State Feed Regulatory Programs

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:

Table of Contents
Table of Contents

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Background

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Introduction

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Definitions
Standard 1
Regulatory Foundation
Standard 2
Training
Standard 3
Inspection Program
Standard 4
Auditing
Standard 5
Feed-Related Illnesses or Death and Emergency Response
Standard 6
Enforcement Program
Standard 7
Outreach Activities
Standard 8
Planning and Resources
Standard 9
Assessment and Improvement
Standard 10
Laboratory Services
Standard 11
Sampling Program
Appendix 1.1
Self-Assessment Worksheet
Appendix 1.2
REGULATORY FOUNDATION Worksheet
Appendix 2.1
Self-Assessment Worksheet
Appendix 2.2
Inspector Training Record
Appendix 2.3
Field Training Competencies
Appendix 3.1
Self-Assessment Worksheet
Appendix 3.2
Risk Categorization for Feed Facilities
Appendix 4.1
Self-Assessment Worksheet
Appendix 4.2
Field Inspection Audit Form
Appendix 4.2a
Completing the Field Inspection Audit Form

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Table of Contents
Appendix 4.3
Field Inspection Audit Worksheet
Appendix 4.4
Instructions for Completing the Audit Worksheets
Appendix 4.5
Field Inspection Report Audit Form
Appendix 4.6
Field Inspection Report Audit Worksheet
Appendix 4.7
Sample Collection Audit Form
Appendix 4.7a
Completing the Sample Collection Audit Form
Appendix 4.8
Sample Collection Audit Worksheet
Appendix 4.9
Sample Collection Report Audit Form
Appendix 4.10
Sample Collection Report Audit Worksheet
Appendix 4.11
Corrective Action Plan
Appendix 5.1
Self-Assessment Worksheet
Appendix 5.2
Emergency Contact List
Appendix 6.1
Self-Assessment Worksheet
Appendix 6.2
Enforcement Tools
Appendix 6.3
Factors, Descriptions, and Numerical Weights for Consideration When Selecting an Enforcement
Tool
Appendix 6.4
Enforcement Matrix
Appendix 7.1
Self-Assessment Worksheet
Appendix 7.2
Outreach Plan
Appendix 7.3
OUTREACH ACTIVITY EVENT Overview and Evaluation
Appendix 8.1
Self-Assessment Worksheet
Appendix 8.2
Example Formula for Calculating the Number of Inspectors Required to Conduct Inspections of
Feed Facilities
Appendix 8.3
Example List of Equipment Used for Inspections and Sample Collections
Appendix 8.4
Resources for IMPLEMENTATION of Animal Feed Regulatory Program Standards

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Appendix 9.1
Self-Assessment Worksheet
Appendix 9.2
Assessment and Improvement Plan
Appendix 9.3
IMPLEMENTATION Status of Animal Feed Regulatory Program Standards
Appendix 10
Self-Assessment Worksheet
Appendix 11
Self-Assessment Worksheet

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Background
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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.
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 2009 1. 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 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.
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.
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.

1

Link to the current PFP vision documents available at
http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/ProgramsInitiatives/PartnershipforFoodProtectionPFP/UCM408081.pdf

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Introduction
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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 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.
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 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.
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.
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.

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Definitions
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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 food-producing animals and pets.
Contact Hour(s): One contact hour equals 60 minutes.
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.
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.
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.
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.
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.
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.
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.
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.

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Definitions
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Program(s): An operational unit(s) in a regulatory agency that is responsible for the regulatory
oversight of ANIMAL FEED.
Qualified Field Inspection Auditor: An individual who is recognized by the State’s PROGRAM
as having field experience and communication skills necessary to audit inspectors/investigators.
Qualified Field Inspection Trainer: An individual who is recognized by the State’s PROGRAM
as having field experience and communication skills necessary to train inspectors/investigators.
Regulatory Foundation: The laws, regulations, rules, ordinances, or other regulatory
requirements that govern the operation of an ANIMAL FEED facility.
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.
Start Date: Date employee is hired or reassigned in or into the ANIMAL FEED PROGRAM as the
beginning date for training timelines.

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STANDARD 1
Regulatory Foundation
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1.1 Purpose
This standard describes the elements of the REGULATORY FOUNDATION used by a State PROGRAM
to regulate ANIMAL FEED.
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 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.
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.
1.3.1.1 “EQUIVALENT” means that the State law directly references the relevant FD&C
Act provision or Federal regulation. For State law found EQUIVALENT, the State
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.

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STANDARD 1
Regulatory Foundation
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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.
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:
1.3.2.1 Procedures to review the statutes, regulations, rules, ordinances, and other
prevailing regulatory requirements that:
1.3.2.1.1 Apply to the regulation of ANIMAL FEED;
1.3.2.1.2 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.
1.3.2.2 Timeframes for the review.
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.
1.5 Documentation
The State PROGRAM maintains the records listed here.
1.5.1 Appendix 1.1: Self-Assessment Worksheet
1.5.2 Appendix 1.2: REGULATORY FOUNDATION Worksheet

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STANDARD 1
Regulatory Foundation
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1.5.3 Documented process 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

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STANDARD 2
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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.
2.2 Requirement Summary
The State PROGRAM has a training plan that ensures all inspectors are adequately trained to
perform their work.
2.3 Program Elements
2.3.1 Training Plan and Training Records
2.3.1.1 The State PROGRAM uses a written training plan that ensures all inspectors
receive training required to adequately perform their work assignments. The
training plan includes course curriculum for basic and advanced inspection
training and continuing education.
2.3.1.2 The State PROGRAM provides, or otherwise makes available, inspection training
and continuing education for all inspectors.
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.
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.
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.
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.

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STANDARD 2
Training
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2.3.2 Basic Feed 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.
2.3.2.2 Coursework: The basic feed inspection training consists of coursework in the
following subject areas:
2.3.2.2.1

2.3.2.2.2

2.3.2.2.3

2.3.2.2.4

2.3.2.2.5
2.3.2.2.6
2.3.2.2.7
2.3.2.2.8

2.3.2.2.9
2.3.2.2.10

2.3.2.2.11
2.3.2.2.12
2.3.2.2.13

Animal and Public Health Principles: Fundamental animal and
public health protection principles that support the foundational roles
of the feed inspector.
Basic Animal Nutrition: Basic means of digestion and nutritional
requirements for various animal classes and ingredients that can
cause toxicity.
Basic Feed Ingredients, Processing, and Technology: Typical
ingredients, feedstuffs, processing methods, and technologies
commonly used to manufacture ANIMAL FEED.
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.
Communication: Techniques and skills for effective oral and written
communication and interviewing.
Current Statutes, Regulations, and Policies: Basic knowledge of
Federal and State laws, regulations, and policies.
Feed Defense: Feed defense principles for the protection of feed
from intentional hazard contamination.
Inspections, Compliance, and Enforcement: Conduct inspections
applying the relevant laws and regulations to gather and document
evidence to support possible regulatory actions.
Labeling: Basic feed labeling requirements.
Professionalism: Character conduct, strengths, and values directed
toward providing high quality service to the regulated industry and
the State PROGRAM.
Risk Awareness: Basic principles of BSE; medicated feeds including
VFDs; and physical, chemical, and biological contaminants.
Safety: Appropriate personal safety and bio-security requirements
when conducting field activities.
Sampling: Techniques and skills for collecting various types of
samples using the appropriate methods for preparation, collection,
and shipping.

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STANDARD 2
Training
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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:
2.3.2.3.1 Field training checklist of competencies to be mastered and verified in
the field by the QUALIFIED FIELD INSPECTION TRAINER;
2.3.2.3.2 Documented procedures for JOINT FIELD TRAINING INSPECTIONS;
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;
2.3.2.3.4 The inspector completes basic field training prior to performing
independent inspections;
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 FIELD TRAINING
INSPECTIONS.
2.3.3 Advanced Feed 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.
2.3.3.2 Coursework: The advanced feed inspection training consists of coursework in
the following subject areas:
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.
2.3.3.2.2 Advanced Labeling: Knowledge and application of ANIMAL FEED
labeling requirements (i.e. medicated feed and pet food labeling
requirements).
2.3.3.2.3 Animal Sickness and Death Investigation: Principles of outbreak
investigations.
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 Epidemiology: Acquire basic knowledge of epidemiology principles
and concepts and apply them to animal outbreak investigations
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 Traceback and Traceforward Investigations: Traceback and
traceforward of an implicated product and steps for conducting and
concluding the investigation and reporting the results.

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STANDARD 2
Training
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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.
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:
2.3.3.4.1 Field training checklist of competencies to be mastered and verified in
the field by the QUALIFIED FIELD INSPECTION TRAINER;
2.3.3.4.2 Documented procedures for JOINT FIELD TRAINING INSPECTIONS;
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
2.3.3.4.4 The inspector completes field training prior to performing independent
inspections requiring advanced skills;
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.

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STANDARD 2
Training
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439
440
441

2.3.6 Continuing Education (CE): The State PROGRAM requires that each basic and advanced
inspector participate in continuing education.
2.3.6.1 Each inspector is required to receive 20 CONTACT HOURS of continuing
education every 36 months.
2.3.6.2 The 36 month continuing education interval starts, as 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.
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 peerreviewed article or presentation made at a professional conference;
documentation to verify technical publications related to feed safety have been
read including completion of self-assessment quizzes that accompany journal
articles, written summaries of key points/findings presented in technical
publications, and/or written book reports; an agenda and attendance roster; or
documentation approved by the QUALIFIED FIELD INSPECTION TRAINER.
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.

Animal Feed Regulatory Program Standards
15

STANDARD 2
Training
442
443
444
445
446
447
448
449
450
451

2.5 Documentation
The State PROGRAM maintains the records listed here.
2.5.1 Appendix 2.1: Self-Assessment Worksheet
2.5.2 Training Plan
2.5.3 Appendix 2.2: Inspector Training Record
2.5.4 Appendix 2.3: Field Training Competencies
2.5.5 Documents verifying successful completion of required courses
2.5.6 Documentation for continuing education credit

Animal Feed Regulatory Program Standards
16

STANDARD 3
Inspection Program
452
453
454
455
456
457
458
459
460
461
462
463
464
465
466
467
468
469
470
471
472
473
474
475
476
477
478
479
480
481
482
483
484
485
486
487
488
489
490
491
492
493
494

3.1 Purpose
This standard describes the elements of an effective ANIMAL FEED inspection program.
3.2 Requirement Summary
The State PROGRAM administers an inspection program to determine compliance with ANIMAL
FEED laws.
3.3 Program Elements
3.3.1 Risk-Based Inspection Program
3.3.1.1 The State PROGRAM has documented procedures to:
3.3.1.1.1 Define an up-to-date inventory of feed facilities whose activities fall
under the State’s jurisdiction and authority;
3.3.1.1.2 Maintain the inventory of feed facilities defined in 3.3.1.1.1.
3.3.1.2 The State PROGRAM has documented procedures for defining risk categories.
The three minimum required factors for defining risk categories are:
3.3.1.2.1 Types of feed and feed products;
3.3.1.2.2 Types of processing;
3.3.1.2.3 Compliance history of the facility.
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.
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:
3.3.1.4.1 Are prioritized;
3.3.1.4.2 Have assigned frequencies;
3.3.1.4.3 Have resources allocated.
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.

Animal Feed Regulatory Program Standards
17

STANDARD 3
Inspection Program
495
496
497
498
499
500
501
502
503
504
505
506
507
508
509
510
511
512
513
514
515
516
517
518
519
520
521
522
523
524
525
526
527
528
529
530
531
532
533
534
535
536

3.3.2 Inspection Protocol
3.3.2.1 The State PROGRAM has documented policies and procedures for inspecting
ANIMAL FEED facilities that require the inspectors to:
3.3.2.1.1
3.3.2.1.2

3.3.2.1.3
3.3.2.1.4
3.3.2.1.5
3.3.2.1.6
3.3.2.1.7

3.3.2.1.8

3.3.2.1.9
3.3.2.1.10

3.3.2.1.11
3.3.2.1.12
3.3.2.1.13
3.3.2.1.14
3.3.2.1.15
3.3.2.1.16
3.3.2.1.17
3.3.2.1.18

Review the feed facility’s previous inspection report(s) and
complaint(s);
Present appropriate credentials and written Notice of Inspection to
the feed facility’s owner, operator, or agent in charge; make
appropriate introductions; explain the purpose and scope of the
inspection; and determine inspection authority;
Follow the safety protocols required by the feed facility and the State
PROGRAM;
Follow the biosecurity protocols required by the feed facility and the
State PROGRAM;
Use appropriate equipment and forms needed to conduct inspections;
Establish interstate jurisdiction for FDA inspections, if applicable;
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;
Conduct inspection activities, appropriate for the level of risk,
focused on those firms, products, and processes determined to be
high risk;
Assess employee activities critical to the safe manufacture,
distribution, storage, handling, and disposition of feed;
Properly evaluate the likelihood that conditions, practices, processes,
components, or labeling could cause the product to become
adulterated or misbranded;
Recognize significant non-compliant conditions or practices and
document findings consistent with PROGRAM procedures;
Distinguish between significant and insignificant observations and
isolated incidents versus trends;
Review and evaluate the appropriate ANIMAL FEED facility records
and procedures and verify that the procedures are being followed;
Collect adequate evidence and documentation to support inspection
observations in accordance with PROGRAM procedures;
Verify correction of deficiencies identified during the previous
inspection(s);
Conduct activities in a professional manner;
Use effective interviewing techniques;
Explain findings clearly and adequately throughout the inspection;

Animal Feed Regulatory Program Standards
18

STANDARD 3
Inspection Program
537
538
539
540
541
542
543
544
545
546
547
548
549
550
551
552
553
554
555
556
557
558
559
560
561
562
563
564
565
566
567
568
569
570
571
572
573
574
575
576
577
578
579
580

3.3.2.1.19 Alert the feed facility’s owner, operator, or agent in charge when an
immediate corrective action is necessary;
3.3.2.1.20 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;
3.3.2.1.21 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.
3.3.3 Recall System
3.3.3.1 The State PROGRAM has a documented recall system. The recall system
includes:
3.3.3.1.1 Written procedures for:
3.3.3.1.1.1 Receiving
3.3.3.1.1.2 Tracking
3.3.3.1.1.3 Evaluating recall notifications
3.3.3.1.1.4 Closing
3.3.3.1.1.5 Maintaining records
3.3.3.1.2 Performing recall effectiveness checks
3.3.4 Consumer Complaints
3.3.4.1 The State PROGRAM has a documented system for handling consumer
complaints. The system includes procedures for:
3.3.4.1.1 Receiving
3.3.4.1.2 Tracking
3.3.4.1.3 Evaluating
3.3.4.1.4 Answering
3.3.4.1.5 Closing
3.3.4.1.6 Maintaining records
3.3.5 Complaints Resulting from State PROGRAM Inspection Activities
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:
3.3.5.1.1 Receiving
3.3.5.1.2 Evaluating
3.3.5.1.3 Maintaining records

Animal Feed Regulatory Program Standards
19

STANDARD 3
Inspection Program
581
582
583
584
585
586
587
588
589
590
591
592
593
594
595
596
597
598
599
600
601
602
603

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.
3.5 Documentation
The State PROGRAM maintains the records listed here.
3.5.1 Appendix 3.1: Self-Assessment Worksheet
3.5.2 Documented procedures for defining the State’s inventory of feed facilities
3.5.3 Documented procedures for updating the State’s inventory of feed facilities
3.5.4 An inventory of feed facilities
3.5.5 Documented procedures used for categorizing feed facilities 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
3.5.7 Documented recall system, which includes written recall procedures
3.5.8 Documented procedures for consumer complaints
3.5.9 Documented procedures for industry complaints about State PROGRAM inspection
activities

Animal Feed Regulatory Program Standards
20

STANDARD 4
Auditing
604
605
606
607
608
609
610
611
612
613
614
615
616
617
618
619
620
621
622
623
624
625
626
627
628
629
630
631
632
633
634
635
636
637
638
639
640
641
642
643
644
645

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.
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.
4.3 Program Elements
4.3.1 The State PROGRAM has written procedures for conducting four types of audits:
4.3.1.1 Field inspection audits as specified in 4.3.3;
4.3.1.2 Field inspection report audits as specified in 4.3.4;
4.3.1.3 Sample collection audits as specified in 4.3.5;
4.3.1.4 Sample collection report audits as specified in 4.3.6.
Note: In general, each type of audit is composed of multiple performance factors. The
performance factors are evaluated during an audit and then used to calculate an
individual’s audit score. The audit score determines the audit rating, which is recorded
as “acceptable” or “needs improvement”. Using 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.
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.
4.3.3 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.

Animal Feed Regulatory Program Standards
21

STANDARD 4
Auditing
646
647
648
649
650
651
652
653
654
655
656
657
658
659
660
661
662
663
664
665
666
667
668
669
670
671
672
673
674
675
676

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.
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.
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.
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;
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.
Note: Directions for calculating performance factor scores and the
cumulative score can be found in 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.
4.3.4.1 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:
Number of Inspections in
12 Months
Less than 20 reports
20 – 400 reports
More than 400 reports

677
678
679
680

Minimum Number of
Reports Required
All
20
5% of reports

Maximum Number of
Reports Required
All
20
50

4.3.4.2 Performance Factors: At a minimum, the performance factors listed in appendix
4.5, or comparable form, are evaluated.

Animal Feed Regulatory Program Standards
22

STANDARD 4
Auditing
681
682
683
684
685
686
687
688
689
690
691
692
693
694
695
696
697
698
699
700
701
702
703
704
705
706
707
708
709
710
711
712
713
714
715
716
717
718
719
720
721
722
723

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;
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.
Note: Directions for calculating performance factor scores and the
cumulative score can be found in 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.
4.3.5.1 Frequency: A minimum of two sample collection audits of each inspector is
conducted every 36 months. The sample collections selected for audits must
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.
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.
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;
4.3.5.3.2 Appendix 4.8, or comparable worksheet, is used to calculate
performance factor scores and a cumulative score for the State
PROGRAM.
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 procedures.

Animal Feed Regulatory Program Standards
23

STANDARD 4
Auditing
724
725
726
727

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:
Number of Samples
Collected in 12 Months
Less than 40 reports
40 – 800 reports
More than 800 reports

728
729
730
731
732
733
734
735
736
737
738
739
740
741
742
743
744
745
746
747
748
749
750
751
752
753
754
755
756
757

Minimum Number of
Reports Required
All
40
5% of reports

Maximum Number of
Reports Required
All
40
70

4.3.6.2 Performance Factors: At a minimum, the performance factors listed in appendix
4.9, or comparable form, are evaluated.
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;
4.3.6.3.2 Appendix 4.10, or comparable worksheet, is used to calculate
performance factor scores and a cumulative score for the State
PROGRAM.
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 occur for any type of 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.
4.3.7.3 A State PROGRAM has a cumulative score (as a result of all audits over 12
months) below 80 percent.
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.

Animal Feed Regulatory Program Standards
24

STANDARD 4
Auditing
758
759
760
761
762
763
764
765
766
767
768
769
770
771
772

4.5 Documentation
The State PROGRAM maintains the records listed here.
4.5.1 Appendix 4.1: Self-Assessment Worksheet
4.5.2 Written procedures for conducting four types of audits
4.5.3 Appendix 4.2: Field Inspection Audit Form
4.5.4 Appendix 4.3: Field Inspection Audit Worksheet
4.5.5 Appendix 4.5: Field Inspection Report Audit Form
4.5.6 Appendix 4.6: Field Inspection Report Audit Worksheet
4.5.7 Appendix 4.7: Sample Collection Audit Form
4.5.8 Appendix 4.8: Sample Collection Audit Worksheet
4.5.9 Appendix 4.9: Sample Collection Report Audit Form
4.5.10 Appendix 4.10: Sample Collection Report Audit Worksheet
4.5.11 Appendix 4.11: Corrective Action Plan

Animal Feed Regulatory Program Standards
25

STANDARD 5
Feed-Related Illnesses or Death and Emergency Response
773
774
775
776
777
778
779
780
781
782
783
784
785
786
787
788
789
790
791
792
793
794
795
796
797
798
799
800
801
802
803
804
805
806
807
808
809
810
811
812
813

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.
5.2 Requirement Summary
The State PROGRAM has a system to conduct emergency response to feed-related illnesses,
deaths, and EMERGENCIES.
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.
5.3.2 The State PROGRAM has written procedures to communicate with the appropriate State
agencies or departments that investigate animal illnesses and food-related illnesses and
outbreak.
Note: These procedures facilitate sharing of information to identify potential feedrelated 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:
5.3.3.1 Determine the appropriate response
5.3.3.2 Initiate the response
5.3.3.3 Complete the response
5.3.4 For feed-related EMERGENCIES, the State PROGRAM manages the event using:
5.3.4.1 A formalized Incident Command System structure or
5.3.4.2 An official action plan 2 that includes:
5.3.4.2.1 Outlining containment
5.3.4.2.2 Communication
5.3.4.2.3 Control
5.3.4.2.4 Correction
5.3.4.2.5 After-action protocols

2

An example of an official action plan can be found in the AAFCO Emergency Response Preparedness Guidance Document (AAFCO Official
Publication).

Animal Feed Regulatory Program Standards
26

STANDARD 5
Feed-Related Illnesses or Death and Emergency Response
814
815
816
817
818
819
820
821
822
823
824
825
826
827
828
829
830
831
832
833
834
835
836
837
838
839
840
841
842
843
844
845
846
847
848
849
850
851
852
853
854
855

5.3.5 The State PROGRAM maintains a list of relevant agencies and emergency contacts.
5.3.5.1 The list is reviewed and updated based on the State defined frequency.
Note: Appendix 5.2 provides a template for an emergency contact list.
5.3.6 The State PROGRAM establishes written procedures to rapidly notify government
agencies, departments, or 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.
5.3.8 The State PROGRAM has a written procedure for:
5.3.8.1 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.
5.4 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.
5.5 Documentation
The State PROGRAM maintains the records listed here.
5.5.1 Appendix 5.1: Self-Assessment Worksheet
5.5.2 Documented written procedure to gather information to identify incidents of feedrelated illnesses, deaths, and EMERGENCIES
5.5.3 Documented procedure to communicate with Agency/Departments
5.5.4 Documented written procedure to determine the appropriate response, initiate the
response, and complete the response for feed-related illnesses, deaths, and
EMERGENCIES

5.5.5 Documented written procedures using a formalized Incident Command System
structure or an official action plan
5.5.6 Emergency contact list
5.5.7 Documented written procedures to rapidly notify government agencies, departments, or
appropriate parties of relevant findings

Animal Feed Regulatory Program Standards
27

STANDARD 5
Feed-Related Illnesses or Death and Emergency Response
856
857
858
859

5.5.8 Documented written procedure to immediately notify law enforcement agencies when
intentional feed contamination or feed-related terrorism is suspected or threatened
5.5.9 Documented procedure for releasing information to the public and coordinating media
information with other jurisdictions

Animal Feed Regulatory Program Standards
28

STANDARD 6
Enforcement Program
860
861
862
863
864
865
866
867
868
869
870
871
872
873
874
875
876
877
878
879
880
881
882
883
884
885
886
887
888
889
890
891
892
893
894
895
896
897
898
899
900
901
902
903

6.1 Purpose
This standard describes the elements of an effective enforcement program.
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.
6.3 Program Elements
6.3.1 The State PROGRAM has an enforcement program that contains documented
ENFORCEMENT STRATEGIES.
6.3.2 The State PROGRAM must use the following six factors listed when selecting an
appropriate enforcement tool:
6.3.2.1 Compliance history
6.3.2.2 Responsiveness
6.3.2.3 Scope
6.3.2.4 Nature of the Violation
6.3.2.5 Impact of the Violation
6.3.2.6 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.
6.3.3 The State PROGRAM has a documented written description for all factors.
6.3.4 The State PROGRAM has documented relative conditions for all factors.
6.3.4.1 Relative conditions of each factor will be assigned a numerical weight.
Note: Appendix 6.3 is an example of factor descriptions, relative conditions, and the
associated numerical weights.
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.
Note: Appendix 6.4 is an example enforcement matrix.

Animal Feed Regulatory Program Standards
29

STANDARD 6
Enforcement Program
904
905
906
907
908
909
910
911
912
913
914
915
916
917
918
919
920
921
922
923
924
925
926
927
928
929
930
931
932

6.3.6 The State PROGRAM has a documented process for conducting the annual evaluation
described in 6.3.7.
6.3.7 The State PROGRAM conducts an annual evaluation of its ENFORCEMENT STRATEGIES to:
6.3.7.1 Determine if the PROGRAM’S ENFORCEMENT STRATEGIES were successful in
achieving compliance;
6.3.7.2 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.
6.4 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.
6.5 Documentation
The State PROGRAM maintains the records listed here.
6.5.1 Appendix 6.1: Self-Assessment Worksheet
6.5.2 Documented ENFORCEMENT STRATEGIES
6.5.3 Documented factors including the description, relative conditions, and associated
numerical weight for each
6.5.4 Enforcement matrix
6.5.5 Documented process for conducting an evaluation of the ENFORCEMENT STRATEGIES
6.5.6 Documented annual evaluation of the ENFORCEMENT STRATEGIES

Animal Feed Regulatory Program Standards
30

STANDARD 7
Outreach Activities
933
934
935
936
937
938
939
940
941
942
943
944
945
946
947
948
949
950
951
952
953
954
955
956
957
958
959
960
961
962
963
964
965
966
967
968
969
970
971
972
973

7.1 Purpose
This standard describes the elements of outreach activities developed and provided by the State
PROGRAM.
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.
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.
7.3.2 The State PROGRAM develops an outreach plan that supports the State PROGRAM
mission and includes:
7.3.2.1 Objectives of an outreach plan
7.3.2.2 Target populations
7.3.2.3 The types of outreach activities (including OUTREACH ACTIVITY EVENTS)
Note: The content and design of the plan will vary depending on the State PROGRAM
priorities and mission.
7.3.3 The templates provided in appendix 7.2, or comparable form, is used to record:
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.
7.4 Outcome
The State PROGRAM uses outreach activities to inform ANIMAL FEED industry stakeholders,
academia, other regulators or consumers about ANIMAL FEED topics.

Animal Feed Regulatory Program Standards
31

STANDARD 7
Outreach Activities
974
975
976
977
978
979
980
981

7.5 Documentation
The State PROGRAM maintains the records listed here.
7.5.1 Appendix 7.1: Self-Assessment Worksheet
7.5.2 Outreach plan
7.5.3 OUTREACH ACTIVITY EVENTS overview and evaluation
7.5.4 Documents to verify the OUTREACH ACTIVITY EVENTS occurred

Animal Feed Regulatory Program Standards
32

STANDARD 8
Planning and Resources
982
983
984
985
986
987
988
989
990
991
992
993
994
995
996
997
998
999
1000
1001
1002
1003
1004
1005
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
1017
1018
1019
1020
1021
1022
1023
1024

8.1 Purpose
This standard describes the elements of workplanning and resource evaluation used by a State
PROGRAM.
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 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.
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
8.3.1 The State PROGRAM has a documented workplan. The workplan must include:
8.3.1.1 Inspection plan
8.3.1.1.1 Number of inspections
8.3.1.1.2 Type of inspection
8.3.1.1.3 Risk category of facility or product
8.3.1.1.4 Frequency
8.3.1.2 Sample plan
8.3.1.2.1 Number of samples
8.3.1.2.2 Type of samples
8.3.1.3 Timeframe that the workplan is applicable.
8.3.2 The State PROGRAM has a documented procedure for evaluating the workplan that
includes:
8.3.2.1 Conducting periodic and annual evaluations of the workplan;
8.3.2.2 Evaluating alignment with PROGRAM objectives and resources.
Note: FDA and the State PROGRAM may meet periodically and develop a coordinated
workplan.

Animal Feed Regulatory Program Standards
33

STANDARD 8
Planning and Resources
1025
1026
1027
1028
1029
1030
1031
1032
1033
1034
1035
1036
1037
1038
1039
1040
1041
1042
1043
1044
1045
1046
1047
1048
1049
1050
1051
1052
1053
1054
1055
1056
1057
1058
1059
1060
1061
1062
1063
1064
1065

8.3.3 The State PROGRAM has a documented procedure for identifying and reviewing 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 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.
8.3.4 To validate the workplan, the State PROGRAM develops a formula that:
8.3.4.1 Calculates the number of staff needed to conduct inspections of its ANIMAL FEED
inventory;
8.3.4.2 Calculates the number of staff needed to conduct sample collections;
8.3.4.3 Uses numerical values that are based on the State PROGRAM’S data;
8.3.4.4 Must be used by the State PROGRAM.
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: Appendix 8.2 provides example formulas that can be used as a baseline for a
State PROGRAM’S 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.
8.3.5 The inspection and sample collection staff must have the equipment needed to conduct
inspections and sample collections.
8.3.6 A list of the equipment required for inspections and sample collections must be:
8.3.6.1 Established by the State PROGRAM
8.3.6.2 Maintained by the State PROGRAM
Note: Appendix 8.3 provides an example list of equipment that may be used for
inspections and sample collections.

Animal Feed Regulatory Program Standards
34

STANDARD 8
Planning and Resources
1066
1067
1068
1069
1070
1071
1072
1073
1074
1075
1076
1077
1078
1079
1080
1081
1082
1083
1084
1085
1086
1087
1088
1089
1090
1091
1092
1093
1094
1095
1096
1097
1098
1099
1100
1101
1102
1103

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:
8.3.7.1 Adequate staff
8.3.7.2 Equipment
8.3.7.3 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.
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 each
standard’s requirements must be completed within three years of the previous
evaluation.
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.
8.5 Documentation
The State PROGRAM maintains the records listed here.
8.5.1 Appendix 8.1: Self-Assessment Worksheet
8.5.2 Workplan
8.5.3 Documented procedure for evaluating the workplan
8.5.4 Documented procedure for identifying and reviewing its resources to accomplish the
workplan within the applicable timeframe
8.5.5 Formula used to calculate number of staff needed to conduct inspections and sample
collections and supporting data
8.5.6 List of required equipment for inspection and sample collection
8.5.7 Appendix 8.4: Resources for IMPLEMENTATION of AFRPS

Animal Feed Regulatory Program Standards
35

STANDARD 9
Assessment and Improvement
1104
1105
1106
1107
1108
1109
1110
1111
1112
1113
1114
1115
1116
1117
1118
1119
1120
1121
1122
1123
1124
1125
1126
1127
1128
1129
1130
1131
1132
1133
1134
1135
1136
1137
1138
1139
1140
1141
1142
1143
1144
1145
1146

9.1 Purpose
This standard tracks the IMPLEMENTATION of each standard and describes the requirements for an
improvement plan.
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 regularly evaluates its status in meeting the requirements of the standards.
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.
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:
9.3.2.1 The individual element or documentation requirement for the standard that was
not fully met;
9.3.2.2 Improvements needed to fully meet the program element or documentation
requirement(s) of the standard;
9.3.2.3 Lists of individual tasks that will be used to address the improvement;
9.3.2.4 A projected completion date for each task;
9.3.2.5 Completion date for each task.
9.3.3 The State PROGRAM reviews and updates its improvement plan (appendix 9.2) on an
annual basis.
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:
9.3.4.1 Self-assessment worksheets for each standard;
9.3.4.2 Required documentation for each standard;

Animal Feed Regulatory Program Standards
36

STANDARD 9
Assessment and Improvement
1147
1148
1149
1150
1151
1152
1153
1154
1155
1156
1157
1158
1159
1160
1161
1162
1163
1164
1165
1166
1167
1168
1169
1170

9.3.4.3 Improvement plan (appendix 9.2);
9.3.4.4 IMPLEMENTATION status (appendix 9.3).
9.3.5 Appendix 9.3, or comparable form, is used to track IMPLEMENTATION status of all the
standards.
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.
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
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.
9.5 Documentation
The State PROGRAM maintains the records listed here.
9.5.1 Appendix 9.1: Self-Assessment Worksheet
9.5.2 Appendix 9.2: Assessment and Improvement Plan
9.5.3 Appendix 9.3: IMPLEMENTATION Status of Animal Feed Regulatory Program Standards

Animal Feed Regulatory Program Standards
37

STANDARD 10
Laboratory Services
1171
1172
1173
1174
1175
1176
1177
1178
1179
1180
1181
1182
1183
1184
1185
1186
1187
1188
1189
1190
1191
1192
1193
1194
1195
1196
1197
1198
1199
1200
1201
1202
1203
1204
1205
1206
1207
1208
1209
1210
1211
1212

10.1 Purpose
This standard describes the elements of utilizing REGULATORY TESTING LABORATORY(IES)
services that support the State PROGRAM.
10.2 Requirement Summary
The State PROGRAM has access to laboratory services that provide analytical data that support
regulatory functions.
The State PROGRAM receives accurate, timely, reliable, and defensible data from the
REGULATORY TESTING LABORATORY(IES).
10.3 Program Elements
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 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.
10.3.3 The State PROGRAM prepares a sample analysis schedule based on a sampling plan 3
in cooperation with REGULATORY TESTING LABORATORY(IES) performing routine
services to ensure compatibility with laboratory capabilities and capacities. At a
minimum, the sample analysis schedule must include:
10.3.3.1
10.3.3.2
10.3.3.3
10.3.3.4

The type(s) of ANIMAL FEED to be analyzed;
Number of samples to be collected;
Estimated timeframe for collection;
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:
10.3.4.1 Sample receipt
10.3.4.2 Preservation
10.3.4.3 Storage
3

A description of a sampling plan can be found in Animal Feed Regulatory Program Standard 11: Sampling Program.

Animal Feed Regulatory Program Standards
38

STANDARD 10
Laboratory Services
1213
1214
1215
1216
1217
1218
1219
1220
1221
1222
1223
1224
1225
1226
1227
1228
1229
1230
1231
1232
1233
1234
1235
1236
1237
1238
1239
1240
1241
1242
1243
1244
1245
1246
1247
1248
1249
1250
1251
1252

10.3.4.4
10.3.4.5
10.3.4.6
10.3.4.7
10.3.4.8

Retention
Disposal
Chain of custody
Report of analysis
Method(s) used to communicate information between the State PROGRAM
and REGULATORY TESTING LABORATORY(IES)

10.3.5 State PROGRAM utilizes REGULATORY TESTING LABORATORY(IES) that:
10.3.5.1 Are accredited by a recognized accreditation body to ISO/IEC
17025:2005 4, or
10.3.5.2 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.

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.
10.5 Documentation
The State PROGRAM maintains the records listed here.
10.5.1 Appendix 10: Self-Assessment Worksheet
10.5.2 A list of routine and non-routine analytical services provided by the REGULATORY
TESTING LABORATORY(IES)
10.5.3 An agreement with REGULATORY TESTING LABORATORY(IES) that provide routine
analytical services unless the laboratory is managed within the PROGRAM
10.5.4 A current sample analysis schedule
10.5.5 Written procedures to maintain the integrity of the samples sent to the REGULATORY
TESTING LABORATORY(IES)

4

A recognized accreditation body must be signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition
Arrangement (MRA).

Animal Feed Regulatory Program Standards
39

STANDARD 11
Sampling Program
1253
1254
1255
1256
1257
1258
1259
1260
1261
1262
1263
1264
1265
1266
1267
1268
1269
1270
1271
1272
1273
1274
1275
1276
1277
1278
1279
1280
1281
1282
1283
1284
1285
1286
1287
1288
1289
1290
1291
1292

11.1 Purpose
This standard describes the elements of an effective ANIMAL FEED sampling program.

11.2 Requirement Summary
The State PROGRAM has a sampling program to support an ANIMAL FEED regulatory program.

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. 5
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.
11.3.1.2 The sampling plan outlines the State PROGRAM’S:
11.3.1.2.1 Sampling priorities
11.3.1.2.2 Sample analysis schedule
11.3.1.2.3 Availability or coordination of analytical support
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:
11.3.2.1
11.3.2.2
11.3.2.3
11.3.2.4
11.3.2.5

Following safety precautions on feed labels;
Following the State PROGRAM’S safety protocol for collecting samples;
Using appropriate method and equipment to collect the sample;
Sealing the sample to initiate chain of custody;
Maintaining and documenting sample integrity, security, and chain of
custody;
11.3.2.6 Issuing receipt 6 for sample(s);
11.3.2.7 Handling 7, packaging, and shipping sample using procedures appropriate
to prevent compromising the condition of sample;
11.3.2.8 Delivering or shipping sample to the appropriate laboratory within
acceptable timeframes.

5

Regulatory samples may be used to support inspection observations.
Receipt could include cost of sample and method of payment.
7
Includes storing sample.
6

Animal Feed Regulatory Program Standards
40

STANDARD 11
Sampling Program
1293
1294
1295
1296
1297
1298
1299
1300
1301
1302
1303
1304
1305
1306
1307
1308
1309
1310
1311
1312
1313
1314
1315
1316
1317
1318
1319
1320
1321
1322
1323
1324
1325
1326
1327
1328
1329
1330

11.3.3 The State PROGRAM has documented instructions for the Sample Collection Report
that includes:
11.3.3.1 Date of the sample collection;
11.3.3.2 Product identification including:
11.3.3.2.1 Name
11.3.3.2.2 Lot numbers or any other codes referencing manufacture
identification
11.3.3.3
11.3.3.4
11.3.3.5
11.3.3.6
11.3.3.7
11.3.3.8

Description of product;
Method of collection and any special techniques used to collect sample;
Lot sampled;
Lot size;
Location where sample was collected;
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 Analysis requested, if applicable;
11.3.3.11 Collection or reproduction of product labels, including customer-formula
feed labels;
11.3.3.12 Receiving and distribution information.

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.
11.5 Documentation
The State PROGRAM maintains the records listed here.
11.5.1
11.5.2
11.5.3
11.5.4

Appendix 11: Self-Assessment Worksheet
Documented annual sampling plan
Documented sampling procedures
Documented sample collection report instructions

Animal Feed Regulatory Program Standards
41

Appendix 1.1: Self-Assessment Worksheet
Instructions: The State PROGRAM identifies if they have a specified component then evaluate if it includes the associated
components. If the State PROGRAM has the main component and associated components check ‘Yes’, if not, check ’No’.
Yes

No

The State PROGRAM conducts as evaluation to determine whether the State’s legal authority and
are EQUIVALENT, EQUIVALENT IN EFFECT, or NOT EQUIVALENT to the sections of the FD&C Act and
Federal regulations specified in appendix 1.2.
Notes:

Yes

No

If a State law or regulation is determined to be “EQUIVALENT” to a Federal law or regulation, the
State
PROGRAM:
Not
Applicable:

Check “Not Applicable” box to the left if requirement is not applicable because no State law or
regulation was determined to be EQUIVALENT.
Yes
No

Specifies the Federal statute or regulation that is incorporated into the State law;
Includes the revision date of the State statutory provision or regulation;
Identifies the date the Federal statutory provision was incorporated into the State
law.
Notes:

Yes

No

The State PROGRAM has a documented process, which includes:
Yes

No

Procedure for reviewing the statutes, regulations, rules, ordinances and other
prevailing regulatory requirements that:
Apply to the regulation of ANIMAL FEED;
Delegate authority to the State Agency;
Describe the State agency’s administrative procedures for establishing
its authority and incorporating rules by reference.
Timeframes for the review.
Notes:

Assessment Completed By:
Name

Date

Animal Feed Regulatory Program Standards
42

Appendix 1.2: REGULATORY FOUNDATION Worksheet
Instructions: Determine if State laws and regulations are “EQUIVALENT”, “EQUIVALENT IN EFFECT”, or “NOT EQUIVALENT” to Federal statutes and regulations. If there is no State
law or regulation that is EQUIVALENT or EQUIVALENT IN EFFECT, mark the NOT EQUIVALENT column; otherwise list the State law or regulation citation in the State citation column
and complete the columns for either EQUIVALENT or EQUIVALENT IN EFFECT as appropriate. The Notes section should be used in part to detail differences between State and
Federal laws and regulations. If regulatory responsibility for State laws relating to provisions in a particular row of this worksheet fall under the jurisdiction of another State
agency, the State PROGRAM should mark “NOT EQUIVALENT” and it is recommended that the State PROGRAM identify the agency who has authority and jurisdiction in the Notes
column.
EQUIVALENT

State
Citation

Revision Date of
Federal
Law/Regulation

Date
Incorporated
into State Law

EQUIVALENT
IN EFFECT

Review Date

NOT
EQUIVALENT

Notes

Federal Food, Drug & Cosmetic Act
201

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

301

Prohibited acts (a), (b), (c),
(d), (e), (f), and (k)

303*

Penalties

304**

Seizure

401

Definitions and standards
for food

402

Adulterated food (a)-(c)

403

Misbranded food (a)-(n)

404

Emergency permit control

406
408

Tolerances for poisonous
ingredients in food
Tolerances and exemptions
for pesticide chemical
residues

*Penalties may vary from Federal statute.
**Although the State PROGRAM may not have authority for seizure, the State PROGRAM could have other legal authority to stop violative products from moving in commerce, for example, detention,
stop-sale orders, withdrawal from distribution, and embargoes.

Animal Feed Regulatory Program Standards
43

Appendix 1.2: REGULATORY FOUNDATION Worksheet (continued)
EQUIVALENT

State
Citation

409

Revision Date of
Federal
Law/Regulation

Date
Incorporated
into State Law

EQUIVALENT
IN EFFECT

Review Date

NOT
EQUIVALENT

Food additives
Adulterated drugs and devices

501
504
512

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

Veterinary feed directive
drugs
New animal drugs (ONLY:
512(a)(2))

701

Regulations and hearings

704

Factory inspection

Title 21 Code of Federal Regulations: Food and Drugs (2016)
General enforcement
regulations
1

(ONLY §§ 1.20-1.23, Subpart L
(§§1.500-1.514), Subpart M
(§§1.600-1.695), and Subpart O
(§§1.900-1.934))

Enforcement policy
7
70
73

(ONLY §§ 7.1-7.13 and §§ 7.407.59)

Color additives
(ONLY §§ 70.20-70.25)

Listing of colors exempt from
certification (ONLY §§ 73.173.615)

74

Listing of color additives
subject to certification (ONLY
§§ 74.101-74.706)

Animal Feed Regulatory Program Standards
44

Notes

Appendix 1.2: REGULATORY FOUNDATION Worksheet (continued)
EQUIVALENT

State
Citation

81

82

Revision Date of
Federal
Law/Regulation

Date
Incorporated
into State Law

General specifications and
general restrictions for
provisional color additives for
use in foods, drugs, and
cosmetics
Listing of certified
provisionally listed colors and
specifications
(ONLY §§ 82.3-82.706)

225
226

500.23

Current good manufacturing
practice for medicated feeds
Current good manufacturing
practice for Type A medicated
articles
Thermally processed low-acid
foods packaged in hermitically
sealed containers (refers to
regulations in 21 CFR 113 and 21
CFR 507)

Emergency permit control
500.24
500.29

500.45

500.50
500.80 500.92
501

(refers to regulations in 21 CFR
108 - ONLY §§ 108.25- 108.35)

Gentian violet for use in
animal feed
Use of polychlorinated
biphenyls (PCB's) in the
production, handling, and
storage of animal feed
Propylene glycol in or on cat
food
Regulation of carcinogenic
compounds used in foodproducing animals
Animal food labeling

Animal Feed Regulatory Program Standards
45

EQUIVALENT
IN EFFECT

Review Date

NOT
EQUIVALENT

Notes

Appendix 1.2: REGULATORY FOUNDATION Worksheet (continued)
EQUIVALENT

State
Citation

502

507

509
510
558
570

573

579
582

584

589

Revision Date of
Federal
Law/Regulation

Date
Incorporated
into State Law

Common or usual name for
nonstandardized animal foods
Current good manufacturing
practice, hazard analysis, and
risk-based preventive controls
for food for animals
Unavoidable contaminants in
animal food and foodpackaging material
New animal drugs (ONLY
Subpart D - Records and Reports)

New animal drugs for use in
animal feeds
Food additives
(EXCEPT § 570.6, § 570.15, and
§570.17)

Food additives permitted in
feed and drinking water of
animals
Irradiation in the production,
processing, and handling of
animal feed and pet food
Substances generally
recognized as safe
Food substances affirmed as
generally recognized as safe in
feed and drinking water of
animals
Substances prohibited from
use in animal food or feed

Animal Feed Regulatory Program Standards
46

EQUIVALENT
IN EFFECT

Review Date

NOT
EQUIVALENT

Notes

Appendix 1.2: REGULATORY FOUNDATION Worksheet (continued)
Additional State Authorities (optional):
Instructions: List any State Authorities used by the State PROGRAM that are pertinent to the regulation of ANIMAL FEED but do not have a comparable Federal
statute or regulation (examples: tolerance for mycotoxins, fluorine, or noxious weeds in feed).

Additional notes and comments:

Assessment Completed By:
Name

Date

Animal Feed Regulatory Program Standards
47

Appendix 2.1: Self-Assessment
Instructions: The State PROGRAM identifies if they have a specified component then evaluate if it includes the associated components.
If the State PROGRAM has the main component and associated components check ‘Yes’, if not, check ’No’.

Training
Yes No
The State PROGRAM uses a written training plan that includes:
Basic curriculum
Advanced curriculum
Continuing education
For inspectors that conduct limited scope inspections (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.
The State PROGRAM maintains records documenting the training completed by all inspectors using appendix 2.2 or
comparable form.
For inspectors with greater than 5 years of experience that do not have documentation of previous training, 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. (This is only permitted at the date of the
initial self-assessment and not subsequent self-assessments.)
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.

Basic Feed Inspector Training
Yes No
The State PROGRAM requires an inspector to successfully complete coursework and field training within 24 months from
the START DATE.
The basic feed inspection training consists of coursework in the following subject areas:
Animal and Public Health Principles
Basic Animal Nutrition
Basic Feed Ingredients, Processing and Technology
Basic National Incident Management System and Incident Command System (ICS)
Communication
Current Statutes, Regulations, and Policies
Feed Defense
Inspections, Compliance, and Enforcement
Labeling
Professionalism
Risk Awareness
Safety
Sampling
The State PROGRAM has established basic field training to complement the basic coursework.
Field training checklist of competencies to be mastered and verified in the field by the QUALIFIED FIELD
INSPECTION TRAINER;
Documented procedures for JOINT FIELD TRAINING INSPECTIONS;

Animal Feed Regulatory Program Standards

48

Appendix 2.1: Self-Assessment (continued)
Yes No
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;
The inspector completes basic field training prior to performing independent inspections;
Appendix 2.3 or comparable form must be used to list the competencies and record the JOINT FIELD TRAINING
INSPECTIONS.

Advanced Feed Inspector Training
Yes No
The State PROGRAM requires an inspector to successfully complete coursework and field training within 60 months from
the START DATE.
The advanced feed inspection training consists of coursework in the following subject areas:
Advanced Feed Ingredients, Processing, and Technology
Advanced Labeling
Animal Sickness and Death Investigation
Current Statutes, Regulations, and Policies
Epidemiology
Microbiological Pathogens
Traceback and Traceforward Investigations
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.
Advanced National Management Systems and Incident Command Systems
BSE and Ruminant Feeding Ban
Medicated Feed Good Manufacturing Practices Regulations
The State PROGRAM has established advanced field training to complement the advanced coursework.
Field training checklist of competencies to be mastered and verified in the field by the QUALIFIED FIELD
INSPECTION TRAINER;
Documented procedures for JOINT FIELD TRAINING INSPECTIONS;
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;
The inspector completes advanced field training prior to performing independent inspections;
Appendix 2.3 or comparable form must be used to list the competencies and record JOINT FIELD TRAINING
INSPECTIONS.

Continuing Education
Yes No
The State PROGRAM requires that each basic and advanced inspector participate in continuing education.
Each inspector is required to receive 20 CONTACT HOURS of continuing education every 36 months.
The 36 month continuing education interval starts, as defined by the State PROGRAM, when the training curriculum
is complete.

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards

Date

49

Appendix 2.2: Inspector Training Record
Inspector Name:

Employment START DATE:

A. Basic Feed Inspector Training
Instructions: If the inspector has greater than five years of experience and an evaluation of the inspector’s previous
performance and experience shows adequate training has been completed, mark the Name and Location of Training
Column, with “Met via Evaluation.”

Subject Areas

Name and Location of
Training

Completion
Date

Animal and Public Health
Principles
Basic Animal Nutrition
Basic Feed Ingredients,
Processing, and Technology
Basic National Incident
Management System and
Incident Command System
Communication
Current Statues, Regulations,
and Policies
Feed Defense
Inspections, Compliance,
and Enforcement
Labeling

Professionalism

Risk Awareness

Safety

Sampling

Animal Feed Regulatory Program Standards

50

Inspector
Initials

Supervisor
Initials

Documentation
Verifying
Completion
(Y/N)

Appendix 2.2: Inspector Training Record (continued)
Inspector Name:

Employment START DATE:

Instructions: Record the name of the firm where the joint training inspection took place as well as the competencies
covered.
Basic Field Training
(Name and Location of Firm)

Competencies Covered

Animal Feed Regulatory Program Standards

51

Completion
Date

Inspectors
Initials

Supervisor
Initials

Mastered
(Y/N)

Appendix 2.2: Inspector Training Record (continued)
Inspector Name:

Employment START DATE:

B. Advanced Feed Inspector Training
Instructions: If the inspector has greater than five years of experience and an evaluation of the inspector’s previous
performance and experience has found that no additional training for a subject area is needed, mark the Name and
Location of Training Column, with “Met via Evaluation.”

Subject Areas

Name and Location of
Training

Completion
Date

Advanced Feed Ingredients,
Processing, and Technology
Advanced Labeling
Animal Sickness and Death
Investigation
Current Statues, Regulations,
and Policies
Epidemiology

Microbiological Pathogens
Traceback and Traceforward
Investigations
Specialized Advanced
Advanced National Incident
Management System and
Incident Command Systems
BSE and Ruminant Feeding
Ban
Medicated Feed Good
Manufacturing Practices
Regulations

Animal Feed Regulatory Program Standards

52

Inspector
Initials

Supervisor
Initials

Documentation
Verifying
Completion
(Y/N)

Appendix 2.2: Inspector Training Record (continued)
Inspector Name:

Employment START DATE:

Instructions: Record the name of the firm where the joint training inspection took place as well as the
competencies covered.
Advanced Field Training
(Name and Location of Firm)

Competencies Covered

Animal Feed Regulatory Program Standards

53

Completion
Date

Inspectors
Initials

Supervisor
Initials

Mastered
(Y/N)

Appendix 2.2: Inspector Training Record (continued)
Inspector Name:

Employment START DATE:

Instructions: Record the continuing education activity as well as the name and location of the activity.
C. Continuing Education
Type of Activity

Animal Feed Regulatory Program Standards

Name and Location of
Activity

54

Completion
Date

Inspectors
Initials

Supervisor
Initials

CONTACT
HOURS

Earned

Appendix 2.3: Field Training Competencies
Inspector Name:

Employment START DATE:

A. Basic Feed Competencies
Instructions: List the competencies to be covered in the State PROGRAM'S basic field training and provide a short
description.
Competency

Description

Minimum Number of JOINT FIELD TRAINING INSPECTIONS Required:

Animal Feed Regulatory Program Standards

55

Appendix 2.3: Field Training Competencies (continued)
Inspector Name:

Employment START DATE:

A. Advanced Field Competencies

Instructions: List the competencies to be covered in the State PROGRAM'S advanced field training and provide a
short description.
Competency

Description

Minimum Number of JOINT FIELD TRAINING INSPECTIONS Required:

Animal Feed Regulatory Program Standards

56

Appendix 3.1: Self-Assessment Worksheet
Instructions: The State PROGRAM identifies if they have a specified component then evaluate if it includes the associated components.
If the State PROGRAM has the main component and associated components answer ‘Yes’, if not, answer ’No’.

Program Elements

Yes/No

Specific
Reference 8

Notes

Section I. Risk-Based Inspection Program
The State PROGRAM has documented procedures to:
•

•

Define an up-to-date inventory of feed facilities
whose activities fall under the State’s jurisdiction
and authority;
Maintain the inventory of feed facilities defined in
3.3.1.1.1.

The State PROGRAM has documented procedures for
defining risk categories. The three minimum
required factors for defining risk categories are:
•
•
•

Types of feed and feed products;
Types of processing;
Compliance history of the facility.

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.
Based on risk factors assigned to a facility or product,
the manufacturing processes, and the inspection
history of the facility, inspections:
•
•
•

Are prioritized;
Have assigned frequencies;
Have resources allocated.

Section II. Inspection Protocol
The State PROGRAM has documented policies and
procedures for inspecting feed facilities that require
inspectors to:
1. Review the feed facility’s previous inspection
report(s) and complaint(s);
2. Present appropriate credentials and written
Notice of Inspection to the feed facility’s
owner, operator, or agent in charge; make
appropriate introductions; explain the purpose
and scope of the inspection; and determine
inspection authority;
3. Follow the safety protocols required by the
feed facility and the State PROGRAM;
4. Follow the biosecurity protocols required by
the feed facility and the State PROGRAM;
5. Use appropriate equipment and forms needed
to conduct inspections;
6. Establish interstate jurisdiction for FDA
inspections, if applicable;

8

Cite the reference (title and date of publication, section, and page number) to demonstrate the program element has been met.

Animal Feed Regulatory Program Standards

57

Appendix 3.1: Self-Assessment Worksheet (continued)
Program Elements

Yes/No

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;
8. Conduct inspection activities focused on
those firms, products, and processes
determined to be high risk;
9. Assess employee activities critical to the safe
manufacture, distribution, storage, handling,
and disposition of feed;
10. Properly evaluate the likelihood that
conditions, practices, processes, components,
or labeling could cause the product to become
adulterated or misbranded;
11. Recognize significant non-compliant
conditions or practices and document
findings consistent with PROGRAM
procedures;
12. Distinguish between significant and
insignificant observations and isolated
incidents versus trends;
13. Review and evaluate the appropriate feed
facility records and procedures and verify that
the procedures are being followed;
14. Collect adequate evidence and documentation
to support inspection observations in
accordance with PROGRAM procedures;
15. Verify correction of deficiencies identified
during the previous inspection(s);
16. Conduct activities in a professional manner;
17. Use effective interviewing techniques;
18. Explain findings clearly and adequately
throughout the inspection;
19. Alert the feed facility’s owner, operator, or
agent in charge when an immediate corrective
action is necessary;
20. Document findings accurately, clearly,
legibly, and concisely on the applicable
form(s) and provide a copy to the firm’s
owner, operator, or agent in charge;
21. Answer questions and provide information as
appropriate;
22. Submit inspection report, sample(s), and
supporting documents to headquarters or
supervisor in a timely manner.

Animal Feed Regulatory Program Standards

58

Specific
Reference

Notes

Appendix 3.1: Self-Assessment Worksheet (continued)

Program Elements

Yes/No

Specific
Reference

Notes

Section III. Recall System
The State PROGRAM has a documented recall system.
•

•

The recall system includes written procedures for:
o Receiving
o Tracking
o Evaluating recall notifications
o Closing
o Maintaining records
The recall system includes performing recall
effectiveness checks

Section IV. Consumer Complaints
The State PROGRAM has a documented system for
handling consumer complaints.

• The consumer complaint system includes
procedures for:
o Receiving
o Tracking
o Evaluating
o Answering
o Closing
o Maintaining records

Section V. Complaints Resulting from State Inspection Activities
The State PROGRAM has a documented system to
handle complaints from industry about State
PROGRAM inspections.

• The industry complaint system includes
procedures for:
o Receiving
o Evaluating
o Maintaining records

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards

Date

59

Appendix 3.2: Risk Categorization for Feed Facilities
Determining Risk Factors for Feed Facilities
Standard 3 requires a State PROGRAM to categorize feed facilities based on risk and to allocate resources and establish
inspection frequencies based upon that categorization. State PROGRAMS should document their categorization and
inspection frequencies. Differences between State PROGRAMS will exist for many reasons including variable resources,
legislative mandates, localized industries and practices, and competing priorities.
A key requirement of this standard is that the State PROGRAM uses a risk-based method for categorizing feed facilities
with a baseline inspection frequency specified for each category.
State PROGRAMS must categorize feed facilities based on at least the following three factors: (1) types of feed and feed
products, (2) type of processing, and (3) compliance history of the feed facility.
The State PROGRAM should consider optional risk factors such as volume of product manufactured, scope of distribution,
or other factors unique to the State’s industries and practices.
The risk associated with each factor may be scored with numerical values that are tabulated to rank the feed facilities and
prioritize inspections.
Risk Categorization Factors for Feed Facilities

A. Required Factors
1. Type of Processing
The following types of processing should be considered.
• Rendering
• Pelleting
• Extrusion
• Roasting
• Steam Flaking
• Refrigeration
• Mixing
• Milling
• Salvaging
• Thermal processing
• Heating
2. Type of Feed
The following types of feed should be considered.
• Mixes species
• Raw pet food
• Pet food
• Medicated feed
• Customer formula feed
• Feed containing prohibited mammalian tissue
• Feed ingredients subject to adulterants such as mycotoxins, pesticides, or industrial chemicals
• Single specie feed
• Non-medicated feed

Animal Feed Regulatory Program Standards

60

Appendix 3.2: Risk Categorization for Feed Facilities (continued)
3. Compliance History
The following types of compliance history should be considered.
• Poor history
• No history
• Inconsistent history
• Good history
The following is an example of a risk associated with a required factor.
Risk

Score

Compliance History
Feed facility with poor history of compliance or no compliance history with feed laws and
regulations

High

3

Medium

2

Feed facility with an inconsistent history of compliance

Low

1

Feed facility is routinely in compliance with feed laws and regulations

B. Optional Factors
1. Volume of Product Manufactured
• Greater than 500 tons/day
• 50 to 500 tons/day
• Less than 50 tons/day
2. Scope of Distribution
• Global
• National
• Interstate
• Regional
• Intrastate
• County
• Local

Animal Feed Regulatory Program Standards

61

Appendix 4.1: Self-Assessment Worksheet
Auditing
Instructions: The State PROGRAM identifies if they have a specified component then evaluate if it includes the associated components.
If the State PROGRAM has the main component and associated components check ‘Yes’, if not, check ’No’.

Yes No
The State program has written procedures for conducting four types of audits:
Field inspection audits
Field inspection report audits
Sample collection audits
Sample collection report audits
A review of the performance factor scores and cumulative scores for each type of audit is completed
at least every 12 months.
Field Inspection Audit
Yes No
PROGRAM conducts field inspection audits
12-month period of performance
Number of audits conducted
Number of corrective action plans required
Inspectors are audited at a minimum against the performance factors found in appendix 4.2
Audits reflect inspector’s assignments and responsibilities
Two audits per inspector completed every 36 months
Audit score calculated for each individual audit
Audit rating recorded for each individual audit
Performance factor score calculated for each performance factor
Cumulative score calculated for the PROGRAM
Field Inspection Report Audit
Yes No
PROGRAM conducts random inspection report audits
12- month period of performance:
Number of inspection reports completed:
Number of inspection reports audited:
Number of corrective action plans required:
Inspection reports were audited according to frequency chart in the standard
Inspection reports are audited at a minimum against the performance factors found in appendix 4.5
Audit score calculated for each individual audit
Audit rating recorded for each individual audit
Performance factor score calculated for each performance factor
Cumulative score calculated for the PROGRAM

Animal Feed Regulatory Program Standards

62

Appendix 4.1: Self-Assessment Worksheet (continued)
Sample Collection Audit
Yes No
PROGRAM conducts sample collection audits
12-month period of performance:
Number of audits conducted:
Number of corrective action plans required:
Inspectors are audited at a minimum against the performance factors found in appendix 4.7
Audits reflect inspector’s assignments and responsibilities
Two audits per inspector completed every 36 months
Audit score calculated for each individual audit
Audit rating recorded for each individual audit
Performance factor score calculated for each performance factor
Cumulative score calculated for the PROGRAM
Sample Collection Report Audit
Yes No
conducts random sample collection report audits
12-month period of performance:
Number of sample collections reports reviewed:
Number of sample collection reports audited:
Number of corrective action plans required:
Sample collection reports were audited according to frequency chart in the standard
Sample collection reports are audited at a minimum against performance factors found in appendix
4.9
Audit score calculated for each individual audit
Audit rating recorded for each individual audit
Performance factor score calculated for each performance factor
Cumulative score calculated for the PROGRAM
PROGRAM

Corrective Action Plan
Yes No
develops corrective action plans using appendix 4.11 when:
An inspector has an audit score below 80 percent for an individual audit
The PROGRAM has a performance factor score below 80 percent for a single performance factor
The PROGRAM has a cumulative score below 80 percent

PROGRAM

Assessment Completed By:

Name

Animal Feed Regulatory Program Standards

Date

63

Appendix 4.2: Field Inspection Audit Form
Field Inspection Audit
Auditor:
Date of Audit:

Inspector:

Type of Inspection:
BSE
GMP
Complaint
Other:

Firm Name:
Firm Address:
Total Number of:

Acceptable
Needs Improvement

Audit Rating:

Tissue Residue

Acceptable
Needs Improvement

Audit Score:
Instructions to the Auditor:
All performance factors must be rated ‘Acceptable’ or ‘Needs Improvement’. The total number of ‘Acceptable’ and
‘Needs Improvement’, as well as the audit score and audit rating, must be recorded in the space above.
To calculate the audit score: Audit Score = [# Acceptable/ (# Acceptable + # Needs Improvement)] x 100.
If the audit score is below eighty percent, the audit rating must be marked as ‘Needs Improvement’.
I.
Pre-Inspection Assessment
1. Did the inspector review the feed facility’s previous inspection report(s) and complaint(s)?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

2. Did the inspector use appropriate equipment and forms to conduct the inspection?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

II.
Inspection Observations and Performance
1. Did the inspector present appropriate credentials and written Notice of Inspection to the feed facility’s owner,
operator, or agent in charge? Make appropriate introductions, explain the purpose and scope of the inspection, and
determine inspection authority?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

2. Did the inspector follow safety protocols required by the feed facility and the state program?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

Animal Feed Regulatory Program Standards

64

Appendix 4.2: Field Inspection Audit Form (continued)
3. Did the inspector follow the bio-security protocols required by the feed facility and the state program?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

4. Did the inspector establish interstate jurisdiction for FDA inspections, if applicable?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

5. Did the inspector recognize relative risk (high to low) of the feed facility based on the state program’s risk-based
inspection program and categorization assigned to a facility or a product, the manufacturing processes, and the
inspection history of the facility?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

6. Did the inspector conduct inspection activities focused on the feed facility’s products and processes determined to be
high risk?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

7. Did the inspector assess feed facility employee activities critical to the safe manufacture, distribution, storage,
handling, and disposition of feed?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

8. Did the inspector properly evaluate the likelihood that conditions, practices, processes, components, or labeling
could cause the product to become adulterated or misbranded?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

9. Did the inspector recognize significant non-compliant conditions or practices and document findings consistent with
program procedures?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

10. Did the inspector distinguish between significant and insignificant observations and isolated incidents versus trends?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

Animal Feed Regulatory Program Standards

65

Appendix 4.2: Field Inspection Audit Form (continued)
11. Did the inspector review and evaluate the appropriate feed facility records and procedures and verify that the
procedures are being followed?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

12. Did the inspector collect adequate evidence and documentation to support inspection observations in accordance
with program procedures?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

13. Did the inspector verify correction of deficiencies identified during the previous inspection(s)?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

14. Did the inspector conduct activities in a professional manner?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

III.
Oral and Written Communications
1. Did the inspector use effective interviewing techniques?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

2. Did the inspector explain findings clearly and adequately throughout the inspection?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

3. Did the inspector alert the feed facility’s owner, operator, or agent in charge when an immediate corrective action
was necessary?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

4. Did the inspector 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?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

Animal Feed Regulatory Program Standards

66

Appendix 4.2: Field Inspection Audit Form (continued)
5. Did the inspector answer questions and provide information as appropriate?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

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

Name of Auditor

Animal Feed Regulatory Program Standards

Signature of Auditor

67

Date

Appendix 4.2a: Completing the Field Inspection Audit Form
For each performance factor, examples of actions and observations that would likely result in a “needs improvement”
rating are provided.

Pre-Inspection Assessment
1. Did the inspector review the previous feed facility’s inspection report(s) and complaint(s)?
Examples of a “needs improvement” rating
a. The inspector does not review the previous inspection report and complaints.
b. The inspector does not review a firm’s response letter to the previous establishment inspection in which
corrective actions were promised.
2. Did the inspector use appropriate equipment and forms to conduct the inspection?
Examples of a “needs improvement” rating
a. The inspector does not have a copy or have electronic access to the pertinent laws and regulations.
b. During a medicated feed mill inspection, the inspector does not have a current copy of Title 21 of the Code of
Federal Regulations Parts 225 and 558 (or a current Feed Additive Compendium) or access on line.
c. The inspector does not have a calculator.
d. The inspector does not have a camera to document violations.
e. The inspector does not have a flashlight to examine poorly lit raw material storage areas.
f.

The inspector uses outdated, improper, or inappropriate forms for the type of inspection conducted.

Inspection Observations and Performance
1. Did the inspector present appropriate credentials and written Notice of Inspection to the feed facility’s owner,
operator, or agent in charge? Make appropriate introductions, explain the purpose and scope of the
inspection, and determine inspection authority?
Example of a “needs improvement” rating
a. Inspector fails to present credentials to the owner, operator, or agent in charge of the establishment.
b. Inspector fails to make appropriate introductions, explain the purpose and scope of the inspection, and
determine inspection authority.
c. Inspector enters the firm through the rear entrance and immediately begins the inspection without issuing a
Notice of Inspection.
d. Upon entering the firm, the inspector fails to issue the Notice of Inspection to the appropriate person.
e. Inspector uses only a business card as identification.
2. Did the inspector follow safety protocols required by the feed facility and the State program?
Example of a “needs improvement” rating
a. The inspector does not ask if any particular safety protocols are mandated at the facility.
b. The inspector does not follow the State PROGRAM’S safety protocol or use personal protective equipment
appropriately.
c. The inspector does not follow the safety protocols mandated by a particular facility.

Animal Feed Regulatory Program Standards

68

Appendix 4.2a: Completing the Field Inspection Audit Form (continued)
3. Did the inspector follow the bio-security protocols required by the feed facility and the State program?
Example of a “needs improvement” rating
a. The inspector does not inquire if any particular bio-security protocols are mandated at the facility.
b. The inspector does not follow the State PROGRAM’S bio-security protocol.
c. The inspector does not follow the bio-security protocols mandated by the feed facility.
4. Did the inspector establish interstate jurisdiction for FDA inspections, if applicable?
Examples of a “needs improvement” rating
a. The inspector fails to confirm the interstate movement of product or ingredients.
b. The inspector conducts an inspection of a licensed feed mill. The inspector fails to determine that product or
ingredients have been received or shipped in interstate commerce by the manufacturer since the last
inspection.
5. Did the inspector recognize relative risk (high to low) of the feed facility based on the State program’s riskbased inspection program and categorization assigned to a facility or a product, the manufacturing processes,
and the inspection history of the facility?
Examples of a “needs improvement” rating

a. The inspector does not recognize the relative risk of the facility because the inspector is not knowledgeable
with the manufacturing process involved at this facility and does not inquire with facility personnel.

b. The inspector organizes inspection activities focused on low risk items and ignores high risk products and
processes.
6. Did the inspector conduct inspection activities focused on the feed facility’s products and processes determined
to be high risk?
Examples of a “needs improvement” rating

a. The inspector does not prioritize high risk inspection activities.
b. The inspector concentrates inspection activities on low risk items and not high risk products and processes.
7. Did the inspector assess feed facility employee activities critical to the safe manufacture, distribution, storage,
handling, and disposition of feed?
Examples of a “needs improvement” rating
a. The inspector conducts the inspection without input from employees responsible for critical activities.
b. The inspector does not review employee training records when required.
c. The inspector observes a trash bin and a reclaim bin in the same area, but he fails to evaluate practices
sufficiently to identify an employee placing trash in the reclaim bin, which subsequently re-enters the process
flow.
d. The inspector fails to recognize distressed dog food being placed into a re-grinder bin containing regrinds for
ruminant feed.
e. The inspector fails to note an employee using medication in a feed when the formula does not call for the
addition of this medication.

Animal Feed Regulatory Program Standards

69

Appendix 4.2a: Completing the Field Inspection Audit Form (continued)
8. Did the inspector properly evaluate the likelihood that conditions, practices, processes, components, or labeling
could cause the product to be adulterated or misbranded?
Examples of a “needs improvement” rating

a. The inspector does not observe critical activities during the inspection and does not discuss procedures in
place to prevent distribution when an error has occurred.

b. The inspector does not review labeling protocols and verify a system was in place to assure proper labeling.
c. The inspector does not recognize possible adulterants (pesticides) that are stored above bagged feeds.
d. The inspector does not investigate a pallet of stacked bags that lack labeling and identification.
e. The inspector fails to investigate feed containing an unapproved drug combination.
9. Did the inspector recognize significant non-compliant conditions or practices and document findings consistent
with program procedures?
Examples of a “needs improvement” rating
a. The inspector concentrates on one item and does not recognize other significant non-compliant conditions.
b. The inspector notices non-compliant products but fails to adequately address them at the time of the
inspection or at the end of the inspection.
c. Inspector fails to identify a feed containing an unapproved drug combination.
d. The inspector fails to note the significance of “back hauling” prohibited materials in a bulk truck used to
transport cattle feed.
10. Did the inspector distinguish between significant and insignificant observations and isolated incidents versus
trends?
Examples of a “needs improvement” rating

a. The inspector keeps reviewing documents until he finds an insignificant violation.
b. The inspector does not emphasize the severity or outcome of significant observations and the need for
immediate action.

c. The inspector does not discuss patterns or trends that were observed.
d. The inspector does not recognize significant pest infestations.
e. The inspector identifies and objects to record keeping deficiencies without considering that corrective action
plans have been implemented by the firm and the deficiency has not reoccurred.
11. Did the inspector review and evaluate the appropriate feed facility records and procedures and verify the
procedures are being followed?
Examples of a “needs improvement” rating

a. The inspector asks for the invoices for customer formula feeds for labeling information and does not realize
that the facility’s procedures use the facility’s mix ticket as the label.

b. The inspector notices drugs are being added to the mixer before any other ingredient when the facility’s SOP
for addition of medications states that medications will be added at five minutes into the mix time.

c. The inspector fails to question alarm notifications and the resulting required procedures.
d. The inspector encounters out of limit drug assays and does not look for follow up actions.
e. The inspector reviews mixer cleanout records but fails to note cleanouts were not done according to the
facility’s SOP.

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Appendix 4.2a: Completing the Field Inspection Audit Form (continued)
12. Did the inspector collect adequate evidence and documentation to support inspection observations in
accordance with program procedures?
Examples of a “needs improvement” rating

a. The inspector reviews the drug inventory and notes that the drug inventory is not accurate but does not collect
documents to support the finding.

b. The inspector notices dead rodents around the mixer hand add area and does not provide supporting evidence
such as photographs, detailed narrative, or affidavits.

c. The inspector mentions that proper caution statements are missing from medicated feed labels yet does not
provide copies of the labeling involved.

d. The inspector simply notes that “housekeeping needs improved” and does not provide documentation to
support the observation.
13. Did the inspector verify correction of deficiencies identified during the previous inspection(s)?
Examples of a “needs improvement” rating
a. The previous inspection of the facility listed inaccurate drug levels on labeling of several feeds. During the
current inspection, the manager informs the inspector that the problem has been corrected. The inspector
simply notes in the report the management’s statement and does not verify that the labels have been changed.
b. The previous inspection noted improper cleanout procedures for all handling equipment. The inspector
verifies that the mixer is being adequately cleaned out but does not verify proper procedures are being used
for other handling equipment.
c. The previous inspection noted that production records were not being checked at the end of the day. The
inspector notes there are initials on some of the records, but the inspector does not further inquire about their
procedures.
14. Did the inspector conduct activities in a professional manner?
Examples of a “needs improvement” rating
a. The inspector does not dress appropriately for the inspection. Upon arrival, clothes were torn and dirty.
b. The inspector fails to wear protective safety equipment that is required by the firm or the State.
c. The firm asks the inspector to use the boot bath before entering the production area, but the inspector ignores
the firm’s request and enters the production area.
d. The inspector is rude and demanding

Oral and Written Communications
1. Did the inspector use effective interviewing techniques?
Examples of a “needs improvement” rating
a. The inspector’s requests for information are ambiguous; consequently, the firm provides documents that are
not relevant to the inspection.
b. The inspector’s requests contain jargon unfamiliar to the firm causing confusion in the facility personnel
responses to inspector.
c. The inspector is confrontational.
d. The inspector asks pointed and directed questions in order to solicit a desired response.
e. The inspector is not a good listener and kept interrupting the facility personnel in their responses.

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Appendix 4.2a: Completing the Field Inspection Audit Form (continued)
2. Did the inspector explain findings clearly and adequately throughout the inspection?
Examples of a “needs improvement” rating
a. The inspector does not discuss a significant deficiency observed in the shelled corn storage or conveyor
system before proceeding to the hammer mill area although the general manager was present at the time.
b. At the conclusion of the inspection, the inspector’s discussion of the deficiencies is vague; therefore,
management is unclear of the significance of the observations and that corrective action should be taken by
the firm.
c. At the conclusion of the inspection, the inspector does not discuss a significant deficiency observed during the
inspection.
3. Did the inspector alert the feed facility’s owner, operator, or agent in charge when an immediate corrective
action was necessary?
Examples of a “needs improvement” rating
a. The inspector fails to advise the firm manager that ruminant feed products containing prohibited material are
being packaged and shipped.
b. The inspector fails to notify the firm manager that he witnessed direct contamination of bagged feed
ingredients with used motor oil.
c. After witnessing direct product contamination with a toxic chemical, the inspector immediately notifies an
employee who was not the most responsible person in the feed facility.
4. Did the inspector 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?
Examples of a “needs improvement” rating
a. The inspector fails to list significant inspectional observations.
b. An inspectional observation states, “Firm did not control hazards,” but no further explanation is provided.
c. The report is illegible or contains several spelling and grammatical errors.
d. Inspector does not leave a summary of inspectional observations with the firm’s owner, operator, or agent in
charge.
5. Did the inspector answer questions and provide information as appropriate?
Examples of a “needs improvement” rating
a. The inspector reveals specific information about a pending compliance action against a competitor.
b. The inspector provides a competitor’s formulation to the facility manager.
c. The inspector falsely answers a policy question that leads the firm to take an inappropriate corrective action.

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Appendix 4.3: Field Inspection Audit Worksheet
State Program:

Reviewed By:

Performance Period:
Cumulative Score
(5):

Date:

Auditor Initials and Date of Audit (1)
Initials

At
(3)

Date

Performance
Factors (2)
I.1
I.2
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
II.10
II.11
II.12
II.13
II.14
III.1
III.2
III.3
III.4
III.5
Audit Score
(2)

Performance Ratings

Subtotal - Enter the sum of the totals from all continuation sheets.
Total (4) - Enter the final sums (subtotal + sums of (3) on this form).
(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

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NIt
(3)

Performance
Factor Score
(3)

Appendix 4.3: Field Inspection Audit Worksheet (continuation sheet)

State Program:

Reviewed By:
Auditor Initials and Date of Audit (1)

Initials

At
(3)

Date

Performance
Factors (2)
I.1
I.2
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
II.10
II.11
II.12
II.13
II.14
III.1
III.2
III.3
III.4
III.5
Audit Score
(2)

Performance Ratings

Subtotal - Enter the sum of the totals from all continuation sheets.
Total (4) - Enter the final sums (subtotal + sums of (3) on this form).
(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

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NIt
(3)

Performance
Factor Score
(3)

Appendix 4.4: Instructions for Completing Audit Worksheets
The four audit worksheets allow the State PROGRAM to recognize trends and identify specific areas in the inspection and
sample collection programs that may need improvement.
Worksheets found in appendices 4.3, 4.6, 4.8, and 4.10 are used to calculate performance factor scores and a cumulative
score for a twelve month performance period. A performance factor score or cumulative score below eighty percent
indicates the need for improvement and requires corrective action.
Instructions: The numbers listed in parentheses on each of the worksheets correspond to the numbered instructions below
(e.g. Auditor Initials and Date of Audit (1) on the worksheet is number 1. below).
1. For each audit, record the auditor’s initials and date of audit.
2. For each audit, record the rating for each performance factor (A = Acceptable; NI = Needs Improvement) as well
as the audit score.
3. Count the number of A and NI for each performance factor (row), and record the total number of acceptable and
needs improvements ratings, as well as calculate the performance factor score.
At = Total Number of Acceptable Ratings
NIt = Total Number of Needs Improvement Ratings
Performance Factor Score = [At / (At + NIt)] x 100
4. Sum the Total Number of Acceptable and Total Number of Needs Improvement ratings for all audits.
∑ At = Sum of Total Number of Acceptable Ratings
∑ NIt = Sum of Total Number of Needs Improvement Ratings
Note: ∑ is the statistical symbol for the sum of all numbers
5. Calculate the cumulative score for all audits. Record the cumulative score in the space provided in the box located
at the top of the Worksheet.
Cumulative Score = [ ∑ At / ( ∑ At + ∑ NIt )] x 100
6. Identify and make notes about trends and single performance factors rated as Needs Improvement in multiple
audits.

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Appendix 4.5: Field Inspection Report Audit Form
Field Inspection Report Audit
Date of Audit:
Date of Inspection:

Auditor:

Type of Inspection:
BSE
GMP
Complaint
Other:

Firm Name:
Firm Address:
Total Number of:

Acceptable
Needs Improvement

Audit Rating:

Tissue Residue

Acceptable
Needs Improvement

Audit Score:
Instructions to the Auditor:
All performance factors must be rated ‘Acceptable’ or ‘Needs Improvement’. The total number of ‘Acceptable’ and
‘Needs Improvement’, as well as the audit score and audit rating, must be recorded in the space above.
To calculate the audit score: Audit Score = [# Acceptable/(# Acceptable + # Needs Improvement)] x 100.
If the audit score is below eighty percent, the audit rating must be marked as ‘Needs Improvement’.
I.
Organization of the Report
1. Format of the inspection report followed the State program’s current policies and procedures.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

2. Required fields on inspection report or related report forms are completed.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

3. Written observations were clear and concise.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

4. Submitted report within timeframes.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

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Appendix 4.5: Field Inspection Report Audit Form (continued)
II.
Record of Findings
1. Recorded name and title of facility managers and key personnel.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

2. Recorded name and title of personnel interviewed during the inspection.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

3. Recorded findings not in compliance with laws and regulations.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

4. Recorded significant findings (if any).
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

5. Recorded the collection of all samples, exhibits, photographs, or photocopies to support findings.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

6. Recorded any refusals encountered during the inspection.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

III.
Communication with Facility Personnel
1. Provided a summary of findings.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

2. Recorded responses, replies, or corrective action commitments.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

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Appendix 4.5: Field Inspection Report Audit Form (continued)
IV.
General Comments
Enter any general comments or recommendations as a result of this audit.

Name of Auditor

Animal Feed Regulatory Program Standards

Signature of Auditor

78

Date

Appendix 4.6: Field Inspection Report Audit Worksheet
State Program:

Reviewed By:

Performance Period:
Cumulative Score
(5):

Date:

Auditor Initials and Date of Audit (1)
Initials

At
(3)

Date

Performance
Factors (2)
I.1
I.2
I.3
I.4
II.1
II.2
II.3
II.4
II.5
II.6
III.1
III.2
Audit Score
(2)

Performance Ratings

Subtotal - Enter the sum of the totals from all continuation sheets.
Total (4) - Enter the final sums (subtotal + sums of (3) on this form).
(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

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NIt
(3)

Performance
Factor Score
(3)

Appendix 4.6: Field Inspection Report Audit Worksheet (continuation sheet)

State Program:

Reviewed By:
Auditor Initials and Date of Audit (1)

Initials

At
(3)

Date

Performance
Factors (2)
I.1
I.2
I.3
I.4
II.1
II.2
II.3
II.4
II.5
II.6
III.1
III.2
Audit Score
(2)

Performance Ratings

Subtotal - Enter the sum of the totals from all continuation sheets.
Total (4) - Enter the final sums (subtotal + sums of (3) on this form).
(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

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NIt
(3)

Performance
Factor Score
(3)

Appendix 4.7: Sample Collection Audit Form
Sample Collection Audit
Auditor:
Date of Audit:

Inspector:

Type of Sample Collection:
Surveillance
Compliance

Firm Name:
Firm Address:

Total Number of:

Investigational
Other:
Acceptable
Needs Improvement

Audit Rating:

Regulatory
Acceptable
Needs Improvement

Audit Score:
Instructions to the Auditor:
All performance factors must be rated ‘Acceptable’ or ‘Needs Improvement’. The total number of ‘Acceptable’ and
‘Needs Improvement’, as well as the audit score and audit rating, must be recorded in the space above.
To calculate the audit score: Audit Score = [# Acceptable/(# Acceptable + # Needs Improvement)] x 100.
If the audit score is below eighty percent, the audit rating must be marked as ‘Needs Improvement’.
I.
Sample Collection Observations and Performance
1. Did the inspector follow safety precautions on the feed label?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

2. Did the inspector follow the State program’s safety protocol for collecting samples?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

3. Did the inspector use the appropriate method and equipment to collect the sample?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

4. Did the inspector seal the sample to initiate chain of custody?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

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Appendix 4.7: Sample Collection Audit Form (continued)
5. Did the inspector maintain and document sample integrity, security, and chain of custody?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

6. Did the inspector issue a receipt for sample(s)?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

7. Were the samples handled, packaged, and shipped using procedures appropriate to prevent compromising the
condition of the sample?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

8. Was the sample delivered or shipped to the appropriate laboratory within acceptable timeframes?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

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

Name of Auditor

Animal Feed Regulatory Program Standards

Signature of Auditor

82

Date

Appendix 4.7a: Completing the Sample Collection Audit Form
For each performance factor, examples of actions and observations that would likely result in a “needs improvement”
rating are provided.
Sample Collection Observations and Performance
1. Did the inspector follow safety precautions on the feed label?
Examples of a “needs improvement” rating
a. The inspector does not review all labeling that accompanies the feed prior to sampling.
b. The inspector does not have a label available prior to sampling.
c. The inspector does not review the whole container or back of label.
d. The inspector is not knowledgeable about the nature and use of the product they are sampling.
2. Did the inspector follow the State program’s safety protocol for collecting samples?
Examples of a “needs improvement” rating
a. The inspector does not have a copy or have electronic access to the State PROGRAM’S safety protocol.
b. Inspector does not have proper personal protective equipment that may be needed.
c. The inspector takes bulk samples out of a bulk vehicle and does not use appropriate fall protection equipment.
3. Did the inspector use the appropriate method and equipment to collect the sample?
Example of a “needs improvement” rating
a. Inspector simply hand grabs three or four handfuls out of the top of one bag.
b. Inspector collects a sample of a Type A medicated article and then collects a complete feed for a different
species without cleaning sampling equipment in between samples to prevent cross-contamination.
c. Inspector pours half of his collected sample into the firm’s container because the firm requested they have a
portion of his sample.
d. Inspector collects ten probes from ten fifty pound bags but does not seal the probe holes or left the product in
an unsalable condition.
e. The inspector does not have a copy or have electronic access to the State PROGRAM’S sampling procedures.
f.

The inspector collects ten probes for a lot of feed. Eight of the sample cores are white in color and two are
green. The inspector does not note this on the sample collection form or investigate it further.

g. A sample is to be tested for microbial activity, but the inspector does not follow proper aseptic protocols.
h. Inspector calls ahead to the facility and requests they have samples collected by the facility’s personnel and
ready for pickup.
4. Did the inspector seal the sample to initiate chain of custody?
Example of a “needs improvement” rating
a. The inspector collects three samples in the facility but does not document and seal the open samples until
returning to his car.
b. The inspector seals the container in such a manner whereby it can be opened without breaking the official
custody seal.

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Appendix 4.7a: Completing the Sample Collection Audit Form (continued)
5. Did the inspector maintain and document sample integrity, security, and chain of custody?
Example of a “needs improvement” rating
a. The inspector does not complete the required information (e.g. lot identification number, date of collection, or
guarantees) on the sample collection report.
b. The inspector collects a sample of feed and seals the sample with the wrong official custody seal.
c. High fat samples are placed in containers where the fat may leach into the container (e.g. paper bags).
d. The label on a sampled feed says to store in a cool dry place, but during a period of high temperature, the
collected sample is left in a car trunk for several days prior to shipment to the laboratory.
6. Did the inspector issue a receipt for sample(s)?
Examples of a “needs improvement” rating
a. The inspector collects a sample and does not issue a receipt describing the sample to the owner, operator, or
agent in charge.
b. The inspector tells the owner he would mail him the receipt later in the week.
7. Were the samples handled, packaged, and shipped using procedures appropriate to prevent compromising the
condition of the sample?
Examples of a “needs improvement” rating
a. The feed samples are packaged along with other substances (e.g. pesticides or fertilizers) that might
contaminate the sample during shipment.
b. The samples are not packaged to prevent breakage, spillage, crushing, or other detrimental actions that may be
encountered in shipping the samples.
8. Was the sample delivered or shipped to the appropriate laboratory within acceptable timeframes?
Examples of a “needs improvement” rating

a. The samples are not shipped or delivered according to the State PROGRAM’S protocols.
b. A feed sample containing urea is shipped to the fertilizer laboratory instead of the feed laboratory.
c. A sample of corn, intended to be tested for aflatoxin contamination, is delivered to the State’s seed testing
laboratory instead of the proper feed laboratory.

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Appendix 4.8: Sample Collection Audit Worksheet
State Program:

Reviewed By:

Performance Period:
Cumulative Score
(5):

Date:

Auditor Initials and Date of Audit (1)
Initials

At
(3)

Date

Performance
Factors (2)
I.1
I.2
I.3
I.4
I.5
I.6
I.7
I.8
Audit Score
(2)

Performance Ratings

Subtotal - Enter the sum of the totals from all continuation sheets.
Total (4) - Enter the final sums (subtotal + sums of (3) on this form).
(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

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85

NIt
(3)

Performance
Factor Score
(3)

Appendix 4.8: Sample Collection Audit Worksheet (continuation sheet)
State Program:

Reviewed By:
Auditor Initials and Date of Audit (1)

Initials

At
(3)

Date

Performance
Factors (2)
I.1
I.2
I.3
I.4
I.5
I.6
I.7
I.8
Audit Score
(2)

Performance Ratings

Subtotal - Enter the sum of the totals from all continuation sheets.
Total (4) - Enter the final sums (subtotal + sums of (3) on this form).
(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

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NIt
(3)

Performance
Factor Score
(3)

Appendix 4.9: Sample Collection Report Audit Form
Sample Collection Report Audit
Date of Audit:
Date of Sample Collection:

Auditor:

Type of Sample Collection:
Surveillance
Compliance
Investigational
Regulatory
Other:

Firm Name:
Firm Address:

Number of:

Acceptable
Needs Improvement

Audit Rating:

Acceptable
Needs Improvement

Audit Score:
Instructions to the Auditor:
All performance factors must be rated ‘Acceptable’ or ‘Needs Improvement’. The total number of ‘Acceptable’ and
‘Needs Improvement’, as well as the audit score and audit rating, must be recorded in the space above.
To calculate the audit score: Audit Score = [# Acceptable/(# Acceptable + # Needs Improvement)] x 100.
If the audit score is below eighty percent, the audit rating must be marked as ‘Needs Improvement’.
I.
Organization of the Report
1. Date of sample collection was recorded.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

2. Product identification including name and lot code or any other referencing manufacture information was recorded.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

3. Description of product was recorded.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

4. Collection information including method of collection, lot sampled, lot size, and any special techniques used to
collect sample was recorded.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

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Appendix 4.9: Sample Collection Report Audit Form (continued)
5. Location where sample was collected was recorded.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

6. Name and address of responsible party, guarantor, possessor, or distributor were recorded.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

7. Sample type (surveillance, compliance, investigational, regulatory, or other) was recorded.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

8. Analysis requested was recorded, if applicable.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

9. Product labels, including customer-formula feed labels, are collected or reproduced.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

10. Receiving and distribution information was recorded.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

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

Name of Auditor

Animal Feed Regulatory Program Standards

Signature of Auditor

88

Date

Appendix 4.10: Sample Collection Report Audit Worksheet
State Program:

Reviewed By:

Performance Period:
Cumulative Score
(5):

Date:

Auditor Initials and Date of Audit (1)
Initials

At
(3)

Date

Performance
Factors (2)
I.1
I.2
I.3
I.4
I.5
I.6
I.7
I.8
I.9
I.10
Audit Score
(2)

Performance Ratings

Subtotal - Enter the sum of the totals from all continuation sheets.
Total (4) - Enter the final sums (subtotal + sums of (3) on this form).
(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

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89

NIt
(3)

Performance
Factor Score
(3)

Appendix 4.10: Sample Collection Report Audit Worksheet (continuation sheet)

State Program:

Reviewed By:
Auditor Initials and Date of Audit (1)

Initials

At
(3)

Date

Performance
Factors (2)
I.1
I.2
I.3
I.4
I.5
I.6
I.7
I.8
I.9
I.10
Audit Score
(2)

Performance Ratings

Subtotal - Enter the sum of the totals from all continuation sheets.
Total (4) - Enter the final sums (subtotal + sums of (3) on this form).
(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits.

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90

NIt
(3)

Performance
Factor Score
(3)

Appendix 4.11: Corrective Action Plan
Type of Audit:

Field Inspection Audit

Sample Collection Audit

Field Inspection Report Audit

Sample Collection Report Audit

Instructions: The corrective action for each deficiency, whether an individual or cumulative factor below 80 percent reported during an audit will be described in
the table below. The corrective action plan should be maintained with the originating audit documents.
Performance Factor
(record number from
audit form)

Description of Deficiency

Corrective Action(s)

Verification that Corrective Action
Implemented

Completed By:
Name

Animal Feed Regulatory Program Standards

Date

91

Appendix 5.1: Self-Assessment Worksheet
Instructions: The State PROGRAM identifies if they have a specified component then evaluate if it includes the associated
components. If the State PROGRAM has the main component and associated components check ‘Yes’, if not, check ’No’.
Yes

No

The State PROGRAM has written procedures to gather information to identify incidents of feed-related
illnesses, deaths, and EMERGENCIES.
Notes:

Yes

No

The State PROGRAM has written procedures to communicate with the appropriate State agencies or
departments that investigate animal illnesses and food-related illnesses and outbreak.
Notes:

Yes

No

For feed-related illnesses, deaths, and EMERGENCIES, the State PROGRAM has a written procedure with
criteria to:
Yes No

Determine the appropriate response
Initiate the response
Complete the response
Notes:

Yes

No

For feed-related EMERGENCIES, the State PROGRAM manages the event using:
Yes No

A formalized Incident Command System structure or
An official action plan that includes:
Outlining containment
Communication
Control
Correction
After-action protocols
Notes:

Yes

No

The State PROGRAM maintains a list of relevant agencies and emergency contacts.
Notes:

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Appendix 5.1: Self-Assessment Worksheet (continued)
Yes

No

The State PROGRAM establishes written procedures to rapidly notify government agencies, departments, or
appropriate parties of relevant findings.
Notes:

Yes

No

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.
Notes:

Yes

No

The State PROGRAM has a written procedure for:
Yes No

Releasing information to the public;
Coordinating media information with other jurisdictions to reduce the impact of feed-related
illnesses, deaths, or EMERGENCIES.
Notes:

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards

Date

93

Appendix 5.2: Emergency Contact List
This template may be used to develop an emergency contact list. The content, design, and frequency of update are determined by the State PROGRAM.
Agency
Supervisor
Laboratory
Office of General Counsel
Office of the Director or Administration
Office of Legislative Affairs
Office of Public Information

Department of Homeland Security
Food and Drug Administration
Department of Health and Human Services
Center for Disease Control and Prevention
Environmental Protection Agency
U.S. Department of Agriculture
Energy Department
Department of Defense
National Security Administration

Animal Feed Regulatory Program Standards

Contact Name

Phone Number
Intra-Agency
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
Federal Government
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)

94

Email

Appendix 5.2: Emergency Contact List (continued)
Agency
Federal Bureau of Investigation
Trade Commission
Health Department
Customs Service
Justice Department
Veterinary Medical Diagnostic Lab
Department of Conservation, Natural
Resources, or Environmental Protection
Agency
Department of Agriculture, Plant Board, or
Forestry

Contact Name

Phone Number
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
State/Provincial/Local Government Offices
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)

Board of Pharmacy
State Chemist
Department of Public Safety
Department of Public Health Human Services,
Social Services
State Veterinarian, Animal Health, Livestock
Commission
Attorney General
Department of Commerce

Animal Feed Regulatory Program Standards

95

Email

Appendix 5.2: Emergency Contact List (continued)
Agency

Contact Name

Phone Number
(w)
(c)
(w)
(c)
(w)
(c)

Department of Wildlife and Fisheries
Department of Marine Resources
Department of Professional
Regulation/Inspection
Veterinary Medical Diagnostic Laboratory
Land Grant University/Extension Service
Police, Sheriff, Constable
Fire Department
Hospital (local or regional)
Utilities: Gas, Electric, Water, Sewage
Producer Associations (ex: cattle feeders, pork
producers, poultry producers)

(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
Industry Organizations
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)

National Grain and Feed Associations
American Feed Industry Association
Pet Food Institute
Feed Advisory Committee (Board) Members
Equipment Suppliers Association

Animal Feed Regulatory Program Standards

96

Email

Appendix 5.2: Emergency Contact List (continued)
Agency
Forensics Laboratory
Poison Control Center
Toxicology
Pathology
Universities/University “Centers”
Federal, State, and Local Emergency
Management Agencies

Contact Name
Phone Number
Additional Assistance
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)
(w)
(c)

Email

Completed By:
Name

Animal Feed Regulatory Program Standards

Date

97

Appendix 6.1: Self-Assessment Worksheet
Instructions: The State PROGRAM identifies if they have a specified component then evaluate if it includes the associated components.
If the State PROGRAM has the main component and associated components check ‘Yes’, if not, check ‘No’.
Yes

No
The State PROGRAM has an enforcement program that contains documented ENFORCEMENT STRATEGIES.
Notes:

Yes

No
The State PROGRAM must use the following six factors listed when selecting an appropriate enforcement tool.
Mark “Yes” or “No” in the columns below whether each factor was used for selecting enforcement tools and has
a written description, documented relative condition(s), and a numerical weight assigned for each relative
condition.
Factor
Factor Used
Factor Description
Relative Conditions
Numerical Weight
Compliance history
Responsiveness
Scope
Nature of Violation
Impact of Violation
Resources
Notes:

Yes

No
The State PROGRAM has documented enforcement matrix.
Notes:

Yes

No
The State PROGRAM has documented process for conducting an annual evaluation of ENFORCEMENT STRATEGIES.
Notes:

Yes

No
The State PROGRAM conducts an annual evaluation of its ENFORCEMENT STRATEGIES to:
Yes
No
Determine if the PROGRAM’S ENFORCEMENT STRATEGIES were successful in achieving
Compliance;
Identify potential improvements or modifications of the ENFORCEMENT STRATEGIES, if
any;
Determine if the enforcement priorities remain the same or require modification.
Notes:

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards

Date

98

Appendix 6.2: Enforcement Tools
This appendix is a list of common enforcement tools that may be used by State PROGRAMS. An explanation of each tool
has been provided.
Advisory or informational letter – can be used as a form for both compliance assistance and education and would
usually apply to non-repetitive violations of no risk to health, safety, or the environment. Administrative violations
involving licensing, product registration, and payment of fees are examples.
Warning letters with or without a required response – usually used to clearly outline the violation and require
corrective action(s). The letter might or might not request a written response upon correction. This tool would be
appropriate for violations that have or could present risk to health, safety, or the environment. Further, it could be
appropriate for repetitive administrative violations.
Withdrawal from distribution orders – used when health, safety, or the environment would be put at risk from
distribution of a feed. It might also be used when other tools have failed to achieve compliance for serious administrative
violations or gross labeling violations.
Informal hearings or meetings – used to provide an opportunity to bring together parties to discuss and understand the
nature of a violation. It may lead to an agreed order or consent decree. Use of this tool would be appropriate for many
violations including those that may be chronic; threats to health, safety or the environment; civil penalties, license denials,
revocation, or other serious administrative actions. This tool may be used in conjunction with others to facilitate
compliance.
Mediation – meeting of all parties that produces a consent decree or compliance agreement.
Civil penalty – monetary penalty assessed for a violation. Civil penalty fines are based on a numeric point matrix
determined by the severity of the violation and the repeat nature of the offense. A notice shall be given and an
opportunity for an administrative (formal) hearing must be provided. This tool should be used in addition to other tools to
prevent chronic violations or to address illegal acts when other tools are not available. Where appropriate, an
informational letter, warning letter, informal hearing or meeting, or administrative hearing should precede the use of civil
penalties.
Cancellation, probation, or conditional status – actions that can be taken against a license, permit, or registration due to
repeat violations, including reporting of distributions, payment of fees, or chronic analytical deficiencies.
Administrative hearing – opportunity for an administrative (formal) hearing is provided to the regulated establishment
prior to the issuance of a civil penalty, license denial, or license revocation. An administrative hearing may result in a
consent decree with the regulated establishment. This tool should be used in chronic violations or when threats to health
or safety exist.
Condemnation and confiscation – may be applied to any lot of non-compliant feed and may involve a court in the local
area. A feed found violative by the court may be subject to condemnation and disposition after first allowing the claimant
or manufacturer an opportunity to seek release of the feed or request opportunity to reprocess or re-label the feed for
compliance. This tool would be appropriate for use when a practice or product presents a risk to health, safety, or the
environment. It may also be applicable in other cases such as chronic violations.
Injunction – may be used to restrain a firm from any or all violations. The tool would be used in case of a serious threat
of immediate or irreparable harm. Use may also be appropriate to restrain a firm from operation in wanton violation of a
chronic nature involving administrative aspects of the law.
Criminal prosecution – may be pursued against a firm or person that impedes, obstructs, hinders, or otherwise prevents
or attempts to prevent enforcement of commercial feed regulation. This tool can be used for any violation, but other tools
may be appropriate.

Animal Feed Regulatory Program Standards

99

Appendix 6.3: Factors, Descriptions, and Numerical Weights for Consideration When Selecting an
Enforcement Tool
The following six factors must be used by the State PROGRAM to develop an enforcement matrix: compliance history,
responsiveness, scope, nature of the violation, impact of the violation, and resources.
Below are example descriptions of these six factors, including numerical weights9 and assigned relative conditions. The
descriptors, numerical weights, and relative conditions listed below are examples. The State PROGRAM may consider
these examples when developing the descriptors, numerical weight, and relative conditions that will be utilized by the
State PROGRAM for the six factors that must be included in an enforcement matrix. The State PROGRAM may consider
additional factors.
The sum of the numerical values for all of the factors can be used to help select the appropriate enforcement tool from an
enforcement matrix (see appendix 6.4 for an example).
Factor 1 – Compliance History
The compliance history of the firm or individual can be indicative of their commitment to assuring they are operating in
compliance. Compliance history can include inspections, sample analysis, label reviews, and previous enforcement
actions. It should include consideration of whether corrections were promised and completed, whether corrections were
made promptly, and whether the same or similar problems occur repeatedly. The following relative weights can be used
in assessing the firm’s compliance history:
(0)
firm has extensive history and is always found in compliance
(1)
no history on file for this firm
(2)
firm’s history shows only minor violations, always corrected
(3)
firm’s history shows instances of significant violations or repeated minor violations
(4)
firm’s history shows instances of significant violations and promised corrections are rarely made
Factor 2 – Responsiveness
The responsiveness of the firm or individual can also be used to help assess their commitment to assuring they are
operating in compliance and the level of enforcement action needed to encourage commitment. Does the firm promise
correction and follow through? Are they aware of laws, regulations, and requirements for their operation? Do they have
quality assurance or training programs? Do they accept responsibility for problems that are uncovered? Are corrections
made promptly? Do they make corrections while an inspector is there but do not maintain the correction? When
appropriate, do they examine similar systems and/or products to make overall correction? The following relative weights
can be used in assessing the responsiveness of the firm:
(0)
accept responsibility for assuring compliance; aware of the requirements or have quality assurance or
training programs; corrections are promised and made promptly; when appropriate, extend corrections to
similar products or systems
(1)
accept responsibility for assuring compliance; aware of the requirements; corrections promised but not
made in a timely manner or corrections are not sustained
(2)
do not accept responsibility for assuring compliance; not aware of the requirements; no promise of
correction; no correction
Factor 3 – Scope
Scope of the firm’s business as well as the scope of the violation can be an important factor in choosing an appropriate
enforcement action. Is the distribution of violative products limited to local distribution, multiple counties, Statewide,
multiple States, nationwide, or worldwide? What is the quantity of violative product involved? How many animals are
affected? Are the violative products intended for a limited or unique population, or are they for a broader population?
Does the violation involve a single product or multiple products? Is the violation specific to a single lot? Is the violation
a process violation? Is this an industry practice? The following relative weights can be used in assessing the scope of the
violation:

9

Source of the factors, descriptions, and numerical weights is the AAFCO Enforcement Guidelines-Factor Application section of the
AAFCO.
Animal Feed Regulatory Program Standards

100

Appendix 6.3: Factors, Descriptions, and Numerical Weights for Consideration When Selecting an
Enforcement Tool (continued)
(1)
(2)

(3)

very limited distribution, quantity, or limited purchaser; violation is limited to a single lot
distribution is limited to Statewide or bordering States; violation is limited to one or two products;
quantity of product distributed is relatively small or the number of animals effected is relatively small;
non critical process violation
distribution is unlimited and may involve large quantities of product or affect a large number of animals;
violation involves critical processes or multiple products

Factor 4 – Nature of the Violation
The nature of the violation has an impact on the type of enforcement action and may influence whether the action focuses
on the product, process, or individual. Consider whether the violations are minor or significant; whether they are sporadic
or continuous; whether they involve only record keeping or control issues or they include product defects or
contaminations; whether they are the result of human error; whether they were the result of lack of knowledge and
understanding of the firm or individual’s responsibility or the legal requirements; or whether the violations were done
knowingly or deliberately. When determining whether the violation is significant or not as significant, or whether it
would be a major or minor violation, available and current science and policy should be considered. The following
relative weights can be used in assessing the nature of the violation:
(1)
minor labeling violations or minor sporadic record keeping violations
(2)
violations are not minor but they are isolated incidents, the result of human error, or the result of lack of
knowledge about requirements
(4)
significant GMP or labeling violations; contaminations; fraud
(8)
deliberate, knowing violations that result in hazard to public health
Factor 5 – Impact of the Violation
Selecting the most appropriate enforcement tool is strongly tied to the impact the violation has on the user of the product
(economic impact or fraud), the safety of the animal, and human health safety. The State PROGRAM should consider
whether the violations affect food producing or non-food producing animals. Are the violations economic or fraudulent in
nature? Do the violations compromise animal safety? Do the violations pose a risk to human health safety? Is there a
particular population at risk such as children, immuno-compromised, or the elderly? The following relative weights can
be used in assessing the impact of the violation:
(1)
minor economic or fraud violations
(4)
animal safety concerns
(8)
human health safety concern but limited population
(10) human health safety concern with a risk to all populations
Factor 6 - Resources
Consider what resources the State PROGRAM has to devote to the violative findings. Has the State PROGRAM established
overall compliance goals and objectives? Are the State PROGRAM’S enforcement efforts prioritized? Are the resources
devoted in part to special initiatives? Has the State PROGRAM established communication networks to determine if the
violations have been encountered elsewhere? Are there other agencies that may be able to pursue action consistent with
the State PROGRAM’S compliance goals? The following relative weights can be used in assessing the impact of the
violation:
(1)
no resources are available
(2)
limited resources are available
(3)
ample resources are available

Animal Feed Regulatory Program Standards

101

Appendix 6.4: Enforcement Matrix
Instructions: This is an example that can be used to develop the State PROGRAM’S enforcement matrix. The enforcement
matrix should be designed to incorporate the relative conditions of each factor (with a minimum of the six factors listed in
Standard 6: Enforcement Program) identified by the State PROGRAM. The enforcement matrix can be used to aid the State
PROGRAM in determining which enforcement tool to apply. The content, design, and frequency of update are determined
by the State PROGRAM.
Directions for Use of the Enforcement Matrix:
1. Determine the violation categories. The Example Enforcement Matrix on page 103 provides five examples of major
violation categories: labeling, GMPs, sample results, contaminations, and administrative.
2. For each violation category, identify the enforcement tools that are appropriate for the violation category and the
factor value range from minor to major. Examples of enforcement tools for each violation category from minor
violations (factor value range 4 to 8) to major violations (factor value range 20 to 29) are provided in the Example
Enforcement Matrix.
3. Calculate the sum of the numerical values assigned to each factor. See below for an example calculation:
Factor
1. Compliance History
2. Responsiveness
3. Scope
4. Nature of the Violation
5. Impact of the Violation
6. Resources

Relative Condition Noted
Firm’s history shows only minor violations, always corrected (2)
Accept responsibility for assurance compliance (0)
Distribution is limited to Statewide and/or border states (2)
Minor labeling violations (1)
Minor economic or fraud violations (1)
Limited resources are available (2)
Sum of Numerical Values for Each Factor =

Numerical Value
2
0
2
1
1
2
8

4. Locate the “Factor Value Range” that corresponds with the calculated sum of the numerical value for all factors. The
matrix can be modified to different amounts of factor value ranges and values within each factor range. Using the
example calculation in item 3, the sum of the numerical values is 8. The available enforcement tools for factor value
range from 4 to 8 are “no action” and “information letter.” The State could choose between these two enforcement
tools for the violations reported.
5. Choose the appropriate enforcement tool for the violation category based on the factor value range.

Animal Feed Regulatory Program Standards

102

Appendix 6.4: Enforcement Matrix (continued)
Example Enforcement Matrix 10
Violation
Category

Factor Value Range
4 to 8

No Action

Labeling

Information Letter

No Action

GMPs

Information Letter

No Action

Sample Results

Information Letter

No Action

Contaminations

Information Letter

No Action

Administrative

Information Letter

9 to 12

13 to 19

20 to 29

Condemnation/Seizure

Prosecution

Warning Letter

Informal Hearing/Meeting

Formal Hearing

Stop Sale

Injunction

Injunction

Informal Hearing/Mediation

Refer to Other Agency

Refer to Other Agency

Civil Penalty

Civil Penalty

Condemnation/Seizure

Prosecution

Warning Letter

Informal Hearing/Meeting

Formal Hearing

Stop Sale

Injunction

Injunction

Informal Hearing/Mediation

Refer to Other Agency

Refer to Other Agency

Civil Penalty

Civil Penalty

Condemnation/Seizure

Prosecution

Warning Letter

Informal Hearing/Meeting

Formal Hearing

Stop Sale

Injunction

Injunction

Informal Hearing/Mediation

Refer to Other Agency

Refer to Other Agency

Civil Penalty

Civil Penalty

Condemnation/Seizure

Prosecution

Warning Letter

Informal Hearing/Meeting

Formal Hearing

Stop Sale

Injunction

Injunction

Informal Hearing/Mediation

Refer to Other Agency

Refer to Other Agency

Civil Penalty

Civil Penalty

Condemnation/Seizure

Prosecution

Warning Letter

Informal Hearing/Meeting

Formal Hearing

Stop Sale

Injunction

Injunction

Informal Hearing/Mediation

Refer to Other Agency

Refer to Other Agency

Civil Penalty

Civil Penalty

10

The example enforcement matrix was derived from the Example Violation Chart found in the AAFCO Enforcement GuidelinesFactor Application section of the AAFCO Official Publication.
Animal Feed Regulatory Program Standards

103

Appendix 7.1: Self-Assessment Worksheet
Instructions: The State PROGRAM identifies if they have a specified component then evaluate if it includes the associated
components. If the State PROGRAM has the main component and associated components check ‘Yes’, if not, check ‘No’.
Yes

No
The State PROGRAM has identified methods used for outreach activities to inform ANIMAL FEED
industry stakeholders, academia, other regulators, or consumers.
Notes:

Yes No
The State PROGRAM has an outreach plan:
Yes

No

The outreach plan includes:

Objectives of an outreach plan
Target populations
Types of outreach activities (including OUTREACH ACTIVITY EVENTS)
Notes:

Yes No
The State PROGRAM documents outreach activities:
Yes

No

Documentation includes:

Objectives of an outreach plan
Target populations
Types of outreach activities (including OUTREACH ACTIVITY EVENTS)
Notes:

Yes No
The State PROGRAM documents and evaluates OUTREACH ACTIVITY EVENTS.
Notes:

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards

Date

104

Appendix 7.2: Outreach Plan
Either of the templates below can be used to develop an outreach plan. The content, design, and frequency of update
should be determined by the State PROGRAM.
A. Outreach Plan in Chart Format
Effective Dates:
Objective

Target Population

Type of Outreach Activity

Delivery Method

Completed By:
Name

Date

B. Outreach Plan in Paragraph Format
Effective Dates:
Outreach Objective 1:
List and provide details of outreach activities that will be used to help support this objective, including the
audience that will be reached and the method of delivery.

Outreach Objective 2:
List and provide details of outreach activities that will be used to help support this objective, including the
audience that will be reached and the method of delivery.

Outreach Objective 3:
List and provide details of outreach activities that will be used to help support this objective, including the
audience that will be reached and the method of delivery.

Completed By:
Name

Animal Feed Regulatory Program Standards

Date

105

Appendix 7.3: OUTREACH ACTIVITY EVENT Overview and Evaluation
Instructions: Attach documents such as agendas, meeting summaries, and program evaluations to this form.

Section I. Overview of OUTREACH ACTIVITY EVENT
A. Type of OUTREACH ACTIVITY EVENT (select all that apply)
Meeting
Workshop
Extension Event

Task Force/Committee

Other:

B. Date of OUTREACH ACTIVITY EVENT:
C. Subject or name of OUTREACH ACTIVITY EVENT:
D. Objective of OUTREACH ACTIVITY EVENT:
E. Target population for OUTREACH ACTIVITY EVENT:

Section II. Evaluation of OUTREACH ACTIVITY EVENT
Program Elements

Yes/No

If no, please explain

A. The purpose and objectives were clearly defined
B. The context of the training activity was consistent
with the objectives

C. An evaluation was completed by attendees

D. State PROGRAM reviewed and discussed
comments from attendees

Describe what went well, what could be done better, and what more could be done to improve the OUTREACH
ACTIVITY EVENT.

Completed By:
Name

Animal Feed Regulatory Program Standards

Date

106

Appendix 8.1: Self-Assessment Worksheet
Instructions: The State PROGRAM identifies if they have a specified component then evaluate if it includes the associated
components. If the State PROGRAM has the main component and associated components check ‘Yes’, if not, check ‘No’.
Yes

No
The State PROGRAM has a documented workplan.
Yes

No

Workplan Details:

Inspection plan
Sample plan
Timeframe that the workplan is applicable
Notes:

Yes No
The State PROGRAM has a documented procedure for evaluating the workplan.
Yes

No

Procedure Details How:
PROGRAM
PROGRAM

conducts periodic and annual evaluations of the workplan;
evaluates alignment with PROGRAM objectives and resources.

Notes:

Yes No
The State PROGRAM has a documented procedure for identifying and reviewing its resources to accomplish
the workplan within the applicable timeframe.
Notes:

Yes No
To validate the workplan, the State PROGRAM must develop a formula that:
Yes

No

Calculates the number of staff needed to conduct inspections of its ANIMAL FEED inventory;
Calculates the number of staff needed to conduct sample collections;
Uses numerical values that are based on the State PROGRAM’S data;
Must be used by the State PROGRAM.
Notes:

Yes No
The inspection and sample collection staff must have the equipment needed to conduct inspections and
sample collections.
Notes:

Animal Feed Regulatory Program Standards

107

Appendix 8.1: Self-Assessment Worksheet (continued)

Yes No
A list of the equipment required for inspections and sample collections must be:
Yes

No

Established by the State PROGRAM
Maintained by the State PROGRAM
Notes:

Yes No
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:
Yes

No

Adequate staff
Equipment
Funding
Notes:

Yes No
A baseline resource review must be made concurrently with the baseline evaluation required for AFRPS
Standard 9 and recorded in appendix 8.4.
Date Completed:
Notes:

Yes No
Subsequent resource evaluations to determine the resources necessary for the State PROGRAM to partially
meet, fully meet, or maintain full IMPLEMENTATION of each standard’s requirements must be completed
within three years of the previous evaluation.
Notes:

Assessment Completed By:

Name

Animal Feed Regulatory Program Standards

Date

108

Appendix 8.2: Example Formula for Calculating the Number of Inspectors Required to Conduct
Inspections of Feed Facilities
This appendix is an example of how to calculate the number of field staff required to conduct inspections of feed facilities.
A State PROGRAM may use this example to develop a formula that is suitable for the PROGRAM’S needs and based on data
that can be verified by the PROGRAM. This formula is specific to calculating the number of inspectors needed to conduct
inspections of the establishment inventory according to the workplan and is not applicable to staff needs for other
PROGRAM areas including sample collection, response, laboratory services, or administration.
Calculating the Number of Inspectors:
1. The following data must be collected. Records must be maintained to verify the data used in the calculations.
•
•
•
•
•
•

Risk categorization of feed facilities (example categorization: high risk, medium risk, and low risk)
Number of feed facilities in each risk category
Percent of facilities to be inspected each year in each risk category (in percent)
Percent of facilities to be re-inspected each year in each risk category (in percent)
Average inspection time, including travel time, of feed facilities in each risk category (in hours)
Note: The following formulas do not account for sample collections. For State PROGRAMS that utilize
inspectors to collect samples, the State PROGRAM should consider adding additional time to the average
inspection time, if appropriate, to account for sample collection.

2. Calculate the available annual inspection time, in hours, per inspector (AIT)
The State PROGRAM should determine the average number of hours an inspector has available to conduct
inspections each year after accounting for annual leave, sick leave, holidays, training, and other State PROGRAM
activities.
3. Calculate the number of hours required to inspect feed facilities in each risk category
The example below utilizes three risk categories: high risk, medium risk, and low risk.
•

For High Risk Feed Facilities:

[(#HR x %HRF) + (#HR x %HRRF)] x HRaIT = hHRI per year
Key
#HR
%HRF
%HRRF
HRaIT
hHRI per year
•

Description
Number of High Risk Facilities
Percent of High Risk Facilities to be Inspected per Year (%)
Percent of High Risk Facilities to be Re-Inspected per Year (%)
High Risk Facility Average Inspection Time (h)
Total Hours of High Risk Inspections per Year

For Medium Risk Feed Facilities:

[(#MR x %MRF) + (#MR x %MRRF)] x MRaIT = hMRI per year
Key
#MR
%MRF
%MRRF
MRaIT
hMRI per year
•

Description
Number of Medium Risk Facilities
Percent of Medium Risk Facilities to be Inspected per Year (%)
Percent of Medium Risk Facilities to be Re-Inspected per Year (%)
Medium Risk Facility Average Inspection Time (h)
Total Hours of Medium Risk Inspections per Year (h)

For Low Risk Feed Facilities:

Animal Feed Regulatory Program Standards

109

Appendix 8.2: Example Formula for Calculating the Number of Inspectors Required to Conduct
Inspections of Feed Facilities (continued)

[(#LR x %LRF) + (#LR x %LRRF)] x LRaIT = hLRI per year
Key
#LR
%LRF
%LRRF
LRaIT
hLRI per year

Description
Number of Low Risk Facilities
Percent of Low Risk Facilities to be Inspected per Year (%)
Percent of Low Risk Facilities to be Re-Inspected per Year (%)
Low Risk Facility Average Inspection Time (h)
Total Hours of Low Risk Inspections per year (h)

4. Using the data calculated in 2 and 3, calculate the number of inspectors required to ensure coverage of
PROGRAM’S establishment inventory.
(hHRI per year + hMRI per year + hLRI per year) / AIT = Number of Inspectors Needed

Animal Feed Regulatory Program Standards

110

Appendix 8.3: Example List of Equipment Used for Inspections and Sample Collections
Standard 8 requires a State PROGRAM to develop a list of equipment needed to conduct inspections and sample
collections. The list provided below is an example equipment list for inspections and sample collections. A State
PROGRAM may add and remove equipment from the table in developing the PROGRAM’S list of equipment. After the State
PROGRAM finalizes its list, the State PROGRAM can use the chart below to record whether the equipment is assigned,
available to inspectors, or not available.
Equipment

Assigned

Alcohol swabs and wipes
Blacklight
Calculator
Camera
Cell phone
Clipboard
Computer and printer
Coolant (ice and freezer packs)
Credentials
Dust mask
Eye protection
Flashlight and holder
Hard hat
Hearing protection
Knife and scissors
Light meter
Official seals
Paper, pen, masking tape, and marker
Protective clothing (lab coat, gloves, and shoe covers)
Putty knife and scraper
Regulations, policies, and designated reference material
Required forms
Respirator
Safety shoes
Sampling devices (sieves, triers, scoops, or probes)
Sampling equipment (sterile containers, bags, or swabs)
Shipping containers
Test weights
Thermometer
Vehicle

Animal Feed Regulatory Program Standards

111

Available

Not Available

Appendix 8.4: Resources for IMPLEMENTATION of Animal Feed Regulatory Program Standards
This table provides an overview of a State PROGRAM’S evaluation of the resources needed to implement the Animal Feed Regulatory Program Standards. Based on
the evaluation, indicate for each standard whether the State PROGRAM has the resources needed for funding, staffing, and equipment by inserting ‘Yes’ or ‘No’ in
the corresponding block. If ‘No’, please explain. Resources not related to funding, staffing, and equipment needed for IMPLEMENTATION should be in the “Other
Resources Needed” column.
Standard
1

REGULATORY FOUNDATION

2

Training

3

Inspection Program

4

Auditing

5

Feed-Related Illnesses or Death
and Emergency Response

6

Compliance and Enforcement

7

Outreach Activities

8

Planning and Resources

9

Assessment and Improvement

10

Laboratory Services

11

Sampling Program

Animal Feed Regulatory Program Standards

Funding

Staffing

Equipment

112

Other resources needed

Appendix 9.1: Self-Assessment Worksheet
Instructions: The State PROGRAM identifies if they have a specified component then evaluate if it includes the associated
components. If the State PROGRAM has the main component and associated components check ‘Yes’, if not, check ’No’.
Yes

No

The State PROGRAM uses the self-assessment worksheets from each standard to complete a baseline
evaluation to:
Yes

No

Determine if a standard is fully met, partially met, or not met,
Identify areas or functions that need improving in order to fully meet the
requirements of each standard.
Notes:

Yes

No

The State PROGRAM develops an improvement plan for requirements of the standards that are not
fully met that includes:
Not
Applicable:

Check “Not Applicable” box to left if requirement is not applicable because all requirements of the standard are
fully met
Yes
No

Individual element or documentation requirement for the standard that was not
fully met;
Improvements needed to fully meet the program element or documentation
requirement(s) of the standard;
List of individual tasks that will be used to address the improvement;
Projected completion date for each task;
Completion date for each task.
Notes:

Yes

No

The State PROGRAM reviews and updates its improvement plan (appendix 9.2) annually.
Date Completed:
Notes:

Yes

No

The State PROGRAM completes an evaluation of IMPLEMENTATION status at least
every three years following the baseline evaluation that includes reviewing and updating:
Date Completed:
Yes
No

Self-assessment worksheets for each standard;
Required documentation for each standard;
Improvement plan (appendix 9.2);
IMPLEMENTATION status (appendix 9.3).
Notes:

Animal Feed Regulatory Program Standards

113

Appendix 9.1: Self-Assessment Worksheet (continued)
Yes

No

Appendix 9.3, or comparable form, is used to track IMPLEMENTATION status of all the standards.
Notes:

Yes

No

The State PROGRAM retains records under x.5 of each standard for the three previous years, or per the
State PROGRAM’S record retention policy.
Date Completed:
Notes:

Assessment Completed By:

Name

Animal Feed Regulatory Program Standards

Date

114

Appendix 9.2: Assessment and Improvement Plan
Instructions: This appendix, or a comparable form, is completed for each standard.
Standard Number and Title:
Date Self-Assessment Worksheet Completed:
Subject Matter Expert(s):
IMPLEMENTATION Status
Fully Met

Partially Met

Not Met

Instructions: For elements of the standard that are not fully met, the information listed below is completed.
Element(s) of Standard
Not Fully Met

Improvement(s) Needed to Meet
Element

Projected
Completion
Date for Task

Task(s) to Complete
Identified Improvement

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards

Date

115

Date Task
Completed

Appendix 9.3: IMPLEMENTATION Status of Animal Feed Regulatory Program Standards
This table provides an overview of a State PROGRAM’S evaluation of its IMPLEMENTATION of the Animal Feed Regulatory Program Standards. The self-assessment
worksheets and appendix 9.2: Assessment and Improvement Plan should be used to complete this appendix.
Standard

Self-Assessment
Complete
Incomplete

Date:

2. Training

Complete
Incomplete

Date:

3. Inspection Program

Complete
Incomplete

Date:

4. Auditing

Complete
Incomplete

Date:

Complete
Incomplete

Date:

Complete
Incomplete

Date:

7. Outreach Activities

Complete
Incomplete

Date:

8. Planning and
Resources

Complete
Incomplete

Date:

9. Assessment and
Improvement

Complete
Incomplete

Date:

10. Laboratory Services

Complete
Incomplete

Date:

11. Sampling Program

Complete
Incomplete

Date:

1. REGULATORY
FOUNDATION

5. Feed-Related
Illnesses or Death
and Emergency
Response
6. Enforcement
Program

IMPLEMENTATION Status
Fully Met

Partially Met

Not Met

Fully Met

Partially Met

Not Met

Fully Met

Partially Met

Not Met

Fully Met

Partially Met

Not Met

Fully Met

Partially Met

Not Met

Fully Met

Partially Met

Not Met

Fully Met

Partially Met

Not Met

Fully Met

Partially Met

Not Met

Fully Met

Partially Met

Not Met

Fully Met

Partially Met

Not Met

Fully Met

Partially Met

Not Met

Evaluation Completed By:
Name

Animal Feed Regulatory Program Standards

Date

116

Appendix 10: Self-Assessment Worksheet
Instructions: The State PROGRAM identifies if they have a specified documented procedure then evaluate the procedure to
determine if it includes the associated components. If the State PROGRAM has the procedure and associated components
check ‘Yes’, if not, check ‘No’.
Yes

No

The State PROGRAM has a list of routine and non-routine analytical services.
Notes:

Yes

No

The State PROGRAM has documented formal agreement with REGULATORY TESTING LABORATORY(IES)
managed outside the PROGRAM that conduct routine analytical services.
Notes:

Yes

No

The State PROGRAM prepares a sample analysis schedule based on a sampling plan in cooperation with
REGULATORY TESTING LABORATORY(IES) performing routine services to ensure compatibility with
laboratory capabilities and capacities.
Notes:

Yes

No

The State PROGRAM has a sample analysis schedule with each REGULATORY TESTING LABORATORY(IES)
performing routine services.
Yes

No

The sample analysis schedule includes:

Type(s) of ANIMAL FEED to be analyzed;
Number of samples to be collected;
Estimated timeframe for collection;
Type(s) of analysis to be performed.
Notes:

Yes

No

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:
Yes

No

Sample receipt
Preservation
Storage
Retention
Disposal
Chain of custody
Report of analysis
Method(s) used to communicate information between the State PROGRAM and REGULATORY
TESTING LABORATORY(IES)
Animal Feed Regulatory Program Standards

117

Appendix 10: Self-Assessment Worksheet (continued)
Notes:

Yes

No

The State PROGRAM utilizes REGULATORY TESTING LABORATORY(IES) that are accredited by a recognized
accreditation body to ISO/IEC 17025:2005, or implement and comply with the AAFCO Quality
Assurance/Quality Control guidelines, or implement and comply with the ISO/IEC 17025:2005.
Notes:

Assessment Completed By:

Name

Animal Feed Regulatory Program Standards

Date

118

Appendix 11: Self-Assessment Worksheet
Instructions: The State PROGRAM identifies if they have a specified documented procedure then evaluate the procedure to
determine if it includes the associated components. If the State PROGRAM has the procedure and associated components
check ‘Yes’, if not, check ‘No’.
Program Elements

Yes/No

Specific
Reference 11

Notes

Section I. Sampling Plan
a. The State PROGRAM has a documented annual
sampling plan.
b. The sampling plan is jointly developed and
amended by the State PROGRAM and
REGULATORY TESTING LABORATORY(IES)
performing routine services.
c. The sampling plan outlines the State PROGRAM’S:
• Sampling priorities
• Sample analysis schedule
• Availability or coordination of analytical
support
Section II. Sampling Procedure for Collecting, Storing and Transporting Samples
The State PROGRAM’S has a documented sampling procedure for collecting, storing, and transporting samples that
includes:
a. Following safety precautions on feed labels;
b. Following the State PROGRAM’S safety protocol
for collecting samples;
c. Using appropriate method and equipment to
collect the sample;
d. Sealing sample to initiate chain of custody;
e. Maintaining and documenting sample integrity,
security, and chain of custody;
f. Issuing receipt for sample;
g. Handling, packaging, and shipping sample using
procedures appropriate to prevent compromising
condition of sample;
h. Delivering or shipping sample to the appropriate
laboratory within acceptable timeframes.
Section III. Instructions for Sample Collection Report
The State PROGRAM provides instructions for the sample collection report, including:
a. Date of the sample collection;
b. Product identification including:
• Name
• Lot numbers or other codes referencing

manufacture identification
c. Description of product;
d. Method of collection and any special techniques
used to collect sample;
e. Lot sampled;

11

Reference the document (include section and page number) in which the program element is found.

Animal Feed Regulatory Program Standards

119

Appendix 11: Self-Assessment Worksheet (continued)
Program Elements

Yes/No

Specific
Reference

Notes

Instructions for Sampling Collection Report (continued)
f.

Lot size;

g. Location where sample was collected;
h. Name and address of responsible party, guarantor,
possessor, or distributor;
i. Sample type (surveillance, compliance,
investigational, regulatory, or other);
j. Analysis requested, if applicable;
k. Collection or reproduction of product labels,
including customer-formula feed labels;
l. Receiving and distribution information.
Assessment Completed By:
Name

Animal Feed Regulatory Program Standards

Date

120