Animal Food Regulatory Program Standards

U.S. Department of Health and Human Services

Food and Drug Administration

Office of Regulatory Affairs

Paperwork Reduction Act Statement: This program standards document contains information collection provisions 

that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of

1995 (44 U.S.C. 3501-3521). 

The time required to complete this voluntary information collection is estimated to average 569 minutes per reporting 

response and 40 minutes per recordkeeping response, including the time to review instructions, search existing data 

sources, gather the data needed, and complete and review the information collection. An agency may not conduct or 

sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB 

control number. 

OMB Control No. 0910-0760 

Expiration Date: June 30, 2026
Animal Food Regulatory Program Standards – 2023 2 

Table of Contents

Table of Contents .........................................................................................................................................2

Background ..................................................................................................................................................4

Introduction ..................................................................................................................................................5

Definitions....................................................................................................................................................7

STANDARD 1 Regulatory Foundation .......................................................................................................9

STANDARD 2 Training Program .............................................................................................................11

STANDARD 3 Inspection Program ..........................................................................................................14

STANDARD 4 Audit Program ..................................................................................................................17

STANDARD 5 Animal Food-Related Illnesses or Death and Emergency Response ...............................21

STANDARD 6 Compliance and Enforcement Program ...........................................................................23

STANDARD 7 Outreach Program ............................................................................................................25

STANDARD 8 Program Planning and Resources.....................................................................................26

STANDARD 9 Assessment and Improvement..........................................................................................29

STANDARD 10 Laboratory Services .......................................................................................................31

STANDARD 11 Sampling Program ..........................................................................................................33

Appendix 1.1: Self-Assessment Worksheet...............................................................................................36

Appendix 1.2: Regulatory Foundation Worksheet ....................................................................................37

Appendix 2.1: Self-Assessment Worksheet...............................................................................................43

Appendix 2.2: Inspector Training Record .................................................................................................47

Appendix 2.3: Field Training Competencies .............................................................................................52

Appendix 3.1: Self-Assessment Worksheet...............................................................................................54

Appendix 4.1: Self-Assessment Worksheet...............................................................................................59

Appendix 4.2: Field Inspection Audit Form ..............................................................................................64

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

Appendix 4.4: Field Inspection Report Audit Form ..................................................................................71

Appendix 4.5: Field Inspection Report Audit Worksheet .........................................................................74

Appendix 4.6: Sample Collection Audit Form ..........................................................................................76

Appendix 4.7: Sample Collection Audit Worksheet..................................................................................78

Appendix 4.8: Sample Collection Report Audit Form ..............................................................................80

Appendix 4.9: Sample Collection Report Audit Worksheet ......................................................................84

Appendix 5.1: Self-Assessment Worksheet...............................................................................................86

Appendix 6.1: Self-Assessment Worksheet...............................................................................................88

Appendix 7.1: Self-Assessment Worksheet...............................................................................................90

Appendix 7.2: Outreach Event Overview and Evaluation .........................................................................91

Appendix 8.1: Self-Assessment Worksheet...............................................................................................92
Animal Food Regulatory Program Standards – 2023 3 

Appendix 8.2: Resources for Implementation of Animal Food Regulatory Program Standards ..............94

Appendix 9.1: Self-Assessment Worksheet...............................................................................................95

Appendix 10.1: Self-Assessment Worksheet.............................................................................................97

Appendix 11.1: Self-Assessment Worksheet.............................................................................................99
Animal Food Regulatory Program Standards – 2023 4 

Background 

In the U.S., federal, state, local, tribal, and territorial (SLTT) regulatory agencies ensure the safety 

of ANIMAL FOOD. The Food and Drug Administration (FDA) and state PROGRAMS are responsible 

for ensuring that ANIMAL FOOD moving within their jurisdiction is safe, wholesome, and/or labeled 

properly. These responsibilities can include conducting inspections and regulatory activities that 

help ensure ANIMAL FOOD manufactured, processed, packaged, held, and distributed within their 

jurisdictions are safe and in compliance with applicable laws and regulations. State PROGRAMS

primarily perform inspections under their own regulatory authority. Some state PROGRAMS conduct 

inspections of ANIMAL FOOD establishments under contract with FDA. Because jurisdictions may 

overlap, FDA and state PROGRAMS collaborate and share resources to protect ANIMAL FOOD. To 

better facilitate a partnership among regulatory authorities, state PROGRAMS should achieve 

IMPLEMENTATION with the Animal Food Regulatory Program Standards (AFRPS).

The implementation of seamless partnerships between FDA and SLTTs enable programs with 

comparable regulatory public health systems, as trusted partners, to rely on, coordinate with, and 

leverage one another’s work, data, and actions to meet the public health goal of a safe national food 

supply. The FDA and the Association of American Feed Control Officials (AAFCO) are members 

of the Partnership of Food Protection (PFP). The vision for an Integrated Food Safety System 

(IFSS) was developed in 20091

. One of the foundational principles of an IFSS is the 

IMPLEMENTATION and uniform application of model standards so that federal and SLTT regulatory 

agencies conduct regulatory activities under the same set of standards. Prior to 2010, the Voluntary 

National Retail Food Regulatory Program Standards (VNRFRPS) and the Manufactured Food 

Regulatory Program Standards (MFRPS) were examples of such model standards. However, the 

VNRFRPS and MFRPS were developed for human food only and did not apply to ANIMAL FOOD. 

As further development on the IFSS progressed, there was a recognized need to develop standards 

for ANIMAL FOOD state PROGRAMS. One of the key recommendations that came from the 2010 50-

State workshop (“A United Approach to Public Health”) was the development of standards for 

ANIMAL FOOD state PROGRAMS. Standards provide a consistent, underlying foundation that is 

critical for uniformity across federal and SLTT agencies to ensure the credibility of all programs 

under an IFSS. 

The Food Safety Modernization Act (FSMA) provides further support for developing AFRPS. 

FSMA was signed into law in January 2011 and calls for enhanced partnerships and integration 

with federal and SLTT agencies. The mutual reliance called for by FSMA will allow FDA to 

leverage capacity, inspections, and data collected by other agencies to support regulatory activities 

and further enhance the idea of an IFSS.

In 2011, FDA and AAFCO entered into a partnership to develop the AFRPS and was initially 

launched in January 2014. These standards are designed to promote uniformity and consistency 

among ANIMAL FOOD state PROGRAMS. This is consistent with the principles of the FSMA and the 

fundamental goal of AAFCO and FDA to provide a mechanism for developing and implementing 

uniform and equitable statutes, regulations, and standards to enhance the protection of the nation’s 

ANIMAL FOOD supply. 

1 Link to the current PFP vision documents available at https://www.pfp-ifss.org/about/pfp-vision1/. 
Animal Food Regulatory Program Standards – 2023 5

Introduction

The AFRPS establishes a uniform foundation for the design and management of state PROGRAMS

responsible for the regulation of ANIMAL FOOD. Through IMPLEMENTATION of the AFRPS, a state

PROGRAM is able to achieve and maintain programmatic improvements that help ensure the safety 

and integrity of the U.S. ANIMAL FOOD supply. IMPLEMENTATION of the AFRPS is voluntary. A 

state PROGRAM’S IMPLEMENTATION of the AFRPS helps ensure a uniform and consistent approach 

to ANIMAL FOOD regulation among jurisdictions including the sharing of information and the 

coordination of resources.

The AFRPS is composed of eleven standards that serve as an objective framework to evaluate and 

improve components of a state PROGRAM. The standards cover the state PROGRAM’S REGULATORY

FOUNDATION, training program, inspection program, auditing program, ANIMAL FOOD-related 

illnesses or death and emergency response, compliance and enforcement program, outreach 

program, planning and resources, laboratory services, sampling program, and assessment and 

improvement of standard IMPLEMENTATION.

Each standard is laid out in the following format to ensure uniformity: Purpose (x.1), Requirement 

Summary (x.2), Program Elements (x.3), Outcome (x.4), and Documentation (x.5). The program 

elements describe the best practices of a high-quality state PROGRAM. Required program elements 

and documentation requirements for IMPLEMENTATION are found in the Program Elements (x.3) and 

Documentation (x.5) sections for each standard. Terms in all capital letters correspond to a defined 

term in the Definition section of the document. The term “should” is used sometimes in the 

AFRPS. Program elements and corresponding conditions described as “should” are best practices 

but are optional and not required to IMPLEMENT a standard. To IMPLEMENT the AFRPS, the state

PROGRAM must IMPLEMENT all eleven standards. “Notes” are used sometimes to provide 

clarification, alternatives, and guidance that the state PROGRAM may use to help IMPLEMENT the 

AFRPS. “Notes” do not contain program elements and thus will not be subject to an FDA 

verification assessment.

Each standard has appendices designed to assist the state PROGRAM in achieving and maintaining

IMPLEMENTATION. State PROGRAMS are not obligated to use the appendices provided in the AFRPS. 

Other manual or electronic generated forms, worksheets, and templates may be used if all program 

elements are present.

Each standard has a corresponding self-assessment worksheet (Appendix x.1). The state PROGRAM 

uses the self-assessment worksheets to determine if the program elements are, or remain, fully met, 

partially met, or not met. The self-assessment worksheets are used to develop a strategic 

improvement plan for IMPLEMENTATION of standards.

The state PROGRAM maintains CURRENT AND FIT-FOR-USE documents required in the standards to 

verify IMPLEMENTATION for the purposes of a verification assessment. The AFRPS is not intended 

to address the performance appraisal processes that an agency may use to evaluate individual 

employee performance. 

FDA uses the AFRPS as a tool to promote and verify the development of a high-quality ANIMAL

FOOD regulatory PROGRAM, which includes a process for continuous improvement based upon 

quality management systems. The AFRPS assists both FDA and the states in fulfilling their 

regulatory obligations. State PROGRAMS enrolled in the AFRPS under an FDA funding vehicle are

expected to develop and IMPLEMENT a strategic improvement plan to demonstrate that they are 

moving toward IMPLEMENTATION and to participate in FDA assessments. State PROGRAMS are 

encouraged to build systems that are sustainable and IMPLEMENT plans that result in the standards 

being maintained. 
Animal Food Regulatory Program Standards – 2023 6

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 0910-0760.
Animal Food Regulatory Program Standards – 2023 7

Definitions

Animal Food: Used to represent the definitions for: (1) food and animal feed in the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) sections 201(f) and 201(w), (2) for animal food in Title 21 of 

the Code of Federal Regulations (CFR) section 507.3 (21 CFR 507.3), and (3) for animal feed in 

the AAFCO Official Publication (AAFCO OP).

Contact Hour: One CONTACT HOUR equals 60 minutes.

Corrective Action: Action to correct a DEVIATION from the program elements of a standard. 

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

accordance with state PROGRAM procedures that meet criteria in the most current standard. “Fit-foruse” 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.

Curriculum: A plan which includes documented specific coursework and field training for both 

inspection and sample collection. 

Deviation: Non-fulfillment of a program element.

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.

Emergency: An unforeseen or sudden occurrence requiring immediate action to protect against 

substantial risk to animal and/or public health, and that involves the safety, efficacy, and security of 

the ANIMAL FOOD supply.

Enforcement Strategy: Plans of action designed to prioritize and achieve enforcement goals and 

are developed by the state PROGRAM based on critical and chronic violations and violators and 

contain guidelines for selecting enforcement tools.

Equivalent: State law directly references the relevant FD&C Act provision or federal regulation.

Equivalent in Effect: State law has the same regulatory effect as the relevant FD&C Act provision 

or federal regulation.

Implement/Implementation: Means a state PROGRAM has a particular program element, system, 

or program as required in the Program Elements and Documentation sections of the AFRPS; and 

can demonstrate the use of that particular program element, system, or program.

Joint Field Training Inspection: 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 during an inspection of an establishment which may either be trainer led or trainee led.

No Authority: Responsibility for enforcing a relevant FD&C Act provision or federal regulation

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.

Not Equivalent: There is no state law EQUIVALENT to the relevant FD&C Act provision or federal

regulation, or the federal and state laws address the same matter but are inconsistent and do not 

have the same regulatory effect.

Outreach Activity: A spontaneous or planned activity where the state PROGRAM provides 

materials or information that relates to ANIMAL FOOD topics to industry stakeholders, academia, 

other regulators, or consumers. Materials or information may include but is not limited to 

brochures, pamphlets, printed materials, websites, or other items. 
Animal Food Regulatory Program Standards – 2023 8

Outreach Event: An OUTREACH EVENT which the state PROGRAM hosts, co-hosts, or is an invited 

presenter such as seminars, workshops, conferences, trainings, or meetings that relate to ANIMAL

FOOD topics and that support communication and information exchange among industry 

stakeholders, academia, other regulators, or consumers. 

Preventive Action: Action to prevent the recurrence of a DEVIATION requiring a CORRECTIVE

ACTION. 

Program: An operational unit in a regulatory agency that is responsible for the regulatory 

oversight of ANIMAL FOOD.

Qualified Field Inspection Auditor: An individual who is recognized by the state’s PROGRAM as 

having field experience and communication skills necessary to audit inspectors/investigators.

Qualified Field Inspection Trainer: An individual who is recognized by the state’s PROGRAM as 

having field experience and communication skills necessary to train inspectors/investigators.

Regulatory Foundation: The statutes, regulations, rules, ordinances, or other regulatory 

requirements that govern the operation of an ANIMAL FOOD establishment.

Regulatory Testing Laboratory: A laboratory that conducts measurements and analyses on food 

or ANIMAL FOOD and associated physical samples, which result in qualitative or quantitative 

analytical findings that may be used as a basis for regulatory action.

Sample Analysis Schedule: A schedule of analyses based on the sampling plan developed in 

cooperation with the REGULATORY TESTING LABORATORY performing routine services to ensure 

compatibility with REGULATORY TESTING LABORATORY capabilities and capacities. 

Start Date: Date employee is hired or reassigned in or into the ANIMAL FOOD state PROGRAM as the 

beginning date for training timelines.
Standard 1

Animal Food Regulatory Program Standards – 2023 9

STANDARD 1

Regulatory Foundation

1.1 Purpose

This standard describes the program elements used by a state PROGRAM to effectively evaluate and 

review the REGULATORY FOUNDATION to regulate ANIMAL FOOD.

1.2 Requirement Summary

The state PROGRAM establishes an evaluation of its legal authority and regulatory provisions to 

perform inspections and investigations, gather evidence, collect samples, and take regulatory 

actions under state law to ensure the safety and security of ANIMAL FOOD.

This includes an evaluation of how the state’s legal authority and regulatory provisions correspond 

to the sections of the FD&C Act and CFR specified in Appendix 1.2.

1.3 Program Elements

1.3.1 Evaluation of Legal Authority

The state PROGRAM conducts an evaluation to determine whether the state’s legal 

authority and regulatory provisions are EQUIVALENT, EQUIVALENT IN EFFECT, NOT

EQUIVALENT, or NO AUTHORITY to the specified sections of the current FD&C Act 

and CFR Title 21, and completes Appendix 1.2, or an equivalent form.

Note: In conducting such an evaluation, the state PROGRAM should consult with its 

legal counsel when state law or regulation does not provide for incorporation of 

subsequent revisions of the FD&C Act and CFR, the revision date of the CFR is 

unknown, or the federal law or regulation is partially written into state law or 

regulation.

1.3.2 Regulatory Foundation Evaluation

The state PROGRAM has a procedure that includes:

1.3.2.1 Reviewing the statutes, regulations, rules, ordinances, and other 

prevailing regulatory requirements that:

1.3.2.1.1 Apply to the regulation of ANIMAL FOOD.

1.3.2.1.2 Delegate authority to the state agency.

1.3.2.1.3 Describe the state agency’s administrative procedure for 

establishing its authority and incorporating rules by reference.

1.3.2.2 Timeframe for the review.

1.4 Outcome

The state PROGRAM utilizes the evaluation its REGULATORY FOUNDATION to protect animal and 

public health by ensuring the safety and security of ANIMAL FOOD.
Standard 1

Animal Food Regulatory Program Standards – 2023 10

1.5 Documentation

The state PROGRAM maintains the records, or equivalent forms or worksheets, listed here:

1.5.1 Appendix 1.1: Self-Assessment Worksheet.

1.5.2 Appendix 1.2: Regulatory Foundation Worksheet.

1.5.3 Procedure for reviewing appropriate statutes, regulations, rules, ordinances, and 

other prevailing regulatory requirements.

1.5.4 The statutes, regulations, rules, ordinances, and other prevailing regulatory 

requirements that: (1) apply to the regulation of ANIMAL FOOD, (2) delegate 

authority to the state agency, and (3) describe the state agency’s administrative 

procedure for establishing its authority and incorporating rules by reference.
Standard 2

Animal Food Regulatory Program Standards – 2023 11

STANDARD 2

Training Program 

2.1 Purpose

This standard describes the program elements used by a state PROGRAM to have an effective 

ANIMAL FOOD training program. 

2.2 Requirement Summary

The state PROGRAM establishes a training program that ensures that all inspectors complete 

coursework, field training, and continuing education to effectively perform their assignments and 

responsibilities.

2.3 Program Elements

2.3.1 Training Plan and Training Records

2.3.1.1 The state PROGRAM has a documented training plan that includes training 

and continuing education, as defined by the state PROGRAM, that includes: 

2.3.1.1.1 Description of each inspection type.

2.3.1.1.2 CURRICULUM for each inspection type.

2.3.1.2 For inspectors with greater than five years of experience at the date of the 

initial self-assessment or at the inspectors START DATE, where their 

training documentation is not available, the state PROGRAM:

2.3.1.2.1 Documents an evaluation of the inspector’s performance and 

experience to determine if additional training is needed.

2.3.1.2.2 Maintains proper supporting documents to verify successful 

completion of the requirement, if previous coursework is 

completed before the inspectors START DATE and utilized to 

meet coursework requirements.

2.3.1.3 The state PROGRAM maintains records documenting the training 

completed by all inspectors on Appendix 2.2, or an equivalent form.

2.3.2 Basic ANIMAL FOOD Inspector Training

2.3.2.1 Timeframe

The state PROGRAM requires a basic inspector to successfully complete the 

basic coursework within 24 months from the START DATE.

2.3.2.2 Coursework

Basic inspector training consists of basic coursework in the following 

subject areas:

2.3.2.2.1 Animal and Public Health Principles

2.3.2.2.2 Animal Food Defense 

2.3.2.2.3 Basic Animal Nutrition

2.3.2.2.4 Basic Ingredients, Processing, and Technology
Standard 2

Animal Food Regulatory Program Standards – 2023 12

2.3.2.2.5 Basic National Incident Management System and Incident 

Command System (ICS)

2.3.2.2.6 Communication 

2.3.2.2.7 Current Statutes, Regulations, and Policies 

2.3.2.2.8 Inspections, Compliance, and Enforcement 

2.3.2.2.9 Labeling

2.3.2.2.10 Professionalism

2.3.2.2.11 Risk Awareness

2.3.2.2.12 Safety

2.3.2.2.13 Sample Collection

2.3.2.3 Field Training

The state PROGRAM requires basic field training to complement the basic 

coursework. The basic field training specifies the following:

2.3.2.3.1 The procedure for JOINT FIELD TRAINING INSPECTIONS.

2.3.2.3.2 The number of JOINT FIELD TRAINING INSPECTIONS that are 

conducted in establishments that represent the state PROGRAM

inventory and the type of basic work that will be performed 

by the inspector.

2.3.2.3.3 List the competencies and the minimum number of JOINT

FIELD TRAINING INSPECTIONS on Appendix 2.3, or an 

equivalent form.

2.3.2.3.4 The QUALIFIED FIELD INSPECTION TRAINER verifies the field 

training checklist of competencies in the field for each 

inspection type.

2.3.2.3.5 The inspector completes the minimum basic field training 

requirements for the inspection type, prior to performing 

independent work.

2.3.3 Advanced ANIMAL FOOD Inspector Training

2.3.3.1 Timeframe 

The state PROGRAM requires an advanced inspector to successfully 

complete the advanced coursework within 60 months from the START

DATE.

2.3.3.2 Coursework 

Advanced inspector training consists of advanced coursework in the 

following subject areas but not limited to:

2.3.3.2.1 Advanced Ingredients, Processing, and Technology

2.3.3.2.2 Advanced Inspections, Compliance and Enforcement

2.3.3.2.3 Advanced Labeling

2.3.3.2.4 Animal Illness and Death Investigation

2.3.3.2.5 Current Statutes, Regulations, and Policies

2.3.3.2.6 Epidemiology

2.3.3.2.7 Microbiological Pathogens
Standard 2

Animal Food Regulatory Program Standards – 2023 13

2.3.3.2.8 Traceback and Traceforward Investigations

2.3.3.3 Field Training

The state PROGRAM requires advanced field training to complement the 

advanced coursework. The advanced field training specifies the following:

2.3.3.3.1 The procedure for JOINT FIELD TRAINING INSPECTIONS.

2.3.3.3.2 The number of JOINT FIELD TRAINING INSPECTIONS that are 

conducted in establishments that represent the state PROGRAM

inventory and the type of advanced work that will be 

performed by the inspector.

2.3.3.3.3 List the competencies and the minimum number of JOINT

FIELD TRAINING INSPECTIONS on Appendix 2.3, or an 

equivalent form.

2.3.3.3.4 The QUALIFIED FIELD INSPECTION TRAINER verifies the field 

training checklist of competencies in the field for each 

inspection type.

2.3.3.3.5 The inspector completes the minimum advanced field training 

for the inspection type, prior to performing independent work.

2.3.4 Continuing Education

The state PROGRAM requires that each basic and advanced inspector participate in 

continuing education. The continuing education specifies the following:

2.3.4.1 Each inspector receives 20 CONTACT HOURS of continuing education 

every 36 months.

2.3.4.2 The 36-month continuing education interval starts, as defined by the state

PROGRAM, when the required CURRICULUM is complete.

2.3.4.3 Documentation accompanies each activity submitted for continuing 

education.

2.4 Outcome

The state PROGRAM utilizes the training program to ensure inspectors have the knowledge, skills, 

and abilities to effectively inspect ANIMAL FOOD establishments, conduct investigations, gather 

evidence, collect samples, and take enforcement actions.

2.5 Documentation

The state PROGRAM maintains the records, or equivalent forms or worksheets, listed here:

2.5.1 Appendix 2.1: Self-Assessment Worksheet.

2.5.2 Training Plan.

2.5.3 Appendix 2.2: Inspector Training Record.

2.5.4 Appendix 2.3: Field Training Competencies.

2.5.5 Documents verifying successful completion of required coursework.

2.5.6 Documentation for continuing education.
Standard 3

Animal Food Regulatory Program Standards – 2023 14

STANDARD 3

Inspection Program

3.1 Purpose

This standard describes the program elements used by a state PROGRAM to have an effective 

ANIMAL FOOD inspection program.

3.2 Requirement Summary

The state PROGRAM establishes a risk-based inspection program to determine compliance with 

ANIMAL FOOD laws. This includes procedures to handle recalls, consumer complaints, and 

complaints resulting from state PROGRAM inspection activities. 

3.3 Program Elements

3.3.1 Risk-Based Inspection Program

3.3.1.1 The state PROGRAM has a procedure to define and maintain a current

inventory of ANIMAL FOOD establishments whose activities fall under the 

state PROGRAM’S jurisdiction and authority.

3.3.1.2 The state PROGRAM has a procedure for risk categorization of ANIMAL 

FOOD establishments using the three minimum required factors for 

defining risk categories:

3.3.1.2.1 Types of ANIMAL FOOD and ANIMAL FOOD products.

3.3.1.2.2 Types of processing.

3.3.1.2.3 Compliance history of the establishment.

3.3.1.3 Based on risk categorization of an ANIMAL FOOD establishment, 

inspections are:

3.3.1.3.1 Prioritized.

3.3.1.3.2 Assigned frequencies.

3.3.1.3.3 Allocated resources.

3.3.2 Inspection Procedure

The state PROGRAM has procedures for inspecting ANIMAL FOOD establishments that 

require the inspectors to:

3.3.2.1 Review the ANIMAL FOOD establishment’s history and determine the 

scope of the inspection.

3.3.2.2 Present appropriate credentials and written Notice of Inspection to the 

ANIMAL FOOD establishment’s owner, operator, or agent in charge; make 

appropriate introductions; explain the purpose and scope of the 

inspection; confirm inspection authority and establish FDA jurisdiction, if 

applicable.

3.3.2.3 Follow the safety protocols required by the ANIMAL FOOD establishment 

and the state PROGRAM.
Standard 3

Animal Food Regulatory Program Standards – 2023 15

3.3.2.4 Follow the biosecurity protocols required by the ANIMAL FOOD

establishment and the state PROGRAM.

3.3.2.5 Use appropriate equipment and forms needed to conduct inspections.

3.3.2.6 Recognize the relative risk categorization of the ANIMAL FOOD

establishment based on the risk-based inspection program.

3.3.2.7 Conduct comprehensive inspection activities, appropriate for the level of 

risk, focused on the establishment’s products and processes determined to 

be of higher risk.

3.3.2.8 Assess employee activities critical to the safe manufacturing, processing, 

packaging, handling, holding, and distribution of ANIMAL FOOD.

3.3.2.9 Properly evaluate the potential that conditions, practices, processes, 

components, or labeling could cause the product to become adulterated, 

contaminated, or misbranded.

3.3.2.10 Recognize significant non-compliant conditions or practices and 

document findings consistent with state PROGRAM procedure.

3.3.2.11 Distinguish between significant and insignificant observations and 

isolated incidents versus trends.

3.3.2.12 Review, evaluate, and verify that the appropriate ANIMAL FOOD

establishment records, plans, programs, and/or procedures are established, 

maintained, and/or implemented.

3.3.2.13 Collect adequate evidence and documentation to support inspection 

observations in accordance with state PROGRAM procedures.

3.3.2.14 Verify deficiencies identified during the previous inspections have been 

addressed.

3.3.2.15 Conduct activities in a professional manner.

3.3.2.16 Use effective interviewing techniques.

3.3.2.17 Explain findings clearly and adequately throughout the inspection.

3.3.2.18 Alert the ANIMAL FOOD establishment’s owner, operator, or agent in 

charge when an immediate corrective action is necessary.

3.3.2.19 Document findings accurately, clearly, legibly, and concisely on the 

applicable forms and provide a copy to the ANIMAL FOOD establishment’s 

owner, operator, or agent in charge.

3.3.2.20 Answer questions and provide information as appropriate.

3.3.2.21 Submit inspection report, samples where applicable, and supporting 

evidence and documentation within designated timeframes consistent 

with state PROGRAM procedure.

3.3.3 Recall System

The state PROGRAM has procedures to handle recalls that includes:

3.3.3.1 Receiving 

3.3.3.2 Tracking

3.3.3.3 Evaluating recall notifications

3.3.3.4 Closing

3.3.3.5 Maintaining records

3.3.3.6 Performing recall effectiveness checks, as applicable
Standard 3

Animal Food Regulatory Program Standards – 2023 16

3.3.4 Consumer Complaints

The state PROGRAM has a procedure to handle consumer complaints that includes:

3.3.4.1 Receiving

3.3.4.2 Tracking

3.3.4.3 Evaluating

3.3.4.4 Answering

3.3.4.5 Closing

3.3.4.6 Maintaining records

3.3.5 Complaints Resulting from State PROGRAM Inspection Activities

The state PROGRAM has a procedure to handle industry complaints resulting from 

state PROGRAM inspection activities that includes:

3.3.5.1 Receiving

3.3.5.2 Evaluating

3.3.5.3 Maintaining records

3.4 Outcome

The state PROGRAM utilizes the risk-based ANIMAL FOOD inspection program to significantly 

minimize or prevent the occurrence of ANIMAL FOOD adulteration, contamination, and misbranding.

3.5 Documentation

The state PROGRAM maintains the records, or equivalent forms or worksheets, listed here:

3.5.1 Appendix 3.1: Self-Assessment Worksheet.

3.5.2 An inventory of ANIMAL FOOD establishments.

3.5.3 Procedure for defining and maintaining the state PROGRAM’S current inventory of 

ANIMAL FOOD establishments.

3.5.4 Procedure for categorizing ANIMAL FOOD establishments based on risk, including the 

inspection frequency assigned to each defined risk-based category.

3.5.5 Procedures for inspecting ANIMAL FOOD establishments.

3.5.6 Procedures for recall system.

3.5.7 Procedure for consumer complaints.

3.5.8 Procedure for industry complaints about state PROGRAM inspection activities.
Standard 4

Animal Food Regulatory Program Standards – 2023 17

STANDARD 4

Audit Program

4.1 Purpose

This standard describes the program elements used by a state PROGRAM to have an effective 

ANIMAL FOOD audit program.

4.2 Requirement Summary

The state PROGRAM establishes an audit program to document and evaluate the effectiveness of the

state PROGRAM’S inspections and sample collections. This includes two components: (1) a field 

audit component, which is an on-site performance evaluation of inspection and sample collection

procedures and (2) a report audit component, which is a performance evaluation of the inspection 

and sample collection reports, to verify they are consistently performed according to established 

performance factors.

4.3 Program Elements

4.3.1 Audit Program

The state PROGRAM has procedures for conducting four types of audits:

4.3.1.1 Field inspection audits as described in 4.3.3

4.3.1.2 Field inspection report audits as described in 4.3.4

4.3.1.3 Sample collection audits as described in 4.3.5

4.3.1.4 Sample collection report audits as described in 4.3.6

Note: In general, each type of audit is composed of multiple performance factors.

The performance factors are evaluated during an audit and then used to calculate an 

individual’s audit score. The audit score determines the audit rating, which is 

recorded as “acceptable” or “needs improvement”. Using the individual audits, the 

state PROGRAM calculates a performance factor score for each performance factor and 

a cumulative score for each type of audit. The state PROGRAM uses the audit scores, 

performance factor scores, and calculated scores to recognize trends in the field 

inspection and sample collection programs. The trends are used to identify specific 

areas that need improvement and to take CORRECTIVE ACTION to improve areas.

4.3.2 Audit Program Review

The state PROGRAM conducts a review of the performance factor scores and 

cumulative scores for each of the four types of audits at least every 12 months.

4.3.3 Field Inspection Audit

The state PROGRAM conducts field inspection audits using a QUALIFIED FIELD

INSPECTION AUDITOR to verify that inspections are consistently performed according 

to the state’s PROGRAM procedures.
Standard 4

Animal Food Regulatory Program Standards – 2023 18

4.3.3.1 Frequency 

4.3.3.1.1 Conduct a minimum of two field inspection audits of each 

inspector every 36 months.

4.3.3.1.2 Select field inspections for audits that reflect the inspector’s 

assignments and responsibilities.

4.3.3.2 Performance Factors

Evaluate performance factors listed in the inspection procedure as 

described in 3.3.2 and as listed in Appendix 4.2, or an equivalent form.

4.3.3.3 Performance Documentation

4.3.3.3.1 Record the rating of each performance factor, audit score, and 

audit rating for each field inspection audit on Appendix 4.2, 

or an equivalent form. State PROGRAMS may use the current 

Appendix C found in FMD-76 in lieu of Appendix 4.2.

4.3.3.3.2 Calculate performance factor scores and a cumulative score 

for the state PROGRAM on Appendix 4.3, or an equivalent 

worksheet.

4.3.4 Field Inspection Report Audit 

The state PROGRAM conducts field inspection report audits to verify that inspectional 

findings are consistently reported according to the state PROGRAM’S procedures.

4.3.4.1 Frequency

Review a random selection of field inspection reports to be audited based 

on the number of inspections completed in 12 months of performance 

using Table 1.

Table 1 Field Inspection Report Audit Requirements

# of Inspections in

12 Months

Min # Reports

Required

Max # Reports

Required

Less than 20 reports All All

20 – 400 reports 20 20

More than 400 reports 5% reports 50

4.3.4.2 Performance Factors 

Evaluate the performance factors listed in Appendix 4.4, or an equivalent 

form.

4.3.4.3 Performance Documentation

4.3.4.3.1 Record the rating of each performance factor, audit score, and 

audit rating for each inspection report audit on Appendix 4.4, 

or an equivalent form.

4.3.4.3.2 Calculate performance factor scores and a cumulative score 

for the state PROGRAM on Appendix 4.5, or an equivalent 

worksheet.
Standard 4

Animal Food Regulatory Program Standards – 2023 19

4.3.5 Sample Collection Audit 

The state PROGRAM conducts sample collection audits using a QUALIFIED FIELD

INSPECTION AUDITOR to verify that sample collections are consistently performed 

according to the state PROGRAM’S procedures.

4.3.5.1 Frequency 

4.3.5.1.1 Conduct a minimum of two sample collection audits of each 

inspector every 36 months.

4.3.5.1.2 Select sample collections for audits that reflect the inspector’s 

assignments and responsibilities.

4.3.5.2 Performance Factors 

Evaluate the performance factors listed in the sample collection procedure

as described in 11.3.2 and as listed in Appendix 4.6, or an equivalent form. 

4.3.5.3 Performance Documentation

4.3.5.3.1 Record the rating of each performance factor, audit score, and 

audit rating for each sample collection audit on Appendix 4.6, 

or an equivalent form.

4.3.5.3.2 Calculate performance factor scores and a cumulative score 

for the state PROGRAM on Appendix 4.7, or an equivalent 

worksheet.

4.3.6 Sample Collection Report Audit 

The state PROGRAM conducts sample collection report audits to verify that sample 

collection documentation is consistently performed according to the state PROGRAM’S

procedures.

4.3.6.1 Frequency

Review a random selection of sample collection reports to be audited 

based on the number of samples collected in 12 months of performance 

based using Table 2.

Table 2 Sample Collection Report Audit Requirements

# of Samples Collected in

12 Months

Min # Reports

Required

Max # Reports

Required

Less than 40 reports All All

40 – 800 reports 40 40

More than 800 reports 5% of reports 70

4.3.6.2 Performance Factors

Evaluate the performance factors listed in Appendix 4.8, or an equivalent

form.
Standard 4

Animal Food Regulatory Program Standards – 2023 20

4.3.6.3 Performance Documentation

4.3.6.3.1 Record the rating of each performance factor, audit score, and 

audit rating for each sample collection report audit on 

Appendix 4.8, or an equivalent form.

4.3.6.3.2 Calculate performance factor scores and a cumulative score 

for the state PROGRAM on Appendix 4.9, or an equivalent 

worksheet.

4.3.7 Corrective Action Plan

The state PROGRAM documents CORRECTIVE ACTIONS as described in 9.3.2 for each 

of the four types of audits when any of the following conditions are met:

4.3.7.1 An inspector receives an overall audit rating of “needs improvement” 

(audit score below 80 percent) for an individual audit.

4.3.7.2 A state PROGRAM has a performance factor score (as a result of all audits 

in 12 months of performance) below 80 percent for a single performance 

factor.

4.3.7.3 A state PROGRAM has a cumulative score (as a result of all audits in 12 

months of performance) below 80 percent.

4.4 Outcome

The state PROGRAM utilizes the audit program to evaluate its inspection and sample collection 

activities for effectiveness, to recognize trends, and to document CORRECTIVE ACTIONS, when

necessary.

4.5 Documentation

The state PROGRAM maintains the records, or equivalent forms or worksheets, listed here:

4.5.1 Appendix 4.1: Self-Assessment Worksheet.

4.5.2 Procedure for conducting four types of audits.

4.5.3 Appendix 4.2: Field Inspection Audit Form.

4.5.4 Appendix 4.3: Field Inspection Audit Worksheet.

4.5.5 Appendix 4.4: Field Inspection Report Audit Form.

4.5.6 Appendix 4.5: Field Inspection Report Audit Worksheet.

4.5.7 Appendix 4.6: Sample Collection Audit Form.

4.5.8 Appendix 4.7: Sample Collection Audit Worksheet.

4.5.9 Appendix 4.8: Sample Collection Report Audit Form.

4.5.10 Appendix 4.9: Sample Collection Report Audit Worksheet.
Standard 5 

Animal Food Regulatory Program Standards – 2023 21

STANDARD 5

Animal Food-Related Illnesses or Death and Emergency Response

5.1 Purpose

This standard describes the program elements used by a state PROGRAM to effectively detect, 

identify, and respond to ANIMAL FOOD-related illnesses or deaths and EMERGENCIES. 

5.2 Requirement Summary

The state PROGRAM establishes a system to conduct EMERGENCY response to ANIMAL FOOD-related 

illnesses or deaths and EMERGENCIES. 

5.3 Program Elements

5.3.1 Animal Food-Related Illnesses or Deaths and Emergencies Procedure

5.3.1.1 The state PROGRAM has a procedure to gather information to identify 

incidents of ANIMAL FOOD-related illnesses or deaths and EMERGENCIES.

5.3.1.2 The state PROGRAM has a procedure to communicate with the appropriate 

agencies or departments that investigate ANIMAL FOOD-related illnesses or 

deaths and EMERGENCIES. 

5.3.1.3 For ANIMAL FOOD-related illnesses or deaths and EMERGENCIES, the state

PROGRAM has a procedure to:

5.3.1.3.1 Determine the appropriate response. 

5.3.1.3.2 Initiate the response. 

5.3.1.3.3 Complete the response. 

5.3.2 Emergency Event Management

For ANIMAL FOOD-related EMERGENCIES, the state PROGRAM manages the event 

using: 

5.3.2.1 An Incident Command System, or 

5.3.2.2 An official action plan2. 

The official action plan includes: 

5.3.2.2.1 Containment 

5.3.2.2.2 Communication

5.3.2.2.3 Control 

5.3.2.2.4 Correction and/or Corrective Actions 

5.3.2.2.5 After-action protocols 

2 An example of an official action plan can be found in the AAFCO Emergency Response Preparedness Guidance 

Document (AAFCO Official Publication).
Standard 5

Animal Food Regulatory Program Standards – 2023 22

5.3.3 Animal Food-Related Illnesses or Deaths and Emergencies Notification Procedures 

5.3.3.1 The state PROGRAM maintains a current list of relevant agencies and 

emergency contacts that is reviewed and updated at least every 12 

months.

5.3.3.2 The state PROGRAM has a procedure to rapidly notify government 

agencies, departments, and appropriate parties of relevant findings.

5.3.3.3 The state PROGRAM has a procedure to rapidly notify law enforcement 

agencies when intentional ANIMAL FOOD contamination or ANIMAL FOODrelated terrorism is suspected or threatened.

5.3.3.4 The state PROGRAM has a procedure for:

5.3.3.4.1 Releasing information to the public.

5.3.3.4.2 Coordinating media information with other jurisdictions to 

reduce the impact of ANIMAL FOOD-related illnesses or deaths

and EMERGENCIES.

5.4 Outcome

The state PROGRAM utilizes the EMERGENCY response system to work with government agencies, 

departments, and appropriate parties to gather and share information to reduce ANIMAL FOODrelated illnesses or deaths and EMERGENCIES.

5.5 Documentation

The state PROGRAM maintains the records, or equivalent forms or worksheets, listed here:

5.5.1 Appendix 5.1: Self-Assessment Worksheet.

5.5.2 Procedure to gather information to identify incidents of ANIMAL FOOD-related 

illnesses or deaths and EMERGENCIES.

5.5.3 Procedure to communicate with agency/departments.

5.5.4 Procedure to determine the appropriate response, initiate the response, and complete 

the response for ANIMAL FOOD-related illnesses or deaths and EMERGENCIES.

5.5.5 Procedure using an Incident Command System or an official action plan.

5.5.6 Emergency contact list.

5.5.7 Procedure to rapidly notify government agencies, departments, and appropriate 

parties of relevant findings.

5.5.8 Procedure to rapidly notify law enforcement agencies when intentional ANIMAL

FOOD contamination or ANIMAL FOOD-related terrorism is suspected or threatened.

5.5.9 Procedure for releasing information to the public and coordinating media 

information with other jurisdictions.
Standard 6

Animal Food Regulatory Program Standards – 2023 23

STANDARD 6

Compliance and Enforcement Program

6.1 Purpose

This standard describes the program elements used by a state PROGRAM to have an effective 

ANIMAL FOOD compliance and enforcement program.

6.2 Requirement Summary

The state PROGRAM establishes a compliance and enforcement program with ENFORCEMENT 

STRATEGIES to achieve compliance with ANIMAL FOOD laws. This includes an annual evaluation of 

the ENFORCEMENT STRATEGIES to identify potential improvements or modifications.

6.3 Program Elements

6.3.1 Compliance and Enforcement Program

6.3.1.1 The state PROGRAM has a documented compliance and enforcement 

program that contains ENFORCEMENT STRATEGIES.

6.3.1.2 The state PROGRAM selects an appropriate enforcement tool using the 

following six factors:

6.3.1.2.1 Compliance history

6.3.1.2.2 Responsiveness

6.3.1.2.3 Scope

6.3.1.2.4 Nature of the Violation

6.3.1.2.5 Impact of the Violation

6.3.1.2.6 Resources

6.3.1.3 The state PROGRAM has a documented description for all factors.

6.3.1.4 The state PROGRAM has documented relative conditions with an assigned 

numerical weight for all factors.

6.3.1.5 The state PROGRAM has a documented enforcement matrix designed to 

incorporate the relative conditions of each factor and the application of 

enforcement tools.

6.3.2 Performance Review

The state PROGRAM has a procedure for conducting an evaluation of its 

ENFORCEMENT STRATEGIES at least every 12 months to:

6.3.2.1 Determine if the state PROGRAM’S ENFORCEMENT STRATEGIES were 

successful in achieving compliance.

6.3.2.2 Identify potential improvements or modifications of the ENFORCEMENT 

STRATEGIES, if any.

6.3.2.3 Determine if the enforcement priorities remain the same or require 

modification.
Standard 6

Animal Food Regulatory Program Standards – 2023 24

6.4 Outcome

The state PROGRAM utilizes the compliance and enforcement program to achieve compliance with 

ANIMAL FOOD laws. 

6.5 Documentation

The state PROGRAM maintains the records, or equivalent forms or worksheets, listed here:

6.5.1 Appendix 6.1: Self-Assessment Worksheet.

6.5.2 ENFORCEMENT STRATEGIES.

6.5.3 The ENFORCEMENT STRATEGIES factors including the description, relative conditions, 

and associated numerical weight for each.

6.5.4 Enforcement matrix.

6.5.5 Procedure for conducting an evaluation of the ENFORCEMENT STRATEGIES.

6.5.6 Evaluation of the ENFORCEMENT STRATEGIES at least every 12 months.
Standard 7 

Animal Food Regulatory Program Standards – 2023 25

STANDARD 7

Outreach Program 

7.1 Purpose

This standard describes the program elements used by a state PROGRAM to effectively conduct an 

ANIMAL FOOD outreach program. 

7.2 Requirement Summary 

The state PROGRAM established an outreach program with OUTREACH ACTIVITIES or OUTREACH

EVENTS to inform ANIMAL FOOD industry stakeholders, academia, other regulators, or consumers 

about ANIMAL FOOD topics. 

7.3 Program Elements

7.3.1 Outreach Methods 

The state PROGRAM identifies the methods that will be used for outreach to inform 

ANIMAL FOOD industry stakeholders, academia, other regulators, or consumers about

ANIMAL FOOD topics. 

7.3.2 Outreach Plan

The state PROGRAM has a documented outreach plan at least every 12 months that 

supports the state PROGRAM mission and that includes: 

7.3.2.1 Objectives of an outreach plan. 

7.3.2.2 Target populations. 

7.3.2.3 The types of outreach (including OUTREACH ACTIVITIES or OUTREACH

EVENTS). 

7.3.3 Outreach Events

The state PROGRAM documents and evaluates OUTREACH EVENTS using Appendix 7.2, 

or an equivalent form. 

7.4 Outcome

The state PROGRAM utilizes an outreach plan to inform ANIMAL FOOD industry stakeholders, 

academia, other regulators, or consumers about ANIMAL FOOD topics. 

7.5 Documentation 

The state PROGRAM maintains the records, or equivalent forms or worksheets, listed here: 

7.5.1 Appendix 7.1: Self-Assessment Worksheet. 

7.5.2 Outreach plan. 

7.5.3 Appendix 7.2: Outreach Event Overview and Evaluation. 
Standard 8

Animal Food Regulatory Program Standards – 2023 26

STANDARD 8

Program Planning and Resources

8.1 Purpose

This standard describes the program elements used by a state PROGRAM to effectively conduct the 

ANIMAL FOOD work planning and resources evaluation. 

8.2 Requirement Summary

A state PROGRAM establishes a workplan to support its inspection and sample collection programs.

This includes an evaluation of resource needs for completing the workplan and to IMPLEMENT and 

maintain the AFRPS.

8.3 Program Elements

8.3.1 Workplan

The state PROGRAM has a documented workplan that includes the:

8.3.1.1 Inspection plan

8.3.1.1.1 Number of inspections

8.3.1.1.2 Type of inspection

8.3.1.1.3 Risk category of establishment or product

8.3.1.1.4 Frequency

8.3.1.2 Sample plan

8.3.1.2.1 Number of samples

8.3.1.2.2 Type of samples

8.3.1.3 Timeframe that the workplan is applicable.

8.3.2 Workplan Procedure

8.3.2.1 The state PROGRAM has a procedure for evaluating the workplan that 

includes:

8.3.2.1.1 Conducting evaluations of the workplan at least every 12 

months.

8.3.2.1.2 Evaluating alignment with state PROGRAM objectives and 

resources.

8.3.2.2 The state PROGRAM has a procedure for identifying and evaluating its 

resources to accomplish the workplan within the applicable timeframe.

Note: The resource evaluation should include staffing, equipment, and 

funding needed to support the inspection and sample collection activities 

identified in the workplan.
Standard 8

Animal Food Regulatory Program Standards – 2023 27

Note: The resources needed to train and audit field staff, to support 

laboratory services, compliance and enforcement program, outreach

program, and to respond to ANIMAL FOOD-related illnesses, deaths, or 

EMERGENCIES should be determined by the state PROGRAM. The 

administrative functions needed to support all state PROGRAM areas should 

be considered when determining state PROGRAM resources.

8.3.2.3 The state PROGRAM develops a formula and calculates the number of staff 

needed to accomplish the state PROGRAM’S ANIMAL FOOD workplan based 

on staff assignments, responsibilities, and work hours.

Note: The state PROGRAM should have adequate staff to inspect the state 

PROGRAM’S ANIMAL FOOD inventory and to conduct sample collections 

established in its workplan.

8.3.3 Equipment

The state PROGRAM establishes and maintains a list of the equipment required for 

inspections and sample collections.

8.3.4 Resource Review

8.3.4.1 The state PROGRAM conducts a baseline evaluation of the resources 

required to IMPLEMENT the AFRPS, including the program elements and 

the documentation requirements in the standards to determine whether the 

state PROGRAM has:

8.3.4.1.1 Adequate staff

8.3.4.1.2 Equipment

8.3.4.1.3 Funding

8.3.4.2 The state PROGRAM completes subsequent resource evaluations to 

determine the resources necessary for the state PROGRAM to partially 

meet, fully meet, or maintain IMPLEMENTATION of the program elements

and documentation requirements within three years of the previous 

evaluation.

8.3.4.3 The state PROGRAM records the evaluation on Appendix 8.2, or an 

equivalent form.

8.4 Outcome

The state PROGRAM utilizes the workplan to support its inspection and sample collection programs. 

The state PROGRAM evaluates the resources needed to support both the state PROGRAM and the 

IMPLEMENTATION and maintenance of the AFRPS.
Standard 8

Animal Food Regulatory Program Standards – 2023 28

8.5 Documentation

The state PROGRAM maintains the records, or equivalent forms or worksheets, listed here:

8.5.1 Appendix 8.1: Self-Assessment Worksheet.

8.5.2 Workplan.

8.5.3 Procedure for evaluating the workplan.

8.5.4 Procedure for identifying and evaluating its resources to accomplish the workplan 

within the applicable timeframe.

8.5.5 Formula used to calculate the number of staff needed to accomplish the state 

PROGRAM’S ANIMAL FOOD workplan based on the state PROGRAM staff assignments, 

responsibilities, and work hours. 

8.5.6 List of required equipment for inspection and sample collection.

8.5.7 Appendix 8.2: Resources for Implementation of Animal Food Regulatory Program 

Standards.
Standard 9

Animal Food Regulatory Program Standards – 2023 29

STANDARD 9

Assessment and Improvement

9.1 Purpose

This standard describes the program elements used by a state PROGRAM to effectively evaluate and 

demonstrate IMPLEMENTATION with each of the program standards. 

9.2 Requirement Summary

The state PROGRAM establishes a baseline evaluation utilizing the self-assessment worksheets

completed for each standard. This includes using the results to create a strategic improvement plan

that aids the state PROGRAM in IMPLEMENTING the program elements of each standard.

9.3 Program Elements

9.3.1 State Program Baseline Evaluation

The state PROGRAM conducts a baseline evaluation using the self-assessment 

worksheets from each standard to determine if a standard is fully met, partially met, 

or not met.

9.3.2 Strategic Improvement Plan 

The state PROGRAM develops a strategic improvement plan to IMPLEMENT the 

program elements or documentation requirements of each standard. The strategic 

improvement plan includes the following, as applicable: 

9.3.2.1 The program element or documentation requirement of the standard that 

was not met.

9.3.2.2 Improvements or CORRECTIVE ACTIONS needed to IMPLEMENT the 

program element or documentation requirement of the standard.

9.3.2.3 The cause for any DEVIATIONS requiring CORRECTIVE ACTIONS when the 

state PROGRAM was previously in IMPLEMENTATION with the program 

element or documentation requirement of a standard.

9.3.2.4 The PREVENTIVE ACTION taken to prevent future similar DEVIATIONS when 

the state PROGRAM was previously in IMPLEMENTATION with the program 

element or documentation requirement of the standard that was corrected.

9.3.2.5 Projected completion date for each improvement or CORRECTIVE ACTION.

9.3.2.6 Personnel responsible.

9.3.2.7 Date completed.

9.3.3 Strategic Improvement Plan Review

The state PROGRAM reviews and updates at least every 12 months the following: 

9.3.3.1 The self-assessment worksheets. 

9.3.3.2 The strategic improvement plan. 
Standard 9

Animal Food Regulatory Program Standards – 2023 30

9.3.4 Document Control Procedure

9.3.4.1 The state PROGRAM has a procedure for DOCUMENT CONTROL that ensures 

all guidance and procedures required by the standards are CURRENT AND 

FIT-FOR-USE.

9.3.4.2 The state PROGRAM maintains a master document list of all documents 

subject to this procedure to demonstrate they are CURRENT AND FIT-FORUSE. 

9.3.5 Record Retention

The state PROGRAM retains records required under x.5 of each standard for the three 

previous years, or per the state PROGRAM’S record retention policy.

9.4 Outcome

The state PROGRAM utilizes the strategic improvement plan to achieve and maintain 

IMPLEMENTATION of the required program elements and documentation requirements for all 

standards. 

9.5 Documentation

The state PROGRAM maintains the records, or equivalent forms or worksheets, listed here:

9.5.1 Appendix 9.1: Self-Assessment Worksheet.

9.5.2 Strategic Improvement Plan.

9.5.3 Procedure for Document Control.

9.5.4 Master Document List.
Standard 10 

Animal Food Regulatory Program Standards – 2023 31

STANDARD 10

Laboratory Services

10.1 Purpose

This standard describes the program elements used by a state PROGRAM to effectively utilize 

REGULATORY TESTING LABORATORY services.

10.2 Requirement Summary

The state PROGRAM establishes access to REGULATORY TESTING LABORATORY services that provide 

accurate, timely, reliable, and defensible analytical data. 

10.3 Program Elements

10.3.1 Laboratory Support 

10.3.1.1 The state PROGRAM maintains a list of analytical services the 

REGULATORY TESTING LABORATORY provides for the state PROGRAM. 

10.3.1.2 The state PROGRAM has a documented formal agreement with the 

REGULATORY TESTING LABORATORY that conducts routine analytical 

services unless under the same administrative agency.

10.3.2 Laboratory Sample Integrity Procedure 

The state PROGRAM has procedures developed by the REGULATORY TESTING

LABORATORY to maintain the integrity of the samples sent to the REGULATORY

TESTING LABORATORY for analytical testing that includes:

10.3.2.1 Sample receipt. 

10.3.2.2 Preservation. 

10.3.2.3 Storage. 

10.3.2.4 Retention. 

10.3.2.5 Disposal. 

10.3.2.6 Chain of custody. 

10.3.2.7 Report of analysis. 

10.3.2.8 Methods to communicate information between the state PROGRAM and 

REGULATORY TESTING LABORATORY.

10.3.3 Laboratory Quality Assurance Program 

The state PROGRAM utilizes REGULATORY TESTING LABORATORIES that:

10.3.3.1 Are accredited by a recognized accreditation body to ISO/IEC 

17025:20173, or current version, or 

10.3.3.2 Implement and comply with the AAFCO Quality Assurance/Quality 

Control guidelines, or 

10.3.3.3 Implement and comply with the ISO/IEC 17025:2017, or current version. 

3 A recognized accreditation body must be signatory to the International Laboratory Accreditation Cooperation 

(ILAC) Mutual Recognition Arrangement (MRA).
Standard 10 

Animal Food Regulatory Program Standards – 2023 32

10.4 Outcome

The state PROGRAM utilizes valid and defensible REGULATORY TESTING LABORATORY data to protect

animal and public health and to enforce ANIMAL FOOD laws. 

10.5 Documentation 

The state PROGRAM maintains the records, or equivalent forms or worksheets, listed here: 

10.5.1 Appendix 10.1: Self-Assessment Worksheet. 

10.5.2 A list of all analytical services provided by the REGULATORY TESTING LABORATORY

for the state PROGRAM.

10.5.3 A formal agreement with REGULATORY TESTING LABORATORYIES that provide 

routine analytical services unless the laboratory is under the same administrative 

agency. 

10.5.4 Procedure to maintain the integrity of the samples sent to the REGULATORY TESTING 

LABORATORY. 

10.5.5 ISO Accredited Laboratory: ISO/IEC 17025:2017, or current version, Certificate 

and Scope of Accreditation, or documentation for non-ISO REGULATORY TESTING 

LABORATORIES.
Standard 11

Animal Food Regulatory Program Standards – 2023 33

STANDARD 11

Sampling Program 

11.1 Purpose

This standard describes the program elements used by a state PROGRAM to have an effective 

ANIMAL FOOD sampling program. 

11.2 Requirement Summary

The state PROGRAM established a sampling program to determine compliance with ANIMAL FOOD

laws. This includes a sampling plan, sample collection procedures, and procedures for completing 

the sample collection report. 

11.3 Program Elements

11.3.1 Sampling Plan

The state PROGRAM has a documented sampling plan, at least every 12 months, for 

collecting surveillance, compliance, investigational, regulatory samples, or other 

samples4. 

11.3.1.1 The state PROGRAM and REGULATORY TESTING LABORATORY jointly 

develops and amends the sampling plan, at least every 12 months, for 

performing routine analytical services to allow for advanced planning and 

scheduling of work. 

11.3.1.2 The sampling plan includes the: 

11.3.1.2.1 Availability or coordination of analytical support. 

11.3.1.2.2 Sample priorities. 

11.3.1.2.3 SAMPLE ANALYSIS SCHEDULE. 

The SAMPLE ANALYSIS SCHEDULE includes the: 

11.3.1.2.3.1 Types of ANIMAL FOOD to be analyzed. 

11.3.1.2.3.2 Number of samples to be collected. 

11.3.1.2.3.3 Estimated timeframe for collection. 

11.3.1.2.3.4 Types of analyses to be performed. 

11.3.2 Sample Collection Procedure 

The state PROGRAM has procedures for collecting, storing, and transporting samples 

that includes:

11.3.2.1 Following safety precautions on ANIMAL FOOD labels. 

11.3.2.2 Following the state PROGRAM’S safety protocols for collecting samples. 

11.3.2.3 Using appropriate method, sample collection procedures, and equipment 

to collect the sample. 

11.3.2.4 Sealing the sample to initiate chain of custody. 

4 Regulatory samples may be used to support inspection observations.
Standard 11

Animal Food Regulatory Program Standards – 2023 34

11.3.2.5 Maintaining and documenting sample integrity, security, and chain of 

custody. 

11.3.2.6 Issuing receipt5 for the sample. 

11.3.2.7 Handling6, packaging, and shipping samples to prevent compromising the 

condition of the sample. 

11.3.2.8 Delivering or shipping samples to the appropriate REGULATORY TESTING 

LABORATORY within designated timeframes. 

11.3.3 Sample Collection Report 

The state PROGRAM has a procedure for completing the sample collection report that 

includes the: 

11.3.3.1 Identification of sample collector. 

11.3.3.2 Date of the sample collection. 

11.3.3.3 Product identification. 

The product identification includes the: 

11.3.3.3.1 Name. 

11.3.3.3.2 Lot numbers or any other codes referencing manufacture 

identification. 

11.3.3.4 Description of product. 

11.3.3.5 Method of collection and any special techniques used to collect sample. 

11.3.3.6 Lot sampled. 

11.3.3.7 Lot size. 

11.3.3.8 Location where sample was collected. 

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

distributor. 

11.3.3.10 Sample type (example: surveillance, compliance, investigational, 

regulatory, or other). 

11.3.3.11 Analysis requested, if applicable. 

11.3.3.12 Collection or reproduction of product label, including customer-formula 

label. 

11.3.3.13 Receiving and distribution information. 

11.4 Outcome

The state PROGRAM utilizes the sampling program to align sampling resources to collect, store, 

transport, and document samples to achieve compliance with ANIMAL FOOD laws. 

5 Receipt could include cost of sample and method of payment.

6 Includes storing sample.
Standard 11

Animal Food Regulatory Program Standards – 2023 35

11.5 Documentation 

The state PROGRAM maintains the records, or equivalent forms or worksheets, listed here: 

11.5.1 Appendix 11.1: Self-Assessment Worksheet. 

11.5.2 Sampling plan. 

11.5.3 Sampling collection procedure. 

11.5.4 Procedure for completing the sample collection report. 
Appendix 1.1 

Animal Food Regulatory Program Standards – 2023 36

Appendix 1.1: Self-Assessment Worksheet

Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it 

includes the associated program elements. If the state PROGRAM has the main program element and associated 

program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met 

in the Notes column. The Notes column may be used for additional notes. 

State Agency

Implementation Status Fully Met Partially Met Not Met

Program Elements Yes/No Notes

1.3.1 Evaluation of Legal Authority 

Does the state PROGRAM conduct an evaluation to 

determine whether the state’s legal authority and 

regulatory provisions are EQUIVALENT, EQUIVALENT

IN EFFECT, NOT EQUIVALENT, or NO AUTHORITY to the 

specified sections of the current FD&C Act and CFR 

Title 21, and completes Appendix 1.2, or an 

equivalent form?

1.3.2 Regulatory Foundation Evaluation 

Does the state PROGRAM have a procedure? That

includes: 

1. Reviewing the statutes, regulations, rules,

ordinances, and other prevailing regulatory

requirements?

1.1 Apply to the regulation of ANIMAL FOOD?

1.2 Delegate authority to the state agency? 

1.3 Describe the state agency’s administrative 

procedure for establishing its authority and 

incorporating rules by reference? 

2. Timeframe for the review?

Assessment Completed By:

Name Date
Appendix 1.2 

Animal Food Regulatory Program Standards – 2023 37

Appendix 1.2: Regulatory Foundation Worksheet 

Instructions: Determine if state laws and regulations are EQUIVALENT, EQUIVALENT IN EFFECT, NOT EQUIVALENT, or NO AUTHORITY to the specified 

sections of the current FD&C Act and CFR Title 21. 

A state law or regulation may have the same regulatory effect as the relevant FD&C Act provision or federal regulation if either a single state law or 

regulation has the same regulatory effect as the federal law or regulation, or when multiple laws or regulations of that state are combined and deemed 

EQUIVALENT IN EFFECT to a single federal law or regulation. 

If there is no state law or regulation EQUIVALENT to the relevant FD&C Act provision or federal regulation or the federal and state laws or regulations 

address the same matter but are inconsistent and do not have the same regulatory effect, please select NOT EQUIVALENT. 

Select NO AUTHORITY if regulatory responsibility for a FD&C Act provision or federal regulation falls under the jurisdiction of another agency. 

If the state has laws or regulations pertinent to the regulation of ANIMAL FOOD for which there are no comparable relevant FD&C Act provision or 

federal regulation, these laws or regulations should be listed on Appendix 1.2 or an equivalent form. 

For those laws or regulations for which the state PROGRAM does have authority, record the state law or regulation and the date it was incorporated. 

The Notes section can be used to detail differences between state and federal laws or regulations. 

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 FDA's website: https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
Appendix 1.2 

Animal Food Regulatory Program Standards – 2023 38

State Agency

FD&C 

Act Title Equivalency Status State Citation

Date 

Incorporated

into State Law

Notes

201 Definitions (f), (g), (k), (m), (s), (v) and 

(w)

301 Prohibited acts (a), (b), (c), (d), (e), (f), 

and (k)

 303* Penalties

 304** Seizure

401 Definitions and standards for food

402 Adulterated food (a)-(c)

403 Misbranded food (a)-(n)

404 Emergency permit control

406 Tolerances for poisonous ingredients in 

food

408 Tolerances and exemptions for 

pesticide chemical residues

409 Food Additives

501 Adulterated drugs and devices

(ONLY: 501(a)(2)(B) and 501(a)(6))

504 Veterinary feed directive drugs

512 New animal drugs (ONLY: 512(a)(2))

701 Regulations and hearings

704 Inspection

* Penalties may vary from federal statute.

**Although the state PROGRAM may not have authority for seizure, the state PROGRAM could have other legal authority to stop violative products from moving in commerce, for example, detention, stop-sale orders, 

withdrawal from distribution, and embargoes. 
Appendix 1.2 

Animal Food Regulatory Program Standards – 2023 39

CFR 

Part Title Equivalency Status State Citation

Date 

Incorporated 

into State Law

Notes

1

General enforcement regulations 

(ONLY §1.20-1.23, Subpart L (§1.500-

1.514), Subpart M (§1.600-1.695), and 

Subpart O (§1.900-1.934))

7 Enforcement policy

(ONLY §7.1-7.13 and 7.40-7.59)

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 §74.101-74.706)

81

General specifications and 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)

225 Current good manufacturing practice 

for medicated feeds

226 Current good manufacturing practice 

for Type A medicated articles

500.23

Thermally processed low-acid foods 

packaged in hermitically sealed 

containers (refers to 21 CFR 113 and 21 

CFR 507)

500.24

Emergency permit control

(refers to 21 CFR 108 - ONLY §108.25- 

108.35)
Appendix 1.2 

Animal Food Regulatory Program Standards – 2023 40

CFR 

Part Title Equivalency Status State Citation

Date 

Incorporated 

into State Law

Notes

500.29 Gentian violet for use in animal feed

500.45

Use of polychlorinated biphenyls 

(PCB's) in the production, handling, 

and storage of animal feed

500.50 Propylene glycol in or on cat food

500.80 – 

500.92

Regulation of carcinogenic compounds 

used in food-producing animals

501 Animal food labeling

502 Common or usual name for nonstandardized animal foods

507

Current good manufacturing practice, 

hazard analysis, and risk-based 

preventive controls for food for animals

509 Unavoidable contaminants in animal 

food and food-packaging material

510 New animal drugs (ONLY Subpart D - 

Records and Reports)

558 New animal drugs for use in animal 

feeds

570 Food additives 

(EXCEPT §570.6, §570.15, and §570.17)

573 Food additives permitted in feed and 

drinking water of animals
Appendix 1.2 

Animal Food Regulatory Program Standards – 2023 41

CFR 

Part Title Equivalency Status State Citation

Date 

Incorporated 

into State Law

Notes

579

Irradiation in the production, 

processing, and handling of animal feed 

and pet food

582 Substances generally recognized as safe

584

Food substances affirmed as generally 

recognized as safe in feed and drinking 

water of animals

589 Substances prohibited from use in 

animal food or feed
Appendix 1.2 

Animal Food Regulatory Program Standards – 2023 42

Instructions: List any state laws and/or regulations used by the state PROGRAM that are pertinent to the regulation of ANIMAL FOOD for which there are

no comparable relevant FD&C Act provision or federal regulation (examples: tolerance for mycotoxins, fluorine, or noxious weeds in ANIMAL FOOD).

Additional State Authorities (optional):

Additional notes and comments:

Assessment Completed By:

Name Date
Appendix 2.1 

Animal Food Regulatory Program Standards – 2023 43

Appendix 2.1: Self-Assessment Worksheet

Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it 

includes the associated program elements. If the state PROGRAM has the main program element and associated 

program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met 

in the Notes column. The Notes column may be used for additional notes. 

State Agency

Implementation Status Fully Met Partially Met Not Met

Program Elements Yes/No Notes

2.3.1 Training Plan and Training Records 

Does the state PROGRAM have a documented training 

plan that includes training and continuing education, 

as defined by the state PROGRAM? That includes:

1.1 Description of each inspection type? 

1.2 CURRICULUM for each inspection type? 

For inspectors with greater than five years of 

experience at the date of the initial self-assessment or 

at the inspectors START DATE, where their training 

documentation is not available, does the state 

PROGRAM: 

2.1 Document an evaluation of the inspector’s 

performance and experience to determine if 

additional training is needed? 

2.2 Maintain proper supporting documents to 

verify successful completion of the 

requirement, if previous coursework is 

completed before the inspectors START DATE and 

utilized to meet coursework requirements? 

Does the state PROGRAM maintain records 

documenting the training completed by all inspectors 

on Appendix 2.2, or an equivalent form?
Appendix 2.1 

Animal Food Regulatory Program Standards – 2023 44

Program Elements Yes/No Notes

2.3.2 Basic ANIMAL FOOD Inspector Training 

Timeframe

Does the state PROGRAM require a basic inspector 

to successfully complete the basic coursework 

within 24 months from the START DATE?

Coursework

Does the basic inspector training consist of basic 

coursework in the subject areas listed in 2.3.2.2.1 

– 2.3.2.2.13?

Field Training 

Does the state PROGRAM require basic field 

training to complement the basic coursework? 

Does the basic field training specify the following: 

3.1 The procedure for JOINT FIELD TRAINING

INSPECTIONS?

3.2 The number of JOINT FIELD TRAINING

INSPECTIONS that are conducted in 

establishments that represent the state PROGRAM

inventory and the type of basic work that will be 

performed by the inspector? 

3.3 List the competencies and the minimum number 

of JOINT FIELD TRAINING INSPECTIONS on 

Appendix 2.3, or an equivalent form?

3.4 The QUALIFIED FIELD INSPECTION TRAINER

verifies the field training checklist of 

competencies in the field for each inspection 

type?

3.5 The inspector completes the minimum basic 

field training requirements for the inspection 

type, prior to performing independent work?
Appendix 2.1 

Animal Food Regulatory Program Standards – 2023 45

Program Elements Yes/No Notes

2.3.3 Advanced ANIMAL FOOD Inspector Training 

Timeframe

Does the state PROGRAM require an advanced

inspector to successfully complete the advanced 

coursework within 60 months from the START

DATE?

Coursework

Does the advanced inspector training consist of 

advanced coursework in the subject areas listed in 

2.3.3.2.1 – 2.3.3.2.8, but not limited to? 

Field Training

Does the state PROGRAM require advanced field 

training to complement the advanced coursework? 

Does the advanced field training specify the 

following: 

3.1 The procedure for JOINT FIELD TRAINING

INSPECTIONS?

3.2 The number of JOINT FIELD TRAINING

INSPECTIONS that are conducted in 

establishments that represent the state PROGRAM

inventory and the type of advanced work that 

will be performed by the inspector? 

3.3 List the competencies and the minimum number 

of JOINT FIELD TRAINING INSPECTIONS on 

Appendix 2.3, or an equivalent form?

3.4 The QUALIFIED FIELD INSPECTION TRAINER

verifies the field training checklist of 

competencies in the field for each inspection 

type?

3.5 The inspector completes the minimum advanced 

field training for the inspection type, prior to 

performing independent work?
Appendix 2.1 

Animal Food Regulatory Program Standards – 2023 46

Program Elements Yes/No Notes

2.3.4 Continuing Education 

Does the state PROGRAM require that each basic and 

advanced inspector participate in continuing 

education? Does the continuing education specify the 

following:

Each inspector receives 20 CONTACT HOURS of 

continuing education every 36 months? 

The 36-month continuing education interval starts, as 

defined by the state PROGRAM, when the required 

CURRICULUM is complete? 

Documentation accompanies each activity submitted 

for continuing education? 

Assessment Completed By:

Name Date
 

 

 

 

 

 

Appendix 2.2 

Appendix 2.2: Inspector Training Record 

A. Basic Animal Food Inspector Training 

Instructions: If the inspector has greater than five years of experience and an evaluation of the inspector’s 

previous performance and experience shows adequate training has been completed, mark the Name and 

Location of Training column, with “Met via Evaluation.” 

Inspector Name: Employment Start Date: 

Subject Areas Name and Location of Training Completion Date Documentation 

Verifying Completion 

Animal and Public 

Health Principles 

Animal Food Defense 

Basic Animal Nutrition 

Basic Ingredients, 

Processing, and 

Technology 

Basic National Incident 

Management System and 

Incident Command 

System (ICS) 

Communication 

Current Statutes, 

Regulations, and Policies 

Inspections, Compliance, 

and Enforcement 

Labeling 

Professionalism 

Risk Awareness 

Safety 

Sample Collection 

Animal Food Regulatory Program Standards – 2023 47
Appendix 2.2 

Animal Food Regulatory Program Standards – 2023 48

Appendix 2.2: Inspector Training Record

Instructions: Record the name and location of the establishment where the joint training inspection took place 

as well as the competencies covered. 

Inspector Name: Employment Start Date:

Basic Field Training 

(Name and Location of 

Establishment)

Competencies Covered Completion Date Verified (Y/N)
Appendix 2.2 

Animal Food Regulatory Program Standards – 2023 49

Appendix 2.2: Inspector Training Record

B. Advanced Animal Food Inspector Training

Instructions: If the inspector has greater than five years of experience and an evaluation of the inspector’s 

previous performance and experience shows adequate training has been completed, mark the Name and 

Location of Training column, with “Met via Evaluation.” 

Inspector Name: Employment Start Date:

Subject Areas Name and Location of Training Completion Date Documentation 

Verifying Completion 

Advanced Ingredients, 

Processing, and 

Technology 

Advanced Inspections, 

Compliance, and 

Enforcement

Advanced Labeling 

Animal Illness and Death 

Investigation

Current Statutes, 

Regulations, and Policies 

Epidemiology 

Microbiological 

Pathogens 

Traceback and 

Tracefoward 

Investigations 
Appendix 2.2 

Animal Food Regulatory Program Standards – 2023 50

Appendix 2.2: Inspector Training Record

Instructions: Record the name and location of the establishment where the joint training inspection took place 

as well as the competencies covered. 

Inspector Name: Employment Start Date:

Advanced Field Training 

(Name and Location of 

Establishment)

Competencies Covered Completion Date Verified (Y/N)
Appendix 2.2 

Animal Food Regulatory Program Standards – 2023 51

Appendix 2.2: Inspector Training Record

C. Continuing Education

Instructions: Record the continuing education activity as well as the name and location of the activity.

Inspector Name: Employment Start Date:

Type of Activity Name and Location of Activity Completion Date Contact Hours Earned
Appendix 2.3 

Animal Food Regulatory Program Standards – 2023 52

Appendix 2.3: Field Training Competencies 

A. Basic Field Training Competencies

Instructions: List the competencies to be covered in the state PROGRAM’S basic field training and provide a 

short description. 

Competency Description

Minimum Number of Joint Field Training Inspections Required: 
Appendix 2.3 

Animal Food Regulatory Program Standards – 2023 53

Appendix 2.3: Field Training Competencies

B. Advanced Field Training Competencies

Instructions: List the competencies to be covered in the state PROGRAM’S advanced field training and provide a 

short description. 

Competency Description

Minimum Number of Joint Field Training Inspections Required: 
Appendix 3.1 

Animal Food Regulatory Program Standards – 2023 54

Appendix 3.1: Self-Assessment Worksheet

Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it 

includes the associated program elements. If the state PROGRAM has the main program element and associated 

program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met 

in the Notes column. The Notes column may be used for additional notes. 

State Agency

Implementation Status Fully Met Partially Met Not Met

Program Elements Yes/No Notes

3.3.1 Risk-Based Inspection Program 

1. Does the state PROGRAM have a procedure to define

and maintain a current inventory of ANIMAL FOOD

establishments whose activities fall under the state

PROGRAM’S jurisdiction and authority?

2. Does the state PROGRAM have a procedure for risk

categorization of ANIMAL FOOD establishments using

the three minimum required factors for defining risk

categories?

2.1 Types of ANIMAL FOOD and ANIMAL FOOD

products? 

2.2 Types of processing? 

2.3 Compliance history of the establishment? 

3. Based on risk categorization of an ANIMAL FOOD

establishment, are inspections:

3.1 Prioritized? 

3.2 Assigned frequencies? 

3.3 Allocated resources? 
Appendix 3.1 

Animal Food Regulatory Program Standards – 2023 55

Program Elements Yes/No Notes

3.3.2 Inspection Procedure 

1. Does the state PROGRAM have procedures for

inspecting ANIMAL FOOD establishments? That

require the inspectors to:

1.1 Review the ANIMAL FOOD establishment’s 

history and determine the scope of inspection?

1.2 Present appropriate credentials and written 

Notice of Inspection to the ANIMAL FOOD

establishment’s owner, operator, or agent in 

charge; make appropriate introductions; 

explain the purpose and scope of the 

inspection; confirm inspection authority and 

establish FDA jurisdiction, if applicable?

1.3 Follow the safety protocols required by the 

ANIMAL FOOD establishment and the state 

PROGRAM? 

1.4 Follow the biosecurity protocols required by

the ANIMAL FOOD establishment and the state

PROGRAM? 

1.5 Use appropriate equipment and forms needed 

to conduct inspections?

1.6 Recognize the relative risk categorization of 

the ANIMAL FOOD establishment based on the

risk-based inspection program?

1.7 Conduct comprehensive inspection activities 

appropriate for the level of risk, focused on the 

establishment’s products and processes 

determined to be of higher risk?

1.8 Assess employee activities critical to the safe 

manufacturing, processing, packaging, 

handling, holding, and distribution of ANIMAL

FOOD? 

1.9 Properly evaluate the potential that conditions, 

practices, processes, components, or labeling 

could cause the product to become

adulterated, contaminated, or misbranded?
Appendix 3.1 

Animal Food Regulatory Program Standards – 2023 56

Program Elements Yes/No Notes

1.10 Recognize significant non-compliant

conditions or practices and document findings 

consistent with state PROGRAM procedures? 

1.11 Distinguish between significant and 

insignificant observations and isolated 

incidents versus trends?

1.12 Review, evaluate and verify that the 

appropriate ANIMAL FOOD establishment 

records, plans, programs, and/or procedures 

are established, maintained, and/or 

implemented? 

1.13 Collect adequate evidence and documentation 

to support inspection observations in 

accordance with state PROGRAM procedures? 

1.14 Verify deficiencies identified during the 

previous inspections have been addressed?

1.15 Conduct activities in a professional manner?

1.16 Use effective interviewing techniques?

1.17 Explain findings clearly and adequately 

throughout the inspection?

1.18 Alert the ANIMAL FOOD establishment’s owner, 

operator, or agent in charge when an 

immediate corrective action is necessary?

1.19 Document findings accurately, clearly, legibly,

and concisely on the applicable forms and 

provide a copy to the ANIMAL FOOD

establishment’s owner, operator, or agent in 

charge?

1.20 Answer questions and provide information as 

appropriate?

1.21 Submit inspection report, samples where 

applicable, and supporting evidence and 

documentation within designated timeframes 

consistent with state PROGRAM procedure? 
Appendix 3.1 

Animal Food Regulatory Program Standards – 2023 57

Program Elements Yes/No Notes

3.3.3 Recall System

Does the state PROGRAM have procedures to handle 

recalls? That includes:

1. Receiving?

2. Tracking?

3. Evaluating recall notifications?

4. Closing?

5. Maintaining records?

6. Performing recall effectiveness checks, as

applicable?

3.3.4 Consumer Complaints

Does the state PROGRAM have a procedure to handle 

consumer complaints? That includes: 

1. Receiving?

2. Tracking?

3. Evaluating?

4. Answering?

5. Closing?

6. Maintaining records?
Appendix 3.1 

Animal Food Regulatory Program Standards – 2023 58

Program Elements Yes/No Notes

3.3.5 Complaints Resulting from state PROGRAM Inspection Activities

Does the state PROGRAM have a procedure to handle 

industry complaints resulting from state PROGRAM

inspection activities? That includes: 

1. Receiving?

2. Evaluating?

3. Maintaining records?

Assessment Completed By:

Name Date
Appendix 4.1 

Animal Food Regulatory Program Standards – 2023 59

Appendix 4.1: Self-Assessment Worksheet

Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it 

includes the associated program elements. If the state PROGRAM has the main program element and associated 

program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met 

in the Notes column. The Notes column may be used for additional notes. 

State Agency

Implementation Status Fully Met Partially Met Not Met

Program Elements Yes/No Notes

4.3.1 Audit Program 

Does the state PROGRAM have procedures for

conducting four types of audits: 

1. Field inspection audits as described in 4.3.3?

2. Field inspection report audits as described in 4.3.4?

3. Sample collection audits as described in 4.3.5?

4. Sample collection report audits as described in 4.3.6?

4.3.2 Audit Program Review 

Does the state program conduct a review of the 

performance factor scores and cumulative scores for

each of the four types of audits at least every 12 

months? 

4.3.3 Field Inspection Audit 

Does the state PROGRAM conduct field inspection 

audits using a QUALIFIED FIELD AUDITOR to verify that

inspections are consistently performed according to 

the state’s PROGRAM procedures? 
Appendix 4.1 

Animal Food Regulatory Program Standards – 2023 60

Program Elements Yes/No Notes

1. Frequency

1.1 Are a minimum of two field inspection audits of 

each inspector conducted every 36 months? 

1.2 Do the field inspections selected for audits 

reflect the inspector’s assignments and 

responsibilities?

2. Performance Factors

Are performance factors listed in the inspection 

procedure as described in 3.3.2 and as listed in 

Appendix 4.2, or an equivalent form, evaluated? 

3. Performance Documentation

3.1 Is the rating of each performance factor, audit 

score, and audit rating for each field inspection 

audit recorded on Appendix 4.2, or an 

equivalent form? 

3.2 Are the performance factor scores and the 

cumulative score for the state PROGRAM

calculated on Appendix 4.3, or an equivalent 

worksheet?

4.3.4 Field Inspection Report Audit 

Does the state PROGRAM conduct field inspection 

report audits to verify that inspectional findings are 

consistently reported according to the state 

PROGRAM’S procedures?

1. Frequency

Is the review a random selection of field

inspection reports to be audited based on the 

number of inspections completed in 12 months of 

performance using Table 1 as described in 

4.3.4.1? 
Appendix 4.1 

Animal Food Regulatory Program Standards – 2023 61

Program Elements Yes/No Notes

2. Performance Factors

Are the performance factors listed in Appendix 

4.4, or an equivalent form, evaluated?

3. Performance Documentation:

3.1 Is the rating of each performance factor, audit 

score, and audit rating for each inspection report 

audit recorded on Appendix 4.4, or an 

equivalent form? 

3.2 Are the performance factor scores and a 

cumulative score for the state PROGRAM

calculated on Appendix 4.5, or an equivalent 

worksheet? 

4.3.5 Sample Collection Audit

Does the state PROGRAM conduct sample collection 

audits using a QUALIFIED FIELD AUDITOR to verify that

sample collections are consistently performed

according to the state PROGRAM’S procedures?

1. Frequency

1.1 Are a minimum of two sample collection audits 

of each inspector conducted every 36 months?

1.2 Do sample collections selected for audits reflect 

the inspector’s assignments and responsibilities?

2. Performance Factors

Are performance factors listed in the sample 

collection procedure as described in 11.3.2 and as 

listed in Appendix 4.6, or an equivalent form, 

evaluated?
Appendix 4.1 

Animal Food Regulatory Program Standards – 2023 62

Program Elements Yes/No Notes

3. Performance Documentation:

3.1 Is the rating of each performance factor, audit 

score, and audit rating for each sample 

collection audit recorded on Appendix 4.6, or an 

equivalent form? 

3.2 Are the performance factor scores and the

cumulative score for the state PROGRAM

calculated on Appendix 4.7, or an 

equivalent worksheet?

4.3.6 Sample Collection Report Audit

Does the state PROGRAM conduct sample collection 

report audits to verify that sample collection 

documentation is consistently performed according to 

the state PROGRAM’S procedures? 

1. Frequency

Is the review a random selection of sample

collection reports to be audited based on the 

number of samples collected in 12 months of 

performance based using Table 2 as 

described in 4.3.6.1? 

2. Performance Factors

Are the performance factors listed in Appendix 

4.8, or an equivalent form, evaluated?

3. Performance Documentation:

3.1 Is the rating of each performance factor, audit 

score, and audit rating for each sample 

collection report audit recorded on Appendix 

4.8, or an equivalent form? 

3.2 Are the performance factor scores and a 

cumulative score for the state PROGRAM

calculated on Appendix 4.9, or an equivalent 

worksheet? 
Appendix 4.1 

Animal Food Regulatory Program Standards – 2023 63

Program Elements Yes/No Notes

4.3.7 Corrective Action Plan

Does the state PROGRAM document CORRECTIVE

ACTIONS as described in 9.3.2 for each of the four 

types of audits when any of the following conditions 

are met:

1. An inspector receives an overall audit rating of

“needs improvement” (audit score below 80 percent)

for an individual audit?

2. A state PROGRAM has a performance factor score (as

a result of all audits in 12 months of performance)

below 80 percent for a single performance factor?

3. A state PROGRAM has a cumulative score (as a result

of all audits in 12 months of performance) below 80

percent?

Assessment Completed By:

Name Date
Appendix 4.2: Field Inspection Audit Form 

Animal Food Regulatory Program Standards – 2023 64

Field Inspection Audit

Inspector: Auditor: 

Date of Audit: 

Establishment Name: 

Establishment Address: 

Type of Inspection: 

BSE GMP Tissue Residue

Complaint Other: 

Total Number of: 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 eighty percent, the audit rating must be marked as ‘Needs Improvement’. 

I. Pre-Inspection Assessment

1. Did the inspector review the animal food establishment’s history and determine scope of the inspection?

Acceptable Needs Improvement

Comments (required for Needs Improvement)

2. Did the inspector use appropriate equipment and forms needed to conduct the inspection?

Acceptable Needs Improvement

Comments (required for Needs Improvement)

II. Inspection Observations and Performance

1. Did the inspector present appropriate credentials and written Notice of Inspection to the animal food establishment’s

owner, operator, or agent in charge; make appropriate introductions; explain the purpose and scope of the inspection;

confirm inspection authority and establish FDA jurisdiction, if applicable?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 
Appendix 4.2: Field Inspection Audit Form (continued)

Animal Food Regulatory Program Standards – 2023 65

2. Did the inspector follow safety protocols required by the animal food establishment and the state program?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

3. Did the inspector follow the biosecurity protocols required by the animal food establishment and the state program?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

4. Did the inspector recognize the relative risk categorization of the animal food establishment based on the risk-based

inspection program?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

5. Did the inspector conduct comprehensive inspection activities, appropriate for the level of risk, focused on the

establishment’s products and processes determined to be of higher risk?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

6. Did the inspector assess employee activities critical to the safe manufacturing, processing, packaging, handling,

holding, and distribution of animal food?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

7. Did the inspector properly evaluate the potential that conditions, practices, processes, components, or labeling could

cause the product to become adulterated, contaminated, or misbranded?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 
Appendix 4.2: Field Inspection Audit Form (continued)

Animal Food Regulatory Program Standards – 2023 66

8. Did the inspector recognize significant non-compliant conditions or practices and document findings consistent with

state program procedure?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

9. Did the inspector distinguish between significant and insignificant observations and isolated incidents versus trends?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

10. Did the inspector review, evaluate, and verify that the appropriate animal food establishment records, plans,

programs, and/or procedures are established, maintained, and/or implemented?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

11. Did the inspector collect adequate evidence and documentation to support inspection observations in accordance

with state program procedures?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

12. Did the inspector verify deficiencies identified during the previous inspections have been addressed?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

13. Did the inspector conduct activities in a professional manner?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 
Appendix 4.2: Field Inspection Audit Form (continued)

Animal Food Regulatory Program Standards – 2023 67

III. Oral and Written Communications

1. Did the inspector use effective interviewing techniques?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

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

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

3. Did the inspector alert the animal food establishment’s owner, operator, or agent in charge when an immediate

corrective action is necessary?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

4. Did the inspector document findings accurately, clearly, legibly, and concisely on the applicable forms and provide a

copy to the animal food establishment’s owner, operator, or agent in charge?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

5. Did the inspector answer questions and provide information as appropriate?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

6. Did the inspector submit inspection report, samples where applicable, and supporting evidence and documentation

within designated timeframes consistent with state program procedure?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 
Appendix 4.2: Field Inspection Audit Form (continued)

Animal Food Regulatory Program Standards – 2023 68

IV. General Comments

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

Name of Auditor Signature of Auditor Date
 

 

 

 

 

Appendix 4.3: Field Inspection Audit Worksheet 

State Program: Reviewed By: 

Performance Period: Date: 

Cumulative Score 

(5): 

Auditor Initials and Date of Audit (1) 

At 

(3) 

NIt 

(3) 

Performance 

Factor Score 

(3) 

Initials 

Date 

Performance 

Factors (2) Performance Ratings 

I.1

I.2

II.1

II.2

II.3

II.4

II.5

II.6

II.7

II.8

II.9

II.10

II.11

II.12

II.13

III.1

III.2

III.3

III.4

III.5

III.6

Audit Score 

(2) 

Subtotal - Enter the sum of the totals from all continuation worksheets. 

Total (4) - Enter the final sums (subtotal + sums of (3) on this form). 

(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

Animal Food Regulatory Program Standards – 2023 69
 

 

 

 

 

Appendix 4.3: Field Inspection Audit Worksheet (continuation worksheet) 

State Program: Reviewed By: 

Auditor Initials and Date of Audit (1) 

At 

(3) 

NIt 

(3) 

Performance 

Factor Score 

(3) 

Initials 

Date 

Performance 

Factors (2) Performance Ratings 

I.1

I.2

II.1

II.2

II.3

II.4

II.5

II.6

II.7

II.8

II.9

II.10

II.11

II.12

II.13

III.1

III.2

III.3

III.4

III.5

III.6

Audit Score 

(2) 

Subtotal - Enter the sum of the totals from all continuation worksheets. 

Total (4) - Enter the final sums (subtotal + sums of (3) on this form). 

(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

Animal Food Regulatory Program Standards – 2023 70
Appendix 4.4: Field Inspection Report Audit Form

Animal Food Regulatory Program Standards – 2023 71

Field Inspection Report Audit

Auditor: Date of Audit: 

Date of Inspection: 

Establishment Name: 

Establishment Address: 

Type of Inspection: 

BSE GMP Tissue Residue

 Complaint Other: 

Total Number of: 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 eighty percent, the audit rating must be marked as ‘Needs Improvement’. 

I. Organization of the Report

1. Format of the inspection report followed the state program’s current procedures.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

2. Required fields on inspection report or related report forms are 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. Submitted report within designated timeframes.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 
Appendix 4.4: Field Inspection Report Audit Form (continued)

Animal Food Regulatory Program Standards – 2023 72

II. Record of Findings

1. Recorded name and title of establishment managers and key personnel.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

2. Recorded name and title of personnel interviewed during the inspection.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

3. Recorded findings not in compliance with laws and regulations.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

4. Recorded significant findings, if any.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

5. Recorded the collection of all samples, exhibits, photographs, or photocopies to support findings.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

6. Recorded any refusals encountered during the inspection.

Acceptable Needs Improvement

Comments (required for Needs Improvement)
Appendix 4.4: Field Inspection Report Audit Form (continued)

Animal Food Regulatory Program Standards – 2023 73

III. Communication with Establishment Personnel

1. Provided a summary of findings.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

2. Recorded responses, replies, or corrective action commitments.

Acceptable Needs Improvement

Comments (required for Needs Improvement)

IV. General Comments

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

Name of Auditor Signature of Auditor Date
 

 

 

 

 

 

 

 

 

 

Appendix 4.5: Field Inspection Report Audit Worksheet 

State Program: Reviewed By: 

Performance Period: Date: 

Cumulative Score 

(5): 

Auditor Initials and Date of Audit (1) 

At 

(3) 

NIt 

(3) 

Performance 

Factor Score 

(3) 

Initials 

Date 

Performance 

Factors (2) Performance Ratings 

I.1

I.2

I.3

I.4

II.1

II.2

II.3

II.4

II.5

II.6

III.1

III.2

Audit Score 

(2) 

Subtotal - Enter the sum of the totals from all continuation worksheets. 

Total (4) - Enter the final sums (subtotal + sums of (3) on this form). 

(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

Animal Food Regulatory Program Standards – 2023 74
 

 

 

 

 

 

 

 

 

Appendix 4.5: Field Inspection Report Audit Worksheet (continuation worksheet) 

State Program: Reviewed By: 

Auditor Initials and Date of Audit (1) 

At 

(3) 

NIt 

(3) 

Performance 

Factor Score 

(3) 

Initials 

Date 

Performance 

Factors (2) Performance Ratings 

I.1

I.2

I.3

I.4

II.1

II.2

II.3

II.4

II.5

II.6

III.1

III.2

Audit Score 

(2) 

Subtotal - Enter the sum of the totals from all continuation worksheets. 

Total (4) - Enter the final sums (subtotal + sums of (3) on this form). 

(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

Animal Food Regulatory Program Standards – 2023 75
Appendix 4.6: Sample Collection Audit Form

Animal Food Regulatory Program Standards – 2023 76

Sample Collection Audit

Inspector: Auditor: 

Date of Audit: 

Establishment Name: 

Establishment Address: 

Type of Sample Collection: 

Surveillance Compliance 

 Investigational Regulatory 

Other: 

Total Number of: 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 eighty percent, the audit rating must be marked as ‘Needs Improvement’. 

I. Sample Collection Observations and Performance

1. Did the inspector follow safety precautions on the animal food label?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

2. Did the inspector follow the state program’s safety protocols for collecting samples?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

3. Did the inspector use the appropriate method, sample collection procedures, and equipment to collect the sample?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

4. Did the inspector seal the sample to initiate chain of custody?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 
Appendix 4.6: Sample Collection Audit Form (continued)

Animal Food Regulatory Program Standards – 2023 77

5. Did the inspector maintain and document sample integrity, security, and chain of custody?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

6. Did the inspector issue a receipt for the sample?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

7. Did the inspector handle, package, and ship samples to prevent compromising the condition of the samples?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

8. Did the inspector deliver or ship samples to the appropriate regulatory testing laboratory within designated

timeframes?

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

II. General Comments

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

Name of Auditor Signature of Auditor Date
 

 

 

 

 

 

 

 

Appendix 4.7: Sample Collection Audit Worksheet 

State Program: Reviewed By: 

Performance Period: Date: 

Cumulative Score 

(5): 

Auditor Initials and Date of Audit (1) 

At 

(3) 

NIt 

(3) 

Performance 

Factor Score 

(3) 

Initials 

Date 

Performance 

Factors (2) Performance Ratings 

I.1

I.2

I.3

I.4

I.5

I.6

I.7

I.8

Audit Score 

(2) 

Subtotal - Enter the sum of the totals from all continuation worksheets. 

Total (4) - Enter the final sums (subtotal + sums of (3) on this form). 

(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

Animal Food Regulatory Program Standards – 2023 78
 

 

 

 

 

 

Appendix 4.7: Sample Collection Audit Worksheet (continuation worksheet) 

State Program: Reviewed By: 

Auditor Initials and Date of Audit (1) 

At 

(3) 

NIt 

(3) 

Performance 

Factor Score 

(3) 

Initials 

Date 

Performance 

Factors (2) Performance Ratings 

I.1

I.2

I.3

I.4

I.5

I.6

I.7

I.8

Audit Score 

(2) 

Subtotal - Enter the sum of the totals from all continuation worksheets. 

Total (4) - Enter the final sums (subtotal + sums of (3) on this form). 

(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

Animal Food Regulatory Program Standards – 2023 79
Appendix 4.8: Sample Collection Report Audit Form

Animal Food Regulatory Program Standards – 2023 80

Sample Collection Report Audit

Auditor: Date of Audit: 

Date of Sample Collection: 

Establishment Name: 

Establishment Address: 

Type of Sample Collection: 

Surveillance Compliance 

 Investigational Regulatory 

Other: 

Number of: 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 eighty percent, the audit rating must be marked as ‘Needs Improvement’. 

I. Sample Collection Report

1. Identification of sample collector was recorded.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

2. Date of the sample collection was recorded.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

II. Product Identification

1. Product name was recorded.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 
Appendix 4.8: Sample Collection Report Audit Form (continued)

Animal Food Regulatory Program Standards – 2023 81

2. Lot numbers or any other codes referencing manufacture identification was recorded.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

3. Description of product was recorded.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

4. Method of collection and any special techniques used to collet sample was recorded.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

5. Lot sampled was recorded.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

6. Lot size was recorded.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 
Appendix 4.8: Sample Collection Report Audit Form (continued)

Animal Food Regulatory Program Standards – 2023 82

7. Location where sample was collected was recorded.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

8. Name and address of responsible party, guarantor, possessor, or distributor was recorded.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

9. Sample type (example: surveillance, compliance, investigational, regulatory, or other) was recorded.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

10. Analysis requested was recorded, if applicable.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

11. Collection or reproduction of product labels, including customer-formula labels was recorded.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 
Appendix 4.8: Sample Collection Report Audit Form (continued)

Animal Food Regulatory Program Standards – 2023 83

12. Receiving and distribution information was recorded.

Acceptable Needs Improvement

Comments (required for Needs Improvement) 

III. General Comments

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

Name of Auditor Signature of Auditor Date
 

 

 

 

Appendix 4.9: Sample Collection Report Audit Worksheet 

State Program: Reviewed By: 

Performance Period: Date: 

Cumulative Score 

(5): 

Auditor Initials and Date of Audit (1) 

At 

(3) 

NIt 

(3) 

Performance 

Factor Score 

(3) 

Initials 

Date 

Performance 

Factors (2) Performance Ratings 

I.1

I.2

II.1

II.2

II.3

II.4

II.5

II.6

II.7

II.8

II.9

II.10

II.11

II.12

Audit Score 

(2) 

Subtotal - Enter the sum of the totals from all continuation worksheets. 

Total (4) - Enter the final sums (subtotal + sums of (3) on this form). 

(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

Animal Food Regulatory Program Standards – 2023 84
 

 

 

 

Appendix 4.9: Sample Collection Report Audit Worksheet (continuation worksheet) 

State Program: Reviewed By: 

Auditor Initials and Date of Audit (1) 

At 

(3) 

NIt 

(3) 

Performance 

Factor Score 

(3) 

Initials 

Date 

Performance 

Factors (2) Performance Ratings 

I.1

I.2

II.1

II.2

II.3

II.4

II.5

II.6

II.7

II.8

II.9

II.10

II.11

II.12

Audit Score 

(2) 

Subtotal - Enter the sum of the totals from all continuation worksheets. 

Total (4) - Enter the final sums (subtotal + sums of (3) on this form). 

(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

Animal Food Regulatory Program Standards – 2023 85
Appendix 5.1 

Animal Food Regulatory Program Standards – 2023 86

Appendix 5.1: Self-Assessment Worksheet

Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it 

includes the associated program elements. If the state PROGRAM has the main program element and associated 

program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met 

in the Notes column. The Notes column may be used for additional notes. 

State Agency

Implementation Status Fully Met Partially Met Not Met

Program Elements Yes/No Notes

5.3.1 Animal Food-Related Illnesses or Deaths and Emergencies Procedure

1. Does the state PROGRAM have a procedure to gather

information to identify incidents of ANIMAL FOODrelated illnesses or deaths and EMERGENCIES?

2. Does the state PROGRAM have a procedure to

communicate with the appropriate agencies or

departments that investigate ANIMAL FOOD-related

illnesses or deaths and EMERGENCIES?

3. For ANIMAL FOOD-related illnesses or deaths and

EMERGENCIES, does the state PROGRAM have a

procedure? To:

3.1 Determine the appropriate response? 

3.2 Initiate the response? 

3.3 Complete the response? 

5.3.2 Emergency Event Management 

1. For ANIMAL FOOD-related EMERGENCIES, does the

state PROGRAM manage the event using:

1.1 An Incident Command System? or

1.2 An official action plan? 
Appendix 5.1 

Animal Food Regulatory Program Standards – 2023 87

Program Elements Yes/No Notes

Does the official action plan include: 

1.2.1 Containment? 

1.2.2 Communication? 

1.2.3 Control? 

1.2.4 Correction and/or Corrective Actions? 

1.2.5 After-action protocols? 

5.3.3 Animal Food-Related Illnesses or Deaths and Emergencies Notification Procedures

1. Does the state PROGRAM maintain a current list of

relevant agencies and emergency contacts that is

reviewed and updated at least every 12 months?

2. Does the state PROGRAM have a procedure to rapidly

notify government agencies, departments, and

appropriate parties of relevant findings?

3. Does the state PROGRAM have a procedure to rapidly

notify law enforcement agencies when intentional

ANIMAL FOOD contamination or ANIMAL FOODrelated terrorism is suspected or threatened?

4. Does the state PROGRAM have a procedure for:

4.1 Releasing information to the public? 

4.2 Coordinating media information with other 

jurisdictions to reduce the impact of ANIMAL

FOOD-related illnesses or deaths and 

EMERGENCIES?

Assessment Completed By:

Name Date
Appendix 6.1 

Animal Food Regulatory Program Standards – 2023 88

Appendix 6.1: Self-Assessment Worksheet

Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it 

includes the associated program elements. If the state PROGRAM has the main program element and associated 

program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met 

in the Notes column. The Notes column may be used for additional notes. 

State Agency

Implementation Status Fully Met Partially Met Not Met

Program Elements Yes/No Notes

6.3.1 Compliance and Enforcement Program 

1. Does the state PROGRAM have a documented

compliance and enforcement program that contains

ENFORCEMENTSTRATEGIES?

2. Does the state PROGRAM select an appropriate

enforcement tool? Using the following six factors:

2.1 Compliance history? 

2.2 Responsiveness? 

2.3 Scope? 

2.4 Nature of the Violation? 

2.5 Impact of the Violation? 

2.6 Resources? 

3. Does the state PROGRAM have a documented

description for all factors?

4. Does the state PROGRAM have documented relative

conditions with an assigned numerical weight for all

factors?

5. Does the state PROGRAM have a documented

enforcement matrix designed to incorporate the

relative conditions of each factor and the application

of enforcement tools?
Appendix 6.1 

Animal Food Regulatory Program Standards – 2023 89

Program Elements Yes/No Notes

6.3.2 Performance Review 

1. Does the state PROGRAM have a procedure for

conducting an evaluation of its ENFORCEMENT

STRATEGIES at least every 12 months? To:

1.1 Determine if the state PROGRAM’S

ENFORCEMENT STRATEGIES were successful in 

achieving compliance? 

1.2 Identify potential improvements or

modifications of the ENFORCEMENT

STRATEGIES, if any? 

1.3 Determine if the enforcement priorities remain 

the same or require modification? 

Assessment Completed By:

Name Date
Appendix 7.1 

Animal Food Regulatory Program Standards – 2023 90

Appendix 7.1: Self-Assessment Worksheet

Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it 

includes the associated program elements. If the state PROGRAM has the main program element and associated 

program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met 

in the Notes column. The Notes column may be used for additional notes. 

State Agency

Implementation Status Fully Met Partially Met Not Met

Program Elements Yes/No Notes

7.3.1 Outreach Methods 

Does the state PROGRAM identify the methods that will 

be used for outreach to inform ANIMAL FOOD industry 

stakeholders, academia, other regulators, or

consumers about ANIMAL FOOD topics? 

7.3.2 Outreach Plan 

Does the state PROGRAM have a documented outreach

plan at least every 12 months that supports the state

PROGRAM mission? And that includes: 

1. Objectives of an outreach plan?

2. Target populations?

3. The types of outreach (including OUTREACH

ACTIVITIES or OUTREACH EVENTS)?

7.3.3 Outreach Events 

Does the state PROGRAM document and evaluate

OUTREACH EVENTS using Appendix 7.2, or an 

equivalent form? 

Assessment Completed By:

Name Date
Appendix 7.2 

Animal Food Regulatory Program Standards – 2023 91

Appendix 7.2: Outreach Event Overview and Evaluation 

Instructions: Attach documents such as agendas, meeting summaries, and program evaluations to this form. 

Section I. Overview of Outreach Event

A. Type of outreach event (select all that apply):

Meeting Workshop

Extension Event Other

Task Force/Committee

B. Date of outreach event

C. Objective of outreach event

D. Target population for outreach event

Section II. Evaluation of Outreach Event

Program Elements Yes/No If no, please explain

A. The purpose and objectives were clearly defined

B. The context of the outreach event was

consistent with the objectives

C. An evaluation was completed by attendees

D. State program reviewed and discussed

comments from attendees

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

event. 

Completed By:

Name Date
Appendix 8.1 

Animal Food Regulatory Program Standards – 2023 92

Appendix 8.1: Self-Assessment Worksheet

Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it 

includes the associated program elements. If the state PROGRAM has the main program element and associated 

program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met 

in the Notes column. The Notes column may be used for additional notes. 

State Agency

Implementation Status Fully Met Partially Met Not Met

Program Elements Yes/No Notes

8.3.1 Workplan 

Does the state PROGRAM have a documented 

workplan? That includes the: 

1. Inspection plan?

1.1 Number of inspections? 

1.2 Type of inspection? 

1.3 Risk category of establishment or product? 

1.4 Frequency? 

2. Sample plan?

2.1 Number of samples? 

2.2 Type of samples? 

3. Timeframe that the workplan is applicable?

8.3.2 Workplan Procedure 

1. Does the state PROGRAM have a procedure for

evaluating the workplan? That includes:

1.1 Conducting evaluations of the workplan at least 

every 12 months? 

1.2 Evaluating alignment with state PROGRAM

objectives and resources? 

2. Does the state PROGRAM have a procedure for

identifying and evaluating its resources to

accomplish the workplan within the applicable

timeframe?
Appendix 8.1 

Animal Food Regulatory Program Standards – 2023 93

Program Elements Yes/No Notes

3. Has the state PROGRAM developed a formula and

calculated the number of staff needed to

accomplish the state PROGRAM’S ANIMAL FOOD

workplan based on staff assignments,

responsibilities, and work hours?

8.3.3 Equipment 

Does the state PROGRAM establish and maintain a list 

of the equipment required for inspections and sample 

collections? 

8.3.4 Resource Review 

1. Has the state PROGRAM conducted a baseline

evaluation of the resources required to IMPLEMENT

the AFRPS? Including the program elements and the

documentation requirements in the standards to

determine whether the state PROGRAM has:

1.1 Adequate staff? 

1.2 Equipment? 

1.3 Funding? 

2. Does the state PROGRAM complete subsequent

resource evaluations to determine the resources

necessary for the state PROGRAM to partially meet,

fully meet, or maintain IMPLEMENTATION of the

program elements and documentation requirements

within three years of the previous evaluation?

3. Is the evaluation recorded on Appendix 8.2, or an

equivalent form?

Assessment Completed By:

Name Date
Appendix 8.2 

Animal Food Regulatory Program Standards – 2023 94

Appendix 8.2: Resources for Implementation of Animal Food Regulatory Program Standards 

Instructions: This table provides an overview of a state PROGRAM’S evaluation of the resources needed to IMPLEMENT the Animal Food Regulatory 

Program Standards. Based on the evaluation, indicate for each standard whether the state PROGRAM has the resources needed for funding, staffing, 

and equipment by inserting ‘Yes’ or ‘No’ in the corresponding column. If ‘No’, please explain. Resources not related to funding, staffing, and 

equipment needed for IMPLEMENTATION should be in the “Other Resources Needed” column. 

Note: Information technology may be considered as part of the state PROGRAM’S resource needs.

 Standard Funding Staffing Equipment Other resources needed

1 Regulatory Foundation

2 Training Program

3 Inspection Program

4 Audit Program

5 Animal Food-Related Illness or Death 

and Emergency Response

6 Compliance and Enforcement Program

7 Outreach Program

8 Program Planning and Resources

9 Assessment and Improvement

10 Laboratory Services

11 Sampling Program 
Appendix 9.1 

Animal Food Regulatory Program Standards – 2023 95

Appendix 9.1: Self-Assessment Worksheet

Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it 

includes the associated program elements. If the state PROGRAM has the main program element and associated 

program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met 

in the Notes column. The Notes column may be used for additional notes. 

State Agency

Implementation Status Fully Met Partially Met Not Met

Program Elements Yes/No Notes

9.3.1 Self-Assessment Worksheets

Has the state PROGRAM conducted a baseline 

evaluation using the self-assessment worksheets from 

each standard to determine if a standard is fully met, 

partially met, or not met? 

9.3.2 Strategic Improvement Plan 

Has the state PROGRAM developed a strategic 

improvement plan to IMPLEMENT the program 

elements or documentation requirements of each 

standard? Does the strategic improvement plan 

include the following, as applicable?

1. The program element or documentation requirement

of the standard that was not met?

2. Improvements or CORRECTIVE ACTIONS needed to

IMPLEMENT the program element or documentation

requirement of the standard?

3. The cause for any DEVIATIONS requiring CORRECTIVE

ACTIONS when the state PROGRAM was previously in

IMPLEMENTATION with the program element or

documentation requirement of a standard?

4. The PREVENTIVE ACTION taken to prevent future

similar DEVIATIONS when the state PROGRAM was

previously in IMPLEMENTATION with the program

element or documentation requirement of the

standard that was corrected?
Appendix 9.1 

Animal Food Regulatory Program Standards – 2023 96

Program Elements Yes/No Notes

5. Projected completion date for each improvement or

CORRECTIVE ACTION?

6. Personnel responsible?

7. Date completed?

9.3.3 Strategic Improvement Plan Review 

Does the state PROGRAM review and update at least 

every 12 months? The following: 

1. The self-assessment worksheets?

2. The strategic improvement plan?

9.3.4 Document Control Procedure 

1. Does the state PROGRAM have a procedure for

DOCUMENT CONTROL that ensures all guidance and

procedures required by the standards are CURRENT

AND FIT-FOR-USE?

2. Does the state PROGRAM maintain a master document

list of all documents subject to this procedure to

demonstrate they are CURRENT AND FIT-FOR-USE?

9.3.5 Record Retention

Does the state PROGRAM retain records required under 

x.5 of each standard for the three previous years, or

per the state PROGRAM’S record retention policy?

Assessment Completed By:

Name Date
Appendix 10.1 

Animal Food Regulatory Program Standards – 2023 97

Appendix 10.1: Self-Assessment Worksheet

Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it 

includes the associated program elements. If the state PROGRAM has the main program element and associated 

program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met 

in the Notes column. The Notes column may be used for additional notes. 

State Agency

Implementation Status Fully Met Partially Met Not Met

Program Elements Yes/No Notes

10.3.1 Laboratory Support 

1. Does the state PROGRAM maintain a list of analytical

services the REGULATORY TESTING LABORATORIES

provides for the state PROGRAM?

2. Does the state PROGRAM have a documented formal

agreement with the REGULATORY TESTING

LABORATORY that conducts routine analytical

services unless under the same administrative

agency?

10.3.2 Laboratory Sample Integrity Procedure 

Does the state PROGRAM have procedures developed 

by the REGULATORY TESTING LABORATORY to maintain

the integrity of the samples sent to the REGULATORY

TESTING LABORATORY for analytical testing? That 

includes: 

1. Sample receipt?

2. Preservation?

3. Storage?

4. Retention?

5. Disposal?

6. Chain of custody?

7. Report of analysis?
Appendix 10.1 

Animal Food Regulatory Program Standards – 2023 98

Program Elements Yes/No Notes

8. Methods used to communicate information between

the state PROGRAM and REGULATORY TESTING

LABORATORY?

10.3.3 Laboratory Quality Assurance Program 

Does the state PROGRAM utilize REGULATORY TESTING

LABORATORIES that:

1. Are accredited by a recognized accreditation body to

ISO/IEC17025:2017 or current version? or

2. Implement and comply with the AAFCO Quality

Assurance/Quality Control guidelines? or

3. Implement and comply with the ISO/IEC

17025:2017 or current version?

Assessment Completed By:

Name Date
Appendix 11.1 

Animal Food Regulatory Program Standards – 2023 99

Appendix 11.1: Self-Assessment Worksheet

Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it 

includes the associated program elements. If the state PROGRAM has the main program element and associated 

program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met 

in the Notes column. The Notes column may be used for additional notes. 

State Agency

Implementation Status Fully Met Partially Met Not Met

Program Elements Yes/No Notes

11.3.1 Sampling Plan 

Does the state PROGRAM have a documented 

sampling plan, at least every 12 months, for 

collecting surveillance, compliance, investigational, 

regulatory samples, or other samples?

1. Do the state PROGRAM and REGULATORY TESTING 

LABORATORY jointly develop and amend the

sampling plan, at least every 12 months, for

performing routine analytical services to allow for

advanced planning and scheduling of work?

2. Does the sampling plan include the:

2.1 Availability or coordination of analytical 

support? 

2.2 Sampling priorities?

2.3 SAMPLE ANALYIS SCHEDULE?

Does the SAMPLE ANALYIS SCHEDULE

include the: 

2.3.1 Types of ANIMAL FOOD to be analyzed? 

2.3.2 Number of samples to be collected? 

2.3.3 Estimated timeframe for collection? 

2.3.4 Types of analysis to be performed? 
Appendix 11.1 

Animal Food Regulatory Program Standards – 2023 100

Program Elements Yes/No Notes

11.3.2 Sampling Procedure 

Does the state PROGRAM have procedures for 

collecting, storing, and transporting samples? That 

includes: 

1. Following safety precautions on ANIMAL FOOD

labels?

2. Following the state PROGRAM’S safety protocols for

collecting samples?

3. Using appropriate method, sampling collection

procedures, and equipment to collect the sample?

4. Sealing the sample to initiate chain of custody?

5. Maintaining and documenting sample integrity,

security, and chain of custody?

6. Issuing receipt for the sample?

7. Handling, packaging, and shipping samples to

prevent compromising the condition of sample?

8. Delivering or shipping samples to the appropriate

REGULATORY TESTING LABORATORY within

designated timeframes?

11.3.3 Sample Collection Report 

Does the state PROGRAM have a procedure for 

completing the sample collection report? That 

includes the: 

1. Identification of sample collector?

2. Date of the sample collection?

3. Product identification?
Appendix 11.1 

Animal Food Regulatory Program Standards – 2023 101

Program Elements Yes/No Notes

Does the production identification include the: 

3.1 Name? 

3.2 Lot numbers or any other codes referencing 

manufacture identification? 

4. Description of product?

5. Method of collection and any special techniques

used to collect sample?

6. Lot sampled?

7. Lot size?

8. Location where sample was collected?

9. Name and address of responsible party, guarantor,

possessor, or distributor?

10. Sample type (example: surveillance, compliance,

investigational, regulatory, or other)?

11. Analysis requested, if applicable?

12. Collection or reproduction of product labels,

including customer-formula label?

13. Receiving and distribution information?

Assessment Completed By:

Name Date