Manufactured Food Regulatory Program Standards

September 2022

Summary of Changes

The collection of information has been approved by the Office of Management and 

Budget (OMB) under the Paperwork Reduction Act of 1995 and has been assigned 

OMB control number 0910-0601. 

A copy of the standards is available on the MFRPS site.

U.S. Department of Health and Human Services Food and Drug Administration

Office of Regulatory Affairs

OMB Control No. 0910-0601

Expiration Date: 09-30-2025
2022 MFRPS Summary of Changes Page 2 of 12

SUMMARY OF CHANGES

This summary provides a synopsis of the changes made to the 2022 Manufactured Food 

Regulatory Program Standards (MFRPS). The primary intent of this summary document is 

to provide a broad overview of substantive changes found in the 2022 MFRPS rather than

to identify every word or editing change. This summary document should not be relied 

upon as an absolute comparison that identifies each modification. Refer to the 2022 

MFRPS for detailed change information. 

Changes Recommended by the Manufactured Food Regulatory Program Alliance

(MFRPA)

The FDA works closely with stakeholders through the Association of Food and Drug

Officials (AFDO) Manufactured Food Regulatory Program Alliance (MFRPA) to review 

proposed changes to the MFRPS. Changes may be proposed by the FDA, or by

regulatory state programs. MFRPA proposed changes were provided to the Partnership

for Food Protection (PFP) Governing Council (GC) for review and comment. The PFP GC

does not serve as a voting body on the MFRPS change recommendations, but instead

provides technical review and overall executional and policy comments for the Alliance 

Board and the FDA to consider.

CHANGES MADE THROUGHOUT THE MFRPS

There were several updates and changes made to the 2022 MFRPS to improve program 

effectiveness, understanding, and clarity which are highlighted. Changes voted and 

approved by the MFRPA may be accessed on the MFRPS Index of Shared Documents 

and Best Practices by clicking the appropriate workgroup “Button” at the top of the page. 

Changes throughout this document are italicized and shown in blue. Numerous edits for 

uniformity and clarity were made to the 2022 MFRPS that are not included in this 

summary of changes document. For example, the term “manufactured food firm” is now

used consistently throughout the document rather than “food firms” or “establishments”.

TABLE OF CONTENTS

DEFINITIONS............................................................................................................................................. 3

STANDARD 1 – REGULATORY FOUNDATION.................................................................................. 4

STANDARD 2 – TRAINING PROGRAM................................................................................................ 5

STANDARD 3 – INSPECTION PROGRAM........................................................................................... 6

STANDARD 4 – INSPECTION AUDIT PROGRAM.............................................................................. 7

STANDARD 5 – FOOD RELATED ILLNESS, OUTBREAK AND HAZARDS RESPONSE........... 9

STANDARD 6 – COMPLIANCE AND ENFORCEMENT PROGRAM ............................................... 9

STANDARD 7 – INDUSTRY AND COMMUNITY RELATIONS .......................................................10

STANDARD 8 – PROGRAM RESOURCES........................................................................................10

STANDARD 9 – PROGRAM ASSESSMENT......................................................................................11

STANDARD 10 – LABORATORY SUPPORT.....................................................................................12
2022 MFRPS Summary of Changes Page 3 of 12

DEFINITIONS

• New Definitions

o 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’s program.

o CORRECTION: action to eliminate a detected non-CONFORMITY.

o CORRECTIVE ACTION(S): action to eliminate the cause of a nonCONFORMITY and to prevent recurrence.

• Revised Definitions

o EVALUATION: This definition was modified to say, “Evaluations 

are required for basic and each advanced (specialized) inspection 

type”. In addition, the evaluation should assess an inspector’s 

ability to “Assess advanced (specialized) inspection types (as 

applicable)”. Other required elements during an evaluation remain 

the same. References to use of the Appendix 4.5 Field Audit Form 

have been changed to the Appendix 4.3 Field Inspection Audit 

Form.

o FIELD INSPECTION AUDIT: The definition was modified to say an 

inspector is accompanied by a QUALIFIED FIELD INSPECTION

AUDITOR, rather by a QUALIFIED AUDITOR.

o NOT EQUIVALENT: The definition was modified to remove “there is 

such a state law but it does not apply to the State’s food plan or 

manufacturing establishment program”. The modified definition has 

been revised to the following:

 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. 

o QUALIFIED FIELD INSPECTION AUDITOR: This definition was 

modified to include reference to advanced food inspection training 

coursework and field training to include low-acid canned foods.

o QUALIFIED FIELD INSPECTION TRAINER: This definition was 

modified to include reference to advanced food inspection training 

coursework and field training to include low-acid canned foods.

o TRACEBACK: This is an existing term in the definitions. However, 

the definition has been revised to the following:

 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. 
2022 MFRPS Summary of Changes Page 4 of 12

o TRACEFORWARD: This is an existing term in the definitions. 

However, the definition has been revised to the following:

 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. 

o VERIFICATION AUDIT INSPECTION: This definition was modified 

to say it is an inspection in which an FDA or state QUALIFIED 

FIELD INSPECTION AUDITOR observes a state QUALIFIED FIELD 

INSPECTION AUDITOR performing an audit of a state inspector 

conducting an inspection.

o START DATE: This definition was modified to say it is the date an 

employee is hired or assigned to the manufactured food program as 

the beginning date for training timelines. 

• Removed Definitions

o HIGHLY SUSCEPTIBLE POPULATION: This term was removed as 

it was only referenced via the previous appendix 3.2 which is now a 

job aid. 

STANDARD 1 – REGULATORY FOUNDATION

DEFINITIONS

• New Definitions

o NO AUTHORITY

• Revised Definitions

o NOT EQUIVALENT

UPDATES MADE TO THE STANDARD

• 1.1 – Purpose: No Changes

• 1.2 – Requirement Summary: No Changes

• 1.3 – Program Elements: 

o 1.3.2, “REGULATORY FOUNDATION Assessment” has been revised as 

follows:

 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.

• The following statement was removed from section 1.3.2: “If 

the State program has not adopted the current version of a 

CFR provision the State must provide the revision date of 

the CFR that was adopted for each regulation”.
2022 MFRPS Summary of Changes Page 5 of 12

• 1.4 – Outcome: No changes

• 1.5 – Documentation: No changes

APPENDICES

• New Appendices: None

• Revised Appendices:

o Appendix 1.1, “Self-Assessment Worksheet”, was revised to remove 

“Revision date of the CFR that was adopted for each regulation if the 

State Program has not adopted the current version of a CFR provision”, 

under 1.3.2. 

o Appendix 1.2, “Regulatory Foundation Worksheet”, was previously titled, 

“Statutes and Regulations Worksheet”. Additional revisions include the 

following:

 The addition of drop-down options added for documenting whether

state laws and regulations are EQUIVALENT, EQUIVALENT IN 

EFFECT, NOT EQUIVALENT or NO AUTHORITY to sections of 

the current Federal Food, Drug, and Cosmetic Act (FD&C Act) and 

Code of Federal Regulations (CFR) Title 21.

 The addition of 21 CFR 1; Foreign Supplier Verification Program 

(Subpart L §1.500 – 1.514).

 The addition of 21 CFR 121, Mitigation Strategies to Protect Food 

From Intentional Adulteration.

• Removed Appendices: None

STANDARD 2 – TRAINING PROGRAM

DEFINITIONS

• New Definitions: None

• Revised Definitions

o EVALUATION

o FIELD INSPECTION AUDIT

o QUALIFIED FIELD INSPECTION AUDITOR

o QUALIFIED FIELD INSPECTION TRAINER

o START DATE

UPDATES MADE TO THE STANDARD

• 2.1 – Purpose: No Changes

• 2.2 – Requirement Summary: No Changes

• 2.3 – Program Elements: 

o 2.3.2, “Basic Food Inspection Training”, has been revised as follows:

 2.3.2.2.10, “Food defense”

• The words “awareness training” have been removed. 

o 2.3.3, “Advanced Food Inspection Training”, coursework requirements 

have been revised as follows:
2022 MFRPS Summary of Changes Page 6 of 12

 2.3.3.1.7, “Preventive Controls for Human Food”, has been added.

o 2.3.4, “Experienced Inspectors” requirements for CURRENT 

EXPERIENCED STAFF have been revised as follows:

 2.3.4.1.2, “Basic food inspections course work”, was previously 

titled, “Basic Course Work”.

 2.3.4.1.3, “Specialized food inspection course work certificates”, 

has been revised as follows:

• “Documentation in the Employee Training File” will now 

include “Statement or affidavit explaining the date and 

location that they have successfully completed the 

specialized food inspection training course work”.

• 2.4 – Outcome: No changes

• 2.5 – Documentation: No changes

APPENDICES

• New Appendices: None

• Revised Appendices: None

• Removed Appendices:

o Appendix 2.4, “Curriculum Example Basic Food Inspector Training”, has 

been reclassified as a job aid. 

STANDARD 3 – INSPECTION PROGRAM

DEFINITIONS

• No changes

UPDATES MADE TO THE STANDARD

• 3.1 – Purpose: No changes

• 3.2 – Requirement Summary: No changes

• 3.3 – Program Elements: 

o 3.3.2, “Inspection Procedure”, has been revised as follows: 

 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, supplychain 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 
2022 MFRPS Summary of Changes Page 7 of 12

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”.

 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”.

o 3.3.7, “Sampling Procedure”, has been revised as follows:

 Instructions for the documentation of special sample techniques is 

no longer required (3.3.7.2.4). 

• 3.4 – Outcome: No changes

• 3.5 – Documentation: No changes

APPENDICES

• New Appendices: None

• Revised Appendices:

o Appendix 3.1, “Self-Assessment Worksheet”, has been revised to include 

inspectional elements related to GMP inspections conducted under 21 

CFR 117, as well as for the inspection of hazard-analysis and risk-based 

preventive controls, sanitary transportation practices, and food defense 

plans, as appropriate.

• Removed Appendices: 

o Appendix 3.2, “Risk Classification Criteria for Food Plants”, has been 

reclassified as job aid. The information in this document has been 

modified to include the risk classification criteria described in the FD&C 

Act, Section 421(a)(1). 

STANDARD 4 – INSPECTION AUDIT PROGRAM

DEFINITIONS

• New Definitions:

o CORRECTIVE ACTION(S) 

• Revised Definitions

o EVALUATION

UPDATES MADE TO THE STANDARD

• 4.1 – Purpose: No changes

• 4.2 – Requirement Summary: No changes

• 4.3 – Program Elements: 

o 4.3.1, “Quality Assurance Program”, has been revised as follows:

 4.3.1.4, “Initiating CORRECTIVE ACTION(S), which will be 

documented on the STRATEGIC IMPROVEMENT PLAN as 
2022 MFRPS Summary of Changes Page 8 of 12

described in section 9.3.2”.

o 4.3.2, “FIELD INSPECTION AUDIT”, has been revised as follows:

 4.3.2.3, “State programs may use the current Form FDA 3610 in

lieu of Appendix 4.3”.

o 4.3.5, “CORRECTIVE ACTION”, was previously titled “Corrective Action 

Plan”. This section was revised as follows: “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...”. Additional revisions include the 

following:

 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’”.

• 4.4 – Outcome: No changes

• 4.5 – Documentation: No changes

APPENDICES

• New Appendices: None

• Revised Appendices:

o Appendix 4.1, “Self-Assessment Worksheet”, has been revised as follows: 

 4.3.1, “Quality Assurance”, was revised to include the requirement 

for initiating CORRECTIVE ACTION(S) to be documented on the 

STRATEGIC IMPROVEMENT PLAN as described in 9.3.2.

 4.3.5, “CORRECTIVE ACTIONS”, was revised to included updated 

performance factor requirements.

o Appendix 4.2, “Instructions for Performance Ratings of Audit Findings”, is 

a combination of the prior Appendix documents (4.2a, 4.3a, and 4.4a) for 

the summary of audit findings for field inspection audits, inspection 

reports, and sample reports. The prior Appendix documents 4.2a, 4.3a, 

and 4.4a have been removed.

o Appendix 4.3, “Field Inspection Audit Form”, was previously identified as 

Appendix 4.5. This Appendix has additionally been revised to include 

inspectional elements related to inspections conducted under 21 CFR 

117, as well as for the evaluation of sanitary transportation practices and 

food defense plans, as appropriate.

o Appendix 4.3a, “Summary of Field Inspection Audit Findings”, was 

previously identified as Appendix 4.2, “Performance Rating for the Field 

Inspection Audits”.

o Appendix 4.4, “Inspection Report Audit Form”, was previously identified as 

the Appendix 4.6.

o Appendix 4.4a, “Summary of Inspection Report Audit Findings”, was 

previously identified as the Appendix 4.3, “Performance Rating for 

Inspection Report Audits”.

o Appendix 4.5, “Sample Report Audit Form”, was previously identified as 
2022 MFRPS Summary of Changes Page 9 of 12

the Appendix 4.7. Additional revisions include the following:

 I.1, “Method of collection and equipment was appropriate”.

o Appendix 4.5a, “Summary of Sample Report Audit Findings”, was 

previously identified as the Appendix 4.4, “Performance Rating for the 

Sample Report Audits”.

• Removed Appendices: 

o The prior Appendix 4.5a, “Guidance for Completing the Contract Audit 

Form (FORM FDA 3610)”, has been reclassified as a job aid. 

o The prior Appendix 4.8, “Corrective Action Plan”, has been removed.

STANDARD 5 – FOOD RELATED ILLNESS, OUTBREAK AND HAZARDS 

RESPONSE

DEFINITIONS

• New Definitions: None

• Revised Definitions: 

o TRACEBACK

o TRACEFORWARD

UPDATES MADE TO THE STANDARD

• 5.1 – Purpose: No changes

• 5.2 – Requirement Summary: No changes

• 5.3 – Program Elements: No changes

• 5.4 – Outcome: No changes

• 5.5 – Documentation: No changes

APPENDICES

• No changes

STANDARD 6 – COMPLIANCE AND ENFORCEMENT PROGRAM

DEFINITIONS

• No changes

UPDATES MADE TO THE STANDARD

• 6.1 – Purpose: No changes

• 6.2 – Requirement Summary: No changes

• 6.3 – Program Elements: 

o 6.3.1, “Compliance and Enforcement Program”, has been revised to 

remove the requirement for having “a system to communicate policy and 

guidance to managerial and non-managerial staff”.

o 6.3.2, “Performance Review”, has been revised as follows:

 6.3.2.4, “Require a CORRECTIVE ACTION if performance ratings 

fall below 80%, which will be documented on the STRATEGIC 
2022 MFRPS Summary of Changes Page 10 of 12

IMPROVEMENT PLAN as described in 9.3.2”.

• 6.4 – Outcome: No changes

• 6.5 – Documentation: No changes

APPENDICES

• No changes

STANDARD 7 – INDUSTRY AND COMMUNITY RELATIONS

DEFINITIONS

• No changes

UPDATES MADE TO THE STANDARD

• 7.1 – Purpose: No changes

• 7.2 – Requirement Summary: No changes

• 7.3 – Program Elements: No changes

• 7.4 – Outcome: No changes

• 7.5 – Documentation: No changes

APPENDICES

• No changes

STANDARD 8 – PROGRAM RESOURCES

DEFINITIONS

• No changes

UPDATES MADE TO THE STANDARD

• 8.1 – Purpose: No changes

• 8.2 – Requirement Summary: No changes

• 8.3 – Program Elements: 

o 8.3.1, “Program Assessment”, has been revised to say the “state program 

completes the Resource Summary Report to assess staffing, funding, 

and equipment using the Appendix 8.2 or equivalent form”.

o 8.3.2, “Staffing”, has been revised to say, “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”. 

• 8.4 – Outcome: No changes

• 8.5 – Documentation: 

o 8.5.3, “Documentation of the calculation of number of inspectors” 

o 8.5.4, “List of equipment used for inspections and sample collections”.

APPENDICES

• New Appendices: 

o Appendix 8.1, Self-Assessment Worksheet”, has been created to serve as 
2022 MFRPS Summary of Changes Page 11 of 12

a true self-assessment worksheet.

• Revised Appendices:

o Appendix 8.2, “Resource Summary Report”, was previously identified as 

Appendix 8.1, “Self-Assessment Worksheet”.

o Appendix 8.2a, “Resource Summary Report Instructions”, was previously 

identified as Appendix 8.1a, “Self-Assessment Worksheet Instructions”.

• Removed Appendices: 

o The prior Appendix 8.2, “Calculation for Determining a Number of 

Inspectors”, has been reclassified as a job aid. The information in this 

document has been modified to include the risk classification criteria 

described in the FD&C Act, Section 421(a)(1). 

o The prior Appendix 8.3, “Inspection Equipment”, has been renamed the 

“List of equipment used for inspections and sample collections”. This 

document has also been reclassified as a job aid. 

STANDARD 9 – PROGRAM ASSESSMENT

DEFINITIONS

• New Definitions:

o CORRECTION

o CORRECTIVE ACTION(S)

• Revised Definitions: None

UPDATES MADE TO THE STANDARD

• 9.1 – Purpose: No changes

• 9.2 – Requirement Summary: 

o 9.2, “Requirement Summary”, has been revised as follows: “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: 

o 9.3.2 STRATEGIC IMPROVEMENT PLAN requirements have been 

revised as follows: “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)”. Additional 

revisions include the following:

 9.3.2.2, “Improvement 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 
2022 MFRPS Summary of Changes Page 12 of 12

similar non-CONFORMANCE when the program was previously in 

CONFORMANCE with the individual element or documentation 

requirement of the standard that was corrected”. 

• 9.4 – Outcome: No changes

• 9.5 – Documentation: No changes

APPENDICES

• New Appendices: 

o Appendix 9.1, Self-Assessment Worksheet”, has been created to serve as 

a true self-assessment worksheet.

• Revised Appendices:

o Appendix 9.2, “Self-Assessment Summary Report”, was previously 

identified as Appendix 9.1.

• Removed Appendices: None

STANDARD 10 – LABORATORY SUPPORT

DEFINITIONS

• No changes

UPDATES MADE TO THE STANDARD

• 10.1 – Purpose: No changes

• 10.2 – Requirement Summary: No changes

• 10.3 – Program Elements: 

o 10.3.2, “ISO Accredited Laboratories”, has been revised to identify 

laboratory accreditation as “ISO/IEC 17025:2017 (or current version)”.

o 10.3.3, “Non-ISO Accredited Laboratories”, has been revised to clarify 

laboratories not holding “ISO/IEC 17025:2017 (or current version)” 

accreditation.

• 10.4 – Outcome: No changes

• 10.5 – Documentation: 

o 10.5.5 has been revised as follows: “ISO Accredited Laboratory: ISO/IEC 

17025:2017 (or current version) Certificate and Scope of Accreditation”. 

Reference to accreditation to the ISO/IEC 17025:2005 standards has 

been removed.

APPENDICES

• No changes