Animal Food Regulatory Program Standards

U.S. Department of Health and Human Services

Food and Drug Administration

Office of Regulatory Affairs

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

(OMB) under the Paperwork Reduction Act of 1995.

OMB Control No. 0910-0760

Expiration Date: DRAFT
Animal Food Regulatory Program Standards 2 DRAFT

Table of Contents

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

Background..................................................................................................................................................3

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

Definitions....................................................................................................................................................8

Regulatory Foundation.....................................................................................................12

Training Program .............................................................................................................16

Inspection Program ..........................................................................................................25

Audit Program..................................................................................................................32

Animal Food-Related Illnesses or Death and Emergency Response ...............................40

Compliance and Enforcement Program ...........................................................................44

Outreach Activities Program............................................................................................47

Program Planning and Resources.....................................................................................49

Assessment and Improvement..........................................................................................55

Laboratory Services .......................................................................................................59

Sampling Program..........................................................................................................63
Animal Food Regulatory Program Standards 3 DRAFT

Background

AFRPS 2020 AFRPS 2023 – Proposed Changes

In the United States, Federal and State government agencies ensure the 

safety of ANIMAL FEED. The Food and Drug Administration (FDA) is

responsible for ensuring that all foods and feeds moving in interstate

commerce, except those under the United States Department of 

Agriculture jurisdiction, are safe, wholesome, and labeled properly. 

State agencies are responsible for conducting inspections and regulatory 

activities that help ensure food and feed produced, processed, and 

distributed within their jurisdictions are safe and in compliance with 

State laws and regulations. State agencies primarily perform 

inspections under their own regulatory authority. Some State agencies

conduct inspections of feed facilities under contract with the FDA. 

Because jurisdictions may overlap, FDA and States collaborate and 

share resources to protect ANIMAL FEED. To better facilitate a 

partnership among regulatory authorities, regulatory programs should be 

EQUIVALENT IN EFFECT.

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).

Maximizing resources between FDA and the States supports the 

ongoing work of the Partnership for Food Protection (PFP) to develop 

an Integrated Food Safety System (IFSS). The FDA and the Association 

of American Feed Control Officials (AAFCO) are members of the PFP. 

The vision for an 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, State, territorial, tribal, 

and local regulatory agencies conduct inspections 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 FEED. As further development on the 

IFSS progressed, there was a recognized need to develop standards for 

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 

1 Link to the current PFP vision documents available at https://www.pfp-ifss.org/about/pfp-vision1/.
Animal Food Regulatory Program Standards 4 DRAFT

ANIMAL FEED regulatory 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 FEED

regulatory programs. Standards provide a consistent, underlying 

foundation that is critical for uniformity across State and Federal 

agencies to ensure the credibility of all PROGRAMS under an IFSS.

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 Animal Feed Regulatory Program Standards (AFRPS). 

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

partnerships and integration with Federal, State, local, tribal, and 

territorial partners. The enhanced partnerships and integration called for 

by FSMA will allow FDA to rely on inspections and data collected by 

other agencies to support regulatory activities and further the idea of 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 the AFRPS were initially launched in January 2014. These 

standards are designed to promote uniformity and consistency among 

ANIMAL FEED regulatory 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 FEED supply.

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.
Animal Food Regulatory Program Standards 5 DRAFT

Introduction

AFRPS 2020 AFRPS 2023 – Proposed Changes

The Animal Feed Regulatory Program Standards (AFRPS) establish a 

uniform foundation for the design and management of State PROGRAMS

responsible for the regulation of ANIMAL FEED. Through implementing

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 FEED supply. IMPLEMENTATION of the AFRPS is 

voluntary. A State’s IMPLEMENTATION of the AFRPS helps ensure a 

uniform and consistent approach to ANIMAL FEED regulation among 

jurisdictions including the sharing of information and the coordination 

of resources.

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, inspection program, auditing, feed-related illnesses or death 

and emergency response, enforcement program, outreach activities, 

budget and planning, laboratory services, sampling program, and 

assessment and improvement of standard IMPLEMENTATION.

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 FOODrelated 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 statement (x.1), requirement summary (x.2), description of

program elements (x.3), projected outcomes (x.4), and a list of required

documentation (x.5). The program elements describe the best practices 

of a quality regulatory PROGRAM. Required elements 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 throughout the AFRPS. Program 

elements and corresponding conditions described as “should” are best 

practices but are optional and not required to fully implement a 

standard. To fully implement the AFRPS, the PROGRAM must implement 

all eleven standards. “Notes” are used throughout the AFRPS to provide 

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 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
Animal Food Regulatory Program Standards 6 DRAFT

clarification, alternatives, and guidance that the State PROGRAM may use 

to help implement the AFRPS. “Notes” do not contain requirements and 

thus will not be subject to a FDA verification audit.

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 self-assessment worksheet. The State PROGRAM

uses the self-assessment worksheets to determine if the standard’s

requirements are, or remain, fully met, partially met, or not met. The 

self-assessments are used to develop an improvement plan for fully

implementing the requirements of the standards.

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 to IMPLEMENTATION of standards.

The standards have forms, worksheets, and templates that will help the 

State PROGRAM assess and meet the program elements in the standard.

State PROGRAMS are not obligated to use the forms provided in the 

AFRPS. Other manual or automated forms, worksheets, and templates 

may be used as long as the pertinent data elements are present. Records

and other documents specified in the standards must be maintained in 

good order by the State PROGRAM and must be available to verify the 

information for the purposes of a verification audit. These program 

standards are not intended to address the performance appraisal 

processes that a State agency may use to evaluate individual employee 

performance. (Reworded and separated into different paragraphs.)

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 
Animal Food Regulatory Program Standards 7 DRAFT

PROGRAMS are encouraged to build systems that are sustainable and 

IMPLEMENT plans that result in the standards being maintained. 

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 8 DRAFT

Definitions

AFRPS 2020 AFRPS 2023 – Proposed Changes

Animal Feed: 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 section 507.3 (21 CFR 507.3), and (3) for animal 

feed in the AAFCO Official Publication (AAFCO OP), and is inclusive 

of feed (including raw materials and other ingredients) for foodproducing animals and pets.

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(s): One contact hour equals 60 minutes. Contact Hour: One CONTACT HOUR equals 60 minutes.

Corrective Action: Action to correct a DEVIATION from the program 

elements of a standard. 

Cross-Sector Event(s): For purposes of this standard, a “cross-sector 

event” is a feed-related event that impacts human food or an event 

involving human food that impacts ANIMAL FEED.

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-for-use” is a quality term 

used to indicate that a product or service fits the customer’s defined 

purpose for that product or service. Documentation may be electronic or 

hard copy.

Curriculum: A plan which includes documented specific coursework 

and field training for both inspection and sample collection. 

Deviation: Non-fulfillment of a program element.
Animal Food Regulatory Program Standards 9 DRAFT

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(ies): 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 

ANIMAL FEED supply.

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 Strategies: 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.

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: 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.

Equivalent in Effect: State law has the same regulatory effect as the 

relevant FD&C Act provision or federal regulation.

Implementation: Means a State PROGRAM has a particular element, 

system, or program as required in the Program Elements and 

Documentation sections of the AFRPS; and can demonstrate the use of 

that particular element, system, or program.

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 Inspections: 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 a firm and may either be trainer led or trainee led.

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.
Animal Food Regulatory Program Standards 10 DRAFT

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: (1) There is no State law EQUIVALENT to the relevant 

Federal law or regulation, (2) there is such a State law but it does not 

apply to the State’s PROGRAM, or (3) the Federal and State laws address 

the same matter but are inconsistent and do not have the same 

regulatory effect.

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 Event: An outreach activity which the State 

PROGRAM hosts, co-hosts, or is an invited presenter such as seminars, 

workshops, conferences, trainings, or meetings that relate to feed topics 

and that support communication and information exchange among feed 

industry stakeholders, academia, other regulators, or consumers.

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. 

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. 
Animal Food Regulatory Program Standards 11 DRAFT

Program(s): An operational unit(s) in a regulatory agency that is 

responsible for the regulatory oversight of ANIMAL FEED.

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 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.

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 laws, regulations, rules, ordinances, or 

other regulatory requirements that govern the operation of an ANIMAL

FEED facility.

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

other regulatory requirements that govern the operation of an ANIMAL

FOOD establishment.

Regulatory Testing Laboratory(ies): A laboratory that conducts 

measurements and analyses on food or feed and associated physical 

samples, which result in qualitative or quantitative analytical findings 

that may be used as a basis for regulatory action.

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

FEED PROGRAM as the beginning date for training timelines.

Start Date: Date employee is hired or reassigned in or into the ANIMAL

FOOD state PROGRAM as the beginning date for training timelines.
Animal Food Regulatory Program Standards 12 DRAFT

Regulatory Foundation

AFRPS 2020 AFRPS 2023 – Proposed Changes

1.1 Purpose 1.1 Purpose

This standard describes the elements of the REGULATORY 

FOUNDATION used by a State PROGRAM to regulate

ANIMAL FEED.

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 1.2 Requirement Summary

The State PROGRAM evaluates the scope 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 FEED.

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.

The State PROGRAM evaluation includes a determination

of how the State’s legal authority and regulatory

provisions correspond to the sections of the Federal

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

regulations specified in appendix 1.2.

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 Program Elements

1.3.1 The State PROGRAM conducts an evaluation to determine

whether the State’s legal authority and regulatory

provisions are EQUIVALENT, EQUIVALENT IN EFFECT, or

NOT EQUIVALENT to the sections of the FD&C Act and 

Federal regulations specified in appendix 1.2.

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.

1.3.1.1 “EQUIVALENT” means that the State law directly

references the relevant FD&C Act provision or Federal 

regulation. For State law found EQUIVALENT, the State 
Animal Food Regulatory Program Standards 13 DRAFT

PROGRAM:

1.3.1.1.1 Specifies the Federal statute or regulation that is 

incorporated into the State law;

1.3.1.1.2 Includes the revision date of the State statutory provision 

or regulation as appropriate;

1.3.1.1.3 Identifies the date the Federal statutory provision or 

regulation was incorporated into the State law.

Note: In conducting such an evaluation, the State 

PROGRAM should consult with its legal counsel when 

State law 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.

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.

Note: “EQUIVALENT IN EFFECT” means that the 

State law has the same regulatory effect as the relevant 

FD&C Act provision or Federal regulation. A State law 

may have the same regulatory effect as the Federal law 

or regulation if either a single State law or rule has the 

same regulatory effect as the Federal law or regulation, 

or when multiple laws of that State are combined and 

deemed EQUIVALENT IN EFFECT to a single Federal 

law or regulation.

Note: “NOT EQUIVALENT” means there is no State 

law EQUIVALENT to the relevant Federal law or 

regulation, there is such a State law but it does not apply 

to the State’s PROGRAM, or the Federal and State laws 

address the same matter but are inconsistent and do not 

have the same regulatory effect. For provisions found to 

be “NOT EQUIVALENT”, the State PROGRAM should 

identify which State agency has authority and jurisdiction 

over said provisions, if there is one, in appendix 1.2.
Animal Food Regulatory Program Standards 14 DRAFT

Note: In addition, if the State has laws and regulations 

pertinent to the regulation of ANIMAL FEED for which 

there are no comparable Federal provisions, these laws 

can be listed in appendix 1.2.

1.3.2 The State PROGRAM has a documented process, which

includes:

1.3.2 Regulatory Foundation Evaluation

The state PROGRAM has a procedure that includes:

1.3.2.1 Procedures to review the statutes, regulations, rules, 

ordinances, and other prevailing regulatory requirements 

that:

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 FEED. 1.3.2.1.1 Apply to the regulation of ANIMAL FOOD.

1.3.2.1.2 Delegate authority to the State agency. 1.3.2.1.2 Delegate authority to the state agency.

1.3.2.1.3 Describe the State agency’s administrative procedures

for establishing its authority and incorporating rules by 

reference.

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 Timeframes for the review. 1.3.2.2 Timeframe for the review.

1.4 Outcome 1.4 Outcome

The State PROGRAM has conducted an evaluation of the

scope of their legal authority and has a REGULATORY 

FOUNDATION adequate to protect the public health by

ensuring the safety and security of ANIMAL FEED.

The state PROGRAM utilizes the evaluation of its 

REGULATORY FOUNDATION to protect animal and public 

health by ensuring the safety and security of ANIMAL

FOOD.

1.5 Documentation 1.5 Documentation

The State PROGRAM maintains the records listed here. The state PROGRAM maintains the records, or equivalent 

forms or worksheets, listed here: 

1.5.1 Appendix 1.1: Self-Assessment Worksheet 1.5.1 Appendix 1.1: Self-Assessment Worksheet. 

1.5.2 Appendix 1.2: REGULATORY FOUNDATION Worksheet 1.5.2 Appendix 1.2: Regulatory Foundation Worksheet.
Animal Food Regulatory Program Standards 15 DRAFT

1.5.3 Documented process for reviewing appropriate statutes, 

regulations, rules, ordinances, and other prevailing

regulatory requirements

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 FEED, (2) delegate authority to the

State agency, and (3) describe the State agency’s

administrative procedures for establishing its authority

and incorporating rules by reference

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.
Animal Food Regulatory Program Standards 16 DRAFT

Training Program 

2.1 Purpose 2.1 Purpose

This standard describes the elements of training for 

inspectors in a State PROGRAM to ensure they will have 

the knowledge, skills, and abilities to competently 

inspect feed facilities, conduct investigations, gather 

evidence, collect samples, and take enforcement actions.

This standard describes the program elements used by a 

state PROGRAM to have an effective ANIMAL FOOD

training program. 

2.2 Requirement Summary 2.2 Requirement Summary

The State PROGRAM has a training plan that ensures all 

inspectors are adequately trained to perform their work.

The state PROGRAM establishes a training program that

ensure all inspectors complete coursework, field training, 

and continuing education to effectively perform their 

assignments and responsibilities.

2.3 Program Elements 2.3 Program Elements

2.3.1 Training Plan and Training Records 2.3.1 Training Plan and Training Records

2.3.1.1 The State PROGRAM uses a written training plan that 

ensures all inspectors receive training required to 

adequately perform their work assignments. The training 

plan includes course curriculum for basic and advanced 

inspection training and continuing education.

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:

2.3.1.2 The State PROGRAM provides, or otherwise makes 

available, inspection training and continuing education 

for all inspectors.

2.3.1.1.1 Description of each inspection type.

2.3.1.3 For inspectors that conduct limited scope inspections, as 

defined by the State PROGRAM, (e.g. such as only 

collecting samples or inspections at veterinary clinics), 

the State PROGRAM specifies the curriculum required by 

the limited scope inspectors in their documented training 

plan.

2.3.1.1.2 CURRICULUM for each inspection type.
Animal Food Regulatory Program Standards 17 DRAFT

Note: Curriculum includes coursework and field training.

2.3.1.4 The State PROGRAM maintains records documenting the 

training completed by all inspectors using appendix 2.2 

or a comparable form. (Renumbered to 2.3.1.3)

2.3.1.5 For inspectors with greater than five years of experience 

at the date of the initial self-assessment, where such

documentation is not available, the State PROGRAM

conducts an evaluation of the inspector’s previous

performance and experience to determine if the inspector 

has completed the required training or whether additional 

training is needed. (Reworded. 2.3.1.2; Separated into 

sub-elements. 2.3.1.2.1; 2.3.1.2.2)

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:

2.3.1.6 If previous coursework is completed before the 

inspectors START DATE and utilized to meet coursework 

requirements, proper supporting documents are

maintained to verify successful completion of the 

requirement. (Reworded. 2.3.1.2.2)

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 Basic ANIMAL FOOD Inspector Training

2.3.2.1 Timeframe: 

The State PROGRAM requires a basic inspector to 

successfully complete the basic coursework and field 

training within 24 months from the START DATE.

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: 2.3.2.2 Coursework
Animal Food Regulatory Program Standards 18 DRAFT

The basic feed inspection training consists of coursework 

in the following subject areas:

Basic inspector training consists of basic coursework in 

the following subject areas:

2.3.2.2.1 Animal and Public Health Principles: Fundamental 

animal and public health protection principles that 

support the foundational roles of the feed inspector.

2.3.2.2.1 Animal and Public Health Principles

2.3.2.2.2 Basic Animal Nutrition: Basic means of digestion and 

nutritional requirements for various animal classes and 

ingredients that can cause toxicity.

2.3.2.2.2 Animal Food Defense 

2.3.2.2.3 Basic Feed Ingredients, Processing, and Technology: 

Typical ingredients, feedstuffs, processing methods, and 

technologies commonly used to manufacture ANIMAL

FEED.

2.3.2.2.3 Basic Animal Nutrition

2.3.2.2.4 Basic National Incident Management System and 

Incident Command System (ICS): Introduction to the 

history, principals, and organizational structure of the 

ICS via ICS100, ICS200, IS700, and IS800.

2.3.2.2.4 Basic Ingredients, Processing, and Technology

2.3.2.2.5 Communication: Techniques and skills for effective oral 

and written communication and interviewing.

2.3.2.2.5 Basic National Incident Management System and 

Incident Command System (ICS)

2.3.2.2.6 Current Statutes, Regulations, and Policies: Basic 

knowledge of Federal and State laws, regulations, and 

policies.

2.3.2.2.6 Communication

2.3.2.2.7 Feed Defense: Feed defense principles for the protection 

of feed from intentional hazard contamination.

2.3.2.2.7 Current Statutes, Regulations, and Policies

2.3.2.2.8 Inspections, Compliance, and Enforcement: Conduct 

inspections applying the relevant laws and regulations to 

gather and document evidence to support possible 

regulatory actions.

2.3.2.2.8 Inspections, Compliance, and Enforcement

2.3.2.2.9 Labeling: Basic feed labeling requirements. 2.3.2.2.9 Labeling

2.3.2.2.10 Professionalism: Character conduct, strengths, and values 

directed toward providing high quality service to the 

2.3.2.2.10 Professionalism
Animal Food Regulatory Program Standards 19 DRAFT

regulated industry and the State PROGRAM.

2.3.2.2.11 Risk Awareness: Basic principles of BSE; medicated 

feeds including VFDs; and physical, chemical, and 

biological contaminants.

2.3.2.2.11 Risk Awareness

2.3.2.2.12 Safety: Appropriate personal safety and bio-security 

requirements when conducting field activities.

2.3.2.2.12 Safety

2.3.2.2.13 Sampling: Techniques and skills for collecting various 

types of samples using the appropriate methods for 

preparation, collection, and shipping.

2.3.2.2.13 Sample Collection

2.3.2.3 Field training: 

The State PROGRAM has established basic field training to 

complement the basic coursework. The basic field 

training specifies the following:

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 Field training checklist of competencies to be mastered 

and verified in the field by the QUALIFIED FIELD 

INSPECTION TRAINER; (Reworded. Renumbered. 2.3.2.3.4)

2.3.2.3.1 The procedure for JOINT FIELD TRAINING INSPECTIONS.

2.3.2.3.2 Documented procedures for JOINT FIELD TRAINING 

INSPECTIONS; (Renumbered. 2.3.2.3.1)

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 Number of JOINT FIELD TRAINING INSPECTIONS that are 

conducted in firms that represent the feed facilities in the 

State PROGRAM inventory and the type of routine or basic 

work that will be performed by the inspector;

(Renumbered. 2.3.2.3.2)

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 inspector completes basic field training prior to 

performing independent inspections; (Renumbered. 

2.3.2.3.5)

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 Appendix 2.3 or a comparable form must be used to list 

the competencies and the minimum number of JOINT 

2.3.2.3.5 The inspector completes the minimum basic field 

training requirements for the inspection type, prior to 
Animal Food Regulatory Program Standards 20 DRAFT

FIELD TRAINING INSPECTIONS. (Reworded. Renumbered. 

2.3.2.3.3)

performing independent work.

2.3.3 Advanced ANIMAL FOOD Inspector Training 2.3.3 Advanced ANIMAL FOOD Inspector Training

2.3.3.1 Timeframe: 

The State PROGRAM requires each inspector who

conducts advanced feed inspections to successfully 

complete the advanced inspector coursework and field 

training within 60 months from the START DATE.

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: 

The advanced feed inspection training consists of 

coursework in the following subject areas:

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 Feed Ingredients, Processing, and Technology: 

Ingredients, feedstuffs, processing methods, and 

technologies that are complex or less common and 

explore the major elements of modern feed 

manufacturing and advances in feed technology.

2.3.3.2.1 Advanced Ingredients, Processing, and Technology

2.3.3.2.2 Advanced Inspections, Compliance and Enforcement

2.3.3.2.2 Advanced Labeling: Knowledge and application of 

ANIMAL FEED labeling requirements (i.e. medicated feed 

and pet food labeling requirements).

2.3.3.2.3 Advanced Labeling

2.3.3.2.3 Animal Sickness and Death Investigation: Principles of 

outbreak investigations.

2.3.3.2.4 Animal Illness and Death Investigation

2.3.3.2.4 Current Statutes, Regulations, and Policies: Federal and 

State laws, regulations, and policies for advanced feed 

inspections.

2.3.3.2.5 Current Statutes, Regulations, and Policies

2.3.3.2.5 Epidemiology: Acquire basic knowledge of 

epidemiology principles and concepts and apply them to 

animal outbreak investigations.

2.3.3.2.6 Epidemiology
Animal Food Regulatory Program Standards 21 DRAFT

2.3.3.2.6 Microbiological Pathogens: Microbial hazards in feed 

that could lead to animal or human illnesses or death.

2.3.3.2.7 Microbiological Pathogens

2.3.3.2.7 Traceback and Traceforward Investigations: Traceback 

and traceforward of an implicated product and steps for 

conducting and concluding the investigation and 

reporting the results.

2.3.3.2.8 Traceback and Traceforward Investigations

2.3.3.3 Specialized Curriculum: Inspectors who assist in 

emergency response or conduct specialized inspections 

listed below must complete relevant specialized 

coursework specific to the type of specialized inspections 

that they will be performing in the following subject 

areas.

2.3.3.3.1 Advanced National Incident Management System and 

Incident Command Systems (ICS).

Note: Courses should be specific to the individual’s 

responsibilities but include at a minimum ICS300 and 

ICS400.

2.3.3.3.2 BSE and Ruminant Feeding Ban: Complete coursework 

required to conduct inspections of rendering facilities and 

feed manufactures under the ruminant feed ban 

regulations, 21 CFR 589.2000 and 21 CFR 589.2001, 

that prohibit certain cattle materials from being included 

in any ANIMAL FEED.

2.3.3.3.3 Medicated Feed Good Manufacturing Practices

Regulations: Complete coursework required to conduct 

inspections and differentiate between the regulations that 

apply to FDA-licensed medicated feed mills and 

unlicensed medicated feed mills, and the requirements 

under 21 CFR part 225 Current Good Manufacturing 

Practice for Medicated Feeds, and 21 CFR part 226 

Current Good Manufacturing Practice for Type A 

Medicated Articles.
Animal Food Regulatory Program Standards 22 DRAFT

2.3.3.4 Field training: 

The State PROGRAM has established advanced field 

training to complement the advanced coursework. The 

advanced field training specifies the following:

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:

2.3.3.4.1 Field training checklist of competencies to be mastered

and verified in the field by the QUALIFIED FIELD 

INSPECTION TRAINER; (Reworded. Renumbered. 2.3.3.3.4)

2.3.3.3.1 The procedure for JOINT FIELD TRAINING INSPECTIONS.

2.3.3.4.2 Documented procedures for JOINT FIELD TRAINING 

INSPECTIONS; (Renumbered. 2.3.3.3.1)

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.

2.3.3.4.3 Number of JOINT FIELD TRAINING INSPECTIONS that are 

conducted in firms that represent the feed facilities in the 

State PROGRAM inventory and the type of advanced work 

that will be performed by the inspector (Renumbered.

2.3.3.3.2)

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.

2.3.3.4.4 The inspector completes field training prior to 

performing independent inspections requiring advanced 

skills; (Renumbered. 2.3.3.3.5)

2.3.3.3.4 The QUALIFIED FIELD INSPECTION TRAINER verifies the 

field training checklist of competencies in the field for 

each inspection type.

2.3.3.4.5 Appendix 2.3 or a comparable form must be used to list 

the competencies and the minimum number of JOINT 

FIELD TRAINING INSPECTIONS. (Reworded. Renumbered. 

2.3.3.3.3)

2.3.3.3.5 The inspector completes the minimum advanced field 

training for the inspection type, prior to performing 

independent work.

2.3.6 Continuing Education (CE): 

The State PROGRAM requires that each basic and 

advanced inspector participate in continuing education.

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:

2.3.6.1 Each inspector is required to receive 20 CONTACT HOURS

of continuing education every 36 months.

2.3.4.1 Each inspector receives 20 CONTACT HOURS of 

continuing education every 36 months.

2.3.6.2 The 36 month continuing education interval starts, as 2.3.4.2 The 36-month continuing education interval starts, as 
Animal Food Regulatory Program Standards 23 DRAFT

defined by the State PROGRAM, when the required 

curriculum is complete.

defined by the state PROGRAM, when the required 

CURRICULUM is complete.

Note: The inspector may accrue one CONTACT HOUR for 

each clock hour of participation in any of the following 

training sources: in-house training provided by a 

government agency; distance learning, for example, 

satellite downlinks or web-based training, or feed-related 

courses provided by colleges, schools, associations, and 

research centers.

Note: Of the accumulated 20 CONTACT HOURS of 

continuing education, a maximum of ten (10) CONTACT

HOURS may be accrued from the following activities: 

attendance at professional seminars, symposiums, or 

technical conferences and workshops; delivery of 

presentations at professional conferences; providing 

classroom or field training to new hires; being a course 

instructor in feed safety; or publishing an original article 

in a peer-reviewed professional or trade association 

journal, periodical, or publication.

2.3.6.3 Documentation must accompany each activity submitted 

for continuing education credit.

2.3.4.3 Documentation accompanies each activity submitted for 

continuing education.

Note: Examples of acceptable documentation may 

include: certificates of completion including the course 

dates(s) and number of hours attended or CE credits 

granted; transcripts from a college or university; a letter 

from the administrator of the continuing education 

program attended; a copy of the peer- reviewed article or 

presentation made at a professional conference; 

documentation to verify technical publications related to 

feed safety have been read including completion of selfassessment quizzes that accompany journal articles, 

written summaries of key points/findings presented in 

technical publications, and/or written book reports; an 

agenda and attendance roster; or documentation 

approved by the QUALIFIED FIELD INSPECTION TRAINER.
Animal Food Regulatory Program Standards 24 DRAFT

2.4 Outcome 2.4 Outcome

The State PROGRAM has trained inspectors with the 

knowledge, skills, and abilities to competently inspect 

feed facilities and conduct investigations, gather 

evidence, collect samples, and take enforcement actions 

with ANIMAL FEED facilities.

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 2.5 Documentation

The State PROGRAM maintains the records listed here. The state PROGRAM maintains the records, or equivalent 

forms or worksheets, listed here: 

2.5.1 Appendix 2.1: Self-Assessment Worksheet 2.5.1 Appendix 2.1: Self-Assessment Worksheet.

2.5.2 Training Plan 2.5.2 Training Plan.

2.5.3 Appendix 2.2: Inspector Training Record 2.5.3 Appendix 2.2: Inspector Training Record.

2.5.4 Appendix 2.3: Field Training Competencies 2.5.4 Appendix 2.3: Field Training Competencies.

2.5.5 Documents verifying successful completion of required 

courses

2.5.5 Documents verifying successful completion of required 

coursework.

2.5.6 Documentation for continuing education credit 2.5.6 Documentation for continuing education.
Animal Food Regulatory Program Standards 25 DRAFT

Inspection Program

3.1 Purpose 3.1 Purpose

This standard describes the elements of an effective 

ANIMAL FEED inspection program.

This standard describes the program elements used by a 

state PROGRAM to have an effective ANIMAL FOOD

inspection program.

3.2 Requirement Summary 3.2 Requirement Summary

The State PROGRAM administers an inspection program to 

determine compliance with ANIMAL FEED laws.

The state PROGRAM establishes a risk-based inspection 

program to determine compliance with ANIMAL FOOD

laws. The includes procedures to handle recalls, 

consumer complaints and complaints resulting from state 

program inspection activities.

3.3 Program Elements 3.3 Program Elements

3.3.1 Risk-Based Inspection Program 3.3.1 Risk-Based Inspection Program

3.3.1.1 The State PROGRAM has documented procedures to: 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.

3.3.1.1.1 Define an up-to-date inventory of feed facilities whose 

activities fall under the State’s jurisdiction and authority;

(Combined with 3.3.1.1)

3.3.1.1.2 Maintain the inventory of feed facilities defined in 

3.3.1.1.1. (Combined with 3.3.1.1)

3.3.1.2 The State PROGRAM has documented procedures for 

defining risk categories. The three minimum required 

factors for defining risk categories are:

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 feed and feed products; 3.3.1.2.1 Types of ANIMAL FOOD and ANIMAL FOOD products.
Animal Food Regulatory Program Standards 26 DRAFT

3.3.1.2.2 Types of processing; 3.3.1.2.2 Types of processing.

3.3.1.2.3 Compliance history of the facility. 3.3.1.2.3 Compliance history of the establishment.

3.3.1.3 The State PROGRAM is required to use a minimum of the 

three factors in 3.3.1.2 to assign risk categories to feed 

facilities. (Combined with 3.3.1.2)

3.3.1.4 Based on risk factors assigned to a facility or product, the 

manufacturing processes, and the compliance history of 

the facility, inspections:

3.3.1.3 Based on risk categorization of an ANIMAL FOOD

establishment, inspections are:

3.3.1.4.1 Are prioritized; 3.3.1.3.1 Prioritized.

3.3.1.4.2 Have assigned frequencies; 3.3.1.3.2 Assigned frequencies.

3.3.1.4.3 Have resources allocated. (Reworded. 3.3.1.3.3) 3.3.1.3.3 Allocated resources.

Note: The State PROGRAM should also consider optional 

risk factors, such as volume of feed and feed products 

manufactured, scope of distribution, and other factors 

unique to the State’s industries and practices. Appendix 

3.2 provides additional information about required and 

optional risk factors and risk categories.

3.3.2 Inspection Protocol 3.3.2 Inspection Procedure

The state PROGRAM has procedures for inspecting 

ANIMAL FOOD establishments that require the inspectors 

to:

3.3.2.1 The State PROGRAM has documented policies and

procedures for inspecting ANIMAL FEED facilities that 

require the inspectors to: (Combined with 3.3.2)

3.3.2.1.1 Review the feed facility’s previous inspection report(s) 

and complaint(s);

3.3.2.1 Review the ANIMAL FOOD establishment’s history and 

determine the scope of the inspection.

3.3.2.1.2 Present appropriate credentials and written Notice of 

Inspection to the feed facility’s owner, operator, or agent 

3.3.2.2 Present appropriate credentials and written Notice of 

Inspection to the ANIMAL FOOD establishment’s owner, 
Animal Food Regulatory Program Standards 27 DRAFT

in charge; make appropriate introductions; explain the 

purpose and scope of the inspection; and determine

inspection authority;

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.

3.3.2.1.3 Follow the safety protocols required by the feed facility

and the State PROGRAM;

3.3.2.3 Follow the safety protocols required by the ANIMAL FOOD

establishment and the state PROGRAM.

3.3.2.1.4 Follow the biosecurity protocols required by the feed

facility and the State PROGRAM;

3.3.2.4 Follow the biosecurity protocols required by the ANIMAL

FOOD establishment and the state PROGRAM.

3.3.2.1.5 Use appropriate equipment and forms needed to conduct

inspections;

3.3.2.5 Use appropriate equipment and forms needed to conduct 

inspections.

3.3.2.1.6 Establish interstate jurisdiction for FDA inspections, if 

applicable; (Combined with 3.3.2.1.2)

3.3.2.1.7 Recognize the relative risk (high to low) of feed facilities

based on the State PROGRAM’S risk-based inspection 

program and categorization assigned to a facility or 

product, the manufacturing processes, and the inspection 

history of the facility;

3.3.2.6 Recognize the relative risk categorization of the ANIMAL

FOOD establishment based on the risk-based inspection 

program.

3.3.2.1.8 Conduct inspection activities, appropriate for the level of 

risk, focused on those firms, products, and processes 

determined to be high risk;

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.

3.3.2.1.9 Assess employee activities critical to the safe 

manufacture, distribution, storage, handling, and 

disposition of feed;

3.3.2.8 Assess employee activities critical to the safe 

manufacturing, processing, packaging, handling, holding, 

and distribution of ANIMAL FOOD.

3.3.2.1.10 Properly evaluate the likelihood that conditions, 

practices, processes, components, or labeling could cause 

the product to become adulterated or misbranded;

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.

3.3.2.1.11 Recognize significant non-compliant conditions or 

practices and document findings consistent with 

PROGRAM procedures;

3.3.2.10 Recognize significant non-compliant conditions or 

practices and document findings consistent with state 

PROGRAM procedure.
Animal Food Regulatory Program Standards 28 DRAFT

3.3.2.1.12 Distinguish between significant and insignificant 

observations and isolated incidents versus trends;

3.3.2.11 Distinguish between significant and insignificant 

observations and isolated incidents versus trends.

3.3.2.1.13 Review and evaluate the appropriate ANIMAL FEED

facility records and procedures and verify that the 

procedures are being followed; (Reworded. 3.3.2.12)

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.

3.3.2.1.14 Collect adequate evidence and documentation to support 

inspection observations in accordance with PROGRAM

procedures;

3.3.2.13 Collect adequate evidence and documentation to support 

inspection observations in accordance with state 

PROGRAM procedures.

3.3.2.1.15 Verify correction of deficiencies identified during the 

previous inspection(s);

3.3.2.14 Verify deficiencies identified during the previous 

inspections have been addressed.

3.3.2.1.16 Conduct activities in a professional manner; 3.3.2.15 Conduct activities in a professional manner.

3.3.2.1.17 Use effective interviewing techniques; 3.3.2.16 Use effective interviewing techniques.

3.3.2.1.18 Explain findings clearly and adequately throughout the 

inspection;

3.3.2.17 Explain findings clearly and adequately throughout the 

inspection.

3.3.2.1.19 Alert the feed facility’s owner, operator, or agent in 

charge when an immediate corrective action is necessary;

3.3.2.18 Alert the ANIMAL FOOD establishment’s owner, operator, 

or agent in charge when an immediate corrective action 

is necessary.

3.3.2.1.20 Document findings accurately, clearly, legibly, and 

concisely on the applicable form(s) and provide a copy to 

the feed facility’s owner, operator, or agent in charge;

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.

3.3.2.1.21 Answer questions and provide information as 

appropriate;

3.3.2.20 Answer questions and provide information as 

appropriate.

3.3.2.1.22 Submit inspection report, sample(s), and supporting 

documents to headquarters or supervisor in a timely 

manner.

3.3.2.21 Submit inspection report, samples where applicable, and 

supporting evidence and documentation within 

designated timeframes consistent with state PROGRAM

procedure.
Animal Food Regulatory Program Standards 29 DRAFT

3.3.3 Recall System 3.3.3 Recall System

The state PROGRAM has procedures to handle recalls that 

includes:

3.3.3.1 The State PROGRAM has a documented recall system. The 

recall system includes: (Combined with 3.3.3)

3.3.3.1.1 Written procedures for: (Combined with 3.3.3)

3.3.3.1.1.1 Receiving 3.3.3.1 Receiving

3.3.3.1.1.2 Tracking 3.3.3.2 Tracking

3.3.3.1.1.3 Evaluating recall notifications 3.3.3.3 Evaluating recall notifications

3.3.3.1.1.4 Closing 3.3.3.4 Closing

3.3.3.1.1.5 Maintaining records 3.3.3.5 Maintaining records

3.3.3.1.2 Performing recall effectiveness checks (Renumbered. 

3.3.36)

3.3.3.6 Performing recall effectiveness checks, as applicable

3.3.4 Consumer Complaints 3.3.4 Consumer Complaints

The state PROGRAM has a procedure to handle consumer 

complaints that includes:

3.3.4.1 The State PROGRAM has a documented system for

handling consumer complaints. The system includes 

procedures for: (Reworded. Combined with 3.3.4)

3.3.4.1.1 Receiving 3.3.4.1 Receiving

3.3.4.1.2 Tracking 3.3.4.2 Tracking

3.3.4.1.3 Evaluating 3.3.4.3 Evaluating

3.3.4.1.4 Answering 3.3.4.4 Answering
Animal Food Regulatory Program Standards 30 DRAFT

3.3.4.1.5 Closing 3.3.4.5 Closing

3.3.4.1.6 Maintaining records 3.3.4.6 Maintaining records

3.3.5 Complaints Resulting from State PROGRAM Inspection 

Activities

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 The State PROGRAM has a documented system to handle 

complaints from industry about State PROGRAM

inspections. The system includes procedures for:

(Reworded. Combined with 3.3.5)

3.3.5.1.1 Receiving 3.3.5.1 Receiving

3.3.5.1.2 Evaluating 3.3.5.2 Evaluating

3.3.5.1.3 Maintaining records 3.3.5.3 Maintaining records

3.4 Outcome 3.4 Outcome

The State PROGRAM has an ANIMAL FEED inspection 

program that may prevent the occurrence of feed

adulteration or misbranding by focusing inspection 

resources on high risk facilities, products, processes, and 

facilities with a poor compliance history; obtaining 

immediate corrective actions and long-term compliance 

improvement; and preventing distribution of ANIMAL 

FEED that may be adulterated or misbranded.

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 3.5 Documentation

The State PROGRAM maintains the records listed here. The state PROGRAM maintains the records, or equivalent 

forms or worksheets, listed here: 

3.5.1 Appendix 3.1: Self-Assessment Worksheet 3.5.1 Appendix 3.1: Self-Assessment Worksheet.
Animal Food Regulatory Program Standards 31 DRAFT

3.5.2 Documented procedures for defining the State’s 

inventory of feed facilities (Combined with 3.5.3. 

Renumbered to 3.5.3)

3.5.2 An inventory of ANIMAL FOOD establishments.

3.5.3 Documented procedures for updating the State’s 

inventory of feed facilities (Combined with 3.5.2. 

Renumbered to 3.5.3)

3.5.3 Procedure for defining and maintaining the state 

PROGRAM’S current inventory of ANIMAL FOOD

establishments.

3.5.4 An inventory of feed facilities (Renumbered to 3.5.2)

3.5.5 Documented procedures used for categorizing feed 

facilities based on risk, including the inspection 

frequency assigned to each defined risk-based category

(Renumbered to 3.5.4)

3.5.4 Procedure for categorizing ANIMAL FOOD establishments 

based on risk, including the inspection frequency 

assigned to each defined risk-based category.

3.5.6 Documented policies and procedures for inspecting feed

facilities (Renumbered to 3.5.5)

3.5.5 Procedures for inspecting ANIMAL FOOD establishments.

3.5.7 Documented recall system, which includes written recall 

procedures

3.5.6 Procedures for recall system.

3.5.8 Documented procedures for consumer complaints 3.5.7 Procedure for consumer complaints.

3.5.9 Documented procedures for industry complaints about 

State PROGRAM inspection activities

3.5.8 Procedure for industry complaints about state PROGRAM

inspection activities.
Animal Food Regulatory Program Standards 32 DRAFT

Audit Program

4.1 Purpose 4.1 Purpose

This standard describes the auditing procedures necessary to: 

(1) evaluate the effectiveness of inspections and sample 

collections, (2) recognize trends in the inspection and 

sampling programs, and (3) identify areas in need of 

corrective actions.

This standard describes the program elements used by a state 

PROGRAM to have an effective ANIMAL FOOD audit program.

4.2 Requirement Summary 4.2 Requirement Summary

The State PROGRAM conducts audits to document and evaluate 

the effectiveness of the PROGRAM’S inspections and sample 

collections. Auditing has two components: (1) a field audit 

component, which is an on-site performance evaluation of 

inspection and sample collection to verify they are 

consistently performed according to established performance 

factors and (2) a desk audit component, which is a 

performance review of the inspection and sample collection 

reports to verify the content quality and that a report was 

processed according to established performance factors.

The state PROGRAM establishes an audit program to document 

and evaluate the effectiveness of the state PROGRAM’S

inspection 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 Program Elements

4.3.1 The State PROGRAM has written procedures for conducting 

four types of audits:

4.3.1 Audit Program

The state PROGRAM has procedures for conducting four types 

of audits:

4.3.1.1 Field inspection audits as specified in 4.3.3; 4.3.1.1 Field inspection audits as described in 4.3.3

4.3.1.2 Field inspection report audits as specified in 4.3.4; 4.3.1.2 Field inspection report audits as described in 4.3.4

4.3.1.3 Sample collection audits as specified in 4.3.5; 4.3.1.3 Sample collection audits as described in 4.3.5

4.3.1.4 Sample collection report audits as specified in 4.3.6. 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 Note: In general, each type of audit is composed of multiple 
Animal Food Regulatory Program Standards 33 DRAFT

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 

all of 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.

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 A review of the performance factor scores and cumulative 

scores for each type of audit is completed at least every 12 

months.

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 

written procedures.

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.

4.3.3.1 Frequency: 

A minimum of two field inspection audits of each inspector is 

conducted every 36 months. The inspections selected for 

audits must reflect the inspector’s assignments and 

responsibilities. (Separated into sub-elements. 4.3.3.1.1; 

4.3.3.1.2)

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.
Animal Food Regulatory Program Standards 34 DRAFT

4.3.3.2 Performance Factors: 

At a minimum, performance factors described in the 

inspection protocol within Standard 3: Inspection Program, 

and as listed in appendix 4.2, or comparable form, are 

evaluated. (Reworded)

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.

Note: For each performance factor, examples of actions and 

observations that would likely result in a “needs 

improvement” rating are provided in appendix 4.2a.

(Appendix 4.2a is now a Job Aid.)

4.3.3.3 Performance Documentation: 4.3.3.3 Performance Documentation

4.3.3.3.1 Appendix 4.2, or comparable form, is used to record the rating 

of each performance factor, audit score, and audit rating for 

each field inspection audit; (Reworded)

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 Appendix 4.3, or comparable worksheet, is used to calculate 

performance factor scores and a cumulative score for the State

PROGRAM. (Reworded)

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.

Note: Directions for calculating performance factor scores and 

the cumulative score can be found in appendix 4.4. (Appendix 

4.4 is now a Job Aid. Subsequent Appendices have been 

renumbered to reflect the removal of Appendix 4.4)

4.3.4 Field Inspection Report Audit: 

The State PROGRAM conducts periodic field inspection report 

audits to verify that inspectional findings are obtained and

reported according to the State’s written procedures.

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 The State PROGRAM will review a random selection of field 

inspection reports to be audited based on the number of 

inspections completed during a 12 month period of 

performance using the table below:

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.
Animal Food Regulatory Program Standards 35 DRAFT

Table 1 Field Inspection Report Audit Requirements

Number of

Inspections in 12 

Months

Minimum 

Number 

of

Reports

Required

Maximum 

Number 

of

Reports

Required

Less than 20 reports All All

20 – 400 reports 20 20

More than 400 reports 5% of reports 50

# of Inspections in

12 Months

Min # of

Reports

Required 

Max #

Reports

Required

Less than 20 reports All All

20 – 400 reports 20 20

More than 400 reports 5% of reports 50

4.3.4.2 Performance Factors: 

At a minimum, the performance factors listed in appendix 4.5, 

or comparable form, are evaluated. (Reworded)

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 Performance Documentation

4.3.4.3.1 Appendix 4.5, or comparable form, is used to record the rating 

of each performance factor, audit score, and audit rating for 

each inspection report audit; (Reworded)

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 Appendix 4.6, or comparable worksheet, is used to calculate 

performance factor scores and a cumulative score for the State 

PROGRAM. (Reworded)

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.

Note: Directions for calculating performance factor scores and 

the cumulative score can be found in appendix 4.4. (Appendix 

4.4 is now a Job Aid. Subsequent Appendices have been 

renumbered to reflect the removal of Appendix 4.4)

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’s 

written procedures.

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: 

A minimum of two sample collection audits of each inspector 

4.3.5.1 Frequency
Animal Food Regulatory Program Standards 36 DRAFT

is conducted every 36 months. The sample collections 

selected for audits must reflect the inspector’s assignments 

and responsibilities. (Separated into sub-elements. 4.3.5.1.1; 

4.3.5.1.2)

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: 

At a minimum, performance factors listed in the sampling

protocol described within Standard 11, Sampling Program and 

listed in appendix 4.7 are evaluated.

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.

Note: For each performance factor, examples of actions and 

observations that would likely result in a “needs 

improvement” rating are provided in appendix 4.7a.

(Appendix 4.7a is now a Job Aid.)

4.3.5.3 Performance Documentation: 4.3.5.3 Performance Documentation

4.3.5.3.1 Appendix 4.7, or comparable form, is used to record the rating 

of each performance factor, audit score, and audit rating for 

each sample collection audit;

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 Appendix 4.8, or comparable worksheet, is used to calculate 

performance factor scores and a cumulative score for the State

PROGRAM.

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.

Note: Directions for calculating performance factor scores and 

the cumulative score can be found in appendix 4.4.

4.3.6 Sample Collection Report Audit: 

The State PROGRAM conducts periodic sample collection 

report audits to verify that sample collection documentation is 

consistently performed according to the State’s written

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.
Animal Food Regulatory Program Standards 37 DRAFT

procedures.

4.3.6.1 The State PROGRAM will review a random selection of sample 

collection reports audited based on the number of samples 

collected during a 12 month period of performance based 

using the table below:

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

Number of Samples

Collected in 12 

Months

Minimum 

Number 

of

Reports

Maximum 

Number 

of

Reports

Less than 40 reports All All

40 – 800 reports 40 40

More than 800 reports 5% of reports 70

# of Samples

Collected in 12 

Months

Min # of

Reports

Required

Max # of

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: 

At a minimum, the performance factors listed in appendix 4.9, 

or comparable form, are evaluated. (Reworded)

4.3.6.2 Performance Factors

Evaluate the performance factors listed in Appendix 4.8, or 

an equivalent form.

4.3.6.3 Performance Documentation: 4.3.6.3 Performance Documentation

4.3.6.3.1 Appendix 4.9, or comparable form, is used to record the rating 

of each performance factor, audit score, and audit rating for 

each sample collection report audit;

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 Appendix 4.10, or comparable worksheet, is used to calculate 

performance factor scores and a cumulative score for the State 

PROGRAM.

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.

Note: Directions for calculating performance factor scores and 

the cumulative score can be found in appendix 4.4.

4.3.7 Corrective Action Plan: 

The State PROGRAM has a written corrective action plan using 

appendix 4.11, or comparable form, if any of the following 

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 
Animal Food Regulatory Program Standards 38 DRAFT

occur for any type of audit. 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.

4.3.7.1 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 over 12 months) below 80 percent for a single 

performance factor.

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 over 12 months) below 80 percent.

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 4.4 Outcome

The State PROGRAM’S evaluation of its inspection and sample 

collection activities ensures that they are adequate, complete, 

and that corrective actions are implemented when necessary.

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 4.5 Documentation

The State PROGRAM maintains the records listed here. The state PROGRAM maintains the records, or equivalent 

forms or worksheets, listed here: 

4.5.1 Appendix 4.1: Self-Assessment Worksheet 4.5.1 Appendix 4.1: Self-Assessment Worksheet.

4.5.2 Written procedures for conducting four types of audits 4.5.2 Procedure for conducting four types of audits.

4.5.3 Appendix 4.2: Field Inspection Audit Form 4.5.3 Appendix 4.2: Field Inspection Audit Form.

4.5.4 Appendix 4.3: Field Inspection Audit Worksheet 4.5.4 Appendix 4.3: Field Inspection Audit Worksheet.

4.5.5 Appendix 4.5: Field Inspection Report Audit Form 4.5.5 Appendix 4.4: Field Inspection Report Audit Form.

4.5.6 Appendix 4.6: Field Inspection Report Audit Worksheet 4.5.6 Appendix 4.5: Field Inspection Report Audit Worksheet.

4.5.7 Appendix 4.7: Sample Collection Audit Form 4.5.7 Appendix 4.6: Sample Collection Audit Form.

4.5.8 Appendix 4.8: Sample Collection Audit Worksheet 4.5.8 Appendix 4.7: Sample Collection Audit Worksheet.
Animal Food Regulatory Program Standards 39 DRAFT

4.5.9 Appendix 4.9: Sample Collection Report Audit Form 4.5.9 Appendix 4.8: Sample Collection Report Audit Form.

4.5.10 Appendix 4.10: Sample Collection Report Audit Worksheet 4.5.10 Appendix 4.9: Sample Collection Report Audit Worksheet. 

4.5.11 Appendix 4.11: Corrective Action Plan
Animal Food Regulatory Program Standards 40 DRAFT

Animal Food-Related Illnesses or Death and Emergency Response

5.1 Purpose 5.1 Purpose

This standard describes the functions to detect, identify, 

and respond to alleged feed-related illnesses, deaths, and 

EMERGENCIES, including coordinating roles and 

responsibilities with other jurisdictions and 

communicating with appropriate parties.

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 5.2 Requirement Summary

The State PROGRAM has a system to conduct emergency 

response to feed-related illnesses, deaths, and 

EMERGENCIES.

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 Program Elements

5.3.1 The State PROGRAM has written procedures to gather 

information to identify incidents of feed-related illnesses, 

deaths, and EMERGENCIES.

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.

5.3.2 The State PROGRAM has written procedures to 

communicate with the appropriate State agencies or 

departments that investigate animal illnesses and foodrelated illnesses and outbreak.

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.

Note: These procedures facilitate sharing of information 

to identify potential feed- related illnesses, deaths, 

EMERGENCIES, and CROSS-SECTOR EVENTS.

5.3.3 For feed-related illnesses, deaths, and EMERGENCIES, the 

State PROGRAM has a written procedure with criteria to:

5.3.1.3 For ANIMAL FOOD-related illnesses or deaths and 

EMERGENCIES, the state PROGRAM has a procedure to:
Animal Food Regulatory Program Standards 41 DRAFT

5.3.3.1 Determine the appropriate response 5.3.1.3.1 Determine the appropriate response.

5.3.3.2 Initiate the response 5.3.1.3.2 Initiate the response.

5.3.3.3 Complete the response 5.3.1.3.3 Complete the response.

5.3.4 For feed-related EMERGENCIES, the State PROGRAM

manages the event using:

5.3.2 Emergency Event Management

For ANIMAL FOOD-related EMERGENCIES, the state 

PROGRAM manages the event using:

5.3.4.1 A formalized Incident Command System structure or 5.3.2.1 An Incident Command System, or

5.3.4.2 An official action plan2 that includes: 5.3.2.2 An official action plan. 

The official action plan includes:

5.3.4.2.1 Outlining containment 5.3.2.2.1 Containment

5.3.4.2.2 Communication 5.3.2.2.2 Communication

5.3.4.2.3 Control 5.3.2.2.3 Control

5.3.4.2.4 Correction 5.3.2.2.4 Correction and/or Corrective Actions

5.3.4.2.5 After-action protocols 5.3.2.2.5 After-action protocols

5.3.3 Animal Food-Related Illnesses or Deaths and 

Emergencies Notification Procedures

5.3.5 The State PROGRAM maintains a list of relevant agencies 

and emergency contacts.

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.

5.3.5.1 The list is reviewed and updated based on the State 

defined frequency. (Reworded and combined with 

5.3.3.1)

2 An example of an official action plan can be found in the AAFCO Emergency Response Preparedness Guidance Document (AAFCO Official Publication). 
Animal Food Regulatory Program Standards 42 DRAFT

Note: Appendix 5.2 provides a template for an 

emergency contact list. (Appendix 5.2 is now a Job Aid.)

5.3.6 The State PROGRAM establishes written procedures to 

rapidly notify government agencies, departments, or

appropriate parties of relevant findings.

5.3.3.2 The state PROGRAM has a procedure to rapidly notify 

government agencies, departments, and appropriate 

parties of relevant findings.

5.3.7 The State PROGRAM has a written procedure to 

immediately notify law enforcement agencies when 

intentional feed contamination or feed-related terrorism 

is suspected or threatened.

5.3.3.3 The state PROGRAM has a procedure to rapidly notify law 

enforcement agencies when intentional ANIMAL FOOD

contamination or ANIMAL FOOD-related terrorism is 

suspected or threatened.

5.3.8 The State PROGRAM has a written procedure for: 5.3.3.4 The state PROGRAM has a procedure for:

5.3.8.1 Releasing information to the public; 5.3.3.4.1 Releasing information to the public.

5.3.8.2 Coordinating media information with other jurisdictions 

to reduce the impact of feed-related illnesses, deaths, or 

EMERGENCIES.

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 5.4 Outcome

The State PROGRAM has written procedures for 

documenting and investigating feed-related illnesses, 

deaths, and EMERGENCIES within the PROGRAM’S

authority. The State PROGRAM has established 

communication pathways with government agencies, 

departments, or appropriate parties to gather and share 

information to reduce feed-related illnesses, deaths, or 

EMERGENCIES.

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 FOOD-related illnesses or deaths and 

EMERGENCIES.

5.5 Documentation 5.5 Documentation

The State PROGRAM maintains the records listed here. The state PROGRAM maintains the records, or equivalent 

forms or worksheets, listed here: 

5.5.1 Appendix 5.1: Self-Assessment Worksheet 5.5.1 Appendix 5.1: Self-Assessment Worksheet.

5.5.2 Documented written procedure to gather information to 5.5.2 Procedure to gather information to identify incidents of 
Animal Food Regulatory Program Standards 43 DRAFT

identify incidents of feed-related illnesses, deaths, and 

EMERGENCIES

ANIMAL FOOD-related illnesses or deaths and 

EMERGENCIES.

5.5.3 Documented procedure to communicate with 

Agency/Departments

5.5.3 Procedure to communicate with agency/departments.

5.5.4 Documented written procedures to determine the 

appropriate response, initiate the response, and complete 

the response for feed-related illnesses, deaths, and

EMERGENCIES

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 Documented written procedures using a formalized

Incident Command System structure or an official action 

plan

5.5.5 Procedure using an Incident Command System or an 

official action plan.

5.5.6 Emergency contact list 5.5.6 Emergency contact list.

5.5.7 Documented written procedures to rapidly notify 

government agencies, departments, or appropriate parties 

of relevant findings

5.5.7 Procedure to rapidly notify government agencies, 

departments, and appropriate parties of relevant findings.

5.5.8 Documented written procedure to immediately notify law 

enforcement agencies when intentional feed

contamination or feed-related terrorism is suspected or 

threatened

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 Documented procedure for releasing information to the 

public and coordinating media information with other 

jurisdictions

5.5.9 Procedure for releasing information to the public and 

coordinating media information with other jurisdictions.
Animal Food Regulatory Program Standards 44 DRAFT

Compliance and Enforcement Program

6.1 Purpose 6.1 Purpose

This standard describes the elements of an effective 

enforcement program.

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 6.2 Requirement Summary

The State PROGRAM has documented ENFORCEMENT

STRATEGIES. An annual evaluation of the ENFORCEMENT

STRATEGIES is conducted to identify potential 

improvements or modifications.

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 Program Elements

6.3.1 Compliance and Enforcement Program

6.3.1 The State PROGRAM has an enforcement program that 

contains documented ENFORCEMENT STRATEGIES.

(Reworded)

6.3.1.1 The state PROGRAM has a documented compliance and 

enforcement program that contains ENFORCEMENT

STRATEGIES.

6.3.2 The State PROGRAM must use the following six factors 

listed when selecting an appropriate enforcement tool:

(Reworded)

6.3.1.2 The state PROGRAM selects an appropriate enforcement 

tool using the following six factors:

6.3.2.1 Compliance history 6.3.1.2.1 Compliance history

6.3.2.2 Responsiveness 6.3.1.2.2 Responsiveness

6.3.2.3 Scope 6.3.1.2.3 Scope

6.3.2.4 Nature of the Violation 6.3.1.2.4 Nature of the Violation

6.3.2.5 Impact of the Violation 6.3.1.2.5 Impact of the Violation
Animal Food Regulatory Program Standards 45 DRAFT

6.3.2.6 Resources 6.3.1.2.6 Resources

Note: Appendix 6.2 provides examples of common 

enforcement tools. When selecting enforcement tools, the 

State PROGRAM may consider other factors in addition to 

the ones listed above. (Appendix 6.2 is now a Job Aid.)

6.3.3 The State PROGRAM has a documented written

description for all factors.

6.3.1.3 The state PROGRAM has a documented description for all 

factors.

6.3.4 The State PROGRAM has documented relative conditions 

for all factors.

6.3.1.4 The state PROGRAM has documented relative conditions 

with an assigned numerical weight for all factors.

6.3.4.1 Relative conditions of each factor will be assigned a 

numerical weight. (Combined with 6.3.4)

Note: Appendix 6.3 is an example of factor descriptions, 

relative conditions, and the associated numerical weights.

(Appendix 6.3 is now a Job Aid.)

6.3.5 The State PROGRAM has a documented enforcement 

matrix designed to incorporate the relative conditions of 

each factor and the application of enforcement tools.

6.3.1.5 The state PROGRAM has a documented enforcement 

matrix designed to incorporate the relative conditions of 

each factor and the application of enforcement tools.

Note: Appendix 6.4 is an example enforcement matrix.

(Appendix 6.4 is now a Job Aid.)

6.3.6 The State PROGRAM has a documented process for 

conducting the annual evaluation described in 6.3.7.

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:

6.3.7 The State PROGRAM conducts an annual evaluation of its 

ENFORCEMENT STRATEGIES to: (Combined with 6.3.2)

6.3.7.1 Determine if the PROGRAM’S ENFORCEMENT STRATEGIES

were successful in achieving compliance;

6.3.2.1 Determine if the state PROGRAM’S ENFORCEMENT

STRATEGIES were successful in achieving compliance.
Animal Food Regulatory Program Standards 46 DRAFT

6.3.7.2 Identify potential improvements or modifications of the 

ENFORCEMENT STRATEGIES, if any;

6.3.2.2 Identify potential improvements or modifications of the 

ENFORCEMENT STRATEGIES, if any.

6.3.7.3 Determine if the enforcement priorities remain the same 

or require modification.

6.3.2.3 Determine if the enforcement priorities remain the same 

or require modification.

6.4 Outcome 6.4 Outcome

The State PROGRAM has an effective enforcement 

program with documented ENFORCEMENT STRATEGIES

that identify a means to appropriately select and apply 

enforcement tools. An annual evaluation of the 

enforcement program is conducted to identify potential 

improvements or modifications.

The state PROGRAM utilizes the compliance and 

enforcement program to achieve compliance with 

ANIMAL FOOD laws.

6.5 Documentation 6.5 Documentation

The State PROGRAM maintains the records listed here. The state PROGRAM maintains the records, or equivalent 

forms or worksheets, listed here: 

6.5.1 Appendix 6.1: Self-Assessment Worksheet 6.5.1 Appendix 6.1: Self-Assessment Worksheet.

6.5.2 Documented ENFORCEMENT STRATEGIES 6.5.2 ENFORCEMENT STRATEGIES.

6.5.3 Documented factors including the description, relative 

conditions, and associated numerical weight for each

6.5.3 The ENFORCEMENT STRATEGIES factors including the 

description, relative conditions, and associated numerical 

weight for each.

6.5.4 Enforcement matrix 6.5.4 Enforcement matrix.

6.5.5 Documented process for conducting an evaluation of the 

ENFORCEMENT STRATEGIES

6.5.5 Procedure for conducting an evaluation of the 

ENFORCEMENT STRATEGIES. 

6.5.6 Documented annual evaluation of the ENFORCEMENT

STRATEGIES

6.5.6 Evaluation of the ENFORCEMENT STRATEGIES at least 

every 12 months.
Animal Food Regulatory Program Standards 47 DRAFT

Outreach Activities Program

7.1 Purpose 7.1 Purpose

This standard describes the elements of outreach 

activities developed and provided by the State PROGRAM.

This standard describes the program elements used by a 

state PROGRAM to effectively conduct an ANIMAL FOOD

outreach program.

7.2 Requirement Summary 7.2 Requirement Summary

The State PROGRAM conducts or participates in outreach 

activities and OUTREACH ACTIVITY EVENTS to inform 

ANIMAL FEED industry stakeholders, academia, other 

regulators, or consumers about ANIMAL FEED topics.

The state program establishes 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 Program Elements

7.3.1 The State PROGRAM identifies the methods that will be 

used for outreach activities to inform ANIMAL FEED

industry stakeholders, academia, other regulators, or 

consumers.

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 The State PROGRAM develops an outreach plan that 

supports the State PROGRAM mission and includes:

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 7.3.2.1 Objectives of an outreach plan.

7.3.2.2 Target populations 7.3.2.2 Target populations.

7.3.2.3 The types of outreach activities (including OUTREACH

ACTIVITY EVENTS)

7.3.2.3 The types of outreach (including OUTREACH ACTIVITIES

or OUTREACH EVENTS).

Note: The content and design of the plan will vary 

depending on the State PROGRAM priorities and mission.
Animal Food Regulatory Program Standards 48 DRAFT

7.3.3 The templates provided in appendix 7.2, or comparable 

form, is used to record: (Appendix 7.2 is now a Job Aid. 

Subsequent Appendices have been renumbered to reflect 

the removal of Appendix 7.2)

7.3.3.1 Objectives of an outreach plan

7.3.3.2 Target populations

7.3.3.3 The types of activities (including OUTREACH ACTIVITY

EVENTS)

7.3.4 The State PROGRAM documents and evaluates OUTREACH

ACTIVITY EVENTS. Appendix 7.3, or comparable form, is 

used to document and evaluate OUTREACH ACTIVITY

EVENTS. (Reworded)

7.3.3 Outreach Events

The state PROGRAM documents and evaluates OUTREACH

EVENTS using Appendix 7.2, or an equivalent form.

7.4 Outcome 7.4 Outcome

The State PROGRAM uses outreach activities to inform 

ANIMAL FEED industry stakeholders, academia, other 

regulators, or consumers about ANIMAL FEED topics.

The state PROGRAM utilizes an outreach program to 

inform ANIMAL FOOD industry stakeholders, academia, 

other regulators, or consumers about ANIMAL FOOD

topics.

7.5 Documentation 7.5 Documentation

The State PROGRAM maintains the records listed here. The state PROGRAM maintains the records, or equivalent 

forms or worksheets, listed here: 

7.5.1 Appendix 7.1: Self-Assessment Worksheet 7.5.1 Appendix 7.1: Self-Assessment Worksheet.

7.5.2 Outreach plan 7.5.2 Outreach plan.

7.5.3 OUTREACH ACTIVITY EVENTS overview and evaluation 7.5.3 Appendix 7.2: Outreach Event Overview and Evaluation.

7.5.4 Documents to verify the OUTREACH ACTIVITY EVENTS

occurred
Animal Food Regulatory Program Standards 49 DRAFT

Program Planning and Resources 

8.1 Purpose 8.1 Purpose

This standard describes the elements of workplanning 

and resource evaluation used by a State PROGRAM.

(Reworded)

This standard describes the program elements used by a 

state PROGRAM to effectively conduct the ANIMAL FOOD

work planning and resource evaluation.

8.2 Requirement Summary 8.2 Requirement Summary

A State PROGRAM is required to have a documented

workplan to support its inspection and sample collection 

programs.

A state PROGRAM establishes a workplan to support its 

inspection and sample collection programs.

A State PROGRAM is required to conduct an evaluation of 

resource needs for completing the inspection and sample 

collection projections identified by the workplan and 

additional work conducted by the PROGRAM.

This includes an evaluation of resource needs for 

completing the workplan and to IMPLEMENT and maintain 

the AFRPS.

A State PROGRAM is required to conduct an evaluation of 

the resources needed to fully implement the Animal Feed 

Regulatory Program Standards (AFRPS).

8.3 Program Elements 8.3 Program Elements

8.3.1 The State PROGRAM has a documented workplan. The

workplan must include:

8.3.1 Workplan

The state PROGRAM has a documented workplan that 

includes the:

8.3.1.1 Inspection plan 8.3.1.1 Inspection plan

8.3.1.1.1 Number of inspections 8.3.1.1.1 Number of inspections

8.3.1.1.2 Type of inspection 8.3.1.1.2 Type of inspection

8.3.1.1.3 Risk category of facility or product 8.3.1.1.3 Risk category of establishment or product

8.3.1.1.4 Frequency 8.3.1.1.4 Frequency
Animal Food Regulatory Program Standards 50 DRAFT

8.3.1.2 Sample plan 8.3.1.2 Sample plan

8.3.1.2.1 Number of samples 8.3.1.2.1 Number of samples

8.3.1.2.2 Type of samples 8.3.1.2.2 Type of samples

8.3.1.3 Timeframe that the workplan is applicable. 8.3.1.3 Timeframe that the workplan is applicable.

8.3.2 Workplan Procedure

8.3.2 The State PROGRAM has a documented procedure for 

evaluating the workplan that includes:

8.3.2.1 The state PROGRAM has a procedure for evaluating the 

workplan that includes:

8.3.2.1 Conducting periodic and annual evaluations of the 

workplan;

8.3.2.1.1 Conducting evaluations of the workplan at least every 12 

months.

8.3.2.2 Evaluating alignment with PROGRAM objectives and 

resources.

8.3.2.1.2 Evaluating alignment with state PROGRAM objectives and 

resources.

Note: FDA and the State PROGRAM may meet 

periodically and develop a coordinated workplan.

8.3.3 The State PROGRAM has a documented procedure for 

identifying and reviewing its resources to accomplish the 

workplan within the applicable timeframe.

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 review should include staffing, 

equipment, and funding needed to support the inspection 

and sample collection activities identified in the 

workplan.

Note: The resource evaluation should include staffing, 

equipment, and funding needed to support the inspection 

and sample collection activities identified in the 

workplan.

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

to support laboratory services, compliance, education and

outreach, and to respond to feed-related illnesses, deaths, 

or EMERGENCIES should be determined by the State 

PROGRAM. The administrative functions needed to 

support all PROGRAM areas should be considered when 

determining PROGRAM resources.

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.
Animal Food Regulatory Program Standards 51 DRAFT

8.3.4 To validate the workplan, the State PROGRAM develops a 

formula that: (Reworded. Combined with 8.3.4.1, 8.3.4.2, 

8.3.4.3, and 8.3.4.4)

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.

8.3.4.1 Calculates the number of staff needed to conduct 

inspections of its ANIMAL FEED inventory; (Reworded. 

Combined with 8.3.4.)

8.3.4.2 Calculates the number of staff needed to conduct sample 

collections; (Reworded. Combined with 8.3.4.)

8.3.4.3 Uses numerical values that are based on the State 

PROGRAM’S data; (Reworded. Combined with 8.3.4.)

8.3.4.4 Must be used by the State PROGRAM. (Reworded. 

Combined with 8.3.4.)

Note: The State PROGRAM should have adequate staff to 

inspect the State PROGRAMS ANIMAL FEED inventory and 

to conduct sample collections, which could include 

ANIMAL FEED facilities and retail establishments, based 

on risk categorization and inspection frequency

established by the PROGRAM in its workplan.

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.

Note: Appendix 8.2 provides example formulas that can 

be used as a baseline for a State workplan. The formulas 

in appendix 8.2 do not include methods for estimating 

staff numbers needed for sample collections, compliance 

activities, administrative, or other programmatic 

activities. (Appendix 8.2 is now a Job Aid. Subsequent 

Appendices have been renumbered to reflect the removal 

of Appendix 8.2.)

8.3.5 The inspection and sample collection staff must have the 

equipment needed to conduct inspections and sample 

collections.

8.3.3 Equipment

The state PROGRAM establishes and maintains a list of the 

equipment required for inspections and sample 
Animal Food Regulatory Program Standards 52 DRAFT

collections.

8.3.6 A list of the equipment required for inspections and 

sample collections must be: (Reworded. Combined with 

8.3.6.1 and 8.3.6.2)

8.3.6.1 Established by the State PROGRAM (Reworded. Combined 

with 8.3.6)

8.3.6.2 Maintained by the State PROGRAM (Reworded. Combined 

with 8.3.6)

Note: Appendix 8.3 provides an example list of 

equipment that may be used for inspections and sample 

collections. (Appendix 8.3 is now a Job Aid. Subsequent 

Appendices have been renumbered to reflect the removal 

of Appendix 8.3.)

8.3.4 Resource Review

8.3.7 The State PROGRAM must conduct a review of the 

resources required to fully implement the AFRPS, 

including each of the program elements in the individual

standards. The review recorded in appendix 8.4 must

determine whether the PROGRAM has: (Appendix 8.4 is 

renumbered to Appendix 8.2. Renumbered to 8.3.4.3)

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:

8.3.7.1 Adequate staff 8.3.4.1.1 Adequate staff

8.3.7.2 Equipment 8.3.4.1.2 Equipment

8.3.7.3 Funding 8.3.4.1.3 Funding

Note: Information technology may be considered as part 

of the State PROGRAM’S resource needs.

8.3.8 A baseline resource review in 8.3.7 must be made 

concurrently with the baseline evaluation required for 

AFRPS Standard 9 and recorded in appendix 8.4.

(Reworded. Renumbered to 8.3.4.1. Appendix 8.4 is 
Animal Food Regulatory Program Standards 53 DRAFT

renumbered to Appendix 8.2. Renumbered to 8.3.4.3)

8.3.9 Subsequent resource evaluations to determine the 

resources necessary for the State PROGRAM to partially 

meet, fully meet, or maintain full IMPLEMENTATION of 

standard’s requirements must be completed within three 

years of the previous evaluation.

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 8.4 Outcome

The State PROGRAM has a documented workplan to 

support its inspection and sample collection programs 

and assesses the resources needed to support an ANIMAL

FEED regulatory PROGRAM and implement the AFRPS.

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.

8.5 Documentation 8.5 Documentation

The State PROGRAM maintains the records listed here. The state PROGRAM maintains the records, or equivalent 

forms or worksheets, listed here: 

8.5.1 Appendix 8.1: Self-Assessment Worksheet 8.5.1 Appendix 8.1: Self-Assessment Worksheet.

8.5.2 Workplan 8.5.2 Workplan.

8.5.3 Documented procedure for evaluating the workplan 8.5.3 Procedure for evaluating the workplan.

8.5.4 Documented procedure for identifying and reviewing its 

resources to accomplish the workplan within the 

applicable timeframe

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 number of staff needed to 

conduct inspections and sample collections and 

supporting data

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.
Animal Food Regulatory Program Standards 54 DRAFT

8.5.6 List of required equipment for inspection and sample 

collection

8.5.6 List of required equipment for inspection and sample 

collection.

8.5.7 Appendix 8.4: Resources for IMPLEMENTATION of 

AFRPS

8.5.7 Appendix 8.2: Resources for Implementation of Animal 

Food Regulatory Program Standards.
Animal Food Regulatory Program Standards 55 DRAFT

Assessment and Improvement

9.1 Purpose 9.1 Purpose

This standard tracks the IMPLEMENTATION of each 

standard and describes the requirements for an 

improvement plan.

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 9.2 Requirement Summary

The State PROGRAM conducts a baseline evaluation 

utilizing the self-assessments completed for each 

standard. The results of the baseline evaluation are used

to create an improvement plan that aids the PROGRAM in 

meeting the requirements of each standard.

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.

The State PROGRAM regularly evaluates its status in 

meeting the requirements of the standards.

9.3 Program Elements 9.3 Program Elements

9.3.1 The State PROGRAM uses the self-assessment worksheets 

from each standard to complete a baseline evaluation. 

The baseline evaluation is used to determine if a standard 

is fully met, partially met, or not met, and identify areas 

or functions in the State PROGRAM that need improving in 

order to fully meet the requirements of each standard.

(Reworded. Separated into 9.3.1 and 9.3.2.)

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 Following the baseline evaluation, the State PROGRAM

develops an improvement plan for requirements of the 

standards that are not fully met using appendix 9.2, or 

comparable form. The improvement plan includes the 

following: (Appendix 9.2 is now a Job Aid. Subsequent 

Appendices have been renumbered to reflect the removal 

of Appendix 9.2.)

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 individual element or documentation requirement for 9.3.2.1 The program element or documentation requirement of 
Animal Food Regulatory Program Standards 56 DRAFT

the standard that was not fully met; the standard that was not met.

9.3.2.2 Improvements needed to fully meet the program element 

or documentation requirement(s) of the standard;

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.

9.3.2.3 Lists of individual tasks that will be used to address the

improvement; (Reworded. Combined with 9.3.2.4. 

Renumbered to 9.3.2.5)

9.3.2.5 Projected completion date for each improvement or 

CORRECTIVE ACTION.

9.3.2.4 A projected completion date for each task; (Renumbered 

to 9.3.2.5)

9.3.2.6 Personnel responsible.

9.3.2.5 Completion date for each task. (Reworded. Renumbered 

to 9.3.2.7)

9.3.2.7 Date completed.

9.3.3 The State PROGRAM reviews and updates its 

improvement plan (appendix 9.2) on an annual basis.

9.3.3 Strategic Improvement Plan Review

The state PROGRAM reviews and updates at least every 12 

months the following:

9.3.4 The State PROGRAM completes an evaluation of 

IMPLEMENTATION status at least every three years 

following the baseline evaluation to determine if each 

standard is fully met, partially met, or not met. This 

evaluation includes a review and update of the following:

9.3.3.1 The self-assessment worksheets.

9.3.4.1 Self-assessment worksheets for each standard; 9.3.3.2 The strategic improvement plan.
Animal Food Regulatory Program Standards 57 DRAFT

9.3.4.2 Required documentation for each standard;

9.3.4.3 Improvement plan (appendix 9.2);

9.3.4.4 IMPLEMENTATION status (appendix 9.3). (Implementation 

status has been added to each Appendix x.1: SelfAssessment Worksheet)

9.3.5 Appendix 9.3, or comparable form, is used to track 

IMPLEMENTATION status of all the standards. (Appendix 

9.3 is now a Job Aid.)

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-FOR-USE.

9.3.6 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. (Renumbered 

to 9.3.5)

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.

Note: If FDA provides a State PROGRAM with financial 

assistance to implement the AFRPS, FDA will conduct a 

verification audit of the State PROGRAM’S AFRPS 

IMPLEMENTATION.

9.4 Outcome 9.4 Outcome

The State PROGRAM works to meet the requirements of 

all standards and continues to evaluate and improve the 

PROGRAM to ensure the required elements for all 

standards remain met.

The state PROGRAM utilizes the strategic improvement 

plan to achieve and maintain IMPLEMENTATION of the 

program elements and documentation requirements for 

all standards.
Animal Food Regulatory Program Standards 58 DRAFT

9.5 Documentation 9.5 Documentation

The State PROGRAM maintains the records listed here. The state PROGRAM maintains the records, or equivalent 

forms or worksheets, listed here: 

9.5.1 Appendix 9.1: Self-Assessment Worksheet 9.5.1 Appendix 9.1: Self-Assessment Worksheet.

9.5.2 Appendix 9.2: Assessment and Improvement Plan 9.5.2 Strategic Improvement Plan.

9.5.3 Appendix 9.3: IMPLEMENTATION Status of Animal Feed 

Regulatory Program Standards

9.5.3 Procedure for Document Control.

9.5.4 Master Document List.
Animal Food Regulatory Program Standards 59 DRAFT

Laboratory Services

10.1 Purpose 10.1 Purpose

This standard describes the elements of utilizing 

REGULATORY TESTING LABORATORY(IES) services that 

support the State PROGRAM.

This standard describes the program elements used by a 

state PROGRAM to effectively utilize REGULATORY

TESTING LABORATORY services.

10.2 Requirement Summary 10.2 Requirement Summary

The State PROGRAM has access to laboratory services that 

provide analytical data that support regulatory functions.

The state PROGRAM establishes access to REGULATORY

TESTING LABORATORY services that provide accurate, 

timely, reliable, and defensible analytical data.

The State PROGRAM receives accurate, timely, reliable, 

and defensible data from the REGULATORY TESTING

LABORATORY(IES).

10.3 Program Elements 10.3 Program Elements

10.3.1 Laboratory Support

10.3.1 The State PROGRAM maintains a list of analytical services 

provided by REGULATORY TESTING LABORATORY(IES). 

These types of services include the following:

10.3.1.1 The state PROGRAM maintains a list of analytical services 

the REGULATORY TESTING LABORATORY provides for the 

state PROGRAM.

10.3.1.1 Routine

10.3.1.2 Non-routine

10.3.2 The State PROGRAM has a documented formal agreement 

with the REGULATORY TESTING LABORATORY(IES) that 

conduct routine analytical services unless the laboratory 

is managed within the 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.

10.3.3 The State PROGRAM prepares a sample analysis schedule 

based on a sampling plan3 in cooperation with 

REGULATORY TESTING LABORATORY(IES) performing 

routine services to ensure compatibility with laboratory 
Animal Food Regulatory Program Standards 60 DRAFT

capabilities and capacities. At a minimum, the sample 

analysis schedule must include: (10.3.3; 10.3.3.1-10.3.3.4 

have been moved to Standard 11.)

10.3.3.1 The type(s) of ANIMAL FEED to be analyzed;

10.3.3.2 Number of samples to be collected;

10.3.3.3 Estimated timeframe for collection;

10.3.3.4 Type(s) of analysis to be performed.

10.3.4 The State PROGRAM has written procedures developed by 

the REGULATORY TESTING LABORATORY(IES) to maintain 

the integrity of the samples sent to the laboratory for 

analytical testing that includes:

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:

10.3.4.1 Sample receipt 10.3.2.1 Sample receipt

10.3.4.2 Preservation 10.3.2.2 Preservation

10.3.4.3 Storage 10.3.2.3 Storage

10.3.4.4 Retention 10.3.2.4 Retention

10.3.4.5 Disposal 10.3.2.5 Disposal

10.3.4.6 Chain of custody 10.3.2.6 Chain of custody

10.3.4.7 Report of analysis 10.3.2.7 Report of analysis

10.3.4.8 Method(s) used to communicate information between the 

State PROGRAM and REGULATORY TESTING 

LABORATORY(IES)

10.3.2.8 Methods to communicate information between the state 

PROGRAM and REGULATORY TESTING LABORATORY.

10.3.5 State PROGRAM utilizes REGULATORY TESTING 

LABORATORY(IES) that:

10.3.3 Laboratory Quality Assurance Program

The state PROGRAM utilizes REGULATORY TESTING 

LABORATORIES that:
Animal Food Regulatory Program Standards 61 DRAFT

10.3.5.1 Are accredited by a recognized accreditation body to 

ISO/IEC 17025:20054 or ISO/IEC 17025:2017, or

10.3.3.1 Are accredited by a recognized accreditation body to 

ISO/IEC 17025:20173, or current version, or

10.3.5.2 Implement and comply with the AAFCO Quality 

Assurance/Quality Control guidelines, or

10.3.3.2 Implement and comply with the AAFCO Quality 

Assurance/Quality Control guidelines, or

10.3.5.3 Implement and comply with the ISO/IEC 17025:2005 or 

ISO/IEC 17025:2017.

10.3.3.2 Implement and comply with the ISO/IEC 17025:2017, or 

current version.

Note: ISO/IEC 17025:2005 will be invalid after 

November 30, 2020 per ILAC. Future versions of the 

ISO/IEC 17025 standard shall be evaluated and 

incorporated into Standard 10, as applicable.

10.4 Outcome 10.4 Outcome

The State PROGRAM utilizes valid and defensible 

laboratory testing data to ensure their mission in 

protecting animal and public health and enforcing feed

regulations.

The state PROGRAM utilizes the valid and defensible 

REGULATORY TESTING LABORATORY data to protect 

animal and public health and to enforce ANIMAL FOOD

laws.

10.5 Documentation 10.5 Documentation

The State PROGRAM maintains the records listed here. The state PROGRAM maintains the records, or equivalent 

forms or worksheets, listed here: 

10.5.1 Appendix 10.1: Self-Assessment Worksheet 10.5.1 Appendix 10.1: Self-Assessment Worksheet.

10.5.2 A list of routine and non-routine analytical services 

provided by the REGULATORY TESTING LABORATORY(IES)

10.5.2 A list of all analytical services provided by the 

REGULATORY TESTING LABORATORY for the state 

PROGRAM.

10.5.3 An agreement with REGULATORY TESTING

LABORATORY(IES) that provide routine analytical services 

unless the laboratory is managed within the 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.

3 A recognized accreditation body must be signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA).
Animal Food Regulatory Program Standards 62 DRAFT

10.5.4 A current sample analysis schedule (10.5.4 has been 

moved to Standard 11.)

10.5.4 Procedure to maintain the integrity of the samples sent to 

the REGULATORY TESTING LABORATORY.

10.5.5 Written procedures to maintain the integrity of the 

samples sent to the REGULATORY TESTING

LABORATORY(IES)

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.
Animal Food Regulatory Program Standards 63 DRAFT

Sampling Program

11.1 Purpose 11.1 Purpose

This standard describes the elements of an effective 

ANIMAL FEED sampling program.

This standard describes the program elements used by a 

state PROGRAM to have an effective ANIMAL FOOD

sampling program.

11.2 Requirement Summary 11.2 Requirement Summary

The State PROGRAM has a sampling program to support 

an ANIMAL FEED regulatory program.

The state PROGRAM establishes 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 Program Elements

11.3.1 The State PROGRAM has a documented annual sampling 

plan for collecting surveillance, compliance, 

investigational, regulatory samples, or other samples.

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 annual sampling plan is jointly developed and 

amended by the State PROGRAM and REGULATORY

TESTING LABORATORY(IES) performing routine analytical 

services to allow for advanced planning and scheduling 

of work. (Reworded.)

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 outlines the State PROGRAM’S: 11.3.1.2 The sampling plan includes the:

11.3.1.2.1 Sampling priorities (Renumbered to 11.3.1.2.2) 11.3.1.2.1 Availability or coordination of analytical support.

11.3.1.2.2 Sample analysis schedule (Renumbered to 11.3.1.2.3) 11.3.1.2.2 Sample priorities.

4 Regulatory samples may be used to support inspection observations.
Animal Food Regulatory Program Standards 64 DRAFT

11.3.1.2.3 Availability or coordination of analytical support

(Renumbered to 11.3.1.2.1)

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.

Note: The sampling plan may include estimates of 

analytical costs.

11.3.2 The State PROGRAM has documented sampling

procedures for collecting, storing, and transporting 

samples that includes:

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 feed labels; 11.3.2.1 Following safety precautions on ANIMAL FOOD labels.

11.3.2.2 Following the State PROGRAM’S safety protocol for 

collecting samples;

11.3.2.2 Following the state PROGRAM’S safety protocols for 

collecting samples.

11.3.2.3 Using appropriate method and equipment to collect the 

sample;

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; 11.3.2.4 Sealing the sample to initiate chain of custody.

11.3.2.5 Maintaining and documenting sample integrity, security, 

and chain of custody;

11.3.2.5 Maintaining and documenting sample integrity, security, 

and chain of custody.

11.3.2.6 Issuing receipt for sample(s); 11.3.2.6 Issuing receipt for the sample5.

5 Receipt could include cost of sample and method of payment. 
Animal Food Regulatory Program Standards 65 DRAFT

11.3.2.7 Handling, packaging, and shipping sample using 

procedures appropriate to prevent compromising the 

condition of 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 sample to the appropriate 

laboratory within acceptable timeframes.

11.3.2.8 Delivering or shipping samples to the appropriate 

REGULATORY TESTING LABORATORY within designated 

timeframes.

11.3.3 The State PROGRAM has documented instructions for the

Sample Collection Report that includes:

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.

11.3.3.1 Date of the sample collection; 11.3.3.2 Date of the sample collection.

11.3.3.2 Product identification including: 11.3.3.3 Product identification.

The product identification includes the:

11.3.3.2.1 Name 11.3.3.3.1 Name.

11.3.3.2.2 Lot numbers or any other codes referencing manufacture 

identification

11.3.3.3.2 Lot numbers or any other codes referencing manufacture 

identification.

11.3.3 Description of product; 11.3.3.4 Description of product.

11.3.3.4 Method of collection and any special techniques used to 

collect sample;

11.3.3.5 Method of collection and any special techniques used to 

collect sample.

11.3.3.5 Lot sampled; 11.3.3.6 Lot sampled.

11.3.3.6 Lot size; 11.3.3.7 Lot size.

11.3.3.7 Location where sample was collected; 11.3.3.8 Location where sample was collected.

6 Includes storing sample.
Animal Food Regulatory Program Standards 66 DRAFT

11.3.3.8 Name and address of responsible party, guarantor, 

possessor, or distributor;

11.3.3.9 Name and address of responsible party, guarantor, 

possessor, or distributor.

11.3.3.9 Sample type (surveillance, compliance, investigational, 

regulatory, or other);

11.3.3.10 Sample type (example: surveillance, compliance, 

investigational, regulatory, or other).

11.3.3.10 Analysis requested, if applicable; 11.3.3.11 Analysis requested, if applicable.

11.3.3.11 Collection or reproduction of product labels, including 

customer-formula feed labels;

11.3.3.12 Collection or reproduction of product label, including 

customer-formula label.

11.3.3.12 Receiving and distribution information. 11.3.3.13 Receiving and distribution information.

11.4 Outcome 11.4 Outcome

The State PROGRAM has a sampling program that aligns 

sampling resources with State PROGRAM priorities. The 

annual sampling plan will facilitate efficient use and 

coordination of resources to obtain timely information. 

Samples are collected, stored, transported, and 

documented to support regulatory actions.

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.

11.5 Documentation 11.5 Documentation

The State PROGRAM maintains the records listed here. The state PROGRAM maintains the records, or equivalent 

forms or worksheets, listed here: 

11.5.1 Appendix 11.1: Self-Assessment Worksheet 11.5.1 Appendix 11.1: Self-Assessment Worksheet.

11.5.2 Documented annual sampling plan 11.5.2 Sampling plan.

11.5.3 Documented sampling procedures 11.5.3 Sample collection procedure.

11.5.4 Documented sample collection report instructions 11.5.4 Procedure for completing the sample collection report.