonized GAP audit, Corrective Action Needed for Harmonized 

GAP Plus audit (see G-2.3.a) 

Reason: Procedure for approving suppliers does not have to be written; only the supplier list must 

be written.

Scenario 2: An approved list of raw material suppliers is 18 months old.

Assessment: Compliant. 

Reason: This will be compliant as long as it is accurate.

Scenario 3: Approved supplier program does not include source of diesel fuel for tractors. 

Assessment: Not Applicable. 

Reason: The approved supplier list only needs to include items that could impact food safety. 
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Scenario 4: An approved supplier list includes XYZ Hardware Store for cleaning supplies. XYZ 

Hardware Store has been approved by their program as a supplier for the materials purchased.

Assessment: Compliant. 

Reason: XYZ Hardware Store is an approved supplier. 

Requirement G-2.3.a. Approved supplier program contains written procedures for 

the evaluation, approval, and continued monitoring of suppliers.

Procedure The operation shall document the procedures for evaluation approval, 

and continued monitoring of suppliers. Results of evaluations, 

investigations, and follow up actions shall be recorded for each supplier.

Verification Auditor verifies documentation for procedures for evaluation, approval, 

and continued monitoring of suppliers as well as records documenting 

these activities.

Corrective 

Action

Operation develops procedure and/or records for the evaluation, 

approval and continued monitoring of suppliers.

Documents 

Required

Written Policy.

Mandatory

Expectation 

A procedure for the evaluation, approval and continued monitoring of suppliers which have an 

effect on food safety shall be established, implemented and maintained. The procedure must 

address procurement in emergency situations to ensure that food still conforms to the documented 

specified requirements or specifications, and the supplier has been evaluated. The results of 

evaluations, investigations and follow up actions must be recorded.

Example Scenario 

Scenario: The operation’s Approved Supplier program requires all growers supplying produce to 

ABC Packing to have completed a Harmonized GAP Plus+ Field Operation & Harvesting audit. 

They keep records of all audit reports electronically in file folders on the food safety manager’s 

computer. 

Assessment: Corrective Action Needed

Reason: The operation’s policy does not include the necessary information and therefore is 

incomplete. Missing information includes who approves suppliers, when suppliers are approved, 

how approved suppliers are monitored, how results of evaluations, investigations and follow up 

actions are recorded for each supplier.
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Requirement G-2.3.b. The operation’s Approved Supplier program includes 

procedures for approving contractors.

Procedure The operation’s program includes the approval of any contractors and 

food safety related services utilized by the operation to ensure that all 

specifications are met. The program includes a procedure for accepting 

services from alternate sources.

Verification Auditor verifies that a list of contractors is maintained and current. 

Auditor verifies that any services received from alternate sources has 

followed established procedure.

Corrective 

Action

Operation develops an Approved Supplier program and maintains 

current list. Operation develops a procedure for accepting services from 

alternate sources. Operation ceases utilizing services from noncompliant suppliers or contractors.

Documents 

Required

Record.

Mandatory

Expectation 

A procedure for the evaluation and approval of contractors which provide a service which has an 

effect on food safety shall be established, implemented and maintained. The procedure shall 

address procurement in emergency situations to ensure that food still conforms to the documented 

specified requirements or specifications, and the supplier has been evaluated. The results of 

evaluations, investigations and follow up actions shall be recorded. 

Example Scenario 

Scenario: The operation contracts a pesticide applicator company and a portable toilet 

maintenance company. All other work is done in house. The operation’s SOP states that the Food 

Safety Manager must approve all contractors and document their approvals using a Vendor 

Assessment Checklist. Alternative sources are approved using this same process. 

Assessment: Compliant 

Reason: The operation maintains a file for all contractors and has a procedure to use their Vendor 

Assessment Checklist for all contractor approvals.

Requirement G-2.3.c. Outsourced processes must be identified, documented, and 

monitored.

Procedure Outsourced processes (i.e. pest control, sanitation unit maintenance, 

harvest crews, etc.) must be identified, documented, and monitored.

Verification Auditor verifies that outsourced processes are documented and 

monitored.

Corrective 

Action

Operation identifies, documents and monitors outsourced processes.

Documents 

Required

Record.

Mandatory
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Expectation 

The operation is responsible for ensuring the processes conducted by any contractors and food 

safety related services utilized by the operation are consistent with the operation’s plan, the 

requirements of this standard and in compliance with the Produce Safety Rule. To ensure that all 

specifications are met. Operation shall identify, document, and monitor outsourced processes (e.g., 

pest control, sanitation unit maintenance, harvest crews, etc.) to ensure that its food safety program 

is being followed. 

Example Scenarios 

Scenario 1: Operation contracts nightly cleaning and sanitation of packinghouse and equipment. 

Operation can identify the company that performs this service, provide invoices showing the 

company name and explains that these procedures are performed after the packinghouse stops 

operation for the day. The work is supervised by an employee of the contract firm. However, the 

operation’s food safety manager inspects facilities and equipment before the operation resumes the 

next day to ensure everything is clean and sanitary before packing resumes. Operation explains that 

if any issues are found, which they say is rare, their own personnel make immediate corrections,

and they contact the contract firm.

Assessment: Compliant 

Reason: Operation’s monitoring appears to be sufficient to ensure food safety objectives.

Scenario 2: Operation identifies and provides documentation for the contract harvest crew that 

they use. The contract includes requirements for the training of harvest workers and procedures 

they must follow. Operation relies on the contract firm to conduct training and supervise the crew. 

Auditor observes that harvest bins contain debris from a previous harvest and that some crew 

members are leaving the porta potties and returning to work without washing their hands. 

Assessment: Corrective Action Needed, possible Immediate Action Required. 

Reason: Operation is relying on contract firm to meet requirements written into the contract but 

does not monitor or provide sufficient oversight to ensure procedures are followed.

G-3 Documentation and Recordkeeping 

Documentation and records are an essential part of a Food Safety Plan. Throughout the audit 

standard each requirement dictates whether or not documents or records will need to be created and 

maintained. 
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Requirement G-3.1. Documentation shall be kept that demonstrates the food safety 

plan is being followed.

Procedure Documents and records of procedures, standard operating procedures 

(SOPs) and policies shall be in place for meeting each of the food safety 

standards identified in the Food Safety Plan. Records comply with 

prevailing regulations.

Verification Auditor reviews Food Safety Plan and verifies that all required 

documentation is available.

Corrective 

Action

Operation develops missing documentation or recordkeeping 

procedures.

Documents 

Required

Record.

Mandatory ●

PSR 112.161

Expectation 

The operation must maintain documentation that demonstrates, at a minimum, that it is following its 

Food Safety Plan. Verify these documents, which should include, but are not limited to, policies, 

SOPs, and records. 

Example Scenarios 

Scenario 1: The operation’s SOP states that equipment will be checked for maintenance on a daily 

basis. There is no log for a day when equipment was not used. 

Assessment: Corrective Action Needed. 

Reason: The SOP requires a daily check; the lack of log for a day is inconsistent with the 

operation’s SOP.

Scenario 2: The operation has no record of cleaning/sanitizing an automated produce weighing 

machine on a day that it was used.

Assessment: Corrective Action Needed, unless the lack of the records indicates a potential food 

safety hazard, which would indicate Immediate Action Required.

Reason: The operation is not complying with its policy for cleaning/sanitizing the weighing 

machine.

Scenario 3: There is no written SOP for performing cleaning/sanitation of a food contact 

equipment. 

Assessment: Corrective Action Needed. 

Reason: The operation must follow its food safety plan regarding documentation.

Produce Safety Rule 

112.161: A list of records that are required in the PSR can be found in Appendix II: Records 

Required for the Produce Safety Rule. All records that are required by the Produce Safety Rule 

must include the following information, as applicable: 

• Name and location of the farm
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• Actual values and observations during the observation 

• An adequate description of the produce applicable to the record (e.g., name of commodity, 

lot number or identifier if available)

• Location of area applicable to the record (e.g., specific field or packing shed) 

• Date and time of activity documented 

• Be created at the time of the activity documented

• Be accurate, legible and indelible

• Be dated, signed or initialed by the person who performed the activity documented. 

• Be reviewed, dated, and signed, within a reasonable time after the records are made, by a 

supervisor or responsible party. 

In addition, records required under §§ 112.7(b), 112.30(b)(2), 112.50(b)(2), 112.50(b)(4), 

112.50(b)(6), 112.60(b)(2), 112.60(b)(3), 112.140(b)(1), 112.140(b)(2), 112.150(b)(1), 

112.150(b)(4), and 112.150(b)(6). Appendix II lists all required records and notes which require 

review. For records required by the Produce Safety Regulation these records can rely on or add to 

existing records kept for another purpose. 

Requirement G-3.2. Documentation shall be readily available for inspection.

Procedure Documents and records may be maintained onsite or at an off-site 

location, or accessible electronically, and shall be available for inspection 

in a reasonable timeframe or as required by prevailing regulation. 

Records shall be protected to prevent unauthorized access or potential 

falsification.

Verification Auditor verifies that required documentation can be accessed in a 

reasonable timeframe.

Corrective 

Action

Operation defines in food safety plan where and how documentation is 

maintained and expected retrieval time.

Documents 

Required

N/A.

Mandatory ●

PSR 112.162, 112.166

Expectation 

The auditee must make all documentation readily available for inspection by the auditor. 

Documentation may be maintained onsite or at an accessible off-site location, and in hard copy 

(paper) or electronically so long as it is accessible to the auditor in a reasonable timeframe and kept 

in accordance with prevailing regulations and the company’s Food Safety Plan specifications. The 

standard does not specify whether documents/records must be protected or if “track changes” must 

be enabled to show modifications to them. If the operation’s Food Safety Plan allows records to be 

maintained without changes tracked, for example, an Excel spreadsheet or a paper record written in 

pencil, the auditor will verify to the best of their ability that these records are complete, and no 

falsification of records has occurred for this question to be compliant.

If a document/record is not available at the time of the audit, it is acceptable for the auditee to 

provide this document/record to the auditor in a timeframe that is reasonable to the auditor. For 
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example, if the operation keeps water test records at an off-site location and has forgotten to bring 

them to the onsite audit, it is reasonable to allow the auditee 24 hours to fax or e-mail a copy of 

these reports to the auditor’s office.

Example Scenarios

Scenario 1: A document or record required by the food safety plan is not available for the auditors 

review during the audit but can be provided to the auditor within 24 hours. 

Assessment: Compliant 

Scenario 2: A document or record required by the food safety plan is maintained by a 

subcontractor (e.g., pesticide applicator) and is not accessible by the operation for auditor’s review.

Assessment: Corrective Action Needed

Produce Safety Rule: 

112.162: Off-site storage of records is permitted if such records can be retrieved and provided 

onsite within 24 hours of request for official review. Electronic records are considered to be onsite 

at the farm if they are accessible from an onsite location at the farm.

112.166: All records required under the Produce Safety Rule must be readily available and 

accessible during the retention period for inspection and copying by FDA upon request, except you 

have 24 hours to obtain records kept offsite. If electronic records are kept, or if a reduction 

technique such as microfilm is used to keep true copies of records, FDA must be provided with 

records in a format that is accessible and legible. If the farm is closed for a prolonged period, the 

records may be transferred to some other reasonably accessible location but must be returned to the 

farm within 24 hours for official review upon request. 

Requirement G-3.3. Documentation shall be retained for a minimum period of two 

years, or as required by prevailing regulation.

Procedure Document and record handling policy or procedures require that 

documentation required by the food safety plan shall be retained for a 

minimum of two years, or as required by prevailing regulation.

Verification Auditor reviews document handling procedures and verifies that 

required documentation is available for at least two years, or as required 

by prevailing regulation.

Corrective 

Action

Operation revises documentation procedures.

Documents 

Required

Record.

Mandatory ●

PSR 112.164

Expectation 

Documents must be kept for a minimum period of two years; documents may be kept longer than 

two years. Be aware of local prevailing regulations to determine if records need to be kept for 

longer than 2 years. For example, Texas requires restricted use pesticide records to be kept for 30 
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years. If an operation has 2 years of documents/records available for review and no other prevailing 

regulation requires documents be kept longer, the operation is in compliance with this requirement. 

If Not Applicable is selected, the auditor will include that the business or Food Safety Plan has been 

in operation for less than two years in the comments. 

Example Scenarios 

Scenario 1: Records are kept for the entire time the operation has been in business, which is 3 

months. 

Assessment: Compliant. 

Reason: The company has kept records throughout its operations. Assess the records that the 

operation has been keeping from the time the operation began, and add a comment explaining why 

less than 2 years of records were assessed.

Scenario 2: Records are kept for the length of time the company has had a food safety plan in 

place, which is 1-1/2 years. 

Assessment: Compliant. 

Reason: The company has kept records throughout the lifetime of its food safety plan. Assess the 

records that the operation has been keeping from the time the food safety plan was implemented, 

and add a comment explaining why less than 2 years of records were assessed.

Scenario 3: Records were inadvertently destroyed by a natural disaster (e.g., a fire or hurricane).

Assessment: N/A.

Reason: Due to extenuating circumstances beyond the operation’s control. 

Produce Safety Rule 

112.164: Records are required to be kept for at least two years past the date the record was created. 

Requirement G-3.3.a. Food Safety Plan documentation and records shall be securely 

stored and effectively controlled.

Procedure The Food Safety Plan, documentation, and any records required to 

demonstrate the implementation of food safety are securely stored and 

effectively controlled.

Verification Auditor verifies that documentation and records are securely stored and 

effectively controlled.

Corrective 

Action

Operation stores their documentation and records in a secure location 

and implements effective controls for these records.

Documents 

Required

N/A.

Mandatory

Expectation 

Control of documented information required to demonstrate the effective operation and control of 

processes and the Food Safety Plan shall be established. Records should be stored in a manner to 

prevent intentional or unintentional changes to records (falsification). Records should be stored to 

prevent loss, deterioration, or destruction. 
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Example Scenarios 

Scenario: Food safety plan documentation is stored in the operation’s Food Safety Manager’s 

office, as well as records that have been completed. When asking to review this week’s pre-harvest 

risk assessment records you find out they are kept with the harvest crew manager in his pickup 

truck. 

Assessment: Compliant or Corrective Action Needed. 

Reason: It depends on what the SOP states. If in alignment with the SOP for records storage and 

the records are controlled within the truck, Compliant. If the SOP states all records, except for 

records currently in use must be kept in the office, Corrective Action Needed.

G-4 Worker Education and Training 

Worker education and training are essential to the effective implementation of a Food Safety Plan. 

This section addresses practices that must be implemented in an operation and verified at the time 

of the audit.

Requirement G-4.1. All personnel shall receive food safety training, appropriate to 

their job responsibilities.

Procedure All personnel shall receive training in the food safety policy and plan, 

food safety procedures, sanitation and personal hygiene appropriate to 

their job responsibilities. Personnel shall receive training at hire and 

refresher training at prescribed frequencies, and as needed. 

Documentation of training is available.

Verification Auditor reviews program of required training and examines training 

records for evidence of compliance.

Corrective 

Action

Operation shall develop and deliver required training.

Documents 

Required

Record.

Mandatory ●

PSR 112.21, 112.22 (a)(b); 112.30 (Rec)

Expectation 

All personnel in the operation must receive food safety training appropriate to their job 

responsibilities. For example, harvest workers should be familiar with the company’s safety, 

sanitation, and personal hygiene procedures specific to their jobs. An equipment operator 

responsible for the placement of bins in an apple orchard should be trained on food safety 

procedures related to placement of the harvest bins. All employees should be trained on the 

company’s general food safety policies, sanitation, and personal hygiene. 

Auditors will review the training records for each employee to assess training received when 

employees were hired and refreshers. The operation determines and must specify the frequency of 

refresher trainings. If an operation is only in production for a limited time each year (e.g., 

blueberries’ 4-week harvest), the company may decide to conduct only one annual training. The 
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auditor will include the title and topics covered by training and specify the records that show

training is current as of the date of the audit in the comments.

Example Scenarios

Scenario 1: A contract sanitation crew has documentation of food safety training from another 

operation.

Assessment: Compliant if food safety risks and controls for the harvest crew are the same at this 

operation; if not, then Corrective Action Needed.

Reason: The operation being audited must have reviewed the training received by the harvest crew 

and ensured it applies to this operation.

Scenario 2: Office staff does not attend food safety training.

Assessment: Corrective Action Needed.

Reason: Every employee at a grower operation must take food safety training. The operation must 

determine the level and frequency of food safety training for each employee/position.

Scenario 3: Employees say that they received “tailgate” food safety training; training materials are 

available for review; but there are no records of which individuals were trained or when.

Assessment: Corrective Action Needed.

Reason: The standard requires records of training.

Scenario 4: An operation’s “food safety training” for employees is comprised of handing out 

leaflets on proper practices once a year. No formal training is performed.

Assessment: Compliant.

Reason: So long as there is a record of who received the leaflets and this practice is compliant with 

the operation’s training policies/procedures, then it is compliant with the requirements of the 

standard.

Produce Safety Rule

112.21: All personnel (including temporary, part time, seasonal and contracted) who handle 

covered produce or food contact surfaces, or who are engaged in the supervision thereof,

(a) must receive adequate training, as appropriate to the person’s duties, upon hiring, and 

periodically thereafter, at least once annually, (b) must have a combination of education, training 

and experience necessary to perform the person’s assigned duties. (c)Training must be conducted in 

a manner that is easily understood by personnel being trained. (d) Training must be repeated as 

necessary and appropriate in light of observations or information indicating that personnel are not 

meeting standards of the Produce Safety Rule.

112.22: At a minimum, all personnel who handle covered produce or food contact surfaces, or who 

are engaged in the supervision thereof, must receive training that includes the following: (a) 

Principles of food hygiene and food safety, the importance of health and hygiene, including 

recognizing symptoms of a health condition that is reasonably likely to result in contamination of 

produce or food contact surfaces with human pathogens and those food safety requirements as 

appropriate to the person’s job responsibilities. (b) Additionally, harvest workers’ training must 

include recognition when produce should not be harvested, including produce that may be 

contaminated with known or reasonably foreseeable hazards; the inspection of harvest containers 
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for cleanliness and condition, and correcting problems with containers or equipment and reporting 

them. 

112.30: Records must be established and kept in accordance with Subpart O. PSR requires that 

records for training for food safety must contain dates of training, the training topics covered, and 

the names of people trained. 

Requirement G-4.2. Personnel with supervisory food safety responsibilities shall 

receive training sufficient to their responsibilities.

Procedure The individual designated for food safety responsibilities demonstrates 

knowledge of food safety principles. Food safety designate has 

completed at least one adequate food safety course/workshop, by job 

experience or as required by prevailing regulation.

Verification Auditor reviews the evidence of the individual’s training relevant to 

produce food safety, such as a degree or course certificate or receipt, or 

attendance at a relevant food safety meeting, company training record, 

and/or auditor interview. 

Corrective 

Action

Individual must obtain demonstrable food safety training.

Documents 

Required

Record.

Mandatory ●

PSR 112.22 (c); 112.23

Expectation 

The individual designated for food safety responsibilities who has related work experience in food 

safety, but no formal food safety training will be considered compliant for this question if the 

company meets USDA acceptance criteria for the audit, and also meets the standard of the 

prevailing regulation. The Produce Safety Rule is the prevailing regulation that is applicable to this 

requirement, which requires operations to have at least one supervisor or responsible party for the 

farm to successfully complete food safety curriculum at least equivalent to curriculum currently 

recognized by the FDA. One such curriculum is the Produce Safety Alliance training. One method 

of verifying this requirement is by reviewing the Certificate of Training for the Produce Safety 

Alliance training provided by the Association of Food and Drug Officials (AFDO), however a PSA 

certificate is not the only record that demonstrates compliance. 

Auditor includes training and/or certifications received which are applicable in the comments 

section of the audit report. 

Example Scenario 

Scenario: The designated food safety individual received food safety training at another company 

that is applicable to his current duties, but not since assuming responsibilities at this operation.

Assessment: Compliant. 

Reason: The standard does not require training to have been at this operation, but the individual is 

able to provide documentation of completed training and demonstrate its relevance to current job 
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duties. 

Produce Safety Rule 

112.22 (c): Requires covered operations to have at least one supervisor or responsible party for the 

farm to successfully complete food safety curriculum at least equivalent to curriculum currently 

recognized by the FDA. 

112.23: FDA requires that the operation assign or identify personnel to supervise (or otherwise be 

responsible for) the operation to ensure compliance with the requirements of the Produce Safety 

Rule.

Requirement G-4.3. Contracted personnel are held to the relevant food safety 

standards as they would be as employees.

Procedure Operation shall have procedures and/or records to demonstrate that 

contracted personnel whose activities can affect food safety have been 

informed of and, to the extent that can be verified, are in compliance 

with the relevant requirements of this standard.

Verification Auditor reviews operation’s evidence that contracted personnel are 

trained to the same food safety requirements as employees would be and, 

if practical during the audit, observes contracted personnel for 

compliance.

Corrective 

Action

Operation obtains evidence, trains or discontinues using contracted 

personnel.

Documents 

Required

Record.

Mandatory ●

PSR 112.21, 112.22 (a)(b); 112.30 (Rec)

Expectation 

In addition to observing contracted workers when possible, verify the training record of contractors, 

contracts or letters of guarantee, or statements in the contract/agreement that require contracted 

personnel to be aware of the audited company’s applicable food safety policies and procedures.

Example Scenarios

Scenario 1: Grower utilizes subcontractor for plant protection applications. The subcontractor does 

not provide evidence of water quality brought on site. 

Assessment: Corrective Action Needed

Reason: The subcontractor is not in compliance with water quality standards and requires 

retraining.

Scenario 2: Grower utilizes farm labor subcontractors and only has copy of current state license 

for each. 

Assessment: Corrective Action Needed
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Reason: Farm labor contractor licenses do not necessarily address all onsite food safety training 

requirements.

Produce Safety Rule 

112.21: All personnel (including temporary, part time, seasonal and contracted) who handle 

covered produce or food contact surfaces, or who are engaged in the supervision thereof, 

(a) must receive adequate training, as appropriate to the person’s duties, upon hiring, and 

periodically thereafter, at least once annually, (b) must have a combination of education, training 

and experience necessary to perform the person’s assigned duties. (c)Training must be conducted 

in a manner that is easily understood by personnel being trained. (d) Training must be repeated as 

necessary and appropriate in light of observations or information indicating that personnel are not 

meeting standards of the Produce Safety Rule. 

112.22: At a minimum, all personnel who handle covered produce or food contact surfaces, or who 

are engaged in the supervision thereof, must receive training that includes the following: (a) 

Principles of food hygiene and food safety, the importance of health and hygiene, including 

recognizing symptoms of a health condition that is reasonably likely to result in contamination of 

produce or food contact surfaces with human pathogens and those food safety requirements as 

appropriate to the person’s job responsibilities. (b) Additionally, harvest workers’ training must 

include recognition when produce should not be harvested, including produce that may be 

contaminated with known or reasonably foreseeable hazards; the inspection of harvest containers 

for cleanliness and condition, and correcting problems with containers or equipment and reporting 

them.

112.30: Records must be established and kept in accordance with Subpart O. PSR requires that 

records for training for food safety must contain dates of training, the training topics covered, and 

the names of people trained.

G-5 Microbiological Sampling and Testing

An operation does not need to conduct microbiological sampling and testing unless it is required in 

its Food Safety Plan. When microbiological sampling and testing are required, the operation must 

comply with the requirements in section G-5. If an operation’s Food Safety Plan requires 

microbiological testing that is not food-safety related, verify that the operation is conducting these 

tests in accordance with its plan. Common microbiological tests performed on the farm include 

water, soil, surface of equipment, and product testing. 
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Requirement G-5.1. Where laboratory analysis is required in the Food Safety Plan, 

testing shall be performed by a GLP laboratory using validated 

methods.

Procedure Operation utilizes laboratories that have, at minimum passed a Good 

Laboratory Practices (GLP) audit or participates in a Proficiency 

Testing program, and utilizes BAM, AOAC International or testing 

methods that have been validated for detecting or quantifying the target 

organism(s) or chemical(s).

Verification Auditor reviews operation’s evidence that only GLP laboratories and 

validated methods are used.

Corrective 

Action

Operation discontinues using non-GLP laboratory and non-validated 

testing methods.

Documents 

Required

Record.

Mandatory

Expectation 

Laboratory analysis required in a Food Safety Plan must be performed by a laboratory that: 1) 

passed a Good Laboratory Practices (GLP) audit or 2) participates in a proficiency testing program. 

A laboratory does not need to be accredited to meet this requirement, but if it is not, it does have to 

operate according to GLPs or participate in a proficiency testing program to be in compliance with 

this requirement. 

GLPs are a set of principles that provide a framework within which laboratory studies are planned, 

performed, monitored, recorded, reported, and archived. These studies generate data that are used 

to assess the hazards and risks of pharmaceuticals, agrochemicals, cosmetics, food additives, feed 

additives and contaminants, novel foods biocides, detergents, and other compounds.

Internationally, the Organization for Economic Co-operation and Development (OECD) 

(www.oecd.org) has developed GLP principles. In the United States, GLPs are regulated by the 

FDA in 21 CFR 58 and by the Environmental Protection Agency (EPA) in 40 CFR 160, in the 

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and 40 CFR 792, section 5 of the 

Toxic Substances Control Act (TSCA). Additional information on FDA’s GLPs is at: 

http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/default.htm. Additional 

information on EPA’s GLPs is at: http://www.epa.gov/compliance/good-laboratory-practicesstandards-compliance-monitoring-program. 

The operation is responsible for providing verification of the GLP status of the laboratory they use 

for microbiological sampling and testing. Verification may include GLP approval of the lab, a 

letter from the laboratory that attests to its GLP status, or evidence of GLP approval on the 

laboratory’s website.

Alternatively, a laboratory can provide evidence that they participate in a proficiency testing 

program for the type of analyte that they will be contracted to test for. Proficiency testing 

demonstrates that a laboratory is able to provide accurate results for a specific test or test type. 
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Proficiency testing programs occur on an ongoing basis and would need to be repeated at scheduled 

intervals as directed by the program. The operation is responsible for collecting and maintaining 

documentation that demonstrates that any laboratory they use adheres to these requirements. 

A laboratory also must use FDA’s Bacteriological Analytical Manual (BAM), Association of 

Official Analytical Chemists (AOAC) International, or other testing methods that have been 

validated for detecting or quantifying the target organism(s) or chemical(s). The FDA’s BAM

contains the agency’s preferred laboratory procedures for microbiological analyses of foods and 

cosmetics. More information about BAM is at: 

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006949.htm. AOAC

International is a globally recognized, independent, third-party, non-profit association and voluntary 

consensus standards developing organization. More information on AOAC standards for 

microbiological testing methods are at: https://www.aoac.org/. 

The operation may perform its own testing if 1) its laboratory operates according to GLPs, 

participates in a proficiency testing program, or is ISO 17025 certified; and 2) the testing performed 

is not required in the Food Safety Plan. The operation also may use its own proprietary testing 

methods if the methods are in compliance with the operation’s Food Safety Plan and are 

documented by the laboratory as being validated for the target organism(s). 

Municipal water is regulated by the Environment Protection Agency (EPA) through the National 

Primary Drinking Water Regulations: Revisions to the Total Coliform Rule; Final Rule, 40 CFR 

Part 141 and 142. Requirement 141.852 describes the acceptable analytical methods and laboratory 

certification for drinking water standards. USDA recognizes that these standards meet GLP and 

validated test methods. If an operation is only using municipal water, the documentation that an 

operation needs to provide to meet this requirement are the municipality’s water test results.

The auditor will include the name of the lab in the comments. If the lab is accredited, include the 

type of accreditation. 

Example Scenarios 

Scenario 1: The operation sends all microbiological testing to the State lab and has documentation 

that the State lab meets the requirements.

Assessment: Compliant. 

Reason: The operation has evidence that the laboratory conforms with the requirement. 

Scenario 2: The operation sends all microbiological testing to a laboratory that they describe as 

“ISO 17025 certified,” but has no documentation about the laboratory’s credentials.

Assessment: Corrective Action Needed. 

Reason: The operation must have evidence that the laboratory conforms to the requirement. 

Scenario 3: Records indicate that the operation’s laboratory is performing testing as required in the 

food safety plan but is using its own proprietary test methods. 

Assessment: Compliant or Corrective Action Needed. 

Reason: Compliant if the operation has documentation from the laboratory verifying the method 

has been validated for the organism and product being tested. Corrective Action Needed if no 
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documentation is available, or if the method has not been validated by the laboratory for the specific 

application. 

Scenario 4: The microbiological testing required in the Food Safety Plan is not really food safety, 

but some of the testing was not performed or recorded. 

Assessment: Corrective Action Needed. 

Reason: Even if they do not require a food safety test, the operation must follow its food safety 

plan and documentation. 

Requirement G-5.2. Where microbiological analysis is required in the Food Safety 

Plan, samples shall be collected in accordance with an established 

sampling procedure and prevailing regulations.

Procedure Operation utilizes a written sampling protocol when collecting samples 

for microbiological testing.

Verification Auditor observes that the operation has a sampling protocol for each 

type of microbiological testing required in the operation’s food safety 

plan.

Corrective 

Action

Operation develops or obtains written sampling protocols for each type 

of microbiological testing required in their Food Safety Plan.

Documents 

Required

Written policy.

Mandatory

Expectation 

Verify that the operation has written sampling protocols for all testing required in the Food Safety 

Plan and in accordance with prevailing regulations. For example, a protocol stating that the “QA 

will collect one irrigation water sample per week at random” would be in compliance with this 

requirement. This requirement does not apply to microbiological testing conducted by the operation 

that is not specified in the Food Safety Plan. 

Example Scenario 

Scenario: The operation has a written sampling protocol for all testing required in the food safety 

plan, but not for some other microbiological testing. 

Assessment: Compliant. 

Reason: The standard only applies to testing required by the food safety plan. 
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Requirement G-5.3. Testing, test results and actions taken must be documented.

Procedure All results for microbiological testing, including lab reports or 

certificates of analysis, required in the operation’s food safety plan shall 

be recorded and the records maintained for two years or as required by 

prevailing regulation.

Verification Auditor reviews operation’s recordkeeping of microbiological test 

results.

Corrective 

Action

Operation maintains for at least two years test records for all required 

microbiological tests.

Documents 

Required

Record.

Mandatory

Expectation 

Tests are not the same as analyses. A test is a procedure for critical evaluation; a means of 

determining the presence, quality or truth of something; or a basis of evaluation or judgment. An 

analysis is the separation of something into its constituents in order to find out what it contains, or 

the identification or separation of ingredients of a substance.

 

Verify that the operation maintains records for all microbiological tests required by its Food Safety 

Plan for a minimum of 2 years or as required by prevailing regulation. If the operation has been in 

production for less than 2 years or implemented its microbiological testing requirements less than 2 

years from the start of the audit, the auditor may mark this question as compliant so long as the 

operation’s required microbiological records are present at the time of an audit. If this is the case, 

include a comment explaining these circumstances. The operation would be compliant with this 

requirement if they started a new microbiological testing procedure within the last 4 months and 

they have records for those 4 months. 

The auditor will assess this question as Corrective Action Needed if there are incomplete records

for microbiological testing as specified in the Food Safety Plan, missing records, or records that are 

not available for review. Records of required testing must be kept but need not be the original 

records unless that is specified in the operation’s Food Safety Plan. For example, the operation may 

record only “pass” or “fail” in their in-house records and retain the original test results at the 

laboratory. If the operation’s Food Safety Plan specifies that the laboratory is responsible for 

maintaining testing records and providing them within 24 hours of being requested, the operation 

would be compliant with this requirement if the records are made available for review within 24 

hours of the onsite audit.

The auditor will include the type of testing required (e.g., soil, water, or Adenosine triphosphate 

(ATP) swabbing) and the testing method in the comments. 

Example Scenarios 

Scenario 1: The operation says that weekly microbiological testing was performed throughout the 

previous month, but records from the second week are missing and unavailable.

Assessment: Corrective Action Needed. 
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Reason: Testing records are required to be maintained and made available for review. 

Scenario 2: The operation began a new microbiological testing procedure 6 months ago and only 

has records for those 6 months.

Assessment: Compliant. 

Reason: The operation has all testing records for the tests that were conducted. Include a comment 

that testing and records have only been in place for 6 months. 

Scenario 3: The operation does not maintain in-house records, of test results; it relies on the 

laboratory to maintain all records.

Assessment: Compliant or Corrective Action Needed. 

Reason: Compliant if the operation can obtain the records in a reasonable timeframe (e.g., 24 hr.). 

Corrective Action Needed if the records cannot be provided within a reasonable timeframe. 

Requirement G-5.4. All required testing shall include test procedures and actions to be 

taken based on the results.

Procedure For all microbiological testing required by the Food Safety Plan, 

operation has a written testing procedure that includes test frequency, 

sampling, test procedures, responsibilities and actions to be taken based 

on results. If finished product is tested for pathogens or other 

adulterants, operation’s procedures require that it shall not be 

distributed outside the operation’s control until test results are obtained.

Verification Auditor reviews the operation’s microbiological testing procedures for 

completeness.

Corrective 

Action

Operation revises testing procedures for completeness and to meet 

expectation of the food safety plan.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

Verify that the operation has written procedures for all microbiological testing required by the Food 

Safety Plan. Each written microbiological testing procedure must include test frequency, sampling, 

test procedures, and actions to be taken based on results.

The operation’s procedures must require that all finished product tested for pathogens or other 

adulterants not be distributed outside of the operation’s control until test results are obtained. For 

Field Operations and Harvesting audits, finished products include any product that is packaged in 

the field, such as berries packed in clamshells, lettuce packed in cartons, and melons packed in bins.

The operation’s plan should specify its control policy for finished products. For example, a 

company may ship product before receiving test results if the operation can retain control of the lot 

until the results are obtained and can guarantee 100 percent stock recovery. A Corrective Action 

Needed is required if the company is not able to complete a total recall if records indicate that 

pathogen-positive product was shipped. 
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Additionally, if the operation tests finished product for pathogens, it must have policies and 

procedures for testing whole lots, not just portions of a lot. For example, corrective action would be 

needed if the operation holds a portion of a lot for a customer who requires testing and ships the 

remainder of the lot prior to receiving test results. Action is needed because the pathogen-positive 

result will reflect the entire lot unless there is scientific rational for why the sublots differ.

Corrective actions for any non-conformance to Requirement G-5.4 must include a revision of 

testing procedures to ensure they fully meet the Food Safety Plan’s requirements. This requirement 

should be assessed as Immediate Action Required if the operation’s corrective action to a positive 

test result is to retest the lot, the second test result for the lot is “negative,” and the operation 

considers the first test result a false positive. A positive test result cannot be overturned by a 

negative test result unless the operation demonstrates a laboratory error on the first test. The 

operation’s policy must be changed to require action on the initial test result.

If thresholds are exceeded, the auditor will include the operation’s threshold criteria, the test results, 

and what actions are taken based on the results in the comments. 

Example Scenarios

Scenario 1: The Food Safety Plan does not require product testing, and no testing of product is 

performed. 

Assessment: Not Applicable 

Reason: The standard does not require product testing unless required by the Food Safety Plan. 

Scenario 2: The operation retains records of results of tests required by the Food Safety Plan, but 

has no documentation of the test frequency, test procedures, responsibilities or actions to be taken 

based on results. 

Assessment: Corrective Action Needed. 

Reason: The standard requires that “the operation has a written testing procedure that includes test 

frequency, sampling, test procedures, responsibilities and actions to be taken based on results”. 

G-6 Traceability

Traceability, or traceback, is the ability to track food items back to their source. A traceback system 

cannot prevent the occurrence of a microbiological hazard that may lead to an outbreak of 

foodborne disease, but can complement good agricultural and management practices intended to 

prevent the occurrence of food safety problems. Information gained from a traceback investigation 

also can help identify and eliminate a hazardous risk pathway. 

The FDA’s Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables also 

recommends that producers be able to track product forward throughout the marketing chain, 

including through retail channels to the consumer. Consider any and all reliable methods that an 

operation may use to track product. 
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Some crop groups commingle various growers’ product prior to packing. This commonly occurs 

with tree fruit, tomatoes, and potatoes. When commingling occurs, assess whether or not the 

product can be traced to a reasonably sized group of growers and/or harvest dates. 

Requirement G-6.1. A documented traceability program shall be established.

Procedure Records that enable reconciliation of product delivered to recipients 

(one step forward) shall be maintained except for direct to consumer 

sales. Records shall be maintained that link product with source of the 

produce or production inputs, e.g., soil amendments, fertilizers, 

seeds/transplants, agricultural chemicals, homemade preparations (one 

step backward). Records shall include the date of harvest, quantities, 

farm identification (field or block), transporter and non-transporter. 

Additional information may be included. Contents and retention of 

records shall be consistent with applicable regulations. If using reusable 

containers, procedures ensure that labels are accurate prior to packing.

Verification Auditor reviews traceability program and verifies operation’s ability to 

trace product accurately one step forward and one step back.

Corrective 

Action

Operation establishes an effective traceability program.

Documents 

Required

Written Policy, Record.

Mandatory ●

Expectation 

There is no expectation that traceability must be done a specific way. It is up to the operation to 

determine the traceability system used in their operation. Auditors must verify that all operations 

have a traceability program that, at a minimum, allows a traceback investigation to follow the 

product both forward and backward at least one level in the marketing chain. The traceability 

program must be used for all fresh produce listed in the audit and grown or harvested by the 

operation. A traceability program outlines the controls and record keeping internal to an operation 

– the ability to track where they received a product from and where they moved a product to – 

tracking the product beyond this is beyond the responsibility of the operation (unless specifically 

written into the requirements of their Food Safety Plan). 

Documentation, either paper or electronic, must be accessible during the audit and in case of a 

traceback investigation. 

Verify “one step forward” by ensuring the operation’s records are maintained in a way that allows 

for reconciliation of all product delivered to recipients, except for direct consumer sales. 

Reconciliation may include a comparison of the operation’s records of where the product was sent, 

what is in the marketplace, how much product is remaining for sale, how that product will be 

handled, and how much has been sold or destroyed. 

Direct-to-consumer sales are those made by the farm directly to a consumer via farm stand sales, 

community supported agriculture (CSA) sales, and you-pick operations. In the event that a post-
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harvest operation supplies product to a farm stand or CSA, records tracing the product from the 

post-harvest operation to the farm stand or CSA are required. Operations with only one customer 

are exempt from the trace-forward requirement.

Verify “one step backward” by ensuring the operation’s records are maintained in a way that shows 

the links between a product and its source or production inputs. Verify that production inputs 

include any physical factors used in the production of the produce, such as soil amendments, 

fertilizers, seeds/transplants, agricultural chemicals (pesticides and herbicides), and homemade 

preparations. Also verify that records include the date of harvest, quantity harvested, farm 

identification (field or block), and transporter. Operations with only one supplier are exempt from 

the traceback requirement.

Verify the traceability program is functioning as specified in the Food Safety Plan. This may 

include verifying additional information used in the traceability of the product such as bin tags, 

harvest slips accompanying gondolas of fruit, pallet tags, or stickers used on cartons.

One way to verify that the operation’s traceability system is effectively established and operating is 

to trace the product being harvested to its end destination in the operation being audited. For 

example, when auditing a blueberry growing operation where blueberries are harvested directly into 

clamshells and placed in flats that are palletized in the field, ask the food safety manager or harvest 

crew manager to explain the system for designating how the lot being harvested is identified in the 

field (e.g., row number, block number, or field name) and the meaning of the coding on the stickers 

used on each pallet. You can then follow the code from a pallet that was previously harvested 

though the company’s records forward to distribution and backward to the agricultural inputs used 

in the production of that lot.

Example Scenarios

Scenario 1: A tomato operation can trace product forward to all customers and can traceback most 

agricultural inputs but cannot traceback to where and when transplants are sourced.

Assessment: Corrective Action Needed

Reason: The traceback is incomplete because it does not include all of the required documentation.

Scenario 2: Some of an operation’s product is sold to consumers at a farmer’s market and the 

remainder is sold to a broker. Records indicate the product, date and amount sold at/to each, but 

does not include the names of the consumers who bought at the farmer’s market.

Assessment: Compliant

Reason: The standard does not require traceability records on “direct to consumer sales”.
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Requirement G-6.1.a. Packaging must include product identification.

Procedure Operation must include product identification on all packaging. The 

product identification at a minimum must include the name and address 

of the farm, packer, or distributor of the produce and meet the 

requirements of the prevailing regulation.

Verification Auditor reviews the product identification on all packaging.

Corrective 

Action

Operation establishes product identification on all packaging.

Documents 

Required

N/A.

Mandatory

Expectation 

Auditor is responsible for checking packaging used by operation. Packaging identification must 

include the name and address (street address or post office box, city, state and zip code) of the farm, 

packer or distributor of the produce, country of origin and meet the requirements of any prevailing 

regulations.

Example Scenario 

Scenario: Operation is packing produce into 5 lb. bags. The 5 lb. bag has a clip with the grower’s 

code, indicating location and date packed and grower’s logo. The 5 lb. bag has the product 

description, distributors name and address on the bag. The 5 lb. bags are packed into master 

containers with no identification on the master container.

Assessment: Corrective Action Needed, all packaging must be identified.

Requirement G-6.1.b. If product is intended for export, product meets labeling 

regulations of the country(ies) the product is being exported to. 

Procedure Product shall be labeled according to the applicable regulations in the 

country(ies) in which the product is intended to be sold, if known during 

production.

Verification Auditor reviews operation’s procedure for ensuring adherence to food 

labeling regulations in country(ies) of destination. If the country of 

destination is unknown during production, this item is not applicable.

Corrective 

Action

Operation develops procedures, and diverts non-compliant product to a 

market in which the product meets standards.

Documents 

Required

N/A.

Mandatory

Expectation 

This requirement is only applicable if it is known that the product is intended for export. It is the 

operation’s responsibility to know the labeling regulations in the country of destination. These 

labeling regulations could include allergens, genetically modified organisms (GMOs), warnings, 

organic, or other claims.
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Example Scenario 

Scenario: The auditee sells their product through a broker and does not know the final customer 

for the product.

Assessment: Not Applicable. 

Reason: This question is not applicable if it is not known that the final destination is international. 

Requirement G-6.1.c. If a post-harvest operation supplies product to a farm stand or 

Community Supported Agriculture (CSA), records tracing the product 

from the post-harvest operation to the farm stand or CSA are required.

Procedure In the event that a post-harvest operation supplies product to a farm 

stand or CSA, records tracing the product from the post-harvest 

operation to the farm stand or CSA are required.

Verification Auditor reviews operation’s traceability records.

Corrective 

Action

Operation develops procedures and keeps traceability records for 

product supplied to a farm stand or CSA. 

Documents 

Required

Record.

Mandatory

Expectation 

Direct-to-consumer sales are those made by the farm directly to a consumer via farm stand sales, 

community supported agriculture (CSA) sales, and you-pick operations. In the event that a postharvest operation supplies product to a farm stand or CSA, records tracing the product from the 

post-harvest operation to the farm stand or CSA are required. Operations with only one customer 

are exempt from the trace-forward requirement.

Example Scenario 

Scenario: The packinghouse has a roadside stand where they sell produce. During the audit it is 

asked if the operation has records of what product supplies the road-side stand. The auditee states 

that they don’t keep a record, just randomly pull product as they need it. 

Assessment: Corrective Action Needed. 

Reason: Records tracing the product from the post-harvest operation to the farm stand are required. 
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Requirement G-6.2. A trace back and trace forward exercise shall be performed at 

least annually. 

Procedure The trace back and trace forward exercise shall achieve accurate 

traceability within 4 hr. or as required by applicable regulations. Trace 

exercise shall achieve 100% reconciliation of product to recipients.

Verification Auditor reviews records of most recent trace exercise. If no trace 

exercise was performed in the past year, the operation will perform the 

exercise during the audit.

Corrective 

Action

Operation performs exercise and/or improves traceability program to 

achieve accurate reconciliation.

Documents 

Required

Record.

Mandatory

Expectation

Verify that a traceback or trace-forward exercise has been performed within the past year. If not, 

the operation must perform a trace exercise during the audit. A traceback or trace-forward exercise 

is not the same as but, may be a part of a recall or mock recall. Since the traceability program is an 

internal accounting of where an operation received/sent product, a traceability exercise would test 

the operation’s own ability to track product without needing to contact customers and/or suppliers. 

Check the status of the trace exercise early in the audit to provide the auditee with as much 

opportunity as possible to conduct the trace exercise during the audit. 

This question may be answered as Not Applicable if the operation ships all of its product to only 

one customer. Include the date and product(s) of last traceback and trace-forward exercise, and the 

effectiveness of the reconciliation within the four hours or as required in the comments. 

Example Scenario

Scenario: Operation’s trace program requires them to obtain 100 percent reconciliation within 2 

hours but records indicate the last exercise required 3 hours. 

Assessment: Corrective Action Needed. 

Reason: While the operation achieved the requirements of the standard, they did not achieve their 

internal standard.

G-7 Recall Program

A “recall” is an action that returns marketed product to its origin and removes it from the 

marketplace. A “mock recall” is a practice exercise used to determine where product is shipped, 

and whether it can be returned to origin or removed from the marketing chain. A recall program is:

• Governed by written procedures, 

• Documented by records (including those of a recall or mock recall conducted by the 

operation), 
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• Includes a trace exercise, and 

• Assigns a designated recall team.

Requirement G-7.1. A documented recall program, including written procedures, 

shall be established.

Procedure The recall program shall have a designated recall team. A mock recall 

exercise shall be performed at least annually at the operation being 

audited. The mock recall shall include the trace back and trace forward 

exercise and shall be completed as stated in the program and in 

compliance to applicable regulations.

Verification Auditor reviews records of most recent mock recall performed at the 

operation.

Corrective 

Action

Operation develops and implements corrective actions procedures.

Documents 

Required

Written Policy, Record.

Mandatory ●

Expectation 

Verify that the operation has a recall program in place governed by written procedures, with 

documented records. The written procedures shall include directions on direct customer 

notification about the product being recalled, including how to withdraw, return, dispose or divert 

the affected product; public notification about any hazard presented by the product; effectiveness 

checks to verify that the recall was carried out. The written procedures should define each step of 

the recall process and clearly describe what needs to be done and who is responsible for carrying 

out the task.

The operation shall have a designated a recall team, and can demonstrate, through an annual mock 

recall exercise, that it can identify all affected product, verify contact information for all affected 

customers and the prevailing public health authority, and comply with all regulatory and legal 

obligations. The mock recall must include the traceback and trace-forward exercise and must be 

completed as stated in the recall program and in compliance with applicable regulations. The 

operation may contact its customers to verify contact information is current but not advise them that 

their contact is for a mock recall and still be in compliance with this requirement. An actual recall 

may replace the mock recall.

A designated recall team includes individuals identified in the recall plan who will be assigned tasks 

during a recall. Typically, the team includes individuals who are the most knowledgeable about the 

distribution of the product and can obtain the necessary information accurately and quickly. A 

single person may comprise the “team”; there is no minimum number of team members and the 

team may include non-company consultants. 

This requirement may be answered N/A and the operation can be cleared of recall responsibilities if 

the operation can produce documentation from its sole customer (e.g., cooperative packinghouse) 
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specifying that the customer has a recall team and is responsible for performing any recalls of their 

product. The auditor will include the date of the last actual recall or mock recall in the comments 

section.

Example Scenarios 

Scenario 1: During a mock recall, the operation contacts its customers to verify contact 

information is current but does not tell them it is for a mock recall.

Assessment: Compliant. 

Reason: Verifying contact information is current is expected; advising the customer that the 

information is needed for a mock recall is not required.

Scenario 2: In reviewing the recall procedures, the auditor does not see any personnel assigned to 

the recall team. When questioning the Auditee about the recall team he stated, “No one is 

designated to do recalls.” 

Assessment: Corrective action needed.

Reason: Operation shall have a designated recall team.

Requirement G-7.1.a. The recall program written procedures must include specifications 

for the recall process including direct customer and public notifications as 

well as steps for verification and responsibilities.

Procedure These specifications must address internal and external details of the 

recall process to include:

 Direct customer notification about the product being recalled, 

including how to withdraw, return, dispose or divert the affected 

product.

 Public notification about any hazard presented by the product

 Effectiveness checks to verify that the recall was carried out.

 Definition of each step of the recall process and clearly describe 

what needs to be done and who is responsible for carrying out the 

task.

Verification Auditor reviews the written recall procedures for completeness of 

required specifications.

Corrective 

Action

Operation develops written recall procedures.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

Verify that the operation has a recall program in place governed by written procedures, with 

documented records. The written procedures shall include directions on direct customer 

notification about the product being recalled, including how to withdraw, return, dispose or divert 

the affected product; public notification about any hazard presented by the product; effectiveness 

checks to verify that the recall was carried out. The written procedures should define each step of 
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the recall process and clearly describe what needs to be done and who is responsible for carrying 

out the task.

Example Scenario 

Scenario: When reviewing the operation’s recall procedures, it is noted that steps are listed which 

outline what to do with the product that is being recalled and whose responsibility it is to carry out 

the task. 

Assessment: Compliant. 

Reason: The written procedures define each step of the recall process and clearly describe what 

needs to be done and who is responsible for carrying out the task. 

G-8 Corrective Actions and Food Safety Incidents 

Corrective Actions are taken to rectify a non-conformance with the food safety plan that is observed 

within the operation or during an audit. 

Requirement G-8.1. The operation shall have documented corrective action 

procedures.

Procedure A documented Corrective Action is required for an observation or audit 

that contains a non-conformance with food safety requirements. The 

responsibility, methods, and timelines to address Corrective Actions 

shall be documented and implemented.

Verification Auditor reviews corrective action procedures and examines records for 

evidence of compliance.

Corrective 

Action

Operation develops and implements corrective action procedures.

Documents 

Required

Written Policy, Record.

Mandatory ●

Expectation 

Verify that operations have a corrective action procedure to address any non-conformance with the 

Food Safety Plan that is observed at the operation or during an audit. The procedure must be 

written and must specify the individual(s) responsible for corrective actions, the methods used to 

document and implement corrective actions, and the timeframe in which corrective actions will be 

addressed. The operation decides how best to address corrective actions. To address a corrective 

action, the operation may simply acknowledge that the non-conformance exists and, if it is not a 

major food safety concern, may choose to accept the risk of not correcting the non-conformance.

Example Scenarios 

Scenario 1: A Corrective Action addresses more than one cause for a nonconformity.

Assessment: Compliant. 

Reason: The Corrective Action must include cause analysis and address all correctable causes of 

the nonconformity. 
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Scenario 2: The operation has written corrective action procedures, but there are no records of 

corrective actions.

Assessment: Compliant or Corrective Action Needed. 

Reason: Compliant if there is no evidence that corrective actions have been needed in the past 2 

years. Corrective Action Needed if there is evidence that corrective actions have been needed in the 

past 2 years but there is no record of them. 

Requirement G-8.1.a Corrective action procedures shall include a procedure to 

evaluate complaints.

Procedure For the purpose of preventing recurrence, there shall be a documented 

corrective action procedure to evaluate food safety related complaints, 

and to investigate non-conformities. It shall include a plan to address the 

issue; a plan to prevent recurrence; and demonstration of the evidence 

of effectiveness. The time frame necessary for corrective action shall be 

documented. Objective evidence shall demonstrate that the procedure is 

effective.

Verification Auditor shall verify the operation has a procedure to evaluate 

complaints.

Corrective 

Action

The operation shall develop a procedure for evaluating complaints.

Documents 

Required

Written Policy.

Mandatory

Expectation 

The operation must have a documented system in place to address complaints from customers. This 

system must address and evaluate complaints. The system shall include a plan to address the issue, 

a plan to prevent reoccurrence, and be able to demonstrate evidence of effectiveness. This must 

include the time frame necessary for corrective actions.

Example Scenario 

Scenario: An operation received a customer complaint about a piece of metal being found in a bag 

of spinach. Following their written procedure for complaints, they recorded this incident in their 

corrective action log which documents the date the complaint was received, the complaint, and the 

date the incident occurred, the lot number for the spinach.

Assessment: Corrective Action Needed.

Reason: The operation needs to evaluate and investigate the complaint, have a plan to address the 

issue, have a plan to prevent reoccurrence, demonstrate that this plan is effective, and establish a 

timeframe needed for there to be evidence of corrective action.
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Requirement G-8.1.b. Food safety incidents are recorded and assessed to determine 

severity and risk, and are addressed according to a documented food 

safety incident management procedure.

Procedure A food safety incident management procedure shall be in place. Relevant 

staff shall be aware of their obligations in case of an incident. Incidents 

which could lead to unsafe or non-conforming product are recorded and 

assessed in a timely manner to establish their severity and consumer 

risk. Corrective actions are taken and documented.

Verification Auditor verifies operation has a food safety incident management 

procedure, that food safety incidents are recorded and assessed, and risk 

is addressed by the operation accordingly.

Corrective 

Action

A food safety incident management mechanism will be implemented. 

Staff is trained to record and assess the severity of risk and to respond 

accordingly.

Documents 

Required

Record.

Mandatory

Expectation 

The operation needs to have a policy which requires that incidents which could lead to unsafe or 

non-conforming product are recorded and assessed in a timely manner to establish their severity and 

consumer risk. Corrective actions are taken based on the risk assessment and documented. For 

example, a worker doesn’t wash their hands and starts to handle product. The operation catches it, 

and takes immediate action to remove the worker from the line, remove the handled product from 

the line, and cleans and sterilizes the line. This would need to be documented to show what actions 

were taken, what the disposition of the product was, and what steps were taken to reduce the chance 

of the incident happening again. If the auditee states that they had no incidences to document, 

auditor should document this on the audit report.

Example Scenarios 

Scenario 1: A harvest worker cuts himself with a knife while harvesting broccoli. The worker 

stops, notifies the harvesters and harvest crew leader of the contaminated produce. The crew leader 

follows the operation’s SOP for injuries and contamination of produce. This injury and potential 

contamination are written up in the operation’s Incident Management log. 

Assessment: Compliant. 

Reason: The operation is following their SOPs and Food Safety Plan to manage the incident of the 

worker’s injury. 

Scenario 2: Operation is harvesting potatoes when a hydraulic line bursts. Operation stops 

harvesting, fixes the hydraulic line, segregates the area in the field by marking with do not enter 

ribbon. Operation continues with harvest but avoids contaminated area. Harvest operator contacts 

appropriate, personal to remove contaminated soil and product, as stated in the SOP’s. Incident is 

documented. Section of field is taken out of production until testing concludes that area is safe for 

food production. 
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Assessment: Compliant 

Reason: Operation followed SOP’s to remove contaminated product and prevent future 

contamination. 

Requirement G-8.1.c. The documented incident management procedure is reviewed, 

tested and verified at least once a year.

Procedure An annual review is conducted of the overall documented incident 

management procedure, including a review of records and corrective 

actions related to any food safety incidents that occurred. If there has 

been no food safety incident in the previous year, a mock incident 

management exercise has been conducted by the operation to test the 

existing system. Any identified deficiencies in the incident management 

system have been corrected.

Verification Auditors verify that the operation has conducted an annual review of the 

operation’s incident management procedure. Auditor will verify 

records.

Corrective 

Action

Operation implements an incident management review procedure which 

is tested and verified annually. Training of personnel responsible for 

implementing the incident management procedure may need to occur.

Documents 

Required

Written Policy, Record.

Mandatory

Expectation 

Each operation must have a food safety incident management procedure as specified in requirement 

G-8.1.b. This procedure must minimally be tested and verified by the operation at least once 

annually. A mock exercise may be used to test this system.

The auditor will include the date of the annual review and the date of the actual incident or mock 

incident exercise in the comments. 

Example Scenarios 

Scenario: The operation has a documented incident management procedure. It is reviewed and 

tested on a quarterly basis.

Assessment: Compliant. 

Reason: The minimum requirement is that the food safety incident management plan is tested on 

an annual basis. This operation reviewed and tested their food safety incident management plan 

more frequently than required.
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Requirement G-8.2 Non-conforming product on hold for food safety is clearly 

identified and segregated from other products and packaging materials.

Procedure Operation has a written procedure to clearly identify and segregate onhold, quarantined, and rejected product and materials when held for 

food safety reasons, to prevent commingling with other products or 

adulteration of products, production area, or packaging materials.

Verification Auditor reviews procedure, reviews logs and observes all currently onhold, quarantined, and rejected materials for compliance with 

procedure. 

Corrective 

Action

Non-compliances are corrected on site. If on-hold, quarantined or 

rejected materials are not segregated according to procedure, operation 

shall assess potential for product adulteration. Procedures are developed 

or revised. Retraining is performed.

Documents 

Required

Written Policy, Record.

Mandatory ●

Expectation 

An operation must have clear, written procedures on how to identify and handle potentially 

contaminated or non-conforming product (including non-GAP certified product) and product 

packaging within their operation. These procedures may be a specific holding area while product 

awaits disposition, but could also be accomplished through labeling/identification, or any other 

method to prevent unintended use or delivery, or misrepresentation of product.

Example Scenarios 

Scenario 1: Lettuce comes in from the field to the cooler. Upon receipt, the shipping manager 

notices that the top carton of the pallet of lettuce has one box with bird feces on the top. Following 

the operation’s SOP, the pallet is segregated to the operation’s hold area for further inspection. 

Assessment: Compliant. 

Reason: The adulterated product was segregated from non-adulterated product.

Scenario 2: During an audit of a broccoli field, employees were having their break. One employee 

was observed not washing his hands. Employees returned to their harvesting stations and started 

harvesting. Auditor informed field supervisor of the employee not washing his hands. Field 

supervisor stops the harvest and removes/segregates all produce from the harvesting machinery and 

makes every employee return to wash station to wash hands and disinfect their knives before 

continuing with harvest. All produce that was suspected to be contaminated was destroyed.

Assessment: Compliant 

Reason: Operation was following their SOP’s.

G-9 Self-Audits

Self-audits are tools that operations must use for continuous improvement and to assess their 

compliance with the Produce GAPs Harmonized Food Safety Standard. 
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Requirement G-9.1. The operation shall have documented self-audit procedures.

Procedure Internal audits will be conducted at a minimum annually by an assigned 

individual utilizing this standard to assist in the self-audit. All aspects of 

the operation’s food safety plan will be audited and a written record of 

required corrective action will be documented.

Verification Auditor reviews internal audit procedures and examines records for 

evidence of compliance.

Corrective 

Action

Operation develops and implements internal audit procedures.

Documents 

Required

Record.

Mandatory

Expectation 

Verify that the self-audit evaluated the requirements of the Harmonized Standard. The format of 

the self-audit is not specified; the operation may use the USDA Produce GAPs Harmonized Food 

Safety checklist to conduct its self-audit or another format, at its discretion, so long as the self-audit 

covers all aspects of the operation’s Food Safety Plan. The Harmonized Standards requirements 

must be a part of the self-audit. The operation may also include non-food safety items in their selfaudit.

The auditor will include the date and the role/title of the person who performed the annual self-audit 

in the comments.

Example Scenarios 

Scenario 1: Operation uses USDA Produce GAPs Harmonized Plus+ Food Safety checklist to 

conduct their self-audit, for their Harmonized Plus+ audit.

Assessment: Compliant 

Reason: Harmonized Plus+ Checklist covers all aspects of the operation’s Food Safety Plan. 

Scenario 2: Operation that is preparing for a GAPs Harmonized Plus+ audit is using the GAP/GHP 

audit checklist for their self-audit.

Assessment: Corrective Action Needed

Reason: The GAP/GHP audit checklist does not cover all aspects of the GAPs Harmonized Plus+ 

audit criteria.

G-10 Worker Health and Hygiene, and Toilet/Handwashing Facilities 

Worker health and hygiene, and the availability, use, and maintenance of toilet/handwashing 

facilities are essential components to minimizing food safety risks. Operations must take measures 

to prevent ill or infected persons from contaminating produce with human pathogens. 
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Requirement G-10.1. Operation shall have a policy for toilet, handwashing, hygiene, 

and health.

Procedure Each operation shall establish written policies for their specific 

operations, which shall be in compliance with prevailing regulations for 

Worker Health and Hygiene Practices.

Verification Auditor ensures that policies for toilet, handwashing, hygiene and health 

exist.

Corrective 

Action

Operation develops written policies covering toilets, handwashing, 

hygiene and health.

Documents 

Required

Written Policy.

Mandatory ●

PSR 112.129; 112.130; 112.31; 112.32; 112.33

Expectation 

Verify the operation has documented policies in place that cover the number, cleanliness, and 

maintenance of toilet/handwashing facilities, hygiene practices (e.g., handwashing), and employees’ 

health (e.g., human communicable diseases, injuries, and sickness). These policies must be 

available onsite for your review during the audit. They also must be specific to the operation being 

audited and in compliance with prevailing regulations for worker health and hygiene. 

Information on current Federal regulations are in Appendix I, II, and III of this document; 

familiarize yourself with state and local regulations related to worker health and hygiene.

Example scenario

Scenario: Operation has a policy that covers workers’ hygiene, toilets, and handwashing. 

Assessment: Corrective Action Needed

Reason: Policy does not cover workers’ health (communicable diseases, injuries and sickness.)

Produce Safety Rule 

112.129: (a) The operation must provide personnel with adequate, readily accessible toilet 

facilities, including toilet facilities readily accessible to growing areas during harvesting activities. 

(b) They must be designed, located and maintained to (1) Prevent contamination of produce, food 

contact surfaces, production and growing areas, water sources and water distribution systems with 

human waste; (2) 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; (3) Provide for the 

sanitary disposal of waste and toilet paper. (c) If growing activities take place in a fully-enclosed 

building, hand-washing stations must be in sufficiently close proximity to toilet facilities to make it 

practical for people to wash their hands. 

112.130: (a) The operation must provide personnel with adequate, readily accessible hand-washing 

facilities in a fully enclosed building or during harvesting, packing or holding activities. (b) 

Handwashing facilities must be stocked with soap (or other effective surfactant), running water 

which has no detectible generic E. coli in 100 mL of water and adequate drying devices (such as 
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single service towels, sanitary towel service or electric hand dryers). (b) The operation must 

provide for appropriate disposal of waste (for example, waste water and used single-service towels) 

associated with a hand-washing facility and take appropriate measures to prevent waste water from 

a hand-washing facility from contaminating covered produce, food contact surfaces, growing and 

production areas, water sources and water distribution systems with human waste. 

112.131: (a) The operation must dispose of sewage into an adequate sewage or septic system or 

through other means. (b) The sewage and septic systems must be maintained in a manner, as well 

as (c) Leakages or spills must be managed and disposed in a manner that prevents contamination of 

produce, food contact surfaces, growing and production areas, agricultural water sources and water 

distribution systems with human waste. 

112.32: All personnel who come into contact with produce or food contact surfaces must maintain 

adequate personal cleanliness, avoid contact with animals other than working animals, and take 

appropriate steps to minimize contamination of produce when in direct contact with working 

animals, wash hands thoroughly, use gloves in intact or sanitary condition, removing or covering 

jewelry that cannot be adequately cleaned or sanitized and refraining from eating, chewing gum, or 

using tobacco products in production areas. 

112.33: All visitors must be aware of the operation’s Health and Hygiene policies and procedures, 

as well as have access to toilet and hand-washing facilities.

Requirement G-10.2. Employees and visitors shall be made aware of and follow all 

personal hygiene practices as designated by the operation.

Procedure Operation’s hygiene policies shall apply to all employees, contractors, 

visitors, buyers, product inspectors, auditors, and other personnel in the 

field. The operation shall designate competent supervisory personnel to 

ensure compliance by all workers, visitors, and field personnel with the 

requirements in this section.

Verification Auditor observes personnel in field for evidence of compliance. Auditor 

notes whether s/he was informed of the policy.

Corrective 

Action

Retraining is performed and documented. Affected product is evaluated 

for potential contamination and disposition.

Documents 

Required

N/A.

Mandatory ●

PSR 112.32; 112.33

Expectation 

All onsite employees and visitors at the operation must be made aware of and follow all personal 

hygiene practices required by the operation, including handwashing. Proper sanitation and hygiene 

practices include maintaining adequate personal cleanliness; avoiding contact with animals other 

than working animals and taking appropriate steps to minimize contamination of produce when in 

direct contact with working animals; handwashing; appropriately maintaining/replacing gloves, if 

used; removing or covering hand jewelry that cannot be sanitized; refraining from eating, chewing 
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gum or using tobacco products in areas where produce is handled. Not all of these practices are 

applicable to every operation. The operation should establish and follow those that apply.

The operation must demonstrate reasonable effort to instruct visitors on personal hygiene practices. 

For example, the operation may require visitors to check-in and enter the premises through the 

office, they may post signs in the field stating, “all visitors must check in at the office prior to 

coming onto property.” Some companies may ask visitors to sign-in before entering. Each of these 

is an indication that the facility requires certain hygiene and sanitation practices.

In addition, hygiene requirements must be reinforced through continual periodic reviews of 

employee/visitor habits, training sessions, requirements for attire/uniforms, and other means. A 

statement on hygiene by company management at an orientation session, in an employee handbook, 

or on posted signs is not sufficient. Continual review and follow-up are needed for this to be 

considered a “required process.”

Review company procedures and policies to determine whether there is an established policy and 

what it covers. Auditors are held to the same standard as a visitor and should be asked to go 

through the same procedures required of other visitors. If not, this is a good indication that such 

hygiene practices are not required or appropriately emphasized. 

Example Scenarios 

Scenario 1: You observe a customer leaving toilet facility without washing hands. Supervisor reinstructs customer on handwashing requirements.

Assessment: Compliant - if the operation had instructed the customer about proper handwashing 

before the observed event.

Reason: The operation’s policy and procedures for monitoring and correcting the improper 

handwashing are observed to be working.

Scenario 2: The operation has posted signs around the field with “all visitors must check in at the 

office prior to coming onto property.” In the office, visitors are instructed in safe practices. Utility 

workers are demanding the right to come onto property without notifying the operation, so the 

operation has no opportunity to instruct or monitor the workers in the field.

Assessment: Compliant.

Reason: The operation has demonstrated a reasonable effort to instruct visitors and has no control 

over the utility workers.

Produce Safety Rule

112.32: All personnel who come into contact with produce or food contact surfaces must maintain 

adequate personal cleanliness, avoid contact with animals other than working animals, and take 

appropriate steps to minimize contamination of produce when in direct contact with working 

animals, wash hands thoroughly, use gloves in intact or sanitary condition, removing or covering 

jewelry that cannot be adequately cleaned or sanitized and refraining from eating, chewing gum, or

using tobacco products in production areas.

112.33: All visitors must be aware of the operation’s Health and Hygiene policies and procedures, 

as well as have access to toilet and hand-washing facilities.
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Requirement G-10.3. Toilet facilities and restrooms shall be designed, constructed, 

and located in a manner that minimizes the potential risk for product 

contamination and are directly accessible for servicing.

Procedure Toilet and handwashing facilities are situated during operation and 

servicing, and maintained so as not to pose a hazard to the produce or 

other opportunity for contamination. Restrooms are located away from 

produce handling areas whenever possible. If in a building, restrooms 

should not open directly into product handling areas. Those that do 

open directly into produce handling areas should have additional 

measures in place to mitigate risk, such as a self-closing mechanism, a 

maze-type entrance/exit, or distance.

Verification Auditor visually verifies that toilet and handwashing facilities are not 

positioned, leaking or serviced in a manner that poses a risk of produce 

contamination.

Corrective 

Action

Toilet or handwashing facility is replaced, repaired or repositioned to be 

compliant.

Documents 

Required

N/A.

Mandatory ●

PSR 112.129; 112.130

Expectation 

Operations must comply with Federal regulations in the PSR, 21 CFR 112.129 and 112.130, and in 

the Occupational Safety and Health Standards, 29 CFR, (see Appendix I and III). The design, 

construction, and location of toilets and handwashing facilities are essential in minimizing the 

potential risk for product contamination and enabling proper use and servicing. Review all toilet 

and handwashing facilities pertinent to the operation being audited. Any single toilet or 

handwashing facility within the operation that does not meet minimum requirements would prevent 

this requirement from being answered as compliant for the entire operation.

A toilet facility is a fixture maintained within a toilet room for the purpose of defecation, urination, 

or both. Toilet facilities may be permanent or portable structures. These facilities must be located 

so they do not serve as a source of contamination, i.e., outside of the production area or in a 

production area that has already been harvested. Immediate Action is required if a toilet is a source 

of likely contamination to the crop, e.g., a pit toilet located in the production block or a portable 

toilet in an orchard so that the physical structure is touching unharvested crop. Additionally, verify 

that toilet facilities are near and made readily available to the workers and visitors, and are no more 

than 1⁄4 mile away from farming and harvesting activities. 

There may be some situations where farm workers who don’t have access to restrooms onsite use 

nearby facilities at a gas station, fast food restaurant etc. It is expected that if these workers are 

contacting the harvested crop, they will need to have access to handwashing onsite prior to entering 

the field to resume their duties.
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Verify that toilet facilities are in good repair. A leaking toilet facility may contaminate produce by 

leaking waste into contact with the crop or by cross contamination if the waste is spread to the 

production area by a worker (e.g., via the worker’s shoes). Observe how the operation addresses 

the leak to ensure employees are adhering to the operation’s procedures for handling leaks. The 

operation must immediately address any leaks likely to cause contamination of the produce.

Handwashing facilities with soap and towels may be located within or outside the toilet facility. 

They must be near the toilet facility so employees who contact produce or food contact surfaces

have ample opportunity to wash before returning to work. These units must be designed to capture 

the grey water, which is used water that has not come into contact with the toilet, so they don’t 

contaminate the produce. If grey water is intentionally not captured, Immediate Action will be 

required.

Damage to toilet and handwashing facilities may occur with use. Assess if the damage to the 

facility is recent or ongoing and observe how the operation addresses the damage to determine if the 

employee(s) are adhering to the operation’s procedures for handling damage.

This question must be answered N/A if toilet facilities are not required and are not present.

Example Scenarios (Pre-harvest)

Scenario 1: Operation is harvesting produce from four fields. To make toilets and handwashing 

most accessible and to use fewer units, they have placed portable units outside of the production 

area where the four fields meet. 

Assessment: Compliant

Reason: Toilets are positioned in a manner with easy access to servicing and the harvest crews 

without posing a risk of contaminating produce. Multiple harvest crews may share the same 

facilities as long as the ratio of toilets and handwashing facilities to workers meets the regulatory 

requirements.

Scenario 2: Toilet and handwashing units are located in roadway, adjacent to the field but they 

have no containment for grey water from handwashing unit. Grey water goes directly onto gravel 

of roadway.

Assessment: Immediate Action Required

Reason: The grey water is likely to contaminate the product or product contact surfaces. It is a 

requirement that units are designed to capture all grey water.

Example Scenarios (Post-harvest)

Scenario 1: There is no doorway between the bathrooms and the hallways but there is self-closing 

door into handling areas.

Assessment: Compliant.

Reason: The self-closing doors and restroom are located in a manner that minimizes the potential 

risk for product contamination.

Scenario 2: The restroom floor has cracks and chipped areas such that it cannot be easily cleaned.

Assessment: Corrective Action Needed.

Reason: The condition of the floor poses a harborage risk, which can be carried into the produce 
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handling area. 

Scenario 3: A handwashing faucet is the kind that requires turning (not hands free) and has 

crevices that are not easily cleaned and are visibly dirty.

Assessment: Immediate Action Required.

Reason: The faucet has become a source of contamination.

Produce Safety Rule

112.129: (a) The operation must provide personnel with adequate, readily accessible toilet 

facilities, including toilet facilities readily accessible to growing areas during harvesting activities. 

(b) They must be designed, located and maintained to (1) Prevent contamination of produce, food 

contact surfaces, production and growing areas, water sources and water distribution systems with 

human waste; (2) 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; (3) Provide for the 

sanitary disposal of waste and toilet paper. (c) If growing activities take place in a fully-enclosed 

building, hand-washing stations must be in sufficiently close proximity to toilet facilities to make it 

practical for people to wash their hands. 

112.130: (a) The operation must provide personnel with adequate, readily accessible hand-washing 

facilities in a fully enclosed building or during harvesting, packing or holding activities. (b) 

Handwashing facilities must be stocked with soap (or other effective surfactant), running water 

which has no detectible generic E. coli in 100 mL of water and adequate drying devices (such as 

single service towels, sanitary towel service or electric hand dryers). (b) The operation must 

provide for appropriate disposal of waste (for example, waste water and used single-service towels) 

associated with a hand-washing facility and take appropriate measures to prevent waste water from 

a hand-washing facility from contaminating covered produce, food contact surfaces, growing and 

production areas, water sources and water distribution systems with human waste. 

Requirement G-10.4. Toilet facilities shall be of adequate number, easily accessible to 

employees and visitors and in compliance with applicable regulations.

Procedure The operation will have verification that the number of toilet facilities 

and their location relative to employees meets the more stringent of 

federal, state, or local regulations.

Verification Auditor verifies that the number of available toilet facilities and their 

location is compliant with prevailing regulation for the number of 

employees.

Corrective 

Action

Operation obtains a sufficient number of toilet facilities to be compliant.

Documents 

Required

N/A.

Mandatory ●

PSR 112.129; 112.33(b)

Expectation 
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The operation must have an adequate number of toilet facilities that are easily accessible by 

employees and visitors to promote good sanitary practices of employees in compliance with Federal 

regulations found in the Occupational Safety and Health Standards, 29 CFR (see Appendix III). 

Additional requirements for toilet facilities are described in 21 CFR 112.129 and 112.33(b). 

Specifically, toilet facilities must be designed, located, and maintained to be readily accessible and 

to prevent contamination of covered produce in growing areas during harvest activities, and, in a 

fully-enclosed building, during harvesting, packing, or holding activities. Operation must make 

toilet and handwashing facilities available for visitors. Be aware of state and local regulations that 

apply to the operation being audited to determine if the operation adheres to these requirements.

Example Scenario (Harvest) 

Scenario: Operation has located portable toilets in a clear area surrounded by multiple growing 

fields. Auditor observes that the distance between the portable toilets and growing fields is well 

within the OSHA requirements. However, there is a deep ditch with vegetation between toilets and 

the field being harvested. 

Assessment: Corrective Action Needed or Immediate Action Required. 

Reason: The toilets are not easily accessible. If auditor has reason to believe workers are going 

into the ditch and relieving themselves there rather than using the toilets, this may be even more 

serious.

Example Scenarios (Post-harvest)

Scenario 1: Operation has 20 employees and one unisex toilet.

Assessment: Corrective Action Needed. 

Reason: Two toilets are the minimum number required for 16 – 35 employees per the federal 

regulation CFR 1910.141. 

Scenario 2: Operation has 10 employees (8 men/2 women) and one unisex toilet. 

Assessment: Compliant. 

Reason: According to 29 CFR 1910.141 where toilet rooms will be occupied by no more than one 

person at a time, can be locked from the inside, and contain at least one water closet, separate toilet 

rooms for each sex need not be provided. Corrective Action Needed if more stringent state or local 

regulations apply.

Scenario 3: Operation has 30 employees (15 men/15 women) and two toilets. 

Assessment: Compliant. 

Reason: As long as water closets are distinctively marked for each sex, this is in compliance with 

CFR 1910.141. Corrective Action Needed if more stringent state or local regulations apply. 

Produce Safety Rule 

112.129: (a) The operation must provide personnel with adequate, readily accessible toilet 

facilities, including toilet facilities readily accessible to growing areas during harvesting activities. 

(b) They must be designed, located and maintained to (1) Prevent contamination of produce, food 

contact surfaces, production and growing areas, water sources and water distribution systems with 

human waste; (2) 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; (3) Provide for the 

sanitary disposal of waste and toilet paper. (c) If growing activities take place in a fully-enclosed 
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building, hand-washing stations must be in sufficiently close proximity to toilet facilities to make it 

practical for people to wash their hands. 

112.33: All visitors must be aware of the operation’s Health and Hygiene policies and procedures, 

as well as have access to toilet and hand-washing facilities.

Requirement G-10.5. The practice of disposing of used toilet tissue on the floor, in 

trash receptacles, or in boxes is prohibited except in situations where 

waste systems are not capable of handling toilet paper.

Procedure Operation shall instruct employees that used toilet tissue shall only be 

disposed of in the toilet. If toilet paper cannot be disposed of in the toilet, 

the use of toilet paper disposal containers is acceptable. Containers must 

be used only for toilet paper or other hygiene products and must be 

distinguishable from towel waste containers. Operation shall develop 

SOPs for the sanitary disposal of waste, ensuring adequate monitoring 

and cleaning frequencies to prevent unsanitary conditions.

Verification Auditor observes restrooms for evidence of compliance. Auditor 

observes evidence or existence of toilet paper disposal, if applicable.

Corrective 

Action

Retraining is performed and documented.

Documents 

Required

N/A.

Mandatory ●

PSR 112.129

Expectation 

Auditor shall inspect toilet facilities and review policy for operation’s requirements for disposing of 

toilet tissue. In the event of an emergency situation (i.e. earthquake, flooding, other natural disaster 

etc.), if an operation’s toilet facility waste system is not capable of handling toilet paper this should 

be documented in the policy, along with SOPs for the sanitary disposal of waste. If the operation is 

using a container for the disposal of toilet paper, the container is restricted to toilet paper use only. 

Disposal of waste shall be done by incorporating a sanitary procedure for waste disposal, have 

adequate monitoring of disposal waste and cleaning frequencies to prevent any contamination or 

become a cross contamination factor to product activities. 

If operation is disposing of used toilet tissue in trash receptacles, the auditor will describe the reason 

and state mitigation measures taken to include monitoring and cleaning frequencies in the 

comments. 

Example Scenario 

Scenario: An operation’s written policies and employee training include a prohibition against 

disposing used toilet tissue anywhere except in the toilet. You find used toilet tissue in trash 

receptacle in one toilet stall.

Assessment: Immediate Action Required.
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Reason: All toilet tissue must be disposed of in the toilet, and clearly one or more workers need 

training.

Produce Safety Rule 

112.129: (a) The operation must provide personnel with adequate, readily accessible toilet 

facilities, including toilet facilities readily accessible to growing areas during harvesting activities. 

(b) They must be designed, located and maintained to (1) Prevent contamination of produce, food 

contact surfaces, production and growing areas, water sources and water distribution systems with 

human waste; (2) 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; (3) Provide for the 

sanitary disposal of waste and toilet paper. (c) If growing activities take place in a fully-enclosed

building, hand-washing stations must be in sufficiently close proximity to toilet facilities to make it 

practical for people to wash their hands. 

Requirement G-10.6. Toilet and wash stations shall be maintained in a clean and 

sanitary condition.

Procedure Toilet paper shall be available in toilet facility. Wash stations shall 

include hand wash facilities with water that meets the microbial 

standard for drinking water, hand soap, disposable towels or other hand 

drying device, towel disposal container, and a tank that captures used 

hand wash water for disposal. These stations shall be provided inside or 

adjacent to toilet facilities, and any location where product handling is 

taking place. If portable hand wash water tanks are used, they are 

cleaned and sanitized at a prescribed frequency and the water is 

changed at a prescribed frequencies adequate to prevent unsanitary 

conditions. Restrooms shall include hand wash facilities with water that 

meets the microbial standard for drinking water, hand soap, disposable 

towels or other hand drying device, and towel disposal container. Gray 

water is plumbed or captured for disposal.

Verification Auditor observes toilet and handwashing facilities for compliance. 

Auditor observes checklist or other evidence of a documented system for 

tracking cleaning of toilets and wash stations.

Corrective 

Action

Toilet or handwashing facility is replaced, repaired or maintained to be 

compliant.

Documents 

Required

Record.

Mandatory ●

PSR 112.129; 112.130

Expectation 

The auditor should determine at the beginning of the audit which bathroom and handwashing 

facilities are included in the scope of the audit. Some smaller operations may or may not include 

the use of a residential bathroom due to the home being located on the same property as the 

operation. If included in the scope of the audit, the auditor shall verify that the residential facility 

meets the requirements of the standard.
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It is important to consider the number of people using the facility, the time of day that the 

observation was made (e.g., just after a break/meal period, or the beginning of the work period), the 

cleaning schedule, and the overall appearance of the facility.

A single observation of no drying towels at a handwashing station or toilet paper at a toilet facility 

is not sufficient justification to mark this requirement as Corrective Action Needed. Observe 

multiple handwashing stations or toilet facilities at various times during the audit to determine 

whether there is an ongoing effort to keep the stations properly supplied. Cloth towels used by all 

employees laundered at any frequency are not acceptable “hand drying devices” as they may be 

sources of cross-contamination meriting a Corrective Action.

All dirty toilet tissue must be flushed into the sewer or septic system, or properly disposed of in a 

portable toilet. Feminine hygiene products may be disposed of in a lined and closed receptacle in 

the toilet room. Disposal of dirty/used toilet tissue in a box or other receptacle, or on the toilet 

room floor is an unsanitary and unacceptable practice that is an Immediate Action Required. 

The operation must provide documentation that handwashing water, whether provided by the 

company or a contractor, meets microbial requirements for drinking water. If water is from a 

municipal source, current documentation from the municipality is sufficient. 

There may be instances when employees are using offsite bathrooms within close proximity to the 

operation but are not under the operation’s control, such as a restroom at a restaurant or gas station. 

However, it is expected that when the employees return to the operation, they still have access to a 

handwashing station onsite, so that they may wash their hands before returning to work.

Example Scenarios

Scenario 1: The toilet room has one automatic hand-drying air device that you test, and it does not 

work.

Assessment: Immediate Action Required

Reason: Hand-drying capability has to be provided.

Scenario 2: You move the towel disposal container and observe the floor below the container is 

filthy.

Assessment: Corrective Action Needed.

Reason: The entire toilet room must be in clean and sanitary condition.

Scenario 3: While inspecting a field sanitation unit, you inquire about the quality of water for 

handwashing station. The auditee states that the field sanitation units are supplied by a contractor 

and the contractor is responsible for the water.

Assessment: Corrective Action Needed

Reason: The operation must provide documentation for handwashing water.

Produce Safety Rule

112.129: (a) The operation must provide personnel with adequate, readily accessible toilet 

facilities, including toilet facilities readily accessible to growing areas during harvesting activities. 
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(b) They must be designed, located and maintained to (1) Prevent contamination of produce, food 

contact surfaces, production and growing areas, water sources and water distribution systems with 

human waste; (2) 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; (3) Provide for the 

sanitary disposal of waste and toilet paper. (c) If growing activities take place in a fully-enclosed 

building, hand-washing stations must be in sufficiently close proximity to toilet facilities to make it 

practical for people to wash their hands. 

112.130: (a) The operation must provide personnel with adequate, readily accessible hand-washing 

facilities in a fully enclosed building or during harvesting, packing or holding activities. (b) 

Handwashing facilities must be stocked with soap (or other effective surfactant), running water 

which has no detectible generic E. coli in 100 mL of water and adequate drying devices (such as 

single service towels, sanitary towel service or electric hand dryers). (b) The operation must 

provide for appropriate disposal of waste (for example, waste water and used single-service towels) 

associated with a hand-washing facility and take appropriate measures to prevent waste water from 

a hand-washing facility from contaminating covered produce, food contact surfaces, growing and 

production areas, water sources and water distribution systems with human waste. 

Requirement G-10.7. A response plan is in place for major spills or leaks of field 

sanitation units.

Procedure A written response plan is developed and implemented in the event of a 

major leak or spill.

Verification Auditor verifies existence of the plan and interviews the responsible 

individual for knowledge.

Corrective 

Action

Operation prepares or edits the plan or receives plan from contractors 

of sanitation units. The responsible individual is retrained.

Documents 

Required

Written Policy

Mandatory

PSR 112.131 (a)(b)(c)

Expectation 

Runoff from toilet facilities from leaks or spills has the potential to contaminate covered produce, 

soil, and irrigation water. The operation shall have a written plan in place that outlines the steps to 

respond to a contamination event. The plan should include consideration for the location of the 

toilet facilities to minimize the potential for contamination from human waste and should facilitate 

containment and cleaning of any accidental spills or leaks. For example, the operation could locate 

portable toilet facilities downhill from the growing areas and away from water sources; or could use 

berms or grades to help protect growing areas and water sources and distribution systems from 

contamination from uphill toilet facilities. Sewage transport and other service vehicles should have 

clear access to the toilet facilities to ensure proper collection and disposal of human waste, 

minimizing the likelihood of spills or leakage.

Example Scenarios 
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Scenario 1: The sanitation units at an operation are observed to be clean and in good repair. When 

interviewing the harvest crew manager about what would happen if they were to observe a leak 

from a unit, they state they would notify management of the leak and log the leaking unit in the 

daily field assessment. There is no written response plan.

Assessment: Corrective Action Needed

Reason: A written response plan is required.

Scenario 2: Upon arrival at the harvest field, you observe a portable toilet located outside of the 

orchard tipped over, there are flags around the toilet. The crew foreman states that they have placed 

flags around the toilet and are following the written Sanitation Unit SOP

Assessment: Compliant 

Reason: The operation has a written SOP and the employees have been trained and are following 

the procedure. 

Produce Safety Rule 

112.131: (a) The operation must dispose of sewage into an adequate sewage or septic system or 

through other means. (b) The sewage and septic systems must be maintained in a manner, as well 

as (c) Leakages or spills must be managed and disposed in a manner that prevents contamination of 

produce, food contact surfaces, growing and production areas, agricultural water sources and water 

distribution systems with human waste.

Requirement G-10.8. Personnel shall wash their hands at any time when their hands 

may be a source of contamination.

Procedure Personnel shall wash their hands prior to start of work, after each visit 

to a toilet, after using a handkerchief/tissue, after handling 

contaminated material, after smoking, eating or drinking, after breaks 

and prior to returning to work, after touching animals or waste and at 

any other time when their hands may have become a source of 

contamination. Antiseptic hand rubs may not be used as a substitute for 

soap (or other effective surfactant) and water. Operation management 

reinforces importance of and compliance with handwashing policy.

Verification Auditor observes personnel in field for evidence of compliance. If 

handwashing practices are observed to be compliant, auditor will judge 

management emphasis to be sufficient.

Corrective 

Action

Retraining is performed and documented. Affected product is evaluated 

for potential contamination and disposition.

Documents 

Required

N/A.

Mandatory ●

PSR 112.32(b(3))

Expectation 

Thorough handwashing, including cleaning fingernails and cuticles, at the times listed below is 

critically important to preventing the spread of the many infectious diseases that are transmissible 

through food. 
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Appropriate times to wash hands include:

• Before starting work; 

• Before putting on gloves (if used); 

• After using the toilet; 

• Upon return to the work station after any break or other absence from the work station;

The operation must emphasize that handwashing with soap (or other effective surfactant) and 

running water is required. Hand Sanitizer used alone is not an acceptable practice and does not 

constitute compliance with this requirement. The operation can promote handwashing by regular 

and periodic reviews of employee habits, training, or other means. A statement on handwashing by 

company management at an orientation session, in an employee handbook, or on posted signs is not 

sufficient. Continual review and follow-up are needed for this to be considered a “required 

process.”

Recommended handwashing procedure:

• Wet hands with clean, warm water, apply soap, and work up a lather.

• Rub hands together for at least 20 seconds (i.e., the time it takes to sing the alphabet).

• Clean under fingernails and between the fingers, and rub the fingertips of each hand in the 

suds on the palm of opposite hand.

• Rinse hands under clean, running water.

• Dry hands with a single-use towel.

Review the company’s policy for handwashing prior to observing field harvesting. In addition to 

observing personnel in the field for evidence of compliance to the company’s policy, auditors 

should interview selected personnel regarding when they are required to wash their hands to verify 

employee understanding of the company’s policy.

This question may only be indicated as N/A where the workers are not working directly with the 

produce or food contact surfaces, such as pruning or other similar field work. In cases where a 

supply of toilet facilities is not mandated, handwashing facilities are required under this statement 

whenever employees are handling food products. If a worker who handles produce does not wash 

their hands before beginning and returning to work, and there are no immediate corrective actions 

taken by the auditee, this would be considered an Immediate Action Required condition. If workers 

have washed their hands before starting work and their hands become covered with a material 

sprayed on produce prior to harvesting, such as clay product to prevent sunburn, the material 
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covering their hands would not be considered a source of contamination and the crew would be 

considered in compliance with this requirement. 

Example Scenarios 

Scenario 1: Workers on the sorting line have a small container of hand sanitizer with them and use 

this after sneezing into their hands rather than going to handwashing station 5 minutes away.

Assessment: Immediate Action Required.

Reason: Hand sanitizers are not an alternative for handwashing. 

Scenario 2: Operation’s policy allows sick workers to handle produce and food contact surfaces as 

long as they wash their hands and use hand sanitizer. 

Assessment: Immediate Action Required.

Reason: The standard does not allow for handwashing or sanitizer use as a mitigation for illness. 

If a worker is observed showing signs of illness, this observation should be reported for requirement 

G-10.18. If a worker is observed with exposed cuts, sores or lesions this observation should be 

reported for requirement G-10.19. 

Scenario 3: Operation does not have plumbing or a ready source of potable water, so allows 

produce handlers to use a microbial hand sanitizer instead of washing. 

Assessment: Immediate Action Required.

Reason: The standard requires hands to be washed. 

Produce Safety Rule 

112.32 (b(3)): Personnel in contact with produce or food contact surfaces must wash hands 

thoroughly, including scrubbing with soap (or other effective surfactant) and running water that has 

no detectible E. coli in 100 mL of water, and drying hands thoroughly using single-service towels, 

sanitary towel service, electric hand dryers, or other adequate hand drying devices: Before starting 

work; Before putting on gloves; After using the toilet; Upon return to the work station after any 

break or other absence from the work station; As soon as practical after touching animals (including 

livestock and working animals), or any waste of animal origin; and At any other time when the 

hands may have become contaminated in a manner that is reasonably likely to lead to contamination 

of produce with known or reasonably foreseeable hazards. 

Requirement G-10.9. Signage requiring handwashing is posted.

Procedure Signage in applicable languages and/or pictures shall be provided 

adjacent to hand wash facilities requiring people to wash their hands 

after each toilet visit.

Verification Auditor verifies that signage is present adjacent to all hand wash 

facilities and is in appropriate language or pictures to clearly 

communicate requirements to all employees.

Corrective 

Action

Operation obtains and posts signage to be compliant.

Documents 

Required

N/A.

Mandatory
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Expectation 

Signs are required to be posted in or near the bathrooms to remind/require employees to wash their 

hands after they use the toilet facility. 21 CFR 110.37 (e)(5) states: “Readily understandable signs 

directing employees handling unprotected food, unprotected food packaging materials, or foodcontact surfaces to wash and where appropriate, sanitize their hands before they start work, after 

each absence from post of duty, and when their hands have become soiled or contaminated. These 

signs may be posted in the processing room(s) and in all other areas where employees may handle 

such food, materials, or surfaces.”

Signs should require that employees wash hands before going to work or before returning to work 

from some activity (breaks, meal breaks, etc.) other than handling the produce. Where there are 

non-English speaking employees on the staff; signs must be posted in the native language of the 

workers or have appropriate graphics demonstrating and reminding workers of the requirement. 

Signs should be posted in the native language of the predominant number of workers. 

Auditors should ask questions and make observations to determine whether or not this is being 

followed. Signs that are not posted in close proximity to the handwashing stations will not be 

considered as adequate. This question may only be answered N/A when there are no requirements 

for bathroom/toilet facilities, such as when there are less than the minimum number of workers 

present or in home toilets used only by family members.

Example Scenarios

Scenario 1: Tree crop operation has workers who are primarily English or Spanish speaking. 

Auditor observes signs in both languages adjacent to all hand washing and toilet facilities. 

Assessment: Compliant

Scenario 2: Packinghouse operation has workers who primarily speak Tagalog/Filipino. Auditor 

observes signs in English that also display images of step-by-step instructions. 

Assessment: Compliant 

Reason: The signs need to be readily understandable, written in the native language of employees 

or have appropriate graphics. 

Requirement G-10.10. Clothing, including footwear, shall be effectively maintained 

and worn so as to protect product from risk of contamination.

Procedure Operation shall have a policy that employee clothing shall be clean at the 

start of the day and appropriate for the operation. Clothing shall be 

replaced if it becomes reasonably likely to serve as a source of 

contamination of product or food contact surfaces.

Verification Auditor reviews policy and observes compliance with operation’s policy.

Corrective 

Action

Operation develops or revises clothing policy. Retraining is performed 

and documented.

Documents 

Required

N/A.

Mandatory ●
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Expectation 

Auditors must verify that the operation has a policy that employee clothing, including footwear, 

must be clean at the start of the day and appropriate for the operation to protect the product from 

risk of contamination. This policy does not need to be written. Harvest crews and subcontractors 

should comply with the operation’s food safety practices. Observations will need to be made by 

auditors to verify the effectiveness of the operation’s policy.

In operations where workers may come into direct contact with animals, workers must take steps to 

minimize the likelihood of cross contamination from their shoes and clothing onto produce. This 

can be accomplished by designating certain outerwear, boots, or other footwear for activities that 

involve animals, such as mucking stalls or feeding animals. 

The standard does not specify the type of footwear or clothing that must be used. However, 

footwear or clothing that is used need to be consistent with the company Food Safety Policy. As 

long as footwear is not needed to protect the product from contamination, footwear may include 

open toed sandals or may not be worn at all. Harvesters may wear stick pins to fasten clothes that 

are hidden by outerwear or sleeveless shirts so long as the clothing is consistent with the operation’s 

policy and is not reasonably likely to pose a risk to produce safety. 

Example scenario

Scenario: Auditor observes employee cleaning out animal stalls. This same employee washes his 

hands then leaves the barn and continues to the strawberry field to help harvest the product. 

Assessment: Immediate Action Required

Reason: Animal feces on the boots from cleaning the animal stalls may contaminate the 

strawberries.

Requirement G-10.11. If gloves are used, the operation shall have a glove use policy.

Procedure If rubber, disposable, cloth or other gloves are used in contact with 

product, the operation shall have a glove use policy that specifies how 

and when gloves are to be used, cleaned, replaced and stored. Hands 

must be washed before putting on gloves. Policy shall be in compliance 

with current industry practices or regulatory requirements for that 

commodity.

Verification If gloves are used, auditor observes glove use for compliance with the 

operation’s policy and current industry practices or regulatory 

requirements.

Corrective 

Action 

Operation develops or revises glove policy. Retraining is performed and 

documented. Affected product is evaluated for potential contamination 

and disposition.

Documents 

Required

N/A.

Mandatory ●

PSR 112.32(b(4))
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Expectation

If an operation uses gloves in handling covered produce or food-contact surfaces, it must have a 

glove use policy that includes maintaining gloves in an intact and sanitary condition and replacing 

such gloves when no longer able to do so. In developing its policy, the company may consider what 

types of gloves are being used for what types of tasks, whether gloves are single use or reusable 

and, if they are reusable, how gloves should be stored when not in use, either short-term (e.g., when 

using the toilet or during breaks) and longer term and how to identify and replace gloves when they 

can no longer be maintained in an intact and sanitary condition.

An operation’s glove use policy may be written or unwritten. Auditors should interview company 

personnel to verify that the company’s policy is uniform and understood by personnel, this is 

especially important when the glove use policy is unwritten.

This question may only be assessed as N/A when the operation has no glove use policy, and the 

auditor observes no gloves are being used at the time of the audit. Include if gloves are used, are 

optional, or not used. If gloves are used include the type of gloves and confirm the operation has a 

policy to sanitarily/safely use gloves in the comments.

This question must be assessed as non-compliant if the operation has no glove use policy and the 

auditor observes that gloves are being used (i.e., when it is cold out and an employee decides to 

wear gloves to work, an employee decides to wear gloves to work to protect their hands, etc.).

The operation must adhere to the glove use policy they have in place. For example, an operation’s 

glove policy is that workers on the sorting line wear reusable rubber gloves and that workers are 

responsible for checking their gloves at the start of each shift to ensure the gloves are intact and able 

to be maintained in a clean and sanitary condition. Gloves that are damaged and no longer able to 

be maintained in this condition must be replaced before starting work (or at any other time as 

needed). For example, if gloves are visibly covered in feces or have holes or cracks in them such 

that soil or contaminants can enter the inside of the glove. Workers should understand and follow 

the operation’s policy. The operation should ensure replacement gloves are available when needed. 

If, the Food Safety Plan states that “all product harvesters are to use single use sanitary gloves when 

contacting product” and the auditor observes one worker harvesting without gloves because “they 

ran out of gloves,” corrective action would be needed unless the operation has a provision for when 

gloves are not available.

Example Scenarios

Scenario 1: There is no stated glove policy in the plan. The auditor observes produce handlers 

using gloves appropriately.

Assessment: Corrective Action Needed.

Reason: If gloves are in use, “the operation must have a glove use policy.”

Scenario 2: The operation’s glove use policy is verbal (not documented) and applies to all product 

handlers. Auditor questions a product handler about the glove use policy, and the worker cannot 

describe it.

Assessment: Corrective Action Needed.
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Reason: The product handler is not familiar with the company’s glove use policy. 

Scenario 3: The operation has no glove use policy, and no gloves are observed in use at the 

operation. 

Assessment: Not Applicable, unless current industry practices or regulations require gloves for that 

crop. 

Reason: No gloves are being used. 

Scenario 4: One person is seen wearing clean cotton gloves “because it’s cold.” 

Assessment: Corrective Action Needed. 

Reason: If gloves are used there needs to be a glove use policy.

Produce Safety Rule 

112.32 (b(4)): If an operation chooses to use gloves in handling produce or food contact surfaces, 

they must maintain gloves in an intact and sanitary condition and replace such gloves when no 

longer able to do so. 

Requirement G-10.12. If protective outer garments are worn in the product handling 

areas, they shall be handled in a manner to protect against 

contamination. When appropriate, racks and/or storage containers or 

designated storage area for protective clothing and tools used by 

employees shall be provided. 

Procedure When employees wear protective outer garments, such as aprons and 

sleeves, the operation shall have a policy that employees shall wear 

suitable outer garments, not reasonably likely to serve as a source of 

contamination of product or food contact surfaces. The clothing shall 

not be left on product, work surfaces, equipment or packaging material 

but hung on racks or in designated areas. When appropriate, racks shall 

be available and located so as to avoid potential contamination. In 

addition, storage containers or designated storage areas shall be 

provided to ensure tools used by employees are properly stored prior to 

entering toilet facilities. Operation shall have a policy regarding whether 

protective clothing can be taken home.

Verification If protective clothing is used, auditor observes use for compliance with 

the operation’s policy and current industry practices or regulatory 

requirements. Auditor observes whether storage areas are designated, 

available and used.

Corrective 

Action

Operation develops or revises protective clothing policy or procedures. 

Operation obtains and positions racks and storage containers as 

necessary. Retraining is performed and documented. Affected product 

is evaluated for potential contamination and disposition.

Documents 

Required

N/A.

Mandatory
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Expectation

Protective clothing may include aprons, smocks, sleeve guards, or other personal protective 

equipment. If protective clothing is used by any employee, the operation must have a policy for 

how and when protective clothing is to be cleaned, replaced and stored. This policy is not required 

to be written.

It is the auditor’s responsibility to verify that any protective clothing used (e.g., aprons, gloves, etc.) 

are stored in a manner to avoid potential contamination. Examples of storage include but are not 

limited to racks, shelving, cubbies, etc.

Auditors must verify the operation’s policy is being followed and that the policy does not promote 

storage that will cause contamination of protective equipment or tools. Storage solutions must be 

large enough to accommodate all workers’ protective equipment and tools. Storage that is not large 

enough may lead to items being improperly stored or to fall to the ground resulting in noncompliance with the operation’s policy and this requirement. These storage solutions should also 

be placed in appropriate areas for their intended use. Racks placed near break areas; far enough 

away from the areas to not be contaminated will encourage proper worker use.

Example Scenarios

Scenario 1: The operation states that they have no “protective clothing” but the auditor sees 

workers wearing aprons and sleeve guards during sorting.

Assessment: Corrective Action Needed.

Reason: If protective clothing is used the operation is required to have a policy.

Scenario 2: Workers are observed wearing aprons while eating in the break room.

Assessment: Corrective Action Needed.

Reason: Protective clothing is not being used and stored in a manner to “protect product from risk 

of contamination.”

Scenario 3: Workers wear reasonably clean aprons and protective clothes, but there is no policy 

for how and when protective clothing is to be used and cleaned.

Assessment: Corrective Action Needed.

Reason: If protective clothing is worn, there must be a policy.

Scenario 4: The operation has racks for protective clothing and tools. However, racks are 

inadequate to properly hold clothing and tools as evidenced by some that have fallen on the ground.

Assessment: Corrective Action Required.

Reason: Clothing or tools on the ground may be a source of contamination. The operation should 

improve the storage racks and/or train workers how to use the racks.
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Requirement G-10.13. The wearing of jewelry, body piercings and other loose objects 

(e.g. false nails) shall be in compliance to company policy and applicable 

regulation.

Procedure Operation shall have a policy that personal effects such as jewelry, 

watches or other items shall not be worn or brought into fresh fruit and 

production areas if they pose a threat to the safety and suitability of the 

food. Policy shall be in compliance with current industry practices or 

regulatory requirements for that commodity.

Verification Auditor observes personnel in field for evidence of compliance.

Corrective 

Action

Retraining is performed and documented. Affected product is evaluated 

for potential contamination and disposition.

Documents 

Required

N/A.

Mandatory

PSR 112.32 (b(5))

Expectation 

The operation must have a policy for the wearing of jewelry, body piercings, and other loose 

objects. This policy must comply with applicable regulations. The standard does not specify that 

the operation’s policy must be written. Review the policy (either in writing and/or through 

interviewing employees) and/or training records as well as observe workers to verify compliance 

with requirement G-10.12. If workers are seen wearing jewelry, body piercings or carrying other 

personal effects (i.e., cell phones, headphones, earbuds etc.), observe whether they are wearing or 

using these items is in compliance with the company policy.

Jewelry can be both a safety and a food safety hazard. It can become dislodged from the person 

wearing it and fall into the food item or the container. It can get caught on machinery and injure the 

worker. The intricate places on some jewelry, such as watchbands, can be places where 

microorganisms can reside. Auditors must review the policy and observe employees to determine if 

the policy is being followed.

Example Scenarios 

Scenario 1: Operation’s policy states that no personnel are allowed to wear wrist watches or 

jewelry in the broccoli field while harvesting. Auditor observes field supervisor wearing a 

wristwatch.

Assessment: Corrective Action Needed

Reason: Operation is not compliant with own policy. 

Scenario 2: Auditor interviews employees about wearing jewelry. All employees state that jewelry 

is not allowed. There is no written jewelry policy.

Assessment: Compliant 

Reason: Jewelry policy does not have to be written. 

Produce Safety Rule 
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112.32 (b(5)): The PSR requires that hand jewelry that cannot be adequately cleaned and sanitized 

must be removed or covered during periods in which workers are handling produce. 

Requirement G-10.14. The use of hair coverings shall be in compliance to company 

policy and applicable regulation.

Procedure The operation shall have a policy that addresses use of hair coverings 

(e.g., hair nets, beard nets, caps), which is in compliance with prevailing 

regulation.

Verification Auditor reviews the operation’s policy and observes employees for 

compliance.

Corrective 

Action

Operation develops policy. Retraining is performed.

Documents 

Required

N/A.

Mandatory

Expectation 

The operation’s policy may be written or unwritten on how hair coverings shall be used. If any 

employees are wearing hair coverings in the operation, the operation must have a policy. The 

operation’s policy could be that head coverings are optional and that any head coverings worn 

should be reasonably clean like the rest of their clothes. Verify that all employees are complying 

with the operation’s hair covering policy. If the company requires field workers to wear hair nets in 

the field, workers must wear hair coverings in the field to be in compliance with this requirement. 

Additionally, workers should be aware of the operation’s policy.

This question may only be answered N/A if there is no policy requiring hair coverings and the 

auditor observes that no workers are using hair coverings. 

Example Scenarios 

Scenario 1: The operation requires all packinghouse workers to wear hair nets when handling 

produce. The auditor observes one worker without a hair net. 

Assessment: Corrective Action Needed. 

Reason: The policy requires all packinghouse workers to wear hair nets.

Scenario 2: You observe packinghouse workers at a peach operation wearing ball caps and other 

hats. No hair nets are worn. No workers are without a hat of some kind. The supervisor says that 

hair nets are not required as long as hats are worn. There is no written policy.

Assessment: Compliant. 

Reason: The workers are following the company’s hair covering policy. 
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Requirement G-10.15. Employees’ personal belongings shall be stored in designated 

areas.

Procedure Operation shall have a policy for when and how employee’s personal 

belongings shall be stored so as not to be a source of product 

contamination.

Verification Auditor observes personnel in field for evidence of compliance.

Corrective 

Action

Retraining is performed and documented. Affected product is evaluated 

for potential contamination and disposition.

Documents 

Required

N/A.

Mandatory

Expectation 

The operation must have a policy for when and how employee’s personal belongings must be 

stored. This policy is not required to be written. Make observations and/or interview workers on 

where and how their belongings are to be stored to verify compliance with the operation’s policy. 

Storage may be in the employee’s personal vehicles, buses, or in backpacks if this is designated in 

the operation’s policy and if these storage areas are not observed to be reasonable sources of 

contamination in the operation.

Example Scenarios 

Scenario 1: Field workers are observed wearing backpacks, in which they store their phones and 

other personal objects. Backpacks are allowed in the company policy. 

Assessment: Compliant, unless auditor observes a reasonable potential for contamination. 

Reason: The backpacks are allowed in the company policy for storage of personal belongings. 

Scenario 2: Packinghouse workers are observed storing their personal belongings on the floor in 

the toilet area.

Assessment: Corrective Action Needed or Immediate Action Required.

Reason: Corrective Action Needed - the floor of the toilet area is not an appropriate storage area 

because articles could become a source of product contamination. If clothes that are to be worn in 

the production area are among the belongings stored on the toilet area floor, Immediate Action 

Required. 
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Requirement G-10.16. Smoking, chewing, eating, drinking (other than water), 

chewing gum, spitting, urinating, defecating, and using tobacco shall be 

prohibited except in clearly designated areas. 

Procedure Operation shall have policy prohibiting smoking, eating, spitting, 

chewing gum, tobacco, or drinking (other than water) except in 

designated areas. Such areas shall be designated so as not to provide a 

source of contamination. Operation shall have policy prohibiting 

urinating or defecating in any growing area.

Verification Auditor observes personnel in field for evidence of compliance.

Corrective 

Action

Retraining is performed and documented. Affected product is evaluated 

for potential contamination and disposition.

Documents 

Required

N/A.

Mandatory ●

PSR 112.32 (b(6))

Expectation 

The operation must have a policy (either written or verbal) that smoking, eating, chewing gum or 

tobacco, drinking (other than water), urinating, defecating, or spitting is not permitted in any 

growing area. Observe and interview employees for the adherence and knowledge of this policy. If 

any workers do not have knowledge of the company’s policy the operation is not in compliance 

with this requirement. 

In addition to observations of personnel in the fields, observe the fields for evidence of 

contamination by the prohibited activities. Examples of evidence of contamination may include 

trash or feces located within the field or orchard.

Example Scenario 

Scenario 1: Worker is observed smoking in an area that has already been harvested and is no 

longer in production. Operation’s policy permits smoking, eating and chewing gum in harvested 

areas.

Assessment: Compliant. 

Reason: Compliant, if the auditor does not observe a reasonable potential for produce 

contamination. 

Scenario 2: The policy is not written. You question one worker who does not know the policy. 

Assessment: Corrective Action Needed. 

Reason: The worker was not familiar with the company’s policy. 

Produce Safety Rule 

112.32 (b(6)): Operation shall prohibit eating, chewing gum, or using tobacco products in growing 

and production areas (however, drinking beverages is permitted in designated areas). 
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Requirement G-10.17. Operation shall have a written policy that break areas are 

located so as not to be a source of product contamination.

Procedure Break areas shall be designated and located away from food 

contact/handling zones and production equipment.

Verification Auditor observes break areas for evidence of compliance with Operation 

policy.

Corrective 

Action

Retraining is performed and documented. Affected product is evaluated 

for potential contamination and disposition.

Documents 

Required

Written Policy.

Mandatory

Expectation 

Eating food, chewing gum, drinking beverages, or using tobacco products must be confined to areas 

other than where food may be exposed or where equipment or utensils are washed. Such activities 

must be separated from the area where food handling is being carried out.

Contamination of food may occur in any step of the food handling operation. In field handling 

activities, break areas must be designated in the operation’s written policy. These may be vehicular 

drive areas away from the production/growing area, a previously harvested area, along the edges of 

the field out of the harvesting zone, and/or drive areas between fields.

Break areas are required by the standard to be located away from production equipment. If you 

observe eating, drinking, smoking, etc. on production equipment (tractors, combines, sorters, etc.) 

corrective action will be needed.

Facilities used by employees to take breaks, prepare to go to work, eat lunches, etc. must be clean 

and separate from the packing area and other areas where produce is handled. Some operators will 

have a separate room designed and identified for eating, others will identify an area in a corner of 

the packing house building or somewhere outside of the immediate storage and packing area and 

supply it with tables. All of these are acceptable. The intent is that workers do not eat or take 

breaks within the storage and packing area.

Applicable portions of 29 CFR, Part 1910.141 state: 

(3) Housekeeping. 

(i) All places of employment shall be kept clean to the extent that the nature of the work allows.

(ii) The floor of every workroom shall be maintained, so far as practicable, in a dry condition. 

Where wet processes are used, drainage shall be maintained and false floors, platforms, mats, or 

other dry standing places shall be provided, where practicable, or appropriate waterproof footgear 

shall be provided. 

(iii)To facilitate cleaning, every floor, working place, and passageway shall be kept free from 

protruding nails, splinters, loose boards, and unnecessary holes and openings. 
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Example Scenarios 

Scenario 1: A worker is observed smoking in an area adjacent to the hydrovac cooler while it is in 

operation. The operation’s policy permits smoking only in non-product handling areas.

Assessment: Corrective Action Needed. 

Reason: This is a product handling area, even if no product is currently exposed. 

Scenario 2: The operation’s policy permits eating at sorting line if not in use. The auditor 

observes workers eating while at a lettuce sorting line that is empty during lunch.

Assessment: Corrective Action Needed. 

Reason: Standard requires that “break areas shall be...located away from food contact/handling 

zones.” 

Scenario 3: A greenhouse operation policy does not designate specific areas for workers to eat. 

Workers are observed eating in product staging area. 

Assessment: Corrective Action Needed. 

Reason: The standard requires that “break areas shall be...located away from food 

contact/handling zones.” 

Scenario 4: A driver on a forklift is observed drinking a canned soda in the shipping area. The 

operation’s policy is silent on forklift drivers.

Assessment: Corrective Action Needed. 

Reason: The standard requires that “break areas shall be...located away from...production 

equipment.” 

Requirement G-10.18. Drinking water shall be available to all employees.

Procedure Drinking water, which meets drinking water standards, shall be easily 

accessible to field personnel and in compliance with applicable 

regulation. Bottled water or potable drinking water stations with singleuse cups and a trash receptacle shall be available to all employees.

Verification Auditor observes evidence of drinking water accessibility and 

operation’s evidence that water supplied to personnel meets drinking 

water standards. 

Corrective 

Action

Operation makes drinking water available to employees, in compliance 

with prevailing regulation.

Documents 

Required

Record.

Mandatory

Expectation 

Bottled water use is acceptable in the work area provided it is stored in closed plastic containers 

away from the product flow zone when not being used. All drinking water must meet the drinking 

water standards.

This requirement cannot be assessed as and IAR, as there is no food safety risk posed by the 

noncompliance. Include the drinking water source (i.e., municipal, bottled, well) in the comments.
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Example Scenarios

Scenario 1: Operation provides bottled drinking water to field workers. Receipts of purchase are 

available for review.

Assessment: Compliant 

Reason: Workers have access to drinking water.

Scenario 2: Operation provides a drinking water fountain in the worker’s locker room. No water is 

provided in the fields. 

Assessment: Corrective Action Needed

Reason: Standard requires that “drinking water shall be easily accessible to all employees”.

Requirement G-10.19. Workers and visitors who show signs of illness shall be 

excluded from direct contact with produce or food-contact surfaces.

Procedure Operation shall have a policy that restricts employees, contractors, 

visitors, buyers, product inspectors, auditors, and other personnel in the 

operation who show signs of illness (e.g., vomiting, jaundice, diarrhea) 

from contact with product or food contact surfaces. Policy shall require 

that any person so affected immediately report illness or symptoms of 

illness to the management.

Verification Auditor reviews policy and observes field personnel for evidence of 

compliance.

Corrective 

Action

Operation develops and implements policy. Retraining is performed 

and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

Written Policy.

Mandatory ●

PSR 112.31

Expectation 

Any person who is ill shall be excluded from direct contact with produce or food-contact surfaces

and from food handling areas. Workers and visitors shall be instructed to report illness to 

management. Illness could be identified by medical examination, personal acknowledgement, or 

supervisory observation. 

Management should be familiar with the signs of illness so that if symptoms are evident, 

management can take appropriate steps. Signs of illness may include vomiting, jaundice, or 

diarrhea. Any worker showing signs of illness must be excluded from work assignments that 

involve direct or indirect contact with fresh produce, and restricted from entering food handling 

areas. Operations must have a written policy to follow when workers show signs of possible illness. 

Auditors should interview managers/supervisors to determine their knowledge of known signs of 

illness. The auditor should also look for indications of worker illness, such as frequent trips to the 

toilet facilities by individual employees. For example, a field crew manager should be familiar with 
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the company’s policy for what to do when a worker reports illness to them or when they observe a 

worker who has obvious signs of illness; a worker should be familiar with the company’s policy of 

what they should do when they are ill. 

This question cannot be indicated as N/A. 

Example Scenario 

Scenario: An operation has a written policy, requiring workers to report illness or symptoms of 

illness to the management, but the supervisor says it is illegal to ask workers if they are ill.

Assessment: Compliant, unless you see ill worker(s) in contact with produce or food contact 

equipment. 

Reason: The standard requires that the “Operation shall...restricts personnel who show signs of 

illness”; it does not require operations to ask workers if they are ill.

Produce Safety Rule 

112.31: The operation must take measures to prevent contamination of produce and food contact 

surfaces with microorganisms of public health significance from any person with an applicable 

health condition (such as communicable illnesses that present a public health risk in the context of 

normal work duties, infection, open lesion, vomiting or diarrhea). This means excluding any person 

from working in any capacity that may result in contamination of produce or food contact surfaces 

with human pathogens when the person (by medical examination, the person’s acknowledgement or 

observation) is shown to have or appears to have, an applicable health condition, until the person’s 

health condition no longer presents a risk to public health. Personnel must notify their supervisor(s) 

(or responsible party) if they have, or a reasonable possibility that they have an applicable health 

condition. 

Requirement G-10.19.a. Workers showing signs of illness shall not be allowed to enter 

food handling areas.

Procedure The operation must have a written policy that workers showing signs of 

illness shall not be allowed to enter food handling areas.

Verification Auditors will verify that there is a written policy and that the policy is 

implemented.

Corrective 

Action

Operation develops and implements a policy on restricting ill workers 

from food handling areas. Retraining is performed.

Documents 

Required

Written Policy.

Mandatory ●

PSR 112.31

Expectation 

Any person who is ill shall not be allowed to enter food handling areas. The operation must have a 

written policy that workers showing signs of illness shall not be allowed to enter food handling 

areas.

Example Scenario 
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Scenario: A worker who was feeling ill was reassigned from the grading line to instead operate a 

forklift to transport product and packaging in the production area. 

Assessment: Corrective Action Needed. 

Reason: Workers who are ill must not be allowed to enter food handling areas. 

Requirement G-10.20. Personnel with exposed cuts, sores or lesions shall not be 

engaged in handling product.

Procedure Minor cuts or abrasions on exposed parts of the body are acceptable if 

covered with a non-permeable covering, bandage or glove. Bandages on 

hands shall be covered with gloves in compliance with operation’s glove 

policy.

Verification Auditor observes personnel in field for evidence of compliance.

Corrective 

Action

Retraining is performed and documented. Affected product is evaluated 

for potential contamination and disposition.

Documents 

Required

N/A.

Mandatory ●

PSR 112.31

Expectation 

In addition to observation of field personnel, auditors will interview selected personnel for 

verification of their knowledge of the company’s policy appropriate to their position’s 

responsibilities. This policy does not have to be written but needs to be known by all workers. For 

example, a field crew manager should be familiar with the operation’s policy for what to do when a 

worker reports or they observe a worker with a cut, sore or lesion; a worker should be familiar with 

the operation’s policy of what they should do if they have an exposed cut sore or lesion, this type of 

injury may occur during the farming and/or harvesting activities of the operation. See requirement 

G-10.11 for additional verification requirements if gloves are used to cover minor cuts or abrasions.

Example Scenario 

Scenario: A worker on produce sorting line has a cut on their forearm which, on doctor’s orders, is 

not bandaged. 

Assessment: Corrective Action Needed. 

Reason: The standard requires personnel “with exposed cuts, sores or lesions shall not be engaged 

in handling product.” 

Produce Safety Rule 

112.31: The operation must take measures to prevent contamination of produce and food contact 

surfaces with microorganisms of public health significance from any person with an applicable 

health condition (such as communicable illnesses that present a public health risk in the context of 

normal work duties, infection, open lesion, vomiting or diarrhea). This means excluding any person 

from working in any capacity that may result in contamination of produce or food contact surfaces 

with human pathogens when the person (by medical examination, the person’s acknowledgement or 

observation) is shown to have or appears to have, an applicable health condition, until the person’s 

health condition no longer presents a risk to public health. Personnel must notify their supervisor(s) 
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(or responsible party) if they have, or a reasonable possibility that they have an applicable health 

condition. 

Requirement G-10.21. Operation shall have a blood and bodily fluids policy.

Procedure There shall be a written policy specifying the procedures for the 

handling/disposition of food or product contact surfaces that have been 

in contact with blood or other bodily fluids.

Verification Auditor reviews policy and observes operation for evidence of 

compliance.

Corrective 

Action

Operation develops and implements policy. Retraining is performed 

and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

Verify personnel’s knowledge of the company’s written procedure for blood and bodily fluids 

policy is appropriate to their level of work. Also, verify that the blood and bodily fluids policy is 

implemented by checking paperwork, observing personnel practices and interviewing personnel.

Example Scenario 

Scenario: The operation does not have a written policy, but the field supervisor states, “if anyone 

gets a cut, we buffer and do not harvest two feet around the site and write an incident report”. A 

recent incident report is available for review.

Assessment: Corrective Action Needed

Reason: Standard requires the policy to be written. 

Requirement G-10.22. First aid kits shall be accessible to all personnel.

Procedure The kits shall be readily available in the vicinity of field work and 

maintained in accordance with prevailing regulation. The kit materials 

shall be kept sanitary and in usable condition.

Verification Auditor observes that provisions exist for first aid kit to be readily 

available in vicinity of workers and is stocked in accordance with 

prevailing regulation.

Corrective 

Action

Operation obtains and stocks a first aid kit and ensures it is readily 

accessible near field personnel.

Documents 

Required

N/A.

Mandatory

Expectation 

Observe that the operation has first aid kits readily available to personnel in the vicinity of the field 

work. These first aid kits must be stocked and ready for use. Check kits to make sure commonly 
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used items such as band-aids and antibacterial ointment are present. The contents of the first aid 

kits must not be past their expiration dates. For example, antibacterial ointment with a best used by 

date two years prior to the audit date would not be ready for use.

Example Scenarios 

Scenario 1: The operation has a first aid kit in the foreman’s truck. The kit contains bandages, 

gauze, and antiseptic. The foreman explains that “this is all we are prepared to treat on site; 

anything more severe goes to the hospital.” 

Assessment: Compliant. 

Reason: First aid kits are accessible to personnel.

Scenario 2: The antiseptic is two months past its expiration date.

Assessment: Corrective Action Needed. 

Reason: The auditor is not in a position to evaluate whether being slightly out of date is a public 

health issue, so should adhere to the manufacturer’s recommendations. 

Scenario 3: The antiseptic bottle is empty.

Assessment: Corrective Action Needed. 

Reason: The first aid kit is not fully stocked.

G-11 Waste Management

Requirement G-11.1. Operation has implemented a waste management plan.

Procedure Operation implements procedures for the control, storage and disposal 

of trash, litter, and waste in areas used for produce handling activities. 

Such procedures minimize the potential for trash, litter, or waste to 

attract or harbor pests and protect against contamination of produce, 

food contact surfaces, areas used for produce handling activities, water 

sources, and water distribution systems. Waste treatment and disposal 

systems operate so that they do not constitute a potential source of 

contamination in produce handling areas.

Verification Auditor verifies the operation has implemented a waste management 

plan.

Corrective 

Action

Operation implements a waste management plan.

Documents 

Required

N/A.

Mandatory

Expectation 

Auditor reviews how the operation’s waste management plan is implemented and that the operation 

has procedures in place for controlling, storing and disposing of trash, litter and waste in areas used 

for produce handling activities. Procedures should minimize the potential of trash, litter or waste 

and protect against contamination of produce, food contact surfaces, produce handling activities, 

water sources, and water distribution systems. Auditor verifies through observations, interviews, 
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and a review of documentation (such as training records, waste disposal invoices, etc.) to determine 

if the operation’s procedures are being followed. Furthermore, interviews with employees shall 

demonstrate adherence to the operation’s waste management plan since no specific written plan is 

evident in this requirement.

Example Scenario 

Scenario: Auditor observes field is littered with garbage during harvest. Auditor notices field is 

next to I-5, a major freeway, and there are 2 fences around the field. 

Assessment: Compliant or Corrective Action Needed

Reason: If garbage is of animal or human origin there is a risk of contamination of the harvestable 

portion of crop. As long as the farm manages to collect trash they are compliant, provided that the 

waste management plan also states that any product in contact with the trash is not harvested.

Requirement G-11.2. Trash shall not come in contact with produce.

Procedure Trash handling and removal shall not pose a hazard of contamination of 

produce.

Verification Auditor reviews trash handling procedures for field operation, and 

observes trash handling practices for evidence of compliance.

Corrective 

Action

Operation revises procedures. Retraining is performed and 

documented. Affected product is evaluated for potential contamination 

and disposition.

Documents 

Required

N/A.

Mandatory ●

PSR 112.132

Expectation 

Trash, leaves, trim, culls, and other waste material are removed from the produce handling areas at 

a frequency sufficient to avoid being a source of contamination. Trash and waste materials should 

be removed at a frequency as to not attract or harbor pests. Trash and waste should not contaminate 

agricultural water sources and distribution systems.

Example Scenarios 

Scenario 1: Operation provides field sanitation units on a trailer with outside trash receptacles. 

Trash is found on the ground, as the receptacle was overflowing with trash. Food Safety Plan states 

that trash will be emptied daily or as needed. Interview with employee about trash removal stated 

trash is emptied every other day. 

Assessment: Corrective Action Needed 

Reason: Policy states trash is to be removed daily or as needed.

Scenario 2: Auditor observes trash container in produce handling area is overflowing. Supervisor 

explains that containers are emptied during breaks, and this situation is unusual. Next break is in an 

hour. 

Assessment: Corrective Action Needed.

Reason: Operation should have a contingency for when more trash accumulates than normal. 
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Produce Safety Rule

112.132: The operation must convey, store, and dispose of trash, litter and waste to minimize the 

potential for trash, litter or waste to attract or harbor pests; and protect against the contamination of 

produce, food contact surfaces, areas used for product activity, agricultural water sources and 

agricultural water distribution systems with known or reasonably foreseeable hazards. The 

operation must adequately operate systems for waste treatment and disposal so they do not 

constitute a potential source of contamination in areas used for product activity.

G-12 Food Defense

After September 11, 2001, protection of the nation’s food supply from attacks became a national 

priority. The President issued a series of directives; Homeland Security Presidential Directives 

(HSPD’s) that outline the security of the United States. HSPD 9 addresses the need to protect the 

nation’s food supply. In response, both the FDA and the USDA issued voluntary food defense 

guidelines to help food processors identify measures to prevent or mitigate the risk of intentional 

food contamination. In 2003, the FDA published the Guidance Document Food Producers, 

Processors, and Transporters, Food Security Preventative Measures Guidance. 

Food safety differs from food defense in the following way: Food safety is the protection of food 

products from unintentional contamination by pathogens or chemicals. A GAP & GHP program 

will address reducing the risk of unintentional contamination. Food Defense is the protection of the 

food supply from intentional contamination by chemical, biological, or radiological means by an 

aggressor.

Because of the wide variety and complexity of operations that we can audit for food defense, 

auditors should take into consideration the complexity, size, and scope of the facility. In general, 

farm operations will have different food defense requirements than an enclosed packing shed or 

wholesale distribution warehouse. For instance, it is not practical for a farm to enclose their entire 

operation with fencing, where in a packing facility or warehouse operation, it would be more 

economically feasible. 

Due to the wide variations in food defense facilities and procedures, auditors should take the time to 

review the auditee’s food defense plan prior to the audit to become familiar with it. This makes it 

easier to audit the farm/facility on the day of the audit. 
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Requirement G-12.1. Operation shall assess the potential for unauthorized access to 

growing and/or packing areas and its impact on food safety.

Procedure Operation shall demonstrate an awareness of site security and, if 

deemed necessary for food safety, take reasonable measures to minimize 

the potential for unauthorized access to growing and/or packing areas.

Verification Auditor interviews the responsible individual for awareness of site 

security, and security measures, if applicable.

Corrective 

Action

Security assessment is performed.

Documents 

Required

Risk Assessment.

Mandatory ●

Expectation 

The operation must conduct a written assessment for the operation’s vulnerability to unauthorized 

people accessing the growing, harvesting, packing and storage areas. It should be taken into 

consideration the degree to how easy it is to access various areas throughout the operation. Are 

there items in place that make access more difficult, such as locked doors, fencing, observant 

personnel, physical space constraints, automated equipment etc.?

Example Scenarios 

Scenario 1: A citrus orchard with ripe fruit is along a major roadway. Auditor observes a tourist 

car pulling over to pick fruit. A field manager pulls up to the car and advises them to leave. There 

are no noticeable “no trespassing” signs at orchard along the road. 

Assessment: Compliant

Reason: Observed actions taken, signs are not required. 

Scenario 2: Utility workers come onto property without notifying the operation. 

Assessment: Compliant

Reason: The operation has no control over the utility workers. Auditor should request more 

information to determine if the operation has assessed this to be a food safety risk. 

Requirement G-12.2. Operation shall develop an emergency response plan.

Procedure A response plan is in place in the event of a security event potentially 

impacting food safety. Action taken to reduce risk to product shall be 

documented by means of an incident report or other record of response.

Verification Auditor interviews the responsible individual for knowledge of the 

emergency response plan and, if applicable, reviews incident response 

records.

Corrective 

Action

Emergency response plan is developed.

Documents 

Required

Written Policy, Record.

Mandatory
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Expectation

Auditor reviews operation’s policy for emergency response plan for security issues that 

involve/impact food safety and interviews responsible individual(s) for knowledge and 

effectiveness of emergency response plan. Actions taken to reduce potential risk to product shall be 

documented by means of an incident report or other record of response. An example of a security 

breach may be an instance ranging from a computer being hacked to unauthorized entry into fields, 

produce packing facilities, storage or holding facilities.

An operation must make efforts to identify potential risks to food safety due to trespassers on the 

property. It is not reasonable to expect an operation to account for all possible risk scenarios, 

however an operation must address other types of risk (such as common, routine weather events) 

under consideration of hazards within the Food Safety Plan within G-2.1; physical, chemical, or 

biological risks within F-1.1; or pre-harvest risk within F-9.1)., or a combination of these. The 

requirements within G-12.2 focus on security events that potentially impact food safety.

Example Scenarios

Scenario 1: Two months prior to the audit, a drunk driver ran off the road and into the operation’s 

produce field. The food safety manager shares an incident report, describing the measures taken to 

isolate and not harvest affected sections of the field. No fences or other preventive measures were 

implemented

Assessment: Compliant.

Reason: The operation took reasonable steps to reduce food safety risk. An operation should not be 

expected to implement additional preventive measures (e.g. fencing/barriers) for isolated incidents.

Scenario 2: Packinghouse’s storage was broken into and had produce stolen. Operation shows 

auditor the new locks added to better secure the building, but no incident report is available.

Assessment: Corrective Action Needed.

Reason: Action taken to reduce risk to product “shall be documented by means of an incident 

report or other record of response”. In addition to documented corrective actions, an operation 

should also assess potential risk to food safety due to trespassers on the property.
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Requirement G-12.3.a. Initially and at least annually thereafter, the operation shall 

evaluate and document the risks associated with security (food defense), 

including unintentional security risks.

Procedure A review or new assessment shall be conducted seasonally and any time 

there is a change made to the system or a situation occurs that provides 

the opportunity for the intentional or unintentional introduction of a 

hazard. The risk assessment shall address potential physical, chemical, 

and biological hazards.

Verification Auditor reviews the risk assessment for completeness of consideration of 

potential hazards

Corrective 

Action

Operation develops or updates the risk assessment.

Documents 

Required

Risk Assessment.

Mandatory ●

Expectation 

The purpose of a food security risk assessment is to identify areas in an operation that are 

vulnerable to breeches in security that may result in physical, chemical, or biological contamination 

of produce. The review or new security assessment must be conducted seasonally and any time a 

change is made to the system or there is a situation that occurs that provides for the introduction of 

a hazard. 

The auditor will include the date the food defense assessment was conducted in the comments. 

Example Scenario 

Scenario: Packinghouse’s storage was broken into and had produce stolen. Operation shows 

auditor the new locks added to better secure the building, a new risk assessment was not conducted. 

Assessment: Corrective Action Needed

Reason: “The review or new security assessment must be conducted seasonally and any time a 

change is made to the system or there is a situation that occurs that provides for the introduction of 

a hazard”. 
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Requirement G-12.3.b There shall be a written food defense plan to mitigate risks 

identified in the food defense risk assessment.

Procedure The food defense plan shall include the following: preventive controls, 

monitoring and verification procedures, corrective actions, and

documentation. The plan shall be reviewed following any changes made 

to the food defense risk assessment and adjusted accordingly to 

incorporate such changes. Evidence of management commitment to the 

food defense plan shall be documented. Training and/or retraining of 

personnel having oversight or performance duties shall be documented.

Verification Auditor reviews the food defense plan for accuracy and completeness 

relative to the risk assessment.

Corrective 

Action

Operation develops or updates the food defense plan.

Documents 

Required

Written Policy, Record.

Mandatory

Expectation 

The food defense plan must include preventive controls, monitoring, verification, corrective actions 

and documentation. 

Example Scenario 

Scenario: The operation has a documented food defense plan. The auditor observes food defense 

practices and procedures throughout the packinghouse. When reviewing training records there are 

no records for training on food defense. 

Assessment: Corrective Action Needed.

Reason: The training of personnel having oversight or performance of duties related to food 

defense shall be documented. 

G-13 Food Fraud 

Food fraud is the deliberate and intentional substitution, addition, tampering or misrepresentation of 

food, food ingredients or food packaging, labeling, product information or false or misleading 

statements made about a product for economic gain that could impact consumer health. This could 

be done by the operation or by an individual employee. 
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Requirement G-13.1.a. The operation shall initially and at least annually thereafter, 

evaluate and document the risks associated with food fraud.

Procedure A review or new assessment shall be conducted seasonally and any time 

there is a change made to the system or a situation occurs that could 

provide an opportunity for the misrepresentation of product.

Verification Auditor reviews the risk assessment for completeness of consideration of 

potential hazards.

Corrective 

Action

Operation develops or updates the risk assessment.

Documents 

Required

Risk Assessment.

Mandatory ●

Expectation 

A food fraud vulnerability assessment shall be conducted to identify potential vulnerability and 

prioritize food fraud mitigation measures. The risk assessment shall be conducted at least annually, 

and any time there is a change made to the operation or a situation occurs that could provide an 

opportunity for the misrepresentation of the product.

The vulnerability assessment should be exhaustive and consider a wide range of hazards. Food 

fraud can cover across all activities of a business and so the scope of the hazard identification step 

should cover them all. It is important to address the difference between the hazard (a potential 

source of harm, risk (the probability of loss or injury from a hazard), and vulnerability 

(susceptibility to a risk): many hazards will have a low or very low likelihood and therefore not 

represent a risk; likewise, the susceptibility of a company or system to a risk is not only linked to 

the severity of this risk but more to the company’s awareness of their weakness and how they 

manage it.

Examples of food fraud include:

• Selling gala apples as pink lady apples

• Packaging material sold as food grade made of non-food grade materials 

• Selling non GAP-certified produce, as GAP certified

• International produce marketed as domestic 

• Non-organic produce being sold under the USDA organics label 

The auditor will include the date the food fraud assessment was conducted in the comments.

Example Scenarios 
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Scenario 1: The operation’s food fraud risk assessment contained all items to properly evaluate 

their mushroom operation, except that it was written two years prior to the audit and was not 

reviewed or updated.

Assessment: Corrective action needed. 

Reason: Food fraud risk assessment needs to be reviewed, or a new assessment conducted each 

season.

Scenario 2: Inspector notices an incident on the incident report that relates to food fraud, 

mislabeled packaging; however, when reviewing the food fraud risk assessment there is no mention 

of the assessment of the risk.

Assessment: Corrective action needed.

Reason: Anytime a situation occurs a review or new assessment must be done.

Requirement G-13.1.b. There shall be a written food fraud plan to mitigate risks 

identified in the food fraud risk assessment.

Procedure The food fraud plan shall include the following: preventive controls, 

monitoring and verification procedures, corrective actions, and 

documentation. The plan shall be reviewed following any changes made 

to the food fraud risk assessment and adjusted accordingly to 

incorporate such changes. Evidence of management commitment to the 

food defense plan shall be documented. Training and/or retraining of 

personnel having oversight or performance duties shall be documented.

Verification Auditor reviews the food fraud plan for accuracy and completeness 

relative to the risk assessment.

Corrective 

Action

Operation develops or updates the food fraud plan.

Documents 

Required

Written Policy, Record.

Mandatory

Expectation 

A food fraud vulnerability is the susceptibility or exposure to a food fraud risk, which is regarded as 

a gap or deficiency that could place consumer health at risk if not addressed. Based upon the food 

fraud vulnerability assessment, a documented food fraud plan shall be established specifying the 

measures which shall be maintained and implemented to mitigate the public health risks from the 

identified food fraud vulnerabilities. The food fraud plan will need to be updated at any time where 

the food fraud risk assessment identifies a new potential risk, or where the mitigation strategies are 

deemed to be insufficient or ineffective to address the current risks. 

It is important to note that auditors are not expected to detect fraud or affirm that an anti-fraud 

program is capable of “preventing fraud”. 

The focus of the auditor should be in assessing the approach taken by the company: 

• Is it companywide? 
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• Is it built by a multi-disciplinary team?

• Is it clearly documented and reviewed regularly? 

• What’s the source of information used to support the assessment?

The auditor shall verify that the operation is properly enacting their food fraud plan.

Example Scenario

Scenario 1: Operation’s food fraud plan does not address all the risks stated in the policy.

Assessment: Corrective action needed.

Reason: Food fraud plan is to mitigate risks identified in the food fraud risk assessment.
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FIELD OPERATIONS AND HARVESTING

Field Production

F-1 Field History and Assessment

The following requirements address the evaluation and documentation of field risks.

Requirement F-1.1. The food safety plan shall, initially and at least annually 

thereafter, evaluate and document the risks associated with land use 

history and adjacent land use including equipment and structures.

Procedure When land use or adjacent land use indicates a possibility of physical, 

chemical or biological contamination, preventive controls shall be 

performed and documented to mitigate food safety risk. The assessment 

is re-performed, and documented, at least annually and upon significant 

events, for environmental conditions or risk awareness that has changed 

since the last assessment. The assessment shall address flooding and 

shall include indoor growing facilities and structures such as green 

houses and hydroponics.

Verification Auditor reviews food safety plan to verify that risks associated with field 

history, adjacent land use and indoor growing facilities have been 

evaluated at least annually and preventive controls implemented for 

identified risks.

Corrective 

Action

Operation evaluates and documents risks associated with land use 

history, adjacent land use, and indoor growing facilities and implements 

preventive controls for identified risks.

Documents 

Required

Risk Assessment.

Mandatory ●

Expectation 

Review the operation’s Food Safety Plan to verify that the operation has conducted a written 

assessment at least annually to evaluate, identify, and implement preventative controls for identified 

risks associated with field history, adjacent land use, and indoor growing facilities.

The operation is responsible for assessing and documenting the land use history and adjacent land 

use prior to the land being used for the production of fresh produce. The assessment shall consider 

significant events, which include the potential for flooding events. Growers may use a standard risk 

assessment form provided by one of their shippers, a self-developed assessment, or an assessment 

template from another source so long as it addresses all of the operation’s risks. Auditors must 

verify that the risk assessment is accurate when visiting the fields.

The auditor will include the date and the role/title of the person who conducted the last assessment

in the comments.
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Example Scenarios 

Scenario 1: The operation states the field being audited has been in fresh produce production for 

more than 20 years. The assessment does not include how the field was used prior to that.

Assessment: Compliant or Corrective Action Needed. 

Reason: Compliant, unless you note significant risk from previous land use.

Scenario 2: The operation’s assessment includes onsite risks but does not consider risks from 

adjacent land use.

Assessment: Corrective Action Needed or Immediate Action Required.

Reason: Potential risks from adjacent land use must be considered and the consideration 

documented in the assessment. Either CAN (no imminent food safety hazard) or IAR (lack of 

recognition of a risk has resulted in an immediate food safety risk). 

Scenario 3: The annual assessment of risk states “no change” from the previous year’s assessment. 

The prior assessment is available and compliant. Both the initial assessment and the “no change” 

assessment are dated to demonstrate that the assessment has been conducted annually.

Assessment: Compliant. 

Reason: Risk has been evaluated annually. 

Requirement F-1.1.a. Operation has performed and documented a risk assessment of 

each production area prior to the harvest of that location. The risk 

assessment must include potential cross contamination between 

production sites.

Procedure A system shall be established to maintain the record of agricultural 

activities undertaken at each production unit and records shall be 

available to demonstrate that sites (on farm and adjacent sites) have 

been evaluated with regards to potential food safety hazards. The risk 

assessment must include potential cross contamination between 

production sites.

Verification Auditors verify the operation has performed and documented a risk 

assessment of each production area.

Corrective 

Action

The operation shall perform and document a risk assessment for each 

production area. Training of appropriate personnel may need to take 

place to on conducting and recording this assessment.

Documents 

Required

Risk Assessment.

Mandatory ●

Expectation 

A risk assessment must be performed and documented by the operation for each production area, 

prior to the harvest of that location. The risk assessment must include potential cross contamination 

between production sites. The time and frequency this assessment is conducted is defined by the 

operation in their risk assessment procedure. Verify the risk assessment has been conducted, the 

risk assessment is documented, and the risk assessment addresses the risks of the operation. 

Observations will be important for the auditor to verify the accuracy of this requirement.
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The auditor will include the date and the role/title of the person who conducted the last assessment

in the comments.

Example Scenarios 

Scenario 1: An auditee plants each field on their farm once per year, in the same crop every year. 

The field history risk assessment contains a list of each field, what was planted there last year, what 

surrounds the field, and any identified hazards. Auditee signs off on each field, each year that there 

are no hazards from prior use, or the use of surrounding areas. 

Assessment: Compliant. 

Scenario 2: The risk assessment concludes that there are no potential cross-contamination hazard 

risks from employees moving between production sites, as the fields are in production at different 

times of the year.

Assessment: Compliant (unless auditor observations prove otherwise). 

Reason: The operation has addressed cross-contamination between production sites. 

Requirement F-1.1.b. Operation has identified control measures to all significant 

hazards identified during risk assessment.

Procedure Workers shall be trained on what the food safety hazards are and how to 

manage them. There shall be responsibilities assigned to maintain 

records on the food safety hazards and their management.

Verification Auditor verifies that control measures for all significant hazards 

identified during the risk assessment are implemented.

Corrective 

Action

Operation trains workers on the maintenance of the food safety hazards 

identified and how to manage and record the management of these 

hazards.

Documents 

Required

Written Policy.

Mandatory ●

Expectation

The operation must have a management plan for any risks that are identified during the risk 

assessment. Workers must be trained on what the risks to the operation are, how to manage these 

risks, and how to keep records appropriate to their job responsibilities. 

Example Scenario 

Scenario: Auditee has recorded all risks and has documented mitigation strategies for all 

significant hazards. Employees have not been trained on the mitigation strategies. 

Assessment: Corrective Action Needed. 

Reason: Worker training is required.
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Requirement F-1.2. For indoor growing and field storage buildings, building shall be 

constructed and maintained in a manner that prevents contamination of 

produce.

Procedure Building and equipment structures and surfaces (floors, walls, ceilings, 

doors, frames, hatches, etc.) shall be constructed in a manner that 

facilitates cleaning and sanitation and does not serve as harborage for 

contaminants or pests. Chill and cold storage loading dock areas shall 

be appropriately sealed, drained and graded. Fixtures, ducts, pipes and 

overhead structures shall be installed and maintained so that drips and 

condensation do not contaminate produce, raw materials or food contact 

surfaces. Water from refrigeration drip pans shall be drained and 

disposed of away from product and product contact surfaces. Drip pans 

and drains shall be designed to assure condensate does not become a 

source of contamination. Air intakes shall not be located near potential 

sources of contamination.

Verification Auditor observes building and equipment for evidence that the building 

can be cleaned and maintained to prevent product contamination. 

Corrective 

Action

Building deficiencies are corrected. Affected product is evaluated for 

potential contamination and disposition.

Documents 

Required

N/A.

Mandatory ●

PSR 112.122; 112.126

Expectation 

Observe that indoor buildings and equipment can be cleaned and maintained to prevent product 

contamination. A hoop house is not considered an indoor growing building and should be evaluated 

for compliance when evaluating the field in requirement F-1.1. Greenhouses with dirt floors that 

are not reasonably likely to result in contamination of the edible portion of the crop are compliant 

with requirement F-1.2 unless you observe that the condition of the greenhouse poses a 

contamination risk (e.g., burrowing of rodents in the dirt floor).

If an auditee states that certain parts of the operation are not part of the audit, clearly document 

what buildings and/or structures are exempt from the audit. For example, if the operation says that 

the greenhouse is “not part of this audit” and prohibits the auditor from inspecting the greenhouse, 

exclude the greenhouse from being audited but assess it as a potential source of risk to the crops that 

are included in the scope of the audit. Another example would be exclusion of a “field storage 

facility” that is used for equipment and tools, but not food handling. This structure would not be 

applicable to Requirement F-1.2 unless the auditor observes that the facility poses a food safety risk 

to produce. 

Example Scenarios 

Scenario 1: The “indoor growing building” is a hoop house. 

Assessment: Not Applicable 
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Reason: Hoop houses should be in compliance with field operations standards. 

Scenario 2: The operation is storing product onsite in a temporary storage facility and auditor 

observes that a pest control program is in place. You observe excessive rodent damage to product. 

Assessment: Immediate Action Required.

Reason: Pest control program in place is not effective.

Produce Safety Rule 

112.122: Buildings subject to the requirements of the Produce Safety Rule include (a) any fully or 

partially-enclosed building used for growing, harvesting, packing and holding activities, including 

minimal structures that have a roof but do not have any walls and (b) storage sheds, buildings or 

other structures used to store food contact surfaces (such as harvest containers and food-packing 

materials).

112.26: (a) All buildings must meet the following requirements (1) buildings must be suitable in 

size, construction, and design to facilitate maintenance and sanitary operations for growing, 

harvesting, packing and holding activities to reduce the potential for contamination of produce or 

food contact surfaces with known or reasonably foreseeable hazards. Buildings must provide 

sufficient space for placement of equipment and storage of materials and permit proper precautions 

to be taken to reduce the potential for contamination of produce, food contact surfaces, or packing 

materials with known or reasonably foreseeable hazards. The potential for contamination must be 

reduced by effective design including the separation of operations in which contamination is likely 

to occur, by one or more of the following means: Location, time, partition, enclosed systems or 

other effective means. (2) There must be adequate drainage in all areas where normal operations 

release or discharge water or other liquid waste on the ground or floor of the building. (b) Measures 

to prevent contamination of produce and food contact surfaces in the buildings must be 

implemented, as appropriate, considering the potential for such contamination through: Floors, 

walls, ceilings, fixtures, ducts or pipes: and drip or condensate. 

Requirement F-1.3. Sewage or septic systems are maintained so as not to be a source 

of contamination.

Procedure After a significant event (such as flooding or an earthquake) that could 

negatively impact a sewage or septic system, operation takes appropriate 

steps to ensure that sewage and septic systems continue to operate in a 

manner that does not contaminate produce, food contact surfaces, areas 

used for produce handling, water sources, or water distribution systems.

Verification If a significant event has occurred, Auditor reviews steps taken by 

operation to verify sewage or septic system is not a source of 

contamination. 

Corrective 

Action

Sewage or septic systems deficiencies are corrected. Affected product is 

evaluated for potential contamination and disposition.

Documents 

Required

N/A.

Mandatory ●

PSR 112.131
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Expectation 

The operation is responsible for being aware of events that could cause a problem with sewage or 

septic systems, and is responding appropriately to make sure any contamination risks are addressed. 

The auditor must ask the operation about any recent events and whether they have ensured that their 

sewage and septic systems are operating in a way that will not contaminate produce, surfaces, and 

water sources and systems.

Example Scenarios:

Scenario 1: The grower lives adjacent to the harvest field and his personal septic system has 

malfunctioned. The surface grade is away from the field however the house is on an elevated 

surface above the field. 

Assessment: Compliant. 

Reason: Provided grading is away and as long as any discharge (including cross-contamination) 

didn’t affect the crop. 

Scenario 2: Auditee states septic system is checked after an earthquake. 

Assessment: Depends/Compliant. 

Reason: Compliant if the auditee also has records for microbial compliance of any potentially 

affected water sources following the event. Corrective Action Needed if records for microbial 

compliance are not provided. 

Produce Safety Rule 

112.131: (a) The operation must dispose of sewage into an adequate sewage or septic system or 

through other adequate means. (b) The operation must maintain sewage and septic systems, and (c) 

The operation must manage and dispose of leakages or spills of human waste in a manner that 

prevents contamination of produce, food contact surfaces, areas used for growing, harvesting, 

packing and holding activities, agricultural water sources and agricultural water distribution systems 

with known or reasonably foreseeable hazards. (d) this includes after a significant event (such as 

flooding or an earthquake) that could negatively impact a sewage or septic system. 

F-2 Agricultural Chemicals/Plant Protection Products

Pre-harvest materials include pesticides, growth regulators and fertilizers. Post-harvest materials 

would include waxes, fumigants and fungicides. Personnel in each area being audited should have 

a working knowledge of the use of these materials, if they are using them. This would include what 

the application material would be used for (fertilizer, wax, fungicide, etc.), the appropriate strength 

level, and what to do if there is a spill or the strength is improperly mixed. 

Applicators who hold current State licenses will meet the requirements of this question. However, 

if there are no restricted use materials being used which require the auditee to hold a pesticide 

license, then review training documents that prove the applicators have received training on the 

proper use of the materials. These requirements may only be assessed as N/A when no pre-harvest 

and/or post-harvest materials are used in the scope of the operation being audited. 
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The use of specific chemical brands or formulations tends to be regional. Growers in the same 

geographic region will often work with the same chemical salespeople and cooperative extension 

advisors. Trends may become evident for commonly used chemicals. In these situations, it will 

become apparent when a new chemical is being used, these are chemicals auditors will want to 

selectively sample for verification of compliance with the following requirements. 

Requirement F-2.a. The operation has a current list of agricultural chemicals that are 

used and approved for the crops being grown.

Procedure An agricultural chemical list is available for the commercial brand 

names and active ingredient composition or beneficial organisms of 

agricultural chemicals (including post-harvest chemicals such as 

biocides, waxes and plant-protection products) that are approved for

crops being grown within the scope of the audit for the last 12 months.

Verification Auditor shall verify the operation’s list of agricultural chemicals that are 

used and approved for the crop being grown and for crops grown within 

the scope of the audit for the last twelve months.

Corrective 

Action

Operation will keep a list of agricultural chemicals used and approved.

Documents 

Required

Record.

Mandatory

Expectation 

The operation has a current list of agricultural chemicals that are used and approved for the crops 

being grown. This list shall include the commercial brand names and active ingredient composition 

or beneficial organisms of the chemicals. This list must be updated annually and current for the last 

12 months.

Example Scenario

Scenario: Operation’s chemical records include a list of agricultural chemicals listed only by the 

brand names of chemicals. You verify that all chemicals in the operation are on the list. 

Assessment: Corrective Action Needed

Reason: List of chemicals must include the brand name and the active ingredient composition. 
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Requirement F-2.1. Use of agricultural chemicals shall comply with label directions 

and prevailing regulation.

Procedure Agricultural chemicals, including post-harvest chemicals such as 

biocides, waxes and plant protection products, must be registered for 

such use as required by prevailing regulation, and used in accordance 

with label directions including application rates, worker protection 

standards, personal protection equipment, container disposal, storage, 

and all requirements specified for chemical or compound. Chemicals 

that are not registered pesticides may be permitted for food contact use 

if allowed under regulations of the prevailing agency. Records of 

chemical agricultural use are maintained, and include crop date and 

location of application, chemical used, application rate and method, and 

preharvest interval.

Verification Auditor reviews agricultural chemical use records for evidence of 

compliance with approved uses or label directions.

Corrective 

Action

Operation develops and maintains agricultural chemical use records and 

maintains evidence of proper use of each chemical use. Retraining is 

performed and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

Record.

Mandatory ●

Expectation 

Agricultural chemicals must be registered for use as required by prevailing regulations and used in 

accordance with label directions, including application rate, workers’ protection standards, personal 

protective equipment, container disposal, storage, and all requirements specified for the chemical or 

compound. Note that this standard requires records of compliance with agricultural chemicals; this 

will include regulated and non-regulated chemicals.

The directions for use on an agricultural chemical label, describe how the product may legally be 

used and how the product must not be used. Generally speaking, the necessary information 

includes: 

• The pest(s) that the product may be used to control 

• The sites where the product may be used

• The application methods that are required or preferred

• How much pesticide should be applied and the rate of application 

• Whether there are any restrictions on use: weather, time of day, season of the year, 

contamination of sensitive areas, exposure of nontarget species, etc.
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• The application methods that are prohibited 

• How often pesticide should/may be applied 

• All restricted entry intervals (REIs) pertaining to existing uses, as applicable

• Maximum application rates per treatment and per year

• Pre-harvest intervals (PHIs)

• Storage and disposal

• Any other requirements as necessary

The directions for use reflect EPA’s determination that the use of the product in such a manner does 

not cause unreasonable adverse effects on the environment or human health under the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA). The general rule to go by is the label on an 

agricultural chemical is the law; if the label says you can use it, you can use it.

The directions for use are organized and carefully worded so they can be understood by the person 

expected to use or to supervise the use of the agricultural chemical. The directions for use indicate 

whether any actions mentioned are required, prohibited, encouraged, or discouraged when using the 

product and background information may also be provided.

Charts, tables, and graphics may be seen in many labels’ directions for use and they provide 

accurate information in a clear, concise, and complete manner. For example, an instructional 

statement such as this may be seen: “To make spray solution, mix 1 to 2 pints of this product in 100 

gallons of water. Apply 100 to 200 gallons of diluted spray solution per acre to trees depending on 

tree size and the coverage obtained with the spray equipment used.” Labels for agricultural 

products usually express the application rate in terms of pints/acre for liquid formulations, or 

pounds/acre for solid formulations. The directions for use for an agricultural pesticide used in a 

spray solution also must include the spray volume/unit area or other measurement of coverage, 

depending on the type of formulation. Labels for residential/household use products express the 

application rate in smaller units, such as ounces, teaspoons/gallon, or pounds/square foot. 

In emergency situations, Section 18 of FIFRA authorizes EPA to allow States to use a pesticide for 

an unregistered use for a limited time. There are four types of emergency exemptions: specific, 

quarantine, public health, or crisis. An applicator will need to have a copy of the Section 18 

allowing special use on hand. Current and recent actions under Section 18 are detailed in the 

FIFRA Section 18 Emergency Exemptions Database. This database is found at: 

https://iaspub.epa.gov/apex/pesticides/f?p=124:2::::::. 
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It is an acceptable practice for the operation to not have any application records onsite if the records 

are retained by the pesticide application company and the operation can obtain any record requested 

by the auditor within 24 hours of the audit. 

Example Scenarios 

Scenario 1: The operation has no application records for a restricted use pesticide. They say that 

they are compliant with prevailing regulation because they would not be allowed to purchase any 

product that is not legal.

Assessment: Immediate Action Required.

Reason: Application records for restricted use pesticides are required by law.

Scenario 2: You observe that a container of sprout inhibitor has spilled in the potato storage area. 

The operation has not taken any action because it has just been noticed. The operation immediately 

takes corrective action (following its Spill Procedure SOP) to clean the area according to label 

directions and removing potentially affected product.

Assessment: Compliant 

Reason: The operation has a procedure and is following it. 

Requirement F-2.1.a. Agricultural chemical records include the target organism(s) 

and justification for application.

Procedure The name of the pest(s), disease(s) and/or weed(s) treated and 

justification for the application is documented in all agricultural 

chemical application records.

Verification Auditors shall verify the operation’s records for agricultural chemicals 

used for target organism(s) and justification for application.

Corrective 

Action

Operation will keep agricultural chemical records which include the 

target organism(s) and justification for application.

Documents 

Required

Record. 

Mandatory

Expectation 

Auditor reviews operation’s chemical application records for the target organism(s), name of 

pest(s), disease(s) and or weed(s) and compares the application of chemical to the approved 

chemical product label to verify that the chemical is approved for application of product to the 

target organism(s). All chemical labels are required to show approval-for-use on target organisms. 

Chemical labels and/or records may be accessed by computer. In addition, auditors should make 

themselves aware of their State’s chemical application regulations.

Requirements F-2.1.a and F-2.1.b (see next requirement) have similar record-keeping requirements, 

however auditors should be aware that it is not necessary for the operation to maintain records for 

compliance to these requirements on the same form or in the same location. The example scenario 

that follows demonstrates a particular situation where both requirements are located as part of the 

same record. Auditors should assess each requirement independently for compliance.
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Example Scenario

Scenario: Auditor is reviewing operation’s chemical application records for a chemical used for 

control of the Strawberry Clipper. Auditor then reviews the chemical label to verify that Strawberry 

Clipper is listed as a target organism.

Assessment: Compliant. 

Reason: Strawberry Clipper is listed on the chemical label as a target pest.

Requirement F-2.1.b Records of post-harvest biocides, waxes and plant protection 

products include the identity of the harvested crop, location, application 

dates, treatment, product name, and dose rate.

Procedure Records of agricultural chemical applications shall be available and 

include: crop type and/or variety, location, application date, dose rate 

(a.i./ha), application rate (l/ha), product trade name, active ingredient 

and method of application.

Verification Auditors shall verify that records for post-harvest biocides, waxes and 

plant protection products include the harvested crop, location, 

application dates, treatment, product name, and dose rate.

Corrective 

Action

Operation shall include the harvested crop, location, application dates, 

treatment, product name, and dose rate of post-harvest biocides, waxes 

and plant protection products in their records.

Documents 

Required

Record.

Mandatory

Expectation 

Auditor reviews operation’s chemical application records to ensure products include the identity of 

the harvested crop, crop location, application dates, treatment method and type, name of product, 

and dose rate applied. Auditor shall review product label to verify that the chemical is approved for 

application as stated in this requirement. All chemical labels are required to show active 

ingredients, target organism, acceptable uses, application rates, acceptable application methods, and 

instructions. Chemical labels and/or records may be accessed by computer.

Example Scenarios 

Scenario: Auditor reviews the chemical label and the operation’s record-keeping for use of the 

chemical against Strawberry Clipper, a weevil that causes damage to the buds of strawberries.

Assessment: Compliant. 

Reason: The operation’s records for this chemical and its application include the harvested crop, 

location of crop, date of application, rate of application, and method of application. 
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Requirement F-2.1.c. Use of biological controls shall comply with label directions and 

prevailing regulation.

Procedure Only biological controls which are authorized for the cultivation of the 

specific crop will be used. Any biological control will be used according 

to the manufacturer’s direction. 

Verification Auditor reviews biological controls use records for evidence of 

compliance with approved uses or label directions. 

Corrective 

Action

Operation develops and maintains biological controls use records and 

maintains evidence of proper use of each biological control. Retraining is 

performed and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

Record.

Mandatory

Expectation 

Biological control is the intentional introduction of insects or other organisms into an agricultural 

operation with the specific intention to control a specific pest. Some types of biological controls 

include a natural enemy of the target pest, a pathogen or parasite to attack the target pest, and a 

competitor of the target pest (which can outperform the target pest and reduce its ability to thrive). 

It is important for an operation to consider any restrictions for introducing biological controls and to 

be aware that using pests/pathogens/parasites as biological controls may have unintended 

consequences.

Example Scenario 

Scenario: The auditee introduces spotted lady beetles into their potato fields to control the 

population of Colorado potato beetles. No records are kept since “spotted lady beetles are naturally 

occurring”. 

Assessment: Corrective Action Needed

Reason: Records of biological controls must be kept so that it can be determined whether they are 

being used according to both the directions and any regulations for application.

Requirement F-2.1.d. Operation keeps records of agricultural chemical applications 

used on nursery stock, transplants and other propagation material 

produced on site. 

Procedure Records shall be available of the use of agricultural chemicals on 

propagation materials.

Verification Auditor shall verify operation’s records of agricultural chemical 

applications on propagation materials.

Corrective 

Action

Operation keeps complete records of agricultural chemical applications 

on propagation materials.

Documents 

Required

Record.

Mandatory
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Expectation 

(In addition to Requirement F-2.1): 

If an operation produces propagation materials, they must keep and maintain records of agricultural 

chemical applications. If an operation brings in propagation materials, this requirement will be 

assessed as N/A.

Example Scenarios 

Scenario 1: All nursery stock is purchased from a third-party supplier. No agricultural chemical 

records or letter of guarantee was provided by the third-party supplier. 

Assessment: Not Applicable 

Reason: Nursery stock is not produced on site and therefore is not applicable for this question, 

however, should be covered in the approved supplier program 

 

Scenario 2 Transplants are produced in the greenhouse on site. Chemical records are available. 

Assessment: Compliant 

Reason: Necessary records are available.

Requirement F-2.2. If product is intended for export, agricultural chemical use, 

including post-harvest chemicals, shall consider requirements in the 

intended country of destination.

Procedure The operation shall have procedures, such as pre-harvest interval and 

application rate sufficient to meet the MRL entry requirements of the 

country(ies) in which the product is intended to be traded, if known 

during production.

Verification Auditor reviews operation’s procedure for complying with agricultural 

chemical restrictions in countries of destination. If the country of 

destination is unknown during production, this item is not applicable.

Corrective 

Action

Operation develops procedures, and diverts non-compliant product to a 

market in which the product meets standards.

Documents 

Required

N/A.

Mandatory

Expectation 

If the country of intended export is known, review the operation’s procedure for complying with 

agricultural restrictions in countries of destination. Review records of chemical use to verify 

compliance with the destination country’s requirements, as presented by the auditee.

This question may be answered N/A if the country of destination is unknown during production. 

Example Scenarios 

Scenario 1: The operation has evidence of training about Maximum Residue Levels (MRLs). 

Chemical application records from growers which include Pre-Harvest Interval (PHI) and rates 
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appropriate for sale in the U.S. are maintained. The operation sells to brokers and does not know 

country of destination for product. 

Assessment: Not Applicable. 

Reason: The operation does not know the country of destination. 

Scenario 2: The operation has not adjusted application rates or PHI for country of destination, 

which is known and has a lower MRL than U.S. This operation does not do residue testing and has 

no information to demonstrate that rates and PHI will or will not meet MRL of country of 

destination.

Assessment: Corrective Action Needed. 

Reason: The operation has not considered the requirements for the country of destination. 

Requirement F-2.3. Agricultural chemicals shall be applied, by trained, licensed or 

certified application personnel, as required by prevailing regulation.

Procedure Operation maintains records demonstrating that all personnel 

responsible for chemical applications are trained and/or licensed, or 

supervised by licensed personnel, in compliance with prevailing 

regulation.

Verification Auditor reviews records demonstrating that application personnel are 

licensed and/or trained in compliance with prevailing regulation.

Corrective 

Action

Operation utilizes application personnel who are appropriately licensed 

and/or trained.

Documents 

Required

Record.

Mandatory

Expectation 

Applicators who hold current State licenses will meet the requirements of this question. However, 

if there are no restricted use materials being used which require the auditee to hold a pesticide 

license, auditors must review training documents to verify that the applicators have received 

training on the proper use of the materials. The comment should include the applicator and/or 

personnel name, license number and expiration date.

Records demonstrating that application personnel are licensed and/or trained in compliance with 

prevailing regulations may include: 

• Current copies of private pesticide handler license for each employee applying chemicals

• Training records of employees applying agricultural chemicals

• Letter from subcontractor stating that all applicators/ handlers are licensed if letter provides 

evidence that specific applicators/handlers were licensed at the time of application.

Example Scenarios 
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Scenario 1: The operation does not have copies of the employees’ licenses onsite but can access 

records, stating that records are maintained online by The Department of Agriculture.

Assessment: Compliant 

Reason: The records are accessible for auditor review.

Scenario 2: Operation has record of annually providing pesticide application and handling training 

to employees. Auditor is aware that prevailing regulation requires that operator must be licensed.

Assessment: Corrective Action Needed

Reason: The standard requires application personnel to be licensed and/or trained in compliance 

with prevailing regulation. 

Requirement F-2.3.a. Operator demonstrates knowledge of preparing and calculating 

agricultural chemical mixes. 

Procedure The responsible person must be able to calculate and prepare the 

required application mix according to the label instructions and to 

prevent over or under application. 

Verification Auditors shall verify agricultural chemical mixes are calculated 

properly. Responsible person(s) for applying agricultural chemicals 

should be interviewed.

Corrective 

Action

Retraining of responsible persons may be needed.

Documents 

Required

N/A.

Mandatory

Expectation 

The auditor can determine if the operator preparing and calculating agricultural chemical mixes is 

knowledgeable through observation of the operator preparing the chemical mix, interviewing the 

operator, or reviewing training and application records to make an assessment of compliance. 

Auditors should keep in mind that this requirement has no record requirement, however an auditee 

could provide mix records if available. If mix records are not available, auditors should interview 

the operator about how mixes are prepared, then review labels to ensure that chemical mixing and 

preparation complies with label directions. If an outside chemical applicator is used, the auditor 

should review the letter of guarantee or the spray records.

Example Scenarios 

Scenario 1 Operator is not available to be interviewed, but the operation provides mix records to 

demonstrate how chemicals were prepared. Mix records comply with label directions. 

Assessment: Compliant 

Reason: The mix records were able to show that chemicals were mixed in compliance with label 

directions.

Scenario 2: Chemicals are mixed off-site by a chemical application company. No records are 

available.
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Assessment: Corrective Action Needed

Reason: CAN, if no additional documentation is available. If a letter of guarantee and commercial 

applicator’s licenses are on file would be assessed as Compliant.

Requirement F-2.4. Water used with agricultural chemicals shall not be a potential 

source of product or field contamination.

Procedure Water used to dilute or deliver agricultural chemicals shall be from a 

source in compliance with the Water System Risk Assessment and 

Water Management Plan, consistent with current industry practices or 

regulatory requirements for that commodity.

Verification Auditor reviews the Water System Risk Assessment for evidence that 

water used with agricultural chemicals has been considered, and that 

agricultural chemical use policies are in compliance with the Water 

System Risk Assessment.

Corrective 

Action

Operation revises the Water System Risk Assessment. Operation uses a 

water source in compliance with the Water System Risk Assessment. 

Retraining is performed and documented. Affected product is evaluated 

for potential contamination and disposition.

Documents 

Required

Record.

Mandatory

PSR 112.41

Expectation 

All water used with agricultural chemicals must be of known quality, must be of appropriate 

microbial quality for its use. The water source used for chemical applications must be included in 

the Water System Risk Assessment and Water Management Plan. Not all chemical applications 

require the use of potable water, however, the water must be of microbial quality appropriate for its 

intended use.

For more information on the Water System Risk Assessment and Water Management Plan see 

requirements and guidance in sections F-4.1 and F-5.1 of this manual. 

The auditor will include water source used for agricultural chemical sprays in the comments. If 

applicable, include mitigation methods.

Example Scenario 

Scenario: Operation utilizes an industry-specific Water Risk Assessment addressing all possible 

water sources: holding pond, open canal, direct pump from river, and closed system from mountain 

reservoir. Operation uses direct pump from river and records indicate they are in compliance with 

industry recommendations.

Assessment: Compliant 

Reason: Compliant for this audit requirement. If auditor has reason to believe the Water Risk 

Assessment is not accurate, that would be reflected in audit item F-4.1. 
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Produce Safety Rule 

112.41: All agricultural water must be safe and of adequate sanitary quality for its intended use.

Requirement F-2.4.a. Equipment used to apply agricultural chemicals shall be kept in 

good condition and verified annually to ensure accurate application. 

Procedure The agricultural chemical application machinery has been verified for 

correct operation within the last 12 months and this is certified or 

documented either by participation in an official scheme (where it exists) 

or by having been carried out by appropriately trained and/or licensed 

(where required) personnel.

Verification Auditors shall verify the operations records have been maintained 

within the last 12 months to ensure accurate application of agricultural 

chemicals. Observation should be made that application equipment is in 

good condition if maintained by the operation.

Corrective 

Action

Equipment used for application of agricultural chemicals will be 

brought to a level of good condition and records of its annual 

maintenance will be maintained by the operation.

Documents 

Required

Record.

Mandatory

Expectation 

Auditor conducts a visual inspection on chemical application equipment to ensure that chemical 

application equipment is in good condition. Auditor reviews yearly calibration records for chemical 

application equipment. It is not uncommon for an operation to calibrate their equipment multiple 

times during the season. Calibration needs to be carried out by properly trained or licensed 

personnel. Records need to be maintained for calibration. Auditors should keep in mind that 

chemicals may be applied during different farm activities, such as product going into storage and/or 

products being packed. Equipment must be cleaned and maintained so as not to be a source of 

contamination. In addition, equipment used to apply agricultural chemicals should be included on 

the operation’s equipment list.

Example Scenarios 

Scenario 1: Sprayer is rented by the operation on an annual basis. The rental contract states that 

equipment is calibrated annually. 

Assessment: Compliant 

Reason: The contract is their record. Could be assessed as Corrective Action Needed if auditor 

observes that the equipment is not in good condition or being properly maintained. Best practice 

would include the last date of calibration. 

Scenario 2: Applicator is calibrated annually onsite by a trained employee, but records of 

calibration are not available.

Assessment: Corrective Action Needed

Reason: The standard requires a record be kept of verification activities such as calibration.
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Scenario 3: While auditing a potato farm, inspector notices a spray arm going across a conveyor 

that is unloading fresh dug product from a farm truck into a storage facility. Auditor questions the 

farm’s representative about the chemical being applied and the calibration records for the 

equipment used. Representative can only produce documentation for ratio of water to chemical 

applied. 

Assessment: Corrective Action Needed

Reason: All chemical applying equipment needs to be calibrated and recorded. 

Requirement F-2.5. Agricultural chemical disposal shall not be a source of product or 

field contamination.

Procedure Operation shall have procedures for disposal of waste agricultural 

chemicals and for cleaning of application equipment that protects 

against contamination of product and growing areas.

Verification Auditor observes chemical handling records for evidence of compliance.

Corrective 

Action

Operation develops and implements procedures. Steps are taken to 

mitigate any contamination events.

Documents 

Required

Record.

Mandatory

Expectation 

Review chemical handling records for evidence of compliance. Additionally, observe how 

chemicals and containers for disposal are being stored by the operation to verify that this is in 

compliance with the operation’s Food Safety Plan and applicable regulations. Chemical container 

disposal methods should comply with what is required by the chemical label. Examples of disposal 

statements found on various types of pesticide containers include: 

• Metal containers (non-aerosol):

Triple rinse (or equivalent). Then offer for recycling or reconditioning, or puncture and 

dispose of container in a sanitary landfill, or by other procedures approved by state and local 

authorities. 

• Paper and plastic bags:

Completely empty bag into application equipment. Then dispose of empty bag in a sanitary 

landfill or by incineration, or, if allowed by state and local authorities, by burning. If 

burned, stay out of smoke. 

• Glass containers:

Triple rinse (or equivalent). Then dispose of in a sanitary landfill or by other approved state 

and local procedures. 

• Fiber drums with liners:

Completely empty liner by shaking and tapping sides and bottom to loosen clinging 

particles. Empty residue into application equipment. Then dispose of liner in a sanitary 
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landfill or by incineration if allowed by state and local authorities. If drum is contaminated 

and cannot be reused, dispose of it in the manner required for its liner.

• Plastic containers:

Triple rinse (or equivalent). Then offer for recycling or reconditioning, or puncture and 

dispose of in a sanitary landfill, or incineration, or, if allowed by state and local authorities, 

by burning. If burned, stay out of smoke. 

• Compressed gas cylinders:

Return empty cylinder for reuse (or similar wording).

Example Scenarios 

Scenario 1: Operation has lockable, designated area for empty/used agricultural chemical 

containers and participates in a semi-annual recycling program. However, operation does not have a 

written procedure. 

Assessment: Compliant 

Reason: The standard does not require procedures to be written. 

Scenario 2: The operation applies excess chemical to dirt road adjacent to production area.

Assessment: Corrective Action Needed

Reason: CAN unless prevailing regulation and manufacturer expressly permit it. 

Requirement F-2.5.a. Agricultural chemicals approved for use on the crops being 

grown are stored separately from agricultural chemicals used for other 

purposes.

Procedure Only the agricultural chemicals currently in the approved agricultural 

chemicals list are kept in the storage area. Agricultural chemicals used 

for purposes other than application on crops within the rotation for the 

last 12 months are clearly identified and stored separately within the 

plant protection products storage area.

Verification Auditors shall verify that only chemicals approved for use on crops 

being grown by the operation are stored in a designated storage area.

Corrective 

Action

Operation will establish a designated storage for approved agricultural 

chemicals for use on the crops being grown separated from agricultural 

chemicals used for other purposes.

Documents 

Required

Record

Mandatory

Expectation 

Containment of hazardous materials is required for the protection of the environment from 

contamination as well as for the protection of employees who work in areas where hazardous 

materials are stored and used. Auditor inspects storage of agriculture chemicals used on crops to 

ensure that other types of agriculture chemicals are stored separately. Auditors should be familiar 

with their state’s regulation for chemical storage. “Separately”, as stated in this requirement, does 
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not necessarily mean in another location or different storage area. The primary requirement is that 

an operation must have approved and non-approved agricultural chemicals in designated areas. An 

operation’s employees must know where the chemicals are to be stored and auditors must verify 

compliance by interviewing employees who are responsible for chemical storage. This requirement 

is intended to prevent unintended use of non-approved chemicals.

Example Scenarios 

Scenario 1: Chemicals, including both those approved for use in food production and those not 

approved for produce use, are stored in one chemical storage shed, comingled on shelves. Auditee 

states that employees are trained on which ones are to be used in produce activities and which ones 

are not. 

Assessment: Corrective Action Needed

Reason: Chemicals approved for use on crops being grown by the operation must be stored 

separately from chemicals used for other purposes.

Scenario 2: Chemicals, including both those approved for use in food production and chemicals 

used for other purposes are stored in one chemical storage shed. Approved chemicals are stored on 

the north side of the shed, non-approved chemicals are stored on the south side of the shed. Auditor 

verifies chemical locations and that employees have been trained on storage locations. 

Assessment: Compliant 

Reason: The chemicals are stored in different areas of the chemical shed and can be considered 

separate, if it allows employees to differentiate between approved and non-approved chemicals.

F-3 Water System Description

Requirement F-3.1. A water system description shall be available for review.

Procedure Water sources and the production blocks they may serve shall be 

documented and current. The description shall include one or more of 

the following: maps, photographs, drawings (hand drawings are 

acceptable) or other means to communicate the location of water 

source(s), permanent fixtures and the flow of the water system 

(including holding systems, reservoirs or any water captured for reuse). 

Permanent fixtures include wells, gates, reservoirs, valves, returns and 

other above ground features that make up a complete irrigation system 

shall be documented in such a manner as to enable location in the field

or in hydroponic, aeroponic or aquaponics operations.

Verification Auditor reviews water system description or map, and verifies accuracy 

during inspection.

Corrective 

Action

Operation develops or corrects the water system description or map.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 
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Water system descriptions must describe the sources and distribution of water in an operation. All 

water sources and distribution systems used by the operation for farming need to be documented. 

Water system descriptions may include maps, photographs, drawings, written descriptions, etc. 

Verify that the operation has a written water system description and the completeness and accuracy 

of the water system description in the process of the farm review.

Example Scenarios

Scenario 1: The operation has a Google Earth map of the fields with well and permanent fixture 

locations marked in pen. 

Assessment: Compliant 

Reason: As long as the map is accurate and there are no omissions this would be compliant. 

Scenario 2: The water system description does not include an onsite pond. Operation says that the 

pond is not used for irrigation but may be used to dilute agricultural chemicals or wash out chemical 

containers.

Assessment: Corrective Action Needed or Immediate Action Required

Reason: The water used for other agricultural purposes are part of the water system. IAR - If the 

source of water may reasonably lead to product contamination. 

Scenario 3: Operation has no written description, but only has one well. 

Assessment: Corrective Action Needed

Reason: Standard requires that all “water system descriptions must be available for review”, even 

simple systems should be documented. 

Requirement F-3.2. The water source shall be in compliance with prevailing 

regulations.

Procedure Water shall be sourced from a location and in a manner that is 

compliant with prevailing regulations.

Verification Auditor determines whether the water source is compliant with 

regulations relevant for the intended use of the water.

Corrective 

Action

Operation discontinues use of the source until compliant with 

regulations. Affected produce is evaluated for potential contamination 

and disposition.

Documents 

Required

N/A.

Mandatory

Expectation 

The water source (municipal, well, or surface water) must be in compliance with prevailing 

regulations. The auditor should be familiar with what source water is being used and any applicable 

local and state regulations for that water source. Often for wells and surface water there are local 

regulations for water use. This may include how much water may be used, i.e. if a permit is needed 

to pull water from a canal or stream. 

Example Scenario 
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Scenario: Operation is sourcing irrigation water from a trout stream onsite. The operation states 

there are no local regulations regarding using the stream for irrigation. 

Assessment: Compliant 

Reason: Unless the auditor is aware of contradictory information this is compliant with prevailing 

regulations. 

Requirement F-3.3. Water systems shall not be cross-connected with human or animal 

waste systems.

Procedure Water systems intended to convey untreated human or animal waste 

shall be separated from conveyances utilized to deliver water.

Verification Auditor reviews water system for cross-connections with human or 

animal waste conveyances.

Corrective 

Action

Operation discontinues use of the system until they are separated.

Documents 

Required

N/A.

Mandatory ●

PSR 112.133(d)

Expectation 

A cross-connection is any place in the water system where a water line may be connected with 

piping that may carry other liquids. These may include fertilizer, human waste, animal waste, etc. 

The standard specifies that no cross-connections with human or animal waste conveyances may be 

present. If cross-connections with human or animal waste conveyances are observed, then 

Immediate Action will be required.

Example Scenario

Scenario: Irrigation system is cross-connected to a system that distributes liquefied dairy manure 

to an adjacent grain field. System uses a gate valve to prevent dairy manure from crosscontaminating the irrigation water.

Assessment: Immediate Action Required

Reason: The standard requires that “Water systems intended to convey untreated human or animal 

waste shall be separated from conveyances utilized to deliver agricultural water”.

Produce Safety Rule 

112.133(d): Plumbing must be adequately installed and maintained to not allow backflow from, or 

cross-connection between, piping systems that discharge waste water or sewage and piping systems 

that carry water used for harvesting, packing or holding activities, for sanitary operations, or for use 

in hand-washing facilities.

F-4 Water System Risk Assessment

Water use in crop production involves numerous field operations including irrigation, applications 

of pesticides and fertilizers, cooling, and frost control. Inadequate water quality has the potential to 

be a direct source of contamination and a vehicle for spreading localized contamination in the field, 
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facility, or transportation environments. Wherever water comes in contact with fresh produce, its 

quality dictates the potential for pathogen contamination. If pathogens survive on the produce, they 

may cause food borne illness.

Water can be a carrier of many microorganisms including pathogenic strains of Escherichia coli, 

Salmonella spp., Vibrio cholerae, Shigella spp., Cryptosporidium parvum, Giardia lamblia, 

Cyclospora cayetanensis, Toxiplasma gondii, and the Norwalk and Hepatitis A viruses. Even small 

amounts of contamination with some of these organisms can result in food borne illness.

The quality of water, how and when it is used, and the characteristics of the crop influence the 

potential for water to contaminate produce. In general, the quality of water in direct contact with 

the harvestable portion of produce may need to be of better quality compared to uses where there is 

minimal contact. Other factors that influence the potential for contact with waterborne pathogens, 

and their likelihood of causing food borne illness, include the condition and type of crop, the 

amount of time between contact and harvest, and post-harvest handling practices.

Produce that has a large surface area (such as leafy vegetables) and those with topographical 

features (such as rough surfaces) which foster attachment or entrapment may be at greater risk from 

pathogens, if they are present, especially if contact occurs close to harvest or during post-harvest 

handling. Some sectors of the produce industry use water containing antimicrobial chemicals to 

maintain water quality or minimize surface contamination.

Water usage on the farm includes irrigation and chemical applications of the product. Consider the 

water source and usage when assessing the following requirements.

USDA AMS requires that growers incorporate testing into their water management plan. 

Since finalizing the Produce Safety Rule, FDA has received feedback that some of the standards in 

subpart E need further scientific research. In response to these concerns, FDA is reviewing subpart 

E which has delayed its implementation. Further guidance will be provided in the future once

Subpart E is finalized and regulatory implementation begins.
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Requirement F-4.1. An initial risk assessment shall be performed and documented 

that takes into consideration the historical testing results of the water 

source, the characteristics of the crop, the stage of the crop, and the 

method of application.

Procedure A review or new assessment shall be conducted seasonally and any time 

there is a change made to the system or a situation occurs that could 

introduce an opportunity to contaminate the system. The risk 

assessment shall address potential physical, chemical, and biological 

hazards and hazard control procedures for the water distribution 

system.

Verification Auditor reviews the risk assessment for completeness of consideration of 

potential hazards.

Corrective 

Action

Operation develops or updates the risk assessment.

Documents 

Required

Risk Assessment. 

Mandatory ●

Expectation 

A water risk assessment should take into consideration the source water quality, method of delivery, 

and timing of delivery. Municipal water sources are viewed as the least likely to be contaminated. 

Surface water has the highest risk of contamination. If surface water is being used from a source 

which is not contained within the operation’s boundaries (e.g., river, stream) the operation should 

make every effort to be aware of upstream activities and identify potential sources of 

contamination.

Farming operations must have knowledge of the quality of their water source in order to determine 

whether or not the product could become contaminated. Sources such as wells should be in good 

condition and properly capped and elevated. Land should be sloped away from the wellhead to 

prevent runoff contamination into the well. Backflow prevention devices should be installed. 

Sources such as surface irrigation should be assessed for possible contamination from raw human 

and animal wastes, sewage water discharges, contamination from adjacent land and contamination 

from wildlife presence or manure runoff.

Application methods include irrigation (overhead-sprinkler, flood-surface, furrow, drip-trickle, 

humidifiers, humidicelles, etc.), frost protection, and agricultural chemical application. Drip 

irrigation methods or those where the water does not touch the crop are less likely to promote 

potential contamination than flood irrigation methods. Irrigation with sprinkler methods, or 

chemical application where the water sprinkles or drenches the crop can have higher risk for 

causing contamination, especially if the water quality is unknown. 

The timing in the crop cycle when water is applied should be addressed in the assessment of risk. 

Water applied weeks before harvest poses less risk than water applied to the edible portion of the 

crop near harvest. It is never the intent that potable or microbially safe water should be used in 
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every water application on the farm. Chemical applications or irrigation that occur prior to the crop 

being planted or if the crop is dormant (such as tree fruit) does not require potable water. However, 

chemical or irrigation applications that occur just prior to the crop being harvested must use 

microbially safe water.

Review the operation’s risk assessment to verify that potential physical, chemical and biological 

hazards and hazard control procedures have been addressed to take into account the historical 

testing results of the water source, the characteristics of the crop, the stage of the crop, and the 

method of application. Include the date and the role/title of the person who conducted the last 

assessment in the comments. 

Example Scenario

Scenario: A row crop operation is sourcing irrigation water from an open pond onsite. The 

operation has no testing data but claims there are no risks because their children swim in it.

Assessment: Corrective Action Needed

Reason: The operation must have a credible risk assessment.

F-5 Water Management Plan

Requirement F-5.1. There shall be a water management plan to mitigate risks 

associated with the water system on an ongoing basis.

Procedure The water management plan shall include the following: preventive 

controls, monitoring and verification procedures, corrective actions, and 

documentation. The plan shall be reviewed following any changes made 

to the water system risk assessment and adjusted accordingly to 

incorporate such changes. Training and/or retraining of personnel 

having oversight or performance duties shall be documented.

Verification Auditor reviews the water management plan for accuracy and 

completeness relative to the risk assessment.

Corrective 

Action

Operation develops or updates water management plan.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

All operations must have a written water management plan. The management plan must include 

preventative controls, monitoring and verification procedures, corrective actions, and 

documentation. The standard does not specify the frequency of a plan review; however, the plan 

must be reviewed whenever changes in risk assessment occur. The operation must train personnel 

in a manner consistent with the water management plan.

USDA AMS requires that growers incorporate testing into their water management plan.
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The USDA GAP program believes that it is important to know the quality of water that is being 

used in on your operation even if it is unlikely to contact the edible portion of the crop. It is a 

requirement for all USDA GAP audits that water testing be performed (or water authority 

documentation provided) on all water used in the operation.

Water tests are required to be conducted on a scheduled frequency to verify water quality is meeting 

the operation’s action threshold as outlined in their SOPs. While the standard does not set a 

numerical threshold that water tests should meet, it is expected that the auditee establishes criteria

for their water source based on industry standards/prevailing regulations/historical testing for when 

the source is at a normal level of risk versus when there may be elevated risk of contamination 

based on high numbers of indicator organisms. The minimum testing frequency is as follows, 

unless otherwise justified in the water risk assessment:

• Municipal water: Test results are acquired from the local water authority annually or 

tested by the operation at least annually.

• Well water: Water is tested one time during the growing season. If fecal coliforms are 

present, the well is treated with a sanitizer to reduce pathogen levels and is retested. Wells 

are monitored to make sure casings are secure and well-maintained and that livestock and 

manure storage areas are excluded from the well recharge and pumping area.

• Surface water: Water is tested three (3) times during the growing season – first at planting, 

second at peak use, third at or near harvest. There is not a national irrigation water standard 

which sets the minimum microbial levels allowable for irrigation water. However, there are 

many commodity specific guidelines available which give recommendations for water 

quality. These can serve as a reference source for an operation when determining specific 

thresholds for their irrigation water. For instance, the CA & AZ Leafy Greens Marketing 

Agreements and the Food Safety Standard for the Tomato Supply Chain identify the 

microbial requirements of the EPA Recreational Water Standard as the threshold for 

irrigation water.

Corrective actions, including what to do in the event a water test exceeds maximum threshold 

levels, must be established in the water management plan. Having corrective actions preestablished allows an auditee to take quick and decisive action if water tests results are above 

allowable levels.

Example Scenario

Scenario: Hydroponic greenhouse operation pulls its water from both well and municipal sources. 

In addition, it recycles water from the greenhouse operation, which it treats using a validated UV 

filtration system. The operation tests the well and municipal water but does not test the recycled 

water after it is UV treated.

Assessment: Compliant.

Reason: The requirement intends to ensure that operations have management plans for water and 

incorporate policies and procedures according to their own risk assessment. Provided the Auditor’s 

review of the water management plan demonstrated completeness relative to the risk assessment, 
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this scenario is compliant. There are no specific requirements of F-5.1 requiring the operation to 

test the water after treatment.

Requirement F-5.2. Water testing shall be part of the water management plan, as 

directed by the water risk assessment and current industry standards or 

prevailing regulations for the commodities being grown.

Procedure As required, there shall be a written procedure for water testing during 

the production and harvest season, which includes frequency of 

sampling, who is taking the samples, where sample is taken, how the 

sample is collected, type of test and acceptance criteria. If all water is 

sourced from a municipal source, the municipal testing is sufficient. The 

frequency of testing and point of water sampling shall be determined 

based on the risk assessment and current industry standards or 

prevailing regulations for commodities being produced.

Verification Auditor verifies that a water testing program is in compliance with the 

risk assessment and current industry standards or prevailing 

regulations and is included in the water management plan.

Corrective 

Action

Operation develops a testing program consistent with risks identified in 

the risk assessment and with current industry standards or prevailing 

regulations for the commodities being grown.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

It is important for auditors to be familiar with the regulatory requirements and industry standards 

that are applicable to the operation being audited. A list of industry guidance recognized by the 

FDA can be located in Appendix IV of this manual.

The FDA has currently extended the compliance dates for Subpart E (Agricultural Water) of the 

FSMA Produce Safety Rule, therefore we do not consider the water testing requirements as 

prevailing regulations and are not requiring that auditees adhere to them. When the FDA clarifies 

their water testing standards and sets enforcement dates these will be considered prevailing 

regulations for all covered farms/commodities, and therefore will be required as part of the water 

management plan for all covered Harmonized and Harmonized GAP Plus+ auditees. 

A water management plan must be written and must include the frequency of sampling, who takes 

samples, where samples are taken, how the sample is collected, the type of test, and the acceptance 

criteria for the test. The auditor’s comment on the report should include the water test dates and/or 

results for field operations.

Water samples should be taken from a location which most accurately represents the water which 

will be used on the specialty crop. For example, a grower who pumps irrigation water out of a river 

should collect their water sample as close as possible to the intake pipe in the river. If an auditee 

uses equipment which may reduce risk (e.g., a filter) or introduce risk (e.g., old pipes, or pipes with 
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dead legs) the auditee may wish to take their water sample from the end of their distribution system 

to capture the effects that the system has on the water quality. This should be reflected in their risk 

assessment and water testing procedure. 

 

If a water test can be taken from a location which represents the water used by two different 

operations, then yes both farmers can use the same water test(s), but both auditees will be expected 

to have copies of the test results in their own Food Safety Plans. However, if there are significantly 

different risks in the source where it is pulled by each grower then they will each need to take their 

own water tests. 

Examples

• Two growers pull irrigation water from the same pond which straddles their property line. 

Each grower has their own pump with intake pipes floated towards the center of the pond. 

These growers could pull a representative sample from the middle of their pond and share 

the test results. 

• Two growers each pull irrigation water from the same stream. There are two farms 

separating the growers who also have access to the stream including a cattle farm. In this 

case the growers would each need to collect their own water samples as the risk to the water 

source may change as it moves through the other farms.

The auditor will include frequency of testing and threshold criteria for water test results in the 

comments.

Requirement F-5.3. The testing program shall be implemented consistent with the 

water management plan.

Procedure Testing shall be performed and documented according to procedures 

described in the water management plan.

Verification Auditor reviews testing records for compliance with the written plan.

Corrective 

Action

Operation shall revise testing to be in compliance with the written plan. 

The corrective actions noted in the water management plan shall be 

followed until the conditions have been mitigated and the nonconformity has been resolved.

Documents 

Required

Record.

Mandatory ●

Expectation 

Verify that the water testing program is implemented consistent with the written water management 

plan. Sampling must be consistent with protocol used for collecting samples for microbiological 

testing (see requirement F-5.2). Also, verify the operation’s testing frequency and sampling 

frequency.
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If an auditee sources potable water from a local water authority (municipality, county, etc.) they 

must provide a copy of the most recent annual water report, or other documentation showing that 

the water is being monitored for potential contamination by the local authority. This documentation 

is often available on the water authority’s website or by contacting them directly.

The auditor will include the water test dates, water application method (i.e., drip, overhead, furrow) 

and source (i.e., well, surface, municipal) in the comments and also include target organism and 

present/absent or quantified number from most recent water test results.

Requirement F-5.4. If water is treated to meet microbiological criteria, the treatment 

is approved and effective for its intended use, and is appropriately 

monitored.

Procedure Treatment is approved for its intended use (e.g., EPA-registered 

antimicrobial pesticide, or registration as required by the prevailing 

regulation of the country of use) and is delivered in a manner to ensure 

that the treated water is consistently safe and of adequate sanitary 

quality for its intended use and/or consistently meets the relevant 

microbial quality criteria. Treatment is monitored at a frequency 

adequate to ensure that the treated water is consistently safe and of 

adequate sanitary quality for its intended use and/or consistently meets 

the relevant microbial quality criteria.

Verification Auditor verifies that water treatment is approved for its intended use, 

reviews documentation that it is used effectively to meet the intended 

microbiological criteria, and reviews monitoring records for compliance 

with the operation’s established procedure and acceptance criteria.

Corrective 

Action

Operation discontinues use of unapproved treatments, uses approved 

treatments in an effective manner, and monitors the treatment at an 

adequate frequency.

Documents 

Required

Record.

Mandatory ●

Expectation 

For all chemicals used, including water treatment chemicals, an auditee must have access to the 

chemical’s label. The label needs to show that the chemical has been approved for how the auditee 

is using it – there are different label approvals for cleaning and sanitizing food contact surfaces, for 

produce washing, and for treating water. 

Additional documentation will be based on the sanitizer and should demonstrate that the auditee is 

following the label directions for what needs to be monitored. Monitoring criteria may include 

concentration, contact time, pH, ORP, free chlorine, water temperature, turbidity, and whether or 

not the product is rinsed with potable water after the use of the sanitizer. 
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If water is treated to meet microbiological criteria, verify that the treatment is approved for its 

intended use. The operation must have documentation that clearly states the uses for which the 

treatment is appropriate and how it is to be used effectively to meet the microbiological criteria.

If water treatment is used by the operation, the auditor should document the treatment and the 

parameters for monitoring the effectiveness of the treatment in the comments section of the audit 

report. For chemical treatments include the chemical name and EPA Registration Number. 

Example Scenarios 

Scenario 1: Farm irrigates with water that does not meet microbial thresholds; water is treated with 

Peracetic Acid (PAA). PAA is not recognized by EPA to treat irrigation water.

Assessment: Corrective Action Needed

Reason: Not necessarily a food safety risk, but the label is the law, and it’s not approved for 

irrigation water. The label may permit use for cleaning or to control algae.

Scenario 2: The water treatment records are incomplete with missing periods of time, as long as 7 

days. Current operation at the time of the audit is acceptable but treatment records do not support 

consistent acceptable treatment.

Assessment: Corrective Action Needed

Reason: Treatment must be monitored at an adequate frequency so records should not be 

incomplete.

Requirement F-5.5. If post-harvest handling is used to achieve microbial criteria, 

operation has documentation supporting its use

Procedure If die-off or removal rates or other methods (e.g., commercial washing) 

are used to achieve microbial criteria of water used during growing, 

operation has scientific data or information used to support its 

effectiveness. Documentation includes the specific time interval or log 

reduction applied, how the time interval or log reduction was 

determined, and the dates of corresponding activities such as the dates 

of corresponding activities such as the dates of last irrigation and 

harvest, the dates of harvest and end of storage, and/or the dates of 

activities such as commercial washing.

Verification Auditor verifies documentation for completeness.

Corrective 

Action

Operation obtains documentation on, or discontinues use of, 

unsupported methods, uses approved methods in an effective manner, 

and maintains required documentation.

Documents 

Required

Record.

Mandatory ●

Expectation 

While water treatment is a common way to meet microbial criteria for water used in agriculture, 

there are also other methods, and the science and accepted methods may change over time, such as 

an alternative microbial die off rate being used in combination with water test results for cured
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onions. If an operation is using post-harvest handling methods to meet microbial standards, they 

must have documentation and/or scientific data to show that it is effective. Verify records to see 

that the operation is putting their documented methods into practice appropriately.

Requirement F-5.6. If Operation uses an alternative approach to regulatory 

microbiological testing, Operation has scientific data or information to 

support the alternative.

Procedure If operation uses an alternative testing method, frequency or criteria to 

regulatory requirements, operation has documentation supporting the 

alternative.

Verification Auditor verifies documentation for completeness.

Corrective 

Action

Operation obtains documentation on, or discontinues use of, the 

alternative.

Documents 

Required

Record.

Mandatory ●

Expectation 

An operation may use a different method, frequency or criteria for water testing than the regulatory 

requirement states. If so, they need to have documentation supporting the use of those alternative 

methods. Where regulatory microbial testing for water is absent, this question shall be assessed as 

N/A due to the fact that there is no valid baseline from which to deviate.

If post-harvest handling is used, include the die-off or removal rate, time interval, log reduction and 

dates relevant to these activities in the comments.

F-6 Animal Control

While it is not possible to completely exclude animal life from all fresh produce production areas, 

many field programs include elements to protect crops from animal damage. Growers should 

review existing practices and conditions to assess the potential for significant amounts of 

uncontrolled deposits of animal feces coming into contact with crops. Good agricultural practices 

for minimizing hazards from livestock include but are not limited to:

• Exclusion of domesticated animals from fresh produce fields, vineyards and orchards during 

the growing season. This would include pet dogs, goats, sheep, cows, horses, fowl, 

domesticated or feral cats, etc.

• Depending on the operation, good management practices may include keeping livestock 

confined (e.g., in pens or yards) or preventing their entry into fields by using physical 

barriers such as fences.

• Ensure that animal waste from adjacent fields or waste storage facilities does not 

contaminate the production area. 
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Growers should determine whether surrounding fields and farms are used for animal production. 

They may need to consider measures to ensure that animal waste from adjacent fields or waste 

storage facilities does not contaminate the produce production areas during heavy rains, especially 

if fresh produce is grown in low-lying fields or orchards. Measures might include physical barriers, 

such as ditches, mounds, grass/sod waterways, diversion berms, and vegetative buffer areas that 

prevent flowing or splashing water from contaminating crops. 

High concentrations of wildlife (such as deer, wild pigs or waterfowl in a field) or domesticated

animals (such as cows, sheep, horses, or fowl) may increase the potential for microbial 

contamination by significant or uncontrollable amounts of fecal material. 

Control of wild animal populations in the field may be difficult, especially where crop production 

areas are adjacent to wooded areas, open meadows, and waterways.

Fencing, vegetation removal, and destruction of habitat may result in adverse impact to the 

environment. As always, do not make any recommendations or suggestions on how to control 

wildlife. You should refer the auditee to check for local, state and federal laws that protect riparian 

habitat, restrict removal of vegetation or habitat, or restrict construction of wildlife deterrent fences 

in riparian areas or wildlife corridors.

Requirement F-6.1. The operation has a written risk assessment on animal activity in 

and around the production area.

Procedure There shall be a written assessment of the growing fields and adjacent 

land, prior to each growing season, focusing on domestic and wild 

animal activity including grazing and feeding operations, noting crop 

characteristics, type and approximate number of animals, proximity to 

the growing field, water sources, and other relevant factors.

Verification Auditor reviews the written assessment to ensure it has been performed 

for this season and is complete.

Corrective 

Action

Operation performs and documents assessments.

Documents 

Required

Risk Assessment.

Mandatory ●

PSR 112.83

Expectation 

Verify that the operation has a written risk assessment on animal activity in and around the 

production area. The risk assessment must address domesticated and wild animal activity on 

adjacent lands, their proximity to growing fields and water sources, and other relevant factors.

Currently, there is no conclusive science to validate the exact distance needed between crop 

production areas and sources of potential contamination. You will need to use your best judgment 

and observe the presence of dairy or livestock production facilities, including feedlots (beef, swine, 

chickens, etc.). Concentrated feeding operations are defined by EPA and will have bare ground not 
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covered by vegetation. When these types of facilities are near the crop production area, factors such 

as topography, wooded areas, or other natural barriers must be taken into consideration when 

answering this question. For enclosed greenhouses the auditor should consider the type of barriers 

in place (grass, slope, trees, etc.).

Manure is a major source of potential contamination. Manure storage areas should be constructed 

to contain any potential leaching and runoff from entering the crop production areas. Where it is 

possible that manure lagoons from adjacent or close dairy or livestock facilities can be a possible 

source of contamination, operations must take some measures to prevent the contamination. 

Lagoons must be of sufficient construction to prevent leaking or overflowing or operations must 

protect the crop growing area. Measures might include physical barriers, such as ditches, mounds, 

grass/sod waterways, or diversion berms. In locations where the farming operation is on higher 

elevation ground than the lagoon, there will be little need for such barriers, as the elevation is a 

barrier itself.

Manure containment should also consider potential drift and distance from dried manure piles or 

vented air facilities, such as chicken houses to nearby production areas where wind could have the 

potential to spread the manure. Traffic patterns should be considered concerning vehicles traveling 

to and from the manure storage area which may spread human pathogens to production areas nearby 

through the stirring up of dust, transporting animals or the manure itself. At a minimum, pest 

control programs should monitor for rodents and other burrowing animals in manure storage and 

production areas as these animals may serve as a conduit for human pathogen spread and 

contamination.

In certain cases, it is possible that livestock may have access to the source of the water supply 

(wellhead area or pond/stream) or to the delivery system (canal/ditch). Where this is the case, 

operators should take measures to keep such livestock away.

The auditor will include the date and the role/title of the person who conducted the last assessment

in the comments.

Example Scenario

Scenario: Row crop operation states in their food safety plan that there are no contamination risks 

from animal. The auditor notices one horse in the backyard of an adjacent property. The operation 

says that it is the only horse in the area. 

Assessment: Compliant.

Reason: Compliant as long as there is a risk assessment of the horse and there are adequate barriers 

to prevent and detect intrusion of the horse onto the property.

Produce Safety Requirement

112.83: If there is a reasonable probability that grazing animals, working animals or animal 

intrusion will contaminate produce, the operation must assess the relevant areas used for growing, 

harvesting, packing and holding activities as needed during the growing season (based on the 

produce grown; the practices and conditions; and the observations and experience. If significant 

evidence of potential contamination is found (such as observation of animals, animal excreta or 

crop destruction), the operation must evaluate whether the produce can be harvested. The operation 
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must take all measures reasonably necessary to identity and not harvest produce that is reasonably 

likely to be contaminated with a known hazard and that is visibly contaminated with animal excreta. 

Requirement F-6.2. The operation routinely monitors for animal activity in and 

around the growing area during the growing season.

Procedure There shall be scheduled monitoring of growing fields and adjacent land 

for evidence of animal activity. A frequency of monitoring and 

assessment shall be established based on production factors, such as the 

crop, geography, and other conditions.

Verification Auditor reviews monitoring records to ensure the frequency of 

monitoring is consistent with the schedule.

Corrective 

Action

Operation develops and implements a monitoring schedule.

Documents 

Required

Record.

Mandatory

PSR 112.83

Expectation 

Monitoring should include a visual examination for evidence of potential contamination of covered 

produce by animals in the 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, personnel performing monitoring of partially enclosed buildings could look for bird 

nesting and landing areas in overhead areas, such as the rafters, eaves, powerlines and cables or 

roofs.

Regularly completed “notes,” “scouting lists,” or “crop maintenance reports” may include this 

information. This task does not need to be completed on a daily basis, but a regular schedule that 

shows the producer has an awareness of the animal populations in the production areas. This 

question may only be answered N/A for fully enclosed greenhouses and aeroponic growing 

structures.

Example Scenarios 

Scenario 1: The tree crop operation has no records of monitoring for animals because their food 

safety plan says that there are no risks of contamination from animals.

Assessment: Corrective Action Needed

Reason: The standard requires that there “shall be scheduled monitoring of growing fields and 

adjacent land for evidence of animal activity”.

Scenario 2: The blueberry operation has no established frequency for monitoring for animal 

activity in the field, but procedures require animal activity to be recorded when observed. There are 

three records of animal activity in the past two months.

Assessment: Corrective Action Needed 

Reason: A schedule has not been established.
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Scenario 3: A green pepper operation has procedures to inspect fields each morning for deer and 

large animal activity. There are no procedures to inspect for rodent, bird or amphibian activity.

Assessment: Compliant or Corrective Action Needed

Reason: Compliant if the risk assessment concludes, and observations support, that rodents, birds 

and amphibians do not pose a contamination risk. Otherwise, the risk assessment is incomplete and 

CAN because monitoring is insufficient.

Produce Safety Rule 

112.83: If there is a reasonable probability that grazing animals, working animals or animal 

intrusion will contaminate produce, the operation must assess the relevant areas used for growing, 

harvesting, packing and holding activities as needed during the growing season (based on the 

produce grown; the practices and conditions; and the observations and experience. If significant 

evidence of potential contamination is found (such as observation of animals, animal excreta or 

crop destruction), the operation must evaluate whether the produce can be harvested. The operation 

must take all measures reasonably necessary to identity and not harvest produce that is reasonably 

likely to be contaminated with a known hazard and that is visibly contaminated with animal excreta. 

Requirement F-6.3. Based on the risk assessment, there shall be measures to prevent 

or minimize the potential for contamination from animals, including 

domesticated animals used in farming operation.

Procedure The operation shall have risk-appropriate actions to prevent or 

minimize the potential for contamination of produce with pathogens 

from animal feces, including from domesticated animals used in farming 

operations. There shall be a written record of any mitigation or 

corrective actions. Preventive measures and corrective actions shall 

comply with all local, state and federal regulations concerning animal 

control and natural resource conservation.

Verification Auditor reviews preventive measures and corrective action plans.

Corrective 

Action

Operation develops and implements risk-appropriate corrective actions 

for animal intrusions reasonably likely to contaminate produce in the 

field.

Documents 

Required

Written Policy, Record.

Mandatory ●

PSR 112.81; 112.83; 112.84

Expectation 

Farming operations are never going to be able to completely exclude wild and/or domesticated

animals from entering crop production areas. However, every effort should be made to limit the 

access to the production areas. Ideally, when there are only a few animals on adjacent land, there is 

a low risk of contamination. Occasional entry by normally seldom seen animals is tolerable.

When needed, measures should be taken to reduce the entry into crop production areas by wild and 

domesticated animals, including poultry and pets. This can be accomplished many ways, which can 
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include such items as noise cannons or scare balloons to scare away birds and migratory waterfowl, 

or fencing or other barriers to limit wildlife access. 

Example Scenarios

Scenario 1: The blueberry operation has records indicating that deer are periodically observed in 

the fields. There are no subsequent actions recorded. The operation says that they chase the deer 

away when they see them.

Assessment: Corrective Action Needed

Reason: The standard requires that “there shall be written record of any mitigation or corrective 

actions”.

Scenario 2: The operation uses horses for cultivating fields. The operation’s procedures require 

that horses walk on a lane parallel and separate from the growing rows, and that horse feces are 

collected and removed from the field. Auditor does not observe any contamination within the 

growing rows from the horses.

Assessment: Compliant 

Produce Safety Rule 

112.81: Operations must take steps to minimize opportunities for wild and domestic animals, 

including working animals to contaminate produce. Requirements in outdoor growing areas and in 

partially enclosed buildings include monitoring for evidence of animal intrusion and evaluating 

whether a crop can be harvested. These requirements do not apply to produce grown in a fullyenclosed building or to fish used in aquaculture operations. It should be understood that federal, 

state, or local environmental laws or policies may regulate certain species of animals, and that 

producers may have limited options for their control. 

112.83: Operations which have a reasonable probability that grazing animals, working animals, or 

animal intrusion will contaminate covered produce must assess the relevant areas used for growing, 

harvesting, packing or holding activity for evidence of potential contamination of produce as 

needed during the growing season (based on the produce; the practices and conditions; and the 

observations and experience); and if significant evidence of potential contamination is found (such 

as observation of animals, animal excreta or crop destruction), the operation must evaluate whether 

the produce can be harvested in accordance with the requirements of § 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.

112.84: The Produce Safety Rule does not require farms to take actions that would constitute a 

“taking” of threatened or endangered species as that term is defined by the Endangered Species Act 

(16 U.S.C. 1531-1544); 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. 

F-7 Soil Amendments 
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Soil amendments are any chemical, biological, or physical material intentionally added to the soil to 

improve the chemical or physical condition of the soil in relation to plant growth or to improve the 

capacity of the soil to hold water. 

Animal manure and human fecal matter represent a significant source of potential contamination. 

Properly treated manure or biosolids can be an effective and safe fertilizer. Untreated, improperly 

treated, or re-contaminated manure or biosolids used as a fertilizer, used to improve soil structure, 

or that enters surface or ground waters through runoff, may contain pathogens of public health 

significance that can contaminate produce. Crops in or near the soil are most vulnerable to 

pathogens that may survive in the soil. Low growing crops that may be splashed with soil during 

irrigation or heavy rainfall are also at risk if pathogens in manure persist in the soil. Produce where 

the edible portion of the crop generally does not contact soil is less at risk of contamination 

provided that produce that does contact the ground (e.g., windfalls) is not harvested. As with 

agricultural water, physical characteristics of produce that foster entrapment or attachment also 

affect risk.

When auditing a mushroom operation, the substrate and/or logs used to grow mushrooms must be 

evaluated in this section. A determination must be made whether the substrate was adequately 

treated through a pasteurization or other appropriate process. Refer to the Mushroom Good 

Agricultural Practices Program Guidelines for recommended industry practices to control potential 

food safety hazards in mushroom production. 

Growers using manure or biosolids need to follow good agricultural practices to minimize microbial 

hazards. Growers also need to examine their specific growing environment to identify obvious 

sources of fecal matter that could be a source of contamination. The following requirements in 

section F-7 focus on minimizing risk of soil amendments to fresh produce. 

Another type of soil amendment that may be used is green manure. The most common form of 

green manure is in the form of a cover crop that is grown in the crop’s off-season and then 

incorporated by tilling into the soil in the early spring. Green manure may also come from collected 

lawn 
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trimmings or other plant waste.

Requirement F-7.1. The food safety plan shall address soil amendment risk, 

preparation, use, and storage.

Procedure If animal-based soil amendments or biosolids are used, records of 

composition, dates of treatment, methods utilized and application dates 

must be documented. Evidence of processing adequate to eliminate 

pathogens of human concern, such as letter of guarantee, certificate of 

analysis (COA) or any test results or verification data (e.g., time and 

temperature) demonstrating compliance with process or microbial 

standards, shall be documented. Such soil amendments must be 

produced, handled, stored, and applied in accordance with applicable 

federal, state, or local requirements.

Verification Auditor reviews soil amendment records for completeness and evidence 

of compliance with prevailing regulations. If biosolids are used, it shall 

be noted.

Corrective 

Action

Operation discontinues use of untreated or undocumented animal-based 

soil amendments or biosolids. Operation develops and implements 

policies to obtain treatment information for all animal-based soil 

amendments.

Documents 

Required

Risk Assessment, Record.

Mandatory ●

PSR 112.52; 112.54; 112.55; 112.56; 112.60

Expectation 

Soil amendments are any chemical, biological, or physical material intentionally added to the soil to 

improve the chemical or physical condition of the soil in relation to plant growth or to improve the 

capacity of the soil to hold water. Biosolids are permitted when in compliance with applicable 

federal, state, or local regulations; records of composition, dates of treatment, methods utilized, and 

application dates must be documented. 

Agricultural teas are soil amendments and are considered treated if the biological materials of 

animal origin used to make the tea have been processed to completion by one of the approved FDA 

methods (see requirement F-7.2) and the water used was not surface water nor had any detectable 

generic E. coli in 100 mL water. Treated agricultural teas cannot contain any tea additives, such as 

molasses.

Operations must implement management plans (e.g., timing of applications, storage location, source 

and quality, transport, etc.) that significantly reduce the likelihood that soil amendments being used 

contain human pathogens. Effort must be taken to minimize the time interval between soil 

amendment application and time to harvest. Operations must use soil amendment application 

techniques that control, reduce or eliminate likely contamination of surface agricultural water 

and/or nearby production areas. Equipment used for soil amendment handling, preparation, 

distribution or applications must effectively reduce the potential for cross contamination or use an 
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effective means of equipment sanitation before subsequent use. Storage of soil amendments must

minimize the potential for dispersion into the environment through wind-dispersion or run-off. 

Movement of workers and visitors between soil amendment storage and preparation areas must be 

controlled to prevent cross contamination to fresh produce.

For mushroom operations, every effort to prevent of cross-contamination of non-substrate materials 

and mushrooms with unpasteurized substrate materials must be taken. Operations must receive and 

store raw manure and unpasteurized substrate materials as far away as possible from receiving areas 

where harvest containers, packaging materials, spawn, and other sanitary supplies are received or 

where final product is shipped. Fill and grade areas where standing water can accumulate to permit 

adequate drainage. Runoff must be collected or diverted through the use of barriers such as 

concrete blocks, soil berms, pits, or lagoons to prevent contamination of final product, packaging 

materials and production areas. Substrate used in mushroom production must be prepared based on 

scientific principles that reduce potentially harmful microorganisms to acceptable levels. Records 

of documentation from suppliers of raw materials and packaging materials and/or substrate 

preparation records must be reviewed.

If no soil amendments are used by the auditee, this requirement may be assessed as N/A. The 

auditor will include the date and the role/title of the person who conducted the last assessment in the 

comments.

Example Scenarios

Scenario 1: The operation has no COAs for soil amendments because they do not use components 

of animal origin. Records of compost sources indicate that this is accurate.

Assessment: Compliant.

Reason: The standard is silent on organic soil amendments that do not contain materials of animal 

origin.

Scenario 2: The operation obtains its compost from the municipality, which composts lawn litter. 

The municipality offers no guarantees or test results for the compost. The operation does not test 

the compost. 

Assessment: Corrective Action Needed.

Reason: Lawn litter is usually uncontrolled and can contain dead animals or animal manure. The 

municipality or the operation must compost the lawn litter by a validated process, or the operation 

must obtain test results to verify composting is adequate to destroy pathogens of human health 

concern.

Produce Safety Rule

The requirements of the Produce Safety Rule for soil amendments apply to biological soil 

amendments of animal origins (BSAAO). A BSAAO 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. BSAAOs do not contain any form of human waste.

112.52: The operation must handle, convey and store any BSAAO in a manner and location such 

that it does not become a potential source of contamination to produce, food contact surfaces, areas 

used for growing, harvesting, packing and holding activities, water sources, water distribution 
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systems and other soil amendments. Agricultural teas that are BSAAO may be used in water 

distribution systems provided that all other requirements of the rule are met. Treated and un-treated 

BSAAOs must be handled so that the untreated amendment does not contaminate the treated one. If 

the operation believes that the treated amendment has been contaminated it must be handled as if 

untreated. 

112.54: The FSMA Produce Safety Rule establishes two treatment levels, each with an associated 

microbial standard. The BSAAO treatment level determines how and when growers can apply the 

BSAAO to produce fields. (a) A scientifically valid controlled physical process,

chemical process, biological process, or a combination of processes that has been validated to 

satisfy the microbial standard of 112.55(a), or a scientifically valid process that meets the microbial 

standard in 112.55(b). Two such process are aerated static compost (maintained in aerobic 

conditions at a minimum of 131°F for three consecutive days, followed by adequate curing) or 

turned (windrow) composting (maintained in aerobic conditions at a minimum of 131°F for 15 

days, with a minimum of five turnings, followed by adequate curing)

112.55: (See Appendix I Subpart F, to view the table)

112.56: The operation must apply BSAAO treated in accordance with 112.54(a) in any manner, 

with a minimum application interval of 0 days. The operation must apply BSAAO treated in 

accordance with 112.54(b) in a manner that minimizes the potential for contact with produce during 

and after application, with a minimum application interval of 0 days. Untreated BSAAO must be 

applied in a manner that does not contact produce during application and minimized the potential 

for contact with produce after application. The minimum application interval has not yet been set 

by the FDA.

112.60: Records of any treated BSAAO received from a third party, documentation (such as a 

Certificate of Conformance) must be kept at least annually which show the process used to treat the 

amendment used a scientifically valid process has been carried out with appropriate monitoring and 

that the BSAAO has been handled, conveyed and stored in a manner and location to minimize the 

risk of contamination. For operations treating their own BSAAO, records must document that 

process controls (for example, time, temperature and turnings) were achieved. 
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Requirement F-7.2. If a soil amendment containing raw or incompletely treated 

manure is used, it shall be used in a manner so as not to serve as a 

source of contamination of produce.

Procedure If such a product is used, there shall be documentation on the 

composition, and time and method of application. Such use will be 

consistent with current industry practices or regulatory restrictions for 

that commodity. Untreated human waste shall not be used.

Verification Auditor reviews records for any soil amendment use that may contain 

raw or incompletely treated manure.

Corrective 

Action

Operation discontinues use, or develops and implements policies to 

safely use animal-based soil amendments that may contain raw or 

incompletely treated manure. Produce grown without such controls are 

either diverted to thermal-processed products or destroyed.

Documents 

Required

Record.

Mandatory ●

PSR 112.52; 112.53

Expectation 

The following guidelines must be followed when using raw or incompletely treated manure so that 

it will not be a source of contamination. These include the following:

• When raw manure is applied, it is incorporated at least 2 weeks prior to planting and a 

minimum of 120 days prior to harvest and is not used on crops that are harvested within 120 

days of planting. 

• DO NOT harvest vegetables or fruits until 120 days after raw manure application. 

• Rates, dates, and locations of manure applications must be documented.

• If it is necessary to apply manure or slurry to vegetable or fruit soil, incorporate it at least 

two weeks prior to planting and observe the 120-day pre-harvest interval. If the 120-day 

waiting period is not feasible, such as for short season crops like lettuce or leafy greens, 

apply only properly composted manure. 

Assess whether raw manure is properly used, according to the recommendations. Review manure 

application records to adequately answer this question. If both raw and treated manure are used, the 

treated manure must be properly treated, composted, or exposed to reduce the expected levels of 

pathogens. Any untreated manure that is stored onsite must be stored in a way that ensures that it 

does not leach or runoff into adjacent crop production areas. Auditors must investigate to verify 

that raw manure cannot contaminate treated manure.
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There are various methods used to treat manure so that it is safer as a fertilizer than raw manure. 

The auditee should have selected a scientifically valid process that reduces pathogens. Here are two 

options: 

• Static composting: aerobic, minimum 131°F (55°C) for 3 days, followed by curing with 

proper insulation. 

• Turned composting: aerobic, minimum of 131°F (55°C) for 15 days, minimum 5 turnings, 

followed by curing with proper insulation. 

Growers may use other treatment methods if they meet the same microbial standards and provide 

the same public health protection as static or turned composting methods. These methods can come 

from published scientific literature that verifies the effectiveness of the process.

Example Scenario 

Scenario: Carrot operation applies animal-based compost immediately prior to planting. They 

have documentation of the composition and composting procedures (consistent with current 

industry practices), and time and method of application. 

Assessment: Compliant. 

Reason: There are no industry or regulatory restrictions for carrots on application of fully 

composted manure. 

Produce Safety Rule 

112.52: The operation must handle, convey and store any BSAAO in a manner and location such 

that it does not become a potential source of contamination to produce, food contact surfaces, areas 

used for growing, harvesting, packing and holding activities, water sources, water distribution 

systems and other soil amendments. Agricultural teas that are BSAAO may be used in water 

distribution systems provided that all other requirements of the rule are met. Treated and un-treated 

BSAAOs must be handled so that the untreated amendment does not contaminate the treated one. If 

the operation believes that the treated amendment has been contaminated it must be handled as if 

untreated. 

112.53: Operations may not use human waste for growing produce, except sewage sludge biosolids 

used in accordance with the requirements of 40 CFR part 503, subpart D, or equivalent regulatory 

requirements.

F-8 Vehicles, Equipment, Tools and Utensils 

Transport vehicles, bulk hauling vehicles (tractors, wagons), as well as harvesting equipment, tools, 

utensils (knives, pruners, machetes) will be considered in section F-8. 
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Requirement F-8.1. Equipment, vehicles, tools, utensils and other items or materials 

used in farming operations that may contact produce are identified.

Procedure Operation maintains a list of equipment, vehicles, tools, utensils and 

other items or materials that may pose a risk of produce contamination 

during normal use.

Verification Auditor reviews the list for completeness.

Corrective 

Action

Operation develops a list of equipment, vehicles, tools and utensils that 

may pose a risk of produce contamination during normal use.

Documents 

Required

Record.

Mandatory

Expectation 

The operation must maintain a current and accurate list that has identified all vehicles, equipment, 

tools, and utensils that may contact produce during growing, harvesting, packing and holding 

activities. If the equipment list is absent, incomplete, or not verified as accurate for the current 

year, this will be assessed as a Corrective Action Needed.

Example Scenario 

Scenario: You observe that the operation’s list of equipment does not include a tractor. The 

operation explains that the tractor does not contact produce and is not likely to pose a risk of 

produce contamination during normal use, so does not have to be on the list. 

Assessment: Compliant. 

Reason: If accurate, the operation has assessed the risk of the tractor during normal use.
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Requirement F-8.2. Equipment, vehicles, tools and utensils used in farming operations 

which come into contact with product are in good repair, and are not a 

source of contamination of produce.

Procedure The operation shall develop, implement, and schedule repair, cleaning, 

sanitizing, storage and handling procedures of all food contact surfaces to 

reduce and control the potential for contamination. Records must include 

the date and method of cleaning and sanitizing equipment. As necessary for 

food safety, vehicles and equipment shall be properly calibrated, operated, 

maintained, and used as intended. Equipment traffic flow is prevented 

from traveling through an untreated manure area into the harvesting field. 

These procedures shall be documented. Product contact tools, utensils and 

equipment shall be made of materials that can be cleaned and sanitized. 

Procedures include equipment and vehicles that are in the field 

infrequently.

Verification Auditor observes production and harvest vehicles, equipment, tools and 

utensils which may come into contact with produce for evidence of food 

safety risks. Auditor reviews maintenance, cleaning and sanitation records 

that demonstrate compliance with procedures.

Corrective 

Action

Operation develops maintenance, cleaning and sanitation procedures for 

equipment, vehicles, tools and utensils that may pose a risk for produce 

contamination and disposition.

Documents 

Required

Written Policy, Record.

Mandatory

PSR 112.123; 112.140

Expectation 

Operation must establish and keep documentation of dates and procedures for cleaning and, as 

appropriate, sanitizing equipment, vehicles, tools, and utensils. Auditors verify through 

interviewing and/or reviewing a written policy that these procedures are implemented. Auditors 

review records for compliance with procedures for maintenance, cleaning and sanitation of harvest 

vehicles, equipment, tools, and utensils which may come in contact with produce.

Equipment, vehicles, and tools should be kept as clean as possible, and cleaned on a scheduled basis 

to prevent contamination. Truck beds must be washed or otherwise cleaned whenever they become 

dirty. Ensure that transportation vehicles are clean. Dirty vehicles can contaminate produce with 

harmful microbes. Review equipment to verify this factor.

The auditee’s food safety manual must show the schedule for cleaning and, if appropriate, sanitizing 

vehicles, equipment, tools, and utensils which may come in contact with produce. It is 

understandable that these implements are going to get dirty from constant, repeated use during the 

course of production or harvest and auditors should not answer this as a Corrective Action Needed 

just because a harvester is using a dirty knife. However, this will not be compliant if there is no 

documented procedure for a scheduled cleaning of the implements.
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Example Scenarios

Scenario 1: A spinach harvester is on the equipment list. Records demonstrating maintenance of 

the harvester in the past year are missing. You observe the harvester and do not see any overt 

contamination risks.

Assessment: Corrective Action Needed.

Reason: Maintenance records are required.

Scenario 2: It is apparent, through visual observation of traffic flow routes, that movement of 

people or equipment is occurring from an area spread with raw manure to the harvesting field.

Assessment: Immediate Action Required.

Reason: Contamination from the manure is reasonably likely to have occurred.

Produce Safety Rule

112.123: The operation must use equipment and tools that are of adequate design, construction, and 

workmanship to enable them to be adequately cleaned and properly maintained; and (b) Equipment 

and tools must be: (1) Installed and maintained as to facilitate cleaning of the equipment and of all 

adjacent spaces; and (2) 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 and harboring pests. (c) Seams on food contact surfaces of equipment and tools that are 

used 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. (d)(1) The operation must inspect, maintain, and clean and, when necessary and 

appropriate, sanitize all food contact surfaces of equipment and tools used in growing, harvesting, 

packing and holding activities as frequently as reasonably necessary to protect against 

contamination of produce. (2) The operation must maintain and clean all non-food-contact surfaces 

of equipment and tools subject to this subpart used during harvesting, packing, and holding as 

frequently as reasonably necessary to protect against contamination of produce. (e) If using 

equipment such as pallets, forklifts, tractors, and vehicles such that they are intended to, or likely to, 

contact produce, you must do so in a manner that minimizes the potential for contamination of 

produce or food contact surfaces with known or reasonably foreseeable hazards.

112.140: The operation must establish and keep documentation of the date and method of cleaning 

and sanitizing of equipment used in the growing, harvesting, packing and holding activities.
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Requirement F-8.2.a. All equipment and instruments which have an effect on food 

safety shall be identified, adequately maintained and calibrated at a 

frequency sufficient to assure continuous accuracy.

Procedure The operation shall have a list of equipment and instruments that have 

an effect on food safety (e.g. thermometers, pH meters, scales, chemical 

application devices). This equipment shall be adequately maintained 

and calibrated at a frequency sufficient to assure continuous accuracy. 

A record of calibration shall be maintained.

Verification Auditor reviews equipment and instrument list and calibration records.

Corrective 

Action

Operation develops a list of equipment and instruments. Calibration 

will be performed and recorded.

Documents 

Required

Record.

Mandatory ●

PSR 112.124

Expectation 

Instruments or controls used by an operation 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, must be accurate and precise as necessary 

and appropriate in keeping with their purpose; adequately maintained; and adequate in number for 

their designated uses. 

Accurate means the recorded measurements represent the true value of what is being measured 

while precise means individual measurements are close to each other when being taken under the 

same conditions. Both accuracy and precision are necessary to ensure measurements are valid and 

reliable. The appropriate degree of accuracy and precision needed will vary depending on the 

nature of the instrument and its specific use. 

Instruments must be maintained to ensure they are functioning properly for their intended use. 

They must also be sufficient in number for their intended use. Operations must maintain a list of all 

measuring and monitoring equipment that has an effect on food safety. Examples of equipment that 

may have a bearing on food safety include scales, thermometers, pH meters, chemical 

application/monitoring equipment, etc. For such devices, there should be a calibration and 

maintenance schedule and they must be calibrated following a procedure outlined by the operation. 

Auditors should review an operation’s records of equipment and instruments which have an effect 

on food safety. 

Produce Safety Rule 

112.124: Instruments or controls used 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.
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Requirement F-8.2.b. Calibration of equipment is traceable to a recognized standard.

Procedure Calibration of measuring and monitoring equipment (thermometers, pH

meters, scales, chemical application or monitoring devices) is performed 

using a recognized standard or method.

Verification Auditor reviews the calibration procedures to determine if they follow a 

recognized standard or method.

Corrective 

Action

Operation develops calibration procedures which are traceable to a 

recognized standard or method.

Documents 

Required

Written Policy.

Mandatory

Expectation 

In the United States, many instrument and control vendors and manufacturers provide instructions 

and recommended frequencies for calibration procedures. The National Institute of Science and 

Technology (NIST) sets standards for traceable instruments or other recognized reference solutions 

or instruments for the United States. Other recognized standard-setting organizations include 

International Organization for Standardization (ISO), American National Standards Institute (ANSI) 

and ASTM International (formerly known as American Society for Testing and Materials). In 

addition to the standardization bodies listed, other recognized standards may include calibration of 

thermometers using ice water and calibration of a piece of equipment according to the 

manufacturer’s instructions.

The auditor will include the recognized standards used for calibration in the comments. 

(See section G-5 for more guidance). 
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Requirement F-8.2.c. A cleaning and sanitation program for food contact surfaces 

shall be established, implemented and maintained. The program shall 

include measures for monitoring to verify effectiveness.

Procedure An implemented cleaning and sanitation program shall be established, 

including SOPs. Procedures must include frequency, approved cleaning 

and sanitizing agents, and methods of cleaning and sanitizing chemical 

use. The SOP must justify the frequency of cleaning, demonstrate that 

the cleaning and sanitizing methods are effective on the surfaces that 

they are used on, are being used at appropriate concentrations as 

required by the label. Operation shall demonstrate effectiveness in 

minimizing the potential for cross contamination from cleaning and 

sanitizing. Records of sanitizer chemical concentrations shall be 

maintained.

Verification Auditor reviews the cleaning and sanitation program procedures and 

records for inclusiveness of frequency approval and proper use of 

cleaning and sanitizing agents, and methods of cleaning and sanitizing 

agent use. Auditor reviews chemical records regarding use of approved 

chemicals used for cleaning and sanitizing.

Corrective 

Action

Operation develops and implements program procedures for cleaning 

and sanitation. Operation identifies chemicals approved-for-use in the 

cleaning and sanitation program and establishes and maintains records 

of all cleaning and sanitizer concentrations. Retraining of cleaning and 

sanitation program policies and procedures are performed and 

documented.

Documents 

Required

Written Policy, Records

Mandatory

Expectation 

The emphasis on this requirement is to verify that the cleaning methods and frequencies are 

appropriate and effective for the operation. The type and concentration of the cleaning agent or 

detergent should be selected based upon the type of soil, residue, or material targeted for removal. 

The recommended manufacturer instructions on use, such as physical scrubbing and contact time, 

as well as concentration, should be followed and records kept to document that the correct 

procedure was followed. 

There are many methods that can be employed to determine if cleaning and sanitation are effective. 

Visual inspection is a longstanding method that, with a flashlight or blacklight, can provide an 

assessment of the equipment and surfaces for buildup of organic materials, areas that were missed 

or damage to equipment. Another common rapid approach used in many facilities to assess sanitary 

conditions after cleaning is measurement of levels of adenosine tri-phosphate (ATP) on surfaces or 

in rinse water (e.g., closed systems). ATP can provide an indirect overall estimation of microbial 

contamination and residual organic matter that may still be present to assess the cleaning 

effectiveness. Use of ATP swabs should be in accordance with the manufacturer’s directions. 

Another tool is environmental monitoring for microbial organisms by swabbing designated 
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production areas or equipment and materials used in production. Operations may include additional 

environmental sampling for generic E. coli or total plate count (TPC) or other microbial indicators 

to verify sanitation. 

(See requirement P-3.1.a for more information on environmental monitoring).

Example Scenario

Scenario 1: No cleaning procedures are written in the Food Safety Plan. Operation uses 

subcontractor for nightly cleaning and sanitizing of facility.

Assessment: Corrective Action Needed

Reason: Procedures should be obtained from the subcontractor and included in the Food Safety 

Plan.

Scenario 2: In a visual inspection it is observed that a number of the reusable harvest bins have a 

buildup of organic material prior to the start of the day’s production in which cleaning and 

sanitation have been previously completed. 

Assessment: Corrective Action Needed

Reason: Based on the visual inspection, cleaning was not effectively completed.

Scenario 3: An operation has written SOPs describing the frequency, approved cleaning and 

sanitizing agents, and methods of cleaning and sanitizing chemical use. There are records showing 

the cleaning is being performed in accordance with the written SOP, however there are no 

procedures for ATP testing or microbiological sampling. 

Assessment: Compliant 

Reason: As long as the auditor does not observe dirty or soiled food contact surfaces prior to use in 

production and the operation is in compliance with their written SOP, they are meeting the 

requirement. ATP swabbing or microbiological testing is not required for compliance. 

Requirement F-8.3. Vehicles, equipment, tools and utensils shall be controlled so as not to 

be a source of chemical hazard.

Procedure Operation shall have a written procedure to address the spills and leaks 

(fuel, oil, hydraulic fluids) which might occur during equipment operation 

in the field.

Verification Auditor observes production and harvest vehicles, equipment, tools and 

utensils which may come into contact with produce for evidence of food 

safety risks.

Corrective 

Action

Operation repairs leaks and cleans any food contact surfaces. Affected 

product is evaluated for potential contamination and disposition.

Documents 

Required

Written Policy.

Mandatory

Expectation 
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Auditor reviews operation’s policy to ensure policy has written procedures that address chemical 

hazard spills and leaks such as: fuel, oil, hydraulic fluids, and/or chemical spills. Auditors should 

perform a thorough visual inspection of harvest vehicles, equipment, tools and utensils that may 

come in contact with the product for leaks/chemical hazards that may cause food safety risks.

Example Scenarios 

Scenario 1: Maintenance of a spinach harvester is performed annually, consistent with the 

manufacturer’s recommendation. Records of maintenance are available. You observe the 

harvester, in season but not currently in use. There appears to be leakage of oil. The operation has 

no plans to repair the leak. 

Assessment: Corrective Action Needed

Reason: The leak from the hose is a potential source of chemical contamination.

Scenario 2: The operation has a bone yard of vehicles, tools, and utensils. They do not appear to 

be included in maintenance schedules for spills and leaks.

Assessment: Not Applicable. 

Reason: This audit item only applies to “spills and leaks which might occur during equipment 

operation in the field.” 

Requirement F-8.4. Vehicles, equipment, tools and utensils shall be controlled so as 

not to be a source of physical hazard.

Procedure Operation has a glass and brittle plastic policy that addresses glass on 

production equipment and in growing area. Inspections performed in 

compliance with the policy shall be documented.

Verification Auditor observes production and harvest vehicles, equipment, tools and 

utensils which may come into contact with produce for evidence of food 

safety risks and for compliance with the glass and brittle plastic policy.

Corrective 

Action

Operation develops policy. Retraining is performed. Source of food 

safety risk is mitigated.

Documents 

Required

N/A.

Mandatory

Expectation 

Any exposed glass fixtures (including flood lights or brake/driving lights) on harvesting equipment 

should be protected to reduce the potential for contamination of the crop. This question is meant to 

cover mechanical harvesters or machinery that sits directly over the un-harvested crop. Protection 

can include such practices as using plastic or wire covers, or enclosed fixtures.

The standard does not require written procedures only that inspections be recorded, and equipment 

be in compliance with the operation’s glass and brittle policy.

Workers may drink water in the field if they use a shatter-resistant plastic container. Water 

containers in break areas should be made of unbreakable plastic materials.
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Example Scenarios 

Scenario 1: You observe that items made of breakable glass or brittle plastic (e.g., drinking water 

containers, watches, vehicle headlights) are in use in or adjacent to growing fields.

Assessment: It depends. 

Reason: You will need to determine whether the glass or plastic location is compliant with the 

operation’s policy and if it is a potential hazard.

Scenario 2: Operation is repairing tools in the lettuce field and shards of metal are observed on the 

ground. The operation immediately buffers the area where the tools were being repaired.

Assessment: Compliant. 

Reason: The operation is following their procedures for controlling physical hazards. 

Requirement F-8.5. Cleaning and sanitizing procedures do not pose a risk of product 

contamination.

Procedure Equipment cleaning and sanitizing operations shall be conducted away 

from the product and other equipment to reduce the potential for 

contamination. Water used for cleaning and sanitizing shall meet the 

microbial standards for drinking water.

Verification Auditor reviews cleaning and sanitizing procedures for steps to prevent 

contamination of produce, and observes operation’s evidence of 

compliance.

Corrective 

Action

Operation develops and implements procedures. Retraining is 

performed and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

N/A.

Mandatory

Expectation 

Auditor reviews SOP’s for cleaning of equipment. Equipment cleaning must use water that meets 

microbial standards for drinking water. Auditor evaluates where equipment cleaning and sanitizing 

procedures are to be done. Cleaning and sanitizing are to be implemented away from production 

areas. If the operation is using high pressure when cleaning, care should be taken to not spread 

contamination from one surface (e.g., floors, floor drains) to another, which can occur through 

splashing or aerosolizing.

 

Consideration should be taken to capture the waste water from the washing process as to minimize 

the potential for runoff from these locations to areas used to grow, harvest, store, cool and pack 

produce or food contact equipment, agricultural water sources, and agricultural water distribution 

systems. An operation could, for example, choose to clean harvesting bins downhill from these 

areas or capture the wash water in a drainage area to prevent runoff.

Example Scenarios 

Scenario 1: A citrus operation is washing a large pesticide spray machine with uncontrolled 

surface water. The spray machine does not contact produce during normal operation, so the 
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operation says that the water that is used to clean the machine does not pose a risk for product 

contamination. 

Assessment: Compliant. 

Reason: If accurate, the equipment does not have a food contact surface.

Scenario 2: A blueberry operation is washing a harvester with uncontrolled surface water. The 

harvester has surfaces that contact produce during normal operation. 

Assessment: Corrective Action Needed or Immediate Action Required.

Reason: Corrective Action Needed - if the source of water used to wash food contact surfaces or 

its treatment must be changed to bring it into compliance with the microbial standards for drinking 

water. Immediate Action Required - if produce may have become contaminated. 

Requirement F-8.6. Water tanks are cleaned at a sufficient frequency so as not to be a 

source of contamination.

Procedure There shall be a written procedure for cleaning water tanks, such as 

those used for dust control, the water from which may contact produce 

in the field.

Verification Auditor reviews water tanks cleaning procedures for steps to prevent 

contamination of produce, and observes operation’s evidence of 

compliance.

Corrective 

Action

Operation develops and implements procedures. Retraining is 

performed and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

Water tanks on the farm may be in many forms and are often overlooked. Water tanks may be used 

for drinking water, chemical applications or dust control. Auditors should review written 

procedures for steps that prevent product contamination and make observations of operation’s 

evidence of compliance. Cleaning should not be initiated near crop production areas.

Example Scenarios 

Scenario 1: You observe water tanks dedicated for dust abatement on roads adjacent to the 

growing field (so the water is reasonably likely to contact produce). No written cleaning procedures 

or records for cleaning the water tank are available for review. The tanks appear to be clean.

Assessment: Corrective Action Needed. 

Reason: The standard requires “written procedure” and “evidence of compliance.” 

Scenario 2: You observe a water wagon, used for application of citrus canker chemicals, with 

accumulated soils and algae. It is evident that written cleaning procedures or their performance are 

inadequate to prevent contamination of produce. 

Assessment: Corrective Action Needed or Immediate Action Required.
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Reason: Corrective Action Needed - because while the operation has procedures and records, the 

procedures are inadequate “so as not to be a source of contamination.” Immediate Action Required

- if the water may have contaminated the produce and created an immediate food safety risk. 

Scenario 3: You observe dirty water tanks. The operation says that the tanks are dedicated for 

washing non-food contact equipment and the water from the tanks is not reasonably likely to 

contact produce. 

Assessment: Not applicable, if accurate.

Reason: The water tanks are not used for washing food contact equipment and the water is not 

reasonably likely to contact produce. 

Requirement F-8.7. All cleaning agents shall be approved for their intended use on 

food contact surfaces.

Procedure All chemicals used for cleaning or sanitizing of food contact equipment, 

tools, utensils, containers and other food contact surfaces shall be 

approved for that use, according to the chemical manufacturer or 

supplier and all federal, state and local requirements, and shall be used 

in a manner consistent with the approved use.

Verification Auditor reviews cleaning and sanitizing chemicals purchasing practices 

or procedures, storage area, and use procedures to verify compliance.

Corrective 

Action

Operation ceases use of unapproved chemicals. Retraining is performed 

and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

N/A.

Mandatory

Expectation 

Cleaning is a prerequisite for effective sanitization. Cleaning is the removal of organic matter, 

using appropriate detergent chemicals under recommended conditions. Organic matter from food 

residues such as oils, grease, and protein not only harbor bacteria but can actually prevent sanitizers 

from coming into physical contact with the surface to be sanitized. In addition, the presence of 

organic matter can inactivate or reduce the effectiveness of some types of sanitizers.

For cleaning to be performed properly, the right cleaning agents must be selected for the job. 

Cleaning agents commonly used include detergents, solvent cleaners, acid cleaners, and abrasive 

cleaners. Sanitization follows cleaning. Sanitization is the application of heat or chemicals to a 

properly cleaned (and thoroughly rinsed) food-contact surface, yielding a 99.999% reduction of 

representative pathogenic microorganisms of public health importance. Auditor must review 

evidence that cleaning agents being used are safe for food contact surfaces.

Compressed air or other gases that are mechanically introduced into food or used in the process to 

clean food‐contact surfaces or equipment must be filtered and oil-free. Compressed air must also be 

dried and filtered to exclude microorganisms and moisture prior to use. 
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All post-harvest water needs to meet the microbial standards for drinking water. For the purposes 

of USDA GAP audits, this is considered to be no detectable generic E. coli. This would include 

water used to create steam for cleaning.

Example Scenarios 

Scenario 1: The operation uses household multi-purpose cleaner that was purchased to clean food 

contact surfaces. The cleaner was purchased from a local grocery store. Surfaces are not rinsed 

before use. According to the label, cleaner was not meant to clean food contact surfaces. 

Assessment: Immediate Action Required.

Reason: The cleaning chemical needs to be labeled for the appropriate use. 

Scenario 2: The operation has a bulk cleaning material with an EPA registration number written on 

the container but does not have a product label. The operation has on location the label declaration 

for approved use on food contact surfaces. 

Assessment: Compliant. 

Reason: The cleaning material is approved for used on food contact surfaces.

Scenario 3: The operation purchases a cleaning agent approved for use on floors, but they are 

using it on food contact surfaces also. 

Assessment: Immediate Action Required.

Reason: Immediate Action Required unless the agent is also expressly approved for use on food 

contact surfaces. This chemical is not being used for its intended purpose and is not approved for 

cleaning food grade surfaces.

Scenario 4: Operation uses disinfectant wipes to wipe down product grading line at the end of each 

shift.

Assessment: Immediate Action Required.

Reason: Wipes are not labeled for use on food contact surfaces. 

Harvesting

F-9 Preharvest Assessment
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Requirement F-9.1. A preharvest risk assessment shall be performed.

Procedure The Operation shall have a preharvest assessment procedure, which 

describes when the assessment is performed and that it includes an 

evaluation of conditions that may be reasonably likely to result in 

physical, chemical, or biological contamination of the produce, and 

demonstrates that the Operation is in compliance with the food safety 

plan. Results of the evaluation shall be documented.

Verification Auditor reviews most recent preharvest assessment for completeness 

and consistency with the food safety plan.

Corrective 

Action

Operation develops and implements a preharvest assessment procedure.

Documents 

Required

Risk Assessment.

Mandatory ●

PSR 112.112

Expectation 

The farm operation must have completed a pre-harvest assessment on each production area prior to 

harvesting any crop being certified by the audit. Take care not to interpret the assessment but rather 

to verify the fact that an assessment has been made. The assessment may include statements that

address the following items as applicable:

• Is there evidence of unauthorized entry in the crop area and if so, has it been investigated? 

• Is there evidence of domestic or wild animal crop damage?

• Is there evidence of physical contamination in the crop area? 

• Are fuel and chemicals which might contaminate crop areas isolated?

• If areas are contaminated, are they isolated for “no-harvest”? 

• Are there any other notable sources of biological or physical contamination such as dump 

sites, manure, burning debris, water that may affect food safety?

• Is transportation equipment clean and available?

• The assessment may include other information such as condition of the weather and/or 

crops. 

Also consider, did it address the following areas:

• Intrusion by animals
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• Flooding 

• Potential contamination materials

• Condition of water source and distribution system 

• Unexpected adjacent land activity that will pose a risk to food safety

• Worker hygiene and sanitary facilities

The date of the assessment and the projected date of harvest along with a signature or initials, must 

be included. The assessment may be documented in various forms such as a self-completed audit 

checklist or a separate pre-harvest checklist. This question cannot be answered N/A. The comment 

should include the date and the role/title of the person who conducted the pre-harvest risk 

assessment. 

Example Scenario 

Scenario: A row crop operation uses the same checklist for the pre-season risk assessment, and 

performs the assessment one week before harvesting. Results are recorded. The pre-season 

checklist addresses all of the pre-harvest concerns identified in the Food Safety Plan. The plan 

recognizes that a one-week pre-harvest interval for the assessment is acceptable.

Assessment: Compliant. 

Reason: All parameters of the pre-harvest risk assessment have been met.

Produce Safety Rule 

112.112: The operation must take all measures reasonably necessary to identify, and not harvest, 

produce that is reasonably likely to be contaminated with a known or reasonably foreseeable 

hazard, including steps to identify and not harvest produce that is visibly contaminated with animal 

excreta. At a minimum, identifying and not harvesting produce that is reasonably likely to be 

contaminated with animal excreta or that is visibly contaminated with animal excreta requires a 

visual assessment of the growing area and all produce to be harvested, regardless of the harvest 

method used. 

F-10 Water/Ice Used in the Harvesting and Post-harvest Operations

Post-harvest Water is any water that contacts the crop during the harvest process or at any time after 

harvest, and any water that is applied to food contact surfaces. Post-harvest water includes fluming, 

washing produce, cooling (after harvest), ice, cleaning food contact equipment, cleaning bins and/or 

packaging, and handwashing water. 

All post-harvest water must meet the microbial standards for drinking water. For the purposes of 

USDA GAP audits, this is considered to be no detectable generic E. coli. 

The EPA National Primary Drinking Water Regulations: Revisions to the Total Coliform Rule 

(RTCR) considers E. coli to be an indicator of fecal contamination. If water used for post-harvest 
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purposes shows detectable E. coli immediate corrective action will be needed as this exceeds the 

EPA Maximum Contaminant Level (MCL) for E. coli. 

The RTCR uses total coliforms as an indicator of system operation and condition rather than an 

immediate public health concern. Detectable total coliform no longer has a MCL, however, are 

now used to trigger an assessment of the system. For the purposes of the GAP audits, detectable 

total coliform in a post-harvest water test would need to be evaluated following a company’s 

corrective action process.

Requirement F-10.1. Operation has procedures for water used in contact with product 

or food contact surfaces.

Procedure Standard Operating Procedures (SOPs), including water-change 

schedules, shall be developed for all uses of water. Microbial and/or 

physical/chemical (e.g., test strips) testing shall be performed, as 

appropriate to the specific operation to demonstrate that acceptance 

criteria have been met.

Verification Auditor observes existence of water use SOPs.

Corrective 

Action

Operation develops the SOPs.

Documents 

Required

Written Policy, Record.

Mandatory ●

Expectation 

Auditor’s review of SOPs verifies procedures for managing the quality of water for all uses that 

contact produce or food contact surfaces, including water change schedules. SOP’s should state 

what, when, how and why microbial or other testing is performed and if it is appropriate to the 

specific operation(s) to demonstrate acceptance criteria.

Example Scenarios 

Scenario 1: An operation has no SOPs or acceptance criteria for ice used for top icing of broccoli. 

Assessment: Corrective Action Needed or Immediate Action Required. 

Reason: Corrective Action Needed - if SOPs and acceptance criteria for food-contact ice needs to 

be developed. Immediate Action Required - if the ice being used may reasonably have 

contaminated broccoli. 

Scenario 2: A cherry operation soaks foam pads in water, then places pads on top of cherries for 

transport. The water used is in compliance with operation’s Water Management Plan.

Assessment: Compliant. 

Reason: The operation is following its procedure for the water being used. 
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Requirement F-10.2. Water use SOPs address the microbial quality of water or ice 

that directly contacts the harvested crop or is used on food-contact 

surfaces.

Procedure If water or ice directly contacts the harvested crop or is used on foodcontact surfaces such as in the field, as the final wash step prior to 

consumer packaging, or as a cooling aid in consumer package, 

operation’s water use SOP requires the water or ice when applied meets 

the microbial standards for drinking water, as defined by prevailing 

regulation. Water may be treated (e.g., with chlorine) to achieve 

microbial standards or to prevent cross-contamination. Ice and water 

shall be sourced/ manufactured, transported, and stored under sanitary 

conditions. Special considerations or variances may be appropriate for 

some crops, e.g. cranberries and watercress, where deliberate flooding of 

the field is part of production and harvest practices.

Verification Auditor reviews operation’s policy regarding water quality and its 

transport, and observes evidence that water or ice that contacts 

harvested crop or food contact surfaces meets the microbial standards 

for drinking water.

Corrective 

Action

Operation discontinues using water or ice that does not meet the 

microbial standards of drinking water. Retraining is performed and 

documented. Affected product is evaluated for potential contamination 

and disposition.

Documents 

Required

Record.

Mandatory ●

Expectation 

It is important to know the quality of the water which is being used to make the ice. This can be 

documented through a sales receipt, a COA/letter of guarantee from the supplier, or a water test.

There should be cleaning and maintenance procedures for all tools and equipment that is used for 

handling, transporting, and/or storing ice. These items should also not be used for other purposes 

which cause them to become contaminated by bacteria or chemicals without being cleaned and 

sanitized in between being used and stored in a manner to prevent contamination. If ice is made on 

site there should be a cleaning schedule and cleaning/maintenance procedures for the equipment 

used to make the ice. 

Consideration should be given to how and where iced product is stored. As the ice used on product 

begins to melt it can drip onto anything stored below and potentially carry contamination present on 

the product, packing, pallets, or storage equipment and shelving. If possible, iced product should 

not be stored above other items to eliminate this route of potential cross contamination. Dripping 

ice can also create pooled water on floors if there is not sufficient drainage, which can be a reservoir 

for microorganisms as well as a hazard for employees. 
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Water quality consistent with EPA microbial requirements for drinking water, or similar standards, 

is recommended by the FDA’s Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits 

and Vegetables. While water quality management may vary throughout all operations, packers 

should follow best practices to minimize the potential for the introduction or spread of pathogens by 

water used at and after harvest. 

Water that meets the microbial standards for drinking water is considered “safe and sanitary.” 

Municipal water supplies are regulated by law and are required to be potable. Well water may or 

may not be potable but should be microbially safe. Surface water is subject to various 

uncontrollable influences and should be considered unsafe without further testing and/or effective 

treatment. Untreated surface water must not be applied to the finished product or food contact 

surfaces. Auditors review water tests to determine that the water is microbially safe.

The comment should include the water source for harvest operation and the water’s test results. 

Example Scenarios 

Scenario 1: Operation has an SOP that includes an annual lab test of their well water that is used 

for all produce and equipment cleaning. Copies of the report from the certified lab are available for 

the last three years and the results meet the requirements for drinking water standards.

Assessment: Compliant. 

Scenario 2: An operation is using surface water to wash harvest totes. Their SOP requires that 

they treat the water with 0.1% calcium carbonate as a disinfectant.

Assessment: Corrective Action Needed. 

Reason: 0.1% calcium carbonate is not an effective water antimicrobial.

Requirement F-10.3. If water is re-used, SOPs address antimicrobial treatment.

Procedure Operation’s water use SOPs require re-used water to be treated using an 

approved antimicrobial to prevent it from becoming a source of 

contamination, according to prevailing regulation or industry specific 

standards for the commodity.

Verification Auditor reviews water use SOP for completeness, and observes water 

treatment records for adequacy and consistency of treatment.

Corrective 

Action

Operation discontinues using re-circulated water that is not treated 

sufficiently to prevent contamination of the produce. Retraining is 

performed and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

Record.

Mandatory ●

Expectation 

If an auditee is using recirculated or reused water, it is expected that the water will be treated with a 

sanitizer to prevent cross contamination of product/lots and to maintain the sanitary quality of the 

water.
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Water sanitizers are intended to sanitize the water, not sanitize the product. Sanitizing the water 

may not remove microorganisms from an already contaminated product but will help prevent the 

water from spreading that contamination onto every other product that is contacted by the water.

Treatments of water, including sanitizers must be registered for that use. Registration information 

should be on the label, but in some cases the label information is included in the paperwork that 

comes with the product. Growers may need to find additional information from the manufacturer 

that specifically lists allowable contact with fresh produce or food contact surfaces.

For more information on sanitizers, the Produce Safety Alliance has created an Excel tool for Label 

Sanitizers for Produce available on their resources webpage. This tool shows the different uses for 

which each sanitizer has been approved, the active ingredient(s), product information, and whether 

it can be used in organic operations. 

A schedule must be established for changing batch water and/or a process in place for minimizing 

the build-up of organic material in the water. Reused and batch water can be easily contaminated 

by incoming loads of produce which could introduce hazards such as pathogens. Organic material 

can also bind to sanitizers, making them less effective.

The specific schedule for changing water will depend on how much produce an operation is 

washing/cooling, what type of produce, type of equipment (e.g., large scale vs. small scale, if filters 

are used), soil conditions and type of sanitizer. Measuring and monitoring turbidity in wash water 

can be one way in which an operation determines the frequency to change the batch water based on 

these various operating parameters.

The auditor will include the type of antimicrobial treatment used and the parameters of use (i.e., 

ranges of pH, ppm free chlorine) in the comments. 

Example Scenarios

Scenario 1: The water treatment is not recorded or monitored during the day. Water is used to 

flume tomatoes from harvest areas to packing facilities in greenhouse is treated with 100 ppm total 

chlorine. 

Assessment: Corrective Action Needed. 

Reason: Total chlorine is not an effective way to monitor chlorine in flume systems. Water 

treatment records are required by the standard.

Scenario 2: Cherries are hydrocooled with re-used fresh water that is from a source that meets 

drinking water standards. The water is not treated with an antimicrobial but is replaced daily.

Assessment: Corrective Action Needed. 

Reason: Standard requires “re-used water to be treated using an approved antimicrobial to prevent 

it from becoming a source of contamination.” 
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Scenario 3: Water used to flume potatoes is re-circulated and is treated with citric acid. Citric acid 

use is recorded and monitored electronically. 

Assessment: Corrective Action Needed. 

Reason: Unless the operation has documentation demonstrating otherwise, citric acid is not an 

approved antimicrobial for pathogens of public health concern. 

Requirement F-10.4. Water use SOPs address condition and maintenance of waterdelivery system.

Procedure The water-delivery system shall be maintained so as not to serve as a 

source of contamination of produce, water supplies or equipment with 

pathogens, or to create an unsanitary condition.

Verification Auditor reviews the SOP for inclusion of condition and maintenance of 

water-delivery system, and observes maintenance records for evidence 

of compliance.

Corrective 

Action

Operation revises SOP and implements maintenance procedures.

Documents 

Required

Record.

Mandatory ●

Expectation

Examples of water delivery systems include reservoirs, canals, ditches, pumps, hoses, and other 

facilities that move water. Auditor needs to review SOP for condition and maintenance of water 

delivery system and visually inspect water-delivery system for evidence of compliance.

Example Scenarios 

Scenario 1: An operation uses a sand filter in their water system used for food contact water. The 

sand filter is back flushed whenever the water flow rates drop. The water system is not tested for 

microbial indicators. 

Assessment: Corrective Action Needed. 

Reason: The water system is not being maintained so as not to serve as a source of contamination 

of produce. 

Scenario 2: The operation has recently replaced a ball valve with a gate valve of galvanized 

materials and restarted the line. The water is tested for microbial indicators and found to be 

compliant with drinking water standards. The operation has not assessed whether changing the type 

of valve will create a potential for contamination of the water system, regardless of current test 

results.

Assessment: Corrective Action Needed. 

Reason: The operation has not evaluated the valve for the potential for contamination of the water 

system.
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Requirement F-10.5. If applicable to the specific commodity, water use SOPs address 

control of wash water temperature.

Procedure For produce demonstrated as being susceptible to microbial infiltration 

from wash water, wash water temperature differentials during 

immersion shall be considered.

Verification If applicable to the commodity being wash auditor reviews the SOP for 

inclusion of water temperature control, and observes monitoring and 

records for evidence of compliance.

Corrective 

Action

Operation revises SOP to address and control wash water temperature.

Documents 

Required

Record.

Mandatory

Expectation 

Infiltration can occur if warm produce is placed in water that is cooler than the produce. This 

temperature change creates a pressure differential, allowing water, and contaminants on the surface 

or in the water, to be pulled into the fruit or vegetable through the stem end, scars, cracks, cuts, or 

bruises. Once pathogens are inside the produce, surface washing cannot reduce their levels.

For crops which are susceptible to water infiltration, special attention to the water temperature in 

the dump tank and flumes and the temperature of the product is required. If contaminated water 

infiltrates the product, it is very difficult if not impossible to remove the contamination. The water 

may need to be heated or cooled and/or the product heated or cooled to prevent infiltration of water 

into the product. 

The general recommendation for commodities that are susceptible to water infiltration, is that water 

temperature should be maintained within 10°F of incoming product pulp temperature to minimize 

water infiltration. As more research has been done on infiltration, in addition to temperature of the 

water and fruit, it has been found that the depth of the water, the time the commodity spends in the 

water, produce wounding (including stem scars) and maturity of produce also are factors in water 

infiltration.

For tomatoes specifically, there is guidance that states wash water should be at least 10°F above 

average pulp temperature of the tomatoes when entering the water. There is greater flexibility on 

commodities other than tomatoes (which need to follow the tomato specific guidance) that are 

susceptible to water infiltration to rely more on what is in the operation’s Food Safety Plan to 

describe how they are preventing infiltration versus strictly adhering to the within 10 degrees stated 

in the GAP manual. 

For papayas specifically, guidance recommends that water temperature in dump tanks to be

maintained at least 5°C warmer than the pulp temperature of the papaya to limit infiltration
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of water. Papaya should not be immersed in wash tanks for more than 2 minutes or submerged 

more than 30 cm to minimize potential for infiltration. These recommendations assume that the 

antimicrobial levels in the water are being maintained and monitored. 

If the commodity is susceptible to microbial infiltration, auditors will include the required 

temperature differential in the comments.

Example Scenario 

Scenario 1: There is no written SOP for monitoring a tomato operation’s flume water temperature 

where the tomatoes are washed.

Assessment: Corrective Action Needed. 

Reason: There are current industry practices for tomatoes, SOPs are expected to be written. 

F-11 Containers, Bins and Packaging Materials 

Requirement F-11.1. Operation has written policy regarding storage of harvesting 

containers.

Procedure Harvesting containers shall be stored in a manner so as not to serve as a 

source of contamination to the extent feasible and appropriate.

Verification Auditor observes whether operation has a policy regarding storage of 

harvesting containers used in the field. Auditor observes current 

practices for compliance with policy.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented.

Documents 

Required

Written Policy.

Mandatory

PSR 112.123(b)(2)

Expectation 

Operations must have a written policy regarding the storage of harvesting containers. These 

containers are required to be stored in a manner so that they are not to serve as a source of 

contamination to the extent feasible and appropriate. It is not a requirement that harvesting 

containers be stored indoors. If a grower stores harvesting containers (bins) outdoors and can 

demonstrate they are “not a source of contamination” this is acceptable.

Example Scenarios 

Scenario 1: The operation has a written SOP for the storage of harvesting containers but doesn’t 

follow the policy based on observation. 

Assessment: Corrective Action Needed. 

Reason: The operation is not following their policy for the storage of harvesting containers. A 

policy is only effective if it is being followed.

Scenario 2: Harvest containers are stored outdoors on a clean hard surface, under a mesh “roof.”

Assessment: Compliant. 
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Reason: The container storage procedure is consistent with current industry practice.

Produce Safety Rule 

112.123(b)(2): Equipment and tools must be stored and maintained to protect produce from being 

contaminated with known or reasonably foreseeable hazards and to prevent the equipment and tools 

from attracting and harboring pests.

Requirement F-11.2. Operation has written policy regarding inspection of food 

contact containers prior to use.

Procedure Food-contact totes, bins, packing materials, other harvest containers, 

and pallets shall be visually inspected, clean, intact and free of any 

foreign materials prior to use. Containers shall be sufficiently 

maintained so as not to become a source of contamination.

Verification Auditor observes whether operation has a policy regarding inspection of 

food contact containers and observes current practices for compliance 

with policy.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented.

Documents 

Required

Written Policy.

Mandatory

PSR 112.123(d)(1)

Expectation 

The written policy should include procedures for inspecting food contact containers, the frequency 

of these inspections, the personnel involved, and conditions that should be reported to a supervisor, 

or responsible party to determine appropriate corrective actions to protect covered produce.

The standard is silent on the frequency of inspection. This should be determined by the operation 

based upon several factors such as the type of material of the containers, the construction, how the 

containers are used, cleaned, stored, the age of the containers and frequency of use. There could be 

different inspection frequencies for different food contact containers. 

Ideally, inspections should be performed after each cleaning activity and before using food contact 

containers 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.

Single-use food-packing materials should be inspected upon receipt or immediately before use to

protect against contamination of your covered produce. 

The audited location should be following recommendations for harvest containers, which include: 

• Keep harvest containers as clean as practicable to prevent cross-contamination of fresh 

produce. 
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• Harvest containers used repeatedly during a harvest should be cleaned after each load is 

delivered and prior to reuse. 

• If the containers are stored outside, they should be cleaned and sanitized before being used 

to haul fresh produce. 

• Workers should not stand inside bins.

Example Scenarios 

Scenario 1: The operation power washes plastic harvest bins prior to use. Operation’s written 

policy considers the person who does the washing as being the “inspector.” 

Assessment: Compliant. 

Reason: The plastic harvest bins are being inspected in accordance with the operation’s written 

policy. 

Scenario 2: The operation has an SOP requiring visual inspection of harvest containers prior to 

use. Auditor observes that some bins are not in good repair, and one bin is visibly soiled. 

Assessment: Corrective Action Needed. 

Reason: The SOP is not being implemented consistently.

Produce Safety Rule 

112.123(d)(1): The operation must inspect, maintain, and clean, and when necessary and 

appropriate, sanitize all food contact surfaces of equipment and tools used in growing, harvesting, 

packing and holding activities as frequently as reasonably necessary to protect against 

contamination of produce. 

Requirement F-11.3. Operation has written policy regarding acceptable harvesting 

containers.

Procedure The types and construction of harvest containers and packing materials 

shall be appropriate to the commodity being harvested and suited for 

their intended purpose.

Verification Auditor observes whether operation has a policy regarding what types 

of containers and packing materials are acceptable for use during 

harvest, and observes current practices for compliance with the policy.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented.

Documents 

Required

Written Policy.

Mandatory ●

PSR 112.116; 112.123(a)(c);

Expectation 

Auditor reviews written policy regarding acceptable harvesting containers. Containers must be 

acceptable for commodity being packed. Materials of harvest containers should be considered 

whether they can be adequately cleaned or properly maintained under the conditions of their use 
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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.

Example Scenarios 

Scenario 1: A citrus operation harvest crew uses canvas bags, which are cleaned and stored in 

accordance with operation’s SOP.

Assessment: Compliant. 

Reason: The canvas bags are in compliance with the operation’s SOP.

Scenario 2: An operation doesn’t have written policy on the types of containers appropriate for 

harvest use.

Assessment: Corrective Action Needed. 

Reason: The standard requires a “written policy regarding acceptable harvesting containers.”

Produce Safety Rule 

112.116: Requires that operations use food-packing material that is adequate for its intended use. 

Materials must be cleanable or designed for single use and must be unlikely to support growth or 

transfer of bacteria. If operations reuse food-packing material, the operation must take adequate 

steps to ensure that food-contact surfaces are clean, such as by cleaning food-packing containers or 

using a clean liner. 

112.123: (a) The operation must use equipment and tools that are of adequate design, construction 

and workmanship to enable them to be adequately cleaned and properly maintained. (b) Seams on 

food contact surfaces of equipment and tools used 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. 

Requirement F-11.4. Operation has written policy prohibiting use of harvest containers 

for non-harvest purposes.

Procedure Food-contact totes, bins and other harvest containers designated for 

harvesting shall not be used for other purposes unless clearly marked or 

labeled for that purpose.

Verification Auditor observes whether operation has a policy prohibiting use of harvest 

containers for other uses unless otherwise labeled, and observes current 

practices for compliance with the policy.

Corrective 

Action

Operation develops the policy. Retraining is performed and documented.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 
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The operation must have a written policy concerning harvest containers and appropriate uses within 

the operation. The auditor will observe practices to ensure that the operation is complying with the 

written SOP. 

Example Scenarios 

Scenario 1: Harvest containers are observed as storage for bagged fertilizer without a clear 

marking or designation.

Assessment: Corrective Action Needed. 

Reason: Containers must be prominently marked for this use and workers must not use these for 

picking and transporting produce. 

Scenario 2: The policy is written but fails to clearly establish marking requirements for nonharvest uses of harvest containers.

Assessment: Corrective Action Needed. 

Reason: The policy needs to establish marking requirements for non-harvest uses of containers.

Scenario 3: Field workers are observed storing personal effects in harvest containers. The harvest 

containers are temporarily marked “not for harvest.” There is no written policy permitting 

temporary marking.

Assessment: Corrective Action Needed. 

Reason: There must be a written policy on marking containers for non-harvest purposes. 

F-12 Field Packaging Materials 

Requirement F-12.1. Operation shall have a written policy that visibly contaminated, 

damaged or decayed produce is not harvested, or it is culled.

Procedure Employees are trained that only sound produce appropriate for the 

intended use is harvested, and that produce that has been visibly 

contaminated or otherwise damaged to an extent that it poses a 

microbial food safety hazard is not harvested or is culled.

Verification Auditor reviews written policy and evidence of employee training. 

Auditor inspects the harvest or sorting operation for evidence of 

compliance.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented. Affected product is evaluated for potential contamination 

and disposition.

Documents 

Required

Written Policy.

Mandatory ●

PSR 112.112

Expectation 

Employees responsible for harvesting activities should be trained in the operation’s written policy 

concerning produce visibly contaminated (such as with animal feces or excreta) is not harvested. 

Harvest personnel must be instructed on appropriate actions to be taken when observations of 
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produce that is contaminated occurs. If contamination is widespread, efforts must be taken to 

cordon off the affected areas. The auditor shall review the SOP and validate the operation’s 

compliance with the policy.

Example Scenarios

Scenario 1: You observe that produce with minor damage or decay is being harvested. The written 

policy says that decayed/damaged produce will be removed during sorting. You also observe that 

decayed/damaged produce is culled during sorting.

Assessment: Compliant.

Reason: The decayed/damaged produce is culled during sorting.

Scenario 2: A peach operation has written policy that damaged fruit is harvested but is placed into 

a bin designated for processing.

Assessment: Compliant.

Reason: The damaged fruit is following the operation’s policy if it is not damaged to an extent that 

it poses a microbial food safety risk.

Scenario 3: An auditor observes hail damaged fruit that has healed over prior to being harvested.

Assessment: Compliant.

Reason: The standard prohibits harvest only if “damaged to an extent that it poses a microbial food 

safety hazard.”

Produce Safety Rule

112.112: The operation must take all measures reasonably necessary to identify, and not harvest, 

produce that is reasonably likely to be contaminated with a known or reasonably foreseeable 

hazard, including steps to identify and not harvest produce that is visibly contaminated with animal 

excreta. At a minimum, identifying and not harvesting produce that is reasonably likely to be 

contaminated with animal excreta or that is visibly contaminated with animal excreta requires a 

visual assessment of the growing area and all produce to be harvested, regardless of the harvest 

method used.
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Requirement F-12.2. Product that contacts the ground shall not be harvested unless 

the product normally grows in contact with the ground.

Procedure Operation has considered and developed written policies regarding 

produce that comes in contact with the soil (e.g., drops) and to avoid, to 

the degree practicable, contact of cut surfaces of harvested produce with 

soil. Policy shall be consistent with industry standards or prevailing 

regulations.

Verification Auditor reviews written policy and evidence of employee training. 

Auditor inspects the harvest or sorting operation for evidence of 

compliance.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented. Affected product is evaluated for potential contamination 

and disposition.

Documents 

Required

Written Policy.

Mandatory ●

PSR 112.113, 112.114

Expectation 

Dropped produce is produce that has unintentionally dropped to the ground prior to harvest. 

Dropped produce could have bruises, punctures, or other injuries which can create potential 

pathways for pathogens to contaminate the produce and multiply. A written policy which explains 

whether dropped product can be harvested is required. Employees must be trained on this policy. 

Interview employees to verify their understanding of the dropped product policy.

Auditors will include the type of growing method and if the product grown in contact with the 

ground (e.g., tomatoes staked, or vine grown) in the comments.

Example Scenarios 

Scenario 1: Auditor observes harvest crews picking mushrooms close enough to the growing 

medium that some harvested mushrooms have growing medium on them. 

Assessment: Compliant. 

Reason: Mushrooms normally grow in contact with the growing medium. 

Scenario 2: Auditor observes strawberries being harvested that are in contact with the plastic 

mulch under the plants. 

Assessment: Compliant. 

Reason: Strawberries normally grow in contact with the ground or with plastic mulch.

Scenario 3: Auditor observes a peach harvester putting a peach that she has just dropped on the 

ground into her harvest sack. 

Assessment: Corrective Action Needed. 

Reason: Peaches are not grown in contact with the ground. 
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Produce Safety Rule 

112.113: requires operations to handle harvested covered produce in a manner that protects against 

contamination with known or reasonably foreseeable hazards – for example, by avoiding, to the 

degree practicable, contact of cut surfaces of harvested produce with soil.

112.114: prohibits the distribution of dropped covered produce. This prohibition applies to 

dropped produce that contacts soil when it falls as well as dropped produce that falls onto another 

surface, such as plastic mulch. The prohibition for dropped covered produce does NOT include: 

root crops that grow underground (such as carrots), crops that grow on the ground (such as 

cantaloupe), or produce that is intentionally dropped to the ground as part of harvesting (such as 

almonds). 

Requirement F-12.3. Harvest procedures shall include measures to inspect for and 

remove physical hazards.

Procedure Operation shall have procedures to detect glass/plastic breakage and

remove possible physical contamination such as glass, metal, rocks, or 

other hazardous items, during harvesting operations.

Verification Auditor inspects the harvest or sorting operation for evidence of hazard 

control.

Corrective 

Action

Operation develops the procedure. Affected product is evaluated for 

potential contamination and disposition.

Documents 

Required

N/A.

Mandatory

Expectation 

Harvest procedures for inspecting and removing physical hazards are not required to be written. 

Harvest employees who are responsible for the food safety procedures must be trained on the 

procedures for inspecting and removing physical hazards appropriate to their job responsibilities 

(see requirement G-4.1).

Example Scenarios 

Scenario 1: A strawberry harvest crew has no written procedures for physical hazard control. The 

field-pack operation says that the harvesters are trained to look for and not harvest any strawberries 

that have foreign objects on them. You observe evidence that harvesters have been trained and 

appear to be following the procedure. 

Assessment: Compliant. 

Reason: Harvest crew workers are familiar with and follow the operation’s verbal policy regarding 

physical hazards. 

Scenario 2: A field-packed Romaine lettuce operation is using a mechanical harvester, which they 

say has gaps and other automated mechanisms to remove glass, metal and other physical hazards. 

You see an insect in the harvested product. 

Assessment: Compliant. 

Reason: The insect is not a physical hazard.
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Requirement F-12.4. Cloths, towels, or other materials that pose a risk of crosscontamination shall not be used to wipe produce, unless risk mitigation 

procedures are in place.

Procedure Operations shall not use cloths or other cleaning materials to clean 

produce, unless there is a procedure to reduce risk of crosscontamination.

Verification Auditor reviews whether operation uses cloths or other produce cleaning 

materials and, if so, how operation prevents cross-contamination 

between uses.

Corrective 

Action

Operation ceases use of produce cleaning cloths, or develops procedure 

to prevent cross-contamination. Affected product is evaluated for 

potential contamination and disposition.

Documents 

Required

N/A.

Mandatory

Expectation 

If cleaning materials (cloths, paper towels, etc.) are used repeatedly for cleaning, special steps must 

be taken to ensure they do not become a source of contamination. For example, an operation can 

choose to use one-use paper towels (once and done) to prevent cross contamination. Operations 

must have a procedure for when to discontinue using or change a cleaning material. 

For papayas specifically, sponges or wash mitts must be changed out at least once per shift, or 

sooner if the sponge becomes visibly dirty or otherwise contaminated. During use, sponges should 

be dipped in the papaya wash water with adequate antimicrobial control or a separate antimicrobial

solution for a few seconds between each papaya to reduce the potential for cross-contamination 

between fruit. 

Auditors should interview and observe employees for compliance of the procedure. The comment 

should include the type of cloth, towel, or other cleaning material and procedure for preventing 

cross contamination. 

This requirement may not be answered Not Applicable. If the operation is not using materials to 

wipe produce then this requirement would be assessed as Compliant. 

Example Scenarios 

Scenario 1: A cucumber harvester is seen wiping dirt from some cucumbers on his apron prior to 

putting them in the harvest bin. 

Assessment: Corrective Action Needed or Immediate Action Required.

Reason: Corrective Action Needed as the apron could serve as a risk for contamination. If you 

observe evidence that the practice has resulted in product contamination, then it would be an 

Immediate Action Required.
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Scenario 2: Operation states in their policy that it is acceptable to wipe produce if necessary with a 

one-time use paper towel. Policy states this may only be done if a leaf or plant debris is adhered to 

product. While conducting a field packing audit the auditor witnesses an employee wiping away 

bird droppings and placing product in container for shipment. 

Assessment: Immediate Action Required

Reason: Policy states one-time use paper towels may only be used on leaf or plant debris. If the 

representative/field supervisor also sees this and removes product and retrains employee to follow 

procedure this question may be assessed as compliant.

Requirement F-12.5. Packaging materials shall be appropriate for their intended use.

Procedure The product contact packaging shall be appropriate to the commodity 

being harvested and suited for its intended purpose.

Verification Auditor observes evidence (e.g., information from supplier, customer 

specification, industry standards, prevailing regulation) that the 

packaging does not create an unsafe condition.

Corrective 

Action

Operation discontinues use of the packaging until information can be 

obtained demonstrating safe use. Affected product is evaluated for 

potential contamination and disposition.

Documents 

Required

N/A.

Mandatory ●

PSR 112.116

Expectation 

When selecting material for packaging it’s important to consider if the material is reusable or 

designed for a single use. It should also be unlikely to support growth or transfer of bacteria, taking 

into consideration the handling, maintenance, and storage practices of the operation. An operation 

should not reuse food-packing materials that are designed for single use. Although some single-use 

food-packing materials, such as fiberboard or foam, 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. Twist ties or rubber bands used for herbs bunches etc. are 

considered packing materials and must be assessed under this requirement.

Example Scenarios 

Scenario 1: A tomato operation is field-packing tomatoes directly into cardboard boxes which are 

being reused from other tomato lots. All boxes are labeled with the tomato operation’s name and 

date of harvest.

Assessment: Corrective Action Needed. 

Reason: The Tomato Metrics prohibits re-use of cardboard or fiberboard boxes for field-packing 

because of potential cross-contamination from other lots.

Scenario 2: A strawberry operation is field-packing strawberries directly into new plastic 

clamshells. The operation has an invoice from a national packaging supplier for “strawberry 

clamshells.” 

Assessment: Compliant. 
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Reason: The packaging is appropriate to the crop being harvested. 

Produce Safety Rule 

112.116: Requires that operations use food-packing material that is adequate for its intended use. 

Materials must be cleanable or designed for single use and must be unlikely to support growth or 

transfer of bacteria. If operations reuse food-packing material, the operation must take adequate 

steps to ensure that food-contact surfaces are clean, such as by cleaning food-packing containers or 

using a clean liner. 

Requirement F-12.6. Packaging shall be stored in a manner that prevents 

contamination.

Procedure Packaging storage shall be designed to maintain packaging dry, clean 

and free from dirt or residues so it remains fit for the purpose. 

Particular care shall be taken to prevent packaging from becoming a 

harborage for rodents and other vermin. Packaging shall be stored 

separately from hazardous chemicals, toxic substances and other sources 

of contamination.

Verification Auditor inspects packaging storage area for evidence of compliance.

Corrective 

Action

Operation designates a storage area and practices that reduce risk of 

contamination. Affected packaging is evaluated for potential 

contamination and disposition.

Documents 

Required

N/A.

Mandatory

PSR 112.123(b)(2)

Expectation 

Packaging materials that are not ready for immediate use should be stored in a way that protects 

them from contamination by any source (pests, rodents, dirt, water condensation, etc.). Packaging

stored outside should be covered in some manner to protect against contamination. Observe where 

and how packaging is stored. Containers which are stored in a manner that may lead to 

contamination by any reasonable means will result in Corrective Action Needed.

Example Scenario 

Scenario: You observe rolls of mesh bags, to be used for potato packaging, wrapped in plastic and 

stored in an open, designated part of the potato storage building. The plastic wrapping has some 

dust on it, but is dry, intact and bags inside the wrapping appear clean. 

Assessment: Compliant. 

Reason: Packaging is stored in a manner that prevents contamination. 

Produce Safety Rule 

112.123(b)(2): Equipment and tools must be stored and maintained to protect produce from being 

contaminated with known or reasonably foreseeable hazards and to prevent the equipment and tools 

from attracting and harboring pests. 
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Requirement F-12.7. Operation has written policy regarding whether packaging 

materials are permitted in direct contact with the soil.

Procedure If produce is packed in field, operation has considered and developed 

written policies regarding placement of packaging materials directly on 

the soil, or whether a physical buffer (e.g., buffer bin or slip sheet) is 

required. Policy shall be consistent with industry standards.

Verification Auditor observes whether operation has a policy regarding placement of 

packaging materials used in the field in direct contact with soil. Auditor 

observes current practices for compliance with policy.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented.

Documents 

Required

Written Policy.

Mandatory

PSR 112.113

Expectation 

Produce that is packed in the field must have a policy stating the operation’s procedures for 

packaging. Policy must state if packaging materials are allowed to come in direct contact with the 

soil or if there is a buffer zone between the soil and the packaging. Auditor should observe 

employee practices to ensure that policy is being followed. 

Produce Safety Rule

112.113: You must handle harvested covered produce during covered activities in a manner that 

protects against contamination with known or foreseeable hazards. – for example, by avoiding, to 

the degree practicable, contact of cut surfaces of harvested produce with soil.

Requirement F-12.8.a. The operation has implemented a product release procedure.

Procedure Operations follow product release written procedure to ensure that all 

potential hazards have been addressed prior to transport. Release 

records must be kept.

Verification Auditor observes product release procedure is being followed and 

release records are kept.

Corrective 

Action

Operation develops a written release procedure release procedure. 

Release records are kept.

Documents 

Required

Written Policy.

Mandatory

Expectation 

Product release procedures are the steps taken before harvested product is permitted to leave the 

field (released). Operation develops a product release policy. Auditor reviews the operation’s 

written policy, makes observations that product release policy is being followed, and reviews 

records of product release.
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Example Scenario 

Scenario 1: The operation has a written procedure that the harvest crew foreman visually inspects 

each load of bell peppers before cartons are loaded for transport to the cooler. The harvest crew 

foreman is also responsible for visually inspecting the truck before product is loaded. This 

inspection and the number of cartons shipped from the field is included in the daily harvest log for 

each truck loaded. Quality assurance checks each load when received at the cooler and verifies the 

count of the product entering it into the inventory system if found acceptable to ship. If any food 

safety concerns are found the product is segregated to a separate area of the loading dock. All

records associated with the operation’s written policy were available.

Assessment: Compliant

Reason: Operation was observed following their written policy and records were available to 

review.

F-13 Post-harvest Handling and Storage (Field Prior to Storage or Packinghouse) 

Requirement F-13.1. Harvested produce is handled in a manner such that it is not 

likely to become contaminated.

Procedure Operation has a policy, in compliance with current industry practices or 

regulatory requirements for that commodity, regarding handling, 

walking, stepping, or lying on harvested produce, food contact surfaces 

or packaging materials, or coming in contact with produce that has not 

been handled in compliance with these standards, or that may otherwise 

result in contamination.

Verification Auditor reviews policy and produce handling practices for evidence of 

compliance.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented. Affected product is evaluated for potential contamination 

and disposition.

Documents 

Required

N/A.

Mandatory ●

PSR 112.113

Expectation 

The operation must evaluate their practices during harvesting, packing, and holding, to identify 

conditions that could increase the likelihood of contamination. Steps must be taken to handle 

produce in a manner to minimize contamination of the product. The auditor observes the 

operation’s practices to evaluate if food contact surfaces or the product itself is directly 

contaminated or has a high likelihood of contamination. Produce and chemicals need to be 

separated in a manner that is practical and reasonably would not result in contamination of the 

produce or food contact surfaces.

This policy does not have to be written. To determine if this question is compliant, the auditor 

observes if the actions practiced by the operation are compliant with company policies (including 

glove policy). 
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Example Scenario 

Scenario 1: You observe workers walking on open bins of harvested iceberg lettuce. 

Assessment: Immediate Action Required.

Reason: The practice is reasonably likely to result in product contamination. 

Scenario 2: You see a bottle of stainless-steel cleaner that is used to clean sorting tables lying on 

an open bin of washed pears. 

Assessment: Corrective Action Needed. 

Reason: The cleaner is not stored separately from the produce.

Produce Safety Rule 

112.113: The operation must handle harvested produce during growing, harvesting, packing and 

holding activities in a manner that protects against contamination with known or reasonably 

foreseeable hazards – for example, by avoiding, to the degree practicable, contact of cut surfaces of 

harvested produce with soil. 

Requirement F-13.1.a. When product is field packed, collection, storage, and 

distribution points are maintained in a clean and hygienic condition.

Procedure Areas of collection/storage/distribution points shall be identifiable on 

farm during harvesting. There shall be visual evidence that these areas 

are kept clean. Where there is temporary storage on farm, rodent and 

other animal control measures shall be present.

Verification Auditors shall verify through observation that when products are field 

packed, collection, storage and distribution points are maintained in a 

clean and hygienic condition.

Corrective 

Action

Operation will implement practices that during field packing of produce 

that collection, storage and distribution points are maintained in a clean 

and hygienic condition.

Documents 

Required

N/A.

Mandatory

Expectation 

Operations must make every effort to ensure cleanliness in the post-harvest handling and storage of 

their produce. When field packing is performed, operations must implement practices that are 

conducive to maintaining produce collection, storage and distribution points in a clean and hygienic 

condition. Auditors should be able to visually observe that collection, storage and distribution 

points are clearly identifiable during harvesting and that these areas are clean. If an operation has 

temporary storage or staging areas, animal control measures should also be implemented.

Example Scenarios 

Scenario 1: Strawberries are field packed into plastic clamshells. Clamshells are placed in 

cardboard boxes and stacked in the shade under trees near the field for temporary storage until they 

can be picked up. There is visible bird activity in the trees.
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Assessment: Corrective Action Needed or Immediate Action Required

Reason: CAN due to the potential for contamination from the birds. IAR if there is evidence that 

the birds have contaminated product. 

Scenario 2: Lettuce is field packed. Packed product is moved out of the field and temporarily 

stored on the back of a flatbed truck in the parking area of the operation until the buyer’s trucks 

arrive. The parking area is free of litter and waste, and there is no indication of pest or animal 

activity.

Assessment: Compliant

Reason: The products distribution point is observed in a clean and hygienic condition. 

Requirement F-13.2. Materials that come in contact with the produce shall be clean 

and in good repair.

Procedure Operation has a policy that pallets, produce bins, totes and materials 

that come in contact with the produce or the containers during handling 

or storage shall be cleaned and, if practicable, sanitized sufficient so as 

not to be a source of contamination.

Verification Auditor observes current practices for compliance with policy.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented. Affected materials are evaluated for potential 

contamination and disposition.

Documents 

Required

N/A.

Mandatory ●

PSR 112.123

Expectation 

Food containers shall be clean, in good repair, and not cause contamination. Auditors observe the 

condition of pallets and containers being used and those stored for future use. Auditors interview 

the operation’s personnel to determine what is done with broken or dirty pallets or containers.

Example Scenario 

Scenario: You observe operators placing produce into broken bins. 

Assessment: Corrective Action Needed. 

Reason: These containers are not in good repair. 

Produce Safety Rule 

112.123: The operation must use equipment and tools that are of adequate design, construction, and 

workmanship to enable them to be adequately cleaned and properly maintained; and (b) Equipment 

and tools must be: (1) Installed and maintained as to facilitate cleaning of the equipment and of all 

adjacent spaces; and (2) 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 and harboring pests. (c) Seams on food contact surfaces of equipment and tools that are 

used 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 
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microorganisms. (d)(1) The operation must inspect, maintain, and clean and, when necessary and 

appropriate, sanitize all food contact surfaces of equipment and tools used in growing, harvesting, 

packing and holding activities as frequently as reasonably necessary to protect against 

contamination of produce. (2) The operation must maintain and clean all non-food-contact surfaces 

of equipment and tools subject to this subpart used during harvesting, packing, and holding as 

frequently as reasonably necessary to protect against contamination of produce. (e) If using 

equipment such as pallets, forklifts, tractors, and vehicles such that they are intended to, or likely to, 

contact produce, you must do so in a manner that minimizes the potential for contamination of 

produce or food contact surfaces with known or reasonably foreseeable hazards. 

F-14 Equipment Sanitation & Maintenance 

Requirement F-14.1. The operation shall have a policy, written procedures, and a 

checklist to verify cleanliness and functionality of shipping units (e.g., 

trailer).

Procedure Shipping units shall be clean, functional and free of objectionable odors 

before loading, in compliance with current industry practices or 

regulatory requirements for that commodity. Refrigeration units, if 

used, must be in working order.

Verification Auditor reviews cleaning and inspection procedures and inspects 

produce transport vehicles for cleanliness.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented. Affected product is evaluated for potential contamination 

and disposition.

Documents 

Required

Written Policy, Record.

Mandatory ●

PSR 112.125

Expectation 

All parties involved in the transport of fresh produce should help ensure that sanitation requirements 

for conveyances are maintained throughout the transportation chain. Trucks and transport 

containers must be inspected for cleanliness, odors, and debris before the loading process begins. 

Cleaning and sanitizing, as well as associated documentation, may be included in contracts for 

transportation.

Drivers and operators should be aware of the contents of previously carried loads and consider this 

information when determining current usage. For example, trucks recently used to transport 

animals or animal products would increase the risk of contaminating fresh produce if not properly 

cleaned prior to produce loading. Conveyances may not be in like-new or sterilized condition; 

however, conveyances must be visibly clean.

Review auditee documentation to verify that there is an active policy in place addressing carrier 

condition. The auditee must maintain records verifying that the overall physical condition of 

conveyances is being checked. 
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For operations that use a dedicated fleet of trailers that transport only produce, with no backhaul of 

non-produce items, the auditee must maintain records verifying the overall physical cleanliness of 

the vehicles. However, unless required by the operation’s Food Safety Plan, transport history or 

wash tickets do not need to be maintained for these vehicles. 

Example Scenarios 

Scenario 1: An operation’s products are transported by the customer’s trucks. The operation has 

no control over their condition. You see dirt and debris in one truck prior to loading. 

Assessment: Corrective Action Needed. 

Reason: The operation should not load a dirty truck regardless of ownership. 

Scenario 2: An operation’s written procedure requires trailers to have transport history for 

immediate past 3 loads or to be washed. You observe one truck being loaded without wash ticket 

“because we have to get this load to the customer now.” 

Assessment: Corrective Action Needed or Immediate Action Required.

Reason: A Corrective Action is Needed because the operation is not following their procedure. If 

you observe a reasonable opportunity for contamination an Immediate Action is Required. 

Produce Safety Rule 

112.125: Equipment used to transport produce must be adequately clean before use in transporting 

produce and adequate for use in transporting produce. 

Requirement F-14.2. Loading/unloading procedures and equipment shall minimize 

damage to and prevent contamination of produce.

Procedure Personnel responsible for the loading and unloading of produce shall 

take steps to minimize the potential of physical damage to produce, 

which can introduce and/or promote growth of pathogens. 

Loading/unloading equipment shall be cleaned and well maintained and 

of suitable type to avoid contamination of the produce.

Verification Auditor observes loading/unloading procedures for evidence of practices 

that result in excessive damage to produce. Auditor observes 

loading/unloading equipment for suitability and condition.

Corrective 

Action

Operation revises procedures. Retraining is performed and 

documented. Affected product is evaluated for potential contamination 

and disposition.

Documents 

Required

N/A.

Mandatory

Expectation 

All fresh produce must be carefully packed and loaded to minimize physical damage

and to reduce the potential for contamination during transport. A shipper should have an SOP 

describing the use of acceptable safe loading practices.
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Produce which is damaged during harvesting, packing, or transportation is more susceptible to 

microbial contamination than undamaged product. Precautions should be taken to minimize or 

prevent shifting of the load during transit. Load bracing, straps/belts, and pallet wrapping are 

examples designed to keep containers in place. Shippers should strive to organize each load with a 

realistic attempt at securing packages and preventing spillage during transit.

Example Scenario

Scenario: Cartons of tomatoes are placed on wooden pallets and plastic-strap wrapped, then loaded 

onto trailers by forklift. The forklifts are old but generally in good repair.

Assessment: Compliant.

Reason: The forklift is observed to not cause damage to the produce.
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POST-HARVEST OPERATIONS

Each requirement in the Post-harvest Operations Checklist is taken verbatim from the Produce 

GAPs Harmonized Food Safety Standard. The checklist is designed as a working tool to report the 

verification of each requirement and report any comments that will create a clear picture of the 

observations made by the auditor. 

The instructions in this section are designed to give the auditor additional guidance on utilizing the 

standard. A copy of the audit standard being assessed shall be accessible to an auditor while 

performing all audit activities.

P-1 Product Sourcing

Requirement P-1.1. The operation has a policy and takes affirmative steps to ensure 

that all fresh produce that are packed or stored in the operation are 

grown following requirements in Field Operations and Harvesting

harmonized standard.

Procedure The operation requires all raw product suppliers to provide evidence of 

food safety/GAP programs and compliance. Such evidence must include 

sufficient documentation to demonstrate that the supplier complies with 

the requirements in Field Operations and Harvesting harmonized 

standard.

Verification Auditor reviews policy and verifies that operation’s evidence of supplier 

compliance with food safety/GAP programs is in compliance with the 

operation’s policy.

Corrective 

Action

Operation obtains required documentation. Operation ceases accepting 

or shipping product from non-approved suppliers, until sufficient 

documentation demonstrating compliance is received by the operation.

Documents 

Required

Record.

Mandatory

Expectation 

The operation needs to ensure that all fresh products that are packed or stored in the operation are

grown following the requirements of the Field Operations and Harvesting harmonized standard. 

How the operation ensures these requirements are met is up to each individual operation. This 

requirement is not specifying that the auditee must have a Field Operations and Harvesting audit 

conducted by USDA to meet this requirement. The operation may choose to ensure compliance by 

having auditees complete a third-party audit, internal audit, letter of guarantee, or by other means.

Example Scenarios 

Scenario 1: The operation has a contract in place that requires a new leafy greens grower to 

comply with the Field Operations and Harvesting Harmonized Standards but has no written 

evidence of compliance with the Standards. 

Assessment: Corrective Action Needed. 
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Reason: A contract is not sufficient evidence to demonstrate that the supplier complies with the 

requirements and the operation has no historical evidence.

Scenario 2: The operation has records of compliance for the previous year’s tomatoes, but their 

grower has not had an audit yet this year, so the operation does not have any current evidence of 

compliance.

Assessment: Compliant. 

Reason: The standard does not require the operation to have the grower’s audit results, just to 

receive evidence from the supplier. There is historical evidence of compliance and the operation 

has no indication that the grower is not in compliance. 

Scenario 3: A vertically integrated operation has no evidence at the packinghouse that their 

growing operation is in compliance with the requirements of the Harmonized Standards. 

Assessment: Corrective Action Needed. 

Reason: The operation must have evidence of compliance, even if part of the same company. 

P-2 Agricultural Chemicals

Requirement P-2.1. Use of agricultural chemicals shall comply with label directions 

and prevailing regulation.

Procedure Agricultural chemicals applied post-harvest (e.g., biocides, waxes and 

plant protection products) must be registered for such use as required 

by prevailing regulation, and used in accordance with label directions 

including application rates, worker protection standards, personal 

protection equipment, container disposal, storage, and all requirements 

specified for the chemical or compound. Chemicals that are not 

restricted pesticides may be permitted for food contact use if allowed 

under regulations of the prevailing agency. Records of chemical use are 

maintained.

Verification Auditor reviews post-harvest agricultural chemical use records for 

evidence of compliance with approved uses or label directions.

Corrective 

Action

Operation develops and maintains evidence of proper use of each 

chemical use. Retraining is performed and documented. Affected 

product is evaluated for potential contamination and disposition.

Documents 

Required

Record.

Mandatory ●

Expectation 

Post-harvest chemicals must be registered for use as required by prevailing regulations and used in 

accordance with label directions, including application rate, workers’ protection standards, personal 

protective equipment, container disposal, storage, and all requirements specified for the chemical or 

compound. Note that this standard requires records of compliance with post-harvest chemicals; this 

will include regulated and non-regulated chemicals.
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The directions for use, on a post-harvest chemical label, describe how the product may legally be 

used and how the product must not be used. Generally speaking, the necessary information 

includes:

• The organism(s) that the product may be used to control

• The sites where the product may be used

• The application methods that are required or preferred

• How much of the chemical should be applied and the rate of application

• The application methods that are prohibited

• Maximum application rates per treatment and per year

• Storage and disposal

• Any other requirements as necessary

The directions for use reflect EPA’s determination that the use of the product in such a manner does 

not cause unreasonable adverse effects on the environment or human health under the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA). The general rule to go by on labeling is the 

label on a post-harvest chemical is the law, if the label says you can use it, you can use it.

The directions for use are organized and carefully worded so that they are understood by the person 

expected to use or to supervise the use of the agricultural chemical. The directions for use indicate 

whether any actions mentioned are required, prohibited, encouraged, or discouraged when using the 

product and background information may also be provided.

Charts, tables, and graphics may be seen in many labels’ directions for use and they provide 

accurate information in a clear, concise, and complete manner. 

Post-harvest chemicals may include products used to control fungus or bacteria prior to final 

packaging, cleaning chemicals, water treatment chemicals to prevent cross contamination in wash 

water, bait in pest control devices, lubricants for equipment, etc.

(See Field and Harvest F-2.1)
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Requirement P-2.1.a. Compressed air or other gases that are mechanically introduced 

into food or used in the process to clean food‐contact surfaces or 

equipment must be appropriate for its use.

Procedure Compressed air or other gases that are mechanically introduced into 

food or used in the process to clean food‐contact surfaces or equipment 

must be filtered and oil-free. Compressed air must also be dried and 

filtered to exclude microorganisms and moisture prior to use. These 

processes must be regularly monitored. Compressed air or other gases 

must be adequately stored and handled. 

Verification Auditor reviews records of monitoring and/or maintenance of the 

compressed air or other gases. Auditor observes the use, storage, and/or 

handling of the compressed air or other gases.

Corrective 

Action

Operation develops and maintains compressed air or other gas records 

and associated maintenance records. Retraining is performed.

Documents 

Required

Record.

Mandatory ●

Expectation 

Compressed air or other gases that are mechanically introduced into food or used in the process to 

clean food‐contact surfaces or equipment must be filtered and oil-free. Compressed air must also be 

dried and filtered to exclude microorganisms and moisture prior to use. 

Example Scenario 

Scenario: The operation is using compressed Nitrogen/CO2 mix for their modified atmosphere 

packaging. The gas mixture is food grade appropriate, and the machinery is equipped with filters. 

Assessment: Compliant. 

Reason: The compressed gas is being used in accordance with the label and is filtered.

Requirement P-2.2. If product is intended for export, pre- and post-harvest 

agricultural chemical use shall consider requirements in the intended 

country of destination.

Procedure The operation shall have procedures, such as review of pre-harvest 

intervals and adjustment of post-harvest application rates, sufficient to 

meet the MRL entry requirements of the country(ies) in which the 

product is intended to be traded, if known during post-harvest handling.

Verification Auditor reviews operation’s procedure for complying with agricultural 

chemical restrictions in countries of destination. If destination is 

unknown during post-harvest handling, this item is not applicable.

Corrective 

Action

Operation develops procedures, and diverts non-compliant product to a 

market in which the product meets standards.

Documents 

Required

N/A.

Mandatory
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(See Field and Harvest F-2.2) 

Requirement P-2.3. Agricultural chemicals shall be applied by trained, licensed or 

certified application personnel, as required by prevailing regulation. 

Procedure Operation maintains records demonstrating that all personnel 

responsible for chemical applications are trained and/or licensed, or 

supervised by licensed personnel, in compliance with prevailing 

regulation.

Verification Auditor reviews records demonstrating that application personnel are 

licensed and/or trained in compliance with prevailing regulation.

Corrective 

Action

Operation utilizes application personnel who are appropriately licensed 

and/or trained.

Documents 

Required

Record.

Mandatory

(See Field and Harvest F-2.3) 

P-3 Facility

Requirement P- 3.1. Operation has initially and at least annually thereafter, 

performed and documented a hazard analysis of the packinghouse, and 

addresses all identified hazards.

Procedure Records shall be available to demonstrate that the packinghouse has 

been evaluated with regards to potential food safety hazards associated 

with the packinghouse and the activities taking place within. Workers 

shall be trained on what the food safety hazards are and how to manage 

them.

Verification Auditors verify the operation has performed and documented a hazard 

analysis of the packinghouse Auditor verifies that control measures for 

all significant hazards identified during the analysis are implemented.

Corrective 

Action

The operation shall perform and document a hazard analysis for the 

packinghouse. Training of appropriate personnel may need to take place 

on conducting and recording this assessment. Operation trains workers 

on the maintenance of the food safety hazards identified and how to 

manage and record the management of these hazards.

Documents 

Required

Risk Assessment.

Mandatory ●

Expectation 

A hazard analysis is the process of collecting and evaluating information on hazards and the 

conditions leading to their presence to determine which hazards are significant for food safety and 

therefore should be addressed in a Hazard Analysis and Critical Control Point (HACCP) plan or 

Food Safety Plan. Hazards are any biological, chemical (including radiological), or physical agent 
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that has the potential to cause illness or injury. The hazard analysis must include two elements: (1) 

a hazard identification and (2) a hazard evaluation to determine whether the hazard requires a 

control measure. 

A hazard analysis identifies and evaluates hazards and helps to determine if control measures are 

needed to prevent, eliminate, or further reduce potential contamination. All activities that take 

place in the packinghouse should be assessed such as: receiving and storage of raw material, 

processing, packing, storage, and distribution. Additionally, it is important to identify the various 

equipment and food contact surfaces that are used in the operation when outlining the steps in the 

hazard analysis.

The risk assessment should be reviewed/updated when operational changes occur within the 

packinghouse. The comment should include the date and the role/title of the person who conducted 

the most recent hazard analysis.

Example hazards include:

Biological:

• Bacteria: Listeria monocytogenes, Salmonella, E. coli

• Viruses: Hepatitis A, norovirus

• Parasites: Cryptosporidium, Cyclospora

Chemical:

• Pesticide residues

• Sanitation chemicals

• Lubricants

Physical:

• Glass

• Metal

• Stones

Example Scenarios

Scenario 1: Operation performed and documented a risk assessment of the packinghouse when 

they first began using it 5 years ago. They have not updated the risk assessment since, but they 

state that the risks have not changed.

Assessment: Corrective Action Needed
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Reason: The requirement requires an annual hazard analysis be performed and documented. 

Scenario 2: A risk assessment has been conducted for the packinghouse which was updated two 

months before the time of the audit. During the audit the auditor observes that there is a tomato 

packing line that was not included in the risk assessment. The food safety manager states that they 

just started packing tomatoes on that line two weeks ago. 

Assessment: Corrective Action Needed

Reason: The hazards have not been assessed for that packing line.

Requirement P- 3.1.a. If microbiological hazards requiring a control are identified in 

the hazard analysis of the packinghouse an environmental monitoring 

program shall be established.

Procedure The operation has established an environmental monitoring program 

based on the risks identified in the hazard analysis. The program shall 

address microbiological risks and include procedures for sampling, 

testing and frequency. Acceptable results shall be clearly defined and 

include procedures for when unacceptable results have occurred. 

Records of environmental monitoring sampling, testing and any 

corrective actions shall be kept.

Verification Auditor reviews the environmental monitoring program and records 

and observes current practices for compliance with policy.

Corrective 

Action

Operation develops an environmental monitoring program. Retraining 

is performed and documented. Records of environmental monitoring 

and corrective actions are kept.

Documents 

Required

Written Policy, Record.

Mandatory

Expectation 

If an operation determines that a microbiological hazard requires a control, then a risk-based 

approach must be in place to define the microbiological environmental monitoring program. 

Examples of produce operations where microbiological hazards may be identified in the hazard 

analysis that could potentially require a control are:

• Bagged salad mix or bagged spinach 

• A raw agricultural commodity exposed to the environment after washing before packaging

• Commodities following industry guidelines 

This program must establish, implement and maintain procedures to reduce the risk of crosscontamination. 

The program must identify the target organism, the test method, the frequency of testing, the areas 

to be tested, the acceptance criteria and actions to be taken in the event samples exceed acceptance 
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criteria. The target organism could be the environmental pathogen of concern or an appropriate 

indicator organism.

Environmental pathogens are those pathogens capable of surviving and persisting within the 

manufacturing processing, packing, or holding environment such that food may be contaminated if 

not properly controlled. Those pathogens of concern in the produce industry are often Salmonella

in dry environments and Listeria monocytogenes in wet environments. Pathogenic E. coli is not 

considered an environmental pathogen that would be monitored in an environmental monitoring 

program. 

The environmental monitoring program parameters should be established based on risk. Factors to 

consider when setting the parameters include whether the product receives a reduction step, what 

points along production where the product has exposure to the environment after the reduction step 

and before packaging, whether the product is handled in a wet, verses a dry environment, whether 

the product supports growth of the environmental pathogen, and the shelf life of the product and 

storage conditions. International Fresh has published Listeria guidance for industry with 

information on how to develop an environmental monitoring program for produce operations. 

The Food Safety Preventive Controls Alliance (FSPCA) provides teaching examples of food safety 

plans and hazard analysis performed for a blueberry packing operation, a whole tomato packing 

operation and a fresh cut leafy greens salad operation. These teaching examples demonstrate when 

an environmental monitoring program is appropriate as determined by the hazard analysis and 

provides example environmental monitoring programs. 

Example Scenarios: 

Scenario 1: A strawberry operation which field packs strawberries into clamshells, cools and 

stores the product on site. Their hazard analysis determined that they do not need a microbial 

environmental monitoring program. The operation concluded that any microbial exposure in the 

facility would be controlled through their cleaning SOP’s. 

Assessment: Compliant 

Reason: Operation’s that handle only pre-packaged produce, i.e., produce not exposed to the 

environment are reasonably unlikely to be vulnerable to microbial contamination in the facility. 

Scenario 2: An apple operation’s environmental monitoring program establishes that drains shall 

be swabbed for Listeria spp. quarterly, however the program does not define the acceptable results. 

Auditor reviews most recent swab results and all are negative for Listeria spp. 

Assessment: Corrective Action Needed

Reason: The environmental monitoring program shall establish acceptable results and corrective 

action steps to be taken when results are out of compliance. Routine sampling may be performed 

weekly, monthly or quarterly depending on the amount of product produced, risk and facility 

history. There is no “right” answer as to frequency and number of swabs. It is up to the operation to 

make that determination. However, the operation must comply with their own policy. 
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Requirement P-3.2. Building shall be located, designed, constructed and maintained in 

a manner that prevents contamination of produce during handling, 

storage, and cooling.

Procedure Product flow is designed to minimize risk of cross-contamination. 

Building and equipment structures and surfaces (floors, walls, ceilings, 

doors, frames, hatches, etc.) shall be constructed in a manner that 

facilitates cleaning and sanitation and does not serve as harborage for 

contaminates or pests. Drop ceilings shall enable cleaning and 

monitoring for pest activity. Chill and cold storage loading dock areas 

shall be appropriately sealed, drained and graded, as appropriate for 

the operation. Fixtures, ducts, pipes and overhead structures shall be 

installed and maintained so that drips and condensation do not 

contaminate produce, raw materials or food contact surfaces. Drip pans 

and drains shall be designed to assure condensate does not become a 

source of contamination. Water from refrigeration drip pans shall be 

drained and disposed of away from product and product contact 

surfaces. Floors are designed to minimize and/or facilitate the removal 

of standing water. Air intakes shall not be located near potential sources 

of contamination.

Verification Auditor observes building and equipment for evidence that the building

can be cleaned and maintained to prevent product contamination.

Corrective 

Action

Building deficiencies are corrected. Affected product is evaluated for 

potential contamination and disposition.

Documents 

Required

N/A.

Mandatory

PSR 112.126

Expectation 

Consideration should be given to 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 to determine if the size and construction of the 

building is adequate. For a building to be suitable in size, it should have enough space for the 

operation’s activities to be conducted without contact between produce or food contact surfaces and 

building materials, non-food contact surfaces, or clothing. The placement of equipment should be 

such that personnel can easily perform inspections, maintenance, and cleaning and sanitizing 

activities.

Consideration should be given to the flow of the product throughout the operation to minimize the 

potential for cross contamination. For example, the areas where final product is packaged for 

distribution is not immediately adjacent to areas where incoming field product is being washed, thus 

minimizing the potential for wash water to splash up and contact the finished product. 
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Produce and food contact surfaces must be protected from dripping condensate using practices such 

as: routing condensate to drains, drip pans, or areas away from 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 produce and food contact surfaces to protect them from 

condensate; or controlling the humidity in the building (e.g., through ventilation) to minimize the 

formation of condensate. The operation should limit the amount of standing water that pools on the 

floor for long periods of time. This water could harbor pathogens such as Listeria monocytogenes, 

which thrives in wet, cool environments.

It is the auditees responsibility to ensure that buildings are designed, constructed, and maintained 

properly to facilitate cleaning and sanitation and does not serve as a harborage for contaminates or 

pests and prevents a food safety risks to products during handling.

Example Scenarios

Scenario 1: The packinghouse has three finished walls and bird netting on the fourth.

Assessment: Compliant.

Reason: The structure is built to facilitate cleaning and sanitation and does not serve as harborage 

for contaminants or pests during staging and cooling.

Scenario 2: You observe the condensate drain from the refrigeration unit inside the cold room is 

piped into a floor drain.

Assessment: Compliant.

Reason: The facility is designed in a manner that prevents product contamination.

Produce Safety Rule

112.26: (a) All buildings must meet the following requirements (1) buildings must be suitable in 

size, construction, and design to facilitate maintenance and sanitary operations for growing, 

harvesting, packing and holding activities to reduce the potential for contamination of produce or 

food contact surfaces with known or reasonably foreseeable hazards. Buildings must provide 

sufficient space for placement of equipment and storage of materials and permit proper precautions 

to be taken to reduce the potential for contamination of produce, food contact surfaces, or packing 

materials with known or reasonably foreseeable hazards. The potential for contamination must be 

reduced by effective design including the separation of operations in which contamination is likely 

to occur, by one or more of the following means: Location, time, partition, enclosed systems or 

other effective means. (2) There must be adequate drainage in all areas where normal operations 

release or discharge water or other liquid waste on the ground or floor of the building. (b) Measures 

to prevent contamination of produce and food contact surfaces in the buildings must be 

implemented, as appropriate, considering the potential for such contamination through: Floors, 

walls, ceilings, fixtures, ducts or pipes: and drip or condensate.
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Requirement P-3.3. Adequate lighting shall be provided in all areas.

Procedure Lighting in all areas shall be sufficient to enable cleaning, sanitation, 

repairs, etc.

Verification Auditor observes, directly or by other evidence, that sufficient lighting is 

provided to the worker to clearly see the task being performed.

Corrective 

Action

Operation installs adequate, lighting.

Documents 

Required

N/A.

Mandatory

Example Scenarios 

Scenario 1: Covered lights are available on the perimeter of open-air facility (i.e., roof but no 

walls) but not directly over product lines. Owner states that facility only runs during daylight hours. 

Assessment: Compliant. 

Reason: As long as interviews substantiate daylight only for running and maintenance and 

cleaning activities.

Scenario 2: Lights are located appropriately to enable cleaning, sanitation, repairs, etc. and are not 

directly over food handling areas. Light fixtures are not covered nor are shatterproof bulbs being 

utilized.

Assessment: Compliant for P-3.3 however corrective action needed for P-3.4. 

Reason: The lighting is adequate. The material the lighting is made out of is potentially hazardous 

which does not comply with the requirement of P-3.4. 

Requirement P-3.4. Only essential glass and brittle plastic shall be present in the 

building.

Procedure Light bulbs, fixtures, windows, mirrors, skylights and other glass and 

brittle plastic in the building or in the product path entering or exiting 

the building shall be of the safety type, or shall be otherwise protected to 

prevent breakage. If glass or brittle plastic must be used, there shall be 

a written glass and brittle plastic control policy, including a glass and 

brittle plastic register.

Verification Auditor observes glass and brittle plastic use in building, and glass and 

brittle plastic control policy and glass and brittle plastic register for 

compliance.

Corrective 

Action

Operation develops a glass and brittle plastic control policy or 

eliminates all glass and brittle plastic in the building.

Documents 

Required

Record.

Mandatory

Expectation 

This question pertains to glass light bulbs and any other glass products that may be located above 

the product flow zone. Overhead lighting, regardless of height above the product, that may be 
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susceptible to breakage should be protected from falling onto conveyor lines or into product 

containers such as bins or final packages. Other glass items, either in whole or broken form, must 

be contained or prevented from falling into product.

In the case of lighting equipment (fluorescent, incandescent, krypton vapor, etc.), there are many 

commercially available products and lighting equipment/types that may be used. In some cases, 

lighting fixtures may cover or enclose the bulb; in other cases, the bulbs may be coated with some 

medium that retards breakage and shattering; in other cases, shields to cover the fixture are 

available. Operators must take preventive measures to effectively prevent glass, broken or whole, 

from falling into the flow of product. Observe the lighting or other glass being used in the 

operation and determine whether it is possible that falling pieces may contaminate the produce. 

This question can only be answered N/A when there is no glass over any of the product flow zones. 

Example Scenarios 

Scenario 1: Lights in the storage building are unshielded glass. Products being stored below the 

lights are sealed and palletized with plastic wrapping. 

Assessment: Corrective Action Needed. 

Reason: The standard requires glass to be of the safety type or must be otherwise protected to 

prevent breakage. 

Scenario 2: Lights on the forklift that is used in the storage area are unshielded glass. Product in 

this area is in exposed open top boxes. 

Assessment: Corrective Action Needed. 

Reason: The standard requires glass to be of a safety type or otherwise protected. This assessment 

could be an Immediate Action Required if there is a reasonable probability that the glass could 

break into the boxes. 

Requirement P-3.5. Catwalks above product zones are protected to prevent produce 

or packaging contamination.

Procedure Where workers walk over product contact surfaces, those walkways are 

solid surface or have catch trays installed, are protected by kick plates, 

product covers or other barriers.

Verification Auditor observes catwalks over product zones for evidence of protective 

measures.

Corrective 

Action

Operation retrofits catwalks or product zones to protect against 

potential contamination. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

N/A.

Mandatory

Example Scenarios 

Scenario 1: An equipment-access catwalk above a product conveyor is made of steel grid material 

without kick plates. You observe that personnel access to the catwalk is controlled and infrequent 

during product handling. There is signage at both entry points that instruct personnel to change into 
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designated footwear that is only worn in the catwalk area. You observe the footwear and its use by 

employees, including properly maintained footbaths at both entries to catwalk, is compliant with the 

operation’s policy.

Assessment: Immediate Action Required.

Reason: Designated footwear is not a sufficient protection against materials falling onto the 

conveyor, and sanitizer from the footbath and footwear is reasonably likely to drip onto the 

conveyor. 

Scenario 2: Same as Scenario 1, but catch pan is installed underneath catwalk. You observe the 

catch pan extends the entire length of the catwalk, is wider than the catwalk, and is clean and 

contains no debris.

Assessment: Compliant. 

Reason: The catch pan provides protection to the product from the catwalk. 

Requirement P-3.6. If applicable, operation has a written Allergen Control Program.

Procedure The Allergen Control Program lists the allergens in use or storage at the 

operation specific to country regulations. If applicable, procedures 

address identification and segregation of allergens during storage and 

handling as based on a risk assessment conducted by the operation.

Verification Auditor reviews Allergen Control Program and inspects operation for 

evidence of allergen use and storage.

Corrective 

Action

Operation develops and implements an Allergen Control Program or 

eliminates allergens from the operation.

Documents 

Required

Risk Assessment, Written Policy.

Mandatory ●

Expectation 

FDA has identified nine major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, 

soybean and sesame.

If applicable, the comment should include that the auditor verified there are no allergens present.

See the FDA allergen guidance document for more information on allergen regulations.

Example Scenarios 

Scenario 1: The operation has no allergen control program and there is no evidence that they 

handle allergens. 

Assessment: Not Applicable. 

Reason: If the operation states that no allergens are handled and you observe this to be correct this 

requirement is Not Applicable.

Scenario 2: The operation has no allergen control program and the only allergens on property are 

peanuts in the break room vending machine.

Assessment: Compliant. 
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Reason: Allergens in the break room are not reasonably likely to enter the production area if break 

area and handwashing policies are followed. 

Scenario 3: The operation has no allergen control program, and they handle celery. Celery seed is 

considered an allergen in Australia. 

Assessment: Immediate Action Required or Not Applicable. 

Reason: Immediate Action Required if product from the operation is destined for the European 

Union or other country that considers celery an allergen. Not Applicable if destined for a country 

that does not consider celery an allergen. 

Scenario 4: The operation has no allergen control program, and the operation is co-packing fruit 

baskets with walnuts that they receive pre-sealed in plastic packets. They do not handle exposed 

walnuts. 

Assessment: Corrective Action Needed. 

Reason: The operation needs an Allergen Control Program in case of accidental exposure.

P-4 Pest and Animal Control

Requirement P-4.1. Operation has procedures to manage pests to the extent 

appropriate to the operation.

Procedure Operation has a written pest control program, performed by a trained 

pest control operator (or licensed where required by prevailing 

regulation). The written program includes policies and procedures 

applicable to that operation, such as storage of outside equipment or 

other factors dealing with pest harborages, and maps of the location of 

pest traps outside and inside the operation. Operation maintains a pestcontrol log that includes dates of inspection, inspection reports and steps 

taken to eliminate any problems. Applications of pesticides (e.g., 

insecticides, rodenticides) shall be performed in compliance with local, 

state, and federal pesticide regulations.

Verification Auditor reviews pest control program, pest control operator’s 

credentials, and inspects operation for pest activity.

Corrective 

Action

Operation develops, documents and implements an effective pest control 

program.

Documents 

Required

Written Policy.

Mandatory ●

PSR 112.128

Expectation 

All packing and storage facilities should establish a pest control program to reduce the risk of 

contamination by rodents and other animals, including pets. This program should include regular 

and frequent monitoring of affected and treated areas to accurately assess the program’s 

effectiveness. A pest control log must be maintained that includes inspection dates, inspection 

reports, and procedures implemented to eliminate any problems.
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Generally, all traps and bait stations will be marked and flagged by numbers or some type of coding 

system. It is likely that there will also be a map of the premises that shows the location of such bait 

stations and traps. All bait stations containing poison attractants must be located outside the 

facility. Traps or other non-poison methods should be the only control program located within a 

structure. 

Be aware of and look for an organized method of pest detection and elimination. The comment 

should identify who manages the pest/animal control program.

Example Scenarios

Scenario 1: The operation has contracted with a pest control firm but doesn’t have a written plan 

available.

Assessment: Corrective Action Needed.

Reason: A written plan is required.

Scenario 2: The operation has a written pest management plan with contract requiring the pest 

control company to maintain logs detailing dates and observations during inspections. The logs are 

not maintained onsite.

Assessment: Compliant if logs are available during the audit.

Reason: The operation has written the contract into their pest management plan and logs are 

accessible even though they are maintained off-site.

Scenario 3: During the audit, the auditor observes two rodent traps in the finished product storage 

area with decaying rodents.

Assessment: Corrective Action Needed or Immediate Action Required.

Reason: The decaying rodents indicate that the maintenance of the pest management program is 

not conducted at a frequent enough basis. If an imminent food safety risk is present to the produce 

this would be considered an Immediate Action Required.

Produce Safety Rule

112.128: The operation must take those measures reasonably necessary to protect produce, food 

contact surfaces and food-packing materials from contamination by pests in buildings, including 

routine monitoring for pests as necessary and appropriate. For fully-enclosed buildings, measures 

must be taken to exclude pests from the buildings. For partially-enclosed buildings measures must 

be taken to prevent pests from becoming established in the buildings (such as by use of screens or 

by monitoring for the presence of pest and removing them when present).
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Requirement P-4.2. Operation restricts animals from food handling areas.

Procedure Domesticated animals are prohibited from packhouse, cooling, and 

storage facilities unless procedures are in place for their safe presence. 

Procedures are in place to exclude wild and feral animals to the degree 

practical and to monitor for and mitigate contamination from animal 

excreta.

Verification Auditor looks for evidence of animals or animal activity.

Corrective 

Action

Operation develops, documents and implements an effective animal 

control program.

Documents 

Required

N/A.

Mandatory ●

PSR 112.127; 112.134

Expectation 

The facility should consider the use of screens, wind curtains, bird deterrent tape and traps to 

minimize risk of product contamination. Pet dogs, cats, or other animals should not be allowed in 

the packing and storage facilities. Review the facility’s SOPs to determine if there is a proactive 

effort to exclude animals and pests from the facility. When guide dogs or similar animals are 

present, SOPs must include corrective measures.

Example Scenarios 

Scenario 1: An operation has security dogs within a constrained area outside the building adjacent 

to the perimeter of the property.

Assessment: Compliant. 

Reason: Working animals are maintained in a manner as to minimalize risk to the product.

Scenario 2: During the audit, you observe evidence indicating the presence of multiple bird nesting 

sites in the rafters, over the product handling and packing area. 

Assessment: Immediate Action Required.

Reason: The active presence of the birds must be removed, and a plan established to prevent the 

reoccurrence of the nesting sites.

Scenario 3: The packinghouse is an open structure (three walls and a roof) with no barriers to 

animal entry. Produce, trash, and other animal attractants are only present during work hours 

(removed nightly). Employees are trained to chase away any animals trying to enter the structure 

during work hours, and product contact surfaces are cleaned and sanitized before starting work. 

Employees are also trained to ensure pests do not become established in the structure.

Assessment: Compliant. 

Reason: The operation has policies and procedures to restrict animals from the food handling area 

and prevent pests from becoming established in the structure. 

Produce Safety Rule 

112.127: Operations must take reasonable precautions to prevent contamination of produce, food 
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contact surfaces, and food-packing materials in fully-enclosed buildings with known or reasonably 

foreseeable hazards from domesticated animals by: (1) excluding domesticated animals from fullyenclosed buildings where produce, food contact surfaces, or food-packing material is exposed; or

(2) separating domesticated animals in a fully enclosed building from an area where growing, 

harvesting, packing or a holding activity is conducted on produce by location, time, or partition. (b)

Guard or guide dogs may be allowed in some areas of a fully enclosed building if the presence of 

the dogs is unlikely to result in contamination of produce, food contact surfaces, or food-packing 

materials. 

112.134: If the operation has domesticated animals, there must be a system maintained to control 

animal excreta and litter in a way to prevent contamination of produce, food contact surfaces, areas 

used for growing, harvesting, packing and holding, agricultural water sources, or agricultural water 

distribution systems.

Requirement P-4.3. If used, pest control devices, including rodent traps and electrical 

flying insect devices, are located so as to not contaminate produce or 

food handling surfaces.

Procedure Only non-toxic traps and pest control devices are used inside the 

packing house or storage building.

Verification Auditor reviews pest control program and placement of pest control 

devices.

Corrective 

Action

Operation removes or repositions pest control devices to be compliant.

Documents 

Required

N/A.

Mandatory

Expectation 

Pest control devices, including 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, may 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. Operations using pesticides and pesticide devices 

must follow all applicable Federal, state, and local laws.

Example Scenarios 

Scenario 1: Electrified insect traps are located adjacent to the raw product handling and packing 

areas and multiple fragments of insects appear to be scattered throughout the general area.

Assessment: Corrective Action Needed or possible Immediate Action Required.

Reason: IAR if auditor observes insect fragments on product or food contact surfaces. Otherwise 

CAN; traps must be relocated so as to pose no threat of contamination of the product or food 

handling surfaces.

Scenario 2: The operation uses bait stations inside the open shipping area. The operation’s food 

safety manager explains that no exposed product is stored or handled in the area; all product is 
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palletized by the time it reaches shipping.

Assessment: Corrective Action Needed. 

Reason: Bait stations must not be used in produce handling areas, packaged or not. 

P-5 Equipment, Tools and Utensils 

Requirement P-5.1. All food contact equipment, tools and utensils are designed and 

made of materials that are easily cleaned and maintained.

Procedure The operation shall develop, implement, and schedule repair, cleaning, 

sanitizing, storage and handling procedures of all food contact surfaces 

to reduce and control the potential for contamination. These procedures 

shall be documented. Product contact tools, utensils and equipment 

shall be made of materials that can be cleaned and sanitized. Seams 

between food contact surfaces are smooth and cleanable.

Verification Auditor observes food contact surfaces for design and materials that can 

be easily cleaned and maintained. Auditor reviews cleaning, sanitizing, 

storage and handling procedures.

Corrective 

Action

Operation develops and implements procedures. Operation replaces all 

non-compliant food contact equipment, tools and utensils.

Documents 

Required

Written Policy.

Mandatory ●

PSR 112.123

Expectation 

Food contact tools, equipment and utensils must be of adequate design, construction, and 

workmanship to enable them to be adequately cleaned and properly maintained. Seams on foodcontact surfaces of equipment and tools 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. They must be stored and maintained to protect from 

contamination, including preventing the equipment and tools from attracting and harboring pests.

Example Scenarios 

Scenario 1: You observe post-harvest tools and utensils around the post-harvest work area during 

lunch time on a day when there is no harvest activity.

Assessment: Compliant. 

Reason: As long as the observed storage of tools and utensils is permitted by the operation’s 

storage and handling procedures and the auditor does not observe a reasonable potential for 

contamination. 

Scenario 2: Product contact tools and utensils appear to be suitable, clean, sanitary, and stored 

appropriately, but there are no written procedures. 

Assessment: Corrective Action Needed. 

Reason: The standard requires procedures to be written. 
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Scenario 3: You observe a trim knife in use has been repaired with a weld that is 

corroding/cracking. 

Assessment: Corrective Action Needed. 

Reason: The condition of the food-contact knife is a risk of pathogen harborage or metal 

contamination. This assessment could be an Immediate Action Required if the auditor observes that 

the condition of the knife is severe enough to pose an immediate food safety risk. 

Produce Safety Rule 

112.123: The operation must use equipment and tools that are of adequate design, construction, and 

workmanship to enable them to be adequately cleaned and properly maintained; and (b) Equipment 

and tools must be: (1) Installed and maintained as to facilitate cleaning of the equipment and of all 

adjacent spaces; and (2) 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 and harboring pests. (c) Seams on food contact surfaces of equipment and tools that are 

used 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. (d)(1) The operation must inspect, maintain, and clean and, when necessary and 

appropriate, sanitize all food contact surfaces of equipment and tools used in growing, harvesting, 

packing and holding activities as frequently as reasonably necessary to protect against 

contamination of produce. (2) The operation must maintain and clean all non-food-contact surfaces 

of equipment and tools subject to this subpart used during harvesting, packing, and holding as 

frequently as reasonably necessary to protect against contamination of produce. (e) If using 

equipment such as pallets, forklifts, tractors, and vehicles such that they are intended to, or likely to, 

contact produce, you must do so in a manner that minimizes the potential for contamination of 

produce or food contact surfaces with known or reasonably foreseeable hazards. 

Requirement P-5.2. Equipment is installed in a way that provides access for cleaning.

Procedure Cooling, packing and other food contact equipment is installed away 

from walls and otherwise positioned so as not to inhibit access for 

proper cleaning.

Verification Auditor observes positioning of all food contact equipment for 

compliance.

Corrective 

Action

Operation relocates the equipment to be compliant.

Documents 

Required

N/A.

Mandatory

PSR 112.123(b)(1)

Expectation 

Equipment must be installed to facilitate cleaning of the equipment and of all adjacent spaces. 

Maintenance and cleaning personnel should have easy access to all food contact surfaces, protective 

coverings or barriers, equipment framework, any movable parts, and other relevant parts.

Maintenance and cleaning personnel should also have access to adjacent spaces, such as the floors, 
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walls, ceilings, and other equipment and tools in the immediate vicinity. Observe the installation of 

equipment and visually assess the operation’s activities to confirm practices. 

Consider the potential for installed equipment to accumulate moisture, organic material, or other 

potential sources of contamination that could contact, drip or drain onto covered produce or food 

contact surfaces. 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. 

Example Scenarios 

Scenario 1: You observe that there is walk around space on all sides of food contact equipment but 

are not able to observe washing procedures to verify how washing equipment accesses equipment. 

You observe the equipment is clean.

Assessment: Compliant. 

Reason: The equipment is installed in a way that provides access for cleaning and you did not 

observe deficiencies in cleaning.

Scenario 2: A produce flume, 4 foot wide, is installed with 2 inches clearance from the concrete 

floor. The operation uses a high-pressure hose to clean under the flume.

Assessment: Corrective Action Needed. 

Reason: The flume has not been installed to provide access for proper cleaning. 

Produce Safety Rule 

112.123: The operation must use equipment and tools that are of adequate design, construction, and 

workmanship to enable them to be adequately cleaned and properly maintained; and (b) Equipment 

and tools must be: (1) Installed and maintained as to facilitate cleaning of the equipment and of all 

adjacent spaces.

Requirement P-5.3. Equipment lubrication is managed so as not to contaminate food 

products.

Procedure Only food-grade lubricants are used on food processing and packaging 

equipment or on any other equipment where incidental food contact 

may occur, unless the equipment manufacturer specifies only a non-food 

grade lubricant. Lubricant leaks are fixed or catch pans are installed to 

prevent product contamination.

Verification Auditor reviews purchase or maintenance records to verify all 

lubricants used are food grade. Auditor observes lubrication points to 

verify leaks are controlled.

Corrective 

Action

Operation replaces non-food grade lubricants. Operation fixes lubricant 

leaks or installs catch pans. Retraining is performed and documented. 

Affected product is evaluated for potential contamination and 

disposition.

Documents 

Required

N/A.

Mandatory
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Expectation 

Auditors will consider if the operation uses a closed system. A closed system is a physical system 

that does not interact with other systems, it prevents contamination and spillage. In many 

operations auditors will observe various types of open mechanical systems, such as chains moving 

conveyor belts. It is important that auditors verify that food grade lubricant is used in open systems 

to reduce possible contamination. Catch or drip pans are often used in systems where lubricant 

could possibly leak or drip. Observe that catch or drip pans are properly maintained and placed so 

that they are not overflowing and are located to catch any leaking lubricant.

Example Scenario 

Scenario: Leaking lubrication is noticed on the drive motor fitting for conveyor B. There is no 

catch pan in place under the drive motor, which is located over conveyor C, which contains exposed 

product. There are streaks on Conveyor C, demonstrating that lubricant has dripped onto the 

conveyor. The supervisor explains that it is food grade lubricant. 

Assessment: Immediate Action Required.

Reason: Contamination with food grade lubricant is still adulteration.

Requirement P-5.4. All instruments used to measure temperature, pH, antimicrobial 

levels and/or other important devices used to monitor requirements in 

this section shall be adequately maintained and calibrated at a 

frequency sufficient to assure continuous accuracy.

Procedure Records shall be kept. If an ORP system is used, an independent 

measurement shall be used to verify compliance. Test methods or test 

strips used to monitor requirements shall be appropriate to their use, 

sufficiently sensitive to their intended purpose and available in adequate 

numbers for their designated use.

Verification Auditor reviews calibration and verification procedures and records.

Corrective 

Action

Operation develops, documents and implements calibration and 

verification procedures and records.

Documents 

Required

Record.

Mandatory ●

PSR 112.124

Expectation 

Calibration is essential when using various equipment within the Food Safety Plan. Companies 

must calibrate when necessary or by defined date as may be required by the manufacture. 

Employees must be properly trained in how to calibrate their specific equipment. Training may 

consist of documentation provided by the manufacture or participation in classroom environment. 

The auditor will include the instruments/equipment being calibrated, the method of calibration and 

the frequency of calibration in the comments. 

Example Scenarios 
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Scenario 1: The operation calibrates ORP and pH meters daily before initial production using 

manufacturer’s recommended procedures. Chlorine levels are verified using free chlorine test strips 

of appropriate sensitivity and precision, and within manufacturer’s expiration date. Records are 

kept. 

Assessment: Compliant. 

Reason: The operation calibrates the ORP and pH meters and records are kept of calibration 

activities.

Scenario 2: The operation has switched to chlorine dioxide but continues to use ORP controller 

and chlorine test strips. 

Assessment: Immediate Action Required.

Reason: Unless operation has demonstrated that the ORP controller and chlorine test strips are 

appropriate for monitoring chlorine dioxide.

Scenario 3: Wash water temperature is monitored with an in-line coil thermometer. Temperature 

is recorded daily. There are no calibration records.

Assessment: Corrective Action Needed. 

Reason: Coil thermometers are notorious for losing calibration, and the standard requires 

calibration records to be kept.

Produce Safety Rule 

112.124: Instruments or controls used 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.

Requirement P-5.4.a. Calibration of equipment is traceable to a recognized standard.

Procedure Calibration of measuring and monitoring equipment (thermometers, pH 

meters, scales, chemical application or monitoring devices) is performed 

using a recognized standard or method.

Verification Auditor reviews the calibration procedures to determine if they follow a 

recognized standard or method.

Corrective 

Action

Operation develops calibration procedures which are traceable to a 

recognized standard or method.

Documents 

Required

Written Policy.

Mandatory

Expectation 

(See F-8.2.b) 
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Requirement P-5.5. Foreign material control devices are inspected and maintained.

Procedure If included in the Food Safety Plan, foreign material control devices 

shall be included as part of a Preventive Maintenance Schedule or other 

program and maintained to ensure effective operation. Calibration 

checks shall be performed according to written procedure or 

manufacturer’s recommendations.

Verification Auditor inspects any foreign control devices and maintenance and 

calibration check records for compliance.

Corrective 

Action

Operation develops written procedures for inspection, calibration checks 

and maintenance of foreign material control devices. Retraining is 

performed and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

Record.

Mandatory

Expectation 

A HACCP plan is the foundation of effective foreign material control as it identifies the raw 

materials and process steps where contamination is likely to occur. Using the HACCP risk 

assessment, as well as industry standards, guidelines, regulations, and scientific studies, the facility 

can identify the steps in the process where foreign material control is needed. At the manufacturing 

level, devices commonly used to control foreign material include metal detection, X-ray, optical 

sorting equipment, mechanical sorting equipment (sieves, screens, filters, and magnets), bone 

separators, and visual inspection. Farm processing may include de-stoners, gravity tables, air 

separation, and visual inspection. This list is not exhaustive, and the devices needed in each facility 

will depend on the product being made and the manufacturing process.

Once an operation has identified the required devices, a strong program to control foreign material 

is necessary. Components of this program include standard operating procedures for activities, 

corrective action procedures for any deviations that occur, and employee training. Also essential 

for critical control points is the validation of the system.

If metal detection equipment is used, the auditor will include the frequency the equipment is being 

checked in the comments.

Example Scenarios 

Scenario 1: The metal detector is calibrated by a contract service provider annually. The operation 

checks detection sensitivity and kick-out daily with wand provided by the contractor. Records are 

kept. The production records indicate no metal has ever been detected in product.

Assessment: Compliant. 

Reason: The detection checks are at a frequency required in the Food Safety Plan and by 

manufacturer recommendations.
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Scenario 2: A lemon packing operation has no metal detector on-line or in the Food Safety Plan. 

The operation says washing, roller gaps and visual sorting make foreign material control 

unnecessary.

Assessment: Not Applicable, if accurate.

Reason: The standard does not require foreign material control devices.

Scenario 3: Same as Scenario 2 except the Food Safety Plan says that metal control is unnecessary 

because of washing and sorting, but they have a metal detector on the packing line “because 

customers require it.” The detector is not working. 

Assessment: Not Applicable. 

Reason: The Food Safety Plan does not require a metal detector. Not Applicable, unless auditor 

observes reasons why there is metal contamination risk.

Requirement P- 5.5.a. Metal detection equipment, if utilized shall be checked at a 

scheduled frequency as outlined in the operation’s food safety/HACCP 

plan using iron, non-iron and stainless steel testing wands.

Procedure These systems should be frequently checked to ensure that they are 

working correctly (recorded). Foreign material issues should be noted 

and corrective actions implemented as written in the food safety 

program.

Verification Auditors shall review equipment records to ensure frequency is 

according to established food safety plan.

Corrective 

Action

Procedure is developed and implemented at an established frequency. 

Training is implemented.

Documents 

Required

Record.

Mandatory

Example Scenario 

Scenario: The food safety manual states that the metal detector will be verified with Safe line 2.5 

mm Fe, 2.0 mm non-ferrous, and 3.0 mm 316 Stainless wands on an hourly basis. You observe the 

metal detector check log and notice that calibrations are recorded every two hours. 

Assessment: Corrective Action Needed

Reason: The operation is not in compliance with their own policy. 

P-6 Maintenance and Sanitation 
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Requirement P-6.1. A Preventive Maintenance and/or Master Cleaning Schedule, with 

related SOPs, shall be established.

Procedure There is a written cleaning and sanitation schedule for all food and nonfood contact surfaces including floors, drains, walls, ceilings and other 

surfaces that may pose a source of product contamination. Roof leaks 

shall be promptly identified, controlled and repaired. Operation has 

procedures for cleaning and sanitation of cooling equipment. Drip pans 

and drains shall be maintained to assure condensate does not become a 

source of contamination. If standing water exists, it is removed from 

floors and floors cleaned in a manner and at a frequency sufficient to 

prevent creation of a source of contamination.

Verification Auditor reviews Preventive Maintenance and/or Master Cleaning 

Schedule, observes building and equipment for evidence that the 

building is cleaned and maintained to prevent product contamination. 

Auditor reviews building maintenance records for evidence of repairs.

Corrective 

Action

Operation develops a Preventive Maintenance and/or Master Cleaning 

Schedule, with related SOPs. Building deficiencies are corrected. 

Retraining is performed and documented. Affected product is evaluated 

for potential contamination and disposition.

Documents 

Required

Written Policy, Record.

Mandatory ●

Expectation 

Buildings, fixtures, and other physical facilities of the plant must be monitored and maintained in a 

clean and sanitary condition and must be kept in repair to prevent food from becoming adulterated. 

All areas of the operation should be considered in the Preventive Maintenance and Master Cleaning 

schedules. 

For the Master Cleaning schedule, the operation must identify the cleaning and/or sanitation for the 

facility, including the food handling areas and equipment, specify how often the tasks are 

conducted, responsibilities for the tasks, and how completion of the tasks is documented. 

A Preventive Maintenance (PM) program will include the regular and routine maintenance of 

equipment and other facility infrastructure in order to keep them in suitable condition for 

production. The timing of tasks would be based on the equipment manufacturer’s 

recommendations. The program requires planning and scheduling maintenance of equipment 

before a problem occurs. Examples of items that would be included in the preventive maintenance 

program would be the replacement of filters or screens, changing oil or applying lubrication, and 

the inspection and replacement of production line rollers. 

Operations should regularly inspect and maintain equipment to avoid conditions that can support 

microbial growth. Examples of harborage areas are cracked hoses, torn rubber door seals, standing 

water, dirty conveyor belts, brushes and rusty equipment. Condensation in packing, cooling and 
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storage areas should be eliminated or minimized. Equipment associated with food contact surfaces 

must be cleaned, sanitized, and inspected after maintenance repairs. When construction, 

dismantling, or re-positioning of equipment is done as part of maintenance activities, control 

measures are in place to minimize food safety risks. Verify through interviewing and/or reviewing 

a written policy that these procedures are implemented. Review records for compliance with 

procedures for maintenance, cleaning and sanitation. 

All post-harvest water needs to meet the microbial standards for drinking water. For the purposes 

of USDA GAP audits, this is considered to be no detectable generic E. coli. This would include 

water used to create steam for cleaning.

Example Scenarios 

Scenario 1: There are noticeable water stains on the ceiling over product contact surfaces but no 

standing water on the floor. There is a record of maintenance correcting the source of the water 

stains.

Assessment: Compliant. 

Reason: The problem was documented and has been corrected.

Scenario 2: The operation’s master cleaning schedule indicates that walls, drains and ceilings are 

cleaned once a year. Records are available demonstrating compliance. Annual cleaning is deemed 

to be sufficient to prevent product contamination. 

Assessment: Compliant. 

Reason: Cleaning records are maintained.

Scenario 3: SOPs are written for cleaning and sanitizing equipment and are located in the office 4 

miles away. Your observations and interviews demonstrate operation’s compliance with written 

procedures. 

Assessment: Compliant. 

Reason: SOPs are in place and appropriate for the operation.

Requirement P-6.1.a. Routine housekeeping practices must be implemented. 

Procedure Routine housekeeping practices must be implemented. These could 

include sweeping, mopping, emptying trash and cull piles, cleaning up 

spills, and keeping storage areas neat and tidy.

Verification Auditor verifies operation for evidence of routine housekeeping.

Corrective 

Action

Operation implements routine housekeeping.

Documents 

Required

N/A.

Mandatory

Expectation 

Maintenance and sanitation are key to preventing unintentional cross contamination to the product. 

Basic, routine housekeeping practices are the foundation to an effective sanitation program. Such 

practices could include sweeping, mopping, emptying trash and cull piles, cleaning up spills, and 
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keeping storage areas neat and tidy. Once basic housekeeping practices are in place, a preventive 

maintenance and master cleaning program can be established.

Requirement P-6.1.b. Maintenance activities shall not introduce food safety risks. 

Procedure Procedures for maintenance activities are compliant with all food safety 

requirements and do not create potential sources of chemical, 

microbiological, or physical contamination.

Verification Auditor verifies maintenance activities do not introduce food safety 

risks.

Corrective 

Action

Operation implements maintenance activities in a manner that will not 

introduce a food safety risk.

Documents 

Required

N/A.

Mandatory

Expectation 

Equipment associated with food contact surfaces must be cleaned, sanitized, and inspected after 

maintenance activities and repairs. When construction, dismantling, or re-positioning of equipment 

is done as part of maintenance activities, control measures are in place to minimize food safety 

risks. 

Example Scenario 

Scenario: The auditor observes maintenance being performed on one of the packing lines. There 

was no opportunity to observe if cleaning and sanitation was performed afterwards. Cleaning and 

sanitation records do not indicate cleaning after maintenance is performed. 

Assessment: Corrective Action Needed. 

Reason: Equipment must be cleaned and sanitized after maintenance activities.

Requirement P-6.2. Any temporary repairs on food contact surfaces are constructed 

of food grade material. Operation has a procedure to ensure that 

permanent repairs are implemented in a timely manner.

Procedure Operation has procedures to ensure temporary repairs are compliant 

with all food safety requirements, and do not create potential sources of 

chemical, microbiological or physical contamination. Permanent repairs 

are implemented as soon as practical; operation establishes timelines 

and responsibilities for completion.

Verification Auditor observes temporary repairs, if present, and operation’s plans 

for timely completion.

Corrective 

Action

Operation develops and implements a temporary repair procedure. 

Operation immediately fixes any non-compliant temporary repairs. 

Affected product is evaluated for potential contamination and 

disposition.

Documents 

Required

N/A.

Mandatory
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Expectation 

Operation has procedures both to ensure temporary and permanent repairs are compliant with all 

food safety requirements and do not create potential sources of chemical, microbiological or 

physical contamination. Seams on food contact surfaces of equipment and tools must be either 

smoothly bonded or maintained to minimize accumulation of dirt, filth, food particles and organic 

material. Materials used for temporary and permanent repairs shall be constructed of food grade 

materials. No carpet or materials that cannot be cleaned or do not dry shall be used. Repairs shall 

be inspected and followed by cleaning and sanitation as established by the cleaning procedures 

outlined in requirement P-6.1. 

Example Scenarios 

Scenario 1: Plastic is used for a temporary repair and was secured with clips that do contact the 

product. The operation explains that they are actively looking for a permanent solution. 

Assessment: Compliant. 

Reason: The plastic and clips are approved for food contact, and are to be cleaned and sanitized, 

and are not reasonably likely to pose a physical hazard. 

Scenario 2: Duct tape is used for a temporary repair and no timeline or plan for a permanent fix is 

available.

Assessment: Immediate Action Required.

Reason: Tape presents an opportunity for pathogen harborage and can become a source of foreign 

material. Additional concerns include whether the tape is approved for food contact and can be 

cleaned/sanitized. Further, operation has not established a timeline or responsibilities for 

completion. 

Requirement P-6.3. All cleaning agents shall be approved for their intended use on 

food contact surfaces.

Procedure All chemicals used for cleaning or sanitizing of food contact equipment, 

tools, utensils, containers and other food contact surfaces shall be 

approved for that use, according to the chemical manufacturer or 

supplier and all federal, state and local requirements, and shall be used 

in a manner consistent with the approved use.

Verification Auditor reviews cleaning and sanitizing chemicals purchasing practices 

or procedures, storage area, and use procedures to verify compliance.

Corrective 

Action

Operation ceases use of unapproved chemicals. Retraining is performed 

and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

N/A.

Mandatory

Expectation 

Cleaning is a prerequisite for effective sanitization. Cleaning is the removal of organic matter, 

using appropriate detergent chemicals under recommended conditions. Organic matter from food 
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residues such as oils, grease, and protein not only harbor bacteria but can prevent sanitizers from 

coming into physical contact with the surface to be sanitized. In addition, the presence of organic 

matter can inactivate or reduce the effectiveness of some types of sanitizers, making sanitization 

ineffective.

For cleaning to be performed properly, the right cleaning agents must be selected for the job. 

Cleaning agents commonly used include detergents, solvent cleaners, acid cleaners, and abrasive 

cleaners. Sanitization follows cleaning. Sanitization is the application of heat or chemicals to a 

properly cleaned (and thoroughly rinsed) food-contact surface, yielding a 99.999% reduction of 

representative pathogenic microorganisms of public health importance. Auditor must review 

evidence that cleaning agents being used are safe for food contact surfaces.

Compressed air or other gases that are mechanically introduced into food or used in the process to 

clean food‐contact surfaces or equipment must be filtered and oil-free. Compressed air must also be 

dried and filtered to exclude microorganisms and moisture prior to use.

All post-harvest water needs to meet the microbial standards for drinking water. For the purposes 

of USDA GAP audits, this is considered to be no detectable generic E. coli. This would include 

water used to create steam for cleaning.

Example Scenarios

Scenario 1: The operation uses household multi-purpose cleaner that was purchased to clean food 

contact surfaces. The cleaner was purchased from a local grocery store. Surfaces are not rinsed 

before use. According to the label, cleaner was not meant to clean food contact surfaces. 

Assessment: Immediate Action Required.

Reason: The cleaning chemical needs to be labeled for the appropriate use.

Scenario 2: The operation has a bulk cleaning material with an EPA registration number written on 

the container but does not have a product label. The operation has on location the label declaration

for approved use on food contact surfaces.

Assessment: Compliant.

Reason: The cleaning material is approved for used on food contact surfaces.

Scenario 3: The operation purchases a cleaning agent approved for use on floors, but they are 

using it on food contact surfaces also.

Assessment: Immediate Action Required.

Reason: Immediate Action Required unless the agent is also expressly approved for use on food 

contact surfaces. This chemical is not being used for its intended purpose and is not approved for 

cleaning food grade surfaces.

Scenario 4: Operation uses disinfectant wipes to wipe down product grading line at the end of each 

shift.

Assessment: Immediate Action Required.

Reason: Wipes are not labeled for use on food contact surfaces.
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Requirement P-6.4. Cleaning equipment and tools are clean, in working order and 

stored properly away from product handling area.

Procedure Equipment, utensils and tools used for cleaning or sanitizing, including 

food contact and non-food contact surfaces, are maintained in a manner 

sufficient to avoid becoming a source of produce contamination and are 

stored away from product handling areas.

Verification Auditor reviews practices or procedures for use and storage of cleaning 

and sanitizing equipment, tools and utensils, and observes storage area 

for compliance.

Corrective 

Action

Operation develops written procedures for maintaining and storing 

cleaning and sanitizing equipment, tools and utensils. Retraining is 

performed and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

N/A.

Mandatory

Example Scenarios 

Scenario 1: Operation uses rags, brooms/mops, and floor polisher as cleaning equipment, which 

are cleaned after use and stored on racks/shelves in a room away from production. Cleaning and 

sanitizing chemicals for food contact surfaces and bathrooms are stored separately in a locked 

cabinet. 

Assessment: Compliant. 

Reason: Cleaning equipment and tools are stored properly away from product handling areas. 

Scenario 2: Brooms, mops, and brushes are color coded for bathrooms, outside areas, production 

areas, drains, etc. You find them stacked together on the floor of the storage room. 

Assessment: Corrective Action Needed. 

Reason: Stacking together defeats the purpose of color coding. 
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Requirement P-6.5. Food contact surfaces shall be cleaned, sanitized and maintained 

according to the Food Safety Plan.

Procedure Prior to use, the lines used for washing, grading, sorting, or packing 

shall be cleaned and sanitized as appropriate per risk assessment or 

prevailing regulations. Records must include the date and method of 

cleaning and sanitizing equipment. When in use, the lines shall be 

maintained so as not to be a source of contamination with pathogens.

Verification Auditor reviews cleaning and sanitizing and records and observes food 

contact surfaces to verify compliance.

Corrective 

Action

Operation develops written cleaning and sanitizing procedures and 

records consistent with the Food Safety Plan. Retraining is performed 

and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

Record.

Mandatory ●

PSR 112.123

Expectation 

Determine if the facility has a policy for cleaning and sanitizing all surfaces that come into contact 

with the product. This may be verified through questioning of the workers, through a written policy 

or records of the cleaning process. Review maintenance, cleaning and sanitation records that 

demonstrate compliance with procedures. If you observe that cleaning and sanitizing is not 

sufficient this question must be answered as CAN or IAR depending on the severity.

Example Scenarios 

Scenario 1: Open air packing facility utilizes an approved food contact surface cleaner and rags to 

wipe down white conveyor belts which transport fruit to sorters and packers. 

Assessment: Compliant. 

Reason: Compliant if the product is validated by manufacturer for this use and used according to 

label instructions.

Scenario 2: A power wash system, with water only, is used to blow off produce particles on 

conveyor belts in enclosed facility. Per written procedures, a cleaning crew follows up with rags 

and sanitizing solution for belts only (i.e., belts are run at slow speed and wiped down in place). 

Particles of blueberries and stems remain between belt and edges of machine.

Assessment: Immediate Action Required.

Reason: Cleaning is chronically insufficient since produce residues have accumulated and have 

become a source of contamination.

Scenario 3: No cleaning procedures are written in the Food Safety Plan. The operation uses 

subcontractor for nightly cleaning and sanitizing of facility, food contact and non-contact surfaces.

Assessment: Corrective Action Needed. 

Reason: Procedures should be obtained from the subcontractor and included in the Food Safety 
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Plan.

Produce Safety Rule

112.123: The operation must use equipment and tools that are of adequate design, construction, and 

workmanship to enable them to be adequately cleaned and properly maintained; and (b) Equipment 

and tools must be: (1) Installed and maintained as to facilitate cleaning of the equipment and of all 

adjacent spaces; and (2) 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 and harboring pests. (c) Seams on food contact surfaces of equipment and tools that are 

used 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. (d)(1) The operation must inspect, maintain, and clean and, when necessary and 

appropriate, sanitize all food contact surfaces of equipment and tools used in growing, harvesting, 

packing and holding activities as frequently as reasonably necessary to protect against 

contamination of produce. (2) The operation must maintain and clean all non-food-contact surfaces 

of equipment and tools subject to this subpart used during harvesting, packing, and holding as 

frequently as reasonably necessary to protect against contamination of produce. (e) If using 

equipment such as pallets, forklifts, tractors, and vehicles such that they are intended to, or likely to, 

contact produce, you must do so in a manner that minimizes the potential for contamination of 

produce or food contact surfaces with known or reasonably foreseeable hazards.
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Requirement P-6.5.a. A cleaning and sanitation program for food contact surfaces 

shall be established, implemented and maintained. The program shall 

include measures for monitoring to verify effectiveness.

Procedure An implemented cleaning and sanitation program shall be established, 

including SOPs. Procedures must include frequency, approved cleaning 

and sanitizing agents, and methods of cleaning and sanitizing chemical 

use. The SOP must justify the frequency of cleaning, demonstrate that 

the cleaning and sanitizing methods are effective on the surfaces that 

they are used on, are being used at appropriate concentrations as 

required by the label. Operation shall demonstrate effectiveness in 

minimizing the potential for cross contamination from cleaning and 

sanitizing. Records of sanitizer chemical concentrations shall be 

maintained.

Verification Auditor reviews the cleaning and sanitation program procedures and 

records for inclusiveness of frequency approval and proper use of 

cleaning and sanitizing agents, and methods of cleaning and sanitizing 

agent use. Auditor reviews chemical records regarding use of approved 

chemicals used for cleaning and sanitizing.

Corrective 

Action

Operation develops and implements program procedures for cleaning 

and sanitation. Operation identifies chemicals approved-for-use in the 

cleaning and sanitation program and establishes and maintains records 

of all cleaning and sanitizer concentrations. Retraining of cleaning and 

sanitation program policies and procedures is are performed and 

documented.

Documents 

Required

Written Policy, Record.

Mandatory

Expectation 

(See Requirement F-8.2.c) 

Requirement P-6.6. Transporting equipment shall be maintained to prevent 

contamination of products being transported.

Procedure Pallet jacks, carts, trolleys and forklifts, shall be maintained to prevent 

contamination of products being transported and are listed on the 

Preventive Maintenance and/or Master Cleaning Schedules.

Verification Auditor observes transporting equipment and reviews Schedules and 

records for evidence of compliance.

Corrective 

Action

Operation develops and implements Preventive Maintenance and/or 

Master Cleaning Schedules.

Documents 

Required

Record.

Mandatory

PSR 112.123(e)
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Expectation

Transporting equipment should be kept as clean as possible and cleaned on a scheduled basis to 

assist in preventing contamination. All equipment used to transport should be washed or otherwise 

cleaned whenever they become dirty. Dirty vehicles can contaminate produce with harmful 

microbes, as well as forklifts and pallet jacks that are not maintained and potentially leaking oil or 

other fluid onto facility floor.

Some operations may establish standard procedures and logs to ensure clean and maintained 

equipment. Review records and documentation to verify that a schedule is being followed. This 

also may be verified through questioning of the workers. This requirement should not be assessed 

as compliant if there is no documented procedure for a scheduled cleaning/maintenance of the 

transport equipment.

Example Scenarios

Scenario 1: A forklift used to transport cased, palletized lettuce heads is visibly soiled and has 

flaking paint on the fork and platform areas that touch pallets.

Assessment: Corrective Action Needed.

Reason: The condition of the forklift is a contamination risk for the pallets and other areas of the 

operation, and possibly product through holes in the cases. Immediate Action Required if auditor 

observes evidence of product contamination.

Scenario 2: A maintenance and sanitation schedule lists all forklifts as having weekly inspection 

and service however pallet jacks are on a monthly frequency. Pallet jacks are clean, but forklifts are 

visibly soiled.

Assessment: Corrective Action Needed.

Reason: The cleaning schedule for forklifts should be adjusted.

Produce Safety Rule

112.123: The operation must use equipment and tools that are of adequate design, construction, and 

workmanship to enable them to be adequately cleaned and properly maintained; (e) If using 

equipment such as pallets, forklifts, tractors, and vehicles such that they are intended to, or likely to, 

contact produce, you must do so in a manner that minimizes the potential for contamination of 

produce or food contact surfaces with known or reasonably foreseeable hazards.
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Requirement P-6.7. Waste materials and their removal are managed to avoid 

contamination.

Procedure Trash, leaves, trim, culls, waste water and other waste materials are 

removed from the produce handling areas at a frequency sufficient to 

avoid becoming a source of produce contamination.

Verification Auditor observes waste control procedures in produce handling areas.

Corrective 

Action

Operation develops a written waste control procedure. Operational 

deficiencies are corrected. Retraining is performed and documented.

Documents 

Required

N/A.

Mandatory ●

PSR 112.132

Expectation 

The standard is silent on the type of waste containers required or the frequency for trash removal. 

The operation should select waste containers that are appropriate for their waste collection and 

storage activities. For example, look to see that waste containers are not prone to spills, leaks, or 

overflow and that the waste is being removed at an appropriate frequency, that the volume of waste 

being generated is able to be contained.

Example Scenarios 

Scenario 1: Most of the waste from hand trimming and culling cabbage is carried away by 

conveyor, but you observe some trim waste on the floor around workers. The supervisor explains 

that waste is swept away during breaks and area is cleaned and sanitized nightly.

Assessment: Compliant. 

Reason: Waste materials are managed to avoid becoming a source of contamination.

Scenario 2: You observe trash container in produce handling area is overflowing. The supervisor 

explains that containers are emptied during breaks, and this situation is unusual. The next break is 

in an hour. 

Assessment: Corrective Action Needed. 

Reason: Operation should have a contingency for when more trash accumulates than normal. 

Produce Safety Rule 

112.132: (a) All trash, litter and waste in areas used for growing, harvesting, packing and holding 

of produce must be conveyed, stored and disposed of to minimize the potential to attract or harbor 

pests and protect against contamination of produce, food contact surfaces, areas used to grow, 

harvest, pack or hold produce, agricultural water sources, and agricultural water distribution 

systems with known or reasonably foreseeable hazards. (b) Adequate systems for waste treatment 

and disposal must be operated so that they do not constitute a potential source of contamination in 

growing, harvesting, packing and holding areas. 
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Requirement P-6.8. Outside garbage receptacles/dumpsters are closed and located 

away from building entrances and the area around such sites is 

reasonably clean.

Procedure Waste containers and compactors are located away from produce 

handling areas, are closed or have lids (except for waste collection/cull 

trailers in active use), are emptied on a scheduled basis or as needed, 

and weeds and other pest harborage are minimized around container.

Verification Auditor observes waste container location and management practices.

Corrective 

Action

Operation relocates waste containers. Building deficiencies are 

corrected. Retraining is performed and documented.

Documents 

Required

N/A.

Mandatory

PSR 112.132(a)

Expectation 

Open garbage receptacles/dumpsters attract pests such as birds, vermin, flies, and wildlife because 

of odors and discarded food products. All containers with lids should be kept closed whenever they 

are not in use or should be so located that they are a reasonable distance from the storage building 

entrances in order that pests will not be drawn to the building. They should be emptied regularly.

This question will be a Corrective Action Needed when open or un-lidded receptacles or dumpsters 

are close to the facility entrances and it is likely pests will enter the building. The area surrounding 

the dumpsters or garbage receptacles needs to be maintained in a clean and orderly manner. Keep 

in mind that there may be a small amount of garbage spilled on the outside area surrounding the 

garbage receptacle or dumpster because of how it may be dumped. When the garbage sits or 

accumulates or there is no action being taken to clean the spillage, this question must be answered 

as Corrective Action Needed.

Example Scenarios 

Scenario 1: Waste containers are stored inside the facility, along product movement flow lines and 

are overflowing with waste.

Assessment: Corrective Action Needed, and possible Immediate Action Required. 

Reason: Corrective Action Needed, and possible Immediate Action Required if auditor observes 

reasonable potential for waste to contact product or product contact surfaces.

Scenario 2: You observe the outside area where waste containers are stored to be clean, in good 

condition, but there are odors coming from the containers. 

Assessment: Compliant. 

Reason: Compliant if the odor is the only objectionable condition and the waste containers are 

away from the production area. Waste odors may only take a few hours to develop and are not 

necessarily an indication of a food safety risk. 
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Produce Safety Rule 

112.132: (a) All trash, litter and waste in areas used for growing, harvesting, packing and holding 

of produce must be conveyed, stored and disposed of to minimize the potential to attract or harbor 

pests and protect against contamination of produce, food contact surfaces, areas used to grow, 

harvest, pack or hold produce, agricultural water sources, and agricultural water distribution 

systems with known or reasonably foreseeable hazards.

Requirement P-6.9. The plant grounds are reasonably free of litter, waste culls, 

vegetation, debris and standing water.

Procedure Operation has procedures to maintain the grounds surrounding the 

building in a manner to minimize sources of contamination, such as 

litter, vegetation, waste culls, debris and standing water that may be pest 

attractants or harborages. Equipment and materials stored outside are 

stored away from the building perimeter. Outside storage areas are 

included in pest control program. Vegetation that does not serve as an 

attractant or harborage is permitted.

Verification Auditor observes the grounds for compliance.

Corrective 

Action

Operation removes the attractants and harborages, and develops 

procedure to maintain grounds in compliance.

Documents 

Required

N/A.

Mandatory

PSR 112.132

Expectation 

Grounds in the immediate vicinity of all storage areas should be kept clear of waste, litter and 

improperly stored garbage. The area around the facility should be maintained in a way to 

discourage the breeding, harboring and feeding of pests, such as rodents and reptiles.

If the grounds are not reasonably free of litter, waste, culls, vegetation, debris or standing water or 

the type and/or location is such that the debris represents a possible risk of microbial contamination 

or is sufficient to attract pests to the area, this question should be answered Corrective Action 

Needed.

Piles of wood, such as pieces of broken pallets, garbage or waste collected or scattered along the 

storage grounds, food products, food wrappers, cigarette butts, or soda or drink containers scattered 

across the storage grounds, are all examples of possible reasons to answer this question Corrective 

Action Needed and Immediate Action Required if excessive.

(See Post-harvest Operations Requirement P-9) 

Example Scenarios 

Scenario 1: The facility grounds are not on the cleaning schedule but are clean and maintained at 

the time of inspection. 

Assessment: Compliant. 
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Reason: No schedule is required by the standard. 

Scenario 2: There is an empty water bottle, food wrapper, and a puddle (it rained two days ago) 

near the parking lot, 25 feet from the main building. Grounds closer to the building are well kept.

Assessment: Compliant. 

Reason: The observed trash and puddle are not an unreasonable condition. 

Scenario 3: The facility has no procedure to prevent pest harborage for equipment stored near the 

buildings. There is notable rodent and insect activity observed. 

Assessment: Corrective Action Needed. 

Reason: While the standard does not require written procedures, it does require a procedure. 

Observation of rodent and insect activity demonstrates actual practices are insufficient.

Produce Safety Rule 

112.132: (a) All trash, litter and waste in areas used for growing, harvesting, packing and holding 

of produce must be conveyed, stored and disposed of to minimize the potential to attract or harbor 

pests and protect against contamination of produce, food contact surfaces, areas used to grow, 

harvest, pack or hold produce, agricultural water sources, and agricultural water distribution 

systems with known or reasonably foreseeable hazards. (b) Adequate systems for waste treatment 

and disposal must be operated so that they do not constitute a potential source of contamination in 

growing, harvesting, packing and holding areas. 

Requirement P-6.10. Sewage or septic systems are maintained so as not to be a source 

of contamination.

Procedure After a significant event (such as flooding or an earthquake) that could 

negatively impact a sewage or septic system, operation takes appropriate 

steps to ensure that sewage and septic systems continue to operate in a 

manner that does not contaminate produce, food contact surfaces, areas 

used for produce handling, agricultural water sources, or agricultural 

water distribution systems.

Verification If a significant event has occurred, Auditor reviews steps taken by 

operation to verify sewage or septic system is not a source of 

contamination.

Corrective 

Action

Sewage or septic systems deficiencies are corrected. Affected product is 

evaluated for potential contamination and disposition.

Documents 

Required

N/A.

Mandatory ●

PSR 112.131; 112.133

Expectation 

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). The sewage or septic system should 

be inspected periodically to evaluate that it is in good working order and free from damage. If 
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applicable, the drain field of the septic system should be properly functioning, with no visible 

leakage. Evidence of a sewage or septic system failure might include soggy patches of land around 

the 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. 

After a significant event, such as flooding or an earthquake, the operation must inspect the entire 

system to the extent that it is accessible to identify and correct any defects with the system. When 

the inspection after a significant event indicates defects in the system, the operation must also

consider whether they can continue to perform growing, harvesting, packing, and holding activities 

in a manner that does not contaminate the produce. Temporary measures may be needed to ensure 

the adequate sanitary conditions are available to prevent possible contamination.

Example Scenario

Scenario 1: Auditee states septic system is checked after a significant event. Shows evidence of 

compliance via service invoice after a significant event.

Assessment: Compliant

Reason: Invoice serves as the record of their septic system being checked after a significant event.

Produce Safety Rule

112.131: Sewage must be disposed into an adequate sewage or septic system or through other 

adequate means. Sewage and septic systems, leakages or spills of human waste, which includes 

after a significant event (such as flooding or an earthquake) that could negatively impact a sewage 

or septic system, must be maintained in a manner that prevents contamination of produce, food 

contact surfaces, growing, harvesting, packing or holding areas, agricultural water sources and their 

distribution systems with known or reasonably foreseeable hazards.

112.133: The plumbing must be of an adequate size and design and be installed and maintained to 

distribute water under pressure as needed, in sufficient quantities, in all areas where used in 

growing, harvesting, packing and holding activities for sanitary operations or for hand-washing and 

toilet facilities. It must be able to convey sewage and liquid disposable waste in a manner to 

prevent contamination of produce, areas used to grow, harvest, pack and hold produce or 

agricultural water sources. The plumbing must not allow backflow from or cross connection 

between piping systems that discharge waste water or sewage and piping systems that carry water 

used for growing, harvesting, packing and holding of produce, for sanitary operations or for use in 

handwashing.
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Requirement P-6.11. The sewage disposal system is adequate for the process and 

maintained to prevent direct or indirect product contamination.

Procedure The human waste and gray water sewage system has sufficient capacity 

to handle the operation’s peak flows and not cause direct or indirect 

product contamination. Cross-connections with product contact water 

systems are prohibited. Floor drains are adequate, functional, free of 

obstruction, and are properly maintained and cleaned to prevent them 

from becoming sources of contamination.

Verification Auditor observes operation for evidence of compliance.

Corrective 

Action

Operation suspends operation until sewage disposal system functions so 

as to prevent risk of product contamination. Affected product and 

product handling areas are evaluated for potential contamination and 

disposition.

Documents 

Required

N/A.

Mandatory ●

PSR 112.131; 112.133

Expectation 

A cross-connection is a connection between a water source or distribution pipe (e.g., drinking water, 

water used for handwashing, water used for cooling covered produce) and a liquid waste pipe (e.g., 

sink drain, sewage line, floor drain line). Cross-connections with product contact water systems are 

prohibited. 

Drainage systems involving water contact with 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. 

Evidence of a sewage system failure might include slow draining sinks or drains, sewage odors, 

gurgling noises from the plumbing drain lines, or effluent backup coming from drains, sinks or 

toilets. 

Example Scenario 

Scenario: A hydrocooler waste line is plumbed in the same line with the operation’s floor drains. 

You observe the hydrocooler waste line becomes plugged and water backs up onto operation’s 

floor. 

Assessment: Immediate Action Required.

Reason: Even rare backflow could contaminate the facility structures and equipment, which could 

lead to product contamination. 

Produce Safety Rule

112.131: Sewage must be disposed into an adequate sewage or septic system or through other 

adequate means. Sewage and septic systems, leakages or spills of human waste, which includes 

after a significant event (such as flooding or an earthquake) that could negatively impact a sewage 
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or septic system, must be maintained in a manner that prevents contamination of produce, food 

contact surfaces, growing, harvesting, packing or holding areas, agricultural water sources and their 

distribution systems with known or reasonably foreseeable hazards.

112.133: The plumbing must be of an adequate size and design and be installed and maintained to 

distribute water under pressure as needed, in sufficient quantities, in all areas where used in 

growing, harvesting, packing and holding activities for sanitary operations or for hand-washing and 

toilet facilities. It must be able to convey sewage and liquid disposable waste in a manner to 

prevent contamination of produce, areas used to grow, harvest, pack and hold produce or 

agricultural water sources. The plumbing must not allow backflow from or cross connection 

between piping systems that discharge waste water or sewage and piping systems that carry water 

used for growing, harvesting, packing and holding of produce, for sanitary operations or for use in 

handwashing. 

P-7 Post-Harvest Water/Ice

Requirement P-7.1. A water system description shall be prepared.

Procedure Water sources and the operations they serve shall be documented and 

current. The description shall include one or more of the following: 

maps, photographs, drawings (hand drawings are acceptable) or other 

means to communicate the location of water source(s), permanent 

fixtures and the flow of the water system (including holding systems, 

reservoirs or any water captured for re-use). Permanent fixtures 

include wells, gates, reservoirs, valves, returns, backflow prevention and 

other above ground features that make up a complete water distribution 

system shall be documented in such a manner as to enable location in the 

operation.

Verification Auditor reviews water system description or map, and verifies accuracy 

during operation inspection.

Corrective 

Action

Operation develops or corrects the water system description or map.

Documents 

Required

Record.

Mandatory ●

Expectation 

Water system descriptions must describe the sources and distribution of water in an operation. All 

water sources and distribution systems used by the operation need to be documented. If a water 

source (e.g., a pond on the property) is not used by the operation and the auditor can verify that this 

information is accurate, the source does not have to be included in the operation’s description. 

Water system descriptions may include maps, photographs, drawings, written descriptions, etc. 

Auditors will need to verify that the operation has a written water system description and verify the 

accuracy of the water system description in the process of the review.

Example Scenarios 
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Scenario 1: An operation has a diagram of all internal piping and fixtures, but only a verbal 

description that the water comes from an onsite well.

Assessment: Corrective Action Needed. 

Reason: A water system documentation must include all water sources.

Scenario 2: The water system description does not include one leg of distribution piping. The 

operation says that the water is not used for product handling purposes. 

Assessment: Corrective Action Needed. 

Reason: The water system description must be the “complete water distribution system,” although 

the documentation can state that the water carried by the distribution piping is not used for product 

handling purposes. 

Scenario 3: The operation has no written description, but only uses municipal water. 

Assessment: Corrective Action Needed. 

Reason: A water system description is still required.

Expectation 

The operation must conduct scheduled and routine inspections of their agricultural water systems, to 

the extent they are under the operation’s control (including water sources, water distribution 

systems, facilities, and equipment), to identify conditions that are reasonably likely to introduce 

known or reasonably foreseeable hazards into or onto produce or food-contact surfaces. The 

operation must adequately maintain their water systems to prevent the water system from being a 

source of contamination to produce, food-contact surfaces, areas used for harvesting, packing, 

holding activities, or water sources. 

Requirement P-7.2. Documented scheduled assessment of water system including 

delivery equipment shall be performed.

Procedure The water-delivery system shall be maintained so as not to serve as a 

source of contamination of produce, water supplies or equipment with 

pathogens, or to create an unsanitary condition. Water installations and 

equipment are constructed and maintained to prevent back siphonage 

backflow and cross connections between product contact water and 

waste water. Routine checks verify that back siphonage and backflow 

prevention units are functioning properly (annual or as needed to 

maintain continuous protection). Results are documented.

Verification Auditor reviews maintenance records and examines water system for 

compliance with water system maintenance program, including 

backflow prevention and cross-connections.

Corrective 

Action

Operation corrects deficiencies in ability of water system to reliably 

distribute safe water and schedules water system assessments. Affected 

product is evaluated for potential contamination and disposition.

Documents 

Required

Record.

Mandatory ●

PSR 112.133(d)
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The operation’s water system should be of an adequate size and design and be adequately installed 

and maintained to distribute water under pressure as needed, in sufficient quantities, in all areas 

where used for activities, for sanitary operations, or for hand-washing and toilet facilities; properly 

convey sewage and liquid disposable waste; avoid being a source of contamination; 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 contact with produce or food contact surfaces. 

Operation must correct any significant deficiencies in ability of water system to reliably distribute 

safe water (e.g., repairs to well cap, well casing, sanitary seals, piping tanks and treatment 

equipment, and control of cross-connections).

The operation should have the backflow prevention device checked by a plumber. The auditor 

reviews water system inspection and/or routine check documentation. It is not expected that an 

auditor test that the backflow prevention devices are functioning properly. However, if any obvious 

damage or other evidence that indicates that the system is not functioning properly is observed this 

must be documented in the audit report and assessed as a Corrective Action Needed or Immediate 

Action Required based on the risk observed.

The auditor will include frequency of water delivery system assessment in the comments.

Example Scenario

Scenario: You observe a leak at one of the water supply connections to the equipment wash tank 

and there are rust stains indicating that this has been present for a period of time. The maintenance 

records do not indicate there is a leak and there is no repair history.

Assessment: Corrective Action Needed or Immediate Action Required.

Reason: Corrective Action Needed because there is a leak from the wash tank. This may possibly 

be considered an Immediate Action Required if there is a reason to believe that the leak is 

reasonably likely to result in contamination of the water going into the wash tank.

Produce Safety Rule

112.133(d): Plumbing must be adequately installed and maintained to not allow backflow from, or 

cross-connection between, piping systems that discharge waste water or sewage and piping systems 

that carry water used for harvesting, packing or holding activities, for sanitary operations, or for use 

in hand-washing facilities.
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Requirement P-7.3. Water use SOPs address the microbial quality of water or ice that 

directly contacts the harvested crop or is used on food-contact surfaces.

Procedure If water or ice directly contacts the harvested crop or is used on foodcontact surfaces, operation’s water use SOP requires that water or ice 

when applied meets the microbial standards for drinking water, as 

defined by prevailing regulation or country in which the product is 

intended to be traded, whichever is more stringent. Water may be 

treated (e.g., with chlorine) to achieve the microbial standards or to 

prevent cross-contamination. Ice and water shall be 

sourced/manufactured, transported, and stored under sanitary 

conditions.

Verification Auditor reviews operation’s policy regarding water quality and its 

transport, and observes evidence that water or ice that contacts 

harvested crop or food contact surfaces meets the microbial standards 

for drinking water.

Corrective 

Action

Operation discontinues using water or ice that does not meet the 

microbial standards of drinking water. Retraining is performed and 

documented. Affected product is evaluated for potential contamination 

and disposition.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See Requirement F-10.2) 

The auditor will include the water source for post-harvest operation and the water’s test results in 

the comments.

Example Scenarios 

Scenario 1: An operation has an SOP that includes an annual lab test of their well water that is 

used for all produce and equipment cleaning. Copies of the report from the certified lab are 

available for the last three years.

Assessment: Compliant. 

Reason: The results demonstrate compliance with the microbial standards of the drinking water 

standard. 

Scenario 2: An operation uses city water for all activities in the facility but has nothing on file to 

prove that it meets the microbial requirements of the drinking water standards. 

Assessment: Corrective Action Needed. 

Reason: The operation should have documentation of compliance from the city. 

Scenario 3: Well water is used within the operation for the cleaning of food contact bins. The 

operation states that they perform testing, but no documentation of the tests or results is available.

Assessment: Corrective Action Needed.
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Reason: The operation must have evidence that the water source meets the microbial standards for 

drinking water. 

Scenario 4: An operation only tests the microbial quality of the water and does not perform tests 

for chemicals.

Assessment: Compliant. 

Reason: The Standard only requires compliance to the microbial standards for drinking water. 

Requirement P-7.4. Operation Food Safety Plan includes produce washing process, if 

used.

Procedure If produce is washed, an initial risk assessment of the washing process 

shall be performed that takes into consideration the commodity, type of 

wash system, type of sanitizer, and water quality.

Verification Auditor reviews Food Safety Plan and operational procedures to 

determine if washing process has been considered.

Corrective 

Action

Operation revises Food Safety Plan to include produce washing process.

Documents 

Required

Risk Assessment, Written Policy.

Mandatory ●

Expectation 

If produce is washed, an initial risk assessment shall be conducted to identify the risks associated 

with the washing process which includes the commodity, type of wash system, type of sanitizer and 

water quality. 

The operation must consider the risks associated with the washing process of the produce through 

the complete wash system. The risk assessment must include the water quality at the start of use 

and water management strategies such as water treatments used to reduce cross-contamination risks 

by the water. Treatment methods may vary depending on type of wash water system, such as single 

pass water verses recirculated and reused water. 

Key water quality variables should be included the risk assessment. These key variables include 

pH, temperature and turbidity. The water plan must include procedures that identify the appropriate 

parameters required to maintain the water system. The plan must also include how and when to 

monitor these variables. If using reused water, procedures must include how frequently the water 

should be changed. Change schedules will be influenced by the organic load introduced by the 

commodity, volume of produce, type of produce, operating conditions, type of equipment and type 

of antimicrobial product used. 

The operation must identify the approved antimicrobial product and establish the appropriate 

concentration and monitoring procedures to ensure continuous control of potential hazards in the 

wash water process. The antimicrobial product must be approved for use in postharvest water 

systems and reduce human pathogens of concern. Procedures must include corrective actions 
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needed when monitoring demonstrates the system was out of compliance with parameters 

established in the plan.

If applicable, comment must include a description of the washing process identifying the type of 

wash system and type of sanitizer used for each product. 

Example Scenarios 

Scenario 1: An overhead spray bar is used to wash incoming product. The water source was tested 

by a lab and the results state it is of drinking water quality. The water is re-used and treated with 

sodium hypochlorite appropriately and is recorded in a timely manner. The date on the box of 

sodium hypochlorite test strips used to test the water indicates the test strips are two months beyond 

the expiration date. 

Assessment: Corrective Action Needed or Immediate Action Required.

Reason: CAN, if operation can find a box of test strips within the expiration date, checks the water 

with the good box of test strips, and the water is within the appropriate range. IAR, if a good box of 

test strips or other adequate method of monitoring the water cannot be found. 

Scenario 2: An overhead spray bar is used to wash incoming potatoes. The water is of drinkable 

quality, is not re-used, and is not treated. 

Assessment: Compliant, if considered in the Food Safety Plan. 

Reason: The water used is of appropriate quality for its intended use.

Requirement P-7.5. If used, water antimicrobial treatments shall be monitored 

sufficiently to assure continuous control.

Procedure Microbial, physical or chemical testing shall be performed, as 

appropriate to the specific operation, to demonstrate that acceptance 

criteria have been met.

Verification Auditor reviews monitoring records for compliance with the operation’s 

established procedure and acceptance criteria.

Corrective 

Action

Operation establishes monitoring program that assures continuous 

control of water antimicrobial treatment to meet acceptance criteria.

Documents 

Required

Record.

Mandatory ●

Expectation 

For all chemicals used, including water treatment chemicals, an auditee must have access to the 

chemical’s label. The label needs to show that the chemical has been approved for how the auditee 

is using it – there are different label approvals for use on food contact surfaces, for produce 

washing, and for the treatment of water. 

Additional documentation will be based on the sanitizer and should demonstrate that the auditee is 

following the label directions for what needs to be monitored. Monitoring criteria may include 

concentration, contact time, pH, ORP, free chlorine, water temperature, turbidity, and whether the 

product is rinsed with potable water after the use of the sanitizer.
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The comment should include the frequency of microbial, physical, or chemical testing monitoring.

Example Scenarios 

Scenario 1: The operation has a policy for monitoring the level of chlorine in the wash water but 

does not keep records of monitoring activity. 

Assessment: Corrective Action Needed or Immediate Action Required. 

Reason: Corrective Action Needed because records are required. Possible Immediate Action 

Required if chlorine levels may have dropped or risen to unsafe levels. 

Scenario 2: Monitoring records are missing entries.

Assessment: Corrective Action Needed or Immediate Action Required.

Reason: Corrective Action needed because monitoring must be at sufficient frequency to ensure 

continuous control and records are required. Missing entries could be poor record keeping. They 

could also reflect times when monitoring was not being done as prescribed in company procedures. 

Possible Immediate Action Required if chlorine levels may have dropped or risen to unsafe levels. 

Requirement P-7.6. Re-used water that contacts product or food contact surfaces shall 

be treated using an approved antimicrobial process or chemical 

treatment.

Procedure Re-used water shall be treated using an antimicrobial treatment 

sufficient to prevent cross-contamination, unless prevailing regulation or 

commodity specific standards provide an alternative. Treatments shall 

be in compliance with prevailing regulation or the country in which the 

product is intended to be traded, whichever is more stringent.

Verification Auditor reviews water treatment process and evidence of compliance 

with regulation and the operation’s established procedure.

Corrective 

Action

Operation suspends operation until water treatment functions so as to 

prevent risk of product contamination. Affected product and product 

handling areas are evaluated for potential contamination and 

disposition.

Documents 

Required

Mandatory ●

Expectation 

The USDA GAP program considers water which contacts more than one batch or lot to be re-used

water. This can include both water which is continuously pumped through a system (e.g., a flume, 

or a spray bar where the water is collected and passed through more than once) or stagnant water 

which is not drained between lots (e.g. dump tank or wash sink). Since re-used water contacts 

multiple batches/lots it has the potential to spread contamination across all the product and therefore 

should be carefully considered in a post-harvest water risk assessment.
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If an auditee is using re-used water, it is expected that the water will be treated with a sanitizer to 

prevent cross contamination of product/lots, unless prevailing regulation or commodity specific 

standards provide an alternative. 

For more information on sanitizers, the Produce Safety Alliance has created an Excel tool for Label 

Sanitizers for Produce available on their resources webpage. This tool shows which of the different 

uses each sanitizer has been approved for, the active ingredient, produce information, and whether it 

can be used in organic operations. 

It is important to remember that these water sanitizers are intended to sanitize the water, not sanitize 

the product. Sanitizing the water may not remove microorganisms from an already contaminated 

product but will help prevent the water from spreading that contamination onto every other product 

that is contacted by the water. 

The comment should include the type of antimicrobial treatment used and the concentration/critical 

limits. 

Example Scenarios 

Scenario 1: Re-used water is treated with a concentration of antimicrobial agent that is lower than 

the recommended label rate for the intended use. 

Assessment: Corrective Action Needed or Immediate Action Required.

Reason: Corrective Action Needed unless the operation has validation data demonstrating efficacy 

at the lower rate. Possible IAR if use rates are not sufficient to prevent cross-contamination. 

Scenario 2: Same as Scenario 1, but with a concentration that is greater than the recommended 

rate.

Assessment: Corrective Action Needed or Immediate Action Required.

Reason: Corrective Action Needed because the antimicrobial treatment is not being used in 

accordance with instructions. Possible Immediate Action Required if residues on produce exceed 

legal limits.

Scenario 3: Same as Scenario 1, but with an antimicrobial agent not approved for food use. 

Assessment: Immediate Action Required.

Reason: Treating with a chemical not approved for food use renders the food adulterated. 
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Requirement P-7.7. Operation has documentation demonstrating regulatory approval 

of the wash water antimicrobials in use.

Procedure Only wash water antimicrobials or antimicrobial systems registered or 

approved by EPA, FDA or the prevailing regulatory agency for their 

specific intended use may be used in the dump tank wash water, on the 

spray line or other food contact purposes.

Verification Auditor reviews documentation for appropriateness of use.

Corrective 

Action

Operation obtains documentation or discontinues use of the 

antimicrobial system and implements use of appropriate antimicrobial 

system. Affected product is evaluated for potential contamination and 

disposition.

Documents 

Required

Record.

Mandatory

Expectation 

(See requirement F-10.3) 

Example Scenarios 

Scenario 1: An FDA or EPA approval of the antimicrobial in use for the wash water cannot be 

found on the label and cannot be produced. 

Assessment: Immediate Action Required.

Reason: Inappropriate use of an unauthorized antimicrobial. 

Scenario 2: A label for the wash water antimicrobial in use is present, but its use in the water for 

the category of produce being washed is not on the label. 

Assessment: It depends. 

Reason: This may be Compliant, CAN, or IAR. Listing produce types is not required. Thus, labels 

for antimicrobial chemicals used in wash water may not always specify the category of produce that 

is allowed to be washed. However, all chemicals approved by FDA for washing produce are listed 

in 21 CFR part 173.315 

Scenario 3: A label for the sodium hypochlorite product used in the wash water is present. The 

chemical is approved for use by the proper authority, however, the dose rate in use is below the 

acceptable minimum range provided on the label.

Assessment: Immediate Action Required. 

Reason: Immediate Action Required if the use rate in the wash water produces levels below the 

minimum acceptable range. 
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Requirement P-7.8. If wash water antimicrobial is used, it shall be used in accordance 

with established operational procedure and manufacturer instructions.

Procedure Records shall be kept. Operation shall have a procedure that includes 

minimum limits for antimicrobial in wash water for food safety. 

Procedure shall include how to control, monitor and record use of wash 

water antimicrobial as needed to assure compliance with minimum 

limits. Operation shall have a procedure as to what corrective actions 

are taken if criteria are not met.

Verification Auditor reviews operational procedures and antimicrobial use and 

corrective actions records for compliance.

Corrective 

Action

Operation develops, documents and implements procedures for use of 

the antimicrobial system in compliance with manufacturer instructions. 

Affected product is evaluated for potential contamination and 

disposition.

Documents 

Required

Record.

Mandatory

Expectation 

(See requirement F-10.2 and F-10.3) 

Example Scenarios 

Scenario 1: The operation’s HACCP plan states a Critical Limit of “50 ppm total chlorine 

minimum” in the wash tank. They monitor ORP and automatically add chlorine and adjust pH as 

needed, according to manufacturer’s recommendations. Electronic records can be downloaded 

from the ORP controller.

Assessment: Corrective Action Needed. 

Reason: Operation should be measuring free chlorine, not total chlorine. ORP monitoring and 

records are inconsistent with the stated Critical Limit. HACCP plan does not indicate monitoring of 

pH. 

Scenario 2: Operation washes incoming produce twice: the first tank uses potable water but no 

sanitizer; the second tank uses potable water and 50 ppm free chlorine. The chlorine level is 

monitored in the second tank every half hour, and records indicate compliance with the 50 ppm 

limit.

Assessment: Immediate Action Required.

Reason: The first tank must contain sufficient antimicrobial to prevent cross-contamination, or 

switch to a non-immersion, non-reused (single pass) spray system. If cross-contamination occurs in 

the first tank, there is no assurance that the antimicrobial in the second tank can correct the 

contamination. 

Scenario 3: The operation monitors antimicrobial levels every hour. Records indicate that 

antimicrobial levels are monitored as specified in the Food Safety Plan and are always within the 

operation’s established limits.

Assessment: It depends. 
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Reason: The standard is silent on the minimum frequency for monitoring antimicrobial levels. If 

records demonstrate that the monitoring frequency adheres to the plan and is sufficient, then the 

frequency is compliant. If records demonstrate frequent corrective actions because limits are 

exceeded, then Corrective Action Needed to adjust the frequency.

Requirement P-7.9. If applicable to the specific commodity, water use SOPs address 

control of immersion water temperature.

Procedure For produce that is immersed in water and demonstrated as being 

susceptible to microbial infiltration from water, water temperature 

differentials during immersion shall be controlled in accordance with 

prevailing regulation or industry guidelines.

Verification If applicable to the commodity being immersed, auditor reviews the SOP 

for inclusion of water temperature control, and observes monitoring 

records for evidence of compliance.

Corrective 

Action

Operation revises SOP to address and control water temperature.

Documents 

Required

Record.

Mandatory

Expectation 

(See requirement F-10.5) 

Example Scenarios 

Scenario 1: There is no written SOP for monitoring the flume temperature of the water for 

tomatoes.

Assessment: Corrective Action Needed. 

Reason: Standard Operating Procedures are expected to be written.

Scenario 2: Cantaloupes are washed with a cold-water spray bar. The water contains an approved 

antimicrobial.

Assessment: Not applicable. 

Reason: This item only applies to produce that is immersed.

Requirement P-7.10. Water change schedules shall be developed for all uses of water 

where water is re-used.

Procedure Operation shall have procedures for changing water that is re-used, such 

as recirculated water, flumes and dump tanks.

Verification Auditor observes water use procedures and evidence of compliance.

Corrective 

Action

Operation develops water use procedures. Affected product is evaluated 

for potential contamination and disposition.

Documents 

Required

N/A.

Mandatory
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Expectation

A schedule must be established for changing batch water or a process in place for minimizing the 

build-up of organic material in the water. Recirculated and batch water can be easily contaminated 

by incoming loads of produce which could introduce hazards such as pathogens. Organic material 

can also bind to sanitizers, making them less effective.

The specific schedule for changing water will depend on how much produce an operation is 

washing/cooling, what type of produce, type of equipment (e.g, large scale vs. small scale, if filters 

are used), soil conditions and type of sanitizer. Measuring and monitoring turbidity in wash water 

can be one way in which an operation determines the frequency to change the batch water based on 

these various operating parameters.

The auditor will include the frequency of the re-used water change schedule for each commodity in 

the comments.

Example Scenarios

Scenario 1: You observe the dump tank has lettuce leaves mixed with broccoli florets in turbid 

water. There is no documentation or records of water change schedule. No protocol is available

regarding breaks between products. The operation explains that all produce washed on the same 

day has the same lot code.

Assessment: Corrective Action Needed.

Reason: The operation has no procedures for changing water.

Scenario 2: The operation has a “maximum turbidity” standard for wash water. The operation 

adds fresh water to maintain turbidity below the standard. All wash water is dumped daily.

Assessment: Compliant.

Reason: A water change schedule is in place.

Scenario 3: The operation has a water change schedule for dump tanks, once a day, and for final 

rinse tanks, twice a day. There is no information in records for some of the scheduled water 

changes. Operation explains that product volume was unusually high on those days and they didn’t 

want to lose production time by stopping to change the water.

Assessment: Corrective Action Needed.

Reason: The operation did not follow its procedures for changing water.
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Requirement P-7.11. Debris, damaged and/or visibly contaminated produce shall be 

removed from wash areas/dump tanks to the extent possible.

Procedure Operation has procedures to determine how and when debris, damaged 

and/or visibly contaminated produce shall be removed from wash 

areas/dump tanks.

Verification Auditor reviews procedures and observes wash areas for evidence of 

compliance.

Corrective 

Action

Operation develops, documents and implements a wash area control 

program. Retraining is performed and documented. Affected product 

is evaluated for potential contamination and disposition.

Documents 

Required

N/A.

Mandatory

Expectation 

The operation shall have a policy to handle debris and damaged and/or visibly contaminated 

produce in the wash areas and dump tanks. This policy is not required to be written. Auditor 

interviews the auditee to review the procedures concerning debris and damaged product removal. 

The auditor observes the operation and determines if they are in compliance with the operation’s 

procedures.

P-8 Containers, Bins and Packaging 

Requirement P-8.1. Specifications for all packaging materials that impact on finished 

product safety shall be provided and comply with prevailing regulations.

Procedure The methods and responsibility for developing and approving detailed 

specifications and labels for all packaging shall be documented. A 

register of packaging specifications and label approvals shall be 

maintained and kept current.

Verification Auditor reviews documentation on methods and responsibilities for 

packaging materials and label approvals.

Corrective 

Action

Operation revises labels and packaging materials to be compliant with 

prevailing regulations.

Documents 

Required

Record.

Mandatory

PSR 112.116

Expectation 

(See Requirement F-12.5) 

Example Scenario 

Scenario: Operation has a register of approved packaging and labels for all products. They are 

packing a new product this week and the register has not been updated. 
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Assessment: Depends on how the register is worded. 

Reason: Compliant if the register and labels are still current. Corrective Action Needed if the new 

product is not considered in the register, i.e., the register lists individual products.

Produce Safety Rule

112.116: Food-packing material must be adequate for its intended use, which includes being 

cleanable or designed for single use and unlikely to support growth or transfer of bacteria. If foodpacking material is reused, adequate steps must be taken to ensure that food contact surfaces are 

clean, such as by cleaning food packing containers or using a clean liner.

Requirement P-8.2. Operation has a written procedure for inspecting incoming 

packaging materials.

Procedure All packaging materials are inspected for evidence of contamination 

upon arrival. Results are recorded.

Verification Auditor reviews procedure and examples of packaging for compliance.

Corrective 

Action

Operation creates or revises policy. Contaminated or adulterated 

packaging material is rejected or discarded. Retraining is performed.

Documents 

Required

Written Policy, Records.

Mandatory

PSR 112.123(d)(1)

Expectation 

Auditor reviews the operation’s written policy on inspecting incoming packaging materials and 

reviews the records for compliance against their own policy. If applicable, the auditor also observes 

the operation receiving and inspecting packaging materials to determine if the policy is being 

carried out as intended. 

Example Scenario 

Scenario: An operation has a written procedure to inspect packaging at receiving, but there are no 

records that the inspection was completed.

Assessment: Corrective Action Needed

Reason: The operation has a written procedure, but it also needs to have a documented record that 

the inspection was completed.

Produce Safety Rule 

112.123(d)(1): Food contact surfaces, equipment and tools used in growing, harvesting, packing 

and holding must be inspected, maintained and cleaned and when necessary appropriately sanitized

all food contact surfaces of equipment and tools used, as frequently as reasonably necessary to 

protect against contamination of produce. 
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Requirement P-8.3. Operation has written policy regarding storage and post-storage 

handling of product-contact containers.

Procedure Product-contact containers, as appropriate to the specific Operation 

(e.g., harvest bins, totes, crates, sacks, buckets, finished product clam 

shells, bags or packaging films), shall be stored, or handled (e.g., cleaned 

prior to post-storage use), in a manner so as not to serve as a source of 

contamination.

Verification Auditor observes whether operation has a policy regarding storage and 

handling of product-contact containers used in the operation. Auditor 

observes current practices for compliance with policy.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented.

Documents 

Required

Written Policy.

Mandatory

PSR 112.123(b)(2)

Expectation 

(See requirement F-12.6) 

Example Scenarios 

Scenario 1: A celery operation has written instructions stating that all product containers are stored 

in enclosed warehouse on pallets and wrapped in plastic until use.

Assessment: Compliant. 

Reason: Operation has a written policy on the storage of all product containers and is observed to 

be in compliance.

Scenario 2: Same as Scenario 1, but you see several product containers stored unwrapped in a 

clean area of the warehouse.

Assessment: Corrective Action Needed. 

Reason: CAN - Unless the product containers are about to be used, the practice is not in 

compliance with the written instructions. Either the practice or the instructions must be corrected. 

Scenario 3: The facility has nothing in writing, and auditor observes unassembled cases on dusty, 

overhead shelves.

Assessment: Corrective Action Needed. 

Reason: A written policy is required. A “dusty” shelf is not a compliant storage area.

Scenario 4: An operation manager states that they re-use clamshell containers. A written 

procedure is available showing that clamshells are cleaned and sanitized before use.

Assessment: Compliant. 

Reason: The operation has evidence that clamshells can be cleaned and reused safely.

Produce Safety Rule 
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112.123(b)(2): Equipment and tools must be stored and maintained to protect produce from being 

contaminated with known or reasonably foreseeable hazards and to prevent the equipment and tools 

from attracting and harboring pests. 

Requirement P-8.4. Materials that come in contact with the produce shall be clean and 

in good repair.

Procedure Operation has written procedures for cleaning and, if practicable, 

sanitizing of pallets, produce bins, totes and materials that come in 

contact with the produce during handling or storage so as not to be a 

source of contamination. Procedures require that cleaning and sanitizing 

be documented.

Verification Auditor reviews SOP, cleaning logs and records, interviews responsible 

individuals for knowledge of the SOP and observes containers, 

employees and records for evidence of compliance.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented. Affected materials are evaluated for potential 

contamination and disposition.

Documents 

Required

Written Policy, Records.

Mandatory

PSR 112.123

Expectation 

Perform a visual assessment of the growing, harvesting, packing and holding areas to identify tools, 

equipment, packing and packaging materials, and other food contact surfaces that are likely to or 

intended to contact produce. These materials should be kept clean and in good repair. It is 

recommended that the materials be made of non-porous materials such as stainless steel, PVC, or 

nylon instead of porous materials such as foam, carpet, wood or fabric. The assessment should 

include a determination that the equipment have sufficient space for cleaning. The materials and 

food contact surfaces of equipment and tools should have minimal pits, corrosion, cracks, crevices, 

partially open seams, poorly bonded welds, rough areas or other damage.

Example Scenarios 

Scenario 1: Operation uses wood produce bins for bulk shipping of apples. Their written policy 

states the bins are inspected prior to use to ensure they are clean and in good repair. Record of 

inspections are available for review.

Assessment/Reason: Compliant as long as the bins appear clean and in good repair. 

Scenario 2: Operation’s written policy states all product contact material are cleaned and sanitized 

prior to use however, there are no records being kept. 

Assessment: Corrective Action Needed 

Reason: The standard requires that all cleaning and sanitizing activities are documented. 

Produce Safety Rule 
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112.123: The operation must use equipment and tools that are of adequate design, construction, and 

workmanship to enable them to be adequately cleaned and properly maintained; and (b) Equipment 

and tools must be: (1) Installed and maintained as to facilitate cleaning of the equipment and of all 

adjacent spaces; and (2) 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 and harboring pests. (c) Seams on food contact surfaces of equipment and tools that are 

used 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. (d)(1) The operation must inspect, maintain, and clean and, when necessary and 

appropriate, sanitize all food contact surfaces of equipment and tools used in growing, harvesting, 

packing and holding activities as frequently as reasonably necessary to protect against 

contamination of produce. (2) The operation must maintain and clean all non-food-contact surfaces 

of equipment and tools subject to this subpart used during harvesting, packing, and holding as 

frequently as reasonably necessary to protect against contamination of produce. (e) If using 

equipment such as pallets, forklifts, tractors, and vehicles such that they are intended to, or likely to, 

contact produce, you must do so in a manner that minimizes the potential for contamination of 

produce or food contact surfaces with known or reasonably foreseeable hazards.

Requirement P-8.5. Operation has written policy regarding whether product-contact 

containers are permitted in direct contact with the ground or floor.

Procedure If produce does not normally contact the ground during production, 

Operation has considered and developed written policies regarding 

placement of product-contact containers directly on the ground or floor, 

or whether a physical buffer (e.g., buffer bin or slip sheet) is required, or 

use of containers constructed to prevent contact of the produce or 

produce contact surfaces with the ground. Policy shall be consistent 

with industry standards.

Verification Auditor observes whether operation has a policy regarding placement of 

product-contact containers in direct contact with the ground. Auditor 

observes current practices for compliance with policy.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented.

Documents 

Required

Written Policy.

Mandatory

Example Scenarios 

Scenario 1: The operation has a written procedure for keeping all cartons off the ground. You 

observe two cartons labeled to hold discarded product, on loading dock directly on the ground. 

Assessment: Corrective Action Needed. 

Reason: The requirement only applies to food-contact cartons, but practice is not compliant with 

written procedure. 

Scenario 2: A strawberry operation does not change the container in which product is field packed 

and keeps all containers off the dirt floor of the packinghouse by using slip sheets. Written 
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procedure is available and auditor observes compliant implementation. 

Assessment: Compliant. 

Reason: The operation is following their written procedure. 

Requirement P-8.6. Operation has written policy regarding inspection of food contact 

containers and bins prior to use.

Procedure Food-contact totes, bins, packing and packaging materials, other harvest 

containers, and pallets shall be visually inspected, clean, intact and free 

of any foreign materials prior to use. Containers shall be sufficiently 

maintained so as not to become a source of contamination.

Verification Auditor observes whether operation has a policy regarding inspection of 

food contact containers and observes current practices for compliance 

with policy.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented.

Documents 

Required

Written Policy.

Mandatory

PSR 112.123(d)(1)

Expectation 

Facilities must keep food contact containers as clean as practicable to prevent cross-contamination 

of fresh produce. Any food contact containers used repeatedly during harvest or production should 

be cleaned after each load is delivered and prior to reuse. If the containers are stored outside, they 

should be cleaned and sanitized before being used to haul fresh produce. Workers should not stand 

inside bins.

(See Requirement F-11.2) 

Example Scenarios 

Scenario 1: The operation has SOP requiring visual inspection of stored bins to ensure they are 

clean, intact and free of foreign materials prior to use.

Assessment: Compliant. 

Reason: The operation has a written SOP. 

Scenario 2: Operation obtains a shipment of RPCs (reusable plastic container), which are cleaned 

and inspected by the supplier. The operation’s SOP excludes these RPCs from inspection prior to 

use. 

Assessment: Corrective Action Needed. 

Reason: RPCs are often received with labels and other debris on them and an operation should not 

assume they are clean without inspection.

Produce Safety Rule 

112.123(d)(1): Food contact surfaces, equipment and tools used in growing, harvesting, packing 

and holding must be inspected, maintained and cleaned and when necessary appropriately sanitized 
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all food contact surfaces of equipment and tools used, as frequently as reasonably necessary to 

protect against contamination of produce. 

Requirement P-8.7. Operation has written policy regarding acceptable productcontact containers.

Procedure The types and construction of product-contact containers and packing 

materials shall be appropriate to the commodity being handled and 

suited for their intended purpose. Produce shall only be stored in clean 

and sanitary containers.

Verification Auditor observes whether operation has a policy regarding what types 

of containers and packing materials are acceptable for use, and observes 

current practices for compliance with the policy.

Corrective 

Action

Operation develops the policy. Appropriate product-contact containers 

are obtained. Affected product is evaluated for potential contamination 

and disposition.

Documents 

Required

Written Policy.

Mandatory ●

PSR 112.116

Expectation 

(See requirement F-12.5) 

Example Scenarios 

Scenario 1: A brussels sprouts packing operation uses Reusable Plastic Containers (RPCs), which 

are cleaned and stored in accordance with operation’s SOP.

Assessment: Compliant. 

Reason: The operation has a written policy and operates in accordance with the policy. 

Scenario 2: The operation uses only new, web-style bags from a single supplier for packing 

onions. The operation has no written policy on the types of containers appropriate for product 

packaging. 

Assessment: Corrective Action Needed. 

Reason: The policy must be written, even if only one type of packaging is used. 

Scenario 3: A packinghouse has changed crops and uses existing containers and packing materials 

to pack the “new” crop. 

Assessment: Corrective Action Needed

Reason: The written policy does not demonstrate that the type of packaging has been considered 

for the new crop. 

Produce Safety Rule 

112.116: Requires that operations use food-packing material that is adequate for its intended use. 

Materials must be cleanable or designed for single use and must be unlikely to support growth or 

transfer of bacteria. If operations reuse food-packing material, the operation must take adequate 
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steps to ensure that food-contact surfaces are clean, such as by cleaning food-packing containers or 

using a clean liner. 

Requirement P-8.8. Operation has written policy prohibiting use of product-contact 

containers for non-product purposes unless clearly marked or labeled 

for that purpose.

Procedure Food-contact totes, bins and other product-contact containers shall not 

be used for other purposes unless the operation has a policy or 

procedure that clearly designates approved non-product contact uses 

and how the containers are to be marked or labeled for that purpose. 

Food-contact totes, bins and other packing containers and equipment 

that are no longer cleanable shall not be used for packing but can be 

used for other non-food uses if clearly marked/labeled.

Verification Auditor observes whether operation has a policy prohibiting use of 

product-contact containers for other uses unless otherwise labeled, and 

observes current practices for compliance with the policy.

Corrective 

Action

Operation develops the policy. Retraining is performed and 

documented.

Documents 

Required

Written Policy.

Mandatory

Expectation 

(See Requirement F-11.4) 

Example Scenarios 

Scenario 1: Finished product container on packing line is observed containing waste plastic and 

other non-produce trash without a clear marking or designation. 

Assessment: Corrective Action Needed. 

Reason: Product containers are observed being used for items other than produce without being 

clearly marked or designated.

Scenario 2: Policy is written but fails to clearly establish marking requirements for non-product 

uses of packing containers. 

Assessment: Corrective Action Needed. 

Reason: The written policy must clearly establish marking requirements for non-product use. 

Scenario 3: Workers are observed storing personal effects in packing containers. The packing 

containers are temporarily marked “not for product.” There is no written policy permitting 

temporary marking.

Assessment: Corrective Action Needed. 

Reason: Policy must be written.
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Requirement P-8.9. Pallets shall be kept clean and in good condition as appropriate 

for their intended use.

Procedure Operation inspects pallets prior to use for conditions that may be a 

source of produce contamination. Pallets that are not cleanable are 

removed from use. Pallets and other wooden surfaces are properly 

dried after being washed.

Verification Auditor observes pallets for compliance.

Corrective 

Action

Operation removes noncompliant pallets from use.

Documents 

Required

N/A.

Mandatory

PSR 112.123(d)(2)(e)

Expectation 

Auditor reviews the condition of pallets and containers being used and those stored for future use. 

Auditor interviews the operator to determine what is done with broken or dirty pallets. When 

operators use dirty or broken pallets or do not clean and/or repair pallets this question must be a 

Corrective Action Needed.

(See requirement F-13.2) 

Example Scenarios 

Scenario 1: You observe pallets being used that have minor damage that does not affect the 

holding ability or integrity of the pallet. The pallets are being stacked in racks above other pallets 

holding product. 

Assessment: Corrective Action Needed. 

Reason: Pallets shall be kept in good condition as appropriate for their intended use; pieces of 

wood have the potential to fall into produce if stored on top of or over other product. 

Scenario 2: The operation’s pallet use policy is not written, but employees say that damaged, 

unclean, or otherwise unusable pallets cannot be used and will be segregated. Pallets appear to be 

in compliance.

Assessment: Compliant. 

Reason: The operation has a policy which is understood by employees. 

Produce Safety Rule

112.123(d)(2): All non-food-contact surfaces of equipment and tools used during harvesting, 

packing and holding must be maintained and clean as frequently as reasonably necessary to protect 

against contamination of produce. (e) Equipment such as pallets, forklifts, tractors and vehicles 

such that they are intended to or likely to contact produce, must do so in a manner that minimizes 

the potential for contamination of produce or food contact surfaces with known or reasonably 

foreseeable hazards.
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P-9 Storage 

Requirement P-9.1. Product storage areas and conditions shall be appropriate to the 

commodities stored.

Procedure Produce storage locations and conditions shall not pose a risk of produce 

contamination, consistent with industry standards or prevailing 

regulation.

Verification Auditor observes storage area for evidence that stored produce is 

protected from contamination.

Corrective 

Action

Operation designates and maintains storage areas to prevent 

contamination of produce.

Documents 

Required

N/A.

Mandatory

PSR 112.126

Expectation 

(See requirement P-3.2) 

Example Scenarios 

Scenario 1: Condensate line from cooling unit in produce storage room is draining onto the floor.

Assessment: Immediate Action Required.

Reason: Condensate draining onto the storage room floor creates an unacceptable food safety risk.

Scenario 2: The walls on either side inside of the doorway to the produce storage room are 

damaged/punctured from forklift traffic. There are no maintenance records of when the damage 

occurred, or plans to repair it. 

Assessment: Corrective Action Needed. 

Reason: Damage is sufficient to allow entry or harborage of pests, water, or other contaminants.

Produce Safety Rule 

112.126(a)(1): Buildings must be suitable in size, construction and design to facilitate maintenance 

and sanitary operations for growing, harvesting, packing and holding activities to reduce the 

potential for contamination of produce or food contact surfaces with known or reasonably 

foreseeable hazards. Buildings must provide sufficient space for placement of equipment and 

storage of materials and permit proper precautions to be taken to reduce the potential of 

contamination. Effective design may include 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. (2) Adequate drainage must be provided in all areas where normal 

operations release or discharge water or other liquid waste on the ground or floor of the building. 

(b) Measures must be implemented to prevent contamination of produce and food contact surfaces 

in buildings, as appropriate, considering the potential for such contamination through: (1) Floors, 

walls, ceilings, fixtures, ducts, or pipes; and (2) Drip or condensate. 
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Requirement P-9.2. Iced produce is handled so as not to serve as a source of 

contamination.

Procedure Protective measures are provided in areas where iced product is stored 

over food items in order to prevent melting ice from contaminating 

product below.

Verification Auditor inspects any iced product on premises for compliance.

Corrective 

Action

Operation develops written procedures to handling and storage of iced 

product. Operational deficiencies are corrected. Retraining is 

performed and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

Written Procedure.

Mandatory

PSR 112.113

Expectation 

Many vegetable products are frequently packed with ice or crushed ice put on the tops of the 

cartons or pallets to keep them cold. This would include broccoli and sweet corn. In storage where 

pallets are stacked more than one high or when there are racks to stack pallets one above the other, 

the iced product should be stored on the bottom. If a product is stored beneath an iced product, it 

must be protected from the dripping of melting ice. Auditors must review the storage, ask 

appropriate questions about storage of products packed with ice and assess the results.

Example Scenarios 

Scenario 1: Iced product is stacked in produce storage area. A cover sheet on each pallet drains 

water away from the container below it. Visual inspection confirms that water is not dripping onto 

other produce. 

Assessment: Compliant. 

Reason: Iced product is handled so as not to serve as a source of contamination.

Scenario 2: Iced product is stored only in the bottom rack in the produce storage area. The area is 

drained so that water does not accumulate.

Assessment: Compliant. 

Reason: The iced product is stored so as not to serve as a source of contamination. 

Scenario 3: The operation does not receive or pack iced produce. 

Assessment: Not applicable. 

Reason: The operation does not have iced product to assess. 

Scenario 4: Iced broccoli is stacked on upper shelf. Product in cartons is stored directly below. 

Melting ice is dripping from the upper broccoli cartons. 

Assessment: IAR if there is evidence that melting ice from above iced product has contacted the 

cartons/product stored below. CAN: If there is no evidence that melting ice is contacting the 

product below. 
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Reason: Dripping ice from product stored above has become a source of contamination. 

Produce Safety Rule 

112.113: An operation must handle harvested produce during growing, harvesting, packing and 

holding activities in a manner that protects against contamination with known or reasonably 

foreseeable hazards--for example, by avoiding, to the degree practicable, contact of cut surfaces of 

harvested produce with soil or it is a reasonably foreseeable hazard that ice will melt. 

Requirement P-9.3. Non-product storage areas shall be maintained so as not to be a 

source of product or materials contamination

Procedure Areas designated to store materials, whether indoors or out, shall be 

clean, well ventilated, and designed to protect materials and produce 

form contamination.

Verification Auditor observes storage area for evidence that stored materials are 

protected from contamination.

Corrective 

Action

Operation designates and maintains storage areas to prevent 

contamination of non-product materials.

Documents 

Required

N/A.

Mandatory

PSR 112.126(a)(1)

Example Scenarios 

Scenario 1: A “bone yard” storage area for unused equipment and parts is outside, behind the 

building and is unprotected from the weather. The area is paved and fenced but otherwise not 

maintained.

Assessment: Compliant. 

Reason: The area does not serve as a source of product contamination unless there is evidence of 

pest harborage. 

Scenario 2: Packaging and other dry materials are stored in a locked trailer outside the main 

building. The trailer has a small vent on the roof that is screened to exclude pests. The trailer walls 

are rusting but intact. Materials inside are stacked on pallets or racks, off the floor.

Assessment: Compliant. 

Reason: Packaging and other dry materials are stored in a manner that protects them from 

contamination. 

Produce Safety Rule 

112.126(a)(1): Buildings must be suitable in size, construction and design to facilitate maintenance 

and sanitary operations for growing, harvesting, packing and holding activities to reduce the 

potential for contamination of produce or food contact surfaces with known or reasonably 

foreseeable hazards. Buildings must provide sufficient space for placement of equipment and 

storage of materials and permit proper precautions to be taken to reduce the potential of 

contamination. Effective design may include separation of operations in which contamination is 
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likely to occur, by one or more of the following means: Location, time, partition, enclosed systems 

or other effective means.

Requirement P-9.4. Materials and packaging materials shall be protected from 

contaminants.

Procedure Materials stored in uncovered areas shall be protected from condensate, 

sewage, dust, dirt, chemicals, allergens or other contamination. 

Materials shall be stored off the floor/ground on pallets, slip sheets or 

stands and covered where applicable.

Verification Auditor observes stored materials for protection from contamination.

Corrective 

Action

Operation develops and implements written procedures for materials 

storage. Operational deficiencies are corrected. Affected product is 

evaluated for potential contamination and disposition.

Documents 

Required

N/A.

Mandatory

PSR 112.126

Example Scenarios 

Scenario 1: Packaging and other raw materials are stored in a designated, enclosed area on racks 

but are not covered to protect from contamination. No contamination is seen. 

Assessment: Compliant. 

Reason: Materials and packaging are protected from contaminants unless you observe a reasonable 

likelihood of contamination of the materials as stored.

Scenario 2: Partly used packaging film, is returned for storage in an enclosed room. The 

packaging film is covered in a plastic bag and stored on a rack. 

Assessment: Compliant. 

Reason: Packaging film is protected from contaminants.

Scenario 3: Partly used packaging film is covered in a plastic bag and stored on a pallet outdoors 

in a designated area with a roof to protect from rain. The bag is dusty but adequately sealed to 

prevent contamination.

Assessment: Compliant. 

Reason: The bag provides protection for the film from contaminants.

Produce Safety Rule 

112.126(a)(1): Buildings must be suitable in size, construction and design to facilitate maintenance 

and sanitary operations for growing, harvesting, packing and holding activities to reduce the 

potential for contamination of produce or food contact surfaces with known or reasonably 

foreseeable hazards. Buildings must provide sufficient space for placement of equipment and 

storage of materials and permit proper precautions to be taken to reduce the potential of 

contamination. Effective design may include 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. (2) Adequate drainage must be provided in all areas where normal 
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operations release or discharge water or other liquid waste on the ground or floor of the building. 

(b) Measures must be implemented to prevent contamination of produce and food contact surfaces 

in buildings, as appropriate, considering the potential for such contamination through: (1) Floors, 

walls, ceilings, fixtures, ducts, or pipes; and (2) Drip or condensate. 

Requirement P-9.4.a. The operation has a procedure to ensure that purchased 

materials, work in progress and finished products are used in the correct 

order, and within the allocated shelf life when applicable.

Procedure The operation clearly outlines a procedure in which work in progress, 

finished products, purchased materials, such as packing materials, 

cleaning chemicals and any other materials that may have an impact on 

food safety, shall be used in accordance with the allocated shelf life, i.e. 

materials used on a first in first out basis or in the correct order as 

established by the policy or procedure.

Verification Auditor observes the procedure for stock management is implemented 

effectively.

Corrective 

Action

Operation develops and implements effective procedures for stock 

management.

Documents 

Required

Written Policy.

Mandatory

Expectation 

The operation shall establish a stock management system. This system shall include a procedure 

that describes appropriate policies are established to ensure that purchased materials, work in 

progress and finished products are used in the correct order, and within the allocated shelf life when 

applicable. These purchased materials such as raw incoming product, packaging, cleaning 

chemicals and any other materials that may have an impact on food safety should be included in the 

stock management procedures. The operation will determine the correct order of usage. The 

auditor will verify that the operation is following their procedure correctly.

Example Scenario 

Scenario: The auditor interviews the production manager to explain the operation’s procedure to 

ensure that products are used in the correct order prior to their expiration. The manager explains 

their inventory system of using a combination of FIFO and quality evaluation. However, the 

procedure is not written. 

Assessment: Corrective Action Needed. 

Reason: The procedure needs to be written and clearly outline the steps necessary to ensure that 

purchased materials, work in progress and finished products are used in the correct order, and 

within the allocated shelf life.
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Requirement P-9.5. Adequate space shall be maintained between rows of stored 

materials to allow cleaning and inspection.

Procedure Materials shall be stored away from walls and ceilings. Written 

procedures shall be followed to guarantee the proper cleaning, 

inspection and monitoring for pest activity in storage areas.

Verification Auditor reviews the procedures and observes the storage area to 

determine whether storage practices allow cleaning, inspection and 

monitoring for pest activities.

Corrective 

Action

Operation develops and implements a written procedure, and moves 

material into compliance.

Documents 

Required

Written Procedure.

Mandatory

PSR 112.123(b)(1)

While not part of this requirement, many companies allow at least 18 inches between the wall and 

product as used in other programs including, the Department of Defense, USDA Grain Inspection, 

Packers and Stockyards Administration (GIPSA), USDA Plant Survey’s, and as recommended in 

many state and extension publications to allow for adequate pest control and to conduct inspections. 

Observe the storage area to determine if storage practices allow cleaning, inspection, and 

monitoring for pest activity and follow the operation’s food safety procedure.

Example Scenarios 

Scenario 1: Materials are stored on racks that reach to the ceiling (20 feet), are one pallet deep and 

are bolted to the back wall. There is a 12 inch clearance under the racks. The areas under the racks 

are clean.

Assessment: Corrective Action Needed. 

Reason: Written procedures are required and the actual practices need to maintain sufficient space 

between pallets and the wall and pallets and the ceiling to allow inspection. 

Scenario 2: Written procedures require an 8 inch clearance between racks and between the racks 

and the wall. Spacing is in compliance. Racks can be moved for cleaning and pest inspections.

Assessment: Compliant. 

Reason: The operation is following their written policy which allows adequate space. 

Produce Safety Rule 

112.123(b)(1): Equipment and tools must be installed and maintained as to facilitate cleaning of the 

equipment and of all adjacent spaces.
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Requirement P-9.6. All chemicals shall be stored in a secure separate area. All 

chemicals shall be properly labeled.

Procedure Chemicals, including cleaning maintenance compounds and lubricants, 

when not being used, are stored away from product handling areas and 

in a manner that inhibits unauthorized access. Food-grade and 

nonfood-grade lubricants are kept separate from each other.

Verification Auditor observes that chemicals are properly labeled and storage 

practices protect against product contamination.

Corrective 

Action

Operation designates a secure area for storage of chemicals. Unlabeled 

chemicals are labeled or properly discarded. Retraining is performed 

and documented.

Documents 

Required

N/A.

Mandatory

Example Scenarios 

Scenario 1: Chemicals are stored in a locked, vented cabinet. All facility and equipment cleaning 

and sanitizing chemicals are stored together on the top shelf, lubricants are stored on the bottom 

shelf. All are in original containers with manufacturers’ labels. The cabinet appears clean and 

orderly. 

Assessment: Compliant as long as chemicals are stored according to label and regulatory 

requirements; e.g., storage of incompatible products. 

Reason: Chemicals are stored in a secure separate area.

Scenario 2: Food grade lubricants are used on most equipment in the facility, except for one that 

requires special non-food grade lubricant. All are stored on the same shelf, but the special lubricant 

is clearly marked non-food grade. 

Assessment: Corrective Action Needed. 

Reason: Special labeling does not provide sufficient separation. 

Scenario 3: Chemicals are stored in original containers or transferred to labeled secondary 

containers and stored on designated open shelves in the maintenance area, which is locked with 

limited access.

Assessment: Compliant. 

Reason: Chemicals are stored in a secure separate area. 
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Requirement P-9.7. When produce is cooled, it is cooled to temperatures appropriate 

to the commodity according to current established regulatory or 

industry standards.

Procedure When required for food safety or by industry guidelines, steps are taken 

to minimize temperature increases and minimize the time between 

produce receipt and cooling at the operation. The product temperature 

and equipment control mechanisms are calibrated and monitored at a 

defined frequency and temperatures are kept appropriate to the 

commodity. Records are maintained.

Verification Auditor reviews cooling procedures for commodities requiring 

temperature control, and reviews temperature logs for evidence of 

compliance.

Corrective 

Action

Operation develops and implements procedures to monitor cooling 

procedures in compliance with current established regulatory or 

industry standards.

Documents 

Required

Record.

Mandatory

PSR 112.124

Expectation 

If the operation determines that produce should be cooled to a certain temperature to control a 

microbiological hazard, then the operation must take steps to ensure that the product is cooled 

appropriately. The operation shall provide records of compliance with the established guidelines. 

Records include temperature measurements and equipment calibration. Auditor verifies 

compliance. If temperature control is required, the auditor will list the temperature range for each 

commodity in the comments.

Example Scenario 

Scenario: An operation stores celery at 32 to 36°F. They say that the temperature range came 

from the UC Davis Post-harvest website. Daily monitoring records indicate compliance with the 

range. 

Assessment: Not applicable, unless temperature control of celery is in operation’s Food Safety 

Plan (then compliant).

Reason: Typically, cold storage of celery and other raw agricultural commodities is for quality 

purposes, not food safety. 

Produce Safety Rule 

112.124: Instruments or controls used 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.
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Requirement P-9.8. Where temperature control is required for food safety, cooling 

facilities shall be fitted with temperature monitoring equipment or 

suitable temperature monitoring devices.

Procedure Temperature monitoring equipment shall be located in all temperature

controlled areas, and shall be located so as to accurately monitor the 

temperature. Temperature measuring devices shall be monitored and 

calibrated on a scheduled basis or as needed.

Verification Auditor observes evidence that temperatures are being monitored, and 

reviews calibration records and procedures for temperature monitoring 

equipment.

Corrective 

Action

Operation establishes and implements temperature monitoring 

procedures.

Documents 

Required

Record.

Mandatory

PSR 112.124

Expectation 

The requirement is only applicable for this audit for operations that include temperature as a 

requirement for food safety in their Food Safety Plan. Currently, there are no regulatory 

requirements or crop specific guidance for food safety for raw agricultural commodities.

Example Scenario 

Scenario: The only available thermometer in a cooler is directly across from the evaporator fan 

and indicates 37oF. The core temperatures of cantaloupes in the cooler range as high as 44oF. 

Assessment: Depends on whether Food Safety Plan identifies storage area temperature as 

important for food safety.

Reason: If not, then N/A. If yes, then judgment depends on whether thermometer is accurately 

measuring the room temperature, regardless of measured core temperature. If inaccurate, then 

Corrective Action Needed to ensure room temperature is measured accurately. 

Produce Safety Rule 

112.124: Instruments or controls used 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.
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Requirement P-9.9. Cooling equipment shall be maintained so as not to be a source of 

product contamination.

Procedure Cooling equipment (e.g. hydrocoolers, air coolers), shall be inspected, all 

debris removed, and cleaned and sanitized according to written 

sanitation SOPs.

Verification Auditor reviews cooling equipment maintenance and sanitation 

procedures and inspects equipment for compliance with procedure.

Corrective 

Action

Operation develops and implements effective maintenance and 

sanitation procedures.

Documents 

Required

Written Policy, Record.

Mandatory ●

PSR 112.123

Expectation 

The comment should include the date last maintenance or cleaning was conducted.

Refrigerated storages should be cleaned on a scheduled basis. This will reduce the amount of dust 

and dirt build-up and further reduce the possibility of contamination. Auditors should review the 

cleaning schedule documentation. Below is guidance for cooling from FDA’s Guide to Minimize 

Microbial Food Safety Hazards for Fresh Fruits and Vegetables.

Various methods are available for cooling produce, including water, ice, and forced air. The 

method used depends on the fruit or vegetable and the resources of the operator. In most instances, 

cooling with air (such as vacuum coolers or fans) will pose the lowest risk. 

The benefits of chilling to remove field heat and the temperature requirements for optimum keeping 

quality vary for different types of produce. Adequate refrigeration, in conjunction with crop 

characteristics, is an important safeguard against many pathogens. Further, good quality, intact 

produce is most resistant to microbial contamination and growth. Thus, maintaining temperatures 

that promote optimum product quality may reduce the risk of microbial hazards. 

Air cooling equipment and cooling areas should be monitored, periodically cleaned and inspected. 

Potential sources of contamination should not be located near air intakes. 

Chilling equipment, such as hydrocoolers, and containers holding produce during chilling 

operations should be clean and sanitary. Field soil should be removed as much as possible from 

produce and containers prior to chilling. Interiors of hydrocoolers should routinely be cleaned and 

sanitized.

Example Scenarios 

Scenario 1: A dripping evaporator unit pan is observed, the unit is located above a traffic lane, not 

above stored produce. The splash area below the unit is marked off with yellow paint and signage 

reading “No Storage Permitted.” 
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Assessment: Immediate Action Required.

Reason: This situation provides too high a risk of spreading contamination to other areas and 

stored produce. 

Scenario 2: An evaporator drain pan is misaligned and dripping liquid onto the floor below and 

near palletized produce. The storage pallet is visually wet but the stored whole produce cases 

appear dry. 

Assessment: Immediate Action Required.

Reason: The visible appearance of the cases is insufficient to assure that contamination is not 

occurring and pathogens are known to survive on dry cardboard. 

Produce Safety Rule 

112.123: The operation must use equipment and tools that are of adequate design, construction, and 

workmanship to enable them to be adequately cleaned and properly maintained; and (b) Equipment 

and tools must be: (1) Installed and maintained as to facilitate cleaning of the equipment and of all 

adjacent spaces; and (2) 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 and harboring pests. (c) Seams on food contact surfaces of equipment and tools that are 

used 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. (d)(1) The operation must inspect, maintain, and clean and, when necessary and 

appropriate, sanitize all food contact surfaces of equipment and tools used in growing, harvesting, 

packing and holding activities as frequently as reasonably necessary to protect against 

contamination of produce. (2) The operation must maintain and clean all non-food-contact surfaces 

of equipment and tools subject to this subpart used during harvesting, packing, and holding as 

frequently as reasonably necessary to protect against contamination of produce. (e) If using 

equipment such as pallets, forklifts, tractors, and vehicles such that they are intended to, or likely to, 

contact produce, you must do so in a manner that minimizes the potential for contamination of 

produce or food contact surfaces with known or reasonably foreseeable hazards.

P-10 Transportation (Packinghouse to Customer) 

Requirement P-10.1. There is a written policy for transporters and conveyances to 

maintain a specified temperature(s) during transit.

Procedure When refrigerated transport is required for food safety, transporters 

have written, predetermined temperature ranges for commodities being 

transported.

Verification Auditor reviews documentation of predetermined temperature ranges.

Corrective 

Action

Operation develops, documents and implements temperature range 

requirements.

Documents 

Required

Written Policy.

Mandatory

Expectation 
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The operation must establish a written policy for transporters to maintain temperatures appropriate 

to the crop during transit. Transporters should be aware of the temperature requirements for 

produce being hauled and avoid delivery of mixed loads with incompatible refrigeration 

requirements.

Not all products require refrigeration during transport. In certain cases, shippers may require or 

specify a higher temperature for transportation than recommended for storage conditions. Shippers 

should recommend temperatures according to the product and conditions for transport. In general, 

manifests should be marked with the temperature range that the shipper requires the carrier to 

maintain.

Review auditee documentation to verify that there is an active policy in place addressing the ability 

of conveyances to maintain specified transport temperatures. If there are no transportation 

temperatures required by the auditee, or there is no indication of a required temperature this 

question can be answered Not Applicable. If refrigerated transport temperature control is required, 

the auditor will list the temperature range for each commodity in the comments.

Example Scenarios 

Scenario 1: The operation transports totes of avocados in trailers with no temperature control or 

recording devices. The operation says that their customer has no temperature specifications for 

avocados. 

Assessment: Not Applicable unless temperature control is required for food safety.

Reason: Temperature controls are not included in the company’s food safety plan and are required 

for quality, not food safety purposes. 

Scenario 2: A written procedure recommends that wrapped pallets of cartons of tomatoes, 

cucumbers and peppers be transported in trailers controlled and monitored at 38-41oF, for quality. 

Other produce may also be shipped in the same trailer. No shipping records are available to 

demonstrate compliance.

Assessment: Not Applicable. 

Reason: The standard only requires the operation to have a written specification for food safety. 

Requirement P-10.2. Prior to loading, the vehicle shall be pre-cooled.

Procedure When refrigerated transport is required for food safety, the proper 

temperature for pre-cooling is appropriate to the type of produce and as 

specified by documented protocol.

Verification Auditor reviews documented protocol, shipping checklist records, and 

observes vehicles during loading for compliance.

Corrective 

Action

Operation develops documents and implements vehicle cooling 

requirements.

Documents 

Required

Written Policy, Record.

Mandatory

(Also See P-10.1) 
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Example Scenarios 

Scenario 1: A written procedure recommends that trailers be pre-cooled, controlled and monitored 

at 38-41oF, for quality. Loading records indicate that trailer temperature may occasionally be as 

high as 45oF. 

Assessment: Not Applicable. 

Reason: Not Applicable unless temperature control is required for food safety.

Scenario 2: An operation that ships dry bulb onions in cartons, does not pre-cool or monitor 

shipping trailers. 

Assessment: Not Applicable. 

Reason: Not Applicable unless temperature control is required for food safety.

Scenario 3: An operation stores pears in a warehouse and ships bins as needed to a packinghouse 2 

miles away. Bins are shipped on an open flatbed trailer. 

Assessment: Not Applicable. 

Reason: Not Applicable unless temperature control is required for food safety.

Requirement P-10.3. The refrigerated transport vehicles shall have properly 

maintained and fully functional refrigeration equipment.

Procedure When refrigerated transport is required for food safety, operation has a 

written policy that refrigerated transportation equipment shall be 

controlled by a thermostatic device as necessary to maintain 

temperatures in the cargo area for the particular type of produce being 

transported and as specified by documented protocol.

Verification Auditor reviews written policy and observes refrigerated transport 

vehicles in use at the time of the audit.

Corrective 

Action

Operation develops, documents and implements a policy. Retraining is 

performed and documented.

Documents 

Required

Written Policy.

Mandatory

Example Scenarios 

Scenario 1: An operation has no temperature specifications for shipping cucumbers and uses only 

shipping trailers with no refrigeration equipment or temperature control devices.

Assessment: Not Applicable. 

Reason: Not Applicable unless temperature control is required for food safety. 

Scenario 2: An operation ships everything at 38-41oF and maintains records of trailer temperatures 

at shipping, but policy and measurement protocol are not written. 

Assessment: Not Applicable. 

Reason: Temperature control is maintained for quality purposes and is not required by the 

operation for food safety.
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Requirement P-10.4. Where required, temperatures of product are taken and 

recorded prior to or upon loading.

Procedure When refrigerated transport is required for food safety, operation has a 

written procedure for when and how to measure product temperatures 

prior to or during loading.

Verification Auditor reviews written procedures and observes temperature 

monitoring procedures during loading.

Corrective 

Action

Operation develops, documents and implements a policy. Retraining is 

performed and documented.

Documents 

Required

Written Policy, Record.

Mandatory

Example Scenarios 

Scenario 1: A written procedure is not in place; however, the auditor observes the employees 

taking temperatures where required.

Assessment: Not Applicable. 

Reason: Not Applicable unless temperature control is required for food safety.

Scenario 2: Temperatures are recorded on the bill of lading and not on a checklist. 

Assessment: Not Applicable. 

Reason: Not Applicable unless temperature control is required for food safety.

Requirement P-10.5. The operation shall have a policy, written procedures, and a 

checklist to verify cleanliness and functionality of shipping units (e.g., 

trailer).

Procedure Shipping units shall be clean, functional and free of objectionable odors 

before loading, in compliance with current industry practices or 

regulatory requirements for that commodity. Refrigeration units, if 

used, must be in working order. Procedures prohibit raw animal or 

animal product transport, or other materials that reasonably may be a 

source of contamination with biological, chemical (including allergens) 

or physical hazards, unless appropriate risk mitigation strategies are in 

place. Shipping units shall be washed between loads if prior transport 

included materials that reasonably may be a source of contamination. A 

responsible individual shall sign or initial the completed checklist or 

inspection report.

Verification Auditor reviews cleaning procedures and inspection records and 

inspects produce transport vehicles for cleanliness.

Corrective 

Action

Operation develops the policy and written procedures. Retraining is 

performed and documented. Affected product is evaluated for potential 

contamination and disposition.

Documents 

Required

Written Policy, Record.

Mandatory ●
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(See requirement F-14.1) 

Requirement P-10.6. Loading/unloading procedures and equipment shall minimize 

damage to and prevent contamination of produce.

Procedure Personnel responsible for the loading and unloading of produce shall 

take steps to minimize the potential of physical damage to produce, 

which can introduce and/or promote the growth of pathogens. 

Loading/unloading equipment shall be clean and well maintained and of 

suitable type to avoid contamination of the produce.

Verification Auditor observes loading/unloading procedures for evidence of practices 

that result in excessive damage to produce. Auditor observes 

loading/unloading equipment for suitability and condition.

Corrective 

Action

Operation revises procedures. Retraining is performed and 

documented. Affected product is evaluated for potential contamination 

and disposition.

Documents 

Required

N/A.

Mandatory

(See Requirement F-14.2) 
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USDA LOGO USE

This section is to be completed only for applicants who have applied and are in possession of an 

official Specialty Crops Inspection letter signed by the Director, approving them to use the GAP 

and GHP logo. The GAP & GHP logo is only permitted for use by participants that meet the GAP 

and GHP program logo use requirements. 

The participant must have met the acceptance criteria for all audit scopes applicable to their 

operation. For example, a farming operation that grows, harvests, packs, and ships fruits and 

vegetables must be audited to the scope of the audit for each of those four activities. The checklist 

will be completed as part of the audit process on all subsequent audits as long as the participant 

continues to meet the USDA acceptance criteria of the GAP & GHP audit program. 

L-1 Food Safety Plan or Quality Manual 

Requirement L-1.1. The operation’s food safety plan or quality manual contains 

procedures on how the USDA GAP & GHP logo will be used.

Procedure The operation shall have a written policy describing proper use of the 

logo including having attained approved GAP & GHP program status 

by meeting the acceptance criteria for the audit being performed 

covering all scopes of the audit which are applicable to their operation. 

All commodities grown, handled or processed by the operation must be 

covered by the audit.

Verification Auditor shall review the Food Safety Plan for detailed and complete 

procedures on logo use.

Corrective 

Action

The operation shall develop procedures on USDA GAP & GHP logo use.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

If a farming operation which grows, harvests, packs, and ships fruits and vegetables, they must be 

audited to the scope of the audit associated with those activities. For instance, if an operation has a 

farm and a separate packinghouse facility, but only requests to be audited against the Farm and 

Field Harvest Operation’s scope, they would not be eligible to use the logo. In addition, any 

commodities grown on the farm, whether intended to be included on the audit or not, must be 

included and covered under the audit.
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Requirement L-1.2. There is a designated person to be responsible for the control of 

inventory bearing the logo.

Procedure The operation shall designate, in their food safety plan or quality 

manual, an individual or individuals that are responsible for the control 

of inventory (any containers or labels) bearing the logo or language.

Verification Auditor verifies there is a designated person responsible for control of 

inventory bearing the logo. 

Corrective 

Action

Operation designates an individual, in their food safety plan or quality 

manual, to be responsible for the inventory bearing the USDA logo. 

Documents 

Required

Written Policy.

Mandatory ●

L-2 Traceability and Recall Program

Requirement L-2.1. The operation uses the USDA GAP & GHP logo only on packages, 

containers, or consumer units which are traceable.

Procedure The operation shall have a policy that prohibits the use of the logo on 

any packages, containers or consumer units that are not part of the 

established traceability program.

Verification Auditor reviews policy and observes packages labeled at the facility with 

the USDA GAP&GHP logo are traceable. 

Corrective 

Action

Operation develops policy.

Documents 

Required

Written Policy.

Mandatory ●

L-3 Approved Suppliers 

Requirement L-3.1. The operation has supplied a list of approved suppliers to the 

local Federal or State auditor’s office.

Procedure Operation supplies the local Federal or State office who conduct the 

audits, with a current list of approved suppliers. The operation will 

notify the office of any additions to the suppliers list as well as if a 

supplier is no longer in compliance and must be removed from the list.

Verification Auditor reviews record showing all names of suppliers and verifies dates 

of when their names were given to the local auditor’s office.

Corrective 

Action

Operation supplies list to the local offices.

Documents 

Required

Record.

Mandatory ●
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Requirement L-3.2. All suppliers currently in use by the operation are listed on the 

supplied list of approved suppliers.

Procedure Operation procures ingredients and materials only from approved 

suppliers.

Verification Auditor reviews receipt records and compares suppliers of ingredients 

and materials against list of approved suppliers.

Corrective 

Action

Operation updates and or creates list of approved suppliers, and 

procures only from these suppliers.

Documents 

Required

Written Policy, Record.

Mandatory ●

L-4 GAP & GHP Logo Approved Use 

Requirement L-4.1. The logo is only used on products, processes, and packaging as 

approved on the SC-652.

Procedure The operation shall have a copy of the approved SC-652 which lists the 

products, processes, and packaging types and any other way the logo is 

approved to be used, including websites, social media and banners. The 

logo is being used as approved. 

Verification Auditor verifies that the operation is only using the logo as approved on 

the SC-652.

Corrective 

Action

Operation discontinues use of packaging on unapproved products, 

processes, and/or packaging.

Documents 

Required

Record.

Mandatory ●

Expectation 

Packaging type should be specified for each product on the SC-652 according to how the logo is 

approved to be used i.e. cartons, lugs, flats, master cartons, or bags. The operation shall only use 

the type of packaging that’s specified on the form. The operation is restricted from using the logo 

beyond what is listed on the SC-652 and Specialty Crops Inspection Division approval letter. If 

only approved to use the logo on their website, social media and promotional material, the operation 

cannot use the logo in any other way.
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Requirement L-4.2. All packaging or labels, which bear the GAP & GHP logo, are 

accountable items.

Procedure The operation shall have a policy stating all packaging or labels are 

accounted for.

Verification Auditor reviews policy.

Corrective 

Action

Operation develops policy that ensures accountability of all packaging

or labels bearing the logo.

Documents 

Required

Written Policy, Record.

Mandatory ●

Requirement L-4.3. The operation’s inventory list of these packaging or labels is 

maintained and current.

Procedure The operation shall have an inventory list of any packaging or labels 

bearing the logo or language.

Verification Auditor reviews records for accuracy and to ensure inventory list is up 

to date.

Corrective 

Action

Operation develops and maintains an inventory list of all packaging and 

labels.

Documents 

Required

Record.

Mandatory ●

Requirement L-4.4. The logo is only used on packaging and labels that are clean and 

bright in appearance, without marks, stains, or other evidence of 

previous use.

Procedure The operation is only using packaging and labels that are clean and 

bright in appearance without marks, stains, or other evidence of 

previous use. 

Verification Auditor verifies that packaging and labels are clean and bright in 

appearance. 

Corrective 

Action

Operation updates their practices to use the logo on packaging and 

labels that are clean and bright in appearance. 

Documents 

Required

Record.

Mandatory ●
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TOMATO AUDIT PROTOCOL

In 2019, a Tomato Audit Protocol working group met to update the tomato metrics. As part of this 

update, it was decided that these tomato metrics would only include those requirements that were 

unique to tomatoes or were not in the Harmonized Standard and are intended to be used as an 

addendum to the Harmonized Standard, or other GAP Program. These metrics can be found on the 

Harmonization Initiative’s Website: https://www.unitedfresh.org/food-safety/gap-harmonizationinitiative/. 

USDA has incorporated the Tomato Audit Protocol Addendum into the USDA Harmonized GAP 

and USDA Harmonized GAP Plus+ audit programs as an option to be requested by a tomato 

producer, packer, distributor, or repacker to verify additional tomato specific requirements are being 

met. There are four distinct addendums for the different segments of the tomato industry: Openfield Production and Harvesting, Packinghouse, Greenhouse, and Repacking and Distribution. 

OPEN-FIELD PRODUCTION AND HARVESTING

The development of good agricultural practices for field tomato production must consider all the 

elements of the field production system: location of field site, prior land use, land preparation, 

adjacent land use, agricultural inputs (such as irrigation water, fertilizers, and crop protection 

materials), workers and production practices, single or multiple harvests. Microbial contamination 

can occur from several different sources; evaluation of these risks, and their management, are 

essential to proper food safety procedures in the production of fresh tomatoes. 

TOF-1 Management Responsibility

Requirement TOF-1.1 Operation has current copies of the Commodity Specific Food 

Safety Guidelines for the Fresh Tomato Supply Chain, Food Safety 

Programs and Auditing Protocol for the Fresh Tomato Supply Chain, 

the relevant Harmonized Food Safety Standard, and additional food 

safety documents as required by state and/or federal regulation.

Procedure Operation has a current copy of the Guidelines, this audit document and 

all other required documents. 

Verification Auditor observes the current copies at the operation. 

Corrective 

Action

Operation obtains current copies. 

Documents 

Required

Record.

Mandatory ●

Expectation 

Confirmation that the auditee has current copies of the Commodity Specific Food Safety Guidelines 

for the Fresh Tomato Supply Chain, Food Safety Programs and Auditing Protocol for the Fresh 

Tomato Supply Chain, and the relevant Harmonized Food Safety Standard shall be discussed with 

the auditee prior to the audit. If the auditee does not have the most recent version of these 
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documents, the auditor may provide an internet link or a pdf document for the auditee prior to the 

audit. Verification that copies of these documents are available to the auditee will be made during 

the audit. 

Example Scenarios 

Scenario 1: Operation has a current copy of the Commodity Specific Food Safety Guidelines for the 

Fresh Tomato Supply Chain, Programs and Auditing Protocol for the Fresh Tomato Supply Chain 

and additional food safety documents as required by state and/or federal regulation this audit 

document and all other required documents. 

Assessment: Compliant 

Reason: Operation has a current copy of the Commodity Specific Food Safety Guidelines for the 

Fresh Tomato Supply Chain and additional food safety documents as required by state and/or 

federal regulation. 

 

Scenario 2: Operation does not have a current copy of the Commodity Specific Food Safety 

Guidelines for the Fresh Tomato Supply Chain, Programs and Auditing Protocol for the Fresh 

Tomato Supply Chain and additional food safety documents as required by state and/or federal 

regulation. 

Assessment: Corrective Action Needed. The auditee will need to obtain the most current copy of 

the of the Food Safety Programs and Auditing Protocol for the Fresh Tomato Supply Chain. 

Reason: Operation does not have a current copy of the Commodity Specific Food Safety Guidelines 

for the Fresh Tomato Supply Chain, Programs and Auditing Protocol for the Fresh Tomato Supply 

Chain and additional food safety documents as required by state and/or federal regulation. 

 

TOF-2 Self-Audits 

Requirement TOF-2.1 Operation has procedures for conducting self-audits and 

conducts self-audits to verify compliance with established internal 

policies and procedures.

Procedure In addition to the requirements of the Harmonized Standards, the 

operation’s self-audit procedure ensures compliance with established 

internal policies and procedures, Commodity Specific Food 

Safety Guidelines for the Fresh Tomato Supply Chain, these Tomato 

Metrics, and additional food safety documents as required by state 

and/or federal regulation. 

Verification Auditor reviews the self-audit procedures, and records of self-audits to 

verify compliance with the procedures.

Corrective 

Action

Operation obtains current copies. Operation develops and maintains 

self-audit program, with corrective actions preventive measures, 

documentation and follow-up. 

Documents 

Required

Written Policy, Record.

Mandatory ●

Expectation 
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Auditees must conduct self-audits to verify compliance with established internal policies and 

procedures. There is not a specified format for the self-audit. The self-audit must verify the 

requirements of the Harmonized Standard being utilized and Tomato Audit Protocol Open-Field 

Production Addendum requirements. 

Example Scenarios 

Scenario 1: The operation has procedures for conducting self-audits and conducts self-audits 

annually, but you find that the operation uses a self-made checklist for conducting self-audits. 

Assessment: Compliant 

Reason: As long as the self-audit performed addresses the requirements of the Harmonized 

Standards, ensures compliance with established internal policies and procedures, Commodity 

Specific Food Safety Guidelines for the Fresh Tomato Supply Chain, the Tomato Metrics, and 

additional food safety documents as required by state and/or federal regulation. 

Scenario 2: The operation maintains that they conduct self-audits but do not have a record of the 

self-audit. 

Assessment: Corrective Action Needed. 

Reason: The requirement requires a written policy and records. Records should document when 

the self-audit was started and completed.

Scenario 3: Operation develops and maintains a self-audit program, including a written record of 

required corrective actions and follow-up procedures but does not include preventive measures. 

Assessment: Compliant or Corrective Action Needed. 

Reason: If the operation has sufficiently satisfied the requirements of checklist questions G-8.1 

and G-9.1, this checklist question shall be assessed as compliant.

TOF- 3 Field History and Pre-harvest Assessments

Adjacent land use must be assessed for conditions that may pose a risk to tomato production. These 

risks may include runoff from animal operations or other sources of contamination, domesticated 

animals, wildlife, chemical or sewage treatment plants, landfills or other conditions that pose a food 

safety risk. Appropriate measures must be taken to mitigate any identified food safety risks. These 

measures may include berms, fences, ditches, buffer zones or other strategies to mitigate any known 

risks.
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Requirement TOF-3.1 If the field is subject to flooding, operation has an established 

decision tree or corrective action plan in the event of flooding in the 

production area. Procedures prohibit harvest of product that has come 

into contact with flood waters.

Procedure Flooding is defined as the uncontrolled introduction of large amounts of 

water of unknown quality into the production area that is reasonably 

likely to come into contact with the edible portion of the crop, or 

otherwise cause adulteration of the crop. If the field is subject to 

flooding, procedure is established that includes a decision tree or 

corrective action to take in the event of flooding in a production area. 

Procedure specifies performance of a written risk assessment, which will 

consider whether there is an increased potential of contamination from 

the flood event. If warranted by the risk assessment, a no-harvest zone is 

positioned so that operations in the non-flooded zone are not 

compromised by the flooded zone; for example, 10 feet. 

Verification If the field is subject to flooding, auditor verifies that the operation has a 

policy/procedure regarding flooded fields. Auditor looks for evidence of 

flooding in the field. If the field has flooded since the last audit, the 

auditor observes the operation's risk assessment for current 

acceptability of the field and/or crop.

Corrective 

Action

Operation develops a written procedure for flooded fields. Operation 

must obtain/develop a written risk assessment for the relevant field. 

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

It is important to make the distinction between flooding versus standing water remaining from poor 

drainage after irrigation or substantial rain. Even though any standing water may pose a significant 

contamination risk to the crop, it’s important not to report standing water remaining from poor 

drainage after irrigation or substantial rain as flooding, as the water would not be of unknown 

quality. Standing water that shows signs of algae or insect larva should still be documented and 

reported.

Example Scenarios 

Scenario 1: The operation states that the production area has not flooded in the thirty years that 

they have been growing tomatoes on the land, so a written policy, corrective action plan or decision 

tree has not been established. During the walk through of the field, the auditor observes signs of 

flooding in rows of crops nearest the elevated road. 

Assessment: Immediate Action Required

Reason: Substantial amounts of water that is of unknown quality contacting the edible portion of 

the crop would be considered an Immediate Action Required. Water that is clearly caused by runoff from a road should be considered a contaminant after heavy rainfall. 
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Scenario 2: In checklist question F-1.1, the operation has documented the risk associated with the 

land and adjacent land use history that includes equipment, structures, the possibility of physical, 

biological and chemical contamination with preventative controls, corrective actions and procedures 

that prohibit harvest of product that has come into contact with contaminates and the disposition of 

any possible contaminated product, but the written policy does not specifically state flooding as a 

possible contaminate.

Assessment: Compliant or Corrective Action Needed

Reason: If the field is not subject to flooding this would be compliant. If the field is subject to 

flooding this would be corrective action needed. 

Scenario 3: The operation irrigates with furrows between the raised beds of crops. They do not 

have a written policy or decision tree for what to do in case of flooding because the field is above 

grade on all sides. The water used for irrigation is sourced from a well system and water test results 

show the water meets potable water standards. The auditor observes that several furrows still 

contain large amounts of water from the previous day’s irrigation. The auditor can see that the 

water in the furrows has not been there long enough for algae growth or insect larva to form. 

Assessment: N/A

Reason: If the field is not subject to flooding, a written policy or decision tree is not required.

Requirement TOF-3.2 Operation shall conduct the required Combined Harmonized 

Standard F-9.1 pre-harvest risk assessment no more than five (5) days 

from the first scheduled harvest date.

Procedure The environmental assessment is reperformed, and documented, for 

environmental conditions that reasonably may have changed since the 

last assessment, including flooding, adequacy of water sources for their 

intended use, adjacent land uses, animal migrations, debris, worker 

health and hygiene, or other potential sources of fruit adulteration.

Verification Auditor reviews the reassessment document, including corrective action 

documents for mitigations or deficiencies identified in the preproduction risk assessment, and confirms the assessment occurred 

within five (5) days of the first scheduled harvest date.

Corrective 

Action

Operation develops or modifies the document, or reviews, as needed. 

Perform training as needed. 

Documents 

Required

Risk Assessment.

Mandatory ●

Expectation 

A documented pre-harvest risk assessment must be conducted prior to harvest, no more than five 

days from the first scheduled date. This assessment must include any environmental conditions that 

may have changed since the last assessment, the adequacy of the water source being used, adjacent 

land uses, animal migrations, debris, worker health and hygiene and any other potential sources of 

contamination. 

Example Scenarios 
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Scenario 1: The operation has performed a pre-harvest assessment, and it includes an evaluation of 

conditions that may be reasonably likely to result in physical, chemical, or biological contamination 

of the produce. Results of the evaluation are documented but it does not depict when the assessment 

was performed.

Assessment: Corrective Action Needed, 

Reason: The assessment must have been completed within five days of the expected harvest date. 

Scenario 2: The operation completed a risk assessment dated seven days prior to the harvest date, 

the field manager states that they could not begin to harvest crew due to a shortage of personnel. 

Assessment: Compliant or Corrective Action Needed

Reason: The auditor would need to determine if there were environmental conditions that 

reasonably may have changed since the last assessment.

Scenario 3: A second environmental assessment in the form of a review, based upon current 

conditions is conducted not more than five (5) days from the first scheduled harvest date, but the 

assessment is not signed by the field manager.

Assessment: Compliant 

Reason: The requirement does not state that the assessment must be signed.

TOF- 4 Workers Health/Hygiene and Toilet/Handwashing Facilities 

Requirement TOF-4.1 A response plan is in place in the event of a major spill or leak 

of field sanitation units.

Procedure A written corrective response plan is developed and implemented in the 

event of a major leak or spill.

Verification Auditor verifies existence of the plan and interviews the responsible 

person for knowledge.

Corrective 

Action

Operation prepares or edits the plan. Retrain or replace the responsible 

person.

Documents 

Required

Written Policy, Record.

Mandatory ●

Expectation 

(See requirement G-10.7) 

Example Scenarios 

Scenario 1: A response plan is in place in the event of a major spill or leak of field sanitation units 

but it is not a written policy in the operation’s Food Safety Plan. The field manager states, we 

would call the company who services the units and flag off a ten-foot area around the unit. 

Assessment: Corrective Action Needed. 

Reason: A written corrective response plan must be part of the operation’s Food Safety Plan and 

implemented in the event of a major leak or spill.
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Scenario 2: The field supervisor states that the cleaning crew is responsible for any spills or leaks 

from the field sanitation units and shows you the written policy which states that the company who 

services the units should be contacted in case of a major spill or leak. The policy goes on to state 

that an eight-foot area around the spill should be flagged off to ensure that any affected produce will 

not be harvested. The auditor interviews the person in charge of the cleaning crew to verify that the 

responsible person is aware of the procedure. The cleaning crew lead states that it is the field 

supervisor’s responsibility to contact the service company and flag the area. 

Assessment: Corrective Action Needed. 

Reason: If it is not clear that someone from the operation is going to accept responsibility, the 

written policy needs to be revised and retraining performed. 

Scenario 3: During the inspection of the sanitation units, the auditor observes a wet area under the 

hand washing sink, upon further investigation, it is determined that the hand washing sink drainage 

is leaking. 

Assessment: Corrective Action Needed. 

Reason: Even if the leaking gray water is not directly affecting the production area, there is still a 

possibility that contaminants could runoff into the production area if left unchecked. The auditor 

should be able to determine by the amount of liquid, the size of the wet area and visual verification 

of the location of the leak as to if the leaking gray water would be reasonably likely to contaminate 

the crops. 

Requirement TOF-4.2 If hand wash water tanks are used, they are cleaned and 

sanitized and the water is changed periodically.

Procedure Water tanks used to provide hand wash water shall be maintained at a 

prescribed frequency in a clean and sanitary manner.

Verification Auditor reviews cleaning and sanitizing protocol and service logs, and 

visually observes condition of water tanks for signs of noncompliance.

Corrective 

Action

Clean and sanitize the tank, replace water to compliance.

Documents 

Required

Record.

Mandatory ●

Expectation 

Water used for handwashing must be stored in a manner that maintains the quality of the water for 

no detectable generic E. coli in 100 mL of water. Part of this maintenance is to ensure that tanks 

used to store water are cleaned and sanitized at a prescribed frequency. Additionally, water stored 

in tanks must be changed periodically. 

Example Scenarios 

Scenario 1: Auditor reviews cleaning and service records for the operation’s field sanitation units 

and confirms that the units are inspected every two hours and were serviced and cleaned the 

previous day, the service record does not specifically state that the hand wash water tank was 

cleaned and sanitized at the time of servicing. The auditor requests the service company SOP for 
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cleaning and sanitizing, the SOP states that the tanks are cleaned and sanitized at the beginning of 

each season and can produce records to confirm.

Assessment: Compliant

Reason: The Food Safety Programs and Auditing Protocol for the Fresh Tomato Supply Chain 

states that the hand wash water tanks are to be cleaned and sanitized and/or shall be maintained 

periodically or at a prescribed frequency.

Scenario 2: Auditor observes that the hand wash water tank at the field sanitation unit contains 

sediment of unknown origin, what appears to be green or black water marks around the inside 

perimeter of the tank and the tank lid is not secured. The auditor requests the most recent service 

records for the sanitation unit and finds that it was serviced and cleaned that morning by the 

operation’s cleaning crew. The auditor requests the company SOP for cleaning and servicing of the 

unit and finds that it states that the hand wash water tanks will be cleaned, sanitized, and filled as 

needed.

Assessment: Immediate Action Required.

Reason: The company is not following its SOP regarding cleaning and sanitizing the hand wash 

water tanks.

Scenario 3: Upon inspection of the sanitation units the auditor observes that one sanitation station 

hand wash water tank is empty. The auditor notes that each sanitation station is comprised of four 

hand washing sinks, two water holding tanks each with four faucets, two toilets, four soap 

dispensers and four paper towel dispensers. The auditor also notes that it is nearing the end of the 

harvest crews’ workday and all the other hand wash water tanks observed contain water. The 

sanitation stations are spaced one hundred yards apart to be within one quarter mile or a five-minute

walk from where the eight harvest crews are working. 

Assessment: Compliant

Reason: The operation has a sufficient number of sanitation stations and a sufficient amount of 

water in the second tank on that particular sanitation station.
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Requirement TOF-4.3 Policies shall require hand washing with soap and potable 

water at the appropriate time, such as before starting work, after use of 

toilet facilities, after breaks and when hands may have become 

contaminated. Policy shall apply to employees, outside contractors, 

inspectors, and visitors. Compliance is emphasized by management. 

Procedure Operation shall have a written SOP regarding hand washing practices. 

Operation management reinforces importance of and compliance with 

handwashing policy. Sanitizers may not be used in lieu of soap and 

water hand washing, but may be used to supplement. If gloves are used 

when contacting tomatoes or food contact surfaces, policies will clearly 

communicate that gloves are not a replacement for good handwashing 

practices.

Verification Auditor observes handwashing practices of employees and visitors for 

compliance. If handwashing practices are observed to be compliant, 

auditor will judge management emphasis to be sufficient. Affected 

product is evaluated for potential contamination and disposition.

Corrective 

Action

SOP is developed or revised. Retraining is performed. Management 

increases frequency of or approach to reinforcing hand washing policy.

Documents 

Required

Written Policy, Record.

Mandatory ●

Expectation 

The operation must have a written policy for hand washing with soap and potable water at the 

appropriate times, see requirement G-10.1 for additional guidance. When gloves are used by 

workers that will contact tomatoes or food contact surfaces, the policy must clearly communicate 

that gloves are not a replacement for good handwashing practices, see G-10.11 for additional 

guidance on glove use. 

Example Scenarios 

Scenario 1: While the auditor is observing handwashing practices for compliance, the auditor 

notes that some employees returning from lunch break are only spending five to ten seconds to 

soap, wash and dry their hands. The supervisor escorting the auditor does not think that it’s an 

issue. The auditor notes that easily understandable hand washing signs are posted and specifically 

state that hands should be washed for a minimum of twenty seconds. The auditor recalls that the 

operation’s written SOP states that proper hand washing procedure is to wet, soap and wash hands 

for a minimum of twenty seconds with hot water. 

Assessment: Immediate Action Required.

Reason: The operation’s management is not reinforcing the importance of proper hand washing. 

Scenario 2: The auditor observes that a person exiting the sanitation station did not wash his 

hands. The person is determined by the auditor’s escort to be from an outside company installing 

irrigation pipes in the field. The supervisor states that the person is not working in or around the 

production areas. 
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Assessment: Immediate Action Required. 

Reason: The standard requires that all persons be compliant to the operation’s hygiene policy. 

Scenario 3: At a field sanitation station as the auditor is observing harvest crew hand washing 

practices, the auditor notes that most crew members are only wetting and drying their hands and 

then applying hand sanitizer. The field supervisor states that hand sanitizer is a sufficient substitute 

for soap and water because the crew are all required to use single use gloves while harvesting. The 

company SOP states the same.

Assessment: Immediate Action Required.

Reason: Sanitizers may not be used in lieu of soap and water hand washing but may be used to 

supplement. If gloves are used when contacting tomatoes or food contact surfaces, policies will 

clearly communicate that gloves are not a replacement for good handwashing practices.

Requirement TOF-4.4 If gloves are used, there must be a written SOP regarding their 

use.

Procedure If gloves are used for product or food contact purposes, operation shall 

have a written policy and SOP regarding their use, maintenance and 

disposal, including cleaning of reusable gloves, not taking gloves into 

restrooms or eating areas, replacing gloves that may be damaged or 

have become a source of contamination. The SOP should also address 

limitations of use of non-sanitary gloves (i.e., work gloves). The SOP will 

require that reusable gloves shall not be taken home by workers for 

cleaning and sanitizing.

Verification If gloves are used, auditor reviews the SOP, records of SOP 

performance, and visually verifies that glove use is consistent with the 

SOP; i.e., gloves at the beginning of tomato handling activities are clean 

and not damaged; workers are observed to not wear gloves into 

restrooms or eating areas; and that gloves are not taken into restrooms

or eating areas.

Corrective 

Action

SOP is developed or revised. Non-compliances are corrected on site. 

Retraining is performed.

Documents 

Required

Written Policy, Record.

Mandatory ●

Expectation 

If gloves are used and will contact product or food contact surfaces, the operation must have a 

written policy regarding their use. This SOP should also address limitations on the use of nonsanitary gloves. The policy must also require that reusable gloves shall not be taken home by 

workers for cleaning and sanitizing. See G-10.11 for additional guidance on glove use. 

Example Scenarios 

Scenario 1: During the auditor’s observation of harvesting activities, the auditor observes that the 

harvesters are all wearing different types of gloves. When the auditor asks the field manager about 

glove use, the field manager states that harvest crews are permitted to bring their own gloves from 
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home as long as they are maintained in an intact and sanitary condition at the start of the day and as 

long as they leave the gloves in the field during break or lunch. The auditor continues observation 

of harvest crews until it’s time for the crew to take a break. After the break the auditor notes that 

the harvest crew members are washing their hands and putting on the same gloves that they had 

been using prior to their break, several of the gloves observed were dirty, torn or wet. The field 

manager does not consider the use of the same gloves as a problem. The company SOP states that 

gloves are to be cleaned and sanitized prior to use each day and should be changed if they become 

contaminated, torn or wet. 

Assessment: Immediate Action Required

Reason: Gloves must be changed when they have become torn wet or contaminated, and at any 

time when hands would need to be washed. Appropriately cleaned and sanitized gloves shall be 

issued each day and at such times as needed during the day. Gloves shall not be permitted to be 

taken home by workers. 

Scenario 2: The operation’s SOP states that appropriately cleaned and sanitized gloves shall be 

issued to the harvest crews each day and at such times as needed during the day. The field manager 

keeps a log of to whom and when gloves are issued each day and collects the gloves at the end of 

each day. The gloves are then taken to the packinghouse where they are washed in a cloth washing 

machine and sanitized with the use of chlorine bleach for distribution and use the following day. 

Assessment: Compliant 

Reason: If gloves are utilized, a procedure for glove use must be documented and followed so that 

glove use does not become a source of contamination. Appropriately cleaned and sanitized gloves 

shall be issued each day and at such times as needed during the day.

Scenario 3: In a packinghouse that handles fresh tomatoes, the operation requires that anyone 

handling tomatoes or food contact surfaces wear single use gloves. New single use gloves are made 

available at entrances to the packing facility, hand washing stations and at each sorting line where 

tomatoes are handled. The operation’s written SOP states that single use gloves are required when 

handling any product or food contact surfaces and must be removed before lunch breaks or using 

the restroom and replaced after hands are washed and before commencing work duties. The auditor 

observes and verifies that the employees and staff are following the written policy. 

Assessment: Compliant. 

Reason: The facility has a written procedure regarding glove use and it is being followed by the 

employees and staff. 

TOF- 5 Pesticides
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Requirement TOF-5.1 Pesticide Usage Water used to mix pesticides meets FDA E. coli

standards for water in 21 CFR § 112.44(a); i.e., no detectable generic E. 

coli in 100 mL of agricultural water.

Procedure Operation has a written policy requiring foliar-application pesticides to 

be diluted only with water that meets FDA microbial standards for postharvest agricultural water. Operations will have documentation 

demonstrating compliance, such as test results for the water source used.

Verification Auditor reviews the policy and inspects pesticide mixing and application 

records.

Corrective 

Action

Operation develops a written policy. Retraining of pesticide applicator 

as needed. If unknown or non-drinking quality water was used to 

prepare pesticides, then test the water source for compliance with FDA 

E. coli standards for post-harvest agricultural water. Do not harvest 

product unless water test results demonstrate compliance.

Documents 

Required

Record.

Mandatory ●

Expectation 

Records of testing for agricultural water must be maintained. It is not required that operations test 

agricultural water when water is provided by a public water supply (Municipal) that furnishes water 

meeting the microbial quality requirement, but results or certificates of compliance from the public 

water supplier that demonstrate the water meets the applicable standards are required. It is not 

required that operations test agricultural water when the water is treated by a method effective to 

make the water consistently safe and of adequate sanitary quality for its intended use and/or to meet 

the required standards. If treated, the treatment must be monitored at an adequate frequency to 

ensure that the water is consistently safe and of adequate sanitary quality for its intended use.

Example Scenarios 

Scenario 1: The operation has a written policy requiring foliar-application pesticides to be diluted 

only with water that meets FDA microbial standards for drinking water. The operation contracts 

ABC Ag Air Services for application of all pesticides. The auditor reviews the water test records 

for the water used by ABC Ag Air Services for compliance and finds that the water is from a 

municipal source that meets EPA microbial standards for drinking water and annual testing is 

performed and documented by the municipality. The operation maintains the most recent records of 

the tests.

Assessment: Compliant 

Reason: Water used to mix pesticides meets EPA microbial standards for drinking water; 21 CFR 

Part 112.44(a). 

Scenario 2: Applications of pesticides are contracted through XYZ Ag Services. The contractor 

and the operation use the XYZ Ag Services electronic program as documentation for applications of 

pesticides. The XYZ electronic program includes the field serviced, the chemical and amount used, 

the target organism and justification for the application. The XYZ Ag Services website contains a 
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statement that all foliar chemical applications are applied with potable water. The operation does 

not keep records of the water tests performed for the water used by the contracted company nor are 

they posted on the XYZ Ag Services website. 

Assessment: Corrective Action Needed. 

Reason: Operations will have documentation demonstrating compliance, such as test results for the 

water source used.

TOF- 6 Water Used in Growing Activities

Requirement TOF-6.1 Non-Foliar The water test meets FDA E. coli standards for 

foliar application water as described in 21 CFR § 112.44(b).

Procedure Written procedure requires a BAM or other testing procedure validated 

for generic E. coli quantitation in water.

Verification Auditor reviews water test results and any corrective actions taken to 

bring the water source into compliance.

Corrective 

Action

Perform a sanitary survey for each affected water source, perform any 

remedial action as required and retest. If the retest also exceeds the 

standard, further evaluate potential corrective actions, such as 

treatment, retreatment, or discontinue use of source.

Documents 

Required

Record.

Mandatory ●

Expectation 

The Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain specify that 

any water used for drip irrigation or non-contact uses shall meet the standard for E. coli levels of:

1. A geometric mean of 126 or less colony forming units (CFU) of generic E. coli per 

100 mL of water, AND

2. A statistical threshold value (STV) of 410 or less CFU of generic E. coli per 100 mL 

of water.

Example Scenarios 

Scenario 1: The tomato growing operation irrigates by use of furrows between the beds of crops. 

The operation has a written policy that states tomatoes which have been found in the furrows or in 

contact with the ground during harvesting operations are not to be harvested. When irrigating, the 

furrows are filled with water from an enclosed well. The most current water tests reviewed show 

<1 ppm/100 mL for generic E. coli and total coliforms.

Assessment: Compliant 

Reason: Any non-foliar application of water to tomatoes (e.g., irrigation or crop protection sprays) 

shall meet the microbial standards contained in 21 CFR 112.44(b) 

Scenario 2: The growing operation irrigates by use of furrows between the beds of tomatoes. The 

water is from an aqueduct system that is tested every month, the testing shows that over the last 
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twelve months the water never exceeded a geometric mean of 126 colony forming units of generic 

E. coli per 100 mL of water and a statistical threshold value of 410 or less CFU of generic E. coli

per 100 mL of water.

Assessment: Compliant. 

Reason: Any water used for drip irrigation or non-contact uses shall meet the standard for E. coli

levels of (1) A geometric mean (GM) of 126 or less colony forming units (CFU) of generic E. coli

per 100 mL of water and (2) a statistical threshold value (STV) of 410 or less CFU of generic E. 

coli per 100 mL of water.

Scenario 3: A tomato growing operation irrigates using drip tape embedded in the grow beds. The 

water is sourced from an aqueduct system. Prior to reaching the grow beds, the water passes 

through six filters and a system that adds a chlorinated liquid that the Auditee states is just to help 

keep the lines clear. Water samples are aseptically collected once each month from the water 

connection after the filters and chlorination system and before the grow beds. The water is tested 

by a GLP certified laboratory using the SM9223B method. All water tests are conducted for 

generic E. coli and total coliforms. The most recent water test results are 2.8 MPN/100 mL., 4.5 

MPN/100 mL., 56 MPN/100 mL., 21 MPN/100 mL., 44 MPN/100 mL, 3.2 MPN/100 mL., 33.2 

MPN/100 mL. 

Assessment: Compliant. 

Reason: Any water used for drip irrigation or non-contact uses shall meet the standard for E. coli

levels of (1) A geometric mean (GM) of 126 or less colony forming units (CFU) of generic E. coli

per 100 mL of water and (2) a statistical threshold value (STV) of 410 or less CFU of generic E. 

coli per 100 mL of water.

Requirement TOF-6.2 Foliar The water test meets FDA standards for water in 21 

CFR § 112.44(a); i.e., no detectable generic E. coli in 100 milliliters (mL) 

of agricultural water. 

Procedure Written procedure requires a BAM or other testing procedure validated 

for generic E. coli quantitation in water.

Verification Auditor reviews water test results and any corrective actions taken to 

bring the water source into compliance. If tomatoes have been contacted 

with noncompliant water, auditor reviews the risk assessment and 

disposition.

Corrective 

Action

Perform a sanitary survey for each affected water source, perform any 

remedial action as required and retest. If the retest also exceeds the 

standard, further evaluate potential corrective actions, such as 

treatment, retreatment, or discontinue use of source. Operation shall 

evaluate tomatoes that have been contacted with noncompliant water to 

assess food safety risk. The assessment is documented and tomatoes 

dispositioned accordingly.

Documents 

Required

Record.

Mandatory ●

Expectation 
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The Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain specify that 

any water used for foliar application of water (e.g. irrigation or crop protection sprays) shall have no 

detectable generic E. coli in 100 mL of agricultural water. 

Example Scenarios 

Scenario 1: The farm relies on rainwater for irrigating their crops, a private on site well is 

available for dry years if enough rain has not fallen. The operation has not had the well water tested 

in three years but uses the same well for the farmhouse and a barn that houses the farms animals. 

The farmer states that the water is safe enough for his wife and family because they never got sick 

from its use. The farmer goes on to say that he used the well for irrigation directly after planting the 

propagation materials received from the greenhouse down the road and again about three weeks ago 

for plant protection and fertigation and plans to use the well water again if necessary, just prior to 

harvesting. The farm applies the well water by overhead sprinkler.

Assessment: Immediate Action Required. 

Reason: Records of testing of agricultural waters must be analyzed and maintained. Operations 

will have documentation demonstrating compliance, such as test results for the water source used.

Scenario 2: The operation applies water for irrigation and crop protection materials with a tractor 

sprayer. The water is sourced from the city where the operation resides. The operation does not 

perform microbial testing on the water but has the report from the city dated less than one year ago. 

The operation states that this is the most recent record available from the city.

Assessment: Compliant. 

Reason: There is no requirement to test any agricultural water that is subject to the requirements of 

§112.44 when water is provided by a public water supply that furnishes water that meets the 

microbial quality requirement described in 21 CFR part 112.44(a). Results or certificates of 

compliance from the public water system are required that demonstrate that the water meets the 

required standards. 

TOF- 7 Soil Amendments 
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Requirement TOF-7.1 If fertilizers containing manures or composts are used, only 

properly treated (composted or heat treated) manures are allowed for 

use in fields. Biosolids are not permitted.

Procedure Soil amendment use records are available, reviewed and current 

(conventional or organic). If treated manures are used, records of 

composition, dates of treatment, methods utilized, application dates and 

letter of guarantee, certificate of analysis (COA) or any test results or 

verification data demonstrating compliance with process or microbial 

standards must be documented. For non-composted animal byproducts-containing soil amendments, the operations shall retain a 

certificate or letter showing the lethality of the process. Compost 

applications shall be no less than 45 days prior to harvest.

Verification Auditor reviews the amendment use documents and records 

demonstrating compliance with prevailing national or local established 

composting or heat treatment standards or guidelines.

Corrective 

Action

Operations must obtain the necessary documents. If the documents 

cannot be obtained, field cannot be harvested for that crop cycle.

Documents 

Required

Record.

Mandatory ●

Expectation 

The Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain specify that 

compost applications shall be no less than 45 days prior to harvest. Only properly treated 

(composts or heat-treated manures) are allowed for use in tomato fields. These guidelines also 

specify that biosolids are not allowed for use in tomato fields. See F-7 for additional guidance on 

the use of soil amendments.

Example Scenarios 

Scenario 1: The operation contracts the fertigation and plant protection material application to 

DEF Agriculture Services, Inc. The applications are requested by the operation through the DEF 

electronic system. The operation produces a letter of guarantee from DEF Services as confirmation 

that all materials applied by DEF contain no animal by-products. 

Assessment: Compliant. 

Reason: The letter of guarantee confirms that the applicator does not use biological soil 

amendments. 

Scenario 2: The tomato growing operation applies treated animal-based soil amendments. The 

documentation confirms that the amendments are applied in October of each year. The operation 

plants the fields in April of each year. The operation produces a receipt for the purchase of the 

compost that confirms it was purchased from GES Farms in October. The receipt includes the 

composition of the soil amendment and the dates of treatment.

Assessment: Immediate Action Required

Reason: If treated manures are used, the following must be documented: composition, dates of 

treatment, methods utilized, application dates and test results or process verification data 
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demonstrating compliance with microbial standards. Evidence of processing adequate to eliminate 

pathogens of human concern, such as letter of guarantee, certificate of analysis (COA) or any test 

results or verification data (e.g., time and temperature) demonstrating compliance with process or 

microbial standards, shall be documented. 

Scenario 3: The small family farm in the northeast growing tomatoes for a local retailer applies 

raw cow manure to his growing fields. The owner states that the manure is from his cow grazing 

fields and barn. The owner states that he applies the manure in October after completing the harvest 

and does not begin to plant new crops until May of the following year. 

Assessment: Immediate Action Required

Reason: If fertilizers containing manures or composts are used, only properly treated (composted 

or heat treated) manures are allowed for use in fields. Biosolids are not allowed for use in tomato 

fields.

TOF- 8 Sanitizing Agents Used During Harvest 

Requirement TOF-8.1 All compounds used to clean or sanitize food contact 

containers, tools, utensils, equipment or other food contact surfaces are 

approved for that use by the US EPA, FDA or other prevailing agency. 

Actual use conforms to label directions.

Procedure Documentation is available to demonstrate that cleaning and sanitizing 

products are approved for their use and are used according to label 

directions. Sanitizing chemicals uses shall be documented.

Verification Auditors review documentation and supplies to confirm approved use, 

and interview individuals responsible for their use for knowledge of 

approved use. Auditor reviews records of use, and visually observes use, 

to verify compliance with label directions.

Corrective 

Action

Non-compliances are corrected on site. Records are reviewed for 

potential product adulteration. Retraining is performed.

Documents 

Required

Record.

Mandatory ●

Expectation 

EPA considers any chemical making an antimicrobial claim, including those used to sanitize 

equipment and tomatoes, to be a pesticide. Sanitizing chemicals used must comply with all 

requirements of EPA registration and any federal, state or local regulations. Sanitizing chemicals 

must be appropriately registered for such use and must be used in accordance with label directions. 

Sanitizing chemicals uses shall be documented.

Any surfaces or equipment intended to touch fresh produce is a food contact surface and must be 

cleaned and sanitized at a frequency sufficient to prevent the surfaces from becoming a source of 

contamination. 

Example Scenarios 
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Scenario 1: The operation uses a disinfecting bleach to clean and sanitize all food contact surfaces, 

containers, equipment and utensils. The facility manager states that the cleaning crew mixes the 

substance in accordance with the label instructions for food contact equipment. The mixing 

instructions are posted at the cleaning chemical mixing areas and records of where, when and what 

was cleaned and sanitized is documented with each use. The auditor reviews the use records, 

verifies that the substance is approved for cleaning and sanitizing and use on food contact 

equipment and interviews the cleaning crew for verification that the proper mixing procedure and 

use is being followed. 

Assessment: Compliant. 

Reason: Documentation is available to demonstrate that sanitizing products are approved for their 

intended use and are used according to label directions. The auditor verified that the substance is 

being mixed and used correctly and sanitizing chemical use is documented. 

Scenario 2: The harvest crew lead supervisor cleans the plastic harvesting containers in a secluded 

area away from the field with a disinfectant. Records indicate that the substance is used every 

evening after harvesting for the day has been completed. The product is mixed in accordance with 

the label instructions. The auditor verifies that the product is approved for sanitizing food contact 

equipment, but notes that the label states surfaces need to be cleaned with a cleaning solution prior 

to disinfectant use. The auditee is unable to produce a record of cleaning prior to disinfecting. 

Assessment: Corrective Action Needed. 

Reason: Unless the label states that it cleans and disinfects, it’s not a cleaning solution. The food 

contact containers need to be cleaned before they are sanitized. (according to the label instructions)

Scenario 3: For cleaning and sanitizing food contact surfaces and equipment, the operation’s 

cleaning crew uses a concentrated chlorine solution used for swimming pools directly from the 

container, after use, the crew rinses the food contact surface with potable water. The auditor 

reviews the label instructions and finds that the chemical is not approved for use on food contact 

surfaces or equipment.

Assessment: Immediate Action Required.

Reason: The product is not approved for use of food contact surfaces or equipment. 

TOF- 9 Product Containers 
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Requirement TOF-9.1 Reusable product bins, trays and containers are made of 

impervious materials that can be cleaned and sanitized.

Procedure Written SOP requires that all re-usable product containers are made of 

materials that can be sanitized, or clean and sanitary liners are used. 

Wood is not an appropriate food contact surface. Procedures require 

damaged containers that are no longer easily cleanable or sanitary shall 

be removed from service of food contact purposes.

Verification Auditor reviews SOP, visually observes product bins, trays and 

containers and their use for evidence of noncompliance.

Corrective 

Action

Policy is developed or revised. Non-compliances are corrected. 

Operation makes a commitment for phasing out nonconforming product 

containers; e.g., wooden bins, in a reasonable timeline. Retraining is 

performed.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

Equipment and tools must be used that are of adequate design, construction, and workmanship to 

enable them to be adequately cleaned, sanitized and properly maintained. They must be maintained 

as to facilitate cleaning of the equipment and of all adjacent spaces; and stored and maintained to 

protect tomatoes from being contaminated with known or reasonably foreseeable hazards and to 

prevent the equipment and tools from attracting and harboring pests. The seams on food contact 

surfaces of equipment and tools used must be either smoothly bonded, or maintained to minimize 

accumulation of dirt, food particles, and organic material and thus minimize the opportunity for 

harborage or growth of microorganisms. 

Equipment and tools must be inspected, maintained, and 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 tomatoes. All non-foodcontact surfaces of equipment and tools used during harvesting, packing, and holding must be 

cleaned and maintained as frequently as reasonably necessary to protect against contamination of 

tomatoes. If equipment such as pallets, forklifts, tractors, and vehicles are used so that they are 

intended to, or likely to, contact tomatoes, they must be used in a manner that minimizes the 

potential for contamination of the produce or food contact surfaces with known or reasonably 

foreseeable hazards.

(See F-8 for additional guidance for equipment and tools.) 

Example Scenarios 

Scenario 1: During the auditor’s observation of harvesting, it is observed that one harvest 

employee has cardboard lining the bottom of his plastic harvest buckets. The auditor asks the 

supervisor if this is a common practice. The supervisor is not aware of the cardboard being used. 

When the supervisor asks the harvest employee about the cardboard, it is learned that the harvest 

employee thought that the cardboard would serve as protection for the tomatoes hitting the bottom 
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of the container. The supervisor immediately issues the employee new harvesting containers, and 

instructs him not to place anything but tomatoes in the containers.

Assessment: Corrective Action Needed. 

Reason: Cardboard cannot be sanitized. Policy revised. Retraining is performed. 

Scenario 2: The small farming operation is harvesting tomatoes into plastic buckets that are then 

collected in the field and dumped into wooden bins for transport to the packinghouse. The wooden 

bins are fitted with new clean plastic sheeting prior to each use. The owner states that plastic bins 

are just too expensive for him to purchase at this time but plans to replace the wood bins with 

plastic bins one or two at a time as the wood bins become unusable. 

Assessment: Compliant. 

Reason: The operation is taking precautions to protect the tomatoes from contamination and has a 

plan to replace the wood bins in a reasonable timeframe. 

Requirement TOF-9.2 Operation has a policy that requires bins trays and boxes made 

of corrugated cardboard are for single use only.

Procedure Written policy prohibits re-use of single-use bins, trays and boxes made 

of corrugated cardboard or fiberboard for product contact purposes.

Verification Auditor reviews policy, observes practices related to corrugated 

cardboard or fiberboard bins, trays and boxes for evidence of 

noncompliance.

Corrective 

Action

Policy is developed or revised. Tomatoes that have been packed in a 

reused cardboard or fiberboard bin, tray or box shall be corrected, 

which may include tomatoes are segregated, washed and repacked in 

new containers, or discarded. Retraining is performed.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

The Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain specifies that 

the reuse of single use containers (e.g., corrugated) for the field packing of tomatoes is prohibited.

Harvest containers, such as fiberboard boxes into which tomatoes are placed when harvested, could 

be the same containers in which the tomatoes are distributed (e.g., when tomatoes are field-packed). 

Food-packing materials also include “food-packaging materials,” a term that has long been used to 

generally refer to a container that directly contacts the food. When a food-packing material is used, 

it must be adequate for its intended use, which includes being: Cleanable or designed for single 

use; and unlikely to support growth or transfer of bacteria. 

Auditors should take the following steps to help determine whether food–packing material is 

adequate for its intended use: Identify the types of food-packing materials used and determine 

whether each type is reusable or for single use. Determine whether the food-packing materials are 

unlikely to support the growth or transfer of bacteria, taking into consideration the handling, 

maintenance, and storage practices; and determine whether reusable materials can be cleaned.
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Example Scenarios 

Scenario 1: The operation uses new fiberboard boxes to package fresh tomatoes, the operation’s 

SOP states that fiberboard boxes are for single use only and the written policy prohibits re-use of 

single use boxes, trays and bins made of corrugated cardboard or fiberboard for product contact 

purposes. 

Assessment: Compliant. 

Reason: Operation has a policy that requires bins trays and boxes made of corrugated cardboard 

are for single use only and the written policy prohibits re-use of single use bins, trays and boxes 

made of corrugated cardboard or fiberboard for product contact purposes. 

Scenario 2: The operation uses new fiberboard boxes to package fresh tomatoes but does not have 

a written policy prohibiting their use or re-use for any purpose. 

Assessment: Corrective Action Needed. 

Reason: The operation does not have a policy that requires bins, trays, and boxes made of 

corrugated cardboard are for single use only. 

Scenario 3: The harvesting operation field packs fresh tomatoes into two-pound plastic clamshells, 

the plastic clamshells are then placed into fiberboard containers. The operation’s SOP states that 

fiberboard containers are designated as single use only the auditor notes that the operation has no 

written policy for the plastic clamshells. The auditor does not observe any re-use of the fiberboard 

containers or plastic clamshells.

Assessment: Compliant. 

Reason: The operation’s SOP states that fiberboard containers are designated as single use only. 

No re-use of fiberboard containers was observed by the auditor. 

Requirement TOF-9.3 SOP specifies that workers do not remove harvest buckets from 

the field.

Procedure Written SOP prohibits taking harvest buckets home.

Verification Auditor reviews SOP and observes practices related to handling of 

harvest buckets.

Corrective 

Action

Policy is developed or revised. Retraining is performed.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

The Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain specifies that 

harvest containers should remain under the oversight of farm management. This requirement 

verifies that there is a written SOP that prohibits taking harvest buckets home. 

Example Scenarios 

Scenario 1: The auditee’s SOP specifies that workers do not remove harvest buckets from the field 

until such time as the supervisor collects the harvest containers at the end of the shift. And that 
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harvest containers are not taken home by harvest employees. The auditor observes that at the end of 

the shift, the field supervisor instructs the harvest crew to place the used harvest containers into the 

back of his pick-up truck parked just off the field. 

Assessment: Compliant 

Reason: The auditee’s SOP specifies that workers do not remove harvest buckets from the field 

until such time as the supervisor collects the harvest containers at the end of the shift, and that 

harvest containers are not taken home by harvest employees.

Scenario 2: The harvest operation does not have a written SOP that specifies workers do not 

remove harvest buckets from the field and that harvest containers are not taken home by harvest 

employees. The auditor observes harvest workers taking the harvest containers to the storage trailer 

before breaks or restroom use, and then being issued clean harvest containers prior to returning to 

the harvest activities.

Assessment: Corrective Action Needed. 

Reason: The harvest operation does not have a written SOP that specifies workers are not to 

remove harvest containers from the field and that harvest containers are not taken home by harvest 

employees. 

Scenario 3: The operation’s SOP states that harvest containers shall not be taken home by harvest 

workers and shall remain in control of the field supervisor. The SOP also states that harvest 

containers be replaced and/or washed and sanitized each time the harvest crew re-enters the field. 

The auditor observes the harvest workers taking the harvest containers to the supervisor’s truck 

prior to their lunch break and receiving new (clean) harvest containers after lunch break and prior to 

returning to the field. The auditor reviews cleaning records for the harvest containers, the 

operation’s SOP regarding harvest containers and finds that the operation is following their SOP 

regarding product harvest containers.

Assessment: Compliant 

Reason: The operation has a written procedure and is following their SOP regarding harvest 

containers.

TOF-10 Field Packing of Tomatoes 

Requirement TOF-10.1 Packing containers shall be labeled as to their source, and to 

identify that the product has been field packed.

Procedure Cartons or other primary packaging shall be labeled accurately and 

shall clearly communicate the tomatoes were packaged in the field.

Verification Auditor observes packaging for accuracy and is clearly labeled as field 

packed.

Corrective 

Action

Operation ceases to use non-compliant packaging or labeling. Noncompliances are corrected on site.

Documents 

Required

Record.

Mandatory ●
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Expectation 

The Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain specifies that 

cartons or other primary packaging shall be labeled accurately and shall clearly communicate that 

the tomatoes were packaged in the field. 

Example Scenarios 

Scenario 1: Packing containers are labeled as to their source and identify that the product has been 

field packed. 

Assessment: Compliant. 

Reason: Packing containers are labeled as to their source and identify that the product has been 

field packed. 

Scenario 2: Cartons and other primary packaging is labeled but does not clearly communicate the 

tomatoes were packaged in the field.

Assessment: Corrective Action Needed. 

Reason: Cartons and other primary packaging is not labeled accurately and does not clearly 

communicate the tomatoes were packaged in the field.

Scenario 3: The operation’s field packing containers contain a code number that links the 

container contents to the field and harvest date, commodity name, company name and address, 

grower, field location, date of harvest, harvester’s name and address. According to the auditee the 

code also tells you if the product was field packed or packinghouse packed. 

Assessment: Corrective Action Needed. 

Reason: Cartons or other primary packaging shall be labeled accurately and shall clearly 

communicate the tomatoes were packaged in the field. Due to the operation using a code to label the 

product, the auditor cannot determine if the product was field packed. 

PACKINGHOUSE

The development of good agricultural practices for the tomato packinghouse must address the 

unique needs of each packinghouse. These needs may vary due to location environment, the 

volume of tomatoes handled, local regulations and other components. The overall goal of the food 

safety program is to reduce physical, chemical and microbial risks. 

TPH-1 Management Responsibility
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Requirement TPH-1.1 Operation has current copies of the Commodity Specific Food 

Safety Guidelines for the Fresh Tomato Supply Chain, Food Safety 

Programs and Auditing Protocol for the Fresh Tomato Supply Chain, 

the relevant Harmonized Food Safety Standard, and additional food 

safety documents as required by state and/or federal regulation.

Procedure Operation has a current copy of the Guidelines, this audit document and 

all other required documents.

Verification Auditor observes the current copies at the operation.

Corrective 

Action

Operation obtains current copies.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TOF-1.1) 

Requirement TPH-1.2 Operation has been registered or permitted as a food handling 

establishment as required by state or federal regulation.

Procedure Operation demonstrates knowledge of prevailing requirements and has 

a copy of required permit(s) or registration.

Verification Auditor reviews copies at the operation to verify they are current and 

complete.

Corrective 

Action

Operation applies for or renews required permits or registration.

Documents 

Required

Record.

Mandatory ●

Expectation 

Operations that are required to register with the FDA as a food handling establishment as required 

by state or federal regulation, must provide the auditor records to verify that their registration is 

current and complete. For packinghouses not required to register with the FDA this requirement 

may be answered as N/A.

Example Scenarios 

Scenario 1: Operation has been registered or permitted as a food handling establishment as 

required by state or federal regulation. Operation demonstrates knowledge of prevailing 

requirements and has a copy of required permit(s) or registration. 

Assessment: Compliant.

Reason: Operation is registered or permitted as a food handling establishment as required by state 

or federal regulation. Operation demonstrates knowledge of prevailing requirements and has a copy 

of required permit(s) or registration.
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Scenario 2: Operation has not been registered or permitted as a food handling establishment as 

required by state or federal regulation. Operation demonstrates knowledge of prevailing 

requirements but does not have a copy of required permit(s) or registration.

Assessment: Corrective Action Needed. 

Reason: Operation has not been registered or permitted as a food handling establishment as 

required by state or federal regulation. Operation does not have a copy of required permit(s) or 

registration.

TPH-2 Raw Material Sourcing

Requirement TPH-2.1 The operation has a policy and takes affirmative steps to 

ensure that all fresh tomatoes that are packed or stored in the facility 

are grown following requirements in Tomato Metrics Audit - Open Field 

Production, Harvest and Field Packing.

Procedure The packinghouse requires all raw product suppliers to provide 

evidence of food safety/GAP programs and compliance. Such evidence 

must include sufficient documentation to demonstrate that the supplier 

complies with the requirements in Tomato Metrics Audit - Open Field 

Production, Harvest and Field Packing.

Verification Auditor reviews policy and verifies that operation’s evidence of supplier 

compliance with food safety/GAP programs is in compliance with the 

operation’s policy.

Corrective 

Action

Operation obtains required documentation. Operation ceases accepting 

or shipping product from non-approved suppliers, until sufficient 

documentation demonstrating compliance is received by the operation.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

Packinghouses must be able to demonstrate that fresh tomatoes that are packed or stored in the 

facility are grown following requirements in the Tomato Metrics Audit – Open Field Production, 

Harvest and Field Packing. There shall be a written policy on how this is done. Operations may 

demonstrate that tomatoes meet this requirement by a variety of methods. This may include an 

external audit, internal audit or self-assessment that can verify that the Tomato Metrics are being 

followed. 

Example Scenarios 

Scenario 1: The operation has a written policy and takes affirmative steps to ensure that all 

tomatoes that are packed or stored in the operation are grown following requirements in the Tomato 

Metrics - Open Field Production, Harvest and Field Packing Standard. 

Assessment: Compliant. 

Reason: The operation has a written policy and takes affirmative steps to ensure that all tomatoes 

that are packed or stored in the operation are grown following requirements in the Tomato Metrics - 
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Open Field Production, Harvest and Field Packing. The auditor reviews the policy and third-party 

audit certificates for the operation’s raw product suppliers and finds all documents to be compliant. 

Scenario 2: The operation does not have a written policy regarding taking affirmative steps to 

ensure that all tomatoes that are packed or stored in the operation are grown following requirements 

in the Tomato Metrics - Open Field Production, Harvest and Field Packing Standard. 

Assessment: Corrective Action Needed. 

Reason: The operation does not have a written policy regarding taking affirmative steps to ensure 

that all tomatoes that are packed or stored in the operation are grown following requirements in the 

Tomato Metrics - Open Field Production, Harvest and Field Packing Standard. 

Scenario 3: The operation has a policy and takes affirmative steps to ensure that all tomatoes that 

are packed or stored in the operation are grown following requirements in the Tomato Metrics - 

Open Field Production, Harvest and Field Packing Standard. The policy is not written and the 

auditee is unable to furnish records of their supplier’s third-party audits.

Assessment: Corrective Action Needed. 

Reason: The policy is not written and the auditee is unable to furnish records of their operation’s 

raw product suppliers third party audits. 

Requirement TPH-2.2 Operation has procedures to ensure that the tomato staging 

area and staging practices do not pose a risk of tomato contamination.

Procedure The packinghouse staging area is designed so that overhead areas do not 

pose a contamination risk of uncovered tomatoes, or that tomatoes are 

protected during staging to prevent contamination.

Verification Auditor reviews procedures and inspects staging area for potential 

sources of contamination.

Corrective 

Action

Operation develops procedures and/or redesigns staging area or staging 

practices to prevent reasonably likely to occur opportunities for 

contamination. Tomatoes that have become contaminated are discarded.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

The tomato staging area and staging practices should not pose a risk of contamination for tomatoes. 

The written policy should address the assessment of the staging area that would minimize sources 

of contamination. 

Example Scenarios 

Scenario 1: Operation has written procedures to ensure that the tomato staging area and staging 

practices do not pose a risk of tomato contamination. The auditor confirms that the packinghouse 

staging area is designed so that overhead areas do not pose a contamination risk of uncovered 

tomatoes, and that tomatoes are protected during staging to prevent contamination. 

Assessment: Compliant. 
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Reason: Operation has procedures and a written policy to ensure that the tomato staging area and 

staging practices do not pose a risk of tomato contamination. 

Scenario 2: Operation has written procedures to ensure that the tomato staging area and staging 

practices do not pose a risk of tomato contamination. Upon the auditor’s review of the staging area 

for potential sources of contamination he finds that the staging area is outside of the packinghouse 

and that the area is not covered and/or protected from possible contamination. 

Assessment: Corrective Action Needed. 

Reason: The operation redesigns the staging area or staging practices to prevent reasonably likely 

to occur opportunities for contamination. Tomatoes that have become contaminated are discarded.

Scenario 3: The operation covers the bins of tomatoes arriving from the field prior to storing them 

in the refrigerated area of the warehouse. The operation’s written policy states that bins shall 

remain covered and refrigerated until such time as they can be washed and packed. The auditor 

confirms that the covered bins are protected from possible sources of contamination. 

Assessment: Compliant. 

Reason: The operation is following their written policy and tomatoes are protected from 

reasonably likely to occur possibilities for contamination.

TPH-3 Traceability

Requirement TPH-3.1 Lot identification shall be labeled on all cases and clearly 

legible.

Procedure A product coding system is in place where product or raw material shall 

be labeled with grower and lot identification, and coded to enable access 

to date of harvest and/or packing, origin (name of farm, grower and/or 

packing location), and country of origin for traceback purposes.

Verification Auditor reviews coding procedures, observes cases for appropriate 

coding, and verifies compliance by review of records.

Corrective 

Action

Boxes with missing, inaccurate or illegible coding are labeled with 

appropriate identification. Procedure is developed or revised. Retraining 

is performed.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

All levels of the tomato supply chain shall maintain adequate traceability to a minimum of one step 

forward (immediate next recipient) and one step back (immediate previous supplier) in compliance 

with FDA recordkeeping requirements. Documentation maintained by the packinghouse shall 

include sufficient information about the source (i.e., field packer firm name, identification of 

grower, field location, and date of harvest/field pack) as well as the customer receiving the product 

to allow for the appropriate tracing of product. 
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The packer must have established procedures to ensure that traceability information about the 

source is retained with tomatoes as they move through the packinghouse processes to shipping, 

including during resorting. Corrugated containers must be new and accurately labeled with 

commodity name, packinghouse firm name, and lot identification sufficient to allow for accurate 

traceability. Only containers able to be cleaned and sanitized (e.g., reusable plastic containers, 

“RPCs”) may be reused. If using reusable containers, they shall be cleaned and sanitized before 

reuse. Labels that originate from a prior use or are inaccurate shall be removed or concealed prior to 

packing. 

Example Scenarios 

Scenario 1: The auditor confirms that a product coding system is in place where tomatoes shall be 

labeled with grower and lot identification, and coded to enable access to date of harvest and/or 

packing, origin (name of farm, grower and/or packing location), and country of origin for traceback 

purposes. Auditor verifies that coding systems are working as designed, that the carton labels are 

appropriate and verifies compliance by review of records. 

Assessment: Compliant. 

Reason: Auditor reviewed coding procedures, observed cases for appropriate coding, and verified 

compliance by review of records.

Scenario 2: The operation packs tomatoes in two-pound polyethylene bags. The bags are then 

placed into master cartons of twelve bags each. A product coding system is in place where master 

cartons are labeled with grower and lot identification and date of harvest and/or packing, origin 

(name of farm, grower and/or packing location), and country of origin for traceback purposes. But 

the polyethylene bags only depict a code number. The auditor asks the auditee how the code 

number is used to trace the product, the auditee explains the trace number. The auditor then verifies 

the coding system by review of records and finds the procedure to be in compliance with the 

standard. 

Assessment: Compliant. 

Reason: The auditor verified the coding system by review of records. 

Scenario 3: A product coding system is in place where product or raw material shall be labeled 

with grower and lot identification, and coded to enable access to date of harvest and/or packing, 

origin (name of farm, grower and/or packing location), and country of origin for traceback 

purposes. Upon review by the auditor, it is observed that most of the product codes printed on the 

cartons are illegible.

Assessment: Corrective Action Needed. 

Reason: Boxes with missing, inaccurate, or illegible coding are re-labeled with appropriate 

identification.

TPH-4 Self-Audits 
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Requirement TPH-4.1 Operation has procedures for conducting self-audits and 

conducts self-audits to verify compliance with established internal 

policies and procedures.

Procedure In addition to the requirements of the Harmonized Standards, the 

operation’s self-audit procedure ensures compliance with established 

internal policies and procedures, the Commodity Specific Food Safety 

Guidelines for the Fresh Tomato Supply Chain, these Tomato Metrics, 

and additional food safety documents as required by state and/or federal 

regulation.

Verification Auditor reviews the self-audit procedures, and records of self-audits to 

verify compliance with the procedures.

Corrective 

Action

Operation develops and maintains self-audit program, with corrective 

actions preventive measures, documentation and follow-up.

Documents 

Required

Written Policy, Record.

Mandatory ●

Expectation 

Auditees must conduct self-audits to verify compliance with established internal policies and 

procedures. There is not a specified format for the self-audit. The self-audit must verify the 

requirements of the Harmonized Standard being utilized and Tomato Audit Protocol addendum 

requirements. 

Example Scenarios 

Scenario 1: The operation has written procedures for conducting self-audits and conducts selfaudits annually, but you find that the operation uses a self-made checklist for conducting self-audits.

Assessment: Compliant 

Reason: As long as the self-audit performed addresses the requirements of the Harmonized 

Standards, ensures compliance with established internal policies and procedures, Commodity 

Specific Food Safety Guidelines for the Fresh Tomato Supply Chain, the Tomato Metrics, and 

additional food safety documents as required by state and/or federal regulation. 

Scenario 2: The operation maintains that they conduct self-audits but do not have a record of the 

self-audit. 

Assessment: Corrective Action Needed, 

Reason: The requirement requires a written policy and records. Records should document when 

the self-audit was started and completed.

TPH-5 Product Containers and Packaging Materials 
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Requirement TPH-5.1 Tomato-contact bulk bins, gondolas, totes and trays shall not 

be constructed of wood.

Procedure In accordance with the Post-Harvest Operations Harmonized Standard 

P-8.7 regarding acceptable product-contact containers, operation has 

eliminated or has a plan to eliminate the use of wooden product contact 

containers.

Verification Auditor reviews SOP, visually observes product bins, trays and 

containers and their use for evidence of non-compliance.

Corrective 

Action

Policy is developed or revised. Non-compliances are corrected. 

Operation removes non-conforming product containers from food 

contact purposes. Retraining is performed. Operation develops a plan to 

phase out wooden bins, and demonstrates compliance with the plan.

Documents 

Required

Written Policy.

Mandatory ●

Example Scenarios 

Scenario 1: In the packinghouse the auditor observes plastic and wooden bins containing tomatoes, 

the auditor asks the auditee about the observation. The auditee states that only cull tomatoes are 

placed in the wooden bins and only fresh tomatoes are placed in plastic bins. The operation’s SOP 

confirms that wooden bins are only to be used for trash or tomatoes designated as not for human 

consumption. 

Assessment: Compliant. 

Reason: The operation has a written policy that clearly distinguishes the use of wooden bins as not 

for fresh tomatoes for human consumption.

Scenario 2: The small farming operation is harvesting tomatoes into plastic buckets that are then 

collected in the field and dumped into wooden bins for transport to the packinghouse. The wooden 

bins are fitted with new clean plastic sheeting prior to each use. Once in the packinghouse, the 

tomatoes are dumped into a bath of potable water treated with a chlorine-based sanitizing solution. 

The owner states that plastic bins are just too expensive for him to purchase at this time, but plans to 

replace the wood bins with plastic bins one or two at a time as the wood bins become too damaged

for further use.

Assessment: Compliant. 

Reason: The operation has a plan to replace the wood bins in a reasonable timeframe.

Scenario 3: The farming operation is harvesting tomatoes into wooden bins for transport to the 

packinghouse. At the packinghouse the wooden bins of tomatoes are lowered into a bath containing 

a chlorine-based sanitizer solution. The owner states that plastic bins are just too expensive for him 

to purchase. That’s why he is using a sanitizer in his wash water.

Assessment: Corrective Action Needed. 

Reason: The operation is not lining the wooden bins with any type of material that will protect the 

product from contamination. Wood cannot be sanitized. Auditee has no plan to eliminate the use 

of wooden bins. 
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Requirement TPH-5.2 The operation has written procedures for cleaning and 

sanitizing of produce food contact containers, requiring that bulk bins, 

gondolas, totes and trays are cleaned and sanitized periodically and is 

documented.

Procedure Written SOP is established to ensure that bulk bins, gondolas, totes, 

trays and other food contact containers and implements are adequately 

cleaned and sanitized at a frequency sufficient to maintain clean and 

sanitary food contact surfaces, and documentation of compliance is 

maintained.

Verification Auditor reviews SOP, cleaning logs and records, interviews responsible 

individuals for knowledge of the SOP and observes containers, 

employees and records for evidence of compliance.

Corrective 

Action

Policy is developed or revised. Non-compliances are corrected on site. 

Retraining is performed.

Documents 

Required

Written Policy, Record.

Mandatory ●

Example Scenarios 

Scenario 1: The operation has a written SOP for the cleaning and sanitizing of fresh produce food 

contact containers, requiring that bulk bins, gondolas, totes and trays are cleaned and sanitized 

periodically, the SOP states that bulk bins, totes, and trays are cleaned at the beginning of each 

season and as needed throughout the season with dish soap and a chlorine-based sanitizer solution. 

The gondola type trailers must be dedicated vehicles for the entire harvest season and are power 

washed with food safe cleaner and sanitized with the chlorine-based solution. The auditor reviews 

the cleaning logs for the bulk bins, totes and trays and finds that the logs are dated daily, monthly 

and annually and appear to be complete. The auditor then requests the cleaning logs for the gondola 

type trailers that transport the tomatoes from the field to the packinghouse. The logs list each trailer 

number, the date of the pre-season cleaning and sanitizing of the trailers and the trailer owner and 

company name. The auditor inquires if this is the only cleaning that has been done on the gondola 

type trailers, the auditee states that they are flushed out every day with the chlorine-based sanitizer 

when the trailers arrive at the packinghouse with a load of tomatoes. The auditor observes this 

process and reviews the associated logs during the walk through of the packinghouse. 

Assessment: Compliant. 

Reason: The operation has a written SOP and cleaning logs for all produce contact containers. 

Scenario 2: The operation has a written SOP for the documentation and cleaning of food contact 

containers. The SOP states that food contact containers are cleaned and sanitized at the beginning 

of each harvest season and as needed throughout the season. The auditor reviews the SOP, cleaning 

logs and visually observes the food contact containers for evidence of compliance. The auditor 

finds that the packinghouse employees are using full strength chlorine bleach for cleaning and 

sanitizing the food contact containers. The auditor notes that the label instructions require the 

substance to be diluted with water at a 10 to 1 ratio for sanitizing food contact surfaces.

Assessment: Immediate Action Required.
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Reason: The product that the employees are using is for sanitizing only, produce contact containers 

must be cleaned and sanitized. The packinghouse employees are not following the sanitizer label 

instructions for food contact surfaces. 

Scenario 3: Upon review of the cleaning logs for food contact containers, the auditor observes that 

the most recent cleaning for the bulk bins is dated one year ago. The auditor recalls that the 

operation’s SOP states that cleaning of food contact containers is completed and logged weekly. 

The auditor inquires as to why the most recent cleaning for the bins was not done in accordance 

with the operation’s SOP. The auditee states that he is sure that the bins have been cleaned every 

week since the beginning of the season but cannot produce the most recent cleaning logs. 

Assessment: Immediate Action Required or Corrective Action Needed. 

Reason: The auditor should observe the food contact containers and make a determination based 

on the facts. 

Requirement TPH-5.3 Operation has a policy that requires bins trays and boxes made 

of corrugated cardboard are for single use only.

Procedure Written policy prohibits re-use of single-use bins, trays and boxes made 

of corrugated cardboard or fiberboard for product contact purposes. 

Repacking of tomatoes into a corrugated cardboard container that 

contained the same lot of tomatoes is acceptable, provided the container 

is clean, sanitary and properly labeled.

Verification Auditor reviews policy, observes practices related to corrugated 

cardboard or fiberboard bins, trays and boxes for evidence of noncompliance.

Corrective 

Action

Policy is developed or revised. Tomatoes that have been packed in a reused cardboard or fiberboard bin, tray or box shall be corrected, which 

may include tomatoes are segregated, washed and repacked in new 

containers, or discarded. Retraining is performed.

Documents 

Required

Record.

Mandatory ●

Expectation 

Packaging material should be inspected upon arrival to ensure that packaging material is free from 

contamination. Packaging materials must be stored in a manner as to prevent contamination. 

Containers must be protected from direct contact with the ground or floor. Finished product 

containers must be distinguished from those serving other purposes. The operation must have a 

policy prohibiting the re-use of single use bins, trays and boxes made of corrugated cardboard or 

fiberboard for product contact purpose unless used to pack the same lot of tomatoes. Resorting of 

tomatoes into a corrugated cardboard container that contained the same lot of tomatoes is 

acceptable, provided that the container is clean, sanitary, and properly labeled.

Example Scenarios 
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Scenario 1: The operation has a policy that requires corrugated cardboard food contact containers 

are for single use only. The auditor reviews the SOP and observes practices related to their use. 

The auditor does not observe any evidence of non-compliance.

Assessment: Compliant. 

Reason: The auditor reviewed the policy and confirmed that corrugated cardboard food contact 

containers are being used in compliance with the operation’s SOP and the TPH-5.3 standard 

requirements.

Scenario 2: Operation has an SOP that requires bins, trays and boxes made of corrugated 

cardboard are for single use only. The auditor reviews the SOP and observes practices related to 

their use. The auditor observes the packinghouse operation and finds that employees are packing 

product from corrugated cardboard containers into reusable plastic containers. The corrugated 

cardboard containers are being disassembled and disposed of away from the repacking operation. 

Assessment: Compliant. 

Reason: The standard is specifically regarding re-use of containers made of corrugated cardboard 

or fiberboard. 

Scenario 3: The auditor reviewed the operation’s policy for use of corrugated cardboard or 

fiberboard for product contact purposes. The policy states that corrugated cardboard and/or 

fiberboard produce contact containers are for single use only unless used to pack the same lot of 

tomatoes. During the walk-through of the packinghouse, the auditor observed employees repacking 

pallets of tomatoes that were damaged during transport from the packing line to the cooler. No 

product or product containers had touched the floor, the pallets had only shifted to one side. The 

undamaged corrugated containers were being used to repack the undamaged tomatoes. 

Assessment: Compliant. 

Reason: Repacking of tomatoes into a corrugated cardboard container that contained the same lot 

of tomatoes is acceptable, provided the container is clean, sanitary, and properly labeled.

TPH-6 Packinghouse Condition and Equipment

Requirement TPH-6.1 Facility is constructed/arranged to allow separation of 

incoming, in-process and finished products.

Procedure Facilities or processes assure separation and positioning of incoming raw 

materials so as not to become a source of contamination of in-process 

and finished product.

Verification Auditor observes placement of incoming raw materials, in-process and 

finished products for opportunities for cross-contamination.

Corrective 

Action

Procedures are developed or revised. Non-compliances are corrected on 

site. Retraining is performed.

Documents 

Required

Record.

Mandatory ●

Expectation 
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Buildings, fixtures, food contact surfaces and other physical facilities of the packinghouse must be 

maintained in a clean and sanitary condition and must be kept in repair sufficient to prevent 

tomatoes from becoming adulterated. Storage ripening rooms and distribution facilities must be 

kept clean and sanitary, with debris minimized. All walls, floors, ceilings and other surfaces must

be systematically and periodically cleaned and sanitized to avoid the build-up of mold or other 

potential contaminants. Proper precautions are to be taken to reduce the potential for contamination 

of covered produce, food contact surfaces, or packing materials with known or reasonably 

foreseeable hazards. The potential for contamination must be reduced by effective design including 

the separation of operations in which contamination is likely to occur or by one or more of the 

following means: location, time, partition, enclosed systems, or other effective means. 

Example Scenarios 

Scenario 1: The auditor observes that the operation’s facility is constructed and arranged to allow 

for separation of incoming, in-process, and finished products. The layout of the facility assures 

separation and positioning of incoming raw materials so as not to become a source of contamination 

of in-process and finished product. 

Assessment: Compliant.

Reason: The operation’s facility is constructed and arranged to allow for separation of incoming, 

in-process, and finished products. The layout of the facility assures separation and positioning of 

incoming raw materials so as not to become a source of contamination of in-process and finished 

product.

Scenario 2: The auditor observes that the operation’s facility is not constructed and arranged to 

allow for separation of incoming, in-process, and finished products. The layout of the facility does 

not assure separation and positioning of incoming raw materials so as not to become a source of 

contamination of in-process and finished product. The auditor observes that the potential for 

contamination is reduced by effective timing because the operation only receives raw product in the 

evenings and runs/processes raw product in the morning and afternoon.

Assessment: Compliant.

Reason: The potential for contamination is reduced by effective timing because the operation 

receives raw product in the evenings and runs/processes raw product in the morning and afternoon.

Scenario 3: The auditor observes that the operation’s facility is not constructed and arranged to 

allow for separation of incoming, in-process, and finished products. The layout of the facility does 

not assure separation and positioning of incoming raw materials so as not to become a source of 

contamination of in-process and finished product. The auditor observes the operation’s procedure 

for receiving bins of incoming product and handling of in-process product and pallets of finished 

product and determines that reasonable opportunities for contamination are evident. 

Assessment: Immediate Action Required.

Reason: The auditor observes that the operation’s facility is not constructed and arranged to allow 

for separation of incoming, in-process, and finished products. The layout of the facility does not 

assure separation and positioning of incoming raw materials so as not to become a source of 

contamination of in-process and finished product. The auditor observes the operation’s procedure 

for receiving bins of incoming product and handling of in-process product and pallets of finished 

product and determines that reasonable opportunities for contamination are evident.
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Requirement TPH-6.2 Operation has procedures that minimize the accumulation of 

standing water.

Procedure If floor drains exist, they are adequate, functional, free of obstruction 

and are properly maintained and cleaned sufficient to prevent them 

from becoming sources of contamination. If standing water exists, it is 

removed from floors and floors cleaned in a manner and at a frequency 

sufficient to prevent creation of a source of contamination.

Verification Auditor observes floor drains and evidence of standing water for 

compliance with procedures.

Corrective 

Action

Floor drains are installed, repaired or maintained, or procedures are 

modified, to prevent standing water from becoming a potential source of 

contamination.

Documents 

Required

Written Policy.

Mandatory ●

Example Scenarios 

Scenario 1: The operation has a written policy that states the accumulation of standing water must 

be removed whenever it is present in the facility. Floor drains are cleaned prior to the beginning of 

the season, inspected daily as part of the pre-operation’s procedure, and documented on the 

operation’s master cleaning and maintenance checklist. The auditor observes small amounts of 

standing water around the facility’s dump tanks and observes a packinghouse employee with a floor 

squeegee pushing the water toward the floor drains.

Assessment: Compliant. 

Reason: The operation has a written policy that states the accumulation of standing water must be 

removed whenever it is present in the facility. Floor drains are cleaned prior to the beginning of the 

season, inspected daily as part of the pre-operation’s procedure, and documented on the operation’s 

master cleaning and maintenance checklist. The auditor observed only small amounts of water 

being effectively removed. 

Scenario 2: The operation has a written policy that states the accumulation of standing water must 

be removed daily after equipment cleaning and prior to beginning of each day’s operations. The 

auditor observes that the operation has no floor drains in or around the facility. The auditor also 

observes that several areas around the facility have large amounts of standing water and in some 

areas the water is discolored and contains debris. 

Assessment: Corrective Action Needed. 

Reason: The auditor observed that several areas around the facility have large amounts of standing 

water and in some areas the water is discolored and contains debris. 

Scenario 3: The tomato packing operation does not have a written policy regarding the 

accumulation of standing water in or around the facility, the facility has floor drains under the dump 

tank where the tomatoes enter the wash process and in the refrigerated holding areas. The auditor 

determines that the drains are working as designed as the auditor has not observed any water 

accumulation.

Assessment: Corrective Action Needed. 
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Reason: The operation must have a written policy addressing the accumulation of standing water.

Requirement TPH-6.3 All food contact surfaces are made of material and designed to 

be easily cleaned and sanitized, and are maintained in good condition.

Procedure All tomato contact surfaces and equipment are made of materials, 

designed or constructed to be easily cleaned and sanitized, all food 

contact surfaces are free of rust or corrosion, and seams between food 

contact surfaces are smooth or accessible for cleaning.

Verification Auditor observes product contact surfaces and equipment and their use 

for evidence of non-compliance.

Corrective 

Action

Non-compliances are corrected or replaced. Operation makes a 

commitment for phasing out non-conforming tomato contact surfaces 

and equipment, in a reasonable timeline. Retraining is performed.

Documents 

Required

Mandatory ●

Example Scenarios 

Scenario 1: The operation’s food contact surfaces are made of material and designed to be easily 

cleaned and sanitized, and are maintained in good condition. The auditor reviews the operation’s 

written policy and observes the food contact surfaces for evidence of compliance. The auditor 

determines that the food contact surfaces are adequate.

Assessment: Compliant.

Reason: The auditor reviewed the operation’s written policy and observed the food contact 

surfaces for evidence of compliance. The auditor determined that the food contact surfaces are 

adequate.

Scenario 2: During the auditor’s walk-through of the tomato packing facility, it is observed that 

some food contact surfaces are constructed with wood that is covered with vinyl, the vinyl covers 

have seams and cracks that can support the growth of bacteria. The auditor asks the operation’s 

food safety coordinator if these food contact surfaces are ever in use, the food safety coordinator 

explains that the tables are used for repacking tomatoes. The auditor asks the auditee if they have a 

plan to phase out the use of these tables. The auditee states that they don’t use them that much but 

no plans have been made to replace them.

Assessment: Immediate Action Required.

Reason: All food contact surfaces are not made of material that is designed to be easily cleaned 

and sanitized, and are maintained in good condition. The auditee stated that they have no plan to 

phase out the use of these tables. 

Scenario 3: During the auditor’s walk-through of the tomato packing facility, it is observed that 

some food contact surfaces are not able to be sanitized due to being constructed with wood. The 

applicant states that these surfaces have always been wood and nobody has ever been sick from his

tomatoes. The auditor asks the auditee if he has plans to eliminate the wood food contact surfaces. 

The auditee states that he does not plan to replace something that has been working for ten years. 

Assessment: Corrective Action Needed. 
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Reason: All food contact surfaces are not made of material that is designed to be easily cleaned 

and sanitized and the auditee has no plans to eliminate wood as a food contact surface. 

Requirement TPH-6.4 Wood is not used as a food contact surface.

Procedure Operation has eliminated, or has a plan to eliminate, use of wooden 

items as food contact surfaces.

Verification Auditor inspects facility for evidence of wooden food contact surfaces.

Corrective 

Action

Operation that still utilizes wood as a food contact surface has a plan to 

phase out such surfaces, and is in compliance with the plan.

Documents 

Required

Mandatory ●

Example Scenarios 

Scenario 1: During the auditor’s walk-through of the tomato packing facility, it is observed that 

some food contact surfaces are not able to be sanitized due to being constructed with wood. The 

auditee states that the wood surfaces are covered with clean plastic sheeting each time they are 

used. The auditor observes one table with thick plastic sheeting covering the wood surface and a 

large roll of sheeting in close proximity to the area. The operation’s manager states that he has 

ordered new tables made of stainless steel, but they won’t arrive until the following week. 

Assessment: Compliant. 

Reason: The operation is taking positive steps to reduce the possibility of contamination by 

covering the tables with plastic and the operation has a plan to eliminate the use of wooden items as 

food contact surfaces. 

Scenario 2: During the auditor’s walk-through of the tomato packing facility, it is observed that 

some food contact surfaces are constructed with wood that is covered with vinyl, the vinyl covers 

have seams and cracks. The auditor asks the auditee if these food contact surfaces are ever in use, 

the auditee explains that the tables are used for repacking tomatoes. The auditor asks if they have a 

plan to replace the vinyl covered wood tables, the auditee states that they only use them 

occasionally, so there is no plan to replace them.

Assessment: Immediate Action Required.

Reason: All food contact surfaces are not made of material that is designed to be easily cleaned 

and sanitized, and are not maintained in good condition. The auditee has no plans to eliminate 

wood as a food contact surface. 

Scenario 3: The operation’s food contact surfaces are made of material and designed to be easily 

cleaned and sanitized and are maintained in good condition. The auditor observes the food contact 

surfaces for evidence of compliance. The auditor determines that the food contact surfaces are 

adequate. 

Assessment: Compliant. 

Reason: The auditor observed the food contact surfaces for evidence of compliance. The auditor 

determined that the food contact surfaces are adequate.
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Requirement TPH-6.5 SDS are on file for all chemicals used in the facility, and readily 

accessible.

Procedure Operation maintains a list of all chemicals approved for use in facility 

and maintains SDS for all. SDS are in a location easily accessible by 

employees.

Verification Auditor reviews SDS binder and observes chemicals in facility for 

evidence of compliance.

Corrective 

Action

Obtain missing SDS. Relocate SDS.

Documents 

Required

Records.

Mandatory ●

Example Scenarios 

Scenario 1: The operation maintains a list of all chemicals approved for use in facility and 

maintains SDS for all. SDS are in a location easily accessible by employees.

Assessment: Compliant. 

Reason: The operation maintains a list of all chemicals approved for use in the facility and 

maintains SDS for all. SDS are in a location easily accessible by employees.

Scenario 2: The operation maintains a list of all chemicals approved for use in the facility and 

maintains SDS for all chemicals used in the facility. SDS for chemicals used in the facility are not 

in a location accessible by employees.

Assessment: Corrective Action Needed. 

Reason: The operation maintains a list of all chemicals approved for use in the facility and 

maintains SDS for all, but SDS are not in a location easily accessible by employees.

Scenario 3: SDS are on file for all chemicals used in the facility, and readily accessible. Upon 

review of the operation’s SDS records, the auditor notes that there is no SDS for ABC Sanitizer said 

to be used in the operation’s dump tanks and produce wash system. The auditor asks the 

operation’s chemical specialist about the missing documentation. The employee states that they had 

just started using that chemical this season, prior to using this we used XYD Sanitizer.

Assessment: Corrective Action Needed. 

Reason: SDS are not readily accessible or on file for all chemicals used in the facility.

TPH-7 Worker Health/Hygiene and Toilet/Handwashing Facilities 
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Requirement TPH-7.1 If portable hand wash water tanks are used, they are cleaned 

and sanitized and the water is changed periodically.

Procedure Water tanks used to provide hand wash water shall be maintained at a 

prescribed frequency in a clean and sanitary manner.

Verification Auditor reviews cleaning and sanitizing protocol and service logs, and 

visually observes condition of water tanks for signs of non-compliance.

Corrective 

Action

Clean and sanitize the tank, replace water to compliance.

Documents 

Required

Records.

Mandatory ●

Expectation 

(See requirement TOF-4.2) 

Example Scenarios 

Scenario 1: Auditor reviews cleaning and service records for the operation’s portable sanitation 

units and confirms that the units are inspected every two hours and were serviced and cleaned the 

previous day, the service record does not specifically state that the hand wash water tank was 

cleaned and sanitized at the time of servicing. The auditor requests the service company SOP for 

cleaning and sanitizing, the SOP states that the tanks are cleaned and sanitized at the beginning of 

each season and can produce records to confirm. 

Assessment: Compliant 

Reason: The Food Safety Programs and Auditing Protocol for the Fresh Tomato Supply Chain 

states that the hand wash water tanks are to be cleaned and sanitized and/or shall be maintained 

periodically or at a prescribed frequency. 

Scenario 2: Auditor observes that the hand wash water tank at the portable sanitation unit contains 

sediment of unknown origin, what appears to be green or black water marks around the inside 

perimeter of the tank and the tank lid is not secured. The auditor requests the most recent service 

records for the sanitation unit and finds that it was serviced and cleaned that morning by the 

operation’s cleaning crew. The auditor requests the company SOP for cleaning and servicing of the 

unit and finds that it states that the hand wash water tanks will be cleaned, sanitized and filled as 

needed. 

Assessment: Corrective Action Needed. 

Reason: The company is not following its SOP regarding cleaning and sanitizing the hand wash 

water tanks.

Scenario 3: Upon inspection of the portable sanitation unit the auditor observes that the sanitation 

station hand wash water tank is empty. The auditor notes that this is the only portable sanitation 

station available to maintenance employees.

Assessment: Immediate Action Required

Reason: Water tanks used to provide hand wash water shall be maintained at a prescribed

frequency in a clean and sanitary manner.
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TPH-8 Product Wash Water Management

All water used in the packinghouse must meet the microbial requirements of no detectable generic 

E. coli in 100 mL of water. 

Requirement TPH-8.1 In systems where tomatoes are submerged or dwell in water, 

water temperature is monitored and controlled. Water temperature 

should be at least 10oF above average pulp temperature of tomatoes 

when entering the water.

Procedure Operation shall have methods for determining average pulp 

temperature of a minimum of 5 tomatoes, a procedure for control of 

water temperature, shall monitor temperature at a prescribed frequency 

sufficient to assure continuous compliance (minimum of hourly), and 

shall maintain records of water temperature. Operation shall have a 

procedure as to what corrective actions are taken if criteria are not met. 

Water spray or shower systems, wherein tomatoes are not submerged or 

dwell, do not require temperature control.

Verification Auditor shall review the procedure and shall review records of 

temperature monitoring. Auditor observes process including the 

operation’s sampling of pulp and water temperatures. Auditor reviews 

records for deviations and their disposition.

Corrective 

Action

Procedure is developed or revised. Retraining is performed. Tomatoes 

washed in water at temperatures less than the average measured pulp 

temperature shall be discarded back to the last evidence of compliance.

Documents 

Required

Records.

Mandatory ●

Expectation 

The Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain states:

“i. Internalization of bacteria into the fruit has been demonstrated with tomatoes 

submerged in water without a sanitizer. Water adequately treated with sanitizer is 

the most effective method of controlling internalization of pathogens due to cross 

contamination. 

ii. Cold water immersion as a cooling technique shall not be done. 

iii. While PS § 48 requires operations to maintain and monitor the temperature that is 

appropriate for the commodity and operation (considering the time and depth of 

submersion) and is adequate to minimize the potential for infiltration of 

microorganisms of public health significance into covered produce, studies indicate 

that the temperature differential between wash water and tomato pulp temperature 

may not be as influential as previously thought. Residence time and product depth 
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are influential and may be difficult to strictly control. Therefore, it is prudent for 

water temperature in dump tanks to be maintained at least 10°F warmer than the pulp 

temperature of the tomato.

1. Monitor water temperature and pulp temperature at least hourly.

2. Pulp temperature is the average of at least 5 tomatoes.”

Example Scenarios 

Scenario 1: Operation determines pulp temperature by checking one tomato per load. The 

procedure for control of water temperature is ensuring that the water temperature is at least ten 

degrees warmer than the tomato but averages twenty degrees warmer. The operation monitors 

temperature hourly to assure continuous compliance and maintains records of the lot number, trailer 

number, time of arrival and water and tomato temperatures. The operation has a procedure as to 

what corrective actions are taken if criteria are not met. 

Assessment: Corrective Action Needed.

Reason: The operation shall have methods for determining the average pulp temperature by 

checking a minimum of five tomatoes.

Scenario 2: The operation has a method for determining average pulp temperature by checking a 

minimum of five tomatoes, a procedure for control of the water temperature, monitors temperatures 

hourly and maintains records of the water and tomato temperatures. The water temperature is 

continually twenty degrees higher than the tomato temperature. Operation has a procedure as to 

what corrective actions are taken if criteria are not met. The auditor reviews the records and 

verifies that the operation is following the SOP and is in compliance with the standard.

Assessment: Compliant

Reason: The auditor reviews the records and verifies that the operation is following the SOP and is 

in compliance with the standard.

Scenario 3: A small farming operation chooses to wash their tomatoes in a sanitized stainless steel 

farm sink directly following the harvesting of the crop. The operation’s water is municipal, and 

they add a food grade chlorine-based sanitizer in accordance with the label instructions. They 

check the temperature of five tomatoes and determine the average, then the water temperature is set 

at twenty degrees above the average of the tomato temperatures to allow for cooling. The operation 

ensures that the water pH is between 6.5 and 7.5 and the free chlorine at 150 ppm with test strips. 

They log the temperatures of the water and the tomatoes, the pH, and the free chlorine. The 

tomatoes are placed in a single layer on a plastic submersible tray and lowered into the sink, the 

water just covers the tops of the tomatoes. The tomatoes are removed in eight to ten minutes then 

rinsed with the potable water and set aside to dry prior to packing. Auditor reviews the procedure 

and the records of temperature monitoring. Auditor observes process including the operation’s 

sampling of pulp and water temperatures. Auditor reviews records for deviations and their 

disposition.

Assessment: Compliant.

Reason: Auditor reviewed the procedure and the records of temperature monitoring. Auditor 

observed process including the operation’s sampling of pulp and water temperatures. Auditor 

reviewed records and found no deviations.
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Requirement TPH-8.2 Operations utilizing spray systems in place of whole tomato 

immersion shall design the line so that the entire tomato surface is 

rinsed.

Procedure Spray systems shall be designed such that rinse water contacts all 

surfaces of the tomato.

Verification Auditor observes spray system for compliance.

Corrective 

Action

Equipment or process is redesigned or retrofitted to ensure all surfaces 

of tomato are contacted.

Documents 

Required

Mandatory ●

Example Scenarios 

Scenario 1: The tomato packing operation utilizes a multiple bar spray system in place of a whole 

tomato immersion system. The line is designed to rotate the tomato so that the entire tomato 

surface is rinsed. The operation uses well water that they treat with an antimicrobial that is dosed 

electronically. The operation tests and logs the pH and free chlorine in the spray water every hour 

during operation. The facility does not check or log the wash water temperature.

Assessment: Compliant. 

Reason: Temperature control of water, and the risk of internalization, does not apply to spray bar 

or other processes in which tomatoes are not submerged.

Scenario 2: The operation uses a spray bar system in place of a tomato emersion dump tank. The 

system has two spray bars, one on the top and one on the bottom of the tomatoes moving through 

the line to ensure that the entire surface of the tomatoes are rinsed. The operation’s water is treated 

with chlorine dioxide electronically dosed at 3 ppm as a targeted operating level. The operation’s 

SOP requires that the water be checked once every hour to ensure the ppm remains between 3 and 5 

ppm. The SOP requires the water in the system to be changed daily. Upon the auditor’s observation 

of the independent testing of the wash water of chlorine dioxide showed a level of 1 ppm. Upon 

review of the operation’s hourly water test results the auditor finds that the ppm level has been 

testing at 1 ppm or below since the beginning of the day’s run.

Assessment: Immediate Action Required.

Reason: The operation is not following the SOP regarding PPM levels of chlorine dioxide. The 

use of 1 ppm chlorine dioxide will not be adequate. 

Scenario 3: The tomato packing operation utilizes a spray bar system in place of a whole tomato 

immersion system. The system sprays potable water treated with antimicrobials registered with the 

EPA and labeled for food use. Upon the auditor’s walk-through of the facility, it is observed that 

some tomatoes passing under the far sides of the spray bar are not effectively being rinsed.

Assessment: Corrective Action Needed. 

Reason: Spray systems shall be designed such that rinse water contacts all surfaces of the tomato.
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Requirement TPH-8.3 If a spray bar system is used, operation has a water use SOP 

that addresses treatment of that water.

Procedure Operation’s water use SOP requires spray bar water to be treated using 

an approved antimicrobial to maintain a microbially hostile 

environment on equipment.

Verification Auditor shall review water use SOP for completeness, and observes 

water treatment records for adequacy and consistency of treatment.

Corrective 

Action

Operation discontinues using spray bar water that is not treated 

sufficiently to maintain a hostile environment on equipment. Retraining 

is performed and documented. Affected product is evaluated for 

potential contamination and disposition.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

The Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain states: 

“Although the risk of cross contamination in a single pass spray bar system is lower than in 

a dump tank or flume, antimicrobial use (e.g., chlorine, PAA or chlorine dioxide is still 

required so that a hostile environment on equipment is maintained that limits cross 

contamination, biofilm formation, and the establishment of environmental pathogens.” 

Example Scenarios 

Scenario 1: The operation uses a spray bar system for washing the tomatoes. The operation has a 

water use SOP that addresses treatment of that water. The auditor reviews the water use SOP for 

completeness, and observes water treatment records for adequacy and consistency of treatment. 

The auditor finds that the operation’s SOP is adequate and they are following the policy as written. 

Assessment: Compliant. 

Reason: Auditor reviewed the operation’s water use SOP for completeness and reviewed the water 

treatment records for adequacy and consistency of treatment. The auditor found no deviations from 

the written policy.

Scenario 2: The operation uses a spray bar system for washing the tomatoes the operation has a 

water use SOP that addresses treatment of that water. The auditor reviews the water use SOP for 

completeness, and observes water treatment records for adequacy and consistency of treatment. 

During the review of the records for the water treatment the auditor observes that the operation has 

not documented the change of water in the spray system for an entire week. The auditor reviews 

the operation’s SOP regarding wash water and finds that it states the wash water in the spray system 

must be changed daily. 

Assessment: Immediate Action Required.

Reason: Water used in post-harvest operations must be changed as necessary for the given 

operation. The operation’s SOP states that the water in the system must be changed each week, the 

operation has not followed their SOP. 
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Scenario 3: The operation uses a spray bar system to rinse tomatoes exiting the dump tank, the 

water for the spray bar system is treated with peracetic acid at the same ppm level as the dump tank 

water. The records indicate that the pH, and ppm levels are checked and logged each hour for the 

dump tank and the spray bar water. The auditor finds no deviation from the operation’s SOP.

Assessment: Compliant 

Reason: The auditor reviewed logs and records for the water treatment and found no deviation 

from the operation’s SOP.

Requirement TPH-8.4 If water quality is based upon a chlorine-based sanitizer, the 

process shall be targeted to be at least 100 ppm free available chlorine 

(FAC), measured at the exit of the product from the water system, unless 

validation data are available to demonstrate a lower FAC is effective 

under operating conditions.

Procedure Operation shall have a procedure to manage FAC levels, shall establish 

process adjustments for when the FAC drops below 100 ppm, and shall 

maintain records to verify proper management of levels.

Verification Auditor shall review the procedure and shall review records of FAC 

measurement and appropriate management. Auditor reviews records 

for deviations and their disposition.

Corrective 

Action

Procedure is developed or revised. Retraining is performed. Tomatoes 

washed in water at FAC less than 100 ppm shall be discarded back to 

the last evidence of compliance.

Documents 

Required

Record.

Mandatory ●

Expectation 

When tomatoes are washed, the quality of post-harvest water that contacts fresh produce during 

post-harvest flume transport, cleaning, grading, and surface treatment application is widely 

recognized as an essential pathogen control point to limit cross contamination of fresh produce. 

While the use of antimicrobials in wash water does not constitute a “kill step”, levels must be 

monitored so that the treated water adequately limits cross contamination. Because no point in the 

tomato supply chain applies a validated kill step, wash water is but one hurdle in the continuum of 

safe practices that needs to be implemented; it does not compensate for poor production and/or 

handling practices prior or subsequent to washing. 

Oxidation reduction potential (ORP) is not directly correlated to free chlorine measurements in 

typical tomato dump tanks. Preliminary studies suggest that potential for cross contamination does 

not correlate well with ORP levels. Operations using free chlorine as the wash water antimicrobial 

should not rely solely on ORP readings to manage chlorine levels. Rather, free chlorine levels in 

such systems should be verified by a method such as chemical titration. 

Example Scenarios 
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Scenario 1: The operation’s water quality is based upon a chlorine-based sanitizer, the operation’s 

SOP requires the targeted ppm to be not less than 150 ppm free chlorine and not more than 200 

ppm. The operation’s SOP states that the water be measured at the exit of the product from the 

water system. At the time of the audit, the independent test of the water in the system showed 

levels to be at 175 ppm. The auditor reviews the operation’s records of hourly testing and finds that 

the ppm level has not been below 150 ppm or above 200 ppm. The auditor asks the operator what 

the procedure would be if the levels dropped below 150 ppm or was tested above 200 ppm. The 

operator quoted the operation’s procedure to manage FAC levels.

Assessment: Compliant.

Reason: Operation is following their SOP and has a procedure to manage FAC levels and has 

established a process adjustment for when the FAC drops below 150 ppm and maintains records to 

verify proper management of levels.

Scenario 2: The tomato packing operation dump tank water quality is based upon a chlorine-based 

sanitizer, the operation’s SOP requires the targeted ppm to be not less than 150 ppm free chlorine 

and not more than 200 ppm. The auditor reviews records of the ppm levels for the day and finds 

that the water ppm level dropped to less than 150 ppm just two hours prior to the auditor’s arrival. 

The auditor inquired as to what was done to correct the drop in free chlorine. The system operator 

stated that he adjusted the level after consulting with the operation manager as per the operation’s 

SOP. The documentation provided by the system operator showed that the system did not have 

tomatoes introduced until after the ppm levels were stabilized by the adjustment.

Assessment: Compliant.

Reason: The operation is following their SOP and the system is in compliance with the standard.

Scenario 3: The operation relies on electronic Oxidation Reduction Potential (ORP) for measuring 

the free chlorine in the wash system. The operation’s SOP states that the operation’s process targets 

at least 800 mV ORP levels and shall not be less than 650 mV. The operation’s SOP does not have 

a procedure for action to be taken if levels drop below or exceed the targeted levels. At the time of 

the audit the electronic system is reading the ORP level to be at 600 mV. The auditor asks that an 

independent chemical titration be performed to test the free chlorine levels in the system. The 

system operator states that he is not able to perform the test and the person who can is not available 

today. Upon review of the day’s logs, the auditor observes that the ORP levels have been below 

600 mV since the beginning of the day.

Assessment: Immediate Action Required.

Reason: Oxidation reduction potential (ORP) is not directly correlated to free chlorine 

measurements in typical tomato dump tanks, free chlorine levels in such systems should be verified 

by a method such as chemical titration. The operation’s SOP does not have a procedure for when 

ORP levels drop below the required 650 mV minimum.
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Requirement TPH-8.5 If water quality is based upon a peroxyacetic, peracetic or 

peracid system, levels shall be maintained in accordance with 

manufacturer’s label directions.

Procedure Operation shall have a procedure to manage peracid levels, shall 

establish process targets so as not to drop below the minimum ppm, 

shall establish adjustments for when the peracid level drops below the 

target ppm, and shall maintain records to verify proper management of 

levels.

Verification Auditor shall review the procedure and shall review records of peracetic 

measurement and appropriate management. Auditor reviews records 

for deviations and their disposition.

Corrective 

Action

Procedure is developed or revised. Retraining is performed. Tomatoes 

washed in water at less than manufacturer’s recommendation shall be 

discarded back to the last evidence of compliance.

Documents 

Required

Record.

Mandatory ●

Expectation 

Peroxyacetic, peracetic acid (PAA) or peracid must be used in accordance with the manufacturer’s 

label directions. The Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply 

Chain states: 

“Although its efficacy is less pH dependent than chlorine, it should still be used in systems 

where the pH is maintained below 8.0 (because it dissociates to a less active form at pH 

levels above 8.2).” 

The monitoring of wash systems using PAA is an important part of the management of these wash 

systems. Records shall be kept for all monitoring activities.

 

Example Scenarios 

Scenario 1: The operation’s wash water quality is based upon a peroxyacetic system, levels are 

maintained in accordance with manufacturer’s label directions. Operation has a procedure to 

manage peracid levels and has established process targets so as not to drop below the minimum 

ppm. The operation has established adjustment procedures for when the peracid level drops below 

the target ppm and maintains records to verify proper management of levels. Peracetic acid is used 

according to manufacturer’s label directions.

Assessment: Compliant. 

Reason: The operation has established adjustments for when the peracid level drops below the 

target ppm, and maintains records to verify proper management of levels. Peracetic acid is used 

according to manufacturer’s label directions.

Scenario 2: The operation’s wash water quality is based upon a peroxyacetic system. The 

operation has not established adjustment procedures for when the peracid level drops below the 
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target ppm. The operation’s records indicate that the level of peracetic acid has dropped below the 

acceptable level for affective use (based on the label instructions) several times in the last eight 

hours. 

Assessment: Immediate Action Required

Reason: The operation has not established adjustment procedures for when the peracid level drops 

below the target ppm. The peracid has dropped below the acceptable levels without adjustments. 

Scenario 3: The operation’s wash water quality is based upon a peroxyacetic system, levels are 

maintained in accordance with manufacturer’s label directions. The operation has not maintained 

records to verify proper management of the levels. 

Assessment: Corrective Action Needed. 

Reason: The operation has not maintained records to verify proper management of the peracetic 

acid levels. 

TPH-9 Quarantine or On-hold Materials 

Requirement TPH-9.1 Materials placed on hold, quarantined or rejected are clearly 

identified and segregated from other products and packaging materials.

Procedure Operation has a written procedure to clearly identify and segregate onhold, quarantined and rejected materials, to prevent commingling with 

other products or adulteration of products, production area or 

packaging materials.

Verification Auditor reviews procedure, reviews logs and observes all currently onhold, quarantined and rejected materials for compliance with 

procedure.

Corrective 

Action

Non-compliances are corrected on site. If on-hold, quarantined or 

rejected materials are not segregated according to procedure, operation 

shall assess potential for product adulteration. Procedures are developed 

or revised. Retraining is performed.

Documents 

Required

Record.

Mandatory ●

Example Scenarios 

Scenario 1: Operation has a written procedure to clearly identify and segregate on-hold, 

quarantined and rejected materials, to prevent commingling with other products or adulteration of 

products, production area or packaging materials. The auditor reviews the operation’s written 

procedure, reviews logs and observes that all product currently on-hold, quarantined and rejected is 

in compliance with procedure.

Assessment: Compliant. 

Reason: The auditor reviewed the operation’s written procedure, reviewed logs and observed that 

all product currently on-hold, quarantined and rejected is in compliance with procedure. 

Scenario 2: The operation has a written procedure to clearly identify and segregate on-hold, 

quarantined and rejected materials, to prevent commingling with other products or adulteration of 
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products, production area or packaging materials. During the observations of the packing line, the 

auditor notes that two pallets of tomatoes in the carton stacking area for tomatoes just coming off 

the packing line are tagged quarantined. The auditor inquires as to why the pallets are tagged with 

the quarantined tag. The operation manager was contacted and explained that the pallets were sent 

to the on-hold area just before lunch, and has no idea why the pallets are on the packing line. The 

manager instructs the lift operator to remove them to the on-hold area. 

Assessment: Corrective Action Needed. 

Reason: The operation is not following their written procedure to segregate on-hold, quarantined 

and rejected materials, to prevent commingling with other products or adulteration of products, 

production area or packaging materials. 

TPH-10 Tomato Rerunning Processes 

Requirement TPH-10.1 Tomato lots shall not be commingled in a rerunning process. 

Boxes shall not be reused if prohibited by prevailing regulation or law.

Procedure Operation has a policy prohibiting commingling of tomato lots if lots are 

rerun.

Verification Auditor reviews the policy, observes packing records and, if possible, 

example of rerunning process, for compliance.

Corrective 

Action

Operation ceases commingling lots. Boxes with commingled lots are 

labeled with component tomato sources and lot identification. Policy is 

developed or revised. Retraining is performed.

Documents 

Required

Record.

Mandatory ●

Example Scenarios 

Scenario 1: The operation has a policy prohibiting commingling of tomato lots if lots are rerun. 

Auditor reviews the policy, observes packing records and observes the rerunning process, for 

compliance. The auditor can clearly see that all of the pallets of tomatoes in the run are printed with 

the same lot ID.

Assessment: Compliant. 

Reason: The operation has a policy prohibiting commingling of tomato lots and the auditor can 

clearly see that all of the pallets of tomatoes in the run are printed with the same lot ID.

Scenario 2: The operation has a policy prohibiting commingling of tomato lots if lots are rerun. 

Auditor reviews the policy, observes packing records and observes the rerunning process, for 

compliance. The auditor can clearly see that the pallets of tomatoes in the run are printed with three 

different lot numbers. The auditor asks the crew lead about the three different lot numbers. The 

crew lead states that as long as they are all the same size of tomato, it’s acceptable to mix the lots.

Assessment: Corrective Action Needed. 

Reason: Tomato lots shall not be commingled in a rerunning process. The operation is not 

following their policy prohibiting commingling of tomato lots if lots are rerun.
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TPH-11 Food Defense Awareness

Requirement TPH-11.1 The facility is registered with FDA as required by the Public 

Health Security and Bioterrorism Preparedness and Response Act of 

2002.

Procedure If required by 21 CFR Part 1, Subpart H, facility is registered with FDA 

and registration is current.

Verification Auditor asks whether facility is registered. Facility is not required to 

demonstrate registration to auditor.

Corrective 

Action

Facility registers with FDA as required.

Documents 

Required

Record.

Mandatory ●

Example Scenarios 

Scenario 1: The facility is registered with FDA as required by the Public Health Security and

Bioterrorism Preparedness and Response Act of 2002 as required by 21 CFR Part 1, Subpart H, 

facility is registered with FDA and registration is current.

Assessment: Compliant. 

Reason: The facility is registered with FDA as required by the Public Health Security and 

Bioterrorism Preparedness and Response Act of 2002 as required.

Scenario 2: Operation has not been registered with the FDA or permitted as a food handling 

establishment as required by state or federal regulation. Operation demonstrates knowledge of 

prevailing requirements but does not have a copy of required permit(s) or registration. 

Assessment: Corrective Action Needed. 

Reason: Operation has not been registered or permitted as a food handling establishment as 

required by state or federal regulation. Operation does not have a copy of required permit(s) or 

registration.

Requirement TPH-11.2 There are procedures in place that readily identify employees, 

and those with specific access privileges, e.g., to chemical storage, to the 

water system. 

Procedure Operation has a written procedure for identifying current employees. 

Procedure also indicates which employees have access to restricted areas 

or materials, and how access is restricted.

Verification Auditor reviews procedure, verifies list of special access employees, 

observes restricted areas and materials for evidence of compliance and 

interviews employees for knowledge of procedure.

Corrective 

Action

Procedures are developed or revised. Retraining is performed.

Documents 

Required

Record.

Mandatory ●
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Example Scenarios 

Scenario 1: The operation has written procedures in place that readily identify employees, and 

those with specific access privileges to chemical storage and/or to the water system. Operation has 

a written procedure for identifying current employees. Procedure indicates which employees have 

access to restricted areas or materials, and how access is restricted. The auditor reviews the 

procedure, verifies that the operation has a list of special access employees, observes restricted 

areas and materials for evidence of compliance and interviews employees for knowledge of 

procedure. 

Assessment: Compliant. 

Reason: The auditor reviewed the procedure, verified that the operation has a list of special access 

employees, observed restricted areas and materials for evidence of compliance and interviewed 

employees for knowledge of procedure. 

Scenario 2: The operation has written procedures in place that readily identify employees. The 

written procedure does not indicate which employees have access to restricted areas or materials, 

and how access is restricted.

Assessment: Corrective Action Needed. 

Reason: The written procedure does not indicate which employees have access to restricted areas 

or materials, and how access is restricted.

Scenario 3: The auditor reviews the operation’s procedure and notes that the restricted access is 

achieved by locking doors to sensitive areas and issuing keys only to qualified employees and 

keeping a file of who is issued keys to each door. During the auditor’s walk-through of the 

packinghouse, the auditor observes that the door to the chemical room is unlocked. 

Assessment: Immediate Action Required or Corrective Action Needed. 

Reason: During the auditor’s walk-through of the packinghouse, the auditor observes that the door 

to the chemical room is unlocked. 

GREENHOUSE

TGH-1 Management Responsibility
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Requirement TGH-1.1 Operation has current copies of the Commodity Specific Food 

Safety Guidelines for the Fresh Tomato Supply Chain, Food Safety 

Programs and Auditing Protocol for the Fresh Tomato Supply Chain, 

the relevant Harmonized Food Safety Standard, and additional food 

safety documents as required by state and/or federal regulation.

Procedure Operation has a current copy of the Guidelines, this audit document and 

all other required documents.

Verification Auditor observes the current copies at the operation.

Corrective 

Action

Operation obtains current copies.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TOF-1.1) 

 

TGH-2 Recordkeeping and Traceability 

A. Greenhouse Packing

Requirement TGH-2.1 Containers shall be accurately labeled with commodity name, 

greenhouse firm name and information sufficient to allow for source and 

lot identification.

Procedure A product coding system is in place where product shall be labeled with 

grower and lot identification, and coded to enable access to date of 

harvest and/or packing, origin (name of greenhouse, grower and/or 

packing location), and country of origin for traceback purposes. If using 

reusable containers, procedures ensure that labels are accurate prior to 

packing.

Verification Auditor reviews coding procedures, observes cases for appropriate 

coding, and verifies compliance by review of records.

Corrective 

Action

Boxes with missing, inaccurate or illegible coding are labeled with 

appropriate identification Procedure is developed or revised. Retraining 

is performed.

Documents 

Required

Written Policy.

Mandatory ●

Example Scenarios 

Scenario 1: Containers are accurately labeled with commodity name, greenhouse firm name and 

information sufficient to allow for source and lot identification. A product coding system is in 

place where product is labeled with grower and lot identification and coded to enable access to date 
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of harvest and/or packing, origin (name of greenhouse, grower and/or packing location), and 

country of origin for traceback purposes. When using reusable containers, procedures ensure that 

labels are accurate prior to packing. Auditor reviews coding procedures observes cases for 

appropriate coding and verifies compliance by review of records. 

Assessment: Compliant. 

Reason: Auditor reviewed coding procedures observed cases for appropriate coding and verified 

compliance by review of records. Auditor verified that containers are accurately labeled.

Scenario 2: Containers are accurately labeled with commodity name, greenhouse firm name and 

information sufficient to allow for source and lot identification. A product coding system is in 

place where product is labeled with grower and lot identification and coded to enable access to date 

of harvest and/or packing, origin (name of greenhouse, grower and/or packing location), and 

country of origin for traceback purposes. During the auditor’s review of the written policy, the 

auditor did not find procedures for using reusable containers, no written procedures exist to ensure 

that labels are accurate prior to packing. 

Assessment: Corrective Action Needed. 

Reason: During the auditor’s review of the written policy, the auditor did not find procedures for 

using reusable containers, no written procedures exist to ensure that labels are accurate prior to 

packing. 

Scenario 3: Containers are labeled with commodity name, greenhouse firm name and information 

to allow for source and lot identification. A product coding system is in place where product is 

labeled with grower and lot identification and coded to enable access to date of harvest and/or 

packing, origin (name of greenhouse, grower and/or packing location), and country of origin for 

traceback purposes. As the auditor was verifying the coding system used on the labels of product 

harvested during the audit, the auditor observed that the code used, as explained by the auditee, was 

dated for the next day. The auditor pointed it out to the auditee, the auditee stated that the code on 

the labels was incorrect, but the auditee stated that he did not know what happened, upon review of 

the containers harvested the previous day, the same coding error was discovered. The auditee stated 

that three pallets of that product was shipped out that morning.

Assessment: Corrective Action Needed. 

Reason: The auditor observed that the code on the labels was incorrect, the auditee stated that he 

did not know what happened, upon review of the containers harvested the previous day, the same 

coding error was discovered. The auditee stated that three pallets of that product was shipped out 

that morning.

B. Packinghouse Packed Greenhouse Tomatoes 
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Requirement TGH-2.2 The greenhouse shall maintain supply chain information 

available to the packinghouse to facilitate accurate traceability; i.e., 

quantity, greenhouse identification and date of harvest/pack. 

Procedure Operation has procedures to retain and provide to the packinghouse 

records of source of seed or transplants, soil inputs, irrigation water 

sources and test records, names of crews involved in greenhouse 

operations, and other crop history information relevant to product 

safety. Records are retained for at least two years or as required by 

prevailing regulation.

Verification Auditor reviews policy and reviews records for compliance.

Corrective 

Action

Policy is developed or revised. Non-compliances are corrected on site. 

Retraining is performed.

Documents 

Required

Written Policy.

Mandatory ●

Example Scenarios 

Scenario 1: The greenhouse operation has written procedures to retain and provide to the 

packinghouse records for source of seed or transplants, soil inputs, irrigation water sources and test 

records, names of crews involved in greenhouse operations, and other crop history information 

relevant to product safety. Records are retained for at least two years or as required by prevailing 

regulation. Auditor reviews policy and reviews records for compliance and finds no deviations 

from the written policy.

Assessment: Compliant. 

Reason: Auditor reviewed the policy and records for compliance and found no deviations from the 

written policy. 

Scenario 2: The greenhouse maintains supply chain information and makes it available to the 

packinghouse to facilitate accurate traceability; i.e., quantity, greenhouse identification and date of 

harvest and packing. The operation has written procedures to retain and provide to the 

packinghouse records for source of seed or transplants, soil inputs, irrigation water sources and test 

records. But does not keep records on the names of the employees involved in the daily greenhouse 

operations. When asked by the auditor, the owner states that he hires from a temp agency. 

Assessment: Corrective Action Needed. 

Reason: The operation does not keep records on the names of the employees involved in the daily 

greenhouse operations.

Scenario 3: The greenhouse maintains supply chain information and makes it available to the 

packinghouse to facilitate accurate traceability; i.e., quantity, greenhouse identification and date of 

harvest and packing. The operation has written procedures to retain and provide to the 

packinghouse records for source of seed or transplants, soil inputs, irrigation water sources and test 

records and names of crews involved in greenhouse operations. Upon the auditor’s review of the 

facility’s label, the auditor notes that the greenhouse address is different than the address where the 

audit is taking place. The auditor asks the auditee if he has another location, the auditee states that 
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the address on the cartons is the address of his old greenhouse and he just wanted to use up the old 

materials.

Assessment: Corrective Action Needed. 

Reason: If cartons with the old address have been shipped from the new location it is assessed as 

IAR. If no containers have been shipped from the new location with the old address it would be 

assessed as Corrective Action Needed.

TGH-3 Self-Audit 

Requirement TGH-3.1 Operation has procedures for conducting self-audits and 

conducts self-audits to verify compliance with established internal 

policies and procedures. 

Procedure In addition to the requirements of the Harmonized Standards, the 

operation’s self-audit procedure ensures compliance with established 

internal policies and procedures, the Commodity Specific Food Safety 

Guidelines for the Fresh Tomato Supply Chain, these Tomato Metrics 

and additional food safety documents as required by state and/or federal 

regulation.

Verification Auditor reviews the self-audit procedures, and records of self-audits to 

verify compliance with the procedures.

Corrective 

Action

Operation develops and maintains self-audit program, with corrective 

actions preventive measures, documentation and follow-up.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

Auditees must conduct self-audits to verify compliance with established internal policies and 

procedures. There is not a specified format for the self-audit. The self-audit must verify the 

requirements of the Harmonized standard being utilized and Tomato Audit Protocol Open-Field 

Production Addendum requirements. 

Example Scenarios 

Scenario 1: The operation has procedures for conducting self-audits and conducts self-audits 

annually, but you find that the operation uses a self-made checklist for conducting self-audits. 

Assessment: Compliant 

Reason: As long as the self-audit performed addresses the requirements of the Harmonized 

Standards, ensures compliance with established internal policies and procedures, Commodity 

Specific Food Safety Guidelines for the Fresh Tomato Supply Chain, the Tomato Metrics, and 

additional food safety documents as required by state and/or federal regulation. 

Scenario 2: The operation maintains that they conduct self-audits but do not have a record of the 

self-audit. 

Assessment: Corrective Action Needed. Explain to the auditee that at this point the operation does 

not meet USDA Acceptance Criteria. Any question marked with a ● in the MAN column is 
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considered Mandatory and must either be assessed as compliant (C) or not applicable (N/A) in order 

to meet USDA Acceptance Criteria.

Reason: The requirement requires a written policy and records. Records should document when 

the self-audit was started and completed.

Scenario 3: Operation develops and maintains a self-audit program, including a written record of 

required corrective actions and follow-up procedures but does not include preventive measures. 

Assessment: Compliant or Corrective Action Needed. 

Reason: If the operation has sufficiently satisfied the requirements of checklist questions G-8.1 

and G-9.1, this checklist question shall be assessed as compliant.

TGH-4: Greenhouse 

Requirement TGH-4.1 The greenhouse shall be enclosed.

Procedure The greenhouse shall be permanent or temporary structure, sufficiently 

enclosed to maintain a controlled environment. This does not apply to 

open structures such as shade or hoop houses, which should operate 

according to the auditing protocol for Open Field Production, Harvest 

and Field Packing.

Verification The Auditor shall inspect the structure for compliance with this 

definition.

Corrective 

Action

If the structure is not in compliance, either the facility must be brought 

into compliance or different audit criteria (i.e., auditing protocol for 

Open Field Production, Harvest and Field Packing) should be used.

Documents 

Required

Written Policy, Record.

Mandatory ●

Example Scenarios 

Scenario 1: The greenhouse is a permanent structure, sufficiently enclosed to maintain a controlled 

environment. The auditor inspects the structure for compliance with this definition and finds the 

structure to be in compliance.

Assessment: Compliant. 

Reason: The auditor inspected the structure for compliance with this definition and finds the 

structure to be in compliance.

Scenario 2: The greenhouse is a temporary structure, sufficiently enclosed to maintain a controlled 

environment. The auditor inspects the structure for compliance with this definition and finds the 

structure to be in compliance.

Assessment: Compliant. 

Reason: The auditor inspected the structure for compliance with this definition and finds the 

structure to be in compliance.

Scenario 3: The greenhouse is four posts covered with thick plastic sheeting. Three of the sides of 

the structure are open to the elements.
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Assessment: Corrective Action Needed. 

Reason: The structure is not sufficiently enclosed. If the structure is not in compliance, either the 

facility must be brought into compliance or different audit criteria (i.e., auditing protocol for Open 

Field Production, Harvest and Field Packing) should be used.

Requirement TGH-4.2 A foot dip station or other measure should be used to prevent 

the introduction of harmful microorganisms or agents and a written 

record of the sanitizer and maintenance kept.

Procedure If the facility has determined that footborne contaminants are a risk to 

food safety, they shall have procedures that effectively prevent 

contaminants from being brought into the greenhouse on shoes. This 

could be by means of chemical disinfectants in foot dips, sprays or boot 

wash, or by means of a shoe change procedure. If chemical disinfectants 

are used, the chemical shall be used according to label instructions and 

monitored at a frequency sufficient to assure continual effectiveness, and 

records shall be maintained to demonstrate compliance.

Verification If the facility is using footborne contamination controls, the auditor shall 

review the procedure, and will observe whether those procedures are 

being followed at the time of the audit. The auditor shall also review any 

associated records, including the label instructions for any chemical 

disinfectants used, for evidence of compliance with the facility’s 

procedures.

Corrective 

Action

If the facility is using footborne contamination controls, they shall

develop or implement the procedures to be effective, including training 

in their use.

Documents 

Required

Written Policy, Record.

Mandatory ●

Example Scenarios 

Scenario 1: The facility has determined that foot-borne contaminants are a risk to food safety. 

They have procedures that effectively prevent contaminants from being brought into the greenhouse 

on shoes. This is by means of chemical disinfectants in foot dips for visitors, and by means of a 

shoe change procedure for employees. The chemical disinfectants are used according to label 

instructions and monitored at a frequency sufficient to assure continual effectiveness, and records 

are maintained to demonstrate compliance. The auditor reviews the operation’s written policy, the 

label instructions for the chemical used in the foot bath, and the logs associated with the foot-bath 

monitoring and finds that it is checked daily and changed as needed. 

Assessment: Compliant. 

Reason: The auditor reviewed the written policy, chemical label instructions, and the logs 

associated with the foot-bath monitoring and finds that it is checked daily and changed as needed. 

Scenario 2: The facility has determined that foot-borne contaminants are not a risk to food safety 

as all of the growing tables are four feet off the ground and the operation does not harvest or pack 
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any product that contacts the ground. They have not introduced procedures that effectively prevent 

contaminants from being brought into the greenhouse on shoes. 

Assessment: Compliant. 

Reason: The facility has determined that foot-borne contaminants are not a risk to food safety. 

Scenario 3: If the facility has determined that foot-borne contaminants are a risk to food safety, 

and they have developed written procedures that effectively prevent contaminants from being 

brought into the greenhouse on shoes. This is achieved by means of chemical disinfectants in foot 

dips, sprays, or boot wash, or by means of a shoe change procedure. Upon the auditor’s review of 

the logs associated with boot safety, the auditor observes that a record for testing and changing the 

foot bath solution is not present. The auditor asks the auditee for the records and the auditee states 

that they do not keep records for the checking or changing of the foot-bath solution. 

Assessment: Corrective Action Required.

Reason: If used, chemical disinfectants in footbaths should be monitored at a frequency sufficient 

to assure continual effectiveness, and records shall be maintained to demonstrate compliance.

TGH-5 Worker Health/Hygiene and Toilet/Handwashing Facilities 

Requirement TGH-5.1 Restrooms should not open directly into greenhouse 

production areas. 

Procedure Restrooms that do open directly into greenhouse production areas shall 

be equipped with self-closing mechanisms or have a maze-type 

entrance/exit.

Verification Auditor visually verifies that the toilet facilities are located and designed 

in a compliant manner.

Corrective 

Action

Operation retrofits or relocates the toilet facility.

Documents 

Required

N/A

Mandatory ●

Example Scenarios 

Scenario 1: The facility’s restrooms open directly into greenhouse production area but are not 

equipped with a self-closing mechanism or have a maze-type entrance/exit.

Assessment: Corrective Action Needed. 

Reason: Restrooms that open directly into greenhouse production areas shall be equipped with 

self-closing mechanisms or have a maze-type entrance/exit. 

Scenario 2: The operation’s restrooms do not open directly into greenhouse production area or are

equipped with self-closing mechanisms or have a maze-type entrance/exit.

Assessment: Compliant. 

Reason: The operation’s restrooms do not open directly into greenhouse production area or are

equipped with self-closing mechanisms or have a maze-type entrance/exit.
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Scenario 3: The greenhouse operation utilizes portable sanitation stations positioned outside of the 

greenhouse fifty yards from the production area. The operation has proper documentation and 

records for cleaning and servicing of the units as well as an emergency response plan for any leaks 

of spills from the units.

Assessment: Compliant. 

Reason: The portable sanitation stations are positioned outside of the greenhouse production area. 

The operation has proper documentation and records for cleaning and servicing of the units as well 

as an emergency response plan for any leaks of spills from the units.

Requirement TGH-5.2 If portable hand wash water tanks are used, they are cleaned 

and sanitized and the water is changed periodically. 

Procedure Water tanks used to provide hand wash water shall be maintained at a 

prescribed frequency in a clean and sanitary manner.

Verification Auditor reviews cleaning and sanitizing protocol and service logs, and 

visually observes condition of water tanks for signs of non-compliance.

Corrective 

Action

Clean and sanitize the tank, replace water to compliance.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TOF-4.2) 

Requirement TGH-5.3 Operation shall have a written policy regarding employees’ 

outer garments.

Procedure Policy includes that employees shall wear suitable outer garments, not 

reasonably likely to serve as a source of contamination of tomato or food 

contact surface, and, as appropriate to the operation, use of plastic 

aprons and sleeves, and empty pockets above the waist. Outer garments 

shall be changed after cleaning drains, restrooms or other activities that 

may result in contamination.

Verification Auditor reviews the policy, observes employees for compliance and 

interviews employees for knowledge of the policy.

Corrective 

Action

Policy is developed or revised. Non-compliances are corrected on site. 

Retraining is performed.

Documents 

Required

Written Policy.

Mandatory ●

Example Scenarios 

Scenario 1: Operation has a written policy regarding outer garments. The policy states, visitors 

and employees shall wear suitable outer garments, not reasonably likely to serve as a source of 

contamination of tomato or food contact surfaces, and, as appropriate to the operation. Use of 
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plastic aprons, sleeves and hairnets is required in production and packing areas at all times. Any 

pockets above the waist must be empty. Outer garments (aprons and sleeves) shall not be taken into 

restrooms, lunch or break areas and must be changed after cleaning drains, restrooms or other 

activities that may result in contamination. The auditor conducts interviews and observes that all 

employees and visitors are aware of and following the written policy.

Assessment: Compliant. 

Reason: Operation has a written policy regarding outer garments. The auditor conducted 

interviews and made observations and determined that all employees and visitors are aware of and 

following the written policy.

Scenario 2: Operation has a written policy regarding outer garments. The policy states, employees 

shall wear suitable outer garments, not reasonably likely to serve as a source of contamination of 

tomato or food contact surfaces, and, as appropriate to the operation. Use of plastic aprons, sleeves 

and hairnets is required in the production and packing areas at all times. Any pockets above the 

waist must be empty. Outer garments (aprons and sleeves) shall not be taken into restrooms or 

break/lunch areas and must be changed after cleaning drains, restrooms or other activities that may 

result in contamination. The auditor observes a greenhouse employee enter and exit the restroom 

without removing or replacing the apron, sleeves and hairnet, the employee then enters the 

production and packing area of the greenhouse. 

Assessment: Immediate Action Required

Reason: The operation is not following their SOP regarding outer garments. 

Scenario 3: The operation does not have a written policy regarding outer garments. 

Assessment: Corrective Action Needed. 

Reason: The operation does not have a written policy regarding outer garments. 

TGH-6 Pesticides

Requirement TGH-6.1 Water used to mix pesticides meets FDA E. coli standards for 

water in 21 CFR § 112.44(a); i.e., no detectable generic E. coli in 100 mL 

of agricultural water.

Procedure Operation has a written policy requiring foliar-application pesticides to 

be diluted only with water that meets FDA microbial standards for postharvest agricultural water. Operations will have documentation 

demonstrating compliance, such as test results for the water source used.

Verification Auditor reviews the policy and inspects pesticide mixing and application 

records.

Corrective 

Action

Operation develops a written policy. Retraining of pesticide applicator 

as needed. If unknown or nondrinking quality water was used to 

prepare pesticides, then test the water source for compliance with 

drinking water E. coli standards. Do not harvest product unless test 

results demonstrate compliance.

Documents 

Required

Record.

Mandatory ●
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Expectation 

(See requirement TOF-5.1) 

Example Scenarios:

Scenario 1: The greenhouse operation has a written policy requiring foliar-application pesticides to 

be diluted only with water that meets FDA microbial standards for drinking water. The operation’s 

chemical specialist conducts all applications of pesticides. The auditor reviews the water test 

records for the water used by the operation for compliance and finds that the water is from a 

municipal source that meets EPA microbial standards for drinking water and annual testing is 

performed and documented by the municipality.

Assessment: Compliant 

Reason: Water used to mix pesticides meets EPA microbial standards for drinking water; 21 CFR 

Part 112.44(a). 

Scenario 2: The operation conducts all foliar applications of pesticides. The operation has a policy 

requiring all application of pesticides to be mixed with the onsite well water. The auditor reviews 

the water test records for the water used by the operation for compliance and finds that the water 

used is tested three times annually. The most recent water tests all meet EPA recreational water 

standards for E. coli 21 CFR § 112.44(b) 

Assessment: Immediate Action Required

Reason: Water used to mix pesticides must meet EPA microbial standards for drinking water; 21 

CFR § 112.44(a) i.e., no detectable generic E. coli in 100 milliliters (mL) of agricultural water. 

Scenario 3: The greenhouse operation uses municipal water for the application of pesticides, the 

municipal water is tested by the municipality annually, the operation does not do any additional 

testing of the water. The auditor requests the most recent water quality report from the water 

supplier. The auditee states that they do not have records of the water report from the city.

Assessment: Corrective Action Needed. 

Reason: Operations will have documentation demonstrating compliance, such as test results for the 

water source used.

TGH-7 Water Used in Growing Activities
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Requirement TGH-7.1 Non-Foliar The water test meets FDA E. coli standards for 

foliar application of water as described in 21 CFR § 112.44(b).

Procedure Written procedure requires a BAM or other testing procedure validated 

for generic E. coli quantitation in water.

Verification Auditor reviews water test results and any corrective actions taken to 

bring the water source into compliance.

Corrective 

Action

Perform a sanitary survey for each affected water source, perform any 

remedial action as required and retest. If the retest also exceeds the 

standard, further evaluate potential corrective actions, such as 

treatment, retreatment, or discontinue use of source.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TOF 6.1) 

Example Scenarios 

Scenario 1: The greenhouse operation irrigates by channels molded into the specially constructed 

tables where the containers of produce are placed. The operation has a written policy that states 

tomatoes that have been found on the table or in contact with water during harvesting operations are 

not to be harvested. When irrigating, the table channels are filled with water from an enclosed well. 

The most current water tests reviewed show <1 ppm/100 mL for generic E. coli and total coliforms.

Assessment: Compliant 

Reason: Any non-foliar application of water to tomatoes (e.g., irrigation or crop protection sprays) 

shall meet the microbial standards contained in 21 CFR 112.44(b) 

Scenario 2: The growing operation irrigates by use of channels molded into the specially 

constructed tables where the containers of produce are placed. The operation has a written policy 

that states tomatoes that have been found on the table or in contact with water during harvesting 

operations are not to be harvested. The water is from an aqueduct system that is tested every 

month, the testing shows that over the last twelve months the water never exceeded a geometric 

mean of 126 colony forming units of generic E. coli per 100 mL of water and a statistical threshold 

value of 410 or less CFU of generic E. coli per 100 mL of water.

Assessment: Compliant. 

Reason: While not required by the Produce Safety Rule, any water used for drip irrigation or noncontact uses shall meet the standard for E. coli levels in 21 CFR 112.44(b), i.e., (1) A geometric 

mean (GM) of 126 or less colony forming units (CFU) of generic E. coli per 100 mL of water and 

(2) a statistical threshold value (STV) of 410 or less CFU of generic E. coli per 100 mL of water.
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Requirement TGH-7.2 Foliar The water test meets FDA standards for water in 21 

CFR § 112.44(a); i.e., no detectable generic E. coli in 100 milliliters (mL) 

of agricultural water.

Procedure Written procedure requires a BAM or other testing procedure validated 

for generic E. coli quantitation in water.

Verification Auditor reviews water test results and any corrective actions taken to 

bring the water source into compliance. If tomatoes have been contacted 

with non-compliant water, auditor reviews the risk assessment and 

disposition.

Corrective 

Action

Perform a sanitary survey for each affected water source, perform any 

remedial action as required and retest. If the retest also exceeds the 

standard, further evaluate potential corrective actions, such as 

treatment, retreatment, or discontinue use of source. Operation shall 

evaluate tomatoes that have been contacted with noncompliant water to 

assess food safety risk. The assessment is documented and tomatoes 

dispositioned accordingly.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TOF 6.2) 

Example Scenarios 

Scenario 1: The greenhouse relies on an onsite, private well for irrigation. The operation has not 

had the well water tested in three years but uses the same well for the house where he lives. The 

auditee states that the water is safe enough for his wife and family because they never got sick from 

its use. The auditee goes on to say that he used the well for irrigation all season. The operation 

applies the well water by use of an overhead sprinkler system.

Assessment: Immediate Action Required

Reason: Records of testing of agricultural waters must be analyzed and maintained. Operations 

will have documentation demonstrating compliance, such as test results for the water source used.

Scenario 2: The operation applies water for irrigation and crop protection materials with a hand 

sprayer. The water is sourced from the city where the operation resides. The operation does not 

perform microbial testing on the water but has the report from the city dated over one year ago. The 

operation states that this is the most recent record available from the city.

Assessment: Compliant. 

Reason: There is no requirement to test any agricultural water that is subject to the requirements of 

§112.44 when water is provided by a public water supply that furnishes water that meets the 

microbial quality requirement described in 21 CFR part 112.44(a). Results or certificates of 

compliance from the public water system are required that demonstrate that the water meets the 

required standards. 
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TGH-8 Soil and Soil Amendments 

Requirement TGH-8.1 Soil or other growth medium shall be stored in a manner that 

minimizes opportunities for contamination.

Procedure If soil or growth medium is stored onsite, it is held in a sanitary manner 

to ensure it is not a source of contamination. Procedures for storage of 

growth media shall comply with prevailing laws or regulations in the 

location of the greenhouse.

Verification The auditor shall observe storage location and procedures for evidence 

of compliance.

Corrective 

Action

Operation develops a written procedure and provides training. If there 

is evidence of contamination of public health significance, the medium 

shall not be used.

Documents 

Required

N/A

Mandatory ●

Example Scenarios 

Scenario 1: The greenhouse purchases its organic potting soil from an approved supplier, records 

of purchases and letters of guarantee are available and reviewed by the auditor. The product is 

stored in the operation’s enclosed, sealed and locked storage shed and the area is included in the 

operation’s pest management program. 

Assessment: Compliant. 

Reason: The product is stored in the operation’s enclosed, sealed and locked storage shed and the 

area is included in the operation’s pest management program.

Scenario 2: The greenhouse uses growth medium that is comprised of shredded coconut shells, the 

product is stored in accordance with the label instructions.

Assessment: Compliant. 

Reason: The product is stored in accordance with the label instructions. 

Scenario 3: The operation uses soil obtained from the farming operation that was onsite previous 

to the greenhouse construction. The soil is not stored, it is left in the ground until such time as the 

operation needs more soil inside the greenhouse. A soil assessment and soil testing were done prior 

to purchasing the land and is done annually, the testing provided no evidence of contamination of 

public health significance. 

Assessment: Compliant. 

Reason: A soil assessment and soil testing was done prior to purchasing the land and is performed 

annually, the testing provided no evidence of contamination of public health significance. 
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Requirement TGH-8.2 Fertilizer manufacturer’s instructions for usage and storage 

shall be followed.

Procedure Non-organic fertilizers must be used and stored in compliance with label 

instructions and any prevailing federal, state or local regulations. 

Fertilizer uses shall be documented.

Verification Auditor reviews non-organic fertilizers used, storage location and 

application records.

Corrective 

Action

Perform training on fertilizer handling and recordkeeping procedures, 

as needed.

Documents 

Required

Record.

Mandatory ●

Example Scenarios 

Scenario 1: The operation uses and stores non-organic fertilizers in compliance with label 

instructions and any prevailing federal, state or local regulations. Fertilizer use is documented. 

Auditor reviews non-organic fertilizers used, storage location and application records and finds that 

use, storage, and documentation are in compliance with the label instructions and federal, state and 

local regulations.

Assessment: Compliant. 

Reason: The auditor reviewed non-organic fertilizers used, storage location and application 

records and found that use, storage and documentation is in compliance with the label instructions 

and federal, state and local regulations.

Scenario 2: The operation uses and stores non-organic fertilizers. Fertilizer use is documented. 

Auditor reviews non-organic fertilizers used, storage location and application records and finds that 

use, storage, and documentation are not in compliance with the label instructions and/or federal, 

state and local regulations.

Assessment: Corrective Action Needed. 

Reason: Auditor reviewed non-organic fertilizer use, storage location and application records and 

finds that use, storage, and documentation are not in compliance with the label instructions and/or 

federal, state and local regulations. 
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Requirement TGH-8.3 If fertilizers containing manures or composts are used, only 

properly treated (composted or heat treated) manures are allowed for 

use in greenhouses. Biosolids are not permitted.

Procedure Soil amendment use records are available, reviewed and current 

(conventional or organic). If treated manures are used, records of 

composition, dates of treatment, methods utilized, application dates and 

letter of guarantee, certificate of analysis (COA) or any test results or 

verification data demonstrating compliance with process or microbial 

standards must be documented. For non-composted animal by-products 

containing soil amendments, the operations shall retain a certificate or 

letter showing the lethality of the process. Compost applications shall be 

no less than 45 days prior to harvest.

Verification Auditor reviews the amendment use documents and records 

demonstrating compliance with prevailing national or local established 

composting or heat treatment standards or guidelines.

Corrective 

Action

Operations must obtain the necessary documents. If the documents 

cannot be obtained, crop cannot be harvested for that crop cycle.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TOF 7.1) 

Example Scenarios 

Scenario 1: The operation purchases the liquid soil amendments from DEF Agriculture Services, 

Inc. The fertilizer application date and use are documented. The operation produces a letter of 

guarantee from DEF Services as confirmation that all materials applied by DEF contain no 

untreated manure or animal by-products. 

Assessment: Compliant. 

Reason: The letter of guarantee confirms that the applicator does not use soil amendments 

containing raw or untreated manure. 

Scenario 2: The tomato growing operation applies treated animal-based soil amendments. The 

documentation confirms that the amendments are applied forty-five days prior to the expected 

harvest date. The operation produces a receipt for the purchase of the compost that confirms it was 

purchased from GES Farms in October. The receipt includes the composition of the soil 

amendment and the dates of treatment.

Assessment: Immediate Action Required

Reason: If treated manures are used, the following must be documented: composition, dates of 

treatment, methods utilized, application dates and test results or process verification data 

demonstrating compliance with microbial standards. Evidence of processing adequate to eliminate 

pathogens of human concern, such as letter of guarantee, certificate of analysis (COA) or any test 
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results or verification data (e.g., time and temperature) demonstrating compliance with process or 

microbial standards, shall be documented. 

Scenario 3: The small family greenhouse in the northeast growing tomatoes for a local retailer, 

applies raw cow manure to his growing fields. The owner states that the manure is from his cow 

grazing fields and barn. The owner states that he applies the manure in October after completing 

the harvest and does not begin to plant new crops until May of the following year. 

Assessment: Immediate Action Required

Reason: If fertilizers containing manures or composts are used, only properly treated (composted 

or heat treated) manures are allowed for use. While permitted by the Produce Safety Rule under 

specific conditions, biosolids are not allowed for use in tomato production. 

TGH-9 Sanitizing Agents Used During Harvest 

Requirement TGH-9.1 All compounds used to clean or sanitize food contact 

containers, tools, utensils, equipment or other food contact surfaces are 

approved for that use by the US EPA, FDA or other prevailing agency. 

Actual use conforms to label directions.

Procedure Documentation is available to demonstrate that cleaning and sanitizing 

products are approved for their use, and are used according to label 

directions. Sanitizing chemicals uses shall be documented.

Verification Auditors review documentation and supplies to confirm approved use, 

and interview individuals responsible for their use for knowledge of 

approved use. Auditor reviews records of use, and visually observes use, 

to verify compliance with label directions.

Corrective 

Action

Non-compliances are corrected on site. Records are reviewed for 

potential product adulteration. Retraining is performed.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TOF 8.1) 

Example Scenarios 

Scenario 1: Documentation is available to demonstrate that cleaning and sanitizing products are 

approved for their use and are used according to label directions. Sanitizing chemical use is 

documented daily. The auditor reviews the documentation and supplies to confirm approved use, 

and interviews individuals responsible for their knowledge of approved use. Auditor reviews 

records of use and visually observes use to verify compliance with label directions. 

Assessment: Compliant. 

Reason: The auditor reviewed the documentation and supplies to confirm approved use and 

interviewed individuals responsible for their knowledge of approved use. Auditor reviewed records 

of use and visually observed use to verify compliance with label directions.
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Scenario 2: Documentation is available to demonstrate that cleaning and sanitizing products are 

approved for their use. Sanitizing chemical use is documented. The auditor reviews the 

documentation and supplies to confirm approved use, and interviews individuals responsible for 

their knowledge of approved use. While the auditor is visually observing use to verify compliance 

with label directions, it is observed that the chemical is not being mixed in accordance with the 

label instructions. The head cleaning employee was asked why he mixed the product at a stronger 

concentration. The employee’s reply was if a little is good, then more must be better.

Assessment: Immediate Action Required.

Reason: While the auditor was observing chemical use to verify compliance with label directions, 

it was observed that the chemical is not being mixed in accordance with the label instructions. 

Scenario 3: The auditor reviews the documentation and supplies to confirm approved use, and 

interviews individuals responsible for their knowledge of approved use. The auditor then asks the 

auditee for the records of use, the most recent use log is dated three months ago. The auditee states 

that the head cleaning person retired around that time, and he did not realize until just now that the 

new cleaning crew was not logging chemical use. 

Assessment: Corrective Action Needed. 

Reason: Sanitizing chemicals uses shall be documented.

Requirement TGH-9.2 Chemicals used on product that are not registered pesticides 

may be permitted for food contact use if allowed under regulations of 

the FDA or prevailing agency.

Procedure Any product contact chemicals not specifically approved as registered 

pesticides shall be identified, the authority permitting their use 

identified and their uses documented.

Verification Auditors review documentation and supplies to confirm approved use, 

and interview individuals responsible for their use for knowledge of 

approved use. Auditor reviews records of use, and visually observes use, 

to verify compliance with label directions.

Corrective 

Action

Non-compliances are corrected on site. Records are reviewed for 

potential product adulteration. Retraining is performed.

Documents 

Required

Record.

Mandatory ●

Expectation

EPA considers any chemical making an antimicrobial claim, including those used to sanitize 

equipment and tomatoes, to be a pesticide. Sanitizing chemicals used must comply with all 

requirements of EPA registration and any federal, state or local regulations. Sanitizing chemicals 

must be appropriately registered for such use and must be used in accordance with label directions. 

Sanitizing chemicals uses shall be documented.

Any surfaces or equipment intended to touch fresh produce is a food contact surface and must be 

cleaned and sanitized at a frequency sufficient to prevent the surfaces from becoming a source of 

contamination. 
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Example Scenarios

Scenario 1: The operation uses a disinfecting bleach to clean and sanitize all food contact surfaces, 

containers, equipment and utensils. The facility manager states that the cleaning crew mixes the 

substance in accordance with the label instructions for food contact equipment. The mixing 

instructions are posted at the cleaning chemical mixing areas and records of where, when and what 

was cleaned and sanitized are documented with each use. The auditor reviews the use records, 

verifies that the substance is approved for cleaning on food contact equipment, and interviews the 

cleaning crew to verify that the proper mixing procedure and use are being followed.

Assessment: Compliant. 

Reason: Documentation is available to demonstrate that sanitizing products are approved for their 

intended use and are used according to label directions. The auditor verified that the substance is 

being mixed and used correctly and sanitizing chemical use is documented.

Scenario 2: The supervisor oversees the sanitizing of the food contact containers and surfaces. 

Records indicate that the substance used for cleaning is mixed every evening after packing for the 

day has been completed. The product is mixed in accordance with the label instructions. The 

auditor verifies that the product is approved for sanitizing food contact equipment, but notes that the 

label states surfaces need to be cleaned with a cleaning solution prior to sanitizer use. The auditee 

is unable to produce a record of cleaning prior to sanitizing.

Assessment: Corrective Action Needed. 

Reason: Unless the label states that it cleans and sanitizes, it’s not a cleaning solution. The food 

contact containers need to be cleaned before they are sanitized (according to the label instructions).

Scenario 3: For cleaning and sanitizing food contact surfaces and equipment, the operation’s 

cleaning crew uses a concentrated chlorine used for swimming pools directly from the container. 

After use, the crew rinses the food contact surface with potable water. The auditor reviews the label 

instructions and finds that the chemical is not approved for use on food contact surfaces or 

equipment.

Assessment: Immediate Action Required.

Reason: The product is not approved for use of food contact surfaces or equipment.
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TGH-10 Product Wash Water Management

Requirement TGH-10.1 In systems where tomatoes are submerged or dwell in water, 

water temperature is monitored and controlled. Water temperature 

should be at least 10oF above average pulp temperature of tomatoes 

when entering the water.

Procedure Operation shall have methods for determining average pulp 

temperature of a minimum of 5 tomatoes, a procedure for control of 

water temperature, shall monitor temperature at a prescribed frequency 

sufficient to assure continuous compliance (minimum of hourly) and 

shall maintain records of water temperature. Operation shall have a 

procedure as to what corrective actions are taken if criteria are not met. 

Water spray or shower systems, wherein tomatoes are not submerged or 

dwell, do not require temperature control.

Verification Auditor shall review the procedure and shall review records of 

temperature monitoring. Auditor observes process including the 

operation’s sampling of pulp and water temperatures. Auditor reviews 

records for deviations and their disposition.

Corrective 

Action

Procedure is developed or revised. Retraining is performed. Tomatoes 

washed in water at temperatures less than the average measured pulp 

temperature shall be discarded back to the last evidence of compliance.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TOF 8.1) 

Requirement TGH-10.2 Operations utilizing spray systems in place of whole tomato 

immersion shall design the line so that the entire tomato surface is 

rinsed. 

Procedure Spray systems shall be designed such that rinse water contacts all 

surfaces of the tomato.

Verification Auditor observes spray system for compliance.

Corrective 

Action

Equipment or process is redesigned or retrofitted to ensure all surfaces 

of tomato are contacted.

Documents 

Required

N/A

Mandatory ●

Expectation 

(See requirement TPH-8.2) 
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Requirement TGH-10.3 If a spray bar system is used, operation has a water use SOP 

that addresses treatment of that water.

Procedure Operation’s water use SOP requires spray bar water to be treated using 

an approved antimicrobial to maintain a microbially hostile 

environment on equipment.

Verification Auditor shall review water use SOP for completeness, and observes 

water treatment records for adequacy and consistency of treatment.

Corrective 

Action

Operation discontinues using spray bar water that is not treated 

sufficiently to maintain a hostile environment on equipment. Retraining 

is performed and documented. Affected product is evaluated for 

potential contamination and disposition.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

(See requirement TPH 8.3) 

Requirement TGH-10.4 If water quality is based upon a chlorine-based sanitizer, the 

process shall be targeted to be at least 100 ppm free available chlorine 

(FAC), measured at the exit of the product from the water system, unless 

validation data are available to demonstrate a lower FAC is effective 

under operating conditions. 

Procedure Operation shall have a procedure to manage FAC levels, shall establish 

process adjustments for when the FAC drops below 100 ppm, and shall 

maintain records to verify proper management of levels.

Verification Auditor shall review the procedure and shall review records of FAC 

measurement and appropriate management. Auditor reviews records 

for deviations and their disposition.

Corrective 

Action

Procedure is developed or revised. Retraining is performed. Tomatoes 

washed in water at FAC less than 100 ppm shall be discarded back to 

the last evidence of compliance.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TPH-8.4) 
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Requirement TGH-10.5 If water quality is based upon a peroxyacetic, peracetic or 

peracid system, levels shall be maintained in accordance with 

manufacturer’s label directions. 

Procedure Operation shall have a procedure to manage peracid levels, shall 

establish process targets so as not to drop below the minimum ppm, 

shall establish adjustments for when the peracid level drops below the 

target ppm, and shall maintain records to verify proper management of 

levels.

Verification Auditor shall review the procedure and shall review records of peracetic 

measurement and appropriate management. Auditor reviews records 

for deviations and their disposition.

Corrective 

Action

Procedure is developed or revised. Retraining is performed. Tomatoes 

washed in water at less than manufacturer’s recommendation shall be 

discarded back to the last evidence of compliance.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TPH-8.5) 

TGH-11 Product Containers and Packaging Materials 

Requirement TGH-11.1 Operation has a written procedure for inspecting incoming 

packaging material. 

Procedure All packaging materials are inspected for evidence of contamination 

upon arrival. Results are recorded.

Verification Auditor reviews procedure and examples of packaging and receiving 

records for compliance.

Corrective 

Action

Operation creates or revises policy. Contaminated or adulterated 

packaging material is rejected or discarded. Retraining is performed.

Documents 

Required

Record.

Mandatory ●

Example Scenarios 

Scenario 1: The operation has a written procedure for inspecting incoming packaging material. 

The SOP states that all packaging materials are inspected for evidence of contamination upon 

arrival. Results are logged on the incoming product receiving log. Auditor reviews procedure and 

examples of packaging and receiving records for compliance. 

Assessment: Compliant. 

Reason: The auditor reviewed the written procedure and examples of packaging. The auditor 

reviewed receiving records for compliance.
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Scenario 2: The operation has a written procedure for inspecting incoming packaging material. 

The auditor reviews the written procedure. The SOP states that all packaging materials are 

inspected for evidence of contamination upon arrival and that the receiver will note any damage to 

product, pallet wrapping, or pallets on the incoming product receiving log. The auditor reviews 

packaging and receiving records for compliance. The auditor observes that several pallets of 

packaging materials received the previous day had torn, damaged or no wrapping. The auditor 

observes that the receiver did not note the damaged wrapping on the product receiving log. 

Assessment: Corrective Action Needed. 

Reason: The employee has not followed the operation’s SOP regarding documenting damage to 

incoming products. 

Scenario 3: The operation has a written procedure for inspecting incoming packaging material. 

The auditor reviews the written procedure. The SOP states that all packaging materials are 

inspected for evidence of contamination upon arrival and that the receiver will note any damage or 

possible contamination to product, pallet wrapping, or pallets on the incoming product receiving 

log. The auditor reviews packaging and receiving records for compliance. The auditor observes 

that several pallets of packaging materials received the previous day had torn, damaged or no 

wrapping and some packaging was discolored, dirty and torn. One pallet with torn wrapping 

contained evidence of bird droppings. The auditor observes that the receiver noted the damaged 

wrapping on the product receiving log, but did not observe any notes about the discolored, dirty, 

torn packaging or evidence of bird droppings. 

Assessment: Corrective Action Needed. 

Reason: The auditor observes that the receiver noted the damaged wrapping on the product 

receiving log, but did not observe any notes about the discolored, dirty, torn packaging or evidence 

of bird droppings. The operation is not following the SOP. 

Requirement TGH-11.2 Reusable containers and food contact equipment and utensils 

shall be constructed of impervious materials that can be easily cleaned 

and sanitized. 

Procedure Written SOP requires that all reusable product containers are made of 

materials that can be sanitized, or clean and sanitary liners are used. 

Wood is not an appropriate food contact surface. Procedures require 

damaged containers that are no longer easily cleanable or sanitary shall 

be removed from service of food contact purposes.

Verification Auditor reviews SOP, visually observes product bins, trays and 

containers and their use for evidence of non-compliance.

Corrective 

Action

Policy is developed or revised. Non-compliances are corrected. 

Operation makes a commitment for phasing out non-conforming 

product containers; e.g., wooden bins, in a reasonable timeline. 

Retraining is performed.

Documents 

Required

Record.

Mandatory ●

Expectation 
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(See requirement TOF-9.1) 

Example Scenarios 

Scenario 1: During the auditor’s observation of the greenhouse operations, the auditor observes 

several plastic harvesting containers are broken or cracked and held together with duct tape. The 

facility manager states that they ordered new harvest containers, but the order has not yet arrived.

Assessment: Immediate Action Required.

Reason: Using harvest containers that have duct tape may result in contamination of harvested 

product as duct tape cannot be sanitized.

Scenario 2: The greenhouse operation is harvesting tomatoes into wooden crates. The wooden 

crates are fitted with new clean plastic sheeting prior to each use. The owner states that plastic 

crates are just too expensive for him to purchase at this time, but plans to replace the wood crates 

with plastic crates one or two at a time as the wood crates become no longer usable.

Assessment: Compliant. 

Reason: The operation has a plan to replace the wood crates in a reasonable timeframe.

Scenario 3: The greenhouse operation is using wood tables for packing consumer units of 

tomatoes. The consumer units are then placed in master cartons for shipping. The wood tables are 

stained, discolored, some splintering in areas and clearly not suitable for food contact use. The 

auditee states that the product never touches the table. 

Assessment: Immediate Action Required.

Reason: Even though the tomatoes may not contact the table, the consumer units do contact the 

table as do the master cartons into which the consumer units are packed.

Requirement TGH-11.3 Finished product containers are prohibited from direct 

contact with the floor, and pallets, slip sheets, and supports used to keep 

product containers off the floor are clean and in good condition.

Procedure Operation has a policy prohibiting finished product containers in direct 

contact with the floor, and that pallets, slip sheets, and supports used to 

keep product containers off the floor are maintained so as not to be a 

source of contamination.

Verification Auditor reviews policy and examines finished product staging and 

storage areas and pallets, slip sheets, and supports for compliance with 

the policy.

Corrective 

Action

Operation creates or revises policy. Non-compliances are corrected on 

site. Retraining is performed.

Documents 

Required

Written Policy.

Mandatory ●

Example Scenarios 

Scenario 1: The operation has a written policy prohibiting finished product containers in direct 

contact with the floor. The SOP also states that all pallets, slip sheets, and supports used to keep 

product containers off the floor are maintained so as not to be a source of contamination. Auditor 
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Effective Date: July 2022 Page 331 of 422 

reviews the policy and examines finished product staging and storage areas and pallets, slip sheets, 

and supports for compliance with the policy. The auditor finds that the facility is following the SOP 

and is in compliance with the standard. 

Assessment: Compliant. 

Reason: The auditor finds that the facility is following the SOP and is in compliance with the 

standard. 

Scenario 2: The operation has a written policy prohibiting finished product containers in direct 

contact with the floor. The SOP also states that all pallets, slip sheets, and supports used to keep 

product containers off the floor are maintained so as not to be a source of contamination. As the 

auditor reviews the policy and examines finished product staging and storage areas, the auditor 

observes pallets, slip sheets, and supports that are not in compliance with the written policy. 

Assessment: Corrective Action Needed. 

Reason: The auditor observed pallets, slip sheets, and supports that are not in compliance with the 

written policy in the finished product staging and storage areas.

Scenario 3: The auditee states that the operation has a policy prohibiting finished product 

containers in direct contact with the floor. The SOP is not written in the operation’s food safety 

plan. 

Assessment: Corrective Action Needed. 

Reason: The policy must be written. 

REPACKING AND DISTRIBUTION

TPD-1 Management Responsibility

Requirement TPD-1.1 Operation has current copies of the Commodity Specific Food 

Safety Guidelines for the Fresh Tomato Supply Chain, Food Safety 

Programs and Auditing Protocol for the Fresh Tomato Supply Chain, 

the relevant Harmonized Food Safety Standard, and additional food 

safety documents as required by state and/or federal regulation.

Procedure Operation has a current copy of the Guidelines, this audit document and 

all other required documents.

Verification Auditor observes the current copies at the operation.

Corrective 

Action

Operation obtains current copies.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TOF-1.1) 
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Requirement TPD-1.2 Operation has been registered or permitted as a food handling 

establishment as required by state or federal regulation.

Procedure Operation demonstrates knowledge of prevailing requirements and has 

a copy of required permit(s) or registration.

Verification Auditor reviews copies at the operation to verify they are current and 

complete.

Corrective 

Action

Operation applies for or renews required permits or registration.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

(See requirement TPH-1.2) 

Example Scenarios 

Scenario 1: Operation has been registered or permitted as a food handling establishment as 

required by state or federal regulation. Operation demonstrates knowledge of prevailing 

requirements and has a copy of required permit(s) or registration. 

Assessment: Compliant. 

Reason: Operation is registered or permitted as a food handling establishment as required by state 

or federal regulation. Operation demonstrates knowledge of prevailing requirements and has a copy 

of required permit(s) or registration.

Scenario 2: Operation has not been registered or permitted as a food handling establishment as 

required by state or federal regulation. Operation demonstrates knowledge of prevailing 

requirements but does not have a copy of required permit(s) or registration.

Assessment: Corrective Action Needed. 

Reason: Operation has not been registered or permitted as a food handling establishment as 

required by state or federal regulation. Operation does not have a copy of required permit(s) or 

registration.

TPD-2 Raw Material Sourcing
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Requirement TPD-2.1 The operation has a policy and takes affirmative steps to ensure 

that all fresh tomatoes that are packed or stored in the facility are grown 

following requirements in Tomato Metrics Audit - Open Field Production, 

Harvest and Field Packing.

Procedure The packinghouse requires all raw product suppliers to provide 

evidence of food safety/GAP programs and compliance. Such evidence 

must include sufficient documentation to demonstrate that the supplier 

complies with the requirements in Tomato Metrics Audit - Open Field 

Production, Harvest and Field Packing.

Verification Auditor reviews policy and verifies that operation’s evidence of supplier 

compliance with food safety/GAP programs is in compliance with the 

operation’s policy.

Corrective 

Action

Operation obtains required documentation. Operation ceases accepting 

or shipping product from nonapproved suppliers, until sufficient 

documentation demonstrating compliance is received by the operation.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

(See requirement TPH-2.1) 

Example Scenarios 

Scenario 1: The operation has a written policy and takes affirmative steps to ensure that all 

Tomatoes that are packed or stored in the Operation are grown following requirements in the 

Tomato Metrics - Open Field Production, Harvest and Field Packing Standard. 

Assessment: Compliant. 

Reason: The operation has a written policy and takes affirmative steps to ensure that all tomatoes 

that are packed or stored in the operation are grown following requirements in the Tomato Metrics - 

Open Field Production, Harvest and Field Packing. The auditor reviews the policy and third-party

audit certificates for the operation’s raw product suppliers and finds all documents to be compliant. 

Scenario 2: The operation does not have a written policy regarding taking affirmative steps to 

ensure that all tomatoes that are packed or stored in the operation are grown following requirements 

in the Tomato Metrics - Open Field Production, Harvest and Field Packing Standard. 

Assessment: Corrective Action Needed. 

Reason: The operation does not have a written policy regarding taking affirmative steps to ensure 

that all tomatoes that are packed or stored in the operation are grown following requirements in the 

Tomato Metrics - Open Field Production, Harvest and Field Packing Standard. 

Scenario 3: The operation has a policy and takes affirmative steps to ensure that all tomatoes that 

are packed or stored in the operation are grown following requirements in the Tomato Metrics - 

Open Field Production, Harvest and Field Packing Standard. The policy is not written and the 

auditee is unable to furnish records of their suppliers’ third-party audits.
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Assessment: Corrective Action Needed. 

Reason: The policy is not written and the auditee is unable to furnish records of their operation’s 

raw product suppliers’ third-party audits.

Requirement TPD-2.2 Operation has procedures to ensure that the tomato staging 

area and staging practices do not pose a risk of tomato contamination.

Procedure The packinghouse staging area is designed so that overhead areas do not 

pose a contamination risk of uncovered tomatoes, or that tomatoes are 

protected during staging to prevent contamination.

Verification Auditor reviews procedures and inspects staging area for potential 

sources of contamination.

Corrective 

Action

Operation develops procedures and/or redesigns staging area or staging 

practices to prevent reasonably likely to occur opportunities for 

contamination. Tomatoes that have become contaminated are discarded.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

(See requirement TPH-2.2) 

Example Scenarios 

Scenario 1: Operation has written procedures to ensure that the tomato staging area and staging 

practices do not pose a risk of tomato contamination. The auditor confirms that the packinghouse 

staging area is designed so that overhead areas do not pose a contamination risk of uncovered 

tomatoes, and that tomatoes are protected during staging to prevent contamination. 

Assessment: Compliant. 

Reason: Operation has procedures and a written policy to ensure that the tomato staging area and 

staging practices do not pose a risk of tomato contamination. 

Scenario 2: Operation has written procedures to ensure that the tomato staging area and staging 

practices do not pose a risk of tomato contamination. Upon the auditor’s review of the staging area 

for potential sources of contamination he finds that the staging area is outside of the packinghouse 

and that the area is not covered and/or protected from possible contamination. 

Assessment: Corrective Action Needed. 

Reason: The operation redesigns the staging area or staging practices to prevent reasonably likely 

to occur opportunities for contamination. Tomatoes that have become contaminated are discarded.

Scenario 3: The operation covers the bins of tomatoes arriving from the field prior to storing them 

in the refrigerated area of the warehouse. The operation’s written policy states that bins shall 

remain covered and refrigerated until such time as they can be washed and packed. The auditor 

confirms that the covered bins are protected from possible sources of contamination. 

Assessment: Compliant. 

Reason: The operation is following their written policy and tomatoes are protected from 

reasonably likely to occur possibilities for contamination.
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TPD-3 Traceability

Requirement TPD-3.1 All levels of the tomato supply chain shall maintain adequate 

traceability to a minimum of immediate next recipient and immediate 

previous supplier.

Procedure Operation shall have a procedure to identify the sources of incoming 

product and recipients of outgoing product (including trash).

Verification Auditor shall review procedure.

Corrective 

Action

Procedure is developed or revised.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

All levels of the tomato supply chain must maintain adequate traceability to a minimum of one step 

forward (immediate next recipient) and one step back (immediate previous supplier) in compliance 

with FDA recordkeeping requirements. Documentation maintained by the packinghouse must 

include sufficient information about the source (i.e., field packer firm name, identification of 

grower, field location, and date of harvest/field pack) as well as the customer receiving the product 

to allow for the appropriate tracing of product. The packer must have established procedures to 

ensure that traceability information about the source is retained with tomatoes as they move through 

the packinghouse processes to shipping, including during resorting. Corrugated containers must be 

new and accurately labeled with commodity name, packinghouse firm name, and lot identification 

sufficient to allow for accurate traceability. Only containers able to be cleaned and sanitized (e.g., 

reusable plastic containers, “RPCs”) may be reused. If using reusable containers, they must be 

cleaned and sanitized before reuse. Labels that originate from a prior use or are inaccurate must be 

removed or concealed prior to packing.

Example Scenarios 

Scenario 1: The auditor confirms that a product coding system is in place where tomatoes shall be 

labeled with grower and lot identification, and coded to enable access to date of harvest and/or 

packing, origin (name of farm, grower and/or packing location), and country of origin for traceback 

purposes. Auditor verifies that coding systems are working as designed, that the carton labels are 

appropriate and verifies compliance by review of records. 

Assessment: Compliant. 

Reason: Auditor reviewed coding procedures, observed cases for appropriate coding, and verified 

compliance by review of records. 

Scenario 2: The operation packs tomatoes in two-pound polyethylene bags. The bags are then 

placed into master cartons of twelve bags each. A product coding system is in place where master 

cartons are labeled with grower and lot identification and date of harvest and/or packing, origin 

(name of farm, grower and/or packing location), and country of origin for traceback purposes. But 

the polyethylene bags only depict a code number. The auditor asks the auditee how the code 
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number is used to trace the product, the auditee explains the trace number. The auditor then verifies 

the coding system by review of records and finds the procedure to be in compliance with the 

standard. 

Assessment: Compliant. 

Reason: The auditor verified the coding system by review of records.

Scenario 3: A product coding system is in place where product or raw material shall be labeled 

with grower and lot identification, and coded to enable access to date of harvest and/or packing, 

origin (name of farm, grower and/or packing location), and country of origin for traceback 

purposes. Upon review by the auditor, it is observed that most of the product codes printed on the 

cartons are illegible.

Assessment: Corrective Action Needed. 

Reason: Boxes with missing, inaccurate, or illegible coding are re-labeled with appropriate 

identification.

Requirement TPD-3.2 Establish procedures to maintain lot identity of tomatoes, 

including setbacks and primary containers, throughout the repacking 

process. 

Procedure Operation shall have a procedure and maintain records to identify all 

outgoing product lots and shipments with all component tomato lots and 

prior lots in reused primary boxes, in both traceback and trace forward 

directions.

Verification Auditor shall review procedure and review batch records for 

compliance. Auditor shall ask operation to traceback one, auditor 

selected product lot to all supplier lots and primary boxes, and trace 

forward one supplier lot to all product lots and shipments.

Corrective 

Action

Procedure is developed or revised. Retraining is performed.

Documents 

Required

Written Policy.

Mandatory ●

Example Scenarios 

Scenario 1: The operation has a written procedure and maintains records to identify all outgoing 

product lots and shipments with all component tomato lots and prior lots in reused primary boxes, 

in both traceback and trace forward directions. Auditor reviews the procedure and reviews batch 

records for compliance. The auditor asks the operation to traceback one product lot to all supplier 

lots and primary boxes, and trace forward one supplier lot to all product lots and shipments. The 

operation can complete the trace exercise in a reasonable timeframe.

Assessment: Compliant. 

Reason: The operation’s written procedure and documentation is adequate and is able to complete 

the trace exercise.

Scenario 2: The operation has a written procedure and maintains records to identify all outgoing 

product lots and shipments with all component tomato lots and prior lots in reused primary boxes, 
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in both traceback and trace forward directions. Auditor reviews the procedure and reviews batch 

records for compliance. The auditor asks the operation to traceback one product lot to all supplier 

lots and primary boxes, and trace forward one supplier lot to all product lots and shipments. The 

operation does not complete the trace exercise in the timeframe allotted.

Assessment: Corrective Action Needed. 

Reason: The operation’s written procedure and documentation appears adequate but is not able to 

complete the trace exercise.

Scenario 3: The operation has a written procedure and maintains records to identify all outgoing 

product shipments with all component tomato lots and prior lots in reused primary boxes, in both 

traceback and trace forward directions. Auditor reviews the procedure and batch records for 

compliance. The auditor observes that the batch records are incomplete. The auditor asks the 

operation to traceback one product lot to all supplier lots and primary boxes, and trace forward one 

supplier lot to all product lots and shipments. The operation is unable to complete the trace 

exercise.

Assessment: Corrective Action Needed. 

Reason: The operation’s written procedure and documentation is inadequate and is not able to 

complete the trace exercise.

Requirement TPD-3.3 Establish procedures for reconciliation of incoming tomato lots 

to usage.

Procedure Operation shall have a procedure and maintain records of tomato use 

and shrink to allow 100% reconciliation of tomato lots within 4 hrs.

Verification Auditor reviews reconciliation procedure and asks operation to provide 

records to support one, auditor-selected reconciliation.

Corrective 

Action

Procedure is developed or revised. Retraining is performed.

Documents 

Required

Written Policy.

Mandatory ●

Example Scenarios 

Scenario 1: The repacking operation has established procedures for reconciliation of incoming 

tomato lots to usage. The operation has a written procedure and maintains records of tomato use 

and shrink to allow 100% reconciliation of tomato lots within four hours. The auditor reviews 

reconciliation procedure and asks for records to support one reconciliation on a specific lot. The 

auditor finds that the operation has correctly documented and reconciled the lot to 100% in four 

hours. 

Assessment: Compliant. 

Reason: The auditor found that the operation had correctly documented and reconciled the lot to 

100% in four hours. 

Scenario 2: The repacking operation has established procedures for reconciliation of incoming 

tomato lots to usage. The operation has a written procedure and maintains records of tomato use 

and shrink to allow 100% reconciliation of tomato lots within four hours. The auditor reviews 
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reconciliation procedure and asks for records to support one reconciliation on a specific lot. The 

auditor finds that the tomato lot reconciliation does not account for the entire lot of tomatoes.

Assessment: Corrective Action Needed. 

Reason: The auditor found that the tomato lot reconciliation did not account for the entire lot of 

tomatoes.

Scenario 3: The repacking operation has procedures for reconciliation of incoming tomato lots to 

usage. The operation does not have a written procedure to document shrink or allow for 100% 

reconciliation of tomato lots within 4 hours.

Assessment: Corrective Action Needed. 

Reason: The operation does not have a written procedure to document shrink or allow for 100% 

reconciliation of tomato lots within 4 hours. 

TPD-4 Self-Audits 

Requirement TPD-4.1 Operation has procedures for conducting self-audits, and 

conducts self-audits to verify compliance with established internal 

policies and procedures. 

Procedure In addition to the requirements of the Harmonized Standards, the 

operation’s self-audit procedure ensures compliance with established 

internal policies and procedures, the Commodity Specific Food Safety 

Guidelines for the Fresh Tomato Supply Chain, these Tomato Metrics 

and additional food safety documents as required by state and/or federal 

regulation.

Verification Auditor reviews the self-audit procedures, and records of self-audits to 

verify compliance with the procedures.

Corrective 

Action

Operation develops and maintains self-audit program, with corrective 

actions preventive measures, documentation and follow-up.

Documents 

Required

Written Policy, Record.

Mandatory ●

Expectation 

(See requirements TPH-4.1) 

Example Scenarios 

Scenario 1: The operation has written procedures for conducting self-audits and conducts selfaudits annually, but you find that the operation uses a self-made checklist for conducting self-audits.

Assessment: Compliant 

Reason: As long as the self-audit performed addresses the requirements of the Harmonized 

Standards, ensures compliance with established internal policies and procedures, Commodity 

Specific Food Safety Guidelines for the Fresh Tomato Supply Chain, the Tomato Metrics, and 

additional food safety documents as required by state and/or federal regulation. 
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Scenario 2: The operation maintains that they conduct self-audits but do not have a record of the 

self-audit. 

Assessment: Corrective Action Needed, 

Reason: The requirement requires a written policy and records. Records should document when 

the self-audit was started and completed.

Scenario 3: Operation develops and maintains a self-audit program, including a written record of 

required corrective actions and follow-up procedures but does not include preventive measures.

Assessment: Compliant or Corrective Action Needed. 

Reason: If the operation has sufficiently satisfied the requirements of checklist questions G-8.1, G9.1, and TOF 2.1 this checklist question shall be assessed as compliant. 

TPD-5 Product Containers and Packaging Materials 

A. Bins, Gondolas, Totes 

Requirement TPD-5.1 Tomato-contact bulk bins, gondolas, totes and trays shall not be 

constructed of wood.

Procedure In accordance with the Post- Harvest Operations Harmonized Standard 

P-8.7 regarding acceptable product-contact containers, operation has 

eliminated or has a plan to eliminate the use of wooden product contact 

containers.

Verification Auditor reviews SOP, visually observes product bins, trays and 

containers and their use for evidence of noncompliance.

Corrective 

Action

Policy is developed or revised. Non-compliances are corrected. 

Operation removes non-conforming product containers from food 

contact purposes. Retraining is performed. Operation develops a plan to 

phase out wooden bins, and demonstrates compliance with the plan.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

(See requirement TPH-5.1) 
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Requirement TPD-5.2 The operation has written procedures for cleaning and 

sanitizing of produce food contact containers, requiring that bulk bins, 

gondolas, totes and trays are cleaned and sanitized periodically and is 

documented. 

Procedure Written SOP is established to ensure that bulk bins, gondolas, totes, 

trays and other food contact containers and implements are adequately 

cleaned and sanitized at a frequency sufficient to maintain clean and 

sanitary food contact surfaces, and documentation of compliance is 

maintained.

Verification Auditor reviews SOP, cleaning logs and records, interviews responsible 

individuals for knowledge of the SOP and observes containers, 

employees and records for evidence of compliance.

Corrective 

Action

Policy is developed or revised. Non-compliances are corrected on site. 

Retraining is performed.

Documents 

Required

Written Policy, Record.

Mandatory ●

Expectation 

(See requirement TPH-5.2) 

B. Primary Packing Boxes 

Requirement TPD-5.3 The repacker must label the container as being repacked. The 

box contains information on the commodity, repacker identification and 

provides lot identification.

Procedure Operation shall ensure that all product containers containing repacked 

tomatoes are labeled as repacked. The container shall also include the 

commodity, repacker identification, and repacker lot identification.

Verification Auditor observes repacked product boxes for compliance.

Corrective 

Action

Procedure is developed or revised. Retraining is performed.

Documents 

Required

Record.

Mandatory ●

Example Scenarios 

Scenario 1: Operation ensures that all product containers containing repacked tomatoes are labeled 

as repacked. The containers also include the commodity name, packer identification, and packer lot 

identification. Auditor observes repacked product boxes and finds them to be in compliance. 

Assessment: Compliant. 

Reason: Auditor observed repacked product boxes and found them to be in compliance. 
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Scenario 2: The repacker labels the containers with product information, the packer information 

and lot ID but does not identify as repacked product. 

Assessment: Corrective Action Needed. 

Reason: Auditor observes that the repacked containers do not indicate that the product is repacked. 

Scenario 3: The box contains information on the commodity, repacker identification and multiple 

lot identification markings and is clearly printed as repacked. The auditor observes repacked 

product boxes for compliance. 

Assessment: Compliant. 

Reason: If tomato lots are commingled, then tomatoes should be repacked into new or used 

containers where the original label matches at least one tomato in the commingled lot. Reused 

containers shall be clean and sanitary, and accurately labeled with the repacker’s information and 

lot identification that maintains the integrity of traceability information to all the included lots. In 

the event of a recall, all lots in the commingled lot are affected. 

Requirement TPD-5.4 Operation has a process to ensure that inaccurate information 

on previously used boxes is obliterated, or otherwise made clear that 

original information no longer applies, to prevent misidentification.

Procedure Boxes shall not be reused if prohibited by prevailing regulation or law.

Verification Auditor observes one or more repacked lots and repacking 

documentation for those lots using reused cartons to verify that only the 

cartons from the original lot(s) are used to repack reworked tomatoes 

and a positive effort has been made to obliterate (mark out by any 

means) inaccurate information; OR a label that clearly states the

information on the box is no longer valid has been affixed and has the 

proper lot information on the label.

Corrective 

Action

Operation ceases using boxes inappropriately. Procedure is developed or 

revised. Retraining is performed.

Documents 

Required

Written Policy.

Mandatory ●

Example Scenarios 

Scenario 1: The operation has a written policy and a process to ensure that inaccurate information 

on previously used boxes is obliterated, or otherwise made clear that original information no longer 

applies. Auditor observes one or more repacked lots and repacking documentation for those lots 

using reused cartons to verify that only the cartons from the original lot(s) are used to pack 

reworked tomatoes and a positive effort has been made to obliterate (mark out by any means) 

inaccurate information; OR a label that clearly states the information on the box is no longer valid 

has been affixed and has the proper lot information on the label. 

Assessment: Compliant. 

Reason: The operation has a written policy and a process to ensure that inaccurate information on 

previously used boxes is obliterated and the auditor has reviewed the policy, procedure and 

observed repacked lots for compliance.
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Scenario 2: The operation has a written policy and a process to ensure that inaccurate information 

on previously used boxes is obliterated. The auditor observes that on several pallets of containers, 

only the outside facing carton label has been obliterated. The inside facing carton label contains the 

previous lot information.

Assessment: Corrective Action Needed. 

Reason: The auditor observed that on several pallets of containers, only the outside facing carton 

label had been obliterated. The inside facing carton label contained the previous lot information. 

Requirement TPD-5.5 Used boxes may be used as secondary shipping containers, 

provided that the original identification information on the box has been 

obliterated or otherwise made clear that it is no longer accurate.

Procedure Operation may reuse tomato boxes as secondary (no product contact) 

shipping containers. Operation has a process to ensure that inaccurate 

information is obliterated, or otherwise made clear that original 

information no longer applies, to prevent misidentification.

Verification If used boxes are used as secondary shipping containers, auditor 

observes one or more repacked lots and repacking documentation for 

those lots using reused cartons to verify that a positive effort has been 

made to obliterate (mark out by any means) inaccurate information; OR 

a label that clearly states the information on the box is no longer valid 

has been affixed and has the proper lot information on the label.

Corrective 

Action

Operation relabels mislabeled boxes. Procedure is developed or revised. 

Retraining is performed.

Documents 

Required

N/A

Mandatory ●

Example Scenarios 

Scenario 1: The operation has a written policy and a process to ensure that inaccurate information 

on previously used boxes is obliterated, or otherwise made clear that original information no longer 

applies. Auditor observes one or more repacked lots and repacking documentation for those lots 

using reused cartons to verify that only the cartons from the original lot(s) are used to pack 

reworked tomatoes and a positive effort has been made to obliterate (mark out by any means) 

inaccurate information; OR a label that clearly states the information on the box is no longer valid 

has been affixed and has the proper lot information on the label. 

Assessment: Compliant. 

Reason: The operation has a written policy and a process to ensure that inaccurate information on 

previously used boxes is obliterated and the auditor has reviewed the policy, procedure and 

observed re-packed lots for compliance.

Scenario 2: The operation has a written policy and a process to ensure that inaccurate information 

on previously used boxes is obliterated. The auditor observes that on several pallets of containers, 

only the outside facing carton label has been obliterated. The inside facing carton label contains the 

previous lot information.

Assessment: Corrective Action Needed. 
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Reason: The auditor observed that on several pallets of containers, only the outside facing carton 

label had been obliterated. The inside facing carton label contained the previous lot information. 

Scenario 3: The auditor observes pallets of tomato lots that have been commingled during the 

repacking process, each of the three lots of tomatoes are repacked into the original containers that 

they came from, the containers all include the original lot ID numbers and also an additional label 

that indicates the tomatoes have been repacked. 

Assessment: Compliant. 

Reason: The information on the repacked containers is accurate as long as each lot has been 

repacked into the original containers. 

TPD-6 Packinghouse Condition and Equipment

A. General Building 

Requirement TPD-6.1 Facility is constructed/arranged to allow separation of 

incoming, in-process and finished products.

Procedure Facilities or processes assure separation and positioning of incoming raw 

materials so as not to become a source of contamination of in-process 

and finished product.

Verification Auditor observes placement of incoming raw materials, in-process and 

finished products for opportunities for cross-contamination.

Corrective 

Action

Procedures are developed or revised. Non-compliances are corrected on 

site. Retraining is performed.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TPH-6.1) 

Requirement TPD-6.2 Operation has procedures that minimize the accumulation of 

standing water.

Procedure If floor drains exist, they are adequate, functional, free of obstruction 

and are properly maintained and cleaned sufficient to prevent them 

from becoming sources of contamination. If standing water exists, it is 

removed from floors and floors cleaned in a manner and at a frequency 

sufficient to prevent creation of a source of contamination.

Verification Auditor observes floor drains and evidence of standing water for 

compliance with procedures.

Corrective 

Action

Floor drains are installed, repaired or maintained, or procedures are 

modified, to prevent standing water from becoming a potential source of 

contamination.

Documents 

Required

Written Policy.
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Mandatory ●

Expectation 

(See requirement TPH-6.2) 

B. Facility and Equipment

Requirement TPD-6.3 All food contact surfaces are made of material and designed to 

be easily cleaned and sanitized, and are maintained in good condition.

Procedure All tomato contact surfaces and equipment are made of materials, 

designed or constructed to be easily cleaned and sanitized, all food 

contact surfaces are free of rust or corrosion, and seams between food 

contact surfaces are smooth or accessible for cleaning.

Verification Auditor observes product contact surfaces and equipment and their use 

for evidence of non-compliance.

Corrective 

Action

Non-compliances are corrected or replaced. Operation makes a 

commitment for phasing out non-conforming tomato contact surfaces 

and equipment, in a reasonable timeline. Retraining is performed.

Documents 

Required

N/A

Mandatory ●

Expectation 

(See requirement TPH-6.3) 

Requirement TPD-6.4 Wood is not used as a food contact surface. 

Procedure Operation has eliminated, or has a plan to eliminate, use of wooden 

items as food contact surfaces.

Verification Auditor inspects facility for evidence of wooden food contact surfaces.

Corrective 

Action

Operation that still utilizes wood as a food contact surface has a plan to 

phase out such surfaces, and is in compliance with the plan.

Documents 

Required

N/A

Mandatory ●

Expectation 

(See requirement TPH-6.4) 
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Requirement TPD-6.5 SDS are on file for all chemicals used in the facility, and 

readily.

Procedure Operation maintains a list of all chemicals approved for use in facility, 

and maintains SDS for all. SDS are in a location easily accessible by 

employees.

Verification Auditor reviews SDS binder and observes chemicals in facility for 

evidence of compliance.

Corrective 

Action

Obtain missing SDS. Relocate SDS.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TPH-6.5) 

TPD-7 Worker Health/Hygiene and Toilet/Handwashing Facilities

Requirement TPD-7.1 If portable hand wash water tanks are used, they are cleaned 

and sanitized and the water is changed periodically.

Procedure Water tanks used to provide hand wash water shall be maintained at a 

prescribed frequency in a clean and sanitary manner.

Verification Auditor reviews cleaning and sanitizing protocol and service logs, and 

visually observes condition of water tanks for signs of noncompliance.

Corrective 

Action

Clean and sanitize the tank, replace water to compliance.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TOF-4.2) 

TPD-8 Product Wash Water Management
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Requirement TPD-8.1 In systems where tomatoes are submerged or dwell in water, 

water temperature is monitored and controlled. Water temperature 

should be at least 10oF above average pulp temperature of tomatoes 

when entering the water.

Procedure Operation shall have methods for determining average pulp 

temperature of a minimum of 5 tomatoes, a procedure for control of 

water temperature, shall monitor temperature at a prescribed frequency 

sufficient to assure continuous compliance (minimum of hourly), and 

shall maintain records of water temperature. Operation shall have a 

procedure as to what corrective actions are taken if criteria are not met. 

Water spray or shower systems, wherein tomatoes are not submerged or 

dwell do not require temperature control.

Verification Auditor shall review the procedure and shall review records of 

temperature monitoring. Auditor observes process including the 

operation’s sampling of pulp and water temperatures. Auditor reviews 

records for deviations and their disposition.

Corrective 

Action

Procedure is developed or revised. Retraining is performed. Tomatoes 

washed in water at temperatures less than the average measured pulp 

temperature shall be discarded back to the last evidence of compliance.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TPH-8.1) 

Requirement TPD-8.2 Operations utilizing spray systems in place of whole tomato 

immersion shall design the line so that the entire tomato surface is 

rinsed.

Procedure Spray systems shall be designed such that rinse water contacts all 

surfaces of the tomato.

Verification Auditor observes spray system for compliance.

Corrective 

Action

Equipment or process is redesigned or retrofitted to ensure all surfaces 

of tomato are contacted.

Documents 

Required

N/A

Mandatory ●

Expectation 

(See requirement TPH-8.2) 
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Requirement TPD-8.3 If a spray bar system is used, operation has a water use SOP 

that addresses treatment of that water.

Procedure Operation’s water use SOP requires spray bar water to be treated using 

an approved antimicrobial to maintain a microbially hostile 

environment on equipment.

Verification Auditor shall review water use SOP for completeness, and observes 

water treatment records for adequacy and consistency of treatment.

Corrective 

Action

Operation discontinues using spray bar water that is not treated 

sufficiently to maintain a hostile environment on equipment. Retraining 

is performed and documented. Affected product is evaluated for 

potential contamination and disposition.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

(See requirement TPH-8.3) 

Requirement TPD-8.4 If water quality is based upon a chlorine-based sanitizer, the 

process shall be targeted to be at least 100 ppm free available chlorine 

(FAC), measured at the exit of the product from the water system, unless 

validation data are available to demonstrate a lower FAC is effective 

under operating conditions.

Procedure Operation shall have a procedure to manage FAC levels, shall establish 

process adjustments for when the FAC drops below 100 ppm, and shall 

maintain records to verify proper management of levels.

Verification Auditor shall review the procedure and shall review records of FAC 

measurement and appropriate management. Auditor reviews records 

for deviations and their disposition.

Corrective 

Action

Procedure is developed or revised. Retraining is performed. Tomatoes 

washed in water at FAC less than 100 ppm shall be discarded back to 

the last evidence of compliance.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TPH-8.4) 
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Requirement TPD-8.5 If water quality is based upon a peroxyacetic, peracetic or 

peracid system, levels shall be maintained in accordance with 

manufacturer’s label directions.

Procedure Operation shall have a procedure to manage peracid levels, shall 

establish process targets so as not to drop below the minimum ppm, 

shall establish adjustments for when the peracid level drops below the 

target ppm, and shall maintain records to verify proper management of 

levels.

Verification Auditor shall review the procedure and shall review records of peracetic 

measurement and appropriate management. Auditor reviews records 

for deviations and their disposition.

Corrective 

Action

Procedure is developed or revised. Retraining is performed. Tomatoes 

washed in water at less than manufacturer’s recommendation shall be 

discarded back to the last evidence of compliance.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TPH-8.5) 

TPD-9 Quarantine or On-hold Materials 

Requirement TPD-9.1 Materials placed on hold, quarantined or rejected are clearly 

identified and segregated from other products and packaging materials.

Procedure Operation has a written procedure to clearly identify and segregate onhold, quarantined and rejected materials, to prevent commingling with 

other products or adulteration of products, production area or 

packaging materials.

Verification Auditor reviews procedure, reviews logs and observes all currently onhold, quarantined and rejected materials for compliance with 

procedure.

Corrective 

Action

Non-compliances are corrected on site. If on-hold, quarantined or 

rejected materials are not segregated according to procedure, operation 

shall assess potential for product adulteration. Procedures are developed 

or revised. Retraining is performed.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TPH-9.1) 

TPD-10 Food Defense Awareness
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Requirement TPD-10.1 The facility is registered with FDA as required by the Public 

Health Security and Bioterrorism Preparedness and Response Act of 

2002.

Procedure If required by 21 CFR Part 1, Subpart H, facility is registered with FDA 

and registration is current.

Verification Auditor asks whether facility is registered. Facility is not required to 

demonstrate registration to auditor.

Corrective 

Action

Facility registers with FDA as required.

Documents 

Required

Record.

Mandatory ●

Expectation 

(See requirement TPH-11.1) 

Requirement TPD-10.2 There are procedures in place that readily identify employees, 

and those with specific access privileges, e.g., to chemical storage, to the 

water system.

Procedure Operation has a written procedure for identifying current employees. 

Procedure also indicates which employees have access to restricted areas 

or materials, and how access is restricted.

Verification Auditor reviews procedure, verifies list of special access employees, 

observes restricted areas and materials for evidence of compliance and 

interviews employees for knowledge of procedure.

Corrective 

Action

Procedures are developed or revised. Retraining is performed.

Documents 

Required

Written Policy.

Mandatory ●

Expectation 

(See requirement TPH-11.2)
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GLOSSARY

Agricultural Water Refers to water used in the growing environment (for example, field, 

vineyard, or orchard) for agronomic reasons. It includes water used 

for irrigation, transpiration control (cooling), frost protection, or as a 

carrier for fertilizers and pesticides. Typical sources of agricultural 

water include flowing surface waters from rivers, streams, irrigation 

ditches, open canals, impoundments (such as ponds, reservoirs, and 

lakes), wells, and municipal supplies.1

Adequate Means that which is needed to accomplish the intended purpose in 

keeping with good practice. 1

Clean Means that food and food-contact surfaces are washed and rinsed and 

are visually free of dust, dirt, food residues, and other debris. 1

Composting Refers to a managed process in which organic materials, including 

animal manure and other wastes, are digested aerobically or 

anaerobically by microbial action. 1

Control Means (a) to manage the conditions of an operation in order to be 

consistent with established criteria, and (b) to follow correct 

procedures and meet established criteria. 1

Control measure Any action or activity that can be used to prevent, reduce, or 

eliminate a microbiological hazard. 1

Facility The buildings and other physical structures used for or in connection 

with the harvesting, washing, sorting, storage, packaging, labeling, 

holding, or transport of fresh produce. 1

Food-contact surfaces Are those surfaces that contact fresh produce and those surfaces from 

which drainage onto the produce or onto surfaces that contact the 

produce may occur during the normal course of operations. “Food 

contact surfaces” includes equipment, such as containers and 

conveyor belts, that contact fresh produce, whether used in 

harvesting, post-harvesting, and packing operations. It would not 

include tractors, forklifts, hand trucks, pallets, etc. that are used for 

handling or storing large quantities of contained or packed fresh 

produce and that do not come into actual contact with the food. 1

Fresh fruits and 

vegetables

Refers to fresh produce that is likely to be sold to consumers in an 

unprocessed or minimally processed (e.g., raw) form. Fresh produce 

may be intact, such as strawberries, whole carrots, radishes, and fresh 

market tomatoes, or cut during harvesting, such as celery, broccoli, 

and cauliflower. The guidance in this document is also applicable to 

“fresh cut” produce, such as pre-cut, packaged, ready-to-eat salad 

mixes. However, some fresh produce specialty items, such as fresh 

cut produce, may be subject to additional processing steps and/or 

handling that may warrant consideration of specific good 

manufacturing practices in addition to the good agricultural and 

management practices covered in this guidance document. 1
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Good management 

practices

General practices to reduce microbial food safety hazards. The term 

may include both “good agricultural practices” used in growing 

harvesting, sorting, packing and storage operations and “good 

manufacturing practices” used in sorting, packing, storage, and 

transportation operations. 1

Microorganisms Yeasts, molds, bacteria, protozoa, helminthes (worms), and viruses. 

Occasionally, the term “microbe” or “microbial” is used instead of 

the term “microorganisms.” 1

Microbial hazard Occurrence of a microorganism that has the potential to cause illness 

or injury. 1

Mock Recall A practice exercise that is used to determine where product is shipped 

and whether or not it can be returned to the origin or removed from 

the marketing chain.

Municipal biosolids 

(Biosolids)

Are the by-product of human waste treatment by local government 

that may be used as fertilizer or as a soil amendment. 1

Operator The person or persons who have day-to-day responsibility for the 

production, harvesting, washing, sorting, cooling, packaging, 

shipping, or transportation of fresh fruits and vegetables, and 

responsibility for management of all employees who are involved in 

each of these activities. 1

Oxidation-Reduction 

Potential (ORP)

A measurement to oxidize contaminants, a practical method to 

electronically monitor sanitizer effectiveness.

Parts Per Million 

(PPM)

A measurement expressing very dilute concentrations of substances. 

Just as percent means out of a hundred, so parts per million or ppm 

means out of a million.

Pathogen A microorganism capable of causing disease or injury. 1

Pest Any animal or insect of public health importance including, but not 

limited to, birds, rodents, cockroaches, flies, and larvae, that may 

carry pathogens that can contaminate food. 1

Processing water Water used for post-harvest treatment of produce, such as washing, 

cooling, waxing, and product transport. 1

Reasonably Agreeable to reason and sound judgment; logical; rational; fair; not 

excessive or extreme.

Recall A means to return marketed product to its origin; to remove it from 

the marketplace.

Sanitize To treat clean produce by a process that is effective in destroying or 

substantially reducing the number of microorganisms of public health 

concern, as well as other undesirable microorganisms, without 

adversely affecting the quality of the product or its safety for the 

consumer. 1

Sanitize (food contact 

surfaces)

To treat clean produce by a process that is effective in destroying or 

substantially reducing the number of microorganisms of public health 

concern, as well as other undesirable microorganisms, without 

adversely affecting the quality of the involved product or its safety 

for the consumer. It means the application of cumulative heat or 
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chemicals on cleaned food-contact surfaces that, when evaluated for 

efficacy, is sufficient to reduce populations of representative 

microorganisms by 5 log or 99.999%.1

Shall Used to state a mandatory requirement.

Should Used to state recommended or advisory procedures or identify 

recommended equipment.

Traceback The ability to trace a fruit or vegetable back to its field of origin. A 

common practice used by health officials to investigate foodborne 

illness outbreaks.

Transporter The operator of a conveyance such as a truck, railcar, vessel, or 

aircraft used to transport fresh produce from grower to market. 1

1 “Guidance for Industry-Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and 

Vegetables”, U.S. Department of Health and Human Services, Food and Drug Administration, 

Center for Food Safety and Applied Nutrition (CFSAN). October 1998.
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REFERENCE LINKS Version Date 

(Printed for distribution)

FPB 703 Fresh Products Branch Good Agricultural Practices and Good 

Handling Practices (GAP&GHP) Audit Appeals, Complaints and Dispute 

Process: __________ 

https://www.ams.usda.gov/sites/default/files/media/FPB703%20%E2%80%93%20Fresh%20Products%20Branch%20GAPGHP%20Audit%20Procedures.pdf

GAP Audit Program Scope: __________ 

https://www.ams.usda.gov/sites/default/files/media/GAPProgramScope.pdf

SC-237A Request for Audit Service Form: __________ 

https://www.ams.usda.gov/sites/default/files/media/SC237A.pdf

SC-651 Agreement for Participation in Audit Services form: __________ 

https://www.ams.usda.gov/sites/default/files/media/SC651.pdf

Harmonized GAP Standard __________ 

https://www.ams.usda.gov/sites/default/files/media/Harmonized_GAP_Standard_Version2.pdf

Harmonized GAP Checklist: __________ 

https://www.ams.usda.gov/sites/default/files/media/HarmonizedGAPsChecklist5.pdf

Harmonized GAP Plus Standard __________ 

https://www.ams.usda.gov/sites/default/files/media/HarmonizedGAPPlus%2BStandardVersion4.0_

0.pdf

Harmonized GAP Plus Checklist: __________ 

https://www.ams.usda.gov/sites/default/files/media/HarmonizedGAPPlusChecklist4.0.pdf

Aquaponic Operation Good Agricultural Practices: __________ 

https://www.ams.usda.gov/sites/default/files/media/AquaponicOperationGAP.pdf

USDA GAP Program Water FAQs: __________ 

https://www.ams.usda.gov/sites/default/files/media/GAPWATERFAQS.pdf

Checked Materials have been printed from the links in this manual and included for 

reference.
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APPENDIX I – PRODUCE SAFETY RULE (PSR)

Subpart A: General Provisions

§ 112.1 What food is covered by this part? 

(a) Unless it is excluded from this part under § 112.2, food that is produce within the meaning 

of this part and that is a raw agricultural commodity (RAC) is covered by this part. This 

includes a produce RAC that is grown domestically and a produce RAC that will be 

imported or offered for import in any State or territory of the United States, the District of 

Columbia, or the Commonwealth of Puerto Rico. 

(b) For the purpose of this part and subject to the exemptions and qualified exemptions therein, 

covered produce includes all of the following:

(1) Fruits and vegetables such as almonds, apples, apricots, apriums, Artichokes-globetype, Asian pears, avocados, babacos, bananas, Belgian endive, blackberries, 

blueberries, boysenberries, brazil nuts, broad beans, broccoli, Brussels sprouts, burdock, 

cabbages, Chinese cabbages (Bok Choy, mustard, and Napa), cantaloupes, carambolas, 

carrots, cauliflower, celeriac, celery, chayote fruit, cherries (sweet), chestnuts, chicory 

(roots and tops), citrus (such as clementine, grapefruit, lemons, limes, mandarin, 

oranges, tangerines, tangors, and uniq fruit), cowpea beans, cress-garden, cucumbers, 

curly endive, currants, dandelion leaves, fennel- Florence, garlic, genip, gooseberries, 

grapes, green beans, guavas, herbs (such as basil, chives, cilantro, oregano, and parsley), 

honeydew, huckleberries, Jerusalem artichokes, kale, kiwifruit, kohlrabi, kumquats, leek, 

lettuce, lychees, macadamia nuts, mangos, other melons (such as Canary, Crenshaw and 

Persian), mulberries, mushrooms, mustard greens, nectarines, onions, papayas, parsnips, 

passion fruit, peaches, pears, peas, peas-pigeon, peppers (such as bell and hot), pine nuts, 

pineapples, plantains, plums, plumcots, quince, radishes, raspberries, rhubarb, rutabagas, 

scallions, shallots, snow peas, soursop, spinach, sprouts (such as alfalfa and mung bean), 

strawberries, summer squash (such as patty pan, yellow and zucchini), sweetsop, Swiss 

chard, taro, tomatoes, turmeric, turnips (roots and tops), walnuts, watercress, 

watermelons, and yams; and 

(2) Mixes of intact fruits and vegetables (such as fruit baskets).

§ 112.2 What produce is not covered by this part? 

(a) The following produce is not covered by this part: 

(1) Produce that is rarely consumed raw, specifically the produce on the following 

exhaustive list -- asparagus; beans, black; beans, great Northern; beans, kidney; beans, 

lima; beans, navy; beans, pinto; beets, garden (roots and tops); beets, sugar; cashews; 

cherries, sour; chickpeas; cocoa beans; coffee beans; collards; corn, sweet; cranberries; 

dates; dill (seeds and weed); eggplants; figs; ginger; hazelnuts; horseradish; lentils; okra; 

peanuts; pecans; peppermint; potatoes; pumpkins; squash, winter; sweet potatoes; and 

water chestnuts.

(2) Produce that is produced by an individual for personal consumption or produced for 

consumption on the farm or another farm under the same management; and 

(3) Produce that is not a raw agricultural commodity.
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(b) Produce is eligible for exemption from the requirements of this part (except as noted in 

paragraphs (b)(1), (2), and (3) of this section) under the following conditions:

(1) The produce receives commercial processing that adequately reduces the presence of 

microorganisms of public health significance. Examples of commercial processing that 

adequately reduces the presence of microorganisms of public health significance are 

processing in accordance with the requirements of parts 113, 114, or 120 of this chapter, 

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; and

(2) 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;” and

(3) You must either:

(i) Annually obtain written assurance, subject to the requirements of paragraph (b)(6) of 

this section, from the customer that performs the commercial processing described in 

paragraph (b)(1) of this section that the customer has established and is following 

procedures (identified in the written assurance) that adequately reduce the presence 

of microorganisms of public health significance; or

(ii) Annually obtain written assurance, subject to the requirements of paragraph (b)(6) of 

this section, from your customer that an entity in the distribution chain subsequent to 

the customer will perform commercial processing described in paragraph (b)(1) of 

this section and that the customer:

(A)Will disclose in documents accompanying the food, 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”; and

(B) Will only sell to another entity that agrees, in writing, it will either:

(1) Follow procedures (identified in a written assurance) that adequately reduce 

the presence of microorganisms of public health significance; or

(2) Obtain a similar written assurance from its customer that the produce will 

receive commercial processing described in paragraph (b)(1) of this section, 

and that there will be disclosure in documents accompanying the food, 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”; and

(4) You must establish and maintain documentation of your compliance with applicable 

requirements in paragraphs (b)(2) and (3) in accordance with the requirements of subpart 

O of this part, including:

(i) Documents containing disclosures required under paragraph (b)(2) of this section; 

and

(ii) Annual written assurances obtained from customers required under paragraph (b)(3) 

of this section; and

(5) The requirements of this subpart and subpart Q of this part apply to such produce; and

(6) An entity that provides a written assurance under § 112.2(b)(3)(i) or (b)(3)(ii) must act 

consistently with the assurance and document its actions taken to satisfy the written 

assurance.
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§ 112.3 What definitions apply to this part? 

(a) The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and 

Cosmetic Act apply to such terms when used in this part.

(b) For the purpose of this part, the following definitions of very small business and small 

business also apply: 

(1) Very small business. For the purpose of this part, your farm is a very small business if it 

is subject to any of the requirements of this part and, on a rolling basis, the average 

annual monetary value of produce (as defined in paragraph (c) of this section) you sold 

during the previous 3-year period is no more than $250,000. 

(2) Small business. For the purpose of this part, your farm is a small business if it is subject 

to any of the requirements of this part and, on a rolling basis, the average annual 

monetary value of produce (as defined in paragraph (c) of this section) you sold during 

the previous 3-year period is no more than $500,000; and your farm is not a very small 

business as provided in paragraph (b)(1) of this section. 

(c) For the purpose of this part, the following definitions also apply:

Adequate means that which is needed to accomplish the intended purpose in keeping with good 

public health practice.

Adequately reduce microorganisms of public health significance means reduce the presence of such 

microorganisms to an extent sufficient to prevent illness.

Agricultural 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 this rule.

Agricultural tea additive means a nutrient source (such as molasses, yeast extract, or algal powder) 

added to agricultural tea to increase microbial biomass.

Agricultural water means water used in covered activities on covered produce where water is 

intended to, or is likely to, contact covered produce or food contact surfaces, including water used 

in growing activities (including irrigation water applied using direct water application methods, 

water used for preparing crop sprays, and water used for growing sprouts) and in harvesting, 

packing, and holding activities (including water used for washing or cooling harvested produce and 

water used for preventing dehydration of covered produce). 

Animal excreta means solid or liquid animal waste.

Application interval means the time interval between application of an agricultural input (such as a 

biological soil amendment of animal origin) to a growing area and harvest of covered produce from 

the growing area where the agricultural input was applied. 

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.
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Composting means a process to produce stabilized compost in which organic material is 

decomposed by the actions of microorganisms under thermophilic conditions for a designated 

period of time (for example, 3 days) at a designated temperature (for example, 131 °F (55 °C)), 

followed by a curing stage under cooler conditions. 

Covered activity means growing, harvesting, packing, or holding covered produce on a farm. 

Covered activity includes manufacturing/processing of covered produce on a farm, but only to the 

extent that such activities are performed on raw agricultural commodities and only to the extent that 

such activities are within the meaning of “farm” as defined in this chapter. Providing, acting 

consistently with, and documenting actions taken in compliance with written assurances as 

described in § 112.2(b) are also covered activities. This part does not apply to activities of a facility 

that are subject to part 110 of this chapter.

Covered produce means produce that is subject to the requirements of this part in accordance with 

§§ 112.1 and 112.2. The term “covered produce” refers to the harvestable or harvested part of the 

crop. 

Curing means the final stage of composting, which is conducted after much of the readily 

metabolized biological material has been decomposed, at cooler temperatures than those in the 

thermophilic phase of composting, to further reduce pathogens, promote further decomposition of 

cellulose and lignin, and stabilize composition. Curing may or may not involve insulation, 

depending on environmental conditions. 

Direct water application method means using agricultural water in a manner whereby the water is 

intended to, or is likely to, contact covered produce or food contact surfaces during use of the water. 

Farm means:

(1) Primary Production Farm. A Primary Production Farm is an operation under one 

management in one general (but not necessarily contiguous) physical location devoted to the 

growing of crops, the harvesting of crops, the raising of animals (including seafood), or any 

combination of these activities. The term “farm” includes operations that, in addition to 

these activities:

(i) Pack or hold raw agricultural commodities;

(ii) Pack or hold processed food, provided that all processed food used in such activities is 

either consumed on that farm or another farm under the same management, or is 

processed food identified in paragraph (1)(iii)(B)(1) of this definition; and

(iii)Manufacture/process food, provided that: 

(A)All food used in such activities is consumed on that farm or another farm under the 

same management; or

(B) Any manufacturing/processing of food that is not consumed on that farm or another 

farm under the same management consists only of:

(1) Drying/dehydrating raw agricultural commodities to create a distinct commodity 

(such as drying/dehydrating grapes to produce raisins), and packaging and 

labeling such commodities, without additional manufacturing/processing (an 

example of additional manufacturing/processing is slicing);

(2) Treatment to manipulate the ripening of raw agricultural commodities (such as 

by treating produce with ethylene gas), and packaging and labeling treated raw 

agricultural commodities, without additional manufacturing/processing; and

(3) Packaging and labeling raw agricultural commodities, when these activities do 

not involve additional manufacturing/processing (an example of additional 

manufacturing/processing is irradiation); or
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(2) Secondary Activities Farm. A Secondary Activities Farm is an operation, not located on a 

Primary Production Farm, devoted to harvesting (such as hulling or shelling), packing, 

and/or holding of raw agricultural commodities, provided that the Primary Production 

Farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities 

harvested, packed, and/or held by the Secondary Activities Farm owns, or jointly owns, a 

majority interest in the Secondary Activities Farm. A Secondary Activities Farm may also 

conduct those additional activities allowed on a Primary Production Farm in paragraph 

(1)(ii) and (iii) of this definition. 

Food means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act and 

includes seeds and beans used to grow sprouts. 

Food contact surfaces means those surfaces that contact human food and those surfaces from which 

drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs 

during the normal course of operations. “Food contact surfaces” includes food contact surfaces of 

equipment and tools used during harvest, packing and holding. 

Ground water means the supply of fresh water found beneath the Earth’s surface, usually in 

aquifers, which supply wells and springs. Ground water does not include any water that meets the 

definition of surface water.

Growth media means material that acts as a substrate during the growth of covered produce (such as 

mushrooms and some sprouts) that contains, may contain, or consists of components that may 

include any animal waste (such as stabilized compost, manure, non-fecal animal byproducts or table 

waste).

Harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally 

performed on farms for the purpose of removing raw agricultural commodities from the place they 

were grown or raised and preparing them for use as food. Harvesting is limited to activities 

performed on raw agricultural commodities, or on processed foods created by drying/dehydrating a 

raw agricultural commodity without additional manufacturing/processing, on a farm. Harvesting 

does not include activities that transform a raw agricultural commodity into a processed food as 

defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of harvesting 

include cutting (or otherwise separating) the edible portion of the raw agricultural commodity from 

the crop plant and removing or trimming part of the raw agricultural commodity (e.g., foliage, 

husks, roots or stems). Examples of harvesting also include cooling, field coring, filtering, 

gathering, hulling, removing stems and husks from, shelling, sifting, threshing, trimming of outer 

leaves of, and washing raw agricultural commodities grown on a farm. 

Hazard means any biological agent that has the potential to cause illness or injury in the absence of 

its control.

Holding means storage of food and also includes activities performed incidental to storage of a food 

(e.g., activities performed for the safe or effective storage of that food, such as fumigating food 

during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating 

does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding also 

includes activities performed as a practical necessity for the distribution of that food (such as 

blending of the same raw agricultural commodity and breaking down pallets), but does not include 

activities that transform a raw agricultural commodity into a processed food as defined in section 

201(gg) of the Federal Food, Drug, and Cosmetic Act. 

Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, 

and liquid storage tanks. 
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Known or reasonably foreseeable hazard means a biological hazard that is known to be, or has the 

potential to be, associated with the farm or the food. 

Manufacturing/processing means making food from one or more ingredients, or synthesizing, 

preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples 

of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, 

cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct 

commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, 

extracting juice, formulating, freezing, grinding, homogenizing, labeling, milling, mixing, 

packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to 

manipulate ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, 

manufacturing/processing does not include activities that are part of harvesting, packing, or holding. 

Manure means animal excreta, alone or in combination with litter (such as straw and feathers used 

for animal bedding) for use as a soil amendment.

Microorganisms means yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and 

includes species having public health significance. The term “undesirable microorganisms” 

includes those microorganisms that are of public health significance, that subject food to 

decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food 

to be adulterated. 

Mixed-type facility means an establishment that engages in both activities that are exempt from 

registration under section 415 of the Federal Food, Drug, and Cosmetic Act and activities that 

require the establishment to be registered. An example of such a facility is a “farm mixed-type 

facility,” which is an establishment that is a farm, but that also conducts activities outside the farm 

definition that require the establishment to be registered.

Monitor means to conduct a planned sequence of observations or measurements to assess whether a 

process, point or procedure is under control and, when required, to produce an accurate record of 

the observation or measurement.

Non-fecal animal byproduct means 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.

Packing means placing food into a container other than packaging the food and also includes 

activities performed incidental to packing a food (e.g., activities performed for the safe or effective 

packing of that food (such as sorting, culling, grading, and weighing or conveying incidental to 

packing or re-packing)), but does not include activities that transform a raw agricultural commodity, 

as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a processed food as 

defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act 

Pest means any objectionable animals or insects, including birds, rodents, flies, and larvae. 

Pre-consumer vegetative waste means solid waste that is purely vegetative in origin, not considered 

yard trash, and derived from commercial, institutional, or agricultural operations without coming in 

contact with animal products, byproducts or manure or with an end user (consumer). Pre-consumer 

vegetative waste includes material generated by farms, packing houses, canning operations, 

wholesale distribution centers and grocery stores; products that have been removed from their 

packaging (such as out-of-date juice, vegetables, condiments, and bread); and associated packaging 

that is vegetative in origin (such as paper or corn-starch based products). Pre-consumer vegetative 

waste does not include table waste, packaging that has come in contact with materials (such as 

meat) that are not vegetative in origin, or any waste generated by restaurants.
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Produce means any fruit or vegetable (including mixes of intact fruits and vegetables) and includes 

mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs. A fruit is the edible 

reproductive body of a seed plant or tree nut (such as apple, orange, and almond) such that fruit 

means the harvestable or harvested part of a plant developed from a flower. A vegetable is the 

edible part of an herbaceous plant (such as cabbage or potato) or fleshy fruiting body of a fungus 

(such as white button or shiitake) grown for an edible part such that vegetable means the 

harvestable or harvested part of any plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots, 

tubers, bulbs, stems, leaves, or flower parts are used as food and includes mushrooms, sprouts, and 

herbs (such as basil or cilantro). Produce does not include food grains meaning the small, hard 

fruits or seeds of arable crops, or the crops bearing these fruits or seeds, that are primarily grown 

and processed for use as meal, flour, baked goods, cereals and oils rather than for direct 

consumption as small, hard fruits or seeds (including cereal grains, pseudo cereals, oilseeds and 

other plants used in the same fashion). Examples of food grains include barley, dent- or flint-corn, 

sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g., cotton seed, flax 

seed, rapeseed, soybean, and sunflower seed).

Production batch of sprouts means all sprouts that are started at the same time in a single growing 

unit (e.g., a single drum or bin, or a single rack of trays that are connected to each other), whether or 

not the sprouts are grown from a single lot of seed (including, for example, when multiple types of 

seeds are grown in a single growing unit). 

Qualified end-user with respect to a food means the consumer of the food; or a restaurant or retail 

food establishment (as those terms are defined in § 1.227) that is located: 

(i) In the same State or the same Indian reservation as the farm that produced the food; or

(ii) Not more than 275 miles from such farm.

The term “consumer” does not include a business.

Raw agricultural commodity (RAC) means “raw agricultural commodity” as defined in section 

201(r) of the Federal Food, Drug, and Cosmetic Act. 

Sanitize means to adequately treat cleaned surfaces by a process that is effective in destroying 

vegetative cells of microorganisms of public health significance, and in substantially reducing 

numbers of other undesirable microorganisms, but without adversely affecting the product or its 

safety for the consumer.

Sewage sludge biosolids means the solid or semi-solid residue generated during the treatment of 

domestic sewage in a treatment works within the meaning of the definition of “sewage sludge” in 

40 CFR 503.9(w). 

Soil amendment means any chemical, biological, or physical material (such as elemental fertilizers, 

stabilized compost, manure, non-fecal animal byproducts, peat moss, perlite, pre- consumer 

vegetative waste, sewage sludge biosolids, table waste, agricultural tea and yard trimmings) 

intentionally added to the soil to improve the chemical or physical condition of soil in relation to 

plant growth or to improve the capacity of the soil to hold water. The term soil amendment also 

includes growth media that serve as the entire substrate during the growth of covered produce (such 

as mushrooms and some sprouts).

Spent sprout irrigation water means water that has been used in the growing of sprouts.

Stabilized compost means a stabilized (i.e., finished) biological soil amendment produced through a 

controlled composting process. 

Static composting means a process to produce stabilized compost in which air is introduced into 

biological material (in a pile (or row) that may or may not be covered with insulating material, or in 

an enclosed vessel) by a mechanism that does not include turning. Examples of structural features 
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for introducing air include embedded perforated pipes and a constructed permanent base that 

includes aeration slots. Examples of mechanisms for introducing air include passive diffusion and 

mechanical means (such as blowers that suction air from the composting material or blow air into 

the composting material using positive pressure). 

Surface water means all water open to the atmosphere (rivers, lakes, reservoirs, streams, 

impoundments, seas, estuaries, etc.) and all springs, wells, or other collectors that are directly 

influenced by surface water.

Table waste means any post-consumer food waste, irrespective of whether the source material is 

animal or vegetative in origin, derived from individuals, institutions, restaurants, retail operations, 

or other sources where the food has been served to a consumer.

Turned composting means a process to produce stabilized compost in which air is introduced into 

biological material (in a pile, row, or enclosed vessel) by turning on a regular basis. Turning is the 

process of mechanically mixing biological material that is undergoing a composting process with 

the specific intention of moving the outer, cooler sections of the material being composted to the 

inner, hotter sections. 

Visitor means any person (other than personnel) who enters your covered farm with your 

permission. 

Water distribution system means a system to carry water from its primary source to its point of use, 

including pipes, sprinklers, irrigation canals, pumps, valves, storage tanks, reservoirs, meters, and 

fittings.

We means the U.S. Food and Drug Administration (FDA). 

Yard trimmings means purely vegetative matter resulting from landscaping maintenance or land 

clearing operations, including materials such as tree and shrub trimmings, grass clippings, palm 

fronds, trees, tree stumps, untreated lumber, untreated wooden pallets, and associated rocks and 

soils.

You, for purposes of this part, means the owner, operator, or agent in charge of a covered farm that 

is subject to some or all of the requirements of this part.

§ 112.4 Which farms are subject to the requirements of this part?

(a) Except as provided in paragraph (b) of this section, a farm or farm mixed-type facility with 

an average annual monetary value of produce (as “produce” is defined in § 112.3(c)) sold 

during the previous 3-year period of more than $25,000 (on a rolling basis), adjusted for 

inflation using 2011 as the baseline year for calculating the adjustment, is a “covered farm” 

subject to this part. Covered farms subject to this part must comply with all applicable 

requirements of this part when conducting a covered activity on covered produce. 

(b) A farm is not a covered farm if it satisfies the requirements in § 112.5 and we have not 

withdrawn the farm’s exemption in accordance with the requirements of subpart R of this 

part.

112.5 Which farms are eligible for a qualified exemption and associated modified 

requirements based on average monetary value of all food sold and direct farm marketing?

(a) A farm is eligible for a qualified exemption and associated modified requirements in a 

calendar year if:

(1) During the previous 3-year period preceding the applicable calendar year, the average 

annual monetary value of the food (as defined in § 112.3(c)) the farm sold directly to 
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qualified end-users (as defined in § 112.3(c)) during such period exceeded the average 

annual monetary value of the food the farm sold to all other buyers during that period; 

and 

(2) The average annual monetary value of all food (as defined in § 112.3(c)) the farm sold 

during the 3-year period preceding the applicable calendar year was less than $500,000, 

adjusted for inflation.

(b) For the purpose of determining whether the average annual monetary value of all food sold 

during the 3-year period preceding the applicable calendar year was less than $500,000, 

adjusted for inflation, the baseline year for calculating the adjustment for inflation is 2011. 

§ 112.6 What modified requirements apply to me if my farm is eligible for a qualified 

exemption in accordance with § 112.5? 

(a) If your farm is eligible for a qualified exemption in accordance with § 112.5, you are subject 

to the requirements of: 

(1) This subpart A (General Provisions); 

(2) Subpart O of this part (Records);

(3) Subpart Q of this part (Compliance and Enforcement); and 

(4) Subpart R of this part (Withdrawal of Qualified Exemption).

(b) In addition, 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. 

(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 documents 

delivered contemporaneously with the produce in the normal course of business, or, in 

the case of Internet sales, in an electronic notice.

(3) The complete business address that you must include in accordance with the 

requirements of paragraph (b)(1) or (b)(2) of this section 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.

§ 112.7 What records must I establish and keep if my farm is eligible for a qualified 

exemption in accordance with § 112.5? 

If your farm is eligible for a qualified exemption in accordance with § 112.5: 

(a) You must establish and keep records required under this provision in accordance with the 

requirements of subpart O of this part, except that the requirement in § 112.161(a)(4) for a 

signature or initial of the person performing the activity is not required for sales receipts 

kept in the normal course of business. Such receipts must be dated as required under § 

112.161(a)(4). 

(b) You must establish and keep adequate records necessary to demonstrate that your farm 

satisfies the criteria for a qualified exemption that are described in § 112.5, including a 
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written record reflecting that you have performed an annual review and verification of your 

farm’s continued eligibility for the qualified exemption.

Subpart B: General Requirements

§ 112.11 What general requirements apply to persons who are subject to this part? 

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 Federal Food, Drug, and Cosmetic Act on account of such hazards. 

§ 112.12 Are there any alternatives to the requirements established in this part?

(a) You may establish alternatives to certain specific requirements of subpart E of this part, as 

specified in § 112.49, provided that you satisfy the requirements of paragraphs (b) and (c)

of this section.

(b) You may establish and use an alternative to any of the requirements specified in paragraph 

(a) of this section, provided you have adequate scientific data or information to support a 

conclusion that the alternative would provide the same level of public health protection as 

the applicable requirement established in this part, and would not increase the likelihood that 

your covered produce will be adulterated under section 402 of the Federal Food, Drug, and 

Cosmetic Act, in light of your covered produce, practices, and conditions. 

(c) Scientific data and information used to support an alternative to a requirement specified in 

paragraph (a) of this section may be developed by you, available in the scientific literature, 

or available to you through a third party. You must establish and maintain documentation of 

the scientific data and information on which you rely in accordance with the requirements of 

subpart O of this part. You are not required to notify or seek prior approval from FDA 

regarding your decision to establish or use an alternative under this section. 

Subpart C: Personnel Qualifications and Training

§ 112.21 What requirements apply regarding qualifications and training for personnel who 

handle (contact) covered produce or food contact surfaces?

All of the following requirements apply regarding qualifications and training for personnel who 

handle (contact) covered produce or food contact surfaces: 

(a) All personnel (including temporary, part time, seasonal, and contracted personnel) who 

handle covered produce or food contact surfaces, or who are engaged in the supervision 

thereof, must receive adequate training, as appropriate to the person’s duties, upon hiring, 

and periodically thereafter, at least once annually.

(b) All personnel (including temporary, part time, seasonal, and contracted 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 person’s assigned duties in a manner that ensures compliance with this part.

(c) Training must be conducted in a manner that is easily understood by personnel being 

trained.
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(d) Training must be repeated 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 this part. 

§ 112.22 What minimum requirements apply for training personnel who conduct a covered 

activity?

(a) At a minimum, all personnel who handle (contact) covered produce during covered 

activities or supervise the conduct of such activities must receive training that includes all of 

the following:

(1) Principles of food hygiene and food safety; 

(2) The importance of health and personal hygiene for all personnel and visitors, including 

recognizing symptoms of a health condition that is reasonably likely to result in 

contamination of covered produce or food contact surfaces with microorganisms of 

public health significance; and 

(3) The standards established by FDA in subparts C through O of this part that are 

applicable to the employee’s job responsibilities.

(b) Persons who conduct harvest activities for covered produce must also receive training that 

includes all of the following:

(1) Recognizing covered produce that must not be harvested, including covered produce that 

may be contaminated with known or reasonably foreseeable hazards;

(2) Inspecting harvest containers and equipment to ensure that they are functioning properly, 

clean, and maintained so as not to become a source of contamination of covered produce 

with known or reasonably foreseeable hazards; and

(3) Correcting problems with harvest containers or equipment, or reporting such problems to 

the supervisor (or other responsible party), as appropriate to the person’s job 

responsibilities.

(c) 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 Food and Drug Administration. 

§ 112.23 What requirements apply regarding supervisors? 

You must assign or identify personnel to supervise (or otherwise be responsible for) your operations 

to ensure compliance with the requirements of this part.

§ 112.30 Under this subpart, what requirements apply regarding records? 

(a) You must establish and keep records required under this subpart in accordance with the 

requirements of subpart O of this part. 

(b) You must establish and keep records of training that document required training of 

personnel, including the date of training, topics covered, and the persons(s) trained.

Subpart D: Health and Hygiene
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§ 112.31 What measures must I take to prevent ill or infected persons from contaminating 

covered produce with microorganisms of public health significance?

(a) 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 (such as communicable illnesses that present a public health risk 

in the context of normal work duties, infection, open lesion, vomiting, or diarrhea).

(b) The measures you must take to satisfy the requirements of paragraph (a) of this section must 

include all of the following measures:

(1) Excluding 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 person’s acknowledgement, 

or observation) is shown to have, or appears to have, an applicable health condition, 

until the person’s health condition no longer presents a risk to public health; and

(2) Instructing 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.

§ 112.32 What hygienic practices must personnel use?

(a) 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.

(b) The hygienic practices that personnel use to satisfy the requirements of paragraph (a) of this 

section when handling (contacting) covered produce or food contact surfaces during a 

covered activity must include all of the following practices:

(1) Maintaining adequate personal cleanliness to protect against contamination of covered 

produce and food contact surfaces;

(2) Avoiding contact with animals other than working animals, and taking appropriate steps 

to minimize the likelihood of contamination of covered produce when in direct contact 

with working animals;

(3) Washing hands thoroughly, including scrubbing with soap (or other effective surfactant) 

and running water that satisfies the requirements of § 112.44(a) (as applicable) for water 

used to wash hands, and drying hands thoroughly using single-service towels, sanitary 

towel service, electric hand dryers, or other adequate hand drying devices:

(i) Before starting work;

(ii) Before putting on gloves;

(iii)After using the toilet;

(iv)Upon return to the work station after any break or other absence from the work

station;

(v) As soon as practical after touching animals (including livestock and working

animals), or any waste of animal origin; and

(vi)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;

(4) If you choose to use gloves in handling covered produce or food contact surfaces, 

maintaining gloves in an intact and sanitary condition and replacing such gloves when 

no longer able to do so;
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(5) Removing or covering hand jewelry that cannot be adequately cleaned and sanitized 

during periods in which covered produce is manipulated by hand; and 

(6) Not eating, chewing gum, or using tobacco products in an area used for a covered 

activity (however, drinking beverages is permitted in designated areas).

§ 112.33 What measures must I take to prevent visitors from contaminating covered produce 

and food contact surfaces with microorganisms of public health significance?

(a) 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. 

(b) You must make toilet and hand-washing facilities accessible to visitors.

Subpart E: Agricultural Water

§ 112.41 What requirements apply to the quality of agricultural water?

All agricultural water must be safe and of adequate sanitary quality for its intended use.

§ 112.42 What requirements apply to my agricultural water sources, water distribution 

system, and pooling of water?

(a) At the beginning of a growing season, as appropriate, but at least once annually, you must 

inspect all of your agricultural water systems, to the extent they are under your control 

(including water sources, water distribution systems, facilities, and equipment), to identify 

conditions that are reasonably likely to introduce known or reasonably foreseeable hazards 

into or onto covered produce or food contact surfaces in light of your covered produce, 

practices, and conditions, including consideration of the following:

(1) The nature of each agricultural water source (for example, ground water or surface

water);

(2) The extent of your control over each agricultural water source; 

(3) The degree of protection of each agricultural water source;

(4) Use of adjacent and nearby land; and 

(5) The likelihood of introduction of known or reasonably foreseeable hazards to 

agricultural water by another user of agricultural water before the water reaches your 

covered farm.

(b) You must adequately maintain all agricultural water distribution systems to the extent they 

are under your control as necessary and appropriate to prevent the water distribution system 

from being a source of contamination to covered produce, food contact surfaces, areas used 

for a covered activity, or water sources, including by regularly inspecting and adequately 

storing all equipment used in the system. 

(c) You must adequately maintain all agricultural water sources to the extent they are under 

your control (such as wells). Such maintenance includes regularly inspecting each source to 

identify any conditions that are reasonably likely to introduce known or reasonably 

foreseeable hazards into or onto covered produce or food contact surfaces; correcting any 

significant deficiencies (e.g., repairs to well cap, well casing, sanitary seals, piping tanks and 

treatment equipment, and control of cross-connections); and keeping the source free of 
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debris, trash, domesticated animals, and other possible sources of contamination of covered 

produce to the extent practicable and appropriate under the circumstances.

(d) As necessary and appropriate, you must implement measures reasonably necessary to reduce 

the potential for contamination of covered produce with known or reasonably foreseeable 

hazards as a result of contact of covered produce with pooled water. For example, such 

measures may include using protective barriers or staking to keep covered produce from 

touching the ground or using an alternative irrigation method.

§ 112.43 What requirements apply to treating agricultural water?

(a) When agricultural water is treated in accordance with § 112.45:

(1) Any method you use to treat agricultural water (such as with physical treatment, 

including using a pesticide device as defined by the U.S. Environmental Protection 

Agency (EPA); EPA-registered antimicrobial pesticide product; or other suitable 

method) must be effective to make the water safe and of adequate sanitary quality for its 

intended use and/or meet the relevant microbial quality criteria in § 112.44, as 

applicable.

(2) You must deliver any treatment of agricultural water in a manner to ensure that the 

treated water is consistently safe and of adequate sanitary quality for its intended use 

and/or consistently meets the relevant microbial quality criteria in § 112.44, as 

applicable.

(b) You must monitor any treatment of agricultural water at a frequency adequate to ensure that 

the treated water is consistently safe and of adequate sanitary quality for its intended use 

and/or consistently meets the relevant microbial quality criteria in § 112.44, as applicable.

§ 112.44 What specific microbial quality criteria apply to agricultural water used for certain 

intended uses?

(a) When you use agricultural water for any one or more of these following purposes, you must 

ensure there is no detectable generic Escherichia coli (E. coli) in 100 milliliters (mL) of 

agricultural water, and you must not use untreated surface water for any of these purposes:

(1) Used as sprout irrigation water;

(2) Applied in any manner that directly contacts covered produce during or after harvest 

activities (for example, water that is applied to covered produce for washing or cooling 

activities, and water that is applied to harvested crops to prevent dehydration before 

cooling), including when used to make ice that directly contacts covered produce during 

or after harvest activities;

(3) Used to contact food contact surfaces, or to make ice that will contact food contact 

surfaces; and

(4) Used for washing hands during and after harvest activities.

(b) When you use agricultural water during growing activities for covered produce (other than 

sprouts) using a direct water application method, the following criteria apply (unless you 

establish and use alternative criteria in accordance with § 112.49):

(1) A geometric mean (GM) of your agricultural water samples of 126 or less colony 

forming units (CFU) of generic E. coli per 100 mL of water (GM is a measure of the 

central tendency of your water quality distribution); and
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(2) A statistical threshold value (STV) of your agricultural water samples of 410 or less 

CFU of generic E. coli per 100 mL of water (STV is a measure of variability of your 

water quality distribution, derived as a model-based calculation approximating the 90th 

percentile using the lognormal distribution).

§ 112.45 What measures must I take if my agricultural water does not meet the requirements 

of § 112.41 or § 112.44?

(a) If you have determined or have reason to believe that your agricultural water is not safe or 

of adequate sanitary quality for its intended use as required under § 112.41 and/or if your 

agricultural water does not meet the microbial quality criterion for the specified purposes as 

required under § 112.44(a), you must immediately discontinue that use(s), and before you 

may use the water source and/or distribution system again for the intended use(s), you must 

either:

(1) Re-inspect the entire affected agricultural water system to the extent it is under your 

control, identify any conditions that are reasonably likely to introduce known or 

reasonably foreseeable hazards into or onto covered produce or food contact surfaces, 

make necessary changes, and take adequate measures to determine if your changes were 

effective and, as applicable, adequately ensure that your agricultural water meets the 

microbial quality criterion in § 112.44(a); or

(2) Treat the water in accordance with the requirements of § 112.43.

(b) If you have determined that your agricultural water does not meet the microbial quality 

criteria (or any alternative microbial quality criteria, if applicable) required under § 

112.44(b), as soon as practicable and no later than the following year, you must discontinue 

that use, unless you either:

(1) Apply a time interval(s) (in days) and/or a (calculated) log reduction by:

(i) Applying a time interval between last irrigation and harvest using either:

(A)A microbial die-off rate of 0.5 log per day to achieve a (calculated) log reduction 

of your geometric mean (GM) and statistical threshold value (STV) to meet the 

microbial quality criteria in § 112.44(b) (or any alternative microbial criteria, if 

applicable), but no greater than a maximum time interval of 4 consecutive days; 

or

(B) An alternative microbial die-off rate and any accompanying maximum time 

interval, in accordance with § 112.49; and/or

(ii) Applying a time interval between harvest and end of storage using an appropriate 

microbial die-off rate between harvest and end of storage, and/or applying a 

(calculated) log reduction using appropriate microbial removal rates during activities 

such as commercial washing, to meet the microbial quality criteria in § 112.44(b) (or 

any alternative microbial criteria, if applicable), and any accompanying maximum 

time interval or log reduction, provided you have adequate supporting scientific data 

and information;

(2) Re-inspect the entire affected agricultural water system to the extent it is under your 

control, identify any conditions that are reasonably likely to introduce known or 

reasonably foreseeable hazards into or onto covered produce or food contact surfaces, 

make necessary changes, and take adequate measures to determine if your changes were 

effective and adequately ensure that your agricultural water meets the microbial quality 

criteria in § 112.44(b) (or any alternative microbial criteria, if applicable); or
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(3) Treat the water in accordance with the requirements of § 112.43.

§ 112.46 How often must I test agricultural water that is subject to the requirements of § 

112.44?

(a) There is no requirement to test any agricultural water that is subject to the requirements of § 

112.44 when:

(1) You receive water from a Public Water System, as defined under the Safe Drinking 

Water Act (SDWA) regulations, 40 CFR part 141, that furnishes water that meets the 

microbial requirements under those regulations or under the regulations of a State (as 

defined in 40 CFR 141.2) approved to administer the SDWA public water supply 

program, and you have Public Water System results or certificates of compliance that 

demonstrate that the water meets that requirement;

(2) You receive water from a public water supply that furnishes water that meets the 

microbial quality requirement described in § 112.44(a), and you have public water 

system results or certificates of compliance that demonstrate that the water meets that 

requirement; or

(3) You treat water in accordance with the requirements of § 112.43.

(b) Except as provided in paragraph (a) of this section, you must take the following steps for 

each source of water used for purposes that are subject to the requirements of § 112.44(b):

(1) Conduct an initial survey to develop a microbial water quality profile of the agricultural 

water source.

(i) The initial survey must be conducted:

(A)For an untreated surface water source, by taking a minimum total of 20 samples 

of agricultural water (or an alternative testing frequency that you establish and 

use, in accordance with § 112.49) over a minimum period of 2 years, but not 

greater than 4 years.

(B) For an untreated ground water source, by taking a minimum total of four samples 

of agricultural water during the growing season or over a period of 1 year.

(ii) The samples of agricultural water must be representative of your use of the water and 

must be collected as close in time as practicable to, but prior to, harvest. The 

microbial water quality profile initially consists of the geometric mean (GM) and the 

statistical threshold value (STV) of generic Escherichia coli (E. coli) (colony 

forming units (CFU) per 100 milliliter (mL)) calculated using this data set. You 

must determine the appropriate way(s) in which the water may be used based on 

your microbial water quality profile in accordance with § 112.45(b).

(iii)You must update the microbial water quality profile annually as required under 

paragraph (b)(2) of this section, and otherwise required under paragraph (b)(3) of 

this section.

(2) Conduct an annual survey to update the microbial water quality profile of your 

agricultural water.

(i) After the initial survey described in paragraph (b)(1)(i) of this section, you must test 

the water annually to update your existing microbial water quality profile to confirm 

that the way(s) in which the water is used continues to be appropriate. You must 

analyze:
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(A)For an untreated surface water source, a minimum number of five samples per 

year (or an alternative testing frequency that you establish and use, in accordance 

with § 112.49).

(B) For an untreated ground water source, a minimum of one sample per year.

(ii) The samples of agricultural water must be representative of your use of the water and 

must be collected as close in time as practicable to, but prior to, harvest.

(iii)To update the microbial water quality profile, you must calculate revised GM and 

STV values using your current annual survey data, combined with your most recent 

initial or annual survey data from within the previous 4 years, to make up a rolling 

data set of:

(A)At least 20 samples for untreated surface water sources; and

(B) At least 4 samples for untreated ground water sources.

(iv)You must modify your water use, as appropriate, based on the revised GM and STV 

values in your updated microbial water quality profile in accordance with § 

112.45(b).

(3) If you have determined or have reason to believe that your microbial water quality 

profile no longer represents the quality of your water (for example, if there are 

significant changes in adjacent land use that are reasonably likely to adversely affect the 

quality of your water source), you must develop a new microbial water quality profile 

reflective of the time period at which you believe your microbial water quality profile 

changed.

(i) To develop a new microbial water quality profile, you must calculate new GM and 

STV values using your current annual survey data (if taken after the time of the 

change), combined with new data, to make up a data set of:

(A)At least 20 samples for untreated surface water sources; and

(B) At least 4 samples for untreated ground water sources.

(ii) You must modify your water use based on the new GM and STV values in your new 

microbial water quality profile in accordance with § 112.45(b).

(c) If you use untreated ground water for the purposes that are subject to the requirements of § 

112.44(a), you must initially test the microbial quality of each source of the untreated 

ground water at least four times during the growing season or over a period of 1 year, using 

a minimum total of four samples collected to be representative of the intended use(s). Based 

on these results, you must determine whether the water can be used for that purpose, in 

accordance with § 112.45(a). If your four initial sample results meet the microbial quality

criteria of § 112.44(a), you may test once annually thereafter, using a minimum of one 

sample collected to be representative of the intended use(s). You must resume testing at 

least four times per growing season or year if any annual test fails to meet the microbial 

quality criteria in § 112.44(a).

§ 112.47 Who must perform the tests required under § 112.46 and what methods must be 

used?

(a) You may meet the requirements related to agricultural water testing required under § 112.46 

using:

(1) Test results from your agricultural water source(s) performed by you, or by a person or 

entity acting on your behalf; or
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(2) Data collected by a third party or parties, provided the water source(s) sampled by the 

third party or parties adequately represent your agricultural water source(s) and all other 

applicable requirements of this part are met.

(b) Agricultural water samples must be aseptically collected and tested using a method as set 

forth in § 112.151.

§ 112.48 What measures must I take for water that I use during harvest, packing, and holding 

activities for covered produce?

(a) You must manage the water as necessary, including by establishing and following waterchange schedules for re-circulated water, to maintain its safety and adequate sanitary quality 

and minimize the potential for contamination of covered produce and food contact surfaces 

with known or reasonably foreseeable hazards (for example, hazards that may be introduced 

into the water from soil adhering to the covered produce);

(b) You must visually monitor the quality of water that you use during harvest, packing, and 

holding activities for covered produce (for example, water used for washing covered 

produce in dump tanks, flumes, or wash tanks, and water used for cooling covered produce 

in hydrocoolers) for buildup of organic material (such as soil and plant debris).

(c) You must maintain and monitor the temperature of water at a temperature that is appropriate 

for the commodity and operation (considering the time and depth of submersion) and is 

adequate to minimize the potential for infiltration of microorganisms of public health 

significance into covered produce.

§ 112.49 What alternatives may I establish and use in lieu of the requirements of this subpart?

Provided you satisfy the requirements of § 112.12, you may establish and use one or more of the 

following alternatives:

(a) An alternative microbial quality criterion (or criteria) using an appropriate indicator of fecal 

contamination, in lieu of the microbial quality criteria in § 112.44(b);

(b) An alternative microbial die-off rate and an accompanying maximum time interval, in lieu 

of the microbial die-off rate and maximum time interval in § 112.45(b)(1)(i);

(c) An alternative minimum number of samples used in the initial survey for an untreated 

surface water source, in lieu of the minimum number of samples required under § 

112.46(b)(1)(i)(A); and

(d) An alternative minimum number of samples used in the annual survey for an untreated 

surface water source, in lieu of the minimum number of samples required under § 

112.46(b)(2)(i)(A).

§ 112.50 Under this subpart, what requirements apply regarding records?

(a) You must establish and keep records required under this subpart in accordance with the 

requirements of subpart O of this part.

(b) You must establish and keep the following records:

(1) The findings of the inspection of your agricultural water system in accordance with the 

requirements of § 112.42(a);

(2) Documentation of the results of all analytical tests conducted on agricultural water for 

purposes of compliance with this subpart;
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(3) Scientific data or information you rely on to support the adequacy of a method used to 

satisfy the requirements of § 112.43(a)(1) and (2); 

(4) Documentation of the results of water treatment monitoring under § 112.43(b);

(5) Scientific data or information you rely on to support the microbial die-off or removal 

rate(s) that you used to determine the time interval (in days) between harvest and end of 

storage, including other activities such as commercial washing, as applicable, used to 

achieve the calculated log reduction of generic Escherichia coli (E. coli), in accordance 

with § 112.45(b)(1)(ii); 

(6) Documentation of actions you take in accordance with § 112.45. With respect to any 

time interval or (calculated) log reduction applied in accordance with § 112.45(b)(1)(i) 

and/or (b)(1)(ii), such documentation must include the specific time interval or log 

reduction applied, how the time interval or log reduction was determined, and the dates 

of corresponding activities such as the dates of last irrigation and harvest, the dates of 

harvest and end of storage, and/or the dates of activities such as commercial washing);

(7) Annual documentation of the results or certificates of compliance from a public water 

system required under § 112.46(a)(1) or (a)(2), if applicable;

(8) Scientific data or information you rely on to support any alternative that you establish 

and use in accordance with § 112.49; and 

(9) Any analytical methods you use in lieu of the method that is incorporated by reference in 

§ 112.151(a). 

Subpart F--Biological Soil Amendments of Animal Origin and Human Waste 

§ 112.51 What requirements apply for determining the status of a biological soil amendment 

of animal origin?

(a) A biological soil amendment of animal origin is treated if it has been processed to 

completion to adequately reduce microorganisms of public health significance in accordance 

with the requirements of § 112.54, or, in the case of an agricultural tea, the biological 

materials of animal origin used to make the tea have been so processed, the water used to 

make the tea is not untreated surface water, and the water used to make the tea has no 

detectable generic Escherichia coli (E. coli) in 100 milliliters (mL) of water.

(b) A biological soil amendment of animal origin is untreated if it:

(1) Has not been processed to completion in accordance with the requirements of § 112.54, 

or in the case of an agricultural tea, the biological materials of animal origin used to

make the tea have not been so processed, 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;

(2) Has become contaminated after treatment;

(3) Has been recombined with an untreated biological soil amendment of animal origin;

(4) Is or contains a component that is untreated waste that you know or have reason to 

believe is contaminated with a hazard or has been associated with foodborne illness; or

(5) Is an agricultural tea made with biological materials of animal origin that contains an 

agricultural tea additive.
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§ 112.52 How must I handle, convey, and store biological soil amendments of animal origin?

(a) You must handle, convey and store any biological soil amendment of animal origin in a

manner and location such that it does not become a potential source of contamination to 

covered produce, food contact surfaces, areas used for a covered activity, water sources, 

water distribution systems, and other soil amendments. Agricultural teas that are biological 

soil amendments of animal origin may be used in water distribution systems provided that 

all other requirements of this rule are met.

(b) You must handle, convey and store any treated biological soil amendment of animal origin 

in a manner and location that minimizes the risk of it becoming contaminated by an 

untreated or in-process biological soil amendment of animal origin.

(c) You must handle, convey, and store any biological soil amendment of animal origin that you 

know or have reason to believe may have become contaminated as if it was untreated.

§ 112.53 What prohibitions apply regarding use of human waste?

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.

§ 112.54 What treatment processes are acceptable for a biological soil amendment of animal 

origin that I apply in the growing of covered produce?

Each of the following treatment processes are acceptable for a biological soil amendment of animal 

origin that you apply in the growing of covered produce, provided that the resulting biological soil 

amendments are applied in accordance with the applicable requirements of § 112.56:

(a) A scientifically valid controlled physical process (e.g., thermal), chemical process (e.g., high 

alkaline pH), biological process (e.g., composting), or a combination of scientifically valid 

controlled physical, chemical and/or biological processes that has been validated to satisfy 

the microbial standard in § 112.55(a) for Listeria monocytogenes (L. monocytogenes),

Salmonella species, and E. coli O157:H7; or

(b) A scientifically valid controlled physical, chemical, or biological process, or a combination 

of scientifically valid controlled physical, chemical, and/or biological processes, that has 

been validated to satisfy the microbial standard in § 112.55(b) for Salmonella species and 

fecal coliforms. Examples of scientifically valid controlled biological (e.g., composting) 

processes that meet the microbial standard in § 112.55(b) include:

(1) Static composting that maintains aerobic (i.e., oxygenated) conditions at a minimum of 

131 °F (55 °C) for 3 consecutive days and is followed by adequate curing; and

(2) Turned composting that maintains aerobic conditions at a minimum of 131 °F (55 °C) 

for 15 days (which do not have to be consecutive), with a minimum of five turnings, and 

is followed by adequate curing.

§ 112.55 What microbial standards apply to the treatment processes in § 112.54?

The following microbial standards apply to the treatment processes in § 112.54 as set forth in that 

section.

(a) For L. monocytogenes, Salmonella species, and E. coli O157:H7, the relevant standards in 

the table in this paragraph; or
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For the microorganism The microbial standard is

(1) L. monocytogenes Not detected using a method that can detect one 

colony forming unit (CFU) per 5 gram (or 

milliliter, if liquid is being sampled) analytical 

portion.

(2) Salmonella species Not detected using a method that can detect three 

most probable numbers (MPN) per 4 grams (or 

milliliter, if liquid is being sampled) of total 

solids.

(3) E. coli O157:H7 Not detected using a method that can detect

0.3 MPN per 1 gram (or milliliter, if liquid is 

being sampled) analytical portion.

(b) Salmonella species are not detected using a method that can detect three MPN Salmonella

species per 4 grams of total solids (dry weight basis); and less than 1,000 MPN fecal 

coliforms per gram of total solids (dry weight basis).

§ 112.56 What application requirements and minimum application intervals apply to 

biological soil amendments of animal origin?

(a) You must apply the biological soil amendments of animal origin specified in the first 

column of the table in this paragraph in accordance with the application requirements 

specified in the second column of the table in this paragraph and the minimum application 

intervals specified in the third column of the table in this paragraph. 

If the biological soil 

amendment of animal origin 

is

Then the biological soil 

amendment of animal origin 

must be applied

And then the minimum 

application interval is

(1)(i) Untreated In a manner that does not 

contact covered produce during 

application and minimizes the 

potential for contact with 

covered produce after 

application

[Reserved]

(ii) Untreated In a manner that does not 

contact covered produce during 

or after application

0 days
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(2) Treated by a scientifically 

valid controlled physical, 

chemical, or biological 

process, or combination of 

scientifically valid controlled 

physical, chemical, and/or 

biological processes, in 

accordance with the 

requirements of § 112.54(b) to 

meet the microbial standard in 

§ 112.55(b).

In a manner that minimizes 

the potential for contact with 

covered produce during and 

after application

0 days

(3) Treated by a scientifically 

valid controlled physical, 

chemical, or biological 

process, or combination of 

scientifically valid controlled 

physical, chemical, or 

biological processes, in 

accordance with the 

requirements of § 112.54(a) to 

meet the microbial standard in 

§ 112.55(a).

In any manner (i.e., no 

restrictions)

0 days

112.60 Under this subpart, what requirements apply regarding records?

(a) You must establish and keep records required under this subpart in accordance with the 

requirements of subpart O of this part.

(b) For any biological soil amendment of animal origin you use, you must establish and keep the 

following records:

(1) For a treated biological soil amendment of animal origin you receive from a third party, 

documentation (such as a Certificate of Conformance) at least annually that:

(i) The process used to treat the biological soil amendment of animal origin is a 

scientifically valid process that has been carried out with appropriate process 

monitoring; and

(ii) The biological soil amendment of animal origin has been handled, conveyed and 

stored in a manner and location to minimize the risk of contamination by an 

untreated or in process biological soil amendment of animal origin; and

(2) For a treated biological soil amendment of animal origin you produce for your own 

covered farm(s), documentation that process controls (for example, time, temperature, 

and turnings) were achieved.
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Subpart G--[Reserved]

Subpart H--[Reserved]

Subpart I--Domesticated and Wild Animals

§ 112.81 How do the requirements of this subpart apply to areas where covered activities take 

place?

(a) The requirements of this subpart apply when a covered activity takes place in an outdoor 

area or a partially- enclosed building and when, under the circumstances, there is a 

reasonable probability that animals will contaminate covered produce.

(b) The requirements of this subpart do not apply: 

(1) When a covered activity takes place in a fully- enclosed building; or 

(2) To fish used in aquaculture operations. 

§ 112.83 What requirements apply regarding grazing animals, working animals, and animal 

intrusion?

(a) You must take the steps set forth in paragraph (b) of this section if under the circumstances 

there is a reasonable probability that grazing animals, working animals, or animal intrusion 

will contaminate covered produce. 

(b) You must: 

(1) Assess the relevant areas used for a covered activity for evidence of potential 

contamination of covered produce as needed during the growing season (based on your 

covered produce; your practices and conditions; and your observations and experience); 

and 

(2) If significant evidence of potential contamination is found (such as observation of 

animals, animal excreta or crop destruction), you must evaluate whether the covered 

produce can be harvested in accordance with the requirements of § 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.

§ 112.84 Does this regulation require covered farms to take actions that would constitute a 

“taking” of threatened or endangered species; 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? 

No. Nothing in this regulation authorizes 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, or collect, or to attempt to engage in any such conduct), in 

violation of the Endangered Species Act. This regulation 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. 

Subpart J--[Reserved]
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Subpart K--Growing, Harvesting, Packing, and Holding Activities 

§ 112.111 What measures must I take if I grow, harvest, pack or hold both covered and 

excluded produce?

If you grow, harvest, pack or hold produce that is not covered in this part (i.e., excluded produce in 

accordance with § 112.2) and also conduct such activities on covered produce, and the excluded 

produce is not grown, harvested, packed or held in accordance with this part, you must take 

measures during these covered activities, as applicable, to:

(a) Keep covered produce separate from excluded produce (except when covered produce and 

excluded produce are placed in the same container for distribution); and

(b) 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.

§ 112.112 What measures must I take 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, including 

steps to identify and not harvest covered produce that is visibly contaminated with animal excreta. 

At a minimum, identifying and not harvesting covered produce that is reasonably likely to be 

contaminated with animal excreta or that is visibly contaminated with animal excreta requires a 

visual assessment of the growing area and all covered produce to be harvested, regardless of the 

harvest method used.

§ 112.113 How must I handle harvested covered produce during covered activities?

You must handle harvested covered produce during covered activities in a manner that protects 

against contamination with known or reasonably foreseeable hazards--for example, by avoiding, to 

the degree practicable, contact of cut surfaces of harvested produce with soil. 

§ 112.114 What requirements apply to dropped covered produce? 

You must not distribute dropped covered produce. Dropped covered produce is covered produce 

that drops to the ground before harvest. Dropped covered produce does not include root crops that 

grow underground (such as carrots), crops that grow on the ground (such as cantaloupe), or produce 

that is intentionally dropped to the ground as part of harvesting (such as almonds). 

§ 112.115 What measures must I take when 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). 

§ 112.116 What measures must I take when using food-packing (including food packaging) 

material?

(a) You must use food-packing material that is adequate for its intended use, which includes 

being: 

(1) Cleanable or designed for single use; and

(2) Unlikely to support growth or transfer of bacteria.

(b) If you reuse food-packing material, you must take adequate steps to ensure that food contact 

surfaces are clean, such as by cleaning food-packing containers or using a clean liner. 
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Subpart L--Equipment, Tools, Buildings, and Sanitation

§ 112.121 What equipment and tools are subject to the requirements of this subpart?

Equipment and tools subject to the requirements of this subpart are those that are intended to, or 

likely to, contact covered produce; and those instruments or controls used to measure, regulate, or 

record conditions to control or prevent the growth of microorganisms of public health significance. 

Examples include 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, foodpacking material, dump tanks, flumes, and vehicles or other equipment used for transport that are 

intended to, or likely to, contact covered produce).

§ 112.122 What buildings are subject to the requirements of this subpart?

Buildings subject to the requirements of this subpart include:

(a) Any fully- or partially-enclosed building used for covered activities, including minimal 

structures that have a roof but do not have any walls; and

(b) Storage sheds, buildings, or other structures used to store food contact surfaces (such as 

harvest containers and food-packing materials).

§ 112.123 What general requirements apply regarding equipment and tools subject to this 

subpart?

All of the following requirements apply regarding equipment and tools subject to this subpart:

(a) You must use equipment and tools that are of adequate design, construction, and 

workmanship to enable them to be adequately cleaned and properly maintained; and

(b) Equipment and tools must be:

(1) Installed and maintained as to facilitate cleaning of the equipment and of all adjacent 

spaces, and

(2) 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 

and harboring pests.

(c) 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.

(d) (1) You must inspect, maintain, and 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.

(2) You must maintain and clean all non-food-contact surfaces of equipment and tools 

subject to this subpart used during harvesting, packing, and holding as frequently as 

reasonably necessary to protect against contamination of covered produce.

(e) 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.
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§ 112.124 What requirements apply to instruments and controls used to measure, regulate, or 

record?

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:

(a) Accurate and precise as necessary and appropriate in keeping with their purpose;

(b) Adequately maintained; and

(c) Adequate in number for their designated uses.

§ 112.125 What requirements apply to equipment that is subject to this subpart used in the 

transport of covered produce?

Equipment that is subject to this subpart that you use to transport covered produce must be:

(a) Adequately clean before use in transporting covered produce; and

(b) Adequate for use in transporting covered produce.

§ 112.126 What requirements apply to my buildings?

(a) All of the following requirements apply regarding buildings:

(1) Buildings 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. 

Buildings must:

(i) Provide sufficient space for placement of equipment and storage of materials;

(ii) Permit proper precautions to be taken to reduce the potential for contamination of 

covered produce, food contact surfaces, or packing materials with known or 

reasonably foreseeable hazards. The potential for contamination must be reduced by 

effective design including the separation of operations in which contamination is 

likely to occur, by one or more of the following means: Location, time, partition, 

enclosed systems, or other effective means; and

(2) 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.

(b) 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:

(1) Floors, walls, ceilings, fixtures, ducts, or pipes; and

(2) Drip or condensate.

§ 112.127 What requirements apply regarding domesticated animals in and around a fullyenclosed building?

(a) 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 by:

(1) Excluding domesticated animals from fully-enclosed buildings where covered produce, 

food contact surfaces, or food-packing material is 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.
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(b) Guard or guide dogs may be allowed in some areas of a fully enclosed building if the 

presence of the dogs is unlikely to result in contamination of produce, food contact surfaces, 

or food-packing materials.

§ 112.128 What requirements apply regarding pest control in buildings?

(a) 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.

(b) For fully-enclosed buildings, you must take measures to exclude pests from your buildings.

(c) 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).

§ 112.129 What requirements apply to toilet facilities?

All of the following requirements apply to toilet facilities:

(a) You must provide personnel with adequate, readily accessible toilet facilities, including 

toilet facilities readily accessible to growing areas during harvesting activities.

(b) Your toilet facilities must be designed, located, and maintained to:

(1) Prevent contamination of covered produce, food contact surfaces, areas used for a

covered activity, water sources, and water distribution systems with human waste;

(2) 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; and

(3) Provide for the sanitary disposal of waste and toilet paper.

(c) 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.

§ 112.130 What requirements apply for hand-washing facilities?

All of the following requirements apply to hand-washing facilities:

(a) You must provide 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.

(b) Your hand-washing facilities must be furnished with:

(1) Soap (or other effective surfactant);

(2) Running water that satisfies the requirements of § 112.44(a) for water used to wash 

hands; and

(3) Adequate drying devices (such as single service towels, sanitary towel service, or 

electric hand dryers).

(c) You must provide for appropriate disposal of waste (for example, waste water and used 

single-service towels) associated with a hand-washing facility and take appropriate measures 

to prevent waste water from a 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.
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(d) You may not use antiseptic hand rubs as a substitute for soap (or other effective surfactant) 

and water.

§ 112.131 What must I do to control and dispose of sewage?

All of the following requirements apply for the control and disposal of sewage:

(a) You must dispose of sewage into an adequate sewage or septic system or through other 

adequate means.

(b) 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.

(c) 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.

(d) After a significant event (such as flooding or an earthquake) that could negatively impact a 

sewage or septic system, you must take appropriate steps to ensure that sewage and septic 

systems continue to operate in a manner that does not contaminate covered produce, food 

contact surfaces, areas used for a covered activity, agricultural water sources, or agricultural 

water distribution systems.

§ 112.132 What must I do to control and dispose of trash, litter, and waste in areas used for 

covered activities?

All of the following requirements apply to the control and disposal of trash, litter, and waste in 

areas used for covered activities:

(a) You must convey, store, and dispose of trash, litter and waste to:

(1) Minimize the potential for trash, litter, or waste to attract or harbor pests; and

(2) Protect against 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.

(b) You must adequately operate systems for waste treatment and disposal so that they do not 

constitute a potential source of contamination in areas used for a covered activity.

§ 112.133 What requirements apply to plumbing?

The plumbing must be of an adequate size and design and be adequately installed and maintained 

to:

(a) Distribute water under pressure as needed, in sufficient quantities, in all areas where used 

for covered activities, for sanitary operations, or for hand-washing and toilet facilities.

(b) Properly convey sewage and liquid disposable waste;

(c) Avoid being a source of contamination to covered produce, food contact surfaces, areas used 

for a covered activity, or agricultural water sources; and

(d) 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.
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§ 112.134 What must I do to control animal excreta and litter from domesticated animals that 

are under my control?

(a) 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.

(b) [Reserved]

§ 112.140 Under this subpart, what requirements apply regarding records?

(a) You must establish and keep records required under this subpart in accordance with the 

requirements of subpart O of this part. 

(b) You must establish and keep documentation of the date and method of cleaning and 

sanitizing of equipment subject to this subpart used in: 

(1) Growing operations for sprouts; and 

(2) Covered harvesting, packing, or holding activities. 

Subpart M--Sprouts 

§ 112.141 What commodities are subject to this subpart? 

The requirements of this subpart apply to growing, harvesting, packing, and holding of all sprouts, 

except soil- or substrate-grown sprouts harvested without their roots. 

§ 112.142 What requirements apply to seeds or beans used to grow sprouts? 

In addition to the requirements of this part, all of the following requirements apply to seeds or beans 

used to grow sprouts. 

(a) You must take measures reasonably necessary to prevent the introduction of known or 

reasonably foreseeable hazards into or onto seeds or beans that you will use for sprouting. 

(b) Except as provided in paragraph (c) of this section, if you know or have reason to believe 

that a lot of seeds or beans may be contaminated with a pathogen (either because it has been 

associated with foodborne illness; or based on microbial test results, including a positive 

finding of a pathogen in tests required under § 112.144(b)), you must: 

(1) Discontinue use of all seeds or beans from that lot for sprout production and ensure that 

sprouts grown from that lot of seeds or beans do not enter commerce; and

(2) Report the information (association with illness and/or findings of microbial testing) to 

the seed grower, distributor, supplier, or other entity from whom you received the seeds 

or beans. 

(c) If your reason to believe that a lot of seeds or beans may be contaminated was based only on 

microbial test results:

(1) You are not required to take the steps set forth in paragraph (b)(1) of this section if you 

treat your lot of seeds or beans with a process that is reasonably certain to achieve 

destruction or elimination in the seeds or beans of the most resistant microorganisms of 

public health significance that are likely to occur in the seeds or beans; or

(2) You are not required to take the steps set forth in paragraph (b)(1) and (2) of this section 

if you later reasonably determine, through appropriate followup actions, that the lot of 
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seeds or beans is not the source of contamination (e.g., the lot of seeds or beans is not 

the source of a pathogen found in spent sprout irrigation water or sprouts).

(d) You must visually examine seeds and beans, and packaging used to ship seeds or beans, for 

signs of potential contamination with known or reasonably foreseeable hazards.

(e) You must either:

(1) Treat seeds or beans that will be used to grow sprouts using a scientifically valid method 

to reduce microorganisms of public health significance; or

(2) Rely on prior treatment of seeds or beans conducted by a grower, distributor, or supplier 

of the seeds or beans (whether to fulfill this requirement completely or for the purpose of 

considering such prior treatment when applying appropriate additional treatment of the 

seeds or beans at the covered farm immediately before sprouting), provided that you 

obtain documentation (such as a Certificate of Conformance) from the grower, 

distributor, or supplier that:

(i) The prior treatment was conducted using a scientifically valid method to reduce 

microorganisms of public health significance; and

(ii) The treated seeds or beans were handled and packaged following the treatment in a 

manner that minimizes the potential for contamination.

§ 112.143 What measures must I take for growing, harvesting, packing, and holding sprouts?

You must take all of the following measures for growing, harvesting, packing, and holding sprouts:

(a) You must grow, harvest, pack, and hold sprouts in a fully-enclosed building.

(b) Any food contact surfaces you use to grow, harvest, pack, or hold sprouts must be cleaned 

and sanitized before contact with sprouts or seeds or beans used to grow sprouts.

(c) You must conduct testing during growing, harvesting, packing, and holding sprouts, as 

specified in § 112.144.

(d) You must establish and implement a written environmental monitoring plan as specified in § 

112.145.

(e) You must take certain actions if you detect Listeria species or L. monocytogenes in the 

growing, harvesting, packing, or holding environment, as specified in § 112.146.

(f) You must establish and implement a written sampling plan to test spent sprout irrigation 

water or sprouts for pathogens as specified in § 112.147.

(g) You must take certain actions if the samples of spent sprout irrigation water or sprouts test 

positive for a pathogen as specified in § 112.148.

§ 112.144 What testing must I do during growing, harvesting, packing, and holding sprouts?

All of the following testing must be done during growing, harvesting, packing, and holding sprouts:

(a) You must test the growing, harvesting, packing, and holding environment for Listeria 

species or L. monocytogenes in accordance with the requirements of § 112.145.

(b) You must either:

(1) Test spent sprout irrigation water from each production batch of sprouts for E. coli

O157:H7, Salmonella species, and any pathogens meeting the criteria in paragraph (c) of 

this section, in accordance with the requirements of § 112.147; or

(2) If testing spent sprout irrigation water is not practicable (for example, soil-grown sprouts 

harvested with roots or for hydroponically grown sprouts that use very little water), test each 

production batch of sprouts at the in-process stage (i.e., while sprouts are still growing) for
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E. coli O157:H7, Salmonella species, and any pathogens meeting the criteria in paragraph 

(c) of this section, in accordance with the requirements of § 112.147.

(c) In addition to E. coli O157:H7 and Salmonella species, you must conduct tests as provided 

in paragraph (b) of this section for additional pathogens when the following conditions are 

met:

(1) Testing for the pathogen is reasonably necessary to minimize the risk of serious adverse 

health consequences or death from use of, or exposure to, sprouts; and

(2) A scientifically valid test method for the pathogen is available to detect the pathogen in 

spent sprout irrigation water (or sprouts).

§ 112.145 What requirements apply to testing the environment for Listeria species or L. 

monocytogenes?

All of the following testing requirements apply for the growing, harvesting, packing, and holding 

environment for Listeria species or L. monocytogenes.

(a) You must establish and implement a written environmental monitoring plan that is designed 

to identify L. monocytogenes if it is present in the growing, harvesting, packing, or holding 

environment.

(b) Your written environmental monitoring plan must be directed to sampling and testing for 

either Listeria species or L. monocytogenes.

(c) Your written environmental monitoring plan must include a sampling plan that specifies:

(1) What you will test collected samples for (i.e., Listeria species or L. monocytogenes);

(2) How often you will collect environmental samples, which must be no less than monthly, 

and at what point during production you will collect the samples; and

(3) Sample collection sites; the number and location of sampling sites must be sufficient to 

determine whether measures are effective and must include appropriate food contact 

surfaces and non-food-contact surfaces of equipment, and other surfaces within the 

growing, harvesting, packing, and holding environment.

(d) You must aseptically collect environmental samples and test them for Listeria species or L. 

monocytogenes using a method as set forth in § 112.152.

(e) Your written environmental monitoring plan must include a corrective action plan that, at a 

minimum, requires you to take the actions in § 112.146, and details when and how you will 

accomplish those actions, if the growing, harvesting, packing, or holding environment tests 

positive for Listeria species or L. monocytogenes.

§ 112.146 What actions must I take if the growing, harvesting, packing, or holding 

environment tests positive for Listeria species or L. monocytogenes?

You must, at a minimum, take the following actions if you detect Listeria species or L. 

monocytogenes in the growing, harvesting, packing, or holding environment:

(a) Conduct additional testing of surfaces and areas surrounding the area where Listeria species 

or L. monocytogenes was detected to evaluate the extent of the problem, including the 

potential for Listeria species or L. monocytogenes to have become established in a niche;

(b) Clean and sanitize the affected surfaces and surrounding areas;

(c) Conduct additional sampling and testing to determine whether the Listeria species or L. 

monocytogenes has been eliminated;

(d) Conduct finished product testing when appropriate;
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(e) Perform any other actions necessary to prevent recurrence of the contamination; and

(f) Take appropriate action to prevent any food that is adulterated under section 402 of the 

Federal Food, Drug, and Cosmetic Act from entering into commerce.

§ 112.147 What must I do to collect and test samples of spent sprout irrigation water or 

sprouts for pathogens?

All of the following requirements apply for collecting and testing samples of spent sprout irrigation 

water or sprouts for pathogens as required in § 112.144(b):

(a) You must establish and implement a written sampling plan that identifies the number and 

location of samples (of spent sprout irrigation water or sprouts) to be collected for each 

production batch of sprouts to ensure that the collected samples are representative of the 

production batch when testing for contamination.

(b) In accordance with the written sampling plan required under paragraph (a) of this section, 

you must aseptically collect samples of spent sprout irrigation water or sprouts, and test the 

collected samples for pathogens using a method as set forth in § 112.153. You must not 

allow the production batch of sprouts to enter into commerce unless the results of the testing 

of spent sprout irrigation water or sprouts are negative for E. coli O157:H7, Salmonella

species, and, if applicable, a pathogen meeting the criteria in § 112.144(c).

(c) Your written sampling plan must include a corrective action plan that at a minimum, 

requires you to take the actions in § 112.148, and details when and how you will accomplish 

those actions, if the samples of spent sprout irrigation water or sprouts test positive for E. 

coli O157:H7, Salmonella species, or a pathogen meeting the criteria in § 112.144(c).

§ 112.148 What actions must I take if the samples of spent sprout irrigation water or sprouts 

test positive for a pathogen?

You must, at a minimum, take the following actions if the samples of spent sprout irrigation water 

or sprouts test positive for E. coli O157:H7, Salmonella species, or a pathogen meeting the criteria 

in § 112.144(c):

(a) Take appropriate action to prevent any food that is adulterated under section 402 of the 

Federal Food, Drug, and Cosmetic Act from entering into commerce;

(b) Take the steps required in § 112.142(b) with respect to the lot of seeds or beans used to 

grow the affected production batch of sprouts (except as allowed under § 112.142(c));

(c) Clean and sanitize the affected surfaces and surrounding areas; and

(d) Perform any other actions necessary to prevent reoccurrence of the contamination.

§ 112.150 Under this subpart, what requirements apply regarding records?

(a) You must establish and keep records required under this subpart M in accordance with the 

requirements of subpart O of this part.

(b) You must establish and keep the following records:

(1) Documentation of your treatment of seeds or beans to reduce microorganisms of public 

health significance in the seeds or beans, at your farm; or alternatively, documentation 

(such as a Certificate of Conformance) from your seed supplier that seeds or beans are 

treated to reduce microorganisms of public health significance and are appropriately 

handled and packaged following the treatment, in accordance with the requirements of § 

112.142(e);
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(2) Your written environmental monitoring plan in accordance with the requirements of § 

112.145; 

(3) Your written sampling plan for each production batch of sprouts in accordance with the 

requirements of § 112.147(a) and (c); 

(4) Documentation of the results of all analytical tests conducted for purposes of compliance 

with this subpart;

(5) Any analytical methods you use in lieu of the methods that are incorporated by reference 

in §§ 112.152 and 112.153; and 

(6) Documentation of actions you take in accordance with §§ 112.142(b) and (c), 112.146, 

and 112.148. 

Subpart N--Analytical Methods

§ 112.151 What methods must I use to test the quality of water to satisfy the requirements of § 

112.46? 

You must test the quality of water using:

(a) The method of analysis published by the U.S. Environmental Protection Agency (EPA), 

“Method 1603: Escherichia coli (E. coli) in Water by Membrane Filtration Using Modified 

membrane-Thermotolerant Escherichia coli Agar (Modified mTEC), EPA-821-R-09- 007),” 

December, 2009. The Director of the Federal Register approves this incorporation by 

reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy 

from EPA, Office of Water (4303T), 1200 Pennsylvania Avenue, NW., Washington, DC 

20460. You may inspect a copy at FDA’s Main Library, 10903 New Hampshire Ave., Bldg. 

2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and 

Records Administration (NARA). For information on the availability of this material at 

NARA, call 202- 741-6030, or go to: 

http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html; or

(b) (1) A scientifically valid method that is at least equivalent to the method of analysis in § 

112.151(a) in accuracy, precision, and sensitivity; or 

(2) For any other indicator of fecal contamination you may test for pursuant to § 112.49(a), a 

scientifically valid method.

§ 112.152 What methods must I use to test the growing, harvesting, packing, and holding 

environment for Listeria species or L. monocytogenes to satisfy the requirements of § 

112.144(a)? 

You must test the growing, harvesting, packing, and holding environment for Listeria species or L. 

monocytogenes using: 

(a) The method of analysis described in “Testing Methodology for Listeria species or L. 

monocytogenes in Environmental Samples,” Version 1, October 2015, U.S. Food and Drug 

Administration. The Director of the Federal Register approves this incorporation by 

reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 5. You may obtain a copy 

from, and/or inspect a copy at, the Division of Produce Safety, Center for Food Safety and 

Applied Nutrition (CFSAN), U.S. Food and Drug Administration, 5100 Paint Branch Pkwy., 

College Park, MD 20740, 240-402-1600; FDA’s Main Library, 10903 New Hampshire 

Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039; 
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http://www.fda.gov/fsma; or at the National Archives and Records Administration (NARA). 

For information on the availability of this material at NARA, call 202-741-6030, or go to: 

http://www.archives.gov/federal_register/code_of_federal_regulation/ibr_locations.html; or

(b) A scientifically valid method that is at least equivalent to the method of analysis in § 

112.152(a) in accuracy, precision, and sensitivity. 

§ 112.153 What methods must I use to test spent sprout irrigation water (or sprouts) from 

each production batch of sprouts for pathogens to satisfy the requirements of § 112.144(b) 

and (c)?

You must test spent sprout irrigation water (or sprouts) from each production batch for pathogens 

using: 

(a) For E. coli O157:H7, Salmonella species:

(1) The method of analysis described in “Testing Methodologies for E. coli O157:H7 and 

Salmonella species in Spent Sprout Irrigation Water (or Sprouts),” Version 1, October 

2015, U.S. Food and Drug Administration. The Director of the Federal Register 

approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 

part 5. You may obtain a copy from, and/or inspect a copy at, the Division of Produce 

Safety, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug 

Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1600; 

FDA’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 

MD 20993, 301-796-2039; http://www.fda.gov/fsma; or at the National Archives and 

Records Administration (NARA). For information on the availability of this material at 

NARA, call 202–741–6030, or go to: 

http://www.archives.gov/federal_register/code_of_federal_regulation/ibr_locations.html; 

or 

(2) A scientifically valid method that is at least equivalent to the method of analysis in § 

112.153(a)(1) in accuracy, precision, and sensitivity; and 

(b) For any other pathogen(s) meeting the criteria in § 112.144(c), a scientifically valid method. 

Subpart O--Records 

§ 112.161 What general requirements apply to records required under this part?

(a) Except as otherwise specified, all records required under this part must:

(1) Include, as applicable:

(i) The name and location of your farm; 

(ii) Actual values and observations obtained during monitoring; 

(iii) 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; 

(iv) The location of a growing area (for example, a specific field) or other area (for 

example, a specific packing shed) applicable to the record; and

(v) The date and time of the activity documented; 

(2) Be created at the time an activity is performed or observed;

(3) Be accurate, legible, and indelible; and

(4) Be dated, and signed or initialed by the person who performed the activity documented. 
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(b) Records required under §§ 112.7(b), 112.30(b)(2), 112.50(b)(2), 112.50(b)(4), 112.50(b)(6), 

112.60(b)(2), 112.140(b)(1), 112.140(b)(2), 112.150(b)(1), 112.150(b)(4), and

112.150(b)(6), must be reviewed, dated, and signed, within a reasonable time after the 

records are made, by a supervisor or responsible party.

§ 112.162 Where must I store records?

(a) Offsite storage of records is permitted if such records can be retrieved and provided onsite 

within 24 hours of request for official review.

(b) Electronic records are considered to be onsite at your farm if they are accessible from an 

onsite location at your farm.

§ 112.163 May I use existing records to satisfy the requirements of this part?

(a) Existing records (e.g., records that are kept to comply with other Federal, State, or local 

regulations, or for any other reason) do not need to be duplicated if they contain all of the 

required information and satisfy the requirements of this part. Existing records may be 

supplemented as necessary to include all of the required information and satisfy the 

requirements of this part.

(b) The information required by this part does not need to be kept in one set of records. If 

existing records contain some of the required information, any new information required by 

this part may be kept either separately or combined with the existing records.

§ 112.164 How long must I keep records?

(a) (1) You must keep records required by this part for at least 2 years past the date the record 

was created.

(2) Records that a farm relies on during the 3-year period preceding the applicable calendar 

year to satisfy the criteria for a qualified exemption, in accordance with §§ 112.5 and 

112.7, must be retained as long as necessary to support the farm’s status during the 

applicable calendar year.

(b) Records that relate to the general adequacy of the equipment or processes or records that 

relate to analyses, sampling, or action plans being used by a farm, including the results of 

scientific studies, tests, and evaluations, must be retained at the farm for at least 2 years after 

the use of such equipment or processes, or records related to analyses, sampling, or action 

plans, is discontinued.

§ 112.165 What formats are acceptable for the records I keep?

You must keep records as:

(a) Original records;

(b) True copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other 

accurate reproductions of the original records); or

(c) Electronic records. Records that are established or maintained to satisfy the requirements of 

this part and that meet the definition of electronic records in § 11.3(b)(6) of this chapter are 

exempt from the requirements of part 11 of this chapter. Records that satisfy the 

requirements of this part, but that also are required under other applicable statutory 

provisions or regulations, remain subject to part 11 of this chapter.
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§ 112.166 What requirements apply for making records available and accessible to FDA? 

(a) You must have all records required under this part readily available and accessible during 

the retention period for inspection and copying by FDA upon oral or written request, except 

that you have 24 hours to obtain records you keep offsite and make them available and 

accessible to FDA for inspection and copying.

(b) If you use electronic techniques to keep records, or to keep true copies of records, or if you 

use reduction techniques such as microfilm to keep true copies of records, you must provide 

the records to FDA in a format in which they are accessible and legible.

(c) If your farm is closed for a prolonged period, the records may be transferred to some other 

reasonably accessible location but must be returned to your farm within 24 hours for official 

review upon request. 

§ 112.167 Can records that I provide to FDA be disclosed to persons outside of FDA?

Records obtained by FDA in accordance with this part are subject to the disclosure requirements 

under part 20 of this chapter. 

Subpart P--Variances

§ 112.171 Who may request a variance from the requirements of this part? 

A State, Federally- recognized tribe (or “tribe”), or a foreign country from which food is imported 

into the United States may request a variance from one or more requirements of this part, where the 

State, tribe, or foreign country determines that:

(a) The variance is necessary in light of local growing conditions; and 

(b) 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 Federal Food, 

Drug, and Cosmetic Act and to provide the same level of public health protection as the 

requirements of this part.

§ 112.172 How may a State, tribe, or foreign country request a variance from one or more 

requirements of this part?

To request a variance from one or more requirements of this part, the competent authority (i.e., the 

regulatory authority for food safety) for a State, tribe, or a foreign country must submit a petition 

under § 10.30 of this chapter.

§ 112.173 What must be included in the Statement of Grounds in a petition requesting a 

variance? 

In addition to the requirements set forth in § 10.30 of this chapter, the Statement of Grounds in a 

petition requesting a variance must: 

(a) Provide a statement that the applicable State, tribe, or foreign country has determined that 

the variance is necessary in light of local growing conditions and 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 Federal Food, Drug and 

Cosmetic Act and to provide the same level of public health protection as the requirements 

of this part;
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(b) Describe with particularity the variance requested, including the persons to whom the 

variance would apply and the provision(s) of this part to which the variance would apply;

(c) 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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) 

and to provide the same level of public health protection as the requirements of this part.

§ 112.174 What information submitted in a petition requesting a variance or submitted in 

comments on such a petition are publicly available?

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 part 20 of this chapter 

and will be made public as part of the docket associated with this request.

§ 112.175 Who responds to a petition requesting a variance?

The Director or Deputy Directors of the Center for Food Safety and Applied Nutrition (CFSAN), or 

the Director, Office of Compliance, CFSAN, responds to a request for a variance.

§ 112.176 What process applies to a petition requesting a variance?

(a) In general, the procedures set forth in § 10.30 of this chapter govern our response to a 

petition requesting a variance.

(b) Under § 10.30(h)(3) of this chapter, we will publish a notice in the Federal Register, 

requesting information and views on a filed petition, including information and views from 

persons who could be affected by the variance if the petition were to be granted (e.g., 

because their farm is covered by the petition or as a person similarly situated to persons 

covered by the petition).

(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing and will also 

make public a notice on FDA’s Web site announcing our decision to either grant or deny the 

petition.

(1) If we grant the petition, either in whole or in part, we will specify the persons to whom 

the variance applies and the provision(s) of this part to which the variance applies.

(2) If we deny the petition (including partial denials), our written response to the petitioner 

and our public notice announcing our decision to deny the petition will explain the 

reason(s) for the denial.

(d) We will make readily accessible to the public, and periodically update, a list of filed 

petitions requesting variances, including the status of each petition (for example, pending, 

granted, or denied).

§ 112.177 Can an approved variance apply to any person other than those identified in the 

petition requesting that variance?

A State, tribe, or a foreign country that believes that a variance requested by a petition submitted by 

another State, tribe, or foreign country should also apply to similarly situated persons in its 

jurisdiction may request that the variance be applied to its similarly situated persons by submitting 

comments in accordance with § 10.30 of this chapter. These comments must include the 

information required in § 112.173. If FDA determines that these comments should instead be 
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treated as a separate request for a variance, FDA will notify the State, tribe, or foreign country that 

submitted these comments that a separate request must be submitted in accordance with §§ 112.172 

and 112.173.

(a) If we grant a petition requesting a variance, in whole or in part, we may specify that the 

variance also applies to persons in a specific location who are similarly situated to those 

identified in the petition.

(b) If we specify that the variance also applies to persons in a specific location who are similarly 

situated to those identified in the petition, we will inform the applicable State, tribe, or 

foreign country where the similarly situated persons are located of our decision in writing 

and will publish a notice on our Web site announcing our decision to apply the variance to 

similarly situated persons in that particular location.

§ 112.178 Under what circumstances may FDA deny a petition requesting a variance?

We may deny a variance request if it does not provide the information required under

§ 112.173 (including the requirements of § 10.30 of this chapter), or if we determine that the 

variance is not reasonably likely to ensure that the produce is not adulterated under section 402 of 

the Federal Food, Drug and Cosmetic Act and to provide the same level of public health protection 

as the requirements of this part.

§ 112.179 When does a variance approved by FDA become effective?

A variance approved by FDA becomes effective on the date of our written decision on the petition.

§ 112.180 Under what circumstances may FDA modify or revoke an approved variance?

We may modify or revoke a variance if we determine that such variance is not reasonably likely to 

ensure that the produce is not adulterated under section 402 of the Federal Food, Drug, and 

Cosmetic Act and to provide the same level of public health protection as the requirements of this 

part.

§ 112.181 What procedures apply if FDA determines that an approved variance should be 

modified or revoked?

(a) We will provide the following notifications:

(1) We will notify a State, tribe, or a foreign country directly, in writing at the address 

identified in its petition, if we determine that a variance granted in response to its 

petition should be modified or revoked. Our direct, written notification will provide the 

State, tribe, or foreign country with an opportunity to request an informal hearing under 

part 16 of this chapter.

(2) We will publish a notice of our determination that a variance should be modified or 

revoked in the Federal Register. This notice will establish a public docket so that 

interested parties may submit written comments on our determination.

(3) When applicable, we will:

(i) Notify in writing any States, tribes, or foreign countries where a variance applies to 

similarly situated persons of our determination that the variance should be modified 

or revoked;

(ii) Provide those States, tribes, or foreign countries with an opportunity to request an 

informal hearing under part 16 of this chapter; and
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(iii)Include in the Federal Register notice described in paragraph (a)(2) of this section 

public notification of our decision to modify or revoke the variance granted to States, 

tribes, or foreign countries in which similarly situated persons are located.

(b) We will consider submissions from affected States, tribes, or foreign countries and from 

other interested parties as follows:

(1) We will consider requests for hearings by affected States, tribes, or foreign countries 

under part 16 of this chapter. 

(i) If FDA grants a hearing, we will provide the State, tribe, or foreign country with an 

opportunity to make an oral submission. We will provide notice on our Web site of 

the hearing, including the time, date, and place of the hearing. 

(ii) If more than one State, tribe, or foreign country requests an informal hearing under 

part 16 of this chapter about our determination that a particular variance should be 

modified or revoked, we may consolidate such requests (for example, into a single 

hearing).

(2) We will consider written submissions submitted to the public docket from interested

parties.

(c) We will provide notice of our final decision as follows:

(1) On the basis of the administrative record, FDA will issue a written decision, as provided 

for under part 16 of this chapter. 

(2) We will publish a notice of our decision in the Federal Register. The effective date of 

the decision will be the date of publication of the notice.

§ 112.182 What are the permissible types of variances that may be granted? 

A variance(s) may be requested for one or more requirements in subparts A through O in this part. 

Examples of permissible types of variances include:

(a) Variance from the microbial quality criteria when agricultural water is used during growing 

activities for covered produce (other than sprouts) using a direct water application method, 

established in § 112.44(b); 

(b) Variance from the microbial die-off rate that is used to determine the time interval between 

last irrigation and harvest, and/or the accompanying maximum time interval, established in § 

112.45(b)(1)(i); and 

(c) Variance from the approach or frequency for testing water used for purposes that are subject 

to the requirements of § 112.44(b), established in § 112.46(b). 

Subpart Q--Compliance and Enforcement

§ 112.192 What is the applicability and status of this part? 

(a) The failure to comply with the requirements of this part, issued under section 419 of the 

Federal Food, Drug, and Cosmetic Act, is a prohibited act under section 301(vv) of the 

Federal Food, Drug, and Cosmetic Act. 

(b) The criteria and definitions in this part apply in determining whether a food is: 

(1) Adulterated within the meaning of: 

(i) Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that the food has 

been grown, harvested, packed, or held under such conditions that it is unfit for food; 

or 
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(ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that the food has 

been prepared, packed, or held under insanitary conditions whereby it may have 

become contaminated with filth, or whereby it may have been rendered injurious to 

health; or 

(2) In violation of section 361 of the Public Health Service Act (42 U.S.C. 264). 

§ 112.193 What are the provisions for coordination of education and enforcement? 

Under section 419(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act, FDA coordinates 

education and enforcement activities by State, territorial, tribal, and local officials by helping 

develop education, training, and enforcement approaches. 

Subpart R--Withdrawal of Qualified Exemption

§ 112.201 Under what circumstances can FDA withdraw a qualified exemption in accordance 

with the requirements of § 112.5? 

(a) We may withdraw your qualified exemption under § 112.5: 

(1) In the event of an active investigation of a foodborne illness outbreak that is directly 

linked to your farm; or

(2) If we determine that it is necessary to protect the public health and prevent or mitigate a 

foodborne illness outbreak based on conduct or conditions associated with your farm 

that are material to the safety of the food that would otherwise be covered produce 

grown, harvested, packed or held at your farm.

(b) Before FDA issues an order to withdraw your qualified exemption, FDA: 

(1) May consider one or more other actions to protect the public health and prevent or 

mitigate a foodborne illness outbreak, including a warning letter, recall, administrative 

detention, refusal of food offered for import, seizure, and injunction;

(2) Must notify the owner, operator, or agent in charge of the farm, in writing, of 

circumstances that may lead FDA to withdraw the exemption, and provide an 

opportunity for the owner, operator, or agent in charge of the farm to respond in writing, 

within 15 calendar days of the date of receipt of the notification, to FDA’s notification; 

and 

(3) Must consider the actions taken by the farm to address the circumstances that may lead 

FDA to withdraw the exemption. 

§ 112.202 What procedure will FDA use to withdraw an exemption? 

(a) An FDA District Director in whose district the farm is located (or, in the case of a foreign 

farm, the Director of the Office of Compliance in the Center for Food Safety and Applied 

Nutrition), or an FDA official senior to either such Director, must approve an order to 

withdraw the exemption before the order is issued.

(b) Any officer or qualified employee of FDA may issue an order to withdraw the exemption 

after it has been approved in accordance with paragraph (a) of this section. 

(c) FDA must issue an order to withdraw the exemption to the owner, operator, or agent in 

charge of the farm.

(d) FDA must issue an order to withdraw the exemption in writing, signed and dated by the 

officer or qualified employee of FDA who is issuing the order. 
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§ 112.203 What information must FDA include in an order to withdraw a qualified 

exemption?

An order to withdraw a qualified exemption applicable to a farm under § 112.5 must include the 

following information:

(a) The date of the order;

(b) The name, address and location of the farm;

(c) A brief, general statement of the reasons for the order, including information relevant to one 

or both of the following circumstances that leads FDA to issue the order:

(1) An active investigation of a foodborne illness outbreak that is directly linked to the farm; 

or

(2) Conduct or conditions associated with a farm that are material to the safety of the food 

that would otherwise be covered produce grown, harvested, packed and held at such

farm.

(d) A statement that the farm must either:

(1) Comply with subparts B through O of this part on the date that is 120 calendar days from 

the date of receipt of the order, or within a reasonable timeframe, agreed to by FDA, 

based on a written justification, submitted to FDA, for a timeframe that exceeds 120 

calendar days from the date of receipt of the order; or

(2) Appeal the order within 15 calendar days of the date of receipt of the order in 

accordance with the requirements of § 112.206.

(e) A statement that a farm may request that FDA reinstate an exemption that was withdrawn by 

following the procedures in § 112.213.

(f) The text of section 419(f) of the Federal Food, Drug, and Cosmetic Act and of this subpart;

(g) A statement that any informal hearing on an appeal of the order must be conducted as a 

regulatory hearing under part 16 of this chapter, with certain exceptions described in § 

112.208;

(h) The mailing address, telephone number, email address, and facsimile number of the FDA 

district office and the name of the FDA District Director in whose district the farm is located 

(or for foreign farms, the same information for the Director of the Office of Compliance in 

the Center for Food Safety and Applied Nutrition); and

(i) The name and the title of the FDA representative who approved the order.

§ 112.204 What must I do if I receive an order to withdraw a qualified exemption applicable 

to my farm?

The owner, operator, or agent in charge of a farm that receives an order to withdraw a qualified 

exemption applicable to that farm under § 112.5 must either:

(a) Comply with applicable requirements of this part within 120 calendar days of the date from 

receipt of the order or, if operations have ceased and will not resume within 120 calendar 

days, before the beginning of operations in the next growing season, or within a reasonable 

timeframe, agreed to by FDA, based on a written justification, submitted to FDA, for a 

timeframe that exceeds 120 calendar days from the date of receipt of the order; or

(b) Appeal the order within 15 calendar days of the date of receipt of the order in accordance 

with the requirements of § 112.206.
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§ 112.205 Can I appeal or request a hearing on an order to withdraw a qualified exemption 

applicable to my farm?

(a) Submission of an appeal, including submission of a request for an informal hearing, will not 

operate to delay or stay any administrative action, including enforcement action by FDA, 

unless the Commissioner of Food and Drugs, as a matter of discretion, determines that delay 

or a stay is in the public interest.

(b) If the owner, operator, or agent in charge of the farm appeals the order, and FDA confirms 

the order:

(1) The owner, operator, or agent in charge of the farm must comply with applicable 

requirements of this part within 120 calendar days from the date of receipt of the order, 

or, if operations have ceased and will not resume within 120 calendar days, before the 

beginning of operations in the next growing season, or within a reasonable timeframe, 

agreed to by FDA, based on a written justification, submitted to FDA, for a timeframe 

that exceeds 120 calendar days from the date of receipt of the order; and

(2) The owner, operator, or agent in charge of the farm is no longer subject to the modified 

requirements in §§ 112.6 and 112.7.

§ 112.206 What is the procedure for submitting an appeal?

(a) To appeal an order to withdraw a qualified exemption applicable to a farm under § 112.5, 

the owner, operator, or agent in charge of the farm must:

(1) Submit the appeal in writing to the FDA District Director in whose district the farm is 

located (or in the case of a foreign farm, the Director of the Office of Compliance in the 

Center for Food Safety and Applied Nutrition), at the mailing address, email address, or 

facsimile number identified in the order within 15 calendar days of the date of receipt of 

the order; and

(2) Respond with particularity to the facts and issues contained in the order, including any 

supporting documentation upon which the owner, operator or agent in charge of the farm 

relies.

(b) In a written appeal of the order withdrawing an exemption provided under § 112.5, the 

owner, operator, or agent in charge of the farm may include a written request for an informal 

hearing as provided in § 112.207.

§ 112.207 What is the procedure for requesting an informal hearing?

(a) If the owner, operator, or agent in charge of the farm appeals the order, the owner, operator, 

or agent in charge of the farm:

(1) May request an informal hearing; and

(2) Must submit any request for an informal hearing together with its written appeal 

submitted in accordance with § 112.206 within 15 calendar days of the date of receipt of 

the order.

(b) A request for an informal hearing may be denied, in whole or in part, if the presiding officer 

determines that no genuine and substantial issue of material fact has been raised by the

material submitted. If the presiding officer determines that a hearing is not justified, a 

written notice of the determination will be given to the owner, operator, or agent in charge 

of the farm explaining the reason for the denial.
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§ 112.208 What requirements are applicable to an informal hearing?

If the owner, operator, or agent in charge of the farm requests an informal hearing, and FDA grants 

the request:

(a) The hearing will be held within 15 calendar days after the date the appeal is filed or, if 

applicable, within a timeframe agreed upon in writing by the owner, operator, or agent in 

charge of the farm and FDA.

(b) The presiding officer may require that a hearing conducted under this subpart be completed 

within 1 calendar day, as appropriate.

(c) FDA must conduct the hearing in accordance with part 16 of this chapter, except that:

(1) The order withdrawing an exemption under § 112.5, rather than the notice under § 

16.22(a) of this chapter, provides notice of the opportunity for a hearing under this 

section and is part of the administrative record of the regulatory hearing under § 16.80(a) 

of this chapter.

(2) A request for a hearing under this subpart must be addressed to the FDA District 

Director (or, in the case of a foreign farm, the Director of the Office of Compliance in 

the Center for Food Safety and Applied Nutrition) as provided in the order withdrawing 

an exemption.

(3) Section 112.209, rather than § 16.42(a) of this chapter, describes the FDA employees 

who preside at hearings under this subpart.

(4) Section 16.60(e) and (f) of this chapter does not apply to a hearing under this subpart. 

The presiding officer must prepare a written report of the hearing. All written material 

presented at the hearing will be attached to the report. The presiding officer must 

include as part of the report of the hearing a finding on the credibility of witnesses (other 

than expert witnesses) whenever credibility is a material issue, and must include a 

proposed decision, with a statement of reasons. The hearing participant may review and 

comment on the presiding officer’s report within 2 calendar days of issuance of the 

report. The presiding officer will then issue the final decision.

(5) Section 16.80(a)(4) of this chapter does not apply to a regulatory hearing under this 

subpart. The presiding officer’s report of the hearing and any comments on the report by 

the hearing participant under § 112.208(c)(4) are part of the administrative record.

(6) No party shall have the right, under § 16.119 of this chapter to petition the 

Commissioner of Food and Drugs for reconsideration or a stay of the presiding officer’s 

final decision.

(7) If FDA grants a request for an informal hearing on an appeal of an order withdrawing an 

exemption, the hearing must be conducted as a regulatory hearing under a regulation in 

accordance with part 16 of this chapter, except that § 16.95(b) does not apply to a 

hearing under this subpart. With respect to a regulatory hearing under this subpart, the 

administrative record of the hearing specified in §§ 16.80(a)(1), (2), (3), and (5), and § 

112.208(c)(5) constitutes the exclusive record for the presiding officer’s final decision. 

For purposes of judicial review under § 10.45 of this chapter, the record of the 

administrative proceeding consists of the record of the hearing and the presiding 

officer’s final decision.

§ 112.209 Who is the presiding officer for an appeal and for an informal hearing?

The presiding officer for an appeal, and for an informal hearing, must be an FDA Regional Food 

and Drug Director or another FDA official senior to an FDA District Director.
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§ 112.210 What is the timeframe for issuing a decision on an appeal?

(a) If the owner, operator, or agent in charge of a farm appeals the order without requesting a 

hearing, the presiding officer must issue a written report that includes a final decision 

confirming or revoking the withdrawal by the 10th calendar day after the appeal is filed.

(b) If the owner, operator, or agent in charge of a farm appeals the order and requests an 

informal hearing:

(1) If FDA grants the request for a hearing and the hearing is held, the presiding officer 

must provide a 2 calendar day opportunity for the hearing participants to review and 

submit comments on the report of the hearing under § 112.208(c)(4), and must issue a 

final decision within 10 calendar days after the hearing is held; or

(2) If FDA denies the request for a hearing, the presiding officer must issue a final decision 

on the appeal confirming or revoking the withdrawal within 10 calendar days after the 

date the appeal is filed.

§ 112.211 When is an order to withdraw a qualified exemption applicable to a farm revoked?

An order to withdraw a qualified exemption applicable to a farm under § 112.5 is revoked

if:

(a) The owner, operator, or agent in charge of the farm appeals the order and requests an

informal hearing, FDA grants the request for an informal hearing, and the presiding officer 

does not confirm the order within the 10 calendar days after the hearing, or issues a decision 

revoking the order within that time; or

(b) The owner, operator, or agent in charge of the farm appeals the order and requests an 

informal hearing, FDA denies the request for an informal hearing, and FDA does not 

confirm the order within the 10 calendar days after the appeal is filed, or issues a decision 

revoking the order within that time; or

(c) The owner, operator, or agent in charge of the farm appeals the order without requesting an 

informal hearing, and FDA does not confirm the order within the 10 calendar days after the 

appeal is filed, or issues a decision revoking the order within that time.

(d) Confirmation of a withdrawal order by the presiding officer is considered a final Agency 

action for purposes of 5 U.S.C. 702.

§ 112.213 If my qualified exemption is withdrawn, under what circumstances would FDA 

reinstate my qualified exemption?

(a) If the FDA District Director in whose district your farm is located (or, in the case of a 

foreign farm, the Director of the Office of Compliance in the Center for Food Safety and 

Applied Nutrition) determines that the farm has adequately resolved any problems with the 

conduct and conditions that are material to the safety of the food produced or harvested at 

such farm, and that continued withdrawal of the exemption is not necessary to protect the 

public health or prevent or mitigate a foodborne illness outbreak, the FDA District Director 

in whose district your farm is located (or, in the case of a foreign farm, the Director of the 

Office of Compliance in the Center for Food Safety and Applied Nutrition) will, on his own 

initiative or at the request of a farm, reinstate the qualified exemption.

(b) You may ask FDA to reinstate a qualified exemption that has been withdrawn under the 

procedures of this subpart as follows:
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(1) Submit a request, in writing, to the FDA District Director in whose district your farm is 

located (or, in the case of a foreign farm, the Director of the Office of Compliance in the 

Center for Food Safety and Applied Nutrition); and

(2) Present, in writing, data and information to demonstrate that you have adequately 

resolved any problems with the conduct and conditions that are material to the safety of 

the food produced and harvested at your farm, such that continued withdrawal of the 

exemption is not necessary to protect the public health and prevent or mitigate a 

foodborne illness outbreak.

(c) If your qualified exemption was withdrawn under § 112.201(a)(1) and FDA later 

determines, after finishing the active investigation of a foodborne illness outbreak, that the 

outbreak is not directly linked to your farm, FDA will reinstate your qualified exemption 

under § 112.5, and FDA will notify you in writing that your exempt status has been 

reinstated.

(d) If your qualified exemption was withdrawn under § 112.201(a)(1) and (2) and FDA later 

determines, after finishing the active investigation of a foodborne illness outbreak, that the 

outbreak is not directly linked to your farm, FDA will inform you of this finding, and you 

may ask FDA to reinstate your qualified exemption under § 112.5, in accordance with the 

requirements of paragraph (b) of this section.
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APPENDIX II – REQUIRED RECORDS FOR THE PRODUCE SAFETY RULE

Subpart Section Description Required records 112.161(b) Review,

date, sign? 

A 112.2(b)(2) Processing 

Exemption - 

disclosure

Disclosure (“ 

not processed..) 

NO

A 112.2(b)(3) Processing 

exemption 

Written assurances NO

A 112.7(b) Qualified Exemption Records 

demonstrating 

criteria

YES, 

except 

signature

A 112.7(b) Qualified Exemption Written annual 

review/verification

YES

B 112.12(c) Alternatives Scientific data and 

information relied 

on 

NO

C 112.30(b)(2) Personnel Training Date, topic, persons 

trained

YES

E 112.50(b)(1) Water system 

inspection 

Inspection findings NO

E 112.50(b)(2) Ag water analyses Analysis reports YES

E 112.50(b)(3) Water treatment Scientific support of 

adequacy of method

NO

E 112.50(b)(4) Water treatment Monitoring records YES

E 112.50(b)(5) Time interval / 

removal rate

Scientific support NO

E 112.50(b)(6) Time interval / 

removal rate

Monitoring records YES
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E 112.50(b)(7) Public water system Annual certificate NO

E 112.50(b)(8) Alternatives Scientific support NO

E 112.50(b)(9) Water Analysis 

Method

Non-PSR analytical 

methods

NO

F 112.60(b)(1) Treated BSA from 3rd

party

Documentation that 

process is 

scientifically valid 

and monitored; and 

BSAOA was handled 

to minimize 

contamination

NO

F 112.60(b)(2) Treatment of BSA on 

farm

Process monitoring 

(time, temperature, 

turn)

YES

L 112.140(b)(2) Equipment cleaning 

and sanitize

Date and method of 

cleaning and 

sanitizing equipment 

used for harvest, 

pack, hold

YES
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APPENDIX III: DEPARTMENT OF LABOR- TITLE 29

29 CFR 1910 - Occupational Safety and Health Standards

1910 Subpart J – General Environmental Controls 

1910.141 - SANITATION

1910.141(a)

General --

1910.141(a)(1)

Scope. This section applies to permanent places of employment. 

1910.141(a)(2)

Definitions applicable to this section.

Nonwater carriage toilet facility, means a toilet facility not connected to a sewer. 

Number of employees, means unless otherwise specified, the maximum number of employees 

present at any one time on a regular shift.

Personal service room, means a room used for activities not directly connected with the 

production or service function performed by the establishment. Such activities include, but are 

not limited to, first-aid, medical services, dressing, showering, toilet use, washing, and eating. 

Potable water means water that meets the standards for drinking purposes of the State or local 

authority having jurisdiction, or water that meets the quality standards prescribed by the U.S. 

Environmental Protection Agency’s National Primary Drinking Water Regulations (40 CFR 

141). 

Toilet facility, means a fixture maintained within a toilet room for the purpose of defecation or 

urination, or both. 

Toilet room, means a room maintained within or on the premises of any place of employment, 

containing toilet facilities for use by employees.

Toxic material, means a material in concentration or amount which exceeds the applicable limit 

established by a standard, such as 1910.1000 and 1910.1001 or, in the absence of an applicable 

standard, which is of such toxicity so as to constitute a recognized hazard that is causing or is 

likely to cause death or serious physical harm. 
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Urinal, means a toilet facility maintained within a toilet room for the sole purpose of urination.

Water closet, means a toilet facility maintained within a toilet room for the purpose of both 

defecation and urination and which is flushed with water. 

Wet process, means any process or operation in a workroom which normally results in surfaces 

upon which employees may walk or stand becoming wet. 

1910.141(a)(3) 

Housekeeping. 

1910.141(a)(3)(i) 

All places of employment shall be kept clean to the extent that the nature of the work allows. 

1910.141(a)(3)(ii) 

The floor of every workroom shall be maintained, so far as practicable, in a dry condition. 

Where wet processes are used, drainage shall be maintained and false floors, platforms, mats, or 

other dry standing places shall be provided, where practicable, or appropriate waterproof 

footgear shall be provided. 

1910.141(a)(3)(iii) 

To facilitate cleaning, every floor, working place, and passageway shall be kept free from 

protruding nails, splinters, loose boards, and unnecessary holes and openings. 

1910.141(a)(4) 

Waste disposal.

1910.141(a)(4)(i) 

Any receptacle used for putrescible solid or liquid waste or refuse shall be so constructed that it 

does not leak and may be thoroughly cleaned and maintained in a sanitary condition. Such a 

receptacle shall be equipped with a solid tight-fitting cover, unless it can be maintained in a 

sanitary condition without a cover. This requirement does not prohibit the use of receptacles 

which are designed to permit the maintenance of a sanitary condition without regard to the 

aforementioned requirements.

1910.141(a)(4)(ii) 

All sweepings, solid or liquid wastes, refuse, and garbage shall be removed in such a manner as 

to avoid creating a menace to health and as often as necessary or appropriate to maintain the 

place of employment in a sanitary condition. 

1910.141(a)(5)

Vermin control. Every enclosed workplace shall be so constructed, equipped, and maintained, 

so far as reasonably practicable, as to prevent the entrance or harborage of rodents, insects, and 

other vermin. A continuing and effective extermination program shall be instituted where their 

presence is detected.

1910.141(b) 
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Water supply.

1910.141(b)(1)

Potable water.

1910.141(b)(1)(i)

Potable water shall be provided in all places of employment, for drinking, washing of the 

person, cooking, washing of foods, washing of cooking or eating utensils, washing of food 

preparation or processing premises, and personal service rooms.

1910.141(b)(1)(ii)

[Reserved]

1910.141(b)(1)(iii)

Portable drinking water dispensers shall be designed, constructed, and serviced so that sanitary 

conditions are maintained, shall be capable of being closed, and shall be equipped with a tap.

1910.141(b)(1)(iv)

[Reserved]

1910.141(b)(1)(v)

Open containers such as barrels, pails, or tanks for drinking water from which the water must be 

dipped or poured, whether or not they are fitted with a cover, are prohibited.

1910.141(b)(1)(vi)

A common drinking cup and other common utensils are prohibited.

1910.141(b)(2)

Nonpotable water.

1910.141(b)(2)(i)

Outlets for nonpotable water, such as water for industrial or firefighting purposes, shall be 

posted or otherwise marked in a manner that will indicate clearly that the water is unsafe and is 

not to be used for drinking, washing of the person, cooking, washing of food, washing of 

cooking or eating utensils, washing of food preparation or processing premises, or personal 

service rooms, or for washing clothes.

1910.141(b)(2)(ii)

Construction of nonpotable water systems or systems carrying any other nonpotable substance 

shall be such as to prevent backflow or backsiphonage into a potable water system.

1910.141(b)(2)(iii)

Nonpotable water shall not be used for washing any portion of the person, cooking or eating 

utensils, or clothing. Nonpotable water may be used for cleaning work premises, other than 

food processing and preparation premises and personal service rooms: Provided, That this 
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nonpotable water does not contain concentrations of chemicals, fecal coliform, or other 

substances which could create unsanitary conditions or be harmful to employees.

1910.141(c)

Toilet facilities.

1910.141(c)(1) 

General.

1910.141(c)(1)(i)

Except as otherwise indicated in this paragraph (c)(1)(i), toilet facilities, in toilet rooms separate 

for each sex, shall be provided in all places of employment in accordance with table J-1 of this 

section. The number of facilities to be provided for each sex shall be based on the number of 

employees of that sex for whom the facilities are furnished. Where toilet rooms will be 

occupied by no more than one person at a time, can be locked from the inside, and contain at 

least one water closet, separate toilet rooms for each sex need not be provided. Where such 

single-occupancy rooms have more than one toilet facility, only one such facility in each toilet 

room shall be counted for the purpose of table J-1. 

Number of employees Minimum number of water closets1

1 to 15 1

16 to 35 2

36 to 55 3

56 to 80 4

81 to 110 5

111 to 150 6

Over 150 (

2

)

1

Where toilet facilities will not be used by women, urinals may be provided instead of water closets, 

except that the number of water closets in such cases shall not be reduced to less than 2/3 of the 

minimum specified.

2

1 additional fixture for each additional 40 employees. 

1910.141(c)(1)(ii)

The requirements of paragraph (c)(1)(i) of this section do not apply to mobile crews or to 

normally unattended work locations so long as employees working at these locations have 

transportation immediately available to nearby toilet facilities which meet the other 

requirements of this subparagraph. 

1910.141(c)(1)(iii) 

The sewage disposal method shall not endanger the health of employees. 

1910.141(c)(2) 

Construction of toilet rooms.

1910.141(c)(2)(i) 
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Each water closet shall occupy a separate compartment with a door and walls or partitions 

between fixtures sufficiently high to assure privacy. 

1910.141(d)

Washing facilities.

1910.141(d)(1) 

General. Washing facilities shall be maintained in a sanitary condition.

1910.141(d)(2)

Lavatories.

1910.141(d)(2)(i)

Lavatories shall be made available in all places of employment. The requirements of this 

subdivision do not apply to mobile crews or to normally unattended work locations if employees 

working at these locations have transportation readily available to nearby washing facilities 

which meet the other requirements of this paragraph.

1910.141(d)(2)(ii)

Each lavatory shall be provided with hot and cold running water, or tepid running water.

1910.141(d)(2)(iii)

Hand soap or similar cleansing agents shall be provided. 

1910.141(d)(2)(iv)

Individual hand towels or sections thereof, of cloth or paper, air blowers or clean individual 

sections of continuous cloth toweling, convenient to the lavatories, shall be provided. 

1910.141(d)(3) 

Showers. 

1910.141(d)(3)(i) 

Whenever showers are required by a particular standard, the showers shall be provided in 

accordance with paragraphs (d)(3)(ii) through (v) of this section.

1910.141(d)(3)(ii) 

One shower shall be provided for each 10 employees of each sex, or numerical fraction thereof, 

who are required to shower during the same shift. 

1910.141(d)(3)(iii) 

Body soap or other appropriate cleansing agents convenient to the showers shall be provided as 

specified in paragraph (d)(2)(iii) of this section.

1910.141(d)(3)(iv) 

Showers shall be provided with hot and cold water feeding a common discharge line. 
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1910.141(d)(3)(v) 

Employees who use showers shall be provided with individual clean towels.

1910.141(e)

Change rooms. Whenever employees are required by a particular standard to wear protective 

clothing because of the possibility of contamination with toxic materials, change rooms 

equipped with storage facilities for street clothes and separate storage facilities for the protective 

clothing shall be provided. 

1910.141(f) 

Clothes drying facilities. Where working clothes are provided by the employer and become wet 

or are washed between shifts, provision shall be made to insure that such clothing is dry before 

reuse.

1910.141(g) 

Consumption of food and beverages on the premises. 

1910.141(g)(1) 

Application. This paragraph shall apply only where employees are permitted to consume food 

or beverages, or both, on the premises. 

1910.141(g)(2)

Eating and drinking areas. No employee shall be allowed to consume food or beverages in a 

toilet room nor in any area exposed to a toxic material. 

1910.141(g)(3) 

Waste disposal containers. Receptacles constructed of smooth, corrosion resistant, easily 

cleanable, or disposable materials, shall be provided and used for the disposal of waste food. 

The number, size, and location of such receptacles shall encourage their use and not result in 

overfilling. They shall be emptied not less frequently than once each working day, unless 

unused, and shall be maintained in a clean and sanitary condition. Receptacles shall be 

provided with a solid tight-fitting cover unless sanitary conditions can be maintained without 

use of a cover.

1910.141(g)(4) 

Sanitary storage. No food or beverages shall be stored in toilet rooms or in an area exposed to a 

toxic material.

1910.141(h) 

Food handling. All employee food service facilities and operations shall be carried out in 

accordance with sound hygienic principles. In all places of employment where all or part of the 

food service is provided, the food dispensed shall be wholesome, free from spoilage, and shall 

be processed, prepared, handled, and stored in such a manner as to be protected against 

contamination. 
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[39 FR 23502, June 27, 1974, as amended at 40 FR 18446, April 28, 1975; 40 FR 23073, May 

28, 1975; 43 FR 49748, Oct. 24, 1978; 63 FR 33450, June 18, 1998; 76 FR 33607, June 8, 

2011] 

1910 Subpart K – Medical and First Aid

1910.151 Medical Services and first aid 

1910.151(a)

The employer shall ensure the ready availability of medical personnel for advice and 

consultation on matters of plant health. 

1910.151(b)

In the absence of an infirmary, clinic, or hospital in near proximity to the workplace which is 

used for the treatment of all injured employees, a person or persons shall be adequately trained 

to render first aid. Adequate first aid supplies shall be readily available.

1910.151(c)

Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable 

facilities for quick drenching or flushing of the eyes and body shall be provided within the work 

area for immediate emergency use.

[63 FR 33450, June 18, 1998] 

Appendix A to Sec. 1910.151--First aid kits (Non-Mandatory)

First aid supplies are required to be readily available under paragraph § 1910.151(b). An example 

of the minimal contents of a generic first aid kit is described in American National Standard (ANSI) 

Z308.1-1998 “Minimum Requirements for Workplace First-aid Kits.” The contents of the kit listed 

in the ANSI standard should be adequate for small worksites. When larger operations or multiple 

operations are being conducted at the same location, employers should determine the need for 

additional first aid kits at the worksite, additional types of first aid equipment and supplies and 

additional quantities and types of supplies and equipment in the first aid kits.

In a similar fashion, employers who have unique or changing first-aid needs in their workplace may 

need to enhance their first-aid kits. The employer can use the OSHA 300 log, OSHA 301 log, or 

other reports to identify these unique problems. Consultation from the local fire/rescue department, 

appropriate medical professional, or local emergency room may be helpful to employers in these 

circumstances. By assessing the specific needs of their workplace, employers can ensure that 

reasonably anticipated supplies are available. Employers should assess the specific needs of their 

worksite periodically and augment the first aid kit appropriately.

If it is reasonably anticipated that employees will be exposed to blood or other potentially infectious 

materials while using first aid supplies, employers are required to provide appropriate personal 

protective equipment (PPE) in compliance with the provisions of the Occupational Exposure to 
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Blood borne Pathogens standard, § 1910.1030(d)(3) (56 FR 64175). This standard lists appropriate 

PPE for this type of exposure, such as gloves, gowns, face shields, masks, and eye protection. 

[63 FR 33450, June 18, 1998; 70 FR 1141, Jan. 5, 2005; 76 FR 80739, Dec. 27, 2011] 

29 CFR 1928 Occupational Safety and Health Standards for Agriculture 

1928 Subpart I – General Environmental Controls 

1928.110 – FIELD SANITATION

1928.110(a) 

Scope. This section shall apply to any agricultural establishment where eleven (11) or more 

employees are engaged on any given day in hand-labor operations in the field. 

1928.110(b)

Definitions.

Agricultural employer means any person, corporation, association, or other legal entity that: 

[i] Owns or operates an agricultural establishment;

[ii] Contracts with the owner or operator of an agricultural establishment in advance of 

production for the purchase of a crop and exercises substantial control over production; or 

[iii] Recruits and supervises employees or is responsible for the management an condition of an 

agricultural establishment.

Agricultural establishment is a business operation that uses paid employees in the production of 

food, fiber, or other materials such as seed, seedlings, plants, or parts of plants. 

Hand-labor operations means agricultural activities or agricultural operations performed by 

hand or with hand tools. Except for purposes of paragraph (c)(2)(iii) of this section, “hand labor 

operations” also include other activities or operations performed in conjunction with hand labor 

in the field. Some examples of “hand labor operations” are the hand-cultivation, hand-weeding, 

hand-planting and hand-harvesting of vegetables, nuts, fruits, seedlings or other crops, including 

mushrooms, and the hand packing of produce into containers, whether done on the ground, on a 

moving machine or in a temporary packing shed located in the field. “Hand-labor” does not 

include such activities as logging operations, the care or feeding of livestock, or hand-labor 

operations in permanent structures (e.g., canning facilities or packing houses). 

Handwashing facility means a facility providing either a basin, container, or outlet with an 

adequate supply of potable water, soap and single-use towels.

Potable water means water that meets the standards for drinking purposes of the State or local 

authority having jurisdiction, or water that meets the quality standards prescribed by the U.S. 
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Environmental Protection Agency’s National Primary Drinking Water Regulations (40 CFR part 

141). 

Toilet facility means a fixed or portable facility designed for the purpose of adequate collection 

and containment of the products of both defecation and urination which is applied with toilet 

paper adequate to employee needs. Toilet facility includes biological, chemical, flush and 

combustion toilets and sanitary privies.

1928.110(c) 

Requirements. Agricultural employers shall provide the following for employees engaged in 

hand-labor operations in the field, without cost to the employee: 

1928.110(c)(1) 

Potable drinking water.

1928.110(c)(1)(i) 

Potable water shall be provided and placed in locations readily accessible to all employees.

1928.110(c)(1)(ii) 

The water shall be suitably cool and in sufficient amounts, taking into account the air 

temperature, humidity and the nature of the work performed, to meet the needs of all employees. 

1928.110(c)(1)(iii) 

The water shall be dispensed in single-use drinking cups or by fountains. The use of common 

drinking cups or dippers is prohibited. 

1928.110(c)(2)

Toilet and handwashing facilities.

1928.110(c)(2)(i) 

One toilet facility and one handwashing facility shall be provided for each (20) employees or 

fraction thereof, except as stated in paragraph (c)(2)(v) of this section.

1928.110(c)(2)(ii) 

Toilet facilities shall be adequately ventilated, appropriately screened, have self-closing doors 

that can be closed and latched from the inside and shall be constructed to insure privacy. 

1928.110(c)(2)(iii) 

Toilet and handwashing facilities shall be accessibly located an in close proximity to each other. 

The facilities shall be located within a one-quarter-mile walk of each hand laborer’s place of 

work in the field.

1928.110(c)(2)(iv) 

Where due to terrain it is not feasible to locate facilities as required above, the facilities shall be 

located at the point closest vehicular access.

1928.110(c)(2)(v) 
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Toilet and handwashing facilities are not required for employees who perform field work for a 

period of three (3) hours or less (including transportation time to and from the field) during the 

day. 

1928.110(c)(3) 

Maintenance. Potable drinking water and toilet and handwashing facilities shall be maintained 

in accordance with appropriate public health sanitation practices, including the following: 

1928.110(c)(3)(i) 

Drinking water containers shall be constructed of materials that maintain water quality, shall be 

refilled daily or more often as necessary, shall be kept covered and shall be regularly cleaned.

1928.110(c)(3)(ii) 

Toilet facilities shall be operational and maintained in clean and sanitary condition.

1928.110(c)(3)(iii) 

Handwashing facilities shall be refilled with potable water as necessary to ensure an adequate 

supply and shall be maintained in a clean and sanitary condition; and 

1928.110(c)(3)(iv) 

Disposal of wastes from facilities shall not cause unsanitary conditions.

1928.110(c)(4)

Reasonable use. The employer shall notify each employee of the location of the sanitation 

facilities and water and shall allow each employee reasonable opportunities during the workday 

to use them. The employer also shall inform each employee of the importance of each of the 

following good hygiene practices to minimize exposure to the hazards in the field of heat, 

communicable diseases, retention of urine and agrichemical residues.

1928.110(c)(4)(i) 

Use the water and facilities provided for drinking, handwashing and elimination. 

1928.110(c)(4)(ii) 

Drink water frequently and especially on hot days; 

1928.110(c)(4)(iii) 

Urinate as frequently as necessary;

1928.110(c)(4)(iv) 

Wash hands both before and after using the toilet; and 

1928.110(c)(4)(v) 

Wash hands before eating and smoking. 

1928.110(d) 

Dates - 
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1928.110(d)(1)

Effective Date. This standard shall take effect on May 30, 1987.

1928.110(d)(2)

Startup Dates. Employers must comply with the requirements of paragraphs:

1928.110(d)(2)(i)

Paragraph (c)(1), to provide potable drinking water, by May 30, 1987;

1928.110(d)(2)(ii)

Paragraph (c)(2), to provide handwashing and toilet facilities, by July 30, 1987;

1928.110(d)(2)(iii)

Paragraph (c)(3), to provide maintenance for toilet and handwashing facilities, by July 30, 1987; 

and

1928.110(d)(2)(iv)

Paragraph (c)(4), to assure reasonable use, by July 30, 1987.

[52 FR 16095, May 1, 1987; 76 FR 33612, June 8, 2011]
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APPENDIX IV: FDA & INDUSTRY GUIDANCE DOCUMENTS

FDA Guidance Documents 

• Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables

(February 2008) 

• Reducing Microbial Food Safety Hazards For Sprouted Seeds (June 2019) 

• Sampling And Microbial Testing Of Spent Irrigation Water During Sprout Production

(October 1999) 

• Measures to Address the Risk for Contamination by Salmonella Species in Food Containing 

a Pistachio-Derived Product As An Ingredient (June 2009) 

• Measures to Address the Risk for Contamination by Salmonella Species in Food Containing 

a Peanut-Derived Product as an Ingredient (March 2009) 

FDA Draft Guidance Documents

• Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding 

of Produce for Human Consumption (October 2018) 

• Draft Guidance for Industry: Compliance with and Recommendations for Implementation of 

the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human 

Consumption for Sprout Operations (January 2017) 

Industry Guidance in Collaboration with FDA 

• Commodity Specific Food Safety Guidelines for the Production, Harvest, Storage, and 

Packing of Potatoes (June 2013) 

• Commodity-Specific Food Safety Guidelines for Cantaloupes and Netted Melons (March 

2013) 

• Commodity Specific Food Safety Guidelines for the Production, Harvest, Post-Harvest, and 

Processing Unit Operations of Fresh Culinary Herbs (January 2013) 

• Commodity Specific Food Safety Guidelines for the Production, Harvest, Post-Harvest, and 

Valued-Added Unit Operations of Green Onions (February 2010) 

• Commodity Specific Food Safety Guidelines for the Melon Supply Chain, 1st Edition

(November 2005)

• Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain, 3rd 

Edition (September 2018)

• Commodity Specific Food Safety Guidelines for the Lettuce and Leafy Greens Supply 

Chain, 1st Edition (April 2006) 
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APPENDIX V: REQUIRED COMMENTS FOR AUDIT REPORTS

Auditors are required to include comments in the audit report to give a clear understanding of what 

is observed at the time of the audit. All findings related to any question answered CAN or IAR

must be documented in the comment section of the checklist. Auditors may document observations 

associated with any question on the checklist regardless of whether it is a non-conformity to clarify 

why a question was answered compliant. Write a comment for each question answered N/A 

explaining the rationale for that answer. 

The following table is a minimum requirement to ensure that auditors provide uniform baseline 

information on the following requirements. Each audit is a unique situation. Auditors must include 

additional relevant information as it pertains to any of the requirements to increase the 

understanding of what is observed at the time of the audit. 

Req. # Complete comments are required. Address the following in your comments.

G-1.1

G-1.1.a

G-1.2 Include the name(s) of the individual(s) responsible for the Food Safety Plan with

their roles/responsibilities.

G-1.2.a

G-1.3

G-2.1 Include the date and/or version of the current Food Safety Plan being audited.

G-2.2 Include the date the Food Safety Plan was last reviewed. If Not Applicable is 

selected, include that the plan is less than a year old.

G-2.2.a

G-2.3 Include the date of current approved supplier list.

G-2.3.a

G-2.3.b

G-2.3.c

G-3.1

G-3.2

G-3.3 If Not Applicable is selected, include that the business or Food Safety Plan has 

been in operation for less than two years.

G-3.3.a

G-4.1 Include the title and topics covered by training and specify the records that show 

training is current as of the date of the audit.

G-4.2 Include training and/or certifications received which are applicable.

G-4.3

G-5.1 Include the name of the lab. If the lab is accredited, include the type of 

accreditation.

G-5.2

G-5.3 Include the type of testing required (e.g., soil, water, or Adenosine triphosphate 

(ATP) swabbing) and the testing method.

G-5.4 If thresholds are exceeded, state the operation’s threshold criteria, the test results, 

and what actions are taken based on the results.
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Req. # Complete comments are required. Address the following in your comments.

G-6.1

G-6.1.a

G-6.1.b

G-6.2 Include the date and product(s) of last traceback and trace-forward exercise, and 

the effectiveness of the reconciliation within the four hours or as required.

G-7.1 Include the date of the last actual recall or mock recall.

G-8.1

G-8.1.a

G-8.1.b Include there are no incidences to document if the auditee states this during the 

audit.

G-8.1.c Include the date of the annual review and the date of the actual incident or mock 

incident exercise.

G-8.2

G-9.1 Include the date and the role/title of the person who performed the annual selfaudit.

G-10.1

G-10.2

G-10.3

G-10.4

G-10.5 If operation is disposing of used toilet tissue in trash receptacles describe the 

reason and state mitigation measures taken to include monitoring and cleaning 

frequencies. 

G-10.6

G-10.7

G-10.8

G-10.9

G-10.10

G-10.11 Include if gloves are used, are optional, or not used. If gloves are used include the 

type of gloves and confirm the operation has a policy to sanitarily/safely use

gloves.

G-10.12

G-10.13

G-10.14

G-10.15

G-10.16

G-10.17

G-10.18 Include the drinking water source (i.e., municipal, bottled, well).

G-10.19

G-10.20

G-10.21

G-10.22

G-11.1

G-11.2
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Req. # Complete comments are required. Address the following in your comments.

G-12.1

G-12.2

G-12.3.a Include the date the food defense assessment was conducted.

G-12.3.b

G-13.1.a Include the date the food fraud assessment was conducted.

G-13.1.b

F-1.1 Include the date and the role/title of the person who conducted the last assessment.

F-1.1.a Include the date and the role/title of the person who conducted the last assessment.

F-1.1.b

F-1.2

F-1.3

F-2.a

F-2.1

F-2.1.a

F-2.1.b

F-2.1.c

F-2.1.d

F-2.2

F-2.3 Include the applicator and/or personnel name, license number and expiration date.

F-2.3.a

F-2.4 Include water source used for agricultural chemical sprays. If applicable, include 

mitigation methods.

F-2.4.a

F-2.5

F-2.5.a

F-3.1

F-3.2

F-3.3

F-4.1 Include the date and the role/title of the person who conducted the last assessment.

F-5.1

F-5.2 Include frequency of testing and threshold criteria for water test results.

F-5.3 Include the water test dates, water application method (i.e., drip, overhead, furrow) 

and source (i.e., well, surface, municipal). Include target organism and 

present/absent or quantified number from most recent water test results.

F-5.4 If water is treated, include treatment method, for chemical include chemical name 

with EPA Reg. No.

F-5.5 If post-harvest handling is used, include the die-off or removal rate, time interval, 

log reduction and dates relevant to these activities.

F-5.6

F-6.1 Include the date and the role/title of the person who conducted the last assessment.

F-6.2

F-6.3

F-7.1 Include the date and the role/title of the person who conducted the last assessment.
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Req. # Complete comments are required. Address the following in your comments.

F-7.2

F-8.1

F-8.2

F-8.2.a

F-8.2.b Include the recognized standards used for calibration.

F-8.2.c

F-8.3

F-8.4

F-8.5

F-8.6

F-8.7

F-9.1 Include the date and the role/title of the person who conducted the pre-harvest risk 

assessment.

F-10.1

F-10.2 Include the water source for harvest operation and the water’s test results.

F-10.3 Include the type of antimicrobial treatment used and the parameters of use (i.e., 

ranges of pH, ppm free chlorine).

F-10.4

F-10.5 If the commodity is susceptible to microbial infiltration, include the required 

temperature differential.

F-11.1

F-11.2

F-11.3

F-11.4

F-12.1

F-12.2 Include the type of growing method and if the product grown in contact with the 

ground (e.g., tomatoes staked or vine grown).

F-12.3

F-12.4 If used, include the type of cloth, towel, or other cleaning material and procedure 

for preventing cross contamination.

F-12.5

F-12.6

F-12.7

F-12.8.a

F-13.1

F-13.1.a

F-13.2

F-14.1

F-14.2

P-1.1

P-2.1

P-2.2

P-2.3
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Req. # Complete comments are required. Address the following in your comments.

P-3.1 Include the date and the role/title of the person who conducted the most recent 

hazard analysis.

P-3.1.a

P-3.2

P-3.3

P-3.4

P-3.5

P-3.6

P-4.1 Include who manages the pest/animal control program.

P-4.2

P-4.3

P-5.1

P-5.2

P-5.3

P-5.4 Include the instruments/equipment being calibrated, the method of calibration and 

the frequency of calibration.

P-5.4.a Include the recognized standards used for calibration.

P-5.5

P-5.5.a If metal detection equipment is used, include the frequency the equipment is being 

checked.

P-6.1

P-6.2

P-6.3

P-6.4

P-6.5

P-6.5.a

P-6.6

P-6.7

P-6.8

P-6.9

P-6.10

P-6.11

P-7.1

P-7.2 Include frequency of water delivery system assessment.

P-7.3 Include the water source for post-harvest operation and the water’s test results.

P-7.4 Include a description of the washing process identifying the type of wash system 

and type of sanitizer used for each product.

P-7.5 Include the frequency of microbial, physical, or chemical testing monitoring.

P-7.6

P-7.7

P-7.8 Include the type of antimicrobial treatment used and the concentration/critical 

limits.
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Req. # Complete comments are required. Address the following in your comments.

P-7.9 If the commodity is susceptible to microbial infiltration, include the required 

temperature differential.

P-7.10 Include the frequency of the re-used water change schedule for each commodity.

P-7.11

P-8.1

P-8.2

P-8.3

P-8.4

P-8.5

P-8.6

P-8.7

P-8.8

P-8.9

P-9.1

P-9.2

P-9.3

P-9.4

P-9.4.a

P-9.5

P-9.6

P-9.7 If temperature control is required, list the temperature range for each commodity.

P-9.8

P-9.9 Include the date last maintenance or cleaning was conducted on the cooling 

equipment.

P-10.1 If refrigerated transport temperature control is required, list the temperature range 

for each commodity.

P-10.2

P-10.3

P-10.4

P-10.5

P-10.6
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APPENDIX VI: REFERENCES USED FOR MANUAL DEVELOPMENT

AOAC International. (2015). Retrieved from: www.aoac.org

Cornell Good Agricultural Practices Program, (2000). Food Safety Begins on the Farm: A 

Grower’s Guide. Retrieved from: Educational Materials | National Good Agricultural Practices 

Program (cornell.edu)

Gombas, David E. Ph.D., (2013). Produce GAPs Harmonization: The Goal Is in Sight. Food 

Safety Magazine, June/July 2013, 58-66. 

Global Food Safety Initiative (GFSI). (2012). Assessors Guidelines. Global Markets Programme 

Primary Production Scope: Farming of Plants, Farming of Grains and Pulses. Retrieved from: 

https://mygfsi.com/

Oganisation for Economic Co-operation and Development (OECD). (2015). OECD Series on 

Principles of Good Laboratory Practice (GLP) and Compliance Monitoring. Retrieved from: 

OECD iLibrary | Compliance of Laboratory Suppliers with GLP Principles (oecd-ilibrary.org) 

Produce GAPs Harmonization Initiative. (2015). Auditor Training [Curriculum].

Produce Safety Alliance. (2015). Produce Safety Alliance: Train the Trainer [Curriculum].

The White House. (2004). Defense of United States Agriculture and Food (Homeland Security 

Presidential Directive/ HSPD-9). Washington, D.C.: George W. Bush. Retrieved from: Microsoft 

Word - For Immediate Release.doc (usda.gov)

United Fresh Produce Association. GAP Harmonization Initiative. Commodity Specific Food 

Safety Guidelines for the Fresh Tomato Supply Chain Tomato Guidelines, 3rd Edition Retrieved 

from: Product: Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain, 

Third Edition: United Fresh

United States Department of Agriculture. (2009). Good Agricultural Practices and Good Handling 

Practices Audit Verification Program Policy and Instructions. Revised HU-154. 

United States Department of Labor. (2011). 29 CFR 1910: Occupational Safety and Health 

Standards. Retrieved from: 1910 | Occupational Safety and Health Administration (osha.gov)

United States Department of Labor. (2011). 29 CFR 1928 Occupational Safety and Health 

Standards for Agriculture Part 110 Field Sanitation. Retrieved from: 1928.110 - Field Sanitation. | 

Occupational Safety and Health Administration (osha.gov)

United States Environmental Protection Agency. (2015). Summary of the Federal Insecticide, 

Fungicide, and Rodenticide Act. Retrieved from: Summary of the Federal Insecticide, Fungicide, 

and Rodenticide Act | Laws & Regulations | US EPA
SCI Division Inspection Series Program Manual: Harmonized GAP Audit Program 

Effective Date: July 2022 Page 420 of 422 

United States Environmental Protection Agency. (2015). Good Laboratory Practices Standards 

Compliance Monitoring Program. Retrieved from: Good Laboratory Practices Standards 

Compliance Monitoring Program | Compliance | US EPA

United States Environmental Protection Agency. (2015). Search Section 18 Actions [database]. 

Available at: Federal Insecticide, Fungicide, and Rodenticide Act Section 18 Database (epa.gov)

United States Food and Drug Administration. (1986). 21 CFR 110 Current Good Manufacturing 

Practice in Manufacturing, Packing, or Holding Human Food. Retrieved from: 21 CFR § 110.5 

Current good manufacturing practice - Code of Federal Regulations (ecfr.io) 

United States Food and Drug Agency. (1998). Bacteriological Analytical Manual (BAM). Retrieved 

from : Bacteriological Analytical Manual (BAM) | FDA 

United States Food and Drug Administration. (2004). Food Allergen Labeling and Consumer 

Protection Act of 2004 (Public Law 108-282, Title II). Retrieved from: Food Allergen Labeling and 

Consumer Protection Act of 2004 (FALCPA) | FDA

United States Food and Drug Administration. (2007). Guidance for Industry: Food Producers, 

Processors, and Transporters: Food Security Preventive Measures Guidance. Retrieved from: 

Guidance for Industry: Food Security Preventive Measures Guidance for Food Producers, 

Processors, and Transporters | FDA

United States Food and Drug Administration. (1998). Guidance for Industry: Guide to Minimize 

Microbial Food Safety Hazards for Fresh Fruits and Vegetables. College Park, MD: Food and Drug 

Administration. Retrieved from: Guidance for Industry: Guide to Minimize Microbial Food Safety 

Hazards for Fresh Fruits and Vegetables | FDA 

United States Food and Drug Administration. (1997). HACCP Principles & Application Guidelines. 

Retrieved from: HACCP Principles & Application Guidelines | FDA

United States Food and Drug Administration. (2014). Produce & Plant Products Guidance 

Documents & Regulatory Information: Guidance for Industry. Retrieved from: Produce & Plant 

Products Guidance Documents & Regulatory Information | FDA
SCI Division Inspection Series Program Manual: Harmonized GAP Audit Program 

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APPENDIX VII: SUMMARY OF REFERENCE LINKS IN PROGRAM MANUAL

21 CFR 58: 

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58

40 CFR 160: 

https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-160

40 CFR 792: 

https://www.ecfr.gov/current/title-40/chapter-I/subchapter-R/part-792

Bacteriological Analytical Manual (BAM):

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm200

6949.htm

AOAC International: 

https://www.aoac.org/

Emergency Exemption Database:

https://iaspub.epa.gov/apex/pesticides/f?p=124:2::::::

FDA Bioresearch Monitoring Information:

https://www.fda.gov/inspections-compliance-enforcement-and-criminalinvestigations/compliance-actions-and-activities/fda-bioresearch-monitoringinformation

FDA Food Allergies:

https://www.fda.gov/food/food-labeling-nutrition/food-allergies

Good Laboratory Practices Standards Compliance Monitoring Program: 

https://www.epa.gov/compliance/good-laboratory-practices-standardscompliance-monitoring-program

Mushroom Good Agricultural Practices Program Guidelines:

https://www.americanmushroom.org/clientuploads/Food 

_Safety/MGAP_All_Species_2016.pdf

Organization for Economic Co-operation and Development (OECD):

http://www.oecd.org/

Produce Safety Alliance General Resource Listing:

https://producesafetyalliance.cornell.edu/resources/general-resource-listing/

International Fresh Produce GAPs Harmonization Initiative website:

https://www.freshproduce.com/resources/food-safety/produce-gaps-harmonized-audit-standard/
SCI Division Inspection Series Program Manual: Harmonized GAP Audit Program 

Effective Date: July 2022 Page 422 of 422 

USDA GAP & GHP website:

https://www.ams.usda.gov/services/auditing/gap-ghp

Guidance on Environmental Monitoring and Control of Listeria for the Fresh Produce 

Industry:

https://www.freshproduce.com/siteassets/files/reports/food-safety/guidance-on-environmentalmonitoring-and-control-of-listeria.pdf