Manufactured Food

Regulatory Program Standards

U.S. Department of Health and Human Services

Food and Drug Administration

Office of Regulatory Affairs 

The collection of information has been approved by the Office of Management and Budget (OMB)

under the Paperwork Reduction Act of 1995. 

OMB Control No. 0910-0610 

Expiration Date: 09-30-2025
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Manufactured Food Regulatory Program Standards 3 September 2022

TABLE OF CONTENTS

TABLE OF CONTENTS............................................................................................................................ 3

INTRODUCTION ...................................................................................................................................... 5

BACKGROUND ........................................................................................................................................ 6

DEFINITIONS............................................................................................................................................ 7

STANDARD 1 Regulatory Foundation.................................................................................................... 11

STANDARD 2 Training Program ............................................................................................................ 13

STANDARD 3 Inspection Program ......................................................................................................... 19

STANDARD 4 Inspection Audit Program ............................................................................................... 25

STANDARD 5 Food-related Illness, Outbreak and Hazards Response................................................... 28

STANDARD 6 Compliance and Enforcement Program .......................................................................... 31

STANDARD 7 Industry and Community Relations ................................................................................ 33

STANDARD 8 Program Resources.......................................................................................................... 35

STANDARD 9 Program Assessment ....................................................................................................... 36

STANDARD 10 Laboratory Support ....................................................................................................... 38

Appendix 1.1: Self-Assessment Worksheet.............................................................................................. 41

Appendix 1.2: Regulatory Foundation Worksheet ................................................................................... 42

Appendix 2.1: Self-Assessment Worksheet.............................................................................................. 50

Appendix 2.2: Inspector Training Record Summary................................................................................ 54

Appendix 2.3: Inspector Training Record ................................................................................................ 55

Appendix 3.1: Self-Assessment Worksheet.............................................................................................. 60

Appendix 4.1: Self-Assessment Worksheet.............................................................................................. 65

Appendix 4.2: Instructions for Performance Ratings of Audit Findings.................................................. 68

Appendix 4.3: Field Inspection Audit Form............................................................................................. 69

Appendix 4.3a: Summary of Field Inspection Audit Findings................................................................. 77

Appendix 4.4: Inspection Report Audit Form .......................................................................................... 79

Appendix 4.4a: Summary of Inspection Report Audit Findings .............................................................. 82

Appendix 4.5: Sample Report Audit Form............................................................................................... 84

Appendix 4.5a: Summary of Sample Report Audit Findings................................................................... 88

Appendix 5.1: Self-Assessment Worksheet.............................................................................................. 90

Appendix 6.1: Self-Assessment Worksheet.............................................................................................. 93

Appendix 6.2: Calculation of the Level of Conformance to Compliance Procedures.............................. 94

Appendix 6.2a: Instructions for Performance Review of Enforcement Actions...................................... 96

Appendix 7.1: Self-Assessment Worksheet.............................................................................................. 97

Appendix 7.2: Outreach Activity Event and Self-Evaluation Worksheet ................................................ 98

Appendix 8.1: Self-Assessment Worksheet.............................................................................................. 99
Manufactured Food Regulatory Program Standards 4 September 2022

Appendix 8.2: Resource Summary Report ............................................................................................. 100

Appendix 8.2a: Resource Summary Report Instructions........................................................................ 101

Appendix 9.1: Self-Assessment Worksheet............................................................................................ 102

Appendix 9.2: Self-Assessment Summary Report.................................................................................. 105

Appendix 10.1: Self-Assessment Worksheet.......................................................................................... 107
Manufactured Food Regulatory Program Standards 5 September 2022

INTRODUCTION

The Food Safety Modernization Act (FSMA) mandates that the Food and Drug Administration (FDA) 

establish an Integrated Food Safety System (IFSS). An IFSS requires partnerships between federal, state, 

local, and tribal agencies to collaborate and leverage resources to ensure the protection of public health. 

The Manufactured Food Regulatory Program Standards (MFRPS) is a critical component in establishing 

the FDA’s IFSS. The MFRPS (henceforth also referred to as “program standards”) establishes a uniform 

foundation for regulatory agencies responsible for oversight of food manufacturing food firms. When 

fully implemented, the program standards define a set of best practices of a regulatory system. 

Conformance with the program standards requires a regulatory agency to continuously assess, evaluate, 

and take necessary corrective actions to address gaps. MFRPS conformance will facilitate a system of 

mutual reliance between the FDA and other regulatory agencies and support continued improvements in 

regulatory manufactured food programs throughout the nation. 

The program standards are comprised of ten standards that establish requirements for the critical 

elements of a regulatory program designed to protect the public from foodborne illness and injury. These 

elements include the program’s regulatory foundation, staff training, inspection, quality assurance, food 

defense preparedness and response, foodborne illness and incident investigation, enforcement, education 

and outreach, resource management, laboratory resources, and program assessment. Each standard 

contains a purpose statement, requirement summary, description of program elements, projected 

outcomes, and a list of required documentation. The program standards have corresponding selfassessment and supplemental worksheets designed to assist the regulatory program in achieving and 

sustaining conformance. 

The FDA will use the program standards as a tool to continuously improve manufactured food contracts 

and promote the development of a high-quality state manufactured food regulatory program which 

includes a process for continuous improvement based upon quality management systems. The program 

standards will assist both the FDA and the states in fulfilling their regulatory obligations. States will be 

expected to develop and implement improvement plans to demonstrate that they are moving toward full 

implementation and to participate in the FDA audits to determine level of conformance. States are 

encouraged to build sustainable systems including sustainability strategies and plans that will result in 

the standards being maintained in conformance. 

The goal of the MFRPS is to implement a nationally integrated, risk-based, food safety system focused 

on protecting public health. The program standards establish a uniform basis for measuring and 

improving the performance of prevention, intervention, and response activities of manufactured food 

regulatory programs in the United States. The development and implementation of these program 

standards will help federal and state programs better direct their regulatory activities toward reducing 

foodborne illness hazards in manufactured food firms. Consequently, the safety and security of the 

United States food supply will improve as greater focus is placed on prevention. 

The collection of information is approved by the Office of Management and Budget (OMB) under the 

Paperwork Reduction Act of 1995. The OMB control number is 0910-0601. 
Manufactured Food Regulatory Program Standards 6 September 2022

BACKGROUND

The food safety regulatory system in the United States is a tiered system that involves federal, state, and 

local governments. The FDA is responsible for ensuring that all foods moving in interstate commerce, 

except those under the United States Department of Agriculture (USDA) jurisdiction, are safe, 

wholesome, and labeled properly. State agencies conduct inspection and regulatory activities that help 

ensure food produced, processed, or sold within their jurisdictions is safe. Many state agencies also 

conduct manufactured food firm inspections under contract with the FDA. These inspections either are 

performed under the states’ laws and authorities or the provisions of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) or both. To maximize the use of resources among the FDA and the states, 

particularly when their jurisdictions overlap, their inspection programs should be equivalent in effect. 

In June 2000, the Department of Health and Human Services’ Office of the Inspector General (OIG) 

released a report of FDA’s oversight of state contracts. In this report, the OIG recommended that (FDA) 

take steps to promote “equivalency among Federal and State food safety standards, inspection programs, 

and enforcement practices.1

 In response to their findings, the FDA established a committee to develop a 

set of quality standards for manufactured food regulatory programs. The committee was comprised of 

officials from the FDA and state agencies responsible for regulating manufactured food firms.2 The 

result of the committee was the first edition of the program standards published by the FDA in 2007. 

In January 2011, FSMA gave the FDA authority to develop a framework to build the capacity of state 

and local regulatory agencies to support the IFSS model. In 2012, the FDA created the Standards 

Implementation Staff to give assistance, support and guidance to state programs enrolled in the MFRPS. 

Additionally, FDA helped establish the Manufactured Food Regulatory Program Standards (MFRPS) 

Alliance to create a network of state programs and assist with further development and revisions of the 

program standards. 

In December 2011, the OIG released “Vulnerabilities in FDA’s Oversight of State Food Facility 

Inspections”. In response, the FDA stated, “Collaboration with our state partners is critical to an 

integrated national food safety system and is also mandated under the FDA Food Safety Modernization 

Act (FSMA).3 Over the last decade, the FDA has worked to develop and implement the MFRPS which 

will strengthen states’ food safety programs. These program standards reflect an effort in which the FDA 

has been engaged in for many years of partnering, leveraging and empowering agencies to move the 

vision of a nationally integrated food safety system. 

1 Office of Inspector General, FDA Oversight of State Food Firm Inspections: OEI-01-98-00400 (Department of Health and 

Human Services, 2000), p. 5. 

2 A building or structure or facility or parts thereof, used for or in connection with the manufacturing, processing, packaging, 

or holding of human food as defined by 21 CFR Part 117.3.

3 Office of Inspector General, Vulnerabilities in FDA’s Oversight of State Food Facility Inspections: OEI-02-09-00430 

(Department of Health and Human Services, 2011), p. 34.
Manufactured Food Regulatory Program Standards 7 September 2022

DEFINITIONS

1. Assessment: means a systematic, independent, and documented process for obtaining objective 

evidence and evaluating it to determine the extent to which a requirement is met. The MFRPS 

assessments are conducted by the FDA at approximately 18, 36, and 60 months after enrollment. 

Assessments after 60 months will be conducted every two years. The FDA will determine 

IMPLEMENTATION during each assessment. The FDA will determine CONFORMANCE at 60 

months. The FDA may determine CONFORMANCE at 18 and 36 months when a standard is found 

to be fully implemented. 

2. Conformance or Conformity: means the fulfillment of a requirement, specifically a state

program is using and can demonstrate the use of a particular element, system, or program listed 

in the MFRPS.

3. Consumer Complaints: are complaints made by the public regarding food products, facility, 

practices, labeling, and any other related activities.

4. Contact Hour: an inspector qualifies for one contact hour of continuing education for each 

clock hour of participation. Contact hours for a specified presentation, course, or training activity 

will be recognized only one time within a three-year continuing education period. 

5. Correction: action to eliminate a detected non-CONFORMITY. 

6. Corrective Action(s): action to eliminate the cause of a non-CONFORMITY and to prevent 

recurrence.

7. Critical Violations: are violations which are directly linked to public health risk, food 

adulteration, and/or known contributors to foodborne illness unless otherwise defined by the 

state. 

8. Current and Fit-for-Use: “current” indicates that documentation is signed and dated in 

accordance with program policies and procedures that meet criteria in the most current standard. 

“Fit-for-use” is a quality term used to indicate that a product or service fits the customer’s 

defined purpose for that product or service. Documentation may be electronic or hard copy. 

9. Current Experienced Staff: defined by the state program in their training plan.

10. Document Control: document control ensures that documents are reviewed for adequacy, 

approved for release by authorized personnel and distributed to and used at the location where 

the prescribed activity is performed.

11. Environmental Assessment (Also called “Environmental Health Assessment”): means an 

on‐site food product investigation, conducted in conjunction with investigations (e.g., 

TRACEBACK) as needed to assess and rule out the potential that the contaminant of concern was 

introduced at a particular point in the distribution or production system. This is achieved by 

identifying contributing factors and environmental antecedents.

12. Equivalent: means that the state law directly references the relevant provision or regulation of 

the Federal Food, Drug, and Cosmetic Act (FD&C Act) or Title 21 Code of Federal Regulations 
Manufactured Food Regulatory Program Standards 8 September 2022

(CFR). The state program specifies the federal statute or regulation that is incorporated into the 

state law, including the revision date of the state statutory provision or regulation, the date the 

federal statutory provision or regulation was incorporated into the state law, and whether that 

statutory or regulatory provision is included in whole, in part, or modified from the original.

13. Equivalent in Effect: means that the state law has the same regulatory effect as the relevant 

FD&C Act provision or CFR regulation. A state law may have the same regulatory effect as the 

federal law or regulation if either a single state law or rule has the same regulatory effect as the 

federal law or regulation, or when multiple laws of that state are combined and deemed 

EQUIVALENT to a single federal law or regulation. In conducting a self-assessment, the state 

program may need to consult with its legal counsel when a provision is determined to be 

equivalent in effect. 

14. Evaluation: means an inspection in which the ability of an inspector is assessed to determine if 

they are competent to complete independent inspections. Evaluations are required for basic and 

each advanced (specialized) inspection type. The evaluation should assess an inspector’s ability 

to: 

• Prepare for an inspection

• Conduct an inspection 

• Follow procedures identified by the state for the specific type of inspection 

• Communicate during the inspection and on the inspection report; and 

• Assess advanced (specialized) inspection types (as applicable). 

Appendix 4.3 Field Inspection Audit Form, a modified version of the Conference for Food 

Protection Audit form, or an original form created by the state which evaluates the elements 

listed above may be used. It is recommended that new inspectors complete evaluations and 

independent inspections before entering the audit cycle. However, if states use the Appendix 4.3 

– Field Inspection Audit Form, the evaluations may be counted toward the total audits for that 

year.

15. Field Inspection Audit: means an inspection in which a state inspector is accompanied by a 

QUALIFIED FIELD INSPECTION AUDITOR (either the FDA or state) for the purpose of assessing the 

quality and performance of inspections either contract or state. These inspections may be counted 

under 2.3.2.3 and 2.3.3.2 Field Training as EVALUATIONS and also under 4.3.2 Field Inspection 

Audit if Appendix 4.3 is used. 

16. Food-Related Incident: means an unintentional or deliberate contamination, threatened or 

actual, of food that may occur at any point in the production system (e.g., pre‐harvest production, 

processing, distribution) and may cause food-related illness, injury, outbreaks and HAZARDS. 

Examples of food-related incidents include but are not limited to foodborne illness outbreaks and 

food tampering. 

17. Hazard: means any biological, chemical, or physical agent in food that is reasonably likely to 

cause illness or injury in the absence of its control.

18. Implementation: means a state program has a particular element, system, or program as 

required in the Program Elements and documentation requirements for MFRPS. 

19. Industry Complaints: are complaints made by industry about inspections or inspectors. 
Manufactured Food Regulatory Program Standards 9 September 2022

20. Joint Field Training Inspection: means an inspection conducted jointly by the FDA and/or 

state personnel for the purposes of training or enforcement. A joint inspection may be used to 

provide training to a state inspector during an inspection of a manufactured food firm and may 

either be trainer led or trainee led. 

21. Newly Hired Experienced Staff: staff with manufactured food regulatory experience received 

outside the manufactured food safety program to which they are currently employed.

22. No Authority: responsibility for enforcing a specific section of the federal statutes and/or 

regulations lies with another program or agency and not the state program. There is such a state 

law, but it does not apply to the state program.

23. Not Equivalent: means 1) there is no state law EQUIVALENT to the relevant federal law or 

regulation, or 2) the federal and state laws address the same matter but are inconsistent and do 

not have the same regulatory effect.

24. Outreach Activity Event: means an outreach activity which the state program hosts, co-hosts or 

is an invited presenter such as seminars, workshops, conferences, trainings, or meetings that 

relate to food protection topics and that support communication and information exchange 

among regulators, industry, academia, and consumer representatives.

25. Primary Servicing Laboratory: means any laboratory used by the state program for ongoing or 

routine testing. 

26. Qualified Date: begins when an inspector has completed all basic course and field elements and 

has been signed off to do independent inspections. This date is used to calculate the start of the 

continuing education hours in 2.3.5.

27. Qualified Field Inspection Auditor: means an individual who is recognized by the regulatory 

jurisdiction’s food safety program manager as having field experience and communication skills 

necessary to audit other inspectors/investigators and who has:

• Demonstrated the competency for basic food inspection auditing to the food safety 

program manager;

• Successfully completed advanced food inspection training coursework and field training 

in any areas where the auditor performs advanced auditing, such as low-acid canned 

foods, acidified foods, seafood HACCP, or juice inspections; 

• Been assigned this auditing responsibility; and

• Completed the required audit training per the state program requirements

28. Qualified Field Inspection Trainer: means an individual who is recognized by the regulatory 

jurisdiction’s food safety program manager as having field experience and communication skills 

necessary to train or supervise other inspectors/investigators and who has:

• Demonstrated the competency for basic food inspection training to the food safety 

program manager;

• Successfully completed advanced food inspection training coursework and field training 

in any areas where the trainer performs advanced training, such as low-acid canned 

foods, acidified foods, seafood HACCP, or juice inspections; and

• Been assigned this training responsibility.

• State program includes a definition of “qualified trainer” within their training plan.
Manufactured Food Regulatory Program Standards 10 September 2022

29. Recall Audit Checks: are conducted by the state agency to verify that the manufactured food 

firm’s recall was successful as defined by the state’s recall procedures. 

30. Regulatory Foundation: means laws, regulations, rules, ordinances, or other regulatory 

requirements that govern the operation of a manufactured food firm.

31. Sampling Program: means a program in which the state collects samples as part of their 

manufactured food program in one or more of the sampling types as defined in the Partnership 

for Food Protection’s (PFP) Food/Feed Testing Laboratories Best Practices Manual4 . The 

program can be based on state defined sampling frequency and does not have to be continuous or 

routine. 

32. Start Date: date an employee is hired or assigned to the manufactured food program as the 

beginning date for training timelines.

33. Strategic Improvement Plan: means a type of improvement plan that includes the following 

information: (1) the individual element or documentation requirement of the standard that was 

not met, (2) improvements needed to meet the program element or documentation requirement of 

the standard, (3) projected completion dates for each task, (4) personnel responsible, and (5) date 

completed.

34. Traceback: begins at the end of the supply chain at the point of purchase or point of service 

(e.g., grocery stores and restaurants) and follows the food product back through the points of 

distribution, processing, and production to determine the source of the product and its 

ingredients.

35. Traceforward: traceforward follows the movement of a food in the opposite direction, from the 

source (e.g., a farm or manufacturer) forward to the retail shelf, to determine the scope of a 

potential recall and the impact of the contaminated product on the public health.

36. Verification Audit Inspection: means an inspection in which a qualified FDA or state

QUALIFIED FIELD INSPECTION AUDITOR observes a state QUALIFIED FIELD INSPECTION AUDITOR

performing an audit of a state inspector conducting an inspection

4Reference: PFP Human and Animal Food Testing Laboratories Best Practices Manual: https://www.pfp-ifss.org/ifssresources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/
Standard 1

Manufactured Food Regulatory Program Standards 11 September 2022

STANDARD 1

Regulatory Foundation

1.1 Purpose

This standard describes the elements of the REGULATORY FOUNDATION used by a state program to 

regulate manufactured food firms. 

1.2 Requirement Summary

The state program evaluates the scope of its legal authority and regulatory provisions to ensure the 

protection of manufactured food within its jurisdiction. The state program’s evaluation includes a 

determination of how the state’s REGULATORY FOUNDATION corresponds to the U.S. FDA’s 

REGULATORY FOUNDATION.

1.3 Program Elements

1.3.1 Written Procedure for Evaluation of Legal Authority

The state program has a written procedure to evaluate the legal authority and regulatory 

provisions to inspect and investigate manufactured food firms, gather evidence, collect 

and analyze samples, and take enforcement actions. The written procedure must: 

1.3.1.1 Include timeframes for a regulatory foundation assessment.

1.3.1.2 Describe the regulatory foundation assessment process, to include whenever 

significant changes are made to applicable federal and/or state laws and 

regulations.

1.3.1.3 Address the statutes, regulations, rules, ordinances, and other prevailing 

regulatory requirements that: 

1.3.1.3.1 Apply to the regulation of manufactured food.

1.3.1.3.2 Delegate authority to the state program.

1.3.1.3.3 Describe the state program’s administrative procedures for 

rulemaking to protect public health.

1.3.1.3.4 Identifies and lists other state or federal agencies that have 

authority for any area of the REGULATORY FOUNDATION that the 

state program lacks.

1.3.2 Regulatory foundation Assessment 

The state program must complete Appendix 1.2 or equivalent form. The state program 

conducts a baseline self-assessment to determine if they are EQUIVALENT, EQUIVALENT IN 

EFFECT, NOT EQUIVALENT or have NO AUTHORITY to sections of the current Federal Food, 

Drug, and Cosmetic Act (FD&C Act) and Code of Federal Regulations (CFR) Title 21 

specified in Appendix 1.2.

Note: If the state program has laws and regulations pertinent to the regulation of 

manufactured food, for which there are no federal provisions, these laws and regulations 

can also be listed in Appendix 1.2 or equivalent form.
Standard 1

Manufactured Food Regulatory Program Standards 12 September 2022

Note: In conducting a self-assessment, the state program may need to consult with legal 

counsel when determining whether a provision is EQUIVALENT IN EFFECT.

1.4 Outcome

The state program has the legal authority and regulatory provisions to protect the public health by 

ensuring the safety and security of the manufactured food supply within its jurisdiction. For any part of 

the REGULATORY FOUNDATION that the state program lacks, the state program identifies another state or 

federal program with that regulatory authority to protect public health.

1.5 Documentation

The state program maintains the records listed here.

1.5.1 Written procedure for evaluation for legal authority.

1.5.2 State program’s written regulatory foundation assessment process.

1.5.3 The statutes, regulations, rules, ordinances, and other prevailing regulatory requirements 

that: (1) apply to the regulation of manufactured food, (2) delegate authority to the state 

agency, and (3) describe the state agency’s administrative procedures for rulemaking to 

protect public health.

1.5.4 Appendix 1.1 Self-Assessment Worksheet (or equivalent form).

1.5.5 Appendix 1.2 Regulatory Foundation Worksheet (or equivalent form).

1.5.6 If applicable, review by legal counsel.
Standard 2

Manufactured Food Regulatory Program Standards 13 September 2022

STANDARD 2

Training Program

2.1 Purpose

This standard defines the essential elements of a training program for inspectors.

2.2 Requirement Summary

The state program uses a written training plan that promotes development and demonstrates that all 

inspectors who will conduct manufactured food inspections complete course curriculums, field training, 

and continuing education to adequately perform their work. 

2.3 Program Elements

2.3.1 Training Plan and Training Records

2.3.1.1 The state program uses a written training plan that ensures all inspectors 

receive training required to adequately perform their work assignments. The 

training plan includes course curriculums which provides for basic and 

advanced food inspection training as well as continuing education. 

2.3.1.2 Appendix 2.2 or equivalent form must be used to document and summarize all 

training provided to inspectors.

2.3.1.3 The state program maintains a training history for active inspectors. The 

training history for all inactive inspectors must be kept for three years or per 

the state’s record retention policy. 

2.3.1.4 Appendix 2.3 or equivalent form must be used to document training for each 

inspector. 

2.3.1.5 The state training record summary and individual training records must include 

the inspector’s start date. Equivalent forms including electronic records may be 

used for required appendices.

2.3.2 Basic Food Inspection Training 

The state program requires that each inspector complete a basic food inspection training 

curriculum that consists of coursework and field training described here.

2.3.2.1 Timeframe

The basic food inspection training course curriculum shall be successfully 

completed within 24 months of the inspector’s START DATE with the 

manufactured food program.

2.3.2.2 Course Curriculum: 

The basic food inspection training consists of coursework in the subject areas 

listed in this section. 

2.3.2.2.1 Prevailing statutes, regulations, and ordinances
Standard 2

Manufactured Food Regulatory Program Standards 14 September 2022

2.3.2.2.2 Public health principles

2.3.2.2.3 Emergency management

2.3.2.2.4 Communications skills

2.3.2.2.5 Microbiology

2.3.2.2.6 Epidemiology 

2.3.2.2.7 Basics of HACCP

2.3.2.2.8 Allergen management

2.3.2.2.9 Basic food labeling

2.3.2.2.10 Food defense 

2.3.2.2.11 Sampling technique and preparation 

Note: States may further subdivide their basic training by identifying courses 

required for inspectors who only inspect non-high risk warehouses. These 

courses must be clearly defined in the state training plan. 

2.3.2.3 Field Training

2.3.2.3.1 Each inspector who will inspect general manufactured food firms 

must complete:

2.3.2.3.1.1 10 JOINT FIELD TRAINING INSPECTIONS, field 

inspection audits, or evaluations with a qualified 

field inspection trainer, and

2.3.2.3.1.2 Of the 10, two must be acceptable field inspection 

audits or evaluations by a qualified field inspection 

trainer or qualified field inspection auditor. 

2.3.2.3.2 Each inspector who will only inspect non-high risk food 

warehouses must complete: 

2.3.2.3.2.1 Five joint field training inspections, field inspection 

audits, or evaluations with a qualified field

inspection trainer, and

2.3.2.3.2.2 Of the five, two must be acceptable field inspection 

audits or evaluations by a qualified field inspection 

trainer or qualified field inspection auditor. 

2.3.2.3.3 Inspectors who meet 2.3.2.3.2 and advance to conduct general 

manufactured food firms must complete:

2.3.2.3.3.1 Five additional JOINT FIELD TRAINING INSPECTIONS,

FIELD INSPECTION AUDITS, or EVALUATIONS to fulfill 

requirements identified in 2.3.2.3.1, and 

2.3.2.3.3.2 Of the five, two must be acceptable field inspection 

audits or evaluations by a qualified field inspection 

trainer or qualified field inspection auditor.

2.3.2.3.4 JOINT FIELD TRAINING INSPECTIONS or FIELD INSPECTION 

AUDITS/EVALUATIONS are conducted in manufactured food firms 
Standard 2

Manufactured Food Regulatory Program Standards 15 September 2022

that are representative of the manufactured food firms to be 

inspected by the inspector. Each inspector will complete the 

minimum field training requirements prior to conducting 

independent inspections. 

2.3.3 Advanced Food Inspection Training

The state program requires each inspector who will conduct specialized food inspections 

to complete an advanced inspection training curriculum which consists of relevant 

coursework and field training as described here.

2.3.3.1 Coursework

The state program requires each inspector who will perform specialized food 

inspections to successfully complete the coursework specific to the type of 

specialized food inspections they will be performing. Specialized food 

inspection courses include, but are not limited to:

2.3.3.1.1 Acidified foods

2.3.3.1.2 Low-acid canned foods

2.3.3.1.3 Juice HACCP

2.3.3.1.4 Seafood HACCP

2.3.3.1.5 Traceback Investigations5

2.3.3.1.6 Foodborne Illness Investigations5

2.3.3.1.7 Preventive Controls for Human Food

2.3.3.2 Field Training 

The state program requires that each inspector successfully complete each of 

the following before performing independent specialized food inspections. 

2.3.3.2.1 Participate in two joint field training inspections.

2.3.3.2.2 After successful completion of the course participate in one 

EVALUATION or FIELD INSPECTION AUDIT that is found to be 

acceptable by a QUALIFIED FIELD INSPECTION TRAINER or

QUALIFIED FIELD INSPECTION AUDITOR prior to conducting 

independent inspections.

2.3.3.2.3 Within one year after being released to do specialized food 

inspections complete a second EVALUATION or FIELD INSPECTION 

AUDIT that is found to be acceptable by a QUALIFIED FIELD 

INSPECTION TRAINER or QUALIFIED FIELD INSPECTION AUDITOR in 

the area of specialty. 

2.3.4 Experienced Inspectors 

The criterion for conducting a minimum of 10 JOINT FIELD TRAINING INSPECTIONS and 

required coursework is intended for new employees or employees new to the food safety 

5 These advanced food inspection training courses are not subject to 2.3.3.2 Field Training requirements.
Standard 2 

Manufactured Food Regulatory Program Standards 16 September 2022

program. For CURRENT EXPERIENCED STAFF or NEWLY HIRED EXPERIENCED STAFF, a state

program’s training plan shall include the following unless the state determines in their 

training plan that all staff will be required to complete the program elements in 2.3.2 and 

2.3.3:

2.3.4.1 Current Experienced Staff

Missing Record Documentation in Employee Training 

File

2.3.4.1.1 JOINT FIELD 

TRAINING 

INSPECTIONS

Statement or affidavit explaining the 

background or experience that justifies a 

waiver of the basic or specialized JOINT 

FIELD TRAINING INSPECTIONS.

2.3.4.1.2 Basic food 

inspections 

course work 

Document training records available. 

Create a statement or affidavit explaining 

the background or experience that 

justifies a waiver of the missing basic 

food inspection course work.

2.3.4.1.3 Specialized food 

inspection course 

work certificates

Statement or affidavit explaining the date 

and location that they have successfully 

completed the specialized food inspection 

training course work. 

2.3.4.2 Newly Hired Experienced Staff

Missing Record Documentation in Employee Training 

File

2.3.4.2.1 JOINT FIELD 

TRAINING 

INSPECTIONS

Statement or affidavit explaining the 

background or experience that justifies a 

waiver of some or all of the basic or 

specialized JOINT FIELD TRAINING 

INSPECTIONS. Conduct two successful 

EVALUATIONS or FIELD INSPECTION 

AUDITS within 6 months of the 

inspector’s QUALIFIED DATE.

2.3.4.2.2 Basic food 

inspection 

training course 

work 

Document training records available. 

Statement or affidavit explaining the 

background or experience that justifies a 

waiver of the basic food inspection 

course work.

2.3.4.2.3 Specialized food 

inspection course 

work certificates

Statement or affidavit explaining the date 

and location that they have successfully 

completed the specialized food inspection 

training course work. 

2.3.5 Continuing Education 

Within the scope of this standard, the goal of continuing education and training is to 

enhance the inspector’s knowledge, skills, and ability to perform manufactured food 
Standard 2

Manufactured Food Regulatory Program Standards 17 September 2022

inspections. The objective is to build upon the inspector’s knowledge base.

2.3.5.1 Each inspector must accumulate 20 contact hours of continuing education in 

food safety every 36 months. 

2.3.5.2 The 36-month continuing education interval starts at the qualified date, when 

the basic training cycle is completed. 

2.3.5.3 The program may establish an alternate timeframe to track continuing 

education as long as the alternate timeframe and how that timeframe still meets 

or exceeds the intent of the standard (at least 20 contact hours every 36 

months) are clearly identified in program procedures. 

2.3.5.4 The inspector qualifies for contact hours for participation in any of the 

following activities that are related specifically to manufactured food safety or 

manufactured food inspectional work:

2.3.5.4.1 Attendance at national or regional seminars / technical 

conferences.

2.3.5.4.2 Professional symposiums / college courses.

2.3.5.4.3 Food-related training provided by government agencies (e.g., 

USDA, state, local).

2.3.5.4.4 Food safety related conferences and workshops.

2.3.5.4.5 Distance learning opportunities that pertain to food safety.

2.3.5.4.6 Training approved by a qualified field inspection trainer.

2.3.5.5 Of the accumulated 20 contact hours of continuing education, a maximum of 

ten (10) contact hours may be accrued from the following activities:

2.3.5.5.1 Delivering presentations at professional conferences.

2.3.5.5.2 Providing classroom and/or field training to newly hired 

inspectors, or being a course instructor in food safety.

2.3.5.5.3 Publishing an original article in a peer-reviewed professional or 

trade association journal/periodical. 

2.3.5.6 Of the accumulated 20 contact hours of continuing education, a maximum of 

four (4) contact hours may be accrued for reading technical publications 

related to manufactured food safety.

2.3.5.7 Documentation must accompany each activity submitted for continuing 

education credit. Examples of acceptable documentation may include: 

2.3.5.7.1 Certificates of completion indicating the course date(s) and number 

of hours attended or CE credits granted.

2.3.5.7.2 Transcripts from a college or university.

2.3.5.7.3 A letter from the administrator of the continuing education 

program attended.

2.3.5.7.4 A copy of the peer-reviewed article or presentation made at a 

professional conference; or documentation to verify technical 
Standard 2

Manufactured Food Regulatory Program Standards 18 September 2022

publications related to food safety have been read including 

completion of self-assessment quizzes that accompany journal 

articles, written summaries of key points/findings presented in 

technical publications, and/or written book reports.

2.3.5.7.5 An agenda and attendance roster.

2.3.5.7.6 Documentation approved by the qualified field inspection trainer.

2.3.6 Coursework Sources

Basic, advanced, and continuing education coursework must be obtained from one of the 

sources listed here: 

2.3.6.1 Training provided by a government agency (including in-house training).

2.3.6.2 Distance learning, for example, satellite downlinks or web-based training.6

2.3.6.3 Colleges, schools, research centers, and institutes.

2.3.6.4 Food safety alliances recognized by FDA.

2.4 Outcome 

The state program has trained inspectors with the knowledge, skills, and abilities to competently inspect, 

conduct investigations, gather evidence, collect samples, and take enforcement actions with 

manufactured food firms. 

2.5 Documentation 

The state program maintains the records listed here.

2.5.1 Appendix 2.1 Self-Assessment Worksheet (or equivalent form). 

2.5.2 Appendix 2.2 State Training Record Summary (or equivalent form). 

2.5.3 Appendix 2.3 Individual Training Record (or equivalent form). 

2.5.4 Documents verifying successful completion of required courses.

2.5.5 Course description or agendas for non-FDA courses.

2.5.6 Signed statements for experienced inspectors.

2.5.7 Evaluations or field inspection audits.

2.5.8 Documentation for continuing education credit.

2.5.9 Written Training Plan.

6 FDA/ORA Office of Education Training and Development courses (classroom and online) are listed at: 

https://www.fda.gov/training-and-continuing-education/office-training-education-and-development-oted.
Standard 3

Manufactured Food Regulatory Program Standards 19 September 2022

STANDARD 3

Inspection Program

3.1 Purpose

This standard describes the elements of an effective inspection program for manufactured food firms.

3.2 Requirement Summary

The state program has a manufactured food inspection system. This system provides the foundation for 

inspecting manufactured food firms to determine compliance with the laws administered by federal, 

state, and local governments. In addition, the state program has: (1) a risk-based inspection program, (2) 

an inspection procedure, (3) an inspection report procedure, (4) a system to respond to CONSUMER 

COMPLAINTS, (5) a system to resolve INDUSTRY COMPLAINTS about inspections, (6) a recall system, and 

(7) a sampling procedure.

3.3 Program Elements

3.3.1 Risk-based Inspection Program

The state program has an inventory of manufactured food firms for which the state has 

regulatory oversight. The inventory is categorized by the risk associated with the 

likelihood that a FOOD-RELATED INCIDENT will occur. 

3.3.1.1 Inspections are prioritized and frequencies assigned based on established risk 

categories. The state program has a written procedure documenting their 

classification criteria and inspection frequencies.

3.3.1.2 The state program must use the risk factors and classification criteria as 

described in:

3.3.1.2.1 FD&C Act, section 421(a)(1), or

3.3.1.2.2 Develop its own risk factor and classification criteria. If the state 

chooses to develop its own risk factor and classification criteria a 

written rationale must be provided that demonstrates how public 

health is protected.

3.3.2 Inspection Procedure 

The state program has a written procedure for inspecting manufactured food firms that 

requires the inspectors to:

3.3.2.1 Review the previous inspection report and consumer complaints.

3.3.2.2 Have appropriate equipment and forms (if necessary). Equipment must be 

verified and maintained as defined by the state’s standard operating procedures 

or manufacturer’s recommendations.

3.3.2.3 Make appropriate introductions and explain the purpose and scope of the 

inspection.

3.3.2.4 Establish jurisdiction.
Standard 3

Manufactured Food Regulatory Program Standards 20 September 2022

3.3.2.5 Select an appropriate product for the inspection and, if necessary, make 

appropriate adjustments based on what the manufactured food firm is 

producing.

3.3.2.6 Assess employee practices critical to the safe and sanitary production and 

storage of food.

3.3.2.7 Properly evaluate the likelihood that conditions, practices, components, and/or 

labeling could cause the product to be adulterated, misbranded or otherwise in 

violation of applicable law.

3.3.2.8 Recognize significant violative conditions or practices, if present, and record 

findings consistent with state program procedures.

3.3.2.9 Distinguish between significant and insignificant observations and isolated 

incidents versus trends.

3.3.2.10 Review and evaluate the appropriate records and procedures for the 

manufactured food firm operation and effectively apply the information 

obtained from this review (during the inspection).

3.3.2.11 Collect adequate evidence and documentation to support inspection 

observations in accordance with state program procedures.

3.3.2.12 Verify correction of deficiencies identified during the previous inspection.

3.3.2.13 Behave professionally and demonstrate proper sanitary practices during the 

inspection.

3.3.2.14 Properly evaluate good manufacturing practice requirements (21 CFR 117, 

Subparts A, B, and F (for training records only) or equivalent state regulation).

3.3.2.15 When appropriate, verify the manufactured food firm has a written food safety 

plan which includes a written hazard analysis that appropriately addresses 

hazards, and when appropriate, addresses preventive controls (process controls, 

allergen controls, sanitation controls, supply-chain controls, other controls) and 

a recall plan.

3.3.2.16 When appropriate, review the manufactured food firm’s written procedures, 

monitoring, verification, correction, and corrective action records for process, 

allergen, sanitation, supply-chain controls, and other controls which are 

identified in their food safety plan.

3.3.2.17 When appropriate, verify the manufactured food firm is in compliance with the 

modified requirements that apply to a qualified facility (attestation).

3.3.2.18 When appropriate, verify the modified requirements and time/temperature 

controls that apply to a facility solely engaged in the storage of unexposed 

packaged foods that require refrigeration for safety.
Standard 3

Manufactured Food Regulatory Program Standards 21 September 2022

3.3.2.19 When appropriate, assess the sanitary transportation of human food 

requirements that apply to transportation operations.

3.3.2.20 When appropriate, review the manufactured food firm’s food defense plan, 

including mitigation strategies, monitoring, corrective action, and verification 

activities.

3.3.2.21 Use current versions of applicable hazard guides or other guidance, to identify 

and evaluate the hazards associated with product(s) and process(es) when 

conducting inspections of specialized food and processes. 

3.3.2.22 Assess the manufactured food firm’s implementation of sanitation monitoring 

for the applicable eight key areas of sanitation when required by regulation.

3.3.2.23 When appropriate, review the manufactured food firm’s; scheduled process; 

HACCP plan or necessary process controls in the absence of a HACCP plan; 

food safety control plan and applicable monitoring, verification and deviation 

or corrective action records, including those related to sanitation.

3.3.2.24 Recognize deficiencies in the manufactured food firm’s monitoring controls 

and sanitation procedures through in manufactured food firm observations.

3.3.2.25 Use suitable interviewing techniques.

3.3.2.26 Explain findings clearly and adequately throughout the inspection.

3.3.2.27 Alert the manufactured food firm’s person in charge when an immediate 

corrective action is necessary.

3.3.2.28 Answer questions and provide information in an appropriate manner.

3.3.2.29 Write findings accurately, clearly, and concisely on the state document and 

provide a copy to the manufactured food firm’s person in charge.

3.3.3 Inspection Report 

The state program has a written inspection report procedure that requires inspectors to:

3.3.3.1 Submit the inspection report within designated timeframes.

3.3.3.2 Complete the inspection report form completely and accurately.

3.3.3.3 Document violations and observations clearly, legibly, and concisely.

3.3.3.4 Follow-up with corrective action, compliance, and enforcement.

3.3.4 Food Recalls7

7Reference: PFP Best Practices for Improving FDA and State Communication During Recalls (version 2) can be found: 

https://www.pfp-ifss.org/ifss-resources/best-practices-for-improving-fda-and-state-communications-during-recalls-fall-2021/.
Standard 3

Manufactured Food Regulatory Program Standards 22 September 2022

The state program has a food recall system with written recall procedures for:

3.3.4.1 Sharing information about recalls with relevant agencies.

3.3.4.2 Ensuring recalled products are removed promptly from the market.

3.3.4.3 Performing recall audit checks.

3.3.5 Consumer complaints

The state program has a system for handling CONSUMER COMPLAINTS that contains written 

procedures for:

3.3.5.1 Receiving.

3.3.5.2 Tracking.

3.3.5.3 Evaluating.

3.3.5.4 Responding.

3.3.5.5 Closing.

3.3.6 Complaints Resulting from State Program Inspection Activities 

The state program has a system for handling INDUSTRY COMPLAINTS about inspections that

contains written procedures for:

3.3.6.1 Receiving.

3.3.6.2 Evaluating.

3.3.6.3 Responding.

3.3.7 Sampling Procedure4

The state program has a written sampling procedure to ensure its SAMPLING PROGRAM is 

carried out in a manner that is consistent with state procedure. The sampling procedures 

must be reflective of the types of food and samples that the state collects and must include:

3.3.7.1 Procedures that require sample collectors to:

3.3.7.1.1 Use the appropriate method and equipment to collect the sample.

3.3.7.1.2 Record sample chain of custody per state procedure.

3.3.7.1.3 Handle, package, and ship sample using procedures appropriate to 

prevent compromising condition of the sample and ensuring 

security of the sample. 

3.3.7.1.4 Deliver or ship sample to the appropriate laboratory program 

within prescribed timeframes.

3.3.7.2 Instructions for documenting the sample collection must include the following 

elements, when applicable, to the state’s sampling program: 

3.3.7.2.1 Date of Sample Collection.

3.3.7.2.2 Product Identification Including:
Standard 3

Manufactured Food Regulatory Program Standards 23 September 2022

3.3.7.2.2.1 Name of Product

3.3.7.2.2.2 Unique Manufacturing Identification references

3.3.7.2.3 Description of the product.

3.3.7.2.4 Collection information including:

3.3.7.2.4.1 Method of Collection

3.3.7.2.4.2 Lot Sampled

3.3.7.2.4.3 Lot Size

3.3.7.2.5 Location where sample was collected.

3.3.7.2.6 Name and address of responsible party, guarantor, possessor, or 

distributor.

3.3.7.2.7 Sample type.

3.3.7.2.8 Analysis requested if applicable.

3.3.7.2.9 Product labels or specific labeling information that is collected or 

reproduced per state policies. 

3.3.7.2.10 Identification of the sample with the sample number assigned by 

the sampler at the time of collection. 

3.3.7.3 State programs are not required to have a written sampling procedure unless 

they collect samples. However, these programs must have a statement in lieu 

of sampling procedures that explains why a sampling program is not supported 

and how the public health is protected in the absence of such a program. An 

example may include: stating that public health is protected because another 

state or federal agency collects samples and fulfills this need. The statement 

should include the name of the agency and the type of samples that it collects. 

3.3.8 Records Retention 

The state program must maintain records as required under Section 9.3.5.2 for the 

following: 

3.3.8.1 Inspection reports which include follow-up activities.

3.3.8.2 Essential recall information.

3.3.8.3 Consumer complaints.

3.3.8.4 Industry complaints about inspections.8

3.3.8.5 Documentation associated with sample collection.

3.4 Outcome 

The state program is based on an inspection program that reduces the occurrence of foodborne illness, 

injury, or allergic reaction.

8 Records dealing with personnel actions are not subject to review during an ASSESSMENT.
Standard 3

Manufactured Food Regulatory Program Standards 24 September 2022

3.5 Documentation 

The state program maintains the records listed here.

3.5.1 Appendix 3.1 Self-Assessment Worksheet (or equivalent form).

3.5.2 An inventory of manufactured food firms for which the state has regulatory oversight.

3.5.3 Written procedure documenting the classification criteria and inspection frequencies.

3.5.4 Written rationale of the risk factor and classification criteria if a state program develops 

its own risk factor and classification criteria.

3.5.5 Written procedure for inspecting manufactured food firms. 

3.5.6 Written inspection reports procedure.

3.5.7 Written inspection reports, which include follow-up activities.

3.5.8 Written procedure for food recalls.

3.5.9 Essential recall information.

3.5.10 Written procedure for consumer complaints.

3.5.11 Consumer complaints.

3.5.12 Written procedure for industry complaints about inspections.

3.5.13 Industry complaints about inspections.8

3.5.14 Written procedures for sampling or, in the absence of any sampling program, a statement 

explaining how public health is protected.

3.5.15 Sample collection reports.

3.5.16 Documentation associated with sample collection.
Standard 4

Manufactured Food Regulatory Program Standards 25 September 2022

STANDARD 4

Inspection Audit Program

4.1 Purpose

This standard describes the Quality Assurance Program (QAP) and auditing procedures necessary for a 

state program to (1) evaluate the effectiveness and accuracy of the inspection program, inspection 

records, and sampling records; and (2) identify best practices used to achieve quality inspections and 

sample collections. 

4.2 Requirement Summary

The state program has a QAP that conducts audits to assess the effectiveness and accuracy of its 

inspections and sample collections. The QAP has two components: (1) a FIELD INSPECTION AUDIT

component, which is an on-site performance EVALUATION of inspections and (2) a desk audit 

component, which is a performance review of the written reports of inspections and sample collections.

4.3 Program Elements 

4.3.1 Quality Assurance Program 

The state program has a written QAP that contains written procedures for:

4.3.1.1 Conducting field inspection audits as described in section 4.3.2.

4.3.1.2 Conducting inspection report audits as described in section 4.3.3.

4.3.1.3 Conducting sample report audits as described in section 4.3.4.

4.3.1.4 Initiating corrective action(s), which will be documented on the strategic 

improvement plan as described in section 9.3.2.

4.3.2 Field inspection audit

QUALIFIED FIELD INSPECTION TRAINER or QUALIFIED FIELD INSPECTION AUDITOR conducts 

FIELD INSPECTION AUDITS or VERIFICATION AUDIT INSPECTIONS to verify that inspections 

are consistently performed according to the state’s written procedures described in 

Standard 3. 

4.3.2.1 Frequency: The QAP requires a minimum of two field inspection audits of 

each inspector be conducted every 36 months. Inspections selected for audits 

should include the highest risk manufactured food firms that the inspector is 

trained for including specialized food inspections.

4.3.2.2 Performance is documented on Appendix 4.3 or equivalent form and Appendix 

4.3a or a state audit form that meets the program elements in Standard 3, 

Program Element 3.3.2.

4.3.2.3 State programs may use the current Form FDA 3610 in lieu of Appendix 4.3.

4.3.3 Inspection Report Audit

The QAP requires periodic review of inspection reports to verify that inspectional findings 
Standard 4 

Manufactured Food Regulatory Program Standards 26 September 2022

are obtained and reported according to established written procedure. The quality of each 

inspection report is audited using the performance factors listed in Appendix 4.4. An 

overall inspection report rating is calculated using Appendix 4.4a or equivalent form. 

4.3.3.1 The state program will review a random selection of inspection reports based 

on the number of inspections completed in the last 12 months using the table 

below: 

Number of 

Inspections in 12 

Months

Minimum Number 

of Reports 

Required

Maximum 

Number of 

Reports Required

Less than 40 

reports All All

40 – 800 reports 40 40

More than 800 

reports 5% of reports 70 

4.3.3.2 Seven percent (7%) of the inspection reports reviewed must be taken from 

inspections that were audited.

4.3.3.3 Performance is documented on Appendices 4.4 and 4.4a or equivalent forms. 

4.3.4 Sample Report Audit 

If the samples are collected in conjunction with the manufactured food program, the QAP 

requires periodic review of sample reports. This review is to verify that samples were 

properly collected, identified, recorded, and submitted according to established written 

procedure. The quality of each sample report is audited using the performance factors 

listed in Appendix 4.5. An overall sample report rating is calculated using Appendix 4.5a 

or equivalent form. 

4.3.4.1 The state program will review a random selection of sample reports based on 

the number of samples collected in the last 12 months using the table below: 

Number of 

samples in 12 

Months

Minimum Number 

of Reports 

Required

Maximum Number 

of Reports 

Required

Less than 40 

reports All All

40 – 800 reports 40 40

More than 800 

reports 5% of reports 70 

4.3.4.2 Performance is documented on Appendices 4.5 and 4.5a or equivalent forms. 

4.3.5 Corrective action 

The state program shall initiate CORRECTIVE ACTIONS as described in 9.3.2 when the FIELD 

INSPECTION AUDIT, inspection report audit, or sample report audit meets one or more of the 

conditions below:

4.3.5.1 An individual receives an overall rating of “needs improvement”. 
Standard 4

Manufactured Food Regulatory Program Standards 27 September 2022

4.3.5.2 A single performance factor for the program falls below 80%, or four or more 

“needs improvement” ratings are identified in a single performance factor. 

Note that if fewer than four audits are conducted, a performance deficiency 

may be considered for a single performance factor that “needs improvement”.

4.3.5.3 An overall rating for the program falls below 80%. 

4.4 Outcome

The state program systematically evaluates and improves its inspection and sample collection systems to 

ensure that activities and information are accurate, complete, and comply with the jurisdiction’s 

procedures and policies. 

4.5 Documentation 

The state program maintains the records listed here.

4.5.1 Written procedures that describe the Quality Assurance Program.

4.5.2 Appendix 4.1 Self-Assessment Worksheet (or equivalent form).

4.5.3 Appendix 4.3 Field Inspection Audit form (or equivalent form) or a state audit form that 

meets the program elements in Standard 3, Program Element 3.3.2.

4.5.4 Appendix 4.3a Summary of Field Inspection Audit Findings (or equivalent form). 

4.5.5 Appendix 4.4 Inspection Report Audit Form (or equivalent form).

4.5.6 Appendix 4.4a Summary of Inspection Report Audit Findings (or equivalent form).

4.5.7 Appendix 4.5 Sample Report Audit Form (or equivalent form).

4.5.8 Appendix 4.5a Summary of Sample Report Audit Findings (or equivalent form).
Standard 5

Manufactured Food Regulatory Program Standards 28 September 2022

STANDARD 5

Food-related Illness, Outbreak and Hazards Response

5.1 Purpose

This standard describes the food emergency response functions and related activities necessary to 

investigate FOOD-RELATED INCIDENTS to stop, control and prevent HAZARDS that are likely to result in a 

foodborne illness, injury, or outbreak. 

5.2 Requirement Summary

The state program has a written food emergency response program. The program describes surveillance, 

investigation, control measures and post response activities in collaboration with other agencies and 

jurisdictions for responding to reports of food-related illness, injury, outbreaks and HAZARDS, whether 

unintentional or deliberate, and for generating recommendations for foodborne illness prevention.

5.3 Program Elements

5.3.1 Coordination of Food-related Illness, Outbreak and Hazards Response Activities with 

Other Authorities.

5.3.1.1 Memorandum of understanding with other state agencies: If the responsibility 

for state food-related illness and outbreak investigations is assigned to another 

state agency, a memorandum of understanding with this agency is required to 

fulfill the requirements of this standard. 

5.3.1.2 The state program has a written procedure that: 

5.3.1.2.1 Identifies and describes the roles, duties, and responsibilities of 

each program for the requirements in 5.3.2-5.3.5.

5.3.1.2.2 Describes agency collaboration as necessary with the FDA and 

other appropriate local, state, and federal authorities in multijurisdictional FOOD-RELATED INCIDENTS.

5.3.1.2.3 Designates response coordinator(s) to guide program investigation 

efforts in collaboration with all agencies involved.

5.3.1.2.4 Describes how all relevant agencies are notified in case of FOODRELATED INCIDENTS.

5.3.1.2.5 Provides guidance for notification of appropriate law enforcement 

agencies when intentional food contamination is suspected or 

threatened.

5.3.1.2.6 Describes the maintenance of a list(s) of relevant agencies and 

emergency contacts that is updated at least yearly.

5.3.2 Surveillance 

The state program: 

5.3.2.1 Uses epidemiological information from local, state, or federal agencies to 

detect incidents or outbreaks of foodborne illness or injury. 
Standard 5

Manufactured Food Regulatory Program Standards 29 September 2022

5.3.2.2 Maintains notifications of food-related incidents that are reported to the 

program, in a log(s) or database(s).

5.3.3 Investigation/Environmental assessment

The state program: 

5.3.3.1 Uses established procedures with recommended timeframes to investigate 

reports of food-related incidents.

5.3.3.2 Collects environmental assessment data using established procedures similar to 

those found in the most current versions of “International Association for Food 

Protection Procedures to Investigate Foodborne Illnesses" and the CIFOR 

“Guidelines for Foodborne Disease Outbreak Response.”9

5.3.3.3 Coordinates the traceback and traceforward of food implicated in an illness, 

injury, outbreak or found to contain a hazard in accordance with written 

procedures.

5.3.3.4 Has access to laboratory support10 for investigation of reports of food-related 

incidents.

5.3.3.5 Correlates and analyzes environmental assessment data to identify contributing 

factors and antecedents that led to food contamination or adulteration causing 

illness, injury, or outbreak. 

5.3.4 Control Measures

The state program: 

5.3.4.1 Mitigates and contains food-related illness, injury and hazards through 

strategies that include industry education, enforcement, and public awareness 

activities.

5.3.4.2 Maintains a written procedure with criteria for releasing prevention guidance 

and information to the public (includes identifying a media person and 

developing guidelines for coordinating media information with other 

jurisdictions).

5.3.5 Post Response

The state program: 

9 Council to Improve Foodborne Outbreak Response (CIFOR). Guidelines for Foodborne Disease Outbreak Response. 

Atlanta: Council of State and Territorial Epidemiologists available http://cifor.us/ .

10 Specific requirements for laboratory support are contained in Standard 10.
Standard 5

Manufactured Food Regulatory Program Standards 30 September 2022

5.3.5.1 Maintains program investigation and environmental assessment findings and 

reports. 

5.3.5.2 Distributes final program investigation report(s), including an environmental 

assessment if completed, to relevant agencies responsible for reporting 

contributing factors and antecedents to CDC. 

5.3.5.3 Distributes recommendations, when available, from investigation and 

environmental assessment findings and reports to relevant agencies and 

stakeholders responsible for prevention, education, and outreach.

5.4 Outcome

The state program uses a systematic approach for the detection, investigation, mitigation, documentation 

and analysis of FOOD-RELATED INCIDENTS to stop, control and prevent HAZARDS that are likely to result 

in a foodborne illness, injury, or outbreak.

5.5 Documentation

The program maintains the records listed here:

5.5.1 Appendix 5.1 Self-Assessment Worksheet (or equivalent form).

5.5.2 A Memorandum of Understanding, if applicable.

5.5.3 Written procedures for coordination, surveillance, environmental assessment, control 

measures, and post response. 

5.5.4 Records associated with coordination, surveillance, environmental assessment, control 

measures, and post response. 

5.5.5 A log(s) or database(s) that tracks notification of food-related incidents.

5.5.6 Investigation/environmental assessment, reports, and summaries.
Standard 6

Manufactured Food Regulatory Program Standards 31 September 2022

STANDARD 6

Compliance and Enforcement Program

6.1 Purpose

This standard describes the state agency’s strategies, procedures, and actions to enforce the laws and 

regulations to achieve compliance and to evaluate the effectiveness of its compliance and enforcement 

program.

6.2 Requirement Summary

The state program has a written compliance and enforcement program, which describes its compliance 

strategy and procedures. The compliance and enforcement program conducts an annual review and 

records those actions on appendix 6.2. The state calculates an overall rating which is used to determine 

if compliance and enforcement procedures were followed. Results of the review are used to identify 

improvements and modify procedures. 

6.3 Program Elements 

6.3.1 Compliance and Enforcement Program

The state program has a written compliance and enforcement program that: 

6.3.1.1 Contains compliance and enforcement strategies.

6.3.1.2 Describes the procedure to monitor

6.3.1.2.1 critical violations.

6.3.1.2.2 chronic violations.

6.3.1.2.3 chronic violators.

6.3.1.3 Uses a risk-based process to determine when a directed investigation, followup, or re-inspection is needed.

6.3.1.4 Establishes a framework for compliance and enforcement progressive 

actions.11

6.3.2 Performance Review

The state program conducts a performance review of compliance and enforcement actions 

as defined by the state program. The state program will conduct a performance review: 

11Compliance and Enforcement Progressive Actions may include, but are not limited to:

• Preventive actions such as promoting voluntary compliance through education program and consultation;

• Field actions such as verbal warnings, documented warnings, re-inspections, and product embargos;

• Supervisory/management actions such as warning letters or informal hearings;

• Administrative actions such as complaints and evidentiary hearings to suspend or revoke a business license; and 

• Civil or criminal sanctions.
Standard 6

Manufactured Food Regulatory Program Standards 32 September 2022

6.3.2.1 Annually.

6.3.2.2 Document on Appendix 6.2 or equivalent form to evaluate if internal 

compliance and enforcement actions are followed.

6.3.2.3 Use results of the review to identify improvements and modify procedures.

6.3.2.4 Require a corrective action if performance ratings fall below 80%, which will 

be documented on the strategic improvement plan as described in 9.3.2.

6.4 Outcome

The state program has a compliance and enforcement program that has written procedures to ensure that 

compliance actions are supported by sound judgment, adequate evidence, and appropriate 

documentation that is submitted in program-prescribed formats. 

6.5 Documentation

The state program maintains the records listed here.

6.5.1 Appendix 6.1 Self-Assessment Worksheet (or equivalent form).

6.5.2 Written Compliance and Enforcement Program.

6.5.3 Appendix 6.2 Performance Review of Enforcement Actions (or equivalent form).
Standard 7

Manufactured Food Regulatory Program Standards 33 September 2022

STANDARD 7

Industry and Community Relations

7.1 Purpose 

This standard describes the elements of industry and community outreach activities or OUTREACH 

ACTIVITY EVENTS developed and accomplished by the state program.

7.2 Requirement Summary 

The state program participates in activities that support communication and information exchange 

among regulators, industry, academia, and consumer representatives. It also coordinates or participates 

in outreach activities or OUTREACH ACTIVITY EVENTS that provide educational information about food 

protection topics

7.3 Program Elements 

The state program has a written procedure of the methods that will be used for communication 

with food industry stakeholders and consumers. The written procedure includes how the state

program will: 

7.3.1 Identify the methods for communication with food industry stakeholders and consumers. 

7.3.2 Interact with industry and consumers by sponsoring or actively participating in meetings 

such as task forces, advisory boards, or advisory committees.

7.3.3 Tailor outreach efforts to a target population, which may include dissemination of 

information using electronic sources and traditional methods such as mailings. Topics of 

outreach efforts may include food defense, investigation strategies, regulatory 

requirements, violation trends, and emerging issues regarding manufactured foods. 

Representatives from affected food industries, consumers, academia, and other federal, 

state, and local food protection agencies are invited to these meetings. 

7.3.4 Document and evaluate outreach activity events using Appendix 7.2 or equivalent form.

Include documents such as agendas and meeting summaries and program evaluations.

7.4 Outcome 

The state program uses outreach activities or OUTREACH ACTIVITY EVENTS to inform varied populations 

about food protection-related issues. 

7.5 Documentation 

The state program maintains the records listed here. 

7.5.1 Written procedure for methods used to communicate with food industry stakeholders and 

consumers.

7.5.2 Appendix 7.1 Self-Assessment Worksheet (or equivalent form). 

7.5.3 Appendix 7.2 or equivalent documentation for each outreach activity event (or equivalent 

form).
Standard 7

Manufactured Food Regulatory Program Standards 34 September 2022

7.5.4 Meeting summaries, agendas, or other records documenting interaction with food 

industry stakeholders and consumers.
Standard 8

Manufactured Food Regulatory Program Standards 35 September 2022

STANDARD 8

Program Resources

8.1 Purpose

This standard describes the elements for assessing the resources (staff, equipment, and funding) needed 

to support a manufactured food regulatory program. 

8.2 Requirement Summary

The state program conducts an assessment of resource needs for staffing, equipment, and funding for the 

manufactured food regulatory program.

8.3 Program Elements

8.3.1 Program Assessment

The state program completes the Resource Summary Report to assess staffing, funding, 

and equipment using Appendix 8.2 or equivalent form. The administrative functions 

needed to support all program areas should be considered when determining program 

resources.

8.3.2 Staffing 

The state program conducts and documents the calculation for determining the required 

number of inspectors to inspect manufactured food firms in its manufactured food firm 

inventory at a frequency that is based on the manufactured food firm’s risk classification 

and the necessary inspection and travel time. 

8.3.3 Equipment

A list of the equipment required for inspections and sample collections must be 

established and maintained by the state program. 

8.4 Outcome 

The state program assesses and allocates resources needed to support a manufactured food regulatory 

program. 

8.5 Documentation 

The state program maintains the records listed here: 

8.5.1 Appendix 8.1 Self-Assessment Worksheet (or equivalent form).

8.5.2 Appendix 8.2 Resource Summary Report (or equivalent form).

8.5.3 Documentation of the calculation of number of inspectors.

8.5.4 List of equipment used for inspections and sample collections.
Standard 9

Manufactured Food Regulatory Program Standards 36 September 2022

STANDARD 9

Program Assessment

9.1 Purpose 

This standard describes the process a state program uses to assess and demonstrate its CONFORMANCE 

with each of the program standards.

9.2 Requirement Summary 

Managers conduct periodic self-assessments of the manufactured food regulatory program against the 

criteria established in each program standard. These self-assessments are designed to identify the 

strengths and weaknesses of the state programs by using the program standards. 

The results of the self-assessments are used to determine areas or functions of the state program that 

need improvement. The results of the baseline self-assessment are used to develop a STRATEGIC 

IMPROVEMENT PLAN and establish timeframes for making improvements. Subsequent self-assessments 

and FDA ASSESSMENTS are used to track progress toward meeting and maintaining CONFORMANCE with 

the program standards or identifying any non-CONFORMANCE when the program was previously in 

CONFORMANCE with the standards.

9.3 Program Elements

9.3.1 In the first year, the state program conducts a baseline self-assessment to determine if the 

program meets the elements of each standard. The state program uses the appendices and 

worksheets contained herein or equivalent forms. The state program uses the results of its 

self-assessments to complete the Self-Assessment Summary Report (also known as 

Appendix 9.2) or equivalent form.

9.3.2 If the state program fails to meet any of the program elements and documentation 

requirements of a standard, whether identified through self-assessment or FDA 

assessments, the program shall develop or update a written strategic improvement plan 

that includes the following information (as applicable):

9.3.2.1 The individual element or documentation requirement of the standard that was 

not met.

9.3.2.2 Improvements or corrections needed to meet the program element or 

documentation requirement of the standard.

9.3.2.3 The cause for any non-conformance requiring correction when the program 

was previously in conformance with the individual element or documentation 

requirement of a standard.

9.3.2.4 The corrective action taken to prevent future similar non-conformance when 

the program was previously in conformance with the individual element or 

documentation requirement of the standard that was corrected.

9.3.2.5 Projected completion dates for each task.

9.3.2.6 Personnel responsible.
Standard 9

Manufactured Food Regulatory Program Standards 37 September 2022

9.3.2.7 Date completed for each task. 

9.3.3 The state program shall review and update self-assessment appendices and its strategic 

improvement plan at least annually. 

9.3.4 The state program participates in FDA assessments to determine implementation and 

conformance to the standards. The state program addresses FDA assessment observations 

and incorporates corrective actions as needed into its strategic improvement plan. 

9.3.5 The state program must:

9.3.5.1 Have a written document control procedure that ensures that all guidance, 

procedures, documents, and forms required by the standards are current and fitfor-use.

9.3.5.1.1 All of the documents subject to this procedure can demonstrate 

they are CURRENT AND FIT-FOR-USE through maintenance of a

master document list or other system that shows:

9.3.5.1.1.1 Documents are reviewed for accuracy.

9.3.5.1.1.2 Documents are approved for release by authorized

personnel and signed/dated with an approval or 

revision date.

9.3.5.1.1.3 Documents are distributed to applicable staff, as 

appropriate, and used at the location where the 

prescribed activity is performed.

9.3.5.2 Retain records or procedures required under x.5 of each standard for the three 

previous years, or per the state program’s record retention policy, whichever is 

longer. Records or procedures can be maintained either electronically or in 

hardcopy.

9.4 Outcome 

The state program conforms to the program standards through well-defined and written evaluation 

activities and a process for continuous improvement.

9.5 Documentation 

The state program maintains records listed here.

9.5.1 Appendix 9.1 Self-Assessment Worksheet (or equivalent form).

9.5.2 Appendix 9.2 Self-Assessment Summary Report (or equivalent form).

9.5.3 Strategic improvement plan.

9.5.4 Document control procedure.

9.5.5 Record retention rules, policies, or procedures.

9.5.6 FDA Assessment reports.
Standard 10

Manufactured Food Regulatory Program Standards 38 September 2022

STANDARD 10

Laboratory Support

10.1 Purpose

This standard describes the elements of laboratory support for a manufactured food regulatory program. 

10.2 Requirement Summary

The state program has access to the laboratory services needed to support program functions and 

documents its laboratory capabilities including agreements with external laboratories. 

10.3 Program Elements

10.3.1 Laboratory Support

10.3.1.1 The state program has access to a laboratory that is capable of analyzing a 

variety of samples including food, environmental, and clinical samples. 

10.3.1.2 The state program maintains a list of services for routine and non-routine 

analyses such as biological hazard determinations. 

10.3.1.3 The state program has a contract or written agreement with each primary 

servicing laboratory unless under the same administrative agency. The contract 

or written agreement must be documented such as a memorandum of 

understanding, e-mail, or any written format but must contain each the 

components below: 

10.3.1.3.1 Define the responsibilities of each party.

10.3.1.3.2 Describe the types of testing services to be performed.

10.3.1.3.3 Describe how exceptions to planned work will be communicated. 

10.3.1.4 When a program uses a laboratory service from a non-primary servicing 

laboratory, there shall be documentation of the service provided; the 

documentation can be in a simplified format.

10.3.2 ISO Accredited Laboratories 

The state program utilizes laboratories that have a current accreditation to the ISO/IEC 

17025:2017 (or current version) standards to analyze food and environmental samples. 

The accreditation body of the laboratory must be a full member of the International 

Laboratory Accreditation Cooperation (ILAC) and a signatory to the ILAC Mutual 

Recognition Arrangement (MRA).

10.3.3 Non-ISO Accredited Laboratories

If state programs do not use laboratories holding accreditation to ISO/IEC 17025:2017 (or 

current version) for the analysis of food and environmental samples, then the program 

must utilize laboratories that have in place a quality system which incorporates the 

following management and technical requirements of ISO/IEC 17025:2017 (or current 

version) at a minimum:
Standard 10

Manufactured Food Regulatory Program Standards 39 September 2022

10.3.3.1 A documented quality system which incorporates management and technical 

requirements of ISO/IEC 17025:2017 (or current version) and associated 

procedures, that include but are not limited to: 

10.3.3.1.1 Calibration and maintenance of equipment.

10.3.3.1.2 Analyses are performed using validated and verified test 

procedures.

10.3.3.1.3 Documentation of sample traceability.

10.3.3.1.4 Documentation of analytical results and analysts performing work.

10.3.3.1.5 Analysts that are trained and authorized to perform technical 

procedures.

10.3.3.1.6 Periodic audits.

10.3.3.2 A procedure that defines the activities necessary when non-conforming work 

occurs. The documented process must describe how quality control data are 

assessed to assure that test results from non-conforming work are not released. 

The documented process must describe how cause analysis and problem 

resolution are recorded. 

10.3.3.3 A document control procedure that assures documents issued to personnel are 

current, suitable, and reviewed and approved by authorized personnel prior to 

release. The procedure must also assure that obsolete documents are removed 

from use.

10.3.3.4 A documented record keeping process that assures that records of original 

observations and data collection are maintained and sufficient to establish 

traceability of test results to: sample handling and storage, sample analysis 

including data collection, equipment calibration and maintenance, and the 

review of test results prior to release.

10.3.3.5 A documented process to assure that reference materials and reference cultures 

used are fit for purpose, are not outdated, and are traceable to a lot number or 

other unique identifier.

10.3.3.6 A documented process to assure that the laboratory participates in relevant and 

available proficiency testing activities.

10.4 Outcome 

The state program has access to laboratory services described in this standard.

10.5 Documentation 

The state program maintains records listed here.

10.5.1 Appendix 10.1 Self-Assessment Worksheet (or equivalent form).

10.5.2 Contracts or written agreements with primary servicing laboratories.

10.5.3 A list of laboratories used by the state that are non-primary servicing laboratories. 
Standard 10

Manufactured Food Regulatory Program Standards 40 September 2022

10.5.4 Documentation of services provided by primary servicing laboratories and non-primary 

servicing laboratories.

10.5.5 ISO Accredited Laboratory: ISO/IEC 17025:2017 (or current version) Certificate and 

Scope of Accreditation.

10.5.6 Non-ISO Accredited Laboratory Documents:

10.5.6.1 Documented Quality System.

10.5.6.2 Corrective Action.

10.5.6.3 Document Control.

10.5.6.4 Record Keeping.

10.5.6.5 Process for Ensuring Validity of Results (including but not limited to 

Reference Materials and or Proficiency Testing).
 

 

 

 

 

Authority

Appendix 1.1 

Appendix 1.1: Self-Assessment Worksheet 

Instructions: The state program identifies if they have a specified component then evaluates if it includes 

the associated components. If the state program has the main component and associated components 

indicate “Yes”. If not, indicate “No”. 

State Agency: 

Program Elements Yes/No 

If No, please explain why 

element is not met. May use this 

space for additional notes. 

1.3.1 Written Procedure for Evaluation of Legal 

Authority 

Does the state program’s written procedure: 

1. Describe the REGULATORY FOUNDATION 

assessment process? 

2. Include timeframes for conducting a REGULATORY 

FOUNDATION assessment; including whenever 

significant changes are made to applicable Federal 

and/or state laws and regulations? 

3. Address statutes, regulations, rules, ordinances, 

and other prevailing regulatory requirements that: 

a. Apply to the regulation of manufactured food? 

b. Delegate authority to the state’s program? 

c. Describe the state administrative procedures 

for rulemaking to protect public health? 

d. Identify and list other state and federal 

agencies that have authority for any area of the 

REGULATORY FOUNDATION the state program 

lacks? 

1.3.2 REGULATORY FOUNDATION Assessment 

Does the state’s REGULATORY AUTHORITY assessment 

include a baseline self-assessment using Appendix 1.2 

or equivalent form to determine if the state is 

EQUIVALENT, EQUIVALENT IN EFFECT, NOT 

EQUIVALENT, or NO AUTHORITY to sections of the 

FD&C Act and CFRs as specified in Appendix 1.2? 

Assessment Completed By: 

Name Date: 

Manufactured Food Regulatory Program Standards 41 September 2022 
Appendix 1.2 

Manufactured Food Regulatory Program Standards 42 September 2022

Appendix 1.2: Regulatory Foundation Worksheet 

Instructions: Determine if state laws and regulations are EQUIVALENT, EQUIVALENT IN EFFECT, or NOT EQUIVALENT to Federal statutes and regulations. 

Select "NO AUTHORITY" if the program has no regulatory responsibility for a statue or regulation or the authority falls under the jurisdiction of 

another agency. 

For those statutes and regulations for which the state program does have authority, record the state law or regulations and the date it was 

incorporated. The Notes section shall be used in part to detail differences between state and federal laws and regulations, and to clarify when other 

agencies may have regulatory jurisdiction. This self-assessment relates only to human food and public health. Any commodities within the statutes 

and regulations outside this scope do not need to be included on the self-assessment. 

Note: the FD&C Act reference links direct you to the relevant U.S. Code section number. For a cross reference of FD&C Act and U.S. Code sections 

please visit the FDA's website: https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act

State Agency:

Federal Food, Drug & Cosmetic Act

FD&C 

Act/US 

Code

Title Equivalency 

Status State Citation

Date 

Incorporated 

into State Law

Notes

201/321 Definitions (f), (k), (m), 

and (ff)

301/331

Prohibited acts (a), (b), 

(c), (d), (e), (f), (k), and

(v)

 303/333* Penalties

 304/334** Seizure

401/341 Definitions and standards 

for food

402/342 Adulterated food 
Appendix 1.2 

Manufactured Food Regulatory Program Standards 43 September 2022

FD&C 

Act/US 

Code

Title Equivalency 

Status State Citation

Date 

Incorporated 

into State Law

Notes

403/343 Misbranded food (a)-(s)

413/350b New dietary ingredients

701/371 Regulations and hearings 

 703/373*** Records of interstate 

shipments

704/374 Inspection

*Penalties may vary from Federal statute. 

**Although the state program may not have authority for seizure, the state program could have legal authority to stop adulterated and misbranded products from moving in commerce, for example, 

detention, stop-sale orders, withdrawal from distribution, and embargoes.

*** This section covers records in interstate commerce. State laws should include intrastate records.

Title 21 Code of Federal Regulations: Food and Drugs 

21 CFR 

Part Title Equivalency Status State Citation

Date 

Incorporated 

into State Law

Notes

1

General Enforcement 

Regulations 

(§ 1.20-1.24); Foreign 

Supplier Verification 

Program (Subpart L § 

1.500-1.514); 

and Sanitary 

Transportation (Subpart 

O § 1.900-1.934)

7

Enforcement Policy

(ONLY § 7.1-7.13 and § 

7.40-7.59)
Appendix 1.2 

Manufactured Food Regulatory Program Standards 44 September 2022

21 CFR 

Part Title Equivalency Status State Citation

Date 

Incorporated 

into State Law

Notes

70 Color 

Additives 

(ONLY § 70.20-§ 70.25)

73

Listing of Colors Exempt 

From Certification 

(ONLY § 73.1-§ 73.615)

74

Listing of Color 

Additives Subject to Certification (ONLY § 

74.101-§ 706)

81

General Restrictions for 

Provisional Color 

Additives for Use in 

Foods, Drugs, and 

Cosmetics

82

Listing of Certified 

Provisionally Listed 

Colors and Specifications 

(ONLY § 82.3-§ 82.706)

100 General (ONLY § 

100.155)

101 Food 

Labeling (EXCEPT 

§ 101.69 and § 101.108)

102

Common or Usual Name 

for Nonstandardized 

Foods (EXCEPT § 

102.19)

104 Nutritional 

Quality 

guidelines for foods

105 Foods for 

Special Dietary 

Use
Appendix 1.2 

Manufactured Food Regulatory Program Standards 45 September 2022

21 CFR 

Part Title Equivalency Status State Citation

Date 

Incorporated 

into State Law

Notes

106

Infant Formula Quality 

Control Procedures 

(EXCEPT § 106.120)

107 Infant Formula (EXCEPT 

§ 107.200-§ 107.280)

108

Emergency Permit 

Control (ONLY § 108.25-

§ 108.35)

109

Unavoidable 

Contaminants in Food for 

Human Consumption and 

Food-Packaging 

Materials

1101

Current Good 

Manufacturing Practice in 

Manufacturing, Packing, 

or Holding Human Food

111

Current Good 

Manufacturing Practice 

for Dietary Supplements

113

Thermally Processed 

Low-Acid Foods 

Packaged in Hermetically 

Sealed Containers

114 Acidified Foods 

1 21 CFR Part 110 was modernized and codified in 21 CFR Part 117 by the current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for 

Human Food Rule. 
Appendix 1.2 

Manufactured Food Regulatory Program Standards 46 September 2022

21 CFR 

Part Title Equivalency Status State Citation

Date 

Incorporated 

into State Law

Notes

115 Shell Eggs 

117

Current Good 

Manufacturing Practice 

and Hazard Analysis and 

Risk-Based Preventive 

Controls for Human Food

118

Production, Storage, And 

Transportation of Shell 

Eggs

120

Hazard Analysis and 

Critical Control Point 

(HACCP) systems

121

Mitigation Strategies to 

Protect Food from 

Intentional Adulteration

123 Fish and Fishery Products 

129

Processing and Bottling 

of Bottled Drinking 

Water

130

Food Standards: General 

(EXCEPT § 130.5-6 and 

§ 130.17)

131 Milk and Cream

133 Cheeses and Related 

Cheese Products

135 Frozen Desserts

136 Bakery Products 
Appendix 1.2 

Manufactured Food Regulatory Program Standards 47 September 2022

21 CFR 

Part Title Equivalency Status State Citation

Date 

Incorporated 

into State Law

Notes

137 Cereal Flours and Related 

Products

139 Macaroni and Noodle 

Products

145 Canned Fruits

146 Canned Fruit Juices

150

Fruit Butters, Jellies, 

Preserves, and Related 

Products

152 Fruit Pies

155 Canned Vegetables

156 Vegetable Juices

158 Frozen Vegetables

160 Eggs and Egg Products 

161 Fish and Shellfish 

163 Cacao Products 

164 Tree Nut and Peanut 

Products

165 Beverages

166 Margarine

168 Sweeteners and Table 

Syrups
Appendix 1.2 

Manufactured Food Regulatory Program Standards 48 September 2022

21 CFR 

Part Title Equivalency Status State Citation

Date 

Incorporated 

into State Law

Notes

169 Food Dressings and 

Flavorings

170

Food Additives 

EXCEPT § 170.6, § 

170.15, and § 170.17)

172

Food Additives Permitted 

for Direct Addition to 

Food for Human 

Consumption

173

Secondary Direct Food 

Additives Permitted in 

Food for Human 

Consumption

174 Indirect Food Additives: 

General

175

Indirect Food Additives: 

Adhesives and 

Components of Coatings

176

Indirect Food Additives: 

Paper and Paperboard 

Components

177 Indirect Food Additives: 

Polymers

178

Indirect Food Additives: 

Adjuvants, Production 

Aids, And Sanitizers

180

Food Additives Permitted 

In Food Or In Contact 

With Food On An Interim 

Basis Pending Additional 

Study
Appendix 1.2 

Manufactured Food Regulatory Program Standards 49 September 2022

21 CFR 

Part Title Equivalency Status State Citation

Date 

Incorporated 

into State Law

Notes

181 Prior-Sanctioned Food 

Ingredients

182 Substances Generally 

Recognized As Safe

184

Direct Food Substances 

Affirmed As Generally 

Recognized As Safe

186

Indirect Food Substances 

Affirmed As Generally 

Recognized As Safe

189

Substances Prohibited 

From Use In Human 

Food

190 Dietary Supplements 

State laws and regulations used by the program to address regulatory responsibilities outside of the FDA jurisdiction are listed below.

Assessment Completed By:

Name Date:
Appendix 2.1 

Manufactured Food Regulatory Program Standards 50 September 2022

Appendix 2.1: Self-Assessment Worksheet

Instructions: The state program identifies if they have a specified component then evaluates if it includes 

the associated components. If the state program has the main component and associated components 

indicate “Yes”. If not, indicate “No”. 

State Agency:

Program Elements Yes/No

If no, please explain why element is not 

met. May use this space for additional 

notes.

2.3.1. Training Plan and Training Records

Does the state program:

1. Have a written training plan that ensures all

inspectors receive training required to

adequately perform their work assignments?

2. Maintain a training history for active

inspectors?

3. Maintain a history for all inactive inspectors

for three years or per the state’s record

retention policy?

4. Use Appendix 2.2 or equivalent form to

document and summarize all training

provided to inspectors?

5. Use Appendix 2.3 or equivalent form to

document training for each inspector?

6. Training record summary and individual

training records include the inspector’s

START DATE?

2.3.2. Basic Food Inspection Training

Does the state program require that each 

inspector:

1. Complete all basic food inspection training

coursework within 24 months of their START

DATE with manufactured food program?

2. Complete the basic course curriculum in the

subject areas listed in 2.3.2.2.1 – 2.3.2.2.11?

3. Who will inspect general manufactured food

firms complete 10 JOINT FIELD TRAINING

INSPECTIONS FIELD INSPECTION AUDITS, or

EVALUATIONS with a QUALIFIED FIELD

INSPECTION TRAINER?

4. Who will inspect general food manufactured

food firms complete two acceptable FIELD

INSPECTION AUDITS or EVALUATIONS by a

QUALIFIED FIELD INSPECTION TRAINER or

QUALIFIED FIELD INSPECTION AUDITOR?
Appendix 2.1 

Manufactured Food Regulatory Program Standards 51 September 2022

Program Elements Yes/No

If no, please explain why element is not 

met. May use this space for additional 

notes.

5. Who will inspect non-high risk food 

warehouses complete five JOINT FIELD 

TRAINING INSPECTIONS, FIELD INSPECTION 

AUDITS, or EVALUATIONS with a QUALIFIED 

FIELD INSPECTION TRAINER?

6. Who will inspect non-high risk food 

warehouses complete two acceptable FIELD 

INSPECTION AUDITS, or EVALUATIONS with a 

QUALIFIED FIELD INSPECTION TRAINER?

7. Who advances to conduct general 

manufactured food firms from non-high risk 

food warehouses complete five additional 

JOINT FIELD TRAINING INSPECTIONS, FIELD 

INSPECTION AUDITS, or EVALUATIONS to 

fulfill requirements identified in 2.3.2.3.1, of 

which, two are representative of the general 

manufactured food firms?

8. Who advances to conduct general 

manufactured food firms from non-high risk 

food warehouses complete two additional 

acceptable FIELD INSPECTION AUDITS, or 

EVALUATIONS with a QUALIFIED FIELD 

INSPECTION TRAINER?

9. Complete the minimum field training 

requirements prior to conducting independent 

inspections?

2.3.3. Advanced Food Inspection Training

Does the state program require each inspector: 

1. Who performs specialized food inspections 

to complete the coursework specific to the 

type of specialized food inspection they will 

be performing?

2. Who performs specialized food inspections 

to participate in two JOINT FIELD TRAINING 

INSPECTIONS?

3. After successful completion of the course,

participate in one EVALUATION or FIELD 

INSPECTION AUDIT with a QUALIFIED FIELD 

INSPECTION TRAINER or QUALIFIED FIELD 

INSPECTION AUDITOR prior to conducting 

independent inspections?
Appendix 2.1 

Manufactured Food Regulatory Program Standards 52 September 2022

Program Elements Yes/No

If no, please explain why element is not 

met. May use this space for additional 

notes.

4. Within one year after being released to do 

specialized food inspections complete a 

second EVALUATION or FIELD INSPECTION 

AUDIT with a QUALIFIED FIELD INSPECTION 

TRAINER or QUALIFIED FIELD INSPECTION 

AUDITOR in the area of specialty?

2.3.4 Experienced Inspectors

For CURRENT EXPERIENCED STAFF or NEWLY 

HIRED EXPERIENCED STAFF a state program’s 

training plan shall include the following unless 

the state determines in their training plan that all 

staff will be required to complete the program 

elements in 2.3.2 and 2.3.3: 

1. Missing basic course work, does the state

program have a statement or affidavit that 

explains the background or experience that 

justifies the waiver?

2. Missing JOINT FIELD TRAINING INSPECTIONS,

does the state program have a statement or 

affidavit explaining the background or 

experience that justifies a waiver of the basic or 

specialized JOINT FIELD TRAINING INSPECTIONS? 

3. Who is newly hired who had JOINT FIELD 

TRAINING INSPECTIONS waived, were two 

successful EVALUATIONS or FIELD INSPECTION 

AUDITS completed within 6 months of the 

inspector’s QUALIFIED DATE? 

4. Missing specialized coursework, does the state

program have a statement or affidavit 

explaining the date and location that the 

specialized training was completed?

2.3.5 Continuing Education and Training

1. Does each inspector conducting manufactured 

food inspections accumulate 20 CONTACT 

HOURS of continuing education every 36 

months from the start of the QUALIFIED DATE? 

2. Does the state program maintain documentation 

for continuing education credit as outlined in 

2.3.5.7?
Appendix 2.1 

Manufactured Food Regulatory Program Standards 53 September 2022

Program Elements Yes/No

If no, please explain why element is not 

met. May use this space for additional 

notes.

2.3.6 Coursework Sources

Is all basic, advanced, and continuing education 

coursework obtained from sources listed in 

2.3.6.1 – 2.3.6.4?

Assessment Completed By: 

Name Date:
 

Appendix 2.2 

Appendix 2.2: Inspector Training Record Summary 

Instructions: This Appendix is used to document and track inspectors’ training status. Enter the name of all active inspectors. Include the START DATE 

of employment and record the date the inspector completed the coursework and field training for the basic and advanced curriculums. For 

continuing education, indicate the QUALIFIED DATE and number of CONTACT HOURS completed. 

Employee Name START 

DATE 

Basic Food 

Inspection 

Curriculum 

Advanced Food Inspection Curriculum Continuing Education 

Course 

Work 

Field 

Work Area of Specialty Course Work 

Field 

Work 

QUALIFIED 

DATE 

CONTACT 

HOURS 

Assessment Completed By: 

Name Date: 

Manufactured Food Regulatory Program Standards 54 September 2022 
 

 

Appendix 2.3 

Appendix 2.3: Inspector Training Record 

State Agency: 

Name of Inspector: Start Date: 

Basic Food Inspection Curriculum 

Coursework 

Course 

Please provide the course name and location for 

each subject area 

Date Completed 

Course Documentation 

Available for Review 

(Yes/No) 

Prevailing statutes, regulations, and ordinances 

Public health principles 

Emergency management 

Communication skills 

Microbiology 

Epidemiology 

Basics of HACCP 

Allergen management 

Basic food labeling 

Food defense 

Sampling techniques and preparation 

Manufactured Food Regulatory Program Standards 55 September 2022 
Appendix 2.3 

Name of Inspector: Start Date: 

Basic Food Inspection Curriculum 

Fieldwork 

JOINT FIELD TRAINING INSPECTION 

or FIELD INSPECTION AUDITS 

Date 

Completed 

EVALUATION/AUDIT 

Acceptable 

(Yes/No) 

Documentation 

Available for 

Review 

(Yes/No) 

Please provide the name of the 

manufactured food firm and 

identification number. 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

Manufactured Food Regulatory Program Standards 56 September 2022 
Appendix 2.3 

Name of Inspector: Start Date: 

Advanced Food Inspection Curriculum Fieldwork 

Course 

Please provide the name and location of the course. Completion Date 

Course 

Documentation 

Available For 

Review 

(Yes/No) 

Acidified foods 

Low-acid canned food 

Juice HACCP 

Seafood HACCP 

Traceback investigations 

Foodborne illness investigations 

Preventive controls for human foods 

Manufactured Food Regulatory Program Standards 57 September 2022 
 

 

 

Appendix 2.3 

Name of Inspector: Start Date: 

Instructions: Identify and record the type of specialized food inspection conducted for the JOINT FIELD 

TRAINING INSPECTION or FIELD INSPECTION AUDITS, such as acidified foods, low-acid canned foods, juice 

HACCP, seafood HACCP, or preventive controls for human foods. 

Advanced Food Inspection Curriculum Fieldwork 

Specialized food inspection 

JOINT FIELD TRAINING INSPECTION 

or FIELD INSPECTION AUDITS 

Completion 

Date 

EVALUATION/AUDIT 

Acceptable 

(Yes/No) 

Documentation 

Available for 

Review 

(Yes/No) 

Please provide the name of the 

manufactured food firm and 

identification number. 

1. 

2. 

3. 

4. 

Specialized food inspection 

JOINT FIELD TRAINING INSPECTION 

or FIELD INSPECTION AUDITS 

Completion 

Date 

EVALUATION/AUDIT 

Acceptable 

(Yes/No) 

Documentation 

Available for 

Review (Yes/No) 

Please provide the name of the 

manufactured food firm and 

identification number. 

1. 

2. 

3. 

4. 

Manufactured Food Regulatory Program Standards 58 September 2022 
Appendix 2.3 

Name of Inspector: Start Date: 

CONTINUING EDUCATION COURSEWORK 

A total of 20 CONTACT HOURS required every 36 months 

Activities in Program Element 2.3.4.4 

Maximum of 20 CONTACT HOURS 

Type of Activity 

Provide Title and Brief Description 

Date 

Completed 

Documentation 

Available for Review 

(Yes/No) 

CONTACT 

HOURS 

Earned 

Subtotal 

Presenting, Training, or Publishing (Program Element 2.3.4.5) 

Maximum of 10 CONTACT HOURS 

Type of Activity 

Provide Title and Brief Description 

Date 

Completed 

Documentation 

Available for Review 

(Yes/No) 

CONTACT 

HOURS 

Earned 

Subtotal 

Reading Technical Publications (Program Element 2.3.4.6) 

Maximum of 4 CONTACT HOURS 

Type of Activity 

Provide Title and Brief Description 

Date 

Completed 

Documentation 

Available for Review 

(Yes/No) 

CONTACT 

HOURS 

Earned 

Subtotal 

Total CONTACT HOURS Earned 

Manufactured Food Regulatory Program Standards 59 September 2022 
Appendix 3.1 

Manufactured Food Regulatory Program Standards 60 September 2022

Appendix 3.1: Self-Assessment Worksheet

Instructions: The state program identifies if they have a specified component then evaluates if it includes 

the associated components. If the state program has the main component and associated components 

indicate “Yes”. If not, indicate “No”. 

State Agency:

Program Elements Yes/No

If no, please explain why element is not 

met. May use this space for additional 

notes.

3.3.1 Risk-based Inspection Program

1. Does the state program maintain an 

inventory of manufactured food firms for 

which the state has regulatory oversight?

2. Does the state program have a written 

procedure documenting the classification 

criteria and inspection frequencies?

3. Is the inventory categorized by the degree of 

risk associated with the likelihood that a 

FOOD-RELATED INCIDENT will occur?

4. Does the state program use the risk factors 

and classification criteria as described in 

3.3.1.2?

3.3.2 Inspection Procedure

Does the state program’s inspection procedure 

require inspectors to: 

1. Review the previous inspection report and 

CONSUMER COMPLAINTS?

2. Have appropriate forms (if necessary) and 

equipment that has been verified and 

maintained as defined by the state’s standard 

operating procedures or manufacturer’s 

recommendations?

3. Make appropriate introductions and explain 

the purpose and scope of the inspection?

4. Establish jurisdiction?

5. Select an appropriate product for the 

inspection and, if necessary, make 

appropriate adjustments based on what the 

manufactured food firm is producing?

6. Assess employee practices critical to the safe 

and sanitary production and storage of food?

7. Properly evaluate the likelihood that 

conditions, practices, components, and/or 

labeling could cause the product to be 

adulterated or misbranded?
Appendix 3.1 

Manufactured Food Regulatory Program Standards 61 September 2022

Program Elements Yes/No

If no, please explain why element is not 

met. May use this space for additional 

notes.

8. Recognize significant violative conditions or 

practices, and record findings consistent with 

program procedures?

9. Distinguish between significant and 

insignificant observations, and isolated 

incidents versus trends?

10. Review and evaluate the appropriate 

operational records and procedures and 

apply the information obtained from this 

review?

11. Collect adequate evidence and 

documentation in accordance with program 

procedures to support the inspectional 

observations? 

12. Verify correction of deficiencies identified 

during the previous inspection?

13. Behave professionally and demonstrate 

proper sanitary practices during the 

inspection?

14. Properly evaluate good manufacturing 

practice requirements (21 CFR 117, Subparts 

A, B, and F (for training records only) or 

equivalent state regulation)?

15. Verify manufactured food firm has a written 

food safety plan which includes a written 

HAZARD analysis that appropriately 

addresses HAZARDS, and when appropriate, 

addresses preventive controls (process 

controls, allergen controls, sanitation 

controls, supply-chain controls and other 

controls) and a recall plan?

16. When appropriate, review the manufactured 

food firm’s written procedures, monitoring, 

verification, correction, and corrective action 

records for process, allergen, sanitation 

controls, supply-chain controls, and other 

controls which are identified in their food 

safety plan?

17. When appropriate, verify the manufactured 

food firm is in compliance with the modified 

requirements that apply to a qualified facility 

(attestation)?
Appendix 3.1 

Manufactured Food Regulatory Program Standards 62 September 2022

Program Elements Yes/No

If no, please explain why element is not 

met. May use this space for additional 

notes.

18. When appropriate, verify the modified 

requirements and time/temperature controls 

that apply to a facility solely engaged in the 

storage of unexposed packaged foods that 

require refrigeration for safety?

19. When appropriate, assess the sanitary 

transportation of human food requirements 

that apply to transportation operations?

20. When appropriate, review the manufactured 

food firm’s food defense plan, including the 

mitigation strategies, monitoring, corrective 

action, and verification activities?

21. Use current versions of applicable HAZARD

guides or other guidance, to identify and 

evaluate the HAZARDS associated with 

product(s) and process(es) when conducting 

inspections of specialized food and 

processes?

22. Assess the manufactured food firm’s 

implementation of sanitation monitoring for 

the applicable eight key areas of sanitation 

when required by regulation?

23. When appropriate, review the manufactured 

food firm’s; scheduled process; HACCP 

plan or necessary process controls in the 

absence of a HACCP plan; food safety 

control plan and applicable monitoring, 

verification and deviation or corrective 

action records, including those related to 

sanitation?

24. Recognize deficiencies in the manufactured 

food firm’s monitoring controls and 

sanitation procedures through in 

manufactured food firm observations?

25. Use suitable interviewing techniques?

26. Explain findings clearly and adequately 

throughout the inspection?

27. Alert the manufactured food firm’s person in 

charge when an immediate corrective action 

is necessary?

28. Answer questions and provide information 

in an appropriate manner?
Appendix 3.1 

Manufactured Food Regulatory Program Standards 63 September 2022

Program Elements Yes/No

If no, please explain why element is not 

met. May use this space for additional 

notes.

29. Write findings accurately, clearly, and 

concisely on the state document and provide 

a copy to the manufactured food firm’s 

person in charge?

3.3.3 Inspection Reports

Does the state program have written inspection 

report procedures that require inspectors to:

1. Submit inspection report within designated 

timeframes?

2. Complete the inspection report form 

completely and accurately?

3. Document violations and observations 

clearly, legibly, and concisely?

4. Follow-up with corrective action, 

compliance, and enforcement?

3.3.4 Food Recalls

Does the state program have a food recall 

system with written procedures for: 

1. Sharing information about recalls with 

relevant agencies?

2. Ensuring recalled products are removed 

promptly from the market?

3. Performing RECALL AUDIT CHECKS?

3.3.5 CONSUMER COMPLAINTS

Does the program have procedures for 

receiving, tracking, evaluating, responding to, 

and closing CONSUMER COMPLAINTS? 

3.3.6 Complaints Resulting from State Program Inspection Activities

Does the program have procedures for 

receiving, evaluating, and responding to food 

INDUSTRY COMPLAINTS about inspections?

3.3.7 Sampling Procedure

Does the state program’s sampling procedure 

include:

1. Procedures that require sample collectors to:

a. Use the appropriate method and 

equipment to collect the sample?

b. Record sample chain of custody per 

state procedures?

c. Handle, package, and ship sample using 

procedures appropriate to prevent 

compromising condition of the sample 

and ensuring security of the sample? 
Appendix 3.1 

Manufactured Food Regulatory Program Standards 64 September 2022

Program Elements Yes/No

If no, please explain why element is not 

met. May use this space for additional 

notes.

d. Deliver or ship sample to the 

appropriate laboratory within prescribed 

timeframes?

2. Instructions for documenting the applicable 

sample collection information?

a. Date of sample collection?

b. Product identification which includes 

name of product and unique 

manufacturing identification reference?

c. Description of product?

d. Collection information which includes 

method of collection, lot sampled, and 

lot size?

e. Location where sample was collected?

f. Name and address of responsible party, 

guarantor, processor or distributor?

g. Sample type?

h. Analysis requested (if applicable)?

i. Product labeling or labeling 

information?

j. Identification of the sample with a 

sample number assigned at the time of 

collection?

3. For states that do not have a SAMPLING 

PROGRAM, is there a statement that explains 

why a SAMPLING PROGRAM is not supported 

and how public health is protected in the 

absence of such a program?

3.3.8 Records Retention

Does the state program maintain records as 

required under 9.3.5.2 for the following:

1. Inspection reports which include follow-up 

activities?

2. Essential recall information?

3. CONSUMER COMPLAINTS?

4. INDUSTRY COMPLAINTS about inspections?8

5. Documentation associated with sample 

collection?

Assessment Completed By: 

Name Date:
 

Appendix 4.1 

Appendix 4.1: Self-Assessment Worksheet 

Instructions: The state program identifies if they have a specified component then evaluates if it includes 

the associated components. If the state program has the main component and associated components 

indicate “Yes”. If not, indicate “No”. 

State Agency: 

Program Elements Yes/No 

If no, please explain why element is not 

met. May use this space for additional 

notes. 

4.3.1 Quality Assurance 

The state program has a written Quality 

Assurance Program (QAP) that contains 

written procedures for: 

1. Conducting FIELD INSPECTION AUDITS as 

described in section 4.3.2? 

2. Conducting inspection report audits as 

described in section 4.3.3? 

3. Conducting sample report audits as 

described in section 4.3.4? 

4. Initiating CORRECTIVE ACTION, which will 

be documented on the STRATEGIC 

IMPROVEMENT PLAN as described in 

section 9.3.2? 

4.3.2 FIELD INSPECTION AUDIT 

Does the state program: 

1. Use a QUALIFIED TRAINER or QUALIFIED 

AUDITOR conduct FIELD INSPECTION 

AUDITS or VERIFICATION AUDIT 

INSPECTIONS to verify that inspections are 

consistently performed according state 

program’s written inspection procedures 

described in Standard 3? 

2. Conduct a minimum of two FIELD 

INSPECTION AUDITS per inspector 

conducted every 36 months? 

3. Select inspections for FIELD INSPECTION 

AUDITS that include the highest risk 

manufactured food firms that the inspector 

is trained for including specialized food 

inspections? 

4. Complete Appendix 4.3 or equivalent 

form be used to document FIELD 

INSPECTION AUDITS? 

5. Complete Appendix 4.3a or equivalent 

form document overall rating calculations 

of FIELD INSPECTION AUDITS? 

Manufactured Food Regulatory Program Standards 65 September 2022 
 

 

Appendix 4.1 

Program Elements Yes/No 

If no, please explain why element is not 

met. May use this space for additional 

notes. 

4.3.3 Inspection Report Audit 

Does the state program: 

1. Conduct a periodic review of inspection 

reports to verify that inspectional findings 

are obtained and reported according to 

established written procedure? 

2. Use a random selection of inspection 

reports based on the number of inspections 

completed in the last 12 months using the 

table in 4.3.3.1? 

3. Take seven percent (7%) of inspection 

reports reviewed from inspections that 

were FIELD INSPECTION AUDITS? 

4. Complete Appendix 4.4 or equivalent 

form to document inspection report 

audits? 

5. Complete Appendix 4.4a or equivalent 

form to document overall rating 

calculations of inspection report audits? 

4.3.4 Sample Report Audit 

Does the state program: 

1. Conduct a periodic review of sample 

reports to verify that samples were 

collected, identified, recorded, and 

submitted according to established written 

procedure? 

2. Use a random selection of sample reports 

based on the number of samples collected 

in the last 12 months using the table in 

4.3.4.1? 

3. Complete Appendix 4.5 or equivalent 

form to document sample report audits? 

4. Complete Appendix 4.5a or equivalent 

form to document overall rating 

calculations of sample report audits? 

4.3.5 CORRECTIVE ACTION 

Does the state program initiate CORRECTIVE 

ACTIONS as described in 9.3.2 when the FIELD 

INSPECTION AUDIT, inspection report audit, or 

sample report audit meets one or more of the 

conditions below: 

1. An individual receives a rating of “needs 

improvement”? 

Manufactured Food Regulatory Program Standards 66 September 2022 
Appendix 4.1 

Program Elements Yes/No 

If no, please explain why element is not 

met. May use this space for additional 

notes. 

2. A single performance factor for the 

program falls below 80%, or four or more 

“needs improvement” ratings are 

identified in a single performance factor. 

Note that if fewer than four audits are 

conducted, a performance deficiency may 

be considered for a single performance 

factor that “needs improvement”? 

3. An overall rating for the program falls 

below 80%? 

Assessment Completed By: 

Name Date: 

Manufactured Food Regulatory Program Standards 67 September 2022 
Appendix 4.2

Manufactured Food Regulatory Program Standards 68 September 2022

Appendix 4.2: Instructions for Performance Ratings of Audit Findings 

The three performance rating of audit findings summary appendices (4.3a, 4.4a and 4.5a) allow the state 

program to recognize trends and identify specific areas in their audit program that may need 

improvement. 

These summary appendices are used to calculate an overall rating during the performance period and 

identify areas for improvement. The state program shall initiate CORRECTIVE ACTIONS as described in 

9.3.2 when one or more of the conditions below are met: (a) an individual receives an overall rating of 

“needs improvement”; (b) a single performance factor for the program falls below 80%; or (c) an overall 

rating for the program falls below 80%.

INSTRUCTIONS: (1) For each audit, record the manufactured food firm identification number, 

inspection date, auditor’s initials, and date of audit. 

(2) For each audit (vertical column), record the rating for each performance 

factor (A = acceptable; NI = needs improvement). Record the individual audit 

score on the row indicated. 

(3) Count the number of “A” and “NI” for each performance factor 

(horizontal) and record the total number of “A” and “NI” ratings. Calculate the 

performance factor score using the formula below:

At = horizontal total of acceptable ratings.

NIt = horizontal total of needs improvement ratings.

Performance Factor Score = [At/(At + Nit)] x 100

(4) Sum the Total Number of “A” and “NI” ratings for all audits. 

∑ At = vertical sum of acceptable ratings.

∑ NIt = vertical sum of needs improvement ratings.

NOTE: ∑ is the statistical symbol for the sum of all numbers.

(5) Calculate the cumulative score for all audits. Record the cumulative score 

in the space provided at the top of the worksheet.

Cumulative Score = [ ∑ At / ( ∑ At + ∑ NIt )] x 100 

(6) Identify and make notes about trends and single performance factors rated 

as “NI” in multiple audits.
Appendix 4.3 

Manufactured Food Regulatory Program Standards 69 September 2022

Appendix 4.3: Field Inspection Audit Form

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

FIELD INSPECTION AUDIT

AUDITOR STATE INSPECTOR

FIRM Name FEI NUMBER

FIRM ADDRESS

PRODUCT(S) COVERED

AUDIT DATE TIME IN/OUT OVERALL RATING

 Acceptable Needs Improvement

NOTE: Every item marked “needs improvement” must be accompanied by an explanation of 

why the item was judged as needing improvement. 

Overall Rating: If three or less items are marked "needs improvement," the overall rating is 

"acceptable." If four or more items are marked "needs improvement," the overall rating is "needs 

improvement." The overall rating must be marked in the space provided in the header on the first 

page.

All questions must be answered "acceptable" or "needs improvement," except for section II.A. 

Inspection Observations and Performance for ’HACCP-Regulated’ Facilities, section IV. Inspectional 

Observations and Performance for Limited Scope PC and Modified Audits, section V. Inspection 

Observations and Performance for Transportation Operations Subject to the Sanitary Transportation 

of Human and Animal Food Rule, and section VI. Inspection Observations and Performance for Food 

Defense Plan Reviews. If the manufactured food firm is not subject to Seafood or Juice HACCP 

regulations or preventive controls regulations (including modified scope requirements), sanitary 

transportation regulations, and intentional adulteration regulations, leave the scoring for these 

questions blank and check “not applicable.” 

If four or more evaluated items are marked as "needs improvement," the state program manager must 

be notified by the QUALIFIED FIELD INSPECTION AUDITOR that additional training or other performance 

improvement measures for the inspector being audited should be initiated. All contract inspectors who 

receive an overall audit score of "needs improvement" shall receive remedial training in deficient 

areas or as agreed upon by the state and FDA Division prior to resuming contract inspection duties. 
Appendix 4.3 

Manufactured Food Regulatory Program Standards 70 September 2022

I. PRE-INSPECTION ASSESSMENT

1. Did the inspector review the state’s establishment file for the previous inspection report and

possible complaints, or access other available resources in preparation for the inspection?

Acceptable Needs Improvement

Comments (required for Needs Improvement)

2. Did the inspector have the appropriate equipment and forms to properly conduct the inspection?

Acceptable Needs Improvement

Comments (required for Needs Improvement)

II. INSPECTION OBSERVATIONS AND PERFORMANCE

1. Was the FDA/state jurisdiction established?

Acceptable Needs Improvement

Comments (required for Needs Improvement)

2. Did the inspector select an appropriate product for the inspection and, if necessary, make

appropriate adjustments based on what the firm was producing?

Acceptable Needs Improvement

Comments (required for Needs Improvement)

3. Did the inspector assess the employee practices critical to the safe production and storage of food?

Acceptable Needs Improvement

Comments (required for Needs Improvement)
Appendix 4.3 

Manufactured Food Regulatory Program Standards 71 September 2022

4. Did the inspector properly evaluate the likelihood that conditions, practices, components, and/or

labeling could cause the product to be adulterated or misbranded?

Acceptable Needs Improvement

Comments (required for Needs Improvement)

5. Did the inspector recognize significant violative conditions or practices, if present, and record

findings consistent with state and/or the FDA procedures?

Acceptable Needs Improvement

Comments (required for Needs Improvement)

6. Did the inspector demonstrate the ability to distinguish between significant versus insignificant

observations and isolated incidents versus trends?

Acceptable Needs Improvement

Comments (required for Needs Improvement)

7. Did the inspector review and evaluate the appropriate records and procedures for this

establishment’s operation and effectively apply the information obtained from this review?

Acceptable Needs Improvement

Comments (required for Needs Improvement)

8. Did the inspector collect adequate evidence and documentation in accordance with state and/or

FDA procedures given the nature of the inspectional findings?

Acceptable Needs Improvement

Comments (required for Needs Improvement)
Appendix 4.3 

Manufactured Food Regulatory Program Standards 72 September 2022

9. Did the inspector verify correction of deficiencies identified during the previous inspection?

Acceptable Needs Improvement

Comments (required for Needs Improvement)

10. Did the inspector act in a professional manner and demonstrate proper sanitary practices during the

inspection?

Acceptable Needs Improvement

Comments (required for Needs Improvement)

II. A. INSPECTION OBSERVATIONS AND PERFORMANCE FOR ‘HACCPREGULATED’ FACILITIES

Note to Auditor: These four questions apply to only firms subject to HACCP regulations. These four 

questions should be left blank for manufactured food firms not subject to HACCP regulations.

1. Did the inspector use the “Fish and Fishery Products Hazards and Controls Guide” or the “Juice

Hazard Analysis Critical Control Point Hazards and Controls Guidance”, as appropriate, to

identify and evaluate the HAZARDS associated with the product and process?

 Acceptable Needs Improvement Not Applicable 

Comments (required for Needs Improvement)

2. Did the inspector assess the manufactured food firm’s implementation of sanitation monitoring for

the applicable eight key areas of sanitation?

 Acceptable Needs Improvement Not Applicable 

Comments (required for Needs Improvement)
Appendix 4.3 

Manufactured Food Regulatory Program Standards 73 September 2022

3. Did the inspector review the firm’s HACCP plan (or necessary process controls in the absence of a

HACCP plan) and applicable monitoring, verification, and corrective action records, including

those related to sanitation?

 Acceptable Needs Improvement Not Applicable 

Comments (required for Needs Improvement)

4. Did the inspector recognize deficiencies in the firm’s monitoring and sanitation procedures

through in-plant observations?

 Acceptable Needs Improvement Not Applicable 

Comments (required for Needs Improvement)

III. ORAL AND WRITTEN COMMUNICATION

1. Did the inspector identify himself/herself and make appropriate introductions, which include

explaining the purpose and scope of the inspection?

 Acceptable Needs Improvement 

Comments (required for Needs Improvement)

2. Did the inspector use suitable interviewing techniques?

Acceptable Needs Improvement

Comments (required for Needs Improvement)

3. Did the inspector explain findings clearly and adequately throughout the inspection?

Acceptable Needs Improvement

Comments (required for Needs Improvement)
Appendix 4.3 

Manufactured Food Regulatory Program Standards 74 September 2022

4. Did the inspector alert the firm’s appropriate management when immediate corrective action was 

necessary?

 Acceptable Needs Improvement 

Comments (required for Needs Improvement) 

 

5. Did the inspector answer questions and provide information in an appropriate manner?

 Acceptable Needs Improvement 

Comments (required for Needs Improvement) 

 

6. Did the inspector write their findings accurately, clearly, and concisely on the state 

form/document or Form FDA 483 left with the firm?

 Acceptable Needs Improvement 

Comments (required for Needs Improvement) 

 

IV. INSPECTION OBSERVATIONS AND PERFORMANCE FOR LIMITED SCOPE PC 

AND MODIFIED AUDITS

Note to Auditor: Question 2 only applies to limited scope PC inspections. Question 3 only applies to 

manufactured food firms that have submitted a qualified facility attestation. Question 4 only applies to 

facilities solely engaged in the storage of unexposed packaged food. If these questions do not apply, 

select Not Applicable.

1. Did the inspector properly evaluate the current good manufacturing practice requirements (21CFR 

117 Subparts A, B, and F, or equivalent state regulation)? This question applies to all audits 

performed including food, seafood, and juice. It cannot be left blank. 

 Acceptable Needs Improvement 

Comments (required for Needs Improvement) 

 
Appendix 4.3 

Manufactured Food Regulatory Program Standards 75 September 2022

2. Did the inspector conduct a broad-based assessment of the preventive controls program where 

necessary? Applies only to limited scope PC. If this question does not apply, select Not 

Applicable.

 Acceptable Needs Improvement Not Applicable 

Comments (required for Needs Improvement) 

 

3. Did the inspector verify whether the facility has attested and if so confirm whether the provisions 

in the attestation were understood? Applies only to qualified facilities. If this question does not 

apply, select Not Applicable. 

 Acceptable Needs Improvement Not Applicable 

Comments (required for Needs Improvement) 

 

4. Did the inspector properly evaluate the implementation of time/temperature controls? Only answer 

if the facility is a warehouse solely engaged in the storage of unexposed packaged food that 

requires refrigeration for safety. If this question does not apply, select Not Applicable. 

 Acceptable Needs Improvement Not Applicable 

Comments (required for Needs Improvement) 

 

V. INSPECTION OBSERVATIONS AND PERFORMANCE FOR TRANSPORTATION 

OPERATIONS SUBJECT TO THE SANITARY TRANSPORTATION OF HUMAN AND 

ANIMAL FOOD RULE

1. Did the inspector conduct an assessment of the sanitary transportation practices applicable to 

transportation operations? 

 Acceptable Needs Improvement Not Applicable

Comments (required for Needs Improvement) 

 
Appendix 4.3 

Manufactured Food Regulatory Program Standards 76 September 2022

VI. INSPECTION OBSERVATIONS AND PERFORMANCE FOR FOOD DEFENSE 

PLAN REVIEWS

1. Did the inspector conduct an assessment of the food defense plan, including review of mitigation 

strategies, monitoring, corrective actions, and verification activities? 

 Acceptable Needs Improvement Not Applicable 

Comments (required for Needs Improvement) 

 

ADDITIONAL COMMENTS

SIGNATURE OF AUDITOR DATE

 
 

 

Appendix 4.3a 

Appendix 4.3a: Summary of Field Inspection Audit Findings 

State Agency: Performance Period: 

Reviewed By: Date: Performance Rating: 

Performance 

factors (5) 

Auditor’s initials and date of audit (1) At 

(3) 

NIt 

(3) 

Performance ratings (2) 

I.1 

I.2 

II.1 

II.2 

II.3 

II.4 

II.5 

II.6 

II.7 

II.8 

II.9 

II.10 

IIA.1 

IIA.2 

IIA.3 

IIA.4 

III.1 

III.2 

III.3 

III.4 

III.5 

III.6 

IV. 1 

IV.2 

IV.3 

IV.4 

V.1 

VI.1 

Subtotal Enter the sum of the totals from all continuation sheets. 

Total Enter the final sums (subtotal + sums of (3) on this form). 

(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS 

IMPROVEMENT” IN MULTIPLE AUDITS. 

Manufactured Food Regulatory Program Standards 77 September 2022 
 

Appendix 4.3a 

State Agency: Performance Period: 

Performance 

factors (5) 

Auditor’s initials and date of audit (1) 

At 

(3) 

NIt 

(3) 

Performance ratings (2) 

I.1 

I.2 

II.1 

II.2 

II.3 

II.4 

II.5 

II.6 

II.7 

II.8 

II.9 

II.10 

IIA.1 

IIA.2 

IIA.3 

IIA.4 

III.1 

III.2 

III.3 

III.4 

III.5 

III.6 

IV.1 

IV.2 

IV.3 

IV.4 

V.1 

VI.1 

Total Enter the sums of (3). 

(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS 

IMPROVEMENT” IN MULTIPLE AUDITS. 

Manufactured Food Regulatory Program Standards 78 September 2022 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

□ □ 

□ □ 

□ □ 

□ □ 

□ 

□ 

Appendix 4.4 

Appendix 4.4: Inspection Report Audit Form 

MANUFACTURED FOOD REGULATORY PROGRAM STANDARDS 

INSPECTION REPORT AUDIT FORM 

AUDITOR: DATE OF AUDIT: 

DATE OF INSPECTION: 

FIRM NAME: Type of Inspection:

 General Food Seafood HACCP 

FIRM ADDRESS: Juice HACCP LACF 

Acidified Preventive Controls 

Other: 

TOTAL NUMBER: 

Acceptable 

Needs Improvement 

Audit Score: 

AUDIT RATING: 

Acceptable 

Needs Improvement 

INSTRUCTIONS TO THE AUDITOR 

All performance factors must be rated “Acceptable” or “Needs Improvement.” The total number of 

“Acceptable” and “Needs Improvement,” as well as the audit score and audit rating, must be 

recorded in the space above. 

To calculate the audit score: Audit Score = [# Acceptable/ (# Acceptable + # Needs Improvement)] x 

100. 

If the audit score is below 80%, the audit rating must be marked as “Needs Improvement.” 

I. ORGANIZATION AND RECORDS OF FINDINGS 

1. The inspector submitted the report within designated timeframes. 

Acceptable Needs Improvement 

Comments (required for Needs Improvement) 

Manufactured Food Regulatory Program Standards 79 September 2022 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

□ □ 

□ □ 

□ □ 

□ □ 

□ □ 

□ □ 

Appendix 4.4 

2. All required fields on inspection report or related forms were completed. 

Acceptable Needs Improvement 

Comments (required for Needs Improvement) 

3. Written observations were clear and concise. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

4. The inspector followed all current and applicable report writing and documentation procedures. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

5. The inspector identified violations based on state and/or federal regulations. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

6. The inspector reviewed past inspection findings and acted on repeated or unresolved violations. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

7. The inspector recorded significant findings. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

Manufactured Food Regulatory Program Standards 80 September 2022 
 

 

 

□ □ 

□ □ 

□ □ 

Appendix 4.4 

8. The inspector recorded the collection of all samples, exhibits, photographs, or photocopies to 

support findings. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

9. The inspector obtained and documented on-site corrective action at the time of inspection as 

appropriate to the type of violation. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

10. The inspector followed through and documented compliance activities per state policy. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

GENERAL COMMENTS 

Enter any general comments or recommendations as a result of this audit. 

Manufactured Food Regulatory Program Standards 81 September 2022 
Manufactured Food Regulatory Program Standards 82 September 2022 

 

 

 

 

 

Appendix 4.4a 

Appendix 4.4a: Summary of Inspection Report Audit Findings 

State Agency: Performance Period: 

Reviewed By: Date: Performance Rating: 

Performance 

factors (5) 

Firm identification number and date of inspection (1) 

At 

(3) 

NIt 

(3) 

Performance ratings (2) 

I.1

I.2

I.3

I.4

I.5

I.6

I.7

I.8

I.9

I.10

Subtotal Enter the sum of the totals from all continuation sheets. 

Total Enter the final sums (subtotal + sums of (3) on this form). 

(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS

IMPROVEMENT” IN MULTIPLE AUDITS.
 

 

 

 

 

 

Appendix 4.4a 

State Agency: Performance Period: 

Performance 

factors (5) 

Firm identification number and date of inspection (1) 

At 

(3) 

NIt 

(3) 

Performance ratings (2) 

I.1 

I.2 

I.3 

I.4 

I.5 

I.6 

I.7 

I.8 

I.9 

I.10 

Subtotal Enter the sum of the totals from all continuation sheets. 

Total Enter the final sums (subtotal + sums of (3) on this form). 

(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS 

IMPROVEMENT” IN MULTIPLE AUDITS. 

Manufactured Food Regulatory Program Standards 83 September 2022 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

□ □ 

□ 

□ 

Appendix 4.5 

Appendix 4.5: Sample Report Audit Form 

MANUFACTURED FOOD REGULATORY PROGRAM STANDARDS 

SAMPLE REPORT AUDIT FORM 

AUDITOR: DATE OF AUDIT: 

DATE OF INSPECTION: 

FIRM NAME: 

FIRM ADDRESS: 

DATE OF COLLECTION: 

SAMPLE ID #: 

TOTAL NUMBER: 

Acceptable 

Needs Improvement 

Audit Score: 

AUDIT RATING: 

Acceptable 

Needs Improvement 

INSTRUCTIONS TO THE AUDITOR 

All performance factors must be rated “Acceptable” or “Needs Improvement.” The total number of 

“Acceptable” and “Needs Improvement,” as well as the audit score and audit rating, must be recorded 

in the space above. 

To calculate the audit score: Audit Score = [# Acceptable/ (# Acceptable + # Needs Improvement)] x 

100. 

If the audit score is below 80%, the audit rating must be marked as “Needs Improvement.” 

I. SAMPLE OBSERVATIONS AND PERFORMANCE 

1. Method of collection and equipment was appropriate. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

Manufactured Food Regulatory Program Standards 84 September 2022 
 

 

 

 

 

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Appendix 4.5 

2. Record sample chain of custody per state procedure. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

3. Sample was handled, packaged, and shipped to prevent compromising the condition or integrity of 

the sample, as evidenced by acceptance and testing by the receiving laboratory. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

4. Sample was submitted within prescribed timeframes. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

II. SAMPLE COLLECTION 

1. Date of sample collection was recorded. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

2. Product identification including name and manufacturing reference information was recorded. For 

environmental samples a description of the collection point is acceptable. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

Manufactured Food Regulatory Program Standards 85 September 2022 
 

 

 

 

 

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Appendix 4.5 

3. Description of product including sample size was recorded. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

4. Collection information, including method of collection, lot sampled, lot size, and any special 

techniques used to collect the sample was recorded. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

5. Location where sample was collected was recorded. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

6. Name and address of manufacturer, responsible party, guarantor, processor, or distributor were 

recorded. For environmental samples the physical location of the collection site and responsible 

party is acceptable. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

7. Sample type (surveillance, compliance, investigational, or regulatory) was recorded. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

Manufactured Food Regulatory Program Standards 86 September 2022 
 

 

 

 

 

 

□ □ 

□ □ 

□ □ 

Appendix 4.5 

8. The type of analysis requested was recorded if applicable. If the type of analysis is not required on 

sample report per state procedures this item is acceptable. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

9. Product labels or labeling information is collected or reproduced if required by state procedures. 

For environmental samples the description of the location of the sample collection point is 

acceptable. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

10. The sample identification assigned by the sampler at the time of collection was reported. 

Acceptable Needs improvement 

Comments (required for Needs Improvement) 

GENERAL COMMENTS 

Enter any general comments or recommendations as a result of this audit. 

Manufactured Food Regulatory Program Standards 87 September 2022 
 

 

Appendix 4.5a 

Appendix 4.5a: Summary of Sample Report Audit Findings 

State Agency: Performance Period: 

Reviewed By: Date: Performance Rating: 

Performance 

factors (5) 

Sample report identification number and date of sample collection (1) 

At 

(3) 

NIt 

(3) 

Performance ratings (2) 

I.1

I.2

I.3

I.4

II.1

II.2

II.3

II.4

II.5

II.6

II.7

II.8

II.9

II.10

Subtotal Enter the sum of the totals from all continuation sheets. 

Total Enter the final sums (subtotal + sums of (3) on this form). 

(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS

IMPROVEMENT” IN MULTIPLE AUDITS.

Manufactured Food Regulatory Program Standards 88 September 2022 
 

 

 

 

Appendix 4.5a 

State Agency: Performance Period: 

Performance 

factors (5) 

Sample report identification number and date of sample collection (1) 

At 

(3) 

NIt 

(3) 

Performance ratings (2) 

I.1

I.2

I.3

I.4

II.1

II.2

II.3

II.4

II.5

II.6

II.7

II.8

II.9

II.10

Total Enter the sums of (3). 

(5) USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS

IMPROVEMENT” IN MULTIPLE AUDITS.

Manufactured Food Regulatory Program Standards 89 September 2022 
Appendix 5.1 

Manufactured Food Regulatory Program Standards 90 September 2022

Appendix 5.1: Self-Assessment Worksheet

Instructions: The state program identifies if they have a specified component then evaluates if it includes 

the associated components. If the state program has the main component and associated components 

indicate “Yes”. If not, indicate “No”. 

State Agency:

Program Elements Yes/No

If no, please explain why element is not 

met. May use this space for additional 

notes.

5.3.1 Coordination with Other Authorities 

Does the state program: 

1. Have a Memorandum of Understanding 

for foodborne illness outbreak 

investigations, if required? 

2. Have a written procedure that identifies 

and describes the roles, responsibilities, 

and duties of each program responsible 

for supporting foodborne illness outbreak 

response in requirements 5.3.2 – 5.3.5? 

3. Have a written procedure that describes 

agency collaboration as necessary with 

the FDA and other appropriate local, 

state, and federal authorities in multijurisdictional FOOD-RELATED INCIDENTS? 

4. Have a written procedure that designates 

a response coordinator(s) to guide 

program investigation efforts in 

collaboration with all agencies involved? 

5. Have a written procedure that describes 

how all relevant agencies are notified in 

case of FOOD-RELATED INCIDENTS? 

6. Have a written procedure that provides 

guidance for notification of appropriate 

law enforcement agencies when 

intentional food contamination is 

suspected or threatened?

7. Have a written procedure that describes 

the maintenance of a list(s) of relevant 

agencies and emergency contacts that is 

updated at least yearly?
Appendix 5.1 

Manufactured Food Regulatory Program Standards 91 September 2022

Program Elements Yes/No

If no, please explain why element is not 

met. May use this space for additional 

notes.

5.3.2 Surveillance 

Does the state program:

1. Use epidemiological information from 

local, state, or federal agencies to detect 

incidents or outbreaks of foodborne 

illness or injury?

2. Maintain notifications of FOOD-RELATED 

INCIDENTS that are reported to the 

program, in a log(s) or database(s)? 

5.3.3 Investigation/ENVIRONMENTAL ASSESSMENT

Does the state program:

1. Use established procedures with 

recommended timeframes to investigate 

reports of FOOD-RELATED INCIDENTS?

2. Collect ENVIRONMENTAL ASSESSMENT

data using established procedures similar 

to those found in IAFP and CIFOR?

3. Coordinate the TRACEBACK and 

TRACEFORWARD of food implicated in an 

illness, injury, outbreak or found to 

contain a HAZARD in accordance with 

written procedures?

4. Have access to laboratory support for 

investigation of reports of FOOD-RELATED 

INCIDENTS?

5. Correlate and analyze ENVIRONMENTAL 

ASSESSMENT data to identify contributing 

factors and antecedents that led to food 

contamination or adulteration causing 

illness, injury, or outbreak? 

5.3.4 Control Measures

Does the state program:

1. Mitigate and contain food-related illness, 

injury and HAZARDS through strategies 

that include industry education, 

enforcement, and public awareness 

activities?

2. Maintain a written procedure with 

criteria for releasing prevention guidance 

and information to the public?
Appendix 5.1 

Manufactured Food Regulatory Program Standards 92 September 2022

Program Elements Yes/No

If no, please explain why element is not 

met. May use this space for additional 

notes.

5.3.5 Post Response

Does the state program:

1. Maintain program investigation and 

ENVIRONMENTAL ASSESSMENT findings 

and reports?

2. Distribute final program investigation 

report(s), including an ENVIRONMENTAL 

ASSESSMENT if completed to relevant 

agencies responsible for reporting 

contributing factors and antecedents to 

CDC?

3. Distribute recommendations, when 

available, from investigation and 

ENVIRONMENTAL ASSESSMENT findings 

and reports to relevant agencies and 

stakeholders responsible for prevention, 

education, and outreach?

Assessment Completed By: 

Name Date:
 

 

 

 

 

 

 

 

Appendix 6.1 

Appendix 6.1: Self-Assessment Worksheet 

Instructions: The state program identifies if they have a specified component then evaluates if it includes 

the associated components. If the state program has the main component and associated components 

indicate “Yes”. If not, indicate “No”. 

State Agency: 

Program Elements Yes/No

If no, please explain why element is not 

met. May use this space for additional 

notes. 

6.3.1 Compliance and Enforcement Program 

Does the state have a written compliance 

and enforcement program that: 

1. Contains written compliance and 

enforcement strategies? 

2. Describes the procedure to monitor: 

CRITICAL VIOLATIONS, chronic 

violations, and chronic violators? 

3. Uses a risk-based process to determine 

when a directed investigation, follow-up,

or re-inspection is needed? 

4. Establishes a framework for compliance 

and enforcement progressive actions? 

6.3.2 Performance Review 

Does the state program conduct a 

performance review: 

1. Annually? 

2. Document on Appendix 6.2, or 

equivalent form to evaluate if internal 

compliance and enforcement actions are 

followed? 

3. Use results of the review to identify 

improvements and modify procedures? 

4. Require a CORRECTIVE ACTION, which 

will be documented on the STRATEGIC 

IMPROVEMENT PLAN, if performance 

ratings fall below 80%? 

Assessment Completed By:

Name Date: 

Manufactured Food Regulatory Program Standards 93 September 2022 
 

 

 

II 11 

Appendix 6.2 

Appendix 6.2: Calculation of the Level of Conformance to Compliance Procedures 

State Agency: 

Rating for conformance to compliance procedures (4): 

Food firm 

identification 

number (1) 

Enforcement action 

recommended (1) 

Compliance 

procedures 

followed? (2) 

Use this space for comments or to 

explain improvements needed to follow 

compliance procedures 

Subtotal 

Enter the sum of the 

totals from all 

continuation sheets. 

At = NIt = 

Total 

Enter the final sums 

--subtotal + sums of 

(2) -- on this form. 

At = NIt = 

Assessment Completed By: 

Name Date: 

Manufactured Food Regulatory Program Standards 94 September 2022 
 

Appendix 6.2 

Food firm 

identification 

number (1) 

Enforcement action 

recommended (1) 

Compliance 

procedures 

followed? (2) 

Use this space for comments or to 

explain improvements needed to follow 

compliance procedures 

Total Enter the sums of 

(2). At = NIt = 

Manufactured Food Regulatory Program Standards 95 September 2022 
Appendix 6.2a

Manufactured Food Regulatory Program Standards 96 September 2022

Appendix 6.2a: Instructions for Performance Review of Enforcement Actions

Appendix 6.2 is used to record the enforcement actions recommended in the past 12 months and to 

calculate the state agency’s rating for conformance to compliance procedures. Supporting documents 

should be referenced and maintained by the state agency. Please indicate if an action was taken because 

voluntary compliance was not achieved.

It is recommended that all cases be reviewed; otherwise, a statistical approach should be used to 

determine a representative number of cases. Use continuation sheets as necessary. 

INSTRUCTIONS: (1) Record the manufactured food firm identification number and the 

recommended enforcement action.

(2) For each type of enforcement action, record the level of conformance to 

compliance procedures.

A = acceptable; NI = needs improvement

(3) Record the At and NIt .

At = vertical sum of acceptable ratings.

NIt = vertical sum of needs improvement ratings.

(4) Calculate the overall rating for the state agency’s conformance to 

compliance procedures. Record the rating in the box located at the top of 

Appendix 6.2. 

FORMULA: Performance factor rating = [ At / ( At + NIt )] x 100 
Appendix 7.1 

Manufactured Food Regulatory Program Standards 97 September 2022

Appendix 7.1: Self-Assessment Worksheet

Instructions: The state program identifies if they have a specified component then evaluates if it includes 

the associated components. If the state program has the main component and associated components 

indicate “Yes”. If not, indicate “No”. 

State Agency:

Program Elements Yes/No If no, please explain why element is not met. 

May use this space for additional notes.

7.3 Outreach Methods

Does the state program have a written 

procedure that includes how the program 

will: 

1. Identify the methods that will be used 

for communication with the food 

industry stakeholders and consumers?

2. Interact with industry and consumers by 

sponsoring or actively participating in 

meetings such as task forces, advisory 

boards, or advisory committees?

3. Tailor outreach efforts to a target 

population which may include 

dissemination of information using 

electronic sources and traditional 

methods such as mailings?

4. Document and evaluate OUTREACH 

ACTIVITY EVENTS using Appendix 7.2 or 

equivalent form? Include documents 

such as agendas and meeting summaries 

and program evaluations.

Assessment Completed By: 

Name Date:
□ □ 

Appendix 7.2 

Appendix 7.2: Outreach Activity Event and Self-Evaluation Worksheet 

State Agency: 

This worksheet is completed by the state program to document OUTREACH ACTIVITY EVENTS. Attach 

verifying documents such as agendas and meeting summaries and program evaluations to this form. 

Section I. Overview of Outreach Activity 

a. Type of OUTREACH ACTIVITY EVENT (check one): 

Seminar Workshop Training course 

Other 

b. Subject or name of OUTREACH ACTIVITY EVENT: 

c. Date of OUTREACH ACTIVITY EVENT: 

d. Host organization: 

Section II. Self-Evaluation of OUTREACH ACTIVITY EVENTS 

Program Elements Yes/No If no, please explain. 

a. The purpose and objectives were clearly 

defined. 

b. The content of the OUTREACH ACTIVITY EVENT 

was consistent with the objectives 

c. The activity was tailored to a target population. 

Identify target population: 

d. An evaluation was completed by attendees. 

e. State program addressed comments from 

attendees in Section III of this form. 

Section III. Critique of OUTREACH ACTIVITY EVENT 

Discuss what went well, what could be done better, and what more could be done to improve the 

OUTREACH ACTIVITY EVENT. Address comments from attendees, if available. 

Assessment Completed By: 

Name Date: 

Manufactured Food Regulatory Program Standards 98 September 2022 
Appendix 8.1 

Appendix 8.1: Self-Assessment Worksheet 

Instructions: The state program identifies if they have a specified component then evaluates if it includes 

the associated components. If the state program has the main component and associated components 

indicate “Yes”. If not, indicate “No”. 

State Agency: 

Program Elements 

8.3.1 Program Assessment 

Yes/No 

If no, please explain why element is not 

met. May use this space for additional 

notes. 

Does the state program complete the Resource 

Summary Report to assess staffing, funding, 

and equipment using Appendix 8.2 or 

equivalent form? 

8.3.2 Staffing 

Does the state program: 

1. Conduct a calculation for determining the 

required number of inspectors to inspect 

manufactured food firms in its 

manufactured food firm inventory at a 

frequency that is based on the manufactured 

food firm’s risk classification and the 

necessary inspection and travel time? 

2. Document the calculation for determining 

the required number of inspectors to inspect 

manufactured food firms in its 

manufactured food firm inventory? 

8.3.3 Equipment 

Does the state program establish and maintain a 

list of equipment required for inspections and 

sampling? 

Assessment Completed By: 

Name Date: 

Manufactured Food Regulatory Program Standards 99 September 2022 
Appendix 8.2 

Appendix 8.2: Resource Summary Report 

State Agency: 

Does the state program have sufficient funds, staff, equipment, and resources necessary to meet the 

program standards? Answer “Yes” or “No” in each block. If “No”, please explain. Use additional 

pages as needed. 

Standard Funding Staffing Equipment Other resources needed 

1 Regulatory 

Foundation 

2 Training Program 

3 Inspection 

Program 

4 Inspection Audit 

Program 

5 

Food-related 

Illness, 

Outbreaks, and 

Hazard Response 

6 Compliance and 

Enforcement 

7 

Industry and 

Community 

Relations 

8 Program 

Resources 

9 Program 

Assessment 

10 Laboratory 

Support 

Assessment Completed By: 

Name Date: 

Manufactured Food Regulatory Program Standards 100 September 2022 
Appendix 8.2a

Manufactured Food Regulatory Program Standards 101 September 2022

Appendix 8.2a: Resource Summary Report Instructions

The Appendix 8.2 Resource Summary Report summarizes the state program’s assessment of their resources 

for all ten Standards. 

Instructions: For each Standard, the state program conducts an assessment of resource needs for staffing, 

equipment, and funding for the manufactured food regulatory program. Answer “Yes” or ”No” in each 

block. If the response is “No”, please explain the additional resources needed. Use additional pages as 

needed.

When completing Appendix 8.2 the state program should consider the following items: 

• Regulatory Foundation (Standard 1). The state program has resources to evaluate the scope of its 

legal authority and regulatory provisions to ensure the protection of manufactured food within its 

jurisdiction.

• Training Program (Standard 2). The state program has resources to implement a training plan that 

ensures all inspectors conducting manufactured food inspections complete course curriculums, field 

training, and continuing education to adequately perform their work. 

• Inspection Program (Standard 3). The state program has resources to implement a risk-based 

inspection program that reduces the occurrence of foodborne illness, injury, or allergic reactions.

• Inspection Audit Program (Standard 4). The state program has resources to administer and monitor 

the quality of its inspections and sample collections. 

• Food-related Illness, Outbreaks, and Hazards Response (Standard 5). The state program has the 

resources necessary to detect, investigate, mitigate, document, and analyze the food-related incidents 

to stop, control and prevent hazards that are likely to result in a foodborne illness, injury, or outbreak.

• Compliance and Enforcement Program (Standard 6). The state program has resources to administer 

and monitor a compliance and enforcement program.

• Industry and Community Relations (Standard 7). The state program has resources that allow 

participation and assessment of outreach activities and OUTREACH ACTIVITY EVENTS.

• Program Resources (Standard 8). The state program has resources to conduct an assessment of 

resource needs for staffing, equipment, and funding to support a manufactured food regulatory 

program. 

• Program Assessment (Standard 9). The state program has the resources to conduct self-assessments 

and develop and manage a STRATEGIC IMPROVEMENT PLAN resulting in CONFORMANCE with the 

Manufactured Food Regulatory Program Standards and a process for continuous improvement. The 

state program has resources to ensures that all guidance, procedures, documents, and forms required 

by the standards are CURRENT AND FIT-FOR-USE.

• Laboratory Support (Standard 10). The state program has resources to access laboratory services 

needed to support program functions.
 

 

 

 

 

 

 

 

 

 

 

Appendix 9.1 

Appendix 9.1: Self-Assessment Worksheet 

Instructions: The state program identifies if they have a specified component then evaluates if it includes 

the associated components. If the state program has the main component and associated components 

indicate “Yes”. If not, indicate “No”. 

State Agency: 

Program Elements Yes/No 

If no, please explain why element is not 

met. May use this space for additional 

notes. 

9.3.1 Does the state program conduct a 

baseline self-assessment: 

1. Within the first year? 

2. Using the self-assessment worksheets 

associated with each standard? 

3. Using the results of its self-assessments 

to complete Appendix 9.2 (or 

equivalent form)? 

9.3.2 If the state program fails to meet 

any of the program elements or 

documentation requirements, 

whether identified through a selfassessment or FDA ASSESSMENTS, 

did the state program develop a 

STRATEGIC IMPROVEMENT PLAN? 

Does the STRATEGIC IMPROVEMENT PLAN 

include: 

1. The individual element or 

documentation requirement that was not 

met? 

2. Improvements or CORRECTIONS needed 

to meet the program element or 

documentation requirement of the 

standard? 

3. The cause for any non-CONFORMANCE 

requiring CORRECTION when the 

program was previously in 

CONFORMANCE with the individual 

element or documentation requirement 

of a standard? 

Manufactured Food Regulatory Program Standards 102 September 2022 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Appendix 9.1 

Program Elements Yes/No 

If no, please explain why element is not 

met. May use this space for additional 

notes. 

4. The CORRECTIVE ACTION taken to 

prevent future similar nonCONFORMANCE when the program was 

previously in CONFORMANCE with the 

individual element or documentation 

requirement of the standard that was 

corrected? 

5. Projected completion dates for each 

task? 

6. Personnel responsible? 

7. Date completed for each task? 

9.3.3 Does the state program review 

and update the self-assessment 

appendices and STRATEGIC 

IMPROVEMENT PLAN at least 

annually? 

9.3.4 Does the state program: 

1. Participate in FDA ASSESSMENTS to 

determine IMPLEMENTATION and 

CONFORMANCE to the standards? 

2. Address FDA ASSESSMENT 

observations and establish CORRECTIVE 

ACTION? 

9.3.5 Does the state program: 

1. Have a written DOCUMENT CONTROL 

procedure? 

a. Is the state program able to 

demonstrate that all documents are 

CURRENT AND FIT-FOR-USE through 

maintenance of a master document 

list or other system? 

b. Does the master document list or 

other system show: 

i. Documents are reviewed for 

accuracy? 

ii. Documents are approved for 

release by authorized 

personnel and signed/dated 

with an approval or revision 

date? 

Manufactured Food Regulatory Program Standards 103 September 2022 
 

 

 

Appendix 9.1 

Program Elements Yes/No 

If no, please explain why element is not 

met. May use this space for additional 

notes. 

iii. Documents are distributed to 

applicable staff, as 

appropriate, and used at the 

location where the prescribed 

activity is performed? 

2. Retain records or procedures required 

under each standard for the three 

previous years, or per the state 

program’s record retention policy, 

whichever is longer? 

Assessment Completed By: 

Name Date: 

Manufactured Food Regulatory Program Standards 104 September 2022 
 

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Appendix 9.2 

Appendix 9.2: Self-Assessment Summary Report 

State Agency: 

Standard Self-Assessment IMPLEMENTATION

Explain improvements needed to 

fully IMPLEMENT standards 

(required for incomplete selfassessment and partial 

IMPLEMENTATION) 

Regulatory 

Foundation 

Complete 

Incomplete 

Hours used 

Full 

Partial 

Training Program 

Complete 

Incomplete 

Hours used 

Full 

Partial 

Inspection Program 

Complete 

Incomplete 

Hours used 

Full 

Partial 

Inspection Audit 

Program 

Complete 

Incomplete 

Hours used 

Full 

Partial 

Food-related Illness, 

Outbreak, and 

Hazard Response 

Complete 

Incomplete 

Hours used 

Full 

Partial 

Compliance and 

Enforcement 

Complete 

Incomplete 

Hours used 

Full 

Partial 

Outreach Activities 

Complete 

Incomplete 

Hours used 

Full 

Partial 

Program Resources 

Complete 

Incomplete 

Hours used 

Full 

Partial 

Manufactured Food Regulatory Program Standards 105 September 2022 
 

 

 

 

 

 

 

 

I I I l l 

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Appendix 9.2 

Standard Self-Assessment IMPLEMENTATION

Explain improvements needed to 

fully IMPLEMENT standards 

(required for incomplete selfassessment and partial 

IMPLEMENTATION) 

Program Assessment 

Complete 

Incomplete 

Hours used 

Full 

Partial 

Laboratory Support 

Complete 

Incomplete 

Hours used 

Full 

Partial 

Assessment Completed By: 

Name Date: 

Manufactured Food Regulatory Program Standards 106 September 2022 
 

 

 

 

 

 

 

 

Appendix 10.1 

Appendix 10.1: Self-Assessment Worksheet 

Instructions: The state program identifies if they have a specified component then evaluates if it includes 

the associated components. If the state program has the main component and associated components 

indicate “Yes”. If not, indicate “No”. 

State Agency: 

Program Elements Yes/No 

If no, please explain why element is not 

met. May use this space for additional 

notes. 

10.3.1 Laboratory Support 

Does the state program: 

1. Have access to a laboratory that is 

capable of analyzing a variety of samples 

including food, environmental, and 

clinical samples? 

2. Maintains a list of services for routine and 

non-routine analyses such as biological 

HAZARD determinations? 

3. Have a contract or written agreement with 

each PRIMARY SERVICING LABORATORY 

unless under the same administrative 

agency? The contract or written 

agreement can be a memorandum of 

understanding, e-mail, or any written 

format but must contain the components 

below: 

a. Define the responsibilities of each 

party; 

b. Describe the types of testing services 

to be performed; and 

c. Describe how exceptions to planned 

work will be communicated. 

4. Have documentation of the services 

provided, if services are provided from a 

non-PRIMARY SERVICING LABORATORY? 

10.3.2 ISO Accredited Laboratories 

Does the state program use laboratories that 

have a current accreditation to the ISO/IEC 

17025:2017 (or current version) standards to 

analyze food and environmental samples? 

Manufactured Food Regulatory Program Standards 107 September 2022 
 

 

 

 

 

 

Appendix 10.1 

10.3.3 Non-ISO Accredited Laboratories 

If not using laboratories holding accreditation to 

ISO/IEC 17025:2017 (or current version) for the 

analysis of food and environmental samples, is 

the program using laboratories that have in 

place a quality system which incorporates the 

following management and technical 

requirements at a minimum: 

1. A quality system that is documented and 

includes items 10.3.3.1.1 through 

10.3.3.1.6? 

2. A procedure that defines the activities 

necessary to take corrective action when 

non-conforming work occurs? 

3. A document control procedure that assures 

documents issued to personnel are current, 

suitable, and reviewed and approved by 

authorized personnel prior to release? 

4. A documented record keeping process that 

assures that records of original observations 

and data collection are maintained and 

sufficient to establish traceability of test 

results to sample handling and storage, to 

sample analysis including data collection, to 

equipment calibration and maintenance, and 

to the review of test results prior to release? 

5. A documented process to assure that 

reference materials and reference cultures 

used are fit for purpose, are not outdated, 

and are traceable to a lot number or other 

unique identifier? 

6. A documented process to assure that the 

laboratory participates in relevant and 

available proficiency testing activities? 

Assessment Completed By: 

Name Date: 

Manufactured Food Regulatory Program Standards 108 September 2022