State Feed Regulatory Programs in the United States

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

Table of Contents
Table of Contents

1

Background

4

Introduction
Standard 1
Regulatory Foundation
Standard 2
Training
Standard 3
Inspection Program
Standard 4
Auditing

5

Standard 5
Feed-Related Illness 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

Self-Assessment 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 4.2.1
Field Inspection Audit Form
Appendix 4.2.2
Completing the Field Inspection Audit Form
Appendix 4.3
Field Inspection Audit Worksheet

Animal Feed Regulatory Program Standards
June 2013

6
8
14
17
22
24
26
28
31
33
35
38
43
44
49
51
54
56
58
62
67

Page 1

Table of Contents
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 4.7.1

Sample Collection Audit Form
Appendix 4.7.2
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

69
70
73
75
77
79
81
83
85
86
87
91
92
93
96
98
99
100
101

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 AFRPS

Animal Feed Regulatory Program Standards
June 2013

103
105
106

Page 2

Table of Contents

Appendix 9.1

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

Animal Feed Regulatory Program Standards
June 2013

107
108
109
111

Page 3

Background
In the United States, Federal and State government agencies ensure the safety of animal feed 1.
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.
Thedraft vision for an IFSSwas developed in 2009 2. 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. The Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) and
the Manufactured Food Regulatory Program Standards (MFRPS) are examples of such model
standards. However, the VNRFRPS and MFRPS were developed for human food only and do
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. 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

“Food” is defined in section 201(f) of the Federal Food, Drug and Cosmetic Act (FD&C Act) in part as articles used for food for animals and
articles used for components of such articles. In addition, section 201(w) of the FD&C Act defines “animal feed” as “an article which is intended
for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not
limited to a mixture intended to be the sole ration of the animal.” The AAFCO Official Publication (OP), 2011 utilizes essentially the same
definition of the term “animal feed.” For purposes of this document, the term “animal feed” (henceforward referred to as “feed”) is used to
represent the definitions in FD&C Act sections 201(f), 201(w) and the AAFCO OP, and is inclusive of feed for food-producing animals and pets.
2
The draft vision is discussed in “Establishing a Fully Integrated National Food Safety System with Strengthened Inspection, Laboratory, and
Response Capacity,” which is available online at http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/UCM183650.pdf

Animal Feed Regulatory Program Standards
June 2013

Page 4

Introduction
The Animal Feed Regulatory Program Standards (AFRPS) establish a uniform foundation for the
design and management of State programs 3 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 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 feed program. The standards cover the State feed program’s
regulatory foundation, training, inspection program, auditing, feed-related illness 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 contains a purpose statement, requirement summary, description of program
elements, projected outcomes, and a list of required documentation. The program elements
describe the best practices of a quality regulatory program. The terms “must” and “should” are
used throughout the AFRPS. The use of the term “must” requires a State program to implement
the program element and the corresponding conditions in order to fully implement the standard.
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
State program must implement all eleven standards.
Each standard has a self-assessment worksheet except Standard 9: Assessment and Improvement.
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.

3

The term “program,” as used in this document, means an operational unit(s) that is responsible for the regulatory oversight of feed facilities.

Animal Feed Regulatory Program Standards
June 2013

Page 5

STANDARD 1
Regulatory Foundation
1.1 Purpose
This standard describes the elements of the regulatory foundation 4 used by a State program to
regulate animal feed 5.
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 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.
1.3 Program Elements
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. When conducting such an
evaluation, it is advisable that the State program involve qualified legal personnel as appropriate.
•

“Equivalent” means that the State law directly references the relevant FD&C Act
provision or Federal regulation. The State program should specify the Federal statute or
regulation that is incorporated into the State law, including the revision date of the State
statutory provision or regulation, the date the Federal statutory provision or regulation
was incorporated into the State law, and whether that statutory or regulatory provision is
included in whole, in part, or modified from the original. In conducting such an
evaluation, the State program should consult with its legal counsel when (1) State law
does not provide for incorporation of subsequent revisions of the FD&C Act and CFR,
(2) the revision date of the CFR is unknown, or (3) the Federal law or regulation is
partially written into State law or regulation.

•

“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

4

The term “regulatory foundation” as used herein means the laws, regulations, rules, ordinances, or other regulatory requirements that govern the
operation of an animal feed facility.
5
“Food” is defined in section 201(f) of the Federal Food, Drug and Cosmetic Act (FD&C Act) in part as articles used for food for animals and
articles used for components of such articles. In addition, section 201(w) of the FD&C Act defines “animal feed” as “an article which is intended
for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not
limited to a mixture intended to be the sole ration of the animal.” The AAFCO Official Publication (OP), 2011 utilizes essentially the same
definition of the term “animal feed.” For purposes of this document, the term “animal feed” (henceforward referred to as “feed”) is used to
represent the definitions in FD&C Act sections 201(f), 201(w) and the AAFCO OP, and is inclusive of feed for food-producing animals and pets.

Animal Feed Regulatory Program Standards
June 2013

Page 6

STANDARD 1
Regulatory Foundation
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.
•

“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 animal feed
program, or the Federal and State laws address the same matter but are inconsistent and
do not have the same regulatory effect.

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.
The State program has a documented process, which includes timeframes and procedures, to
review the statutes, regulations, rules, ordinances, and other prevailing regulatory requirements
that: (1) apply to the regulation of animal feed, (2) delegate authority to the State agency, and (3)
describe the State agency’s administrative procedures for establishing its authority and
incorporating rules by reference.
1.4 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
feed.
1.5 Documentation
The State program maintains the records listed here.
•
•
•

Appendix 1: Self-Assessment Worksheet
Documented process for reviewing appropriate statutes, regulations, rules, ordinances,
and other prevailing regulatory requirements
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

Animal Feed Regulatory Program Standards
June 2013

Page 7

STANDARD 2
Training
2.1 Purpose
This standard describes the elements of training for inspectors in a State animal feed regulatory
program to ensure they will have the knowledge, skills, and abilities to competently inspect feed
facilities and conduct investigations.
2.2 Requirement Summary
The State program establishes and documents a training plan that ensures all inspectors complete
course curriculums and field training to adequately perform their work. The plan provides for
basic and advanced inspection training as well as continuing education and professional
development.
2.3 Program Elements
The State program establishes and documents a basic and advanced animal feed inspection
training curriculum that consists of coursework, field training, and continuing education.
The State program provides, or otherwise makes available, inspection training and continuing
education for all inspectors.
The State program maintains records documenting the training completed by all inspectors.
Appendix 2.2 or a comparable form must be used to document the training that has been
completed by an inspector.
For inspectors with greater than five years of experience at the date of the initial self assessment,
the State program should provide documentation to support completion of basic and advanced
curriculums. For subject areas where such documentation is not available, the State program
should conduct 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.
A. Basic Feed Inspector Training
The State program requires an inspector to successfully complete courses and field
training within 24 months from the start date.
The State program establishes and documents basic feed inspection training in the
following subject areas.
Subject Areas
• Animal and Public Health Principles: Fundamental animal and public health
protection principles that support the foundational roles of the feed inspector

Animal Feed Regulatory Program Standards
June 2013

Page 8

STANDARD 2
Training
•

Basic Animal Nutrition: Identify basic means of digestion and nutritional
requirements for various animal classes and ingredients that can cause toxicity

•

Basic Feed Ingredients, Processing, and Technology: Identify 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

•

BSE Awareness: Identify the hazards surrounding ruminant animal by-products
being used for animal feed

•

Communication: Techniques and skills for effective oral and written
communication and interviewing

•

Feed Defense: Feed defense principles for the protection of feed from intentional
hazard contamination

•

Inspections, Compliance, and Enforcement: Conduct entry-level inspections
applying the relevant laws and regulations to gather and document evidence to
support possible regulatory actions

•

Labeling: Basic feed label reviews addressing ingredients, misbranding, and
adulteration

•

Prevailing Statutes, Regulations, and Policies: Federal and State laws,
regulations, and policies appropriate for the entry-level inspector

•

Professionalism: Introduction to character conduct, strengths, and values directed
toward providing high quality service to the regulated industry and the State
program

•

Safety: Apply 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

Coursework may be obtained from sources listed here.

Animal Feed Regulatory Program Standards
June 2013

Page 9

STANDARD 2
Training
•

In-house training provided by a government agency

•

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

•

Colleges, schools, associations, and research centers

Field training
The State program has an established basic field training program to complement the
basic coursework curriculum. The basic field training program is developed by the State
and specifies the following:
•

Field training checklist of competencies to be mastered and verified in the field
and

•

Number of joint training inspections required by an inspector.

Joint field training inspections, when an inspector is accompanied by a qualified person
designated by the State program, are conducted in firms that represent the feed facilities
in the State program inventory as well as the type of routine or basic work that will be
performed by the inspector. The inspector must complete the field training program prior
to performing independent inspections.
Appendix 2.3 or a comparable form must be used to list the competencies and record the
required number of joint field training inspections.
B. Advanced Feed Inspector Training
The State program requires an inspector to successfully complete courses and field
training within 60 months from the start date.
The State program establishes and documents advanced feed inspection training in the
following subject areas.
Subject Areas
• Advanced Feed Ingredients, Processing, and Technology: Identify 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

6

FDA/ORA University classroom and long distance learning courses are listed at: http://www.fda.gov/ora/training/course_ora.html.

Animal Feed Regulatory Program Standards
June 2013

Page 10

STANDARD 2
Training
•

Advanced Labeling: Apply medicated feed and pet food labeling requirements
during an inspection

•

Advanced Statutes, Regulations, and Policies: Federal and State laws,
regulations, and policies in animal feed and drugs to include bioterrorism
regulations

•

Animal Sickness and Death Investigation: Assist in outbreak investigations

•

Epidemiology: Acquire basic knowledge of epidemiology principles and
concepts and apply them to animal outbreak investigations

•

Microbiological Pathogens: Distinguish various microbial hazards in feed that
could lead to animal or human illness or death

•

Traceback and Traceforward Investigations: Determine when a traceback and
traceforward are necessary with an implicated product and steps for conducting
and concluding the investigation and reporting the results

The State program requires each inspector who is serving in a specialized capacity to
conduct the following inspections or assist in emergency responses to complete relevant
specialized coursework in the subject areas described here.
•

Advanced National Incident Management System and Incident Command
Systems (ICS): Required for individuals serving an active role in the ICS.
Courses should be specific to the individual’s responsibilities but include at a
minimum ICS300 and ICS400

•

BSE and Ruminant Feeding Ban: Conduct and record 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

•

Good Manufacturing Practices Regulations: 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

Coursework may be obtained from sources listed here.
•

In-house training provided by a government agency

Animal Feed Regulatory Program Standards
June 2013

Page 11

STANDARD 2
Training
•

Distance learning, for example, satellite downlinks, or web-based training 7

•

Colleges, schools, associations, and research centers

Field training
The State program has an established field training program to complement the advanced
coursework curriculum. The advanced field training program is developed by the State
and specifies the following:
•

Field training checklist of competencies to be mastered and verified in the field
and

•

Number of joint training inspections required by an inspector.

Joint field training inspections, when an inspector is accompanied by a qualified person
designated by the State program, are conducted in firms that are representative of the feed
facilities in the State program inventory, as well as the type of advanced work that will be
performed by the inspector. The inspector must complete the field training program prior
to performing independent inspections requiring advanced skills.
Appendix 2.3 or a comparable form must be used to list the competencies and record the
required number of joint field training inspections.
C. Continuing Education
The State program requires that each inspector participate in continuing education. At
thirty six month intervals, each inspector is required to receive 36 contact hours 8 of
continuing education. The 36-month continuing education interval starts when the
advanced training cycle is complete.
The inspector may accrue one contact hour for each clock hour of participation in any of
the sources listed here.

7

8

•

In-house training provided by a government agency

•

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

•

Feed-related courses provided by colleges, schools, associations, and research
centers

FDA/ORA University classroom and long distance learning courses are listed at: http://www.fda.gov/ora/training/course_ora.html.
One contact hour equals 60 minutes.

Animal Feed Regulatory Program Standards
June 2013

Page 12

STANDARD 2
Training
The inspector may accrue a maximum of ten contact hours from a combination of the
sources listed here.
•

Attendance at professional seminars, symposiums, or technical conferences and
workshops

•

Delivery of presentations at professional conferences

•

Providing classroom or field training to new hires

•

Publishing an original article in a peer-reviewed professional or trade association
journal, periodical, or publication

The inspector may accrue a maximum of four contact hours from reading technical
publications related to feed.
2.4 Outcome
The State program has trained inspectors with the knowledge, skills, and abilities to competently
inspect feed facilities and conduct investigations.
2.5 Documentation
The State program maintains the records listed here.
•
•
•
•

Appendix 2.1: Self-Assessment Worksheet
Inspector training record
Competencies for basic and advanced field training
Documents verifying successful completion of courses for all inspectors

Animal Feed Regulatory Program Standards
June 2013

Page 13

STANDARD 3
Inspection Program
3.1 Purpose
This standard describes the elements of an effective animal feed inspection program.
3.2 Requirement Summary
The State administers an inspection program to determine compliance with animal feed laws.
3.3 Program Elements
A. Risk-Based Inspection Program
The State program defines and maintains an up-to-date inventory of feed facilities 9 whose
activities fall under the State’s jurisdiction and authority. Inspections are prioritized,
frequencies assigned, and resources allocated based on risk factors assigned to a facility
or product, the manufacturing processes, and the inspection history of the facility.
The State program is required to use three factors as the basis for categorizing risk. The
three required factors are: (1) types of feed and feed products, (2) types of processing,
and (3) compliance history of the facility. The State program should also (?) consider
other, 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.
B. Inspection Protocol
The State program has documented policies and procedures for inspecting feed facilities
that require the inspectors to
1.
2.

3.
4.
5.
6.

9

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

For the purpose of this standard, “feed facility” means a manufacturer, guarantor, or distributor.

Animal Feed Regulatory Program Standards
June 2013

Page 14

STANDARD 3
Inspection Program
7.

8.
9.
10.

11.
12.
13.
14.
15.
16.
17.
18.
19.
20.

21.
22.

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 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
Alert the feed facility’s owner, operator, or agent in charge when an immediate
corrective action is necessary
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
Answer questions and provide information as appropriate, and
Submit inspection report, sample(s), and supporting documents to headquarters
or supervisor in a timely manner

C. Feed Recall Effectiveness Audits
The State program has a system for conducting feed recall effectiveness audits. The
system includes documented procedures for receiving, tracking, evaluating, closing, and
maintaining records of feed recall effectiveness audits.
D. Consumer Complaints
The State program has a system for handling consumer complaints. The system includes
documented procedures for receiving, tracking, evaluating, answering, closing, and
maintaining records of consumer complaints.

Animal Feed Regulatory Program Standards
June 2013

Page 15

STANDARD 3
Inspection Program
E. Complaints Resulting from State Program Inspection Activities
The State program has a system to handle complaints from industry about State program
inspections. The system includes documented procedures for receiving, evaluating, and
maintaining records of industry complaints about State program inspections.
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 from
facilities that receive, store, manufacture, process, package, transport, or distribute feed,
feed ingredients, pet food, or specialty pet food 10

•

preventing distribution of feed, feed ingredients, pet food, or specialty pet food that may
be adulterated or misbranded and to monitor the recall from distribution and disposition
of adulterated or misbranded feed

3.5 Documentation
The State program maintains the records listed here.
•
•
•
•
•
•

Appendix 3.1: Self-Assessment Worksheet
Documented procedures for defining and updating the State’s inventory of feed facilities
An inventory of feed facilities
Documented procedures used for categorizing feed facilities based on risk, including the
inspection frequency assigned to each defined risk-based category
Documented policies and procedures for inspecting feed facilities
Documented procedures for feed recalls, consumer complaints, and industry complaints
about State program inspections

10

AAFCO defines a “specialty pet” as “any domesticated animal normally maintained in a cage or tank, such as, but
not limited to, gerbils, hamsters, canaries, psittacine birds, mynahs, finches, tropical fish, goldfish, snakes and
turtles, and “specialty pet food” is defined by AAFCO as “any commercial feed prepared and distributed for
consumption by specialty pets (AAFCO Official Publication 2011, p. 103). For purposes of this document, the
definitions for “specialty pet” and “specialty pet food” have the same meaning as defined by AAFCO.

Animal Feed Regulatory Program Standards
June 2013

Page 16

STANDARD 4
Auditing
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. The State program audits field inspections, field inspection
reports, sample collections, and sample collection reports.
Audit data is obtained from observing an inspection or sample collection and reviewing the
reports.
An audit will be completed on a specified frequency and is based on established performance
factors.
4.3 Program Elements
Auditing has two components: (1) a field audit component, which is an on-site performance
evaluation of inspection and sample collection and (2) a desk audit component, which is a
performance review of the inspection and sample collection reports.
Four types of audits must be conducted by the State program: field inspection audit, field
inspection report audit, sample collection audit, and a sample collection report audit. Each
type of audit is composed of multiple performance factors that are evaluated and used to
calculate an individual’s audit score. An individual’s audit score determines the audit rating.
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.
Managers use audit scores, performance factor scores, and cumulative scores to recognize
trends in the field inspection and sample collection programs and identify specific areas that
need improvement. When any of these scores fall below 80 percent, a corrective action plan is
required.
The State program reviews individual audit ratings on a timely and continuous basis.
A review of the performance factor scores and cumulative scores is completed at least every
12 months.

Animal Feed Regulatory Program Standards
June 2013

Page 17

STANDARD 4
Auditing
A. Field Inspection Audit
A qualified auditor conducts field inspection audits to verify that inspections are
consistently performed according to established performance factors.

Frequency

Performance
Factors

A minimum of two field inspection audits of each inspector will
be conducted every 36 months. The inspections selected for
audits must reflect the inspector’s assignments and
responsibilities.
Performance factors are based, at minimum, upon the inspection
protocol described in Standard 3: Inspection Program and listed
in appendix 4.2.1.
For each performance factor, examples of actions and
observations that would likely result in a “needs improvement”
rating are provided in Appendix 4.2.2.
Appendix 4.2.1 or comparable form, must be used to record the
rating of each performance factor, audit score, and audit rating
for each field inspection audit.

Performance
Documentation

Appendix 4.3, or comparable worksheet, must be used to
calculate performance factor scores and a cumulative score.
Directions for calculating performance factor scores and the
cumulative score can be found in appendix 4.4.

B. Field Inspection Report Audit
Finalized field inspection reports are audited to verify the content quality and that the report
was processed according to established performance factors.

Frequency

The State program audits at least 5 percent of all field inspection
reports every 12 months. This 5 percent must include all reports
from field inspections that were audited. If the reports from
field inspections that were audited do not total 5 percent of all
reports, the remaining reports should be selected across
inspectors, supervisors, inspection types, and geographical
locations.

Performance
Factors

At a minimum, the performance factors listed in appendix 4.5
must be used.

Animal Feed Regulatory Program Standards
June 2013

Page 18

STANDARD 4
Auditing
Appendix 4.5, or comparable form, must be used to record the
rating of each performance factor, audit score, and audit rating
for each inspection report audit.
Performance
Documentation

Appendix 4.6, or comparable worksheet, must be used to
calculate performance factor scores and a cumulative score.
Directions for calculating performance factor scores and the
cumulative score can be found in appendix 4.4.

C. Sample Collection Audit
A qualified auditor conducts sample collection audits to verify that sample collections are
consistently performed according to established performance factors.

Frequency

Performance
Factors

A minimum of two sample collection audits of each inspector
will be conducted every 36 months. The sample collections
selected for audits must reflect the inspector’s assignments and
responsibilities.
Performance factors are based, at minimum, upon the inspection
protocol described in Standard 11: Sampling Program and listed
in appendix 4.7.1.
For each performance factor, examples of actions and
observations that would likely result in a “needs improvement”
rating are provided in Appendix 4.7.2.
Appendix 4.7.1, or comparable form, must be used to record the
rating of each performance factor, audit score, and audit rating
for each sample collection audit.

Performance
Documentation

Appendix 4.8, or comparable worksheet, must be used to
calculate performance factor scores and a cumulative score.
Directions for calculating performance factor scores and the
cumulative score can be found in appendix 4.4.

D. Sample Collection Report Audit
Finalized sample collection reports are audited to verify the content quality and that the
report was processed according to established performance factors.

Animal Feed Regulatory Program Standards
June 2013

Page 19

STANDARD 4
Auditing

Frequency

The State program audits at least 5 percent of all sample
collection reports every 12 months. This 5 percent must include
all reports from sample collections that were audited. If the
reports from sample collections that were audited do not total
5 percent of all reports, the remaining reports should be selected
across inspectors, supervisors, sample types, and geographical
locations.

Performance
Factors

At a minimum, the performance factors listed in appendix 4.9
must be used.
Appendix 4.9, or comparable form, must be used to record the
rating of each performance factor, audit score, and audit rating
for each sample collection report audit.

Performance
Documentation

Appendix 4.10, or comparable worksheet, must be used to
calculate performance factor scores and a cumulative score.
Directions for calculating performance factor scores and the
cumulative score can be found in appendix 4.4.

E. Corrective Action Plan
A corrective action plan is required if any of the following occur for any type of audit
•

an inspector has an audit score below 80 percent for an individual audit

•

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

•

a State program has a cumulative score (as a result of all audits over 12 months)
below 80 percent

Appendix 4.11, or comparable worksheet, must be used to document performance factors in
need of correction, a description of the deficiency, the corrective actions to address the
deficiency, and verification that corrective action has been implemented.
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
June 2013

Page 20

STANDARD 4
Auditing
4.5 Documentation
The State program maintains the records listed here.
•
•
•
•

Appendix 4.1: Self-Assessment Worksheet
Audit forms used to record performance factor ratings, calculate an audit score, and
assign the audit rating for each individual audit
Performance factor scores and cumulative scores for each audit type conducted over a
twelve month period
Corrective action plan(s)

Animal Feed Regulatory Program Standards
June 2013

Page 21

STANDARD 5
Feed-Related Illness or Death and Emergency Response
5.1 Purpose
This standard describes the functions to detect, identify, and respond to alleged feed-related
illnesses, deaths, and emergencies 11, including coordinating roles and responsibilities with other
jurisdictions and communicating with appropriate parties.
5.2 Requirement Summary
The State program establishes systems to
•

gather and use information to identify feed-related illnesses, deaths, and emergencies

•

determine, initiate, and complete an appropriate response to alleged feed-related illnesses,
deaths, and emergencies

•

maintain and update an emergency contact list

•

rapidly notify and report findings to government agencies, departments, or other
appropriate parties

•

immediately notify law enforcement agencies when intentional feed contamination or
feed-related terrorism is suspected or threatened

•

release information and communicate with the public

5.3 Program Elements
The State program gathers information to identify incidents of feed-related illnesses, deaths, and
emergencies. The State program has procedures to communicate with the appropriate State
agencies or departments that investigate animal illnesses and food-related illness and outbreak.
These procedures facilitate sharing of information to identify potential feed-related illnesses,
deaths, emergencies, and cross-sector events 12.
The State program has a standard operating procedure to evaluate incoming information. Based
upon the evaluation, the State program has documented criteria determining the appropriate
response as well as the time period in which the appropriate response is to be initiated and
completed. For feed-related emergencies, the State program either manages the event using a

11
“For purposes of this document, an “emergency” is any abnormal situation which, to limit damage to persons, property, or the environment,
requires prompt action beyond normal procedures (AAFCO Official Publication 2011, p. 294).
12
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 feed.

Animal Feed Regulatory Program Standards
June 2013

Page 22

STANDARD 5
Feed-Related Illness or Death and Emergency Response
formalized Incident Command System structure or an official action plan 13 outlining
containment, communication, control, and correction protocols.
The State program maintains a list of relevant agencies and emergency contacts and establishes
procedures to rapidly notify government agencies, departments, or appropriate parties of relevant
findings. Appendix 5.2 provides a template for an emergency contact list. The list should be
updated frequently. The State program will determine how often updates will occur.
The State program has a process to immediately notify law enforcement agencies when
intentional feed contamination or feed-related terrorism is suspected or threatened.
The State program has procedures for releasing information to the public as well as guidelines
for coordinating media information with other jurisdictions. The State program provides
guidance to consumers and industry to reduce the impact of feed-related illnesses, deaths, or
emergencies.
5.4 Outcome
The State program detects, identifies, and responds to 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.
•
•
•

Appendix 5.1: Self-Assessment Worksheet
Emergency contact list
Documented procedures

13

An example of an official action plan can be found in the AAFCO Emergency Response Preparedness Guidance Document (AAFCO Official
Publication 2011 pp.296-297).

Animal Feed Regulatory Program Standards
June 2013

Page 23

STANDARD 6
Enforcement Program
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
The State program has an enforcement program that contains documented enforcement
strategies. Enforcement strategies are 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. Appendix 6.2
provides examples of common enforcement tools.
The State program must use the six factors listed in appendix 6.3 when selecting an appropriate
enforcement tool. The six factors are
1. Compliance history
2. Responsiveness
3. Scope
4. Nature of the Violation
5. Impact of the Violation
6. Resources
The State program may consider factors in addition to the ones listed above.
The State program will provide a description and relative conditions for all factors. Relative
conditions of each factor will be assigned a numerical weight. Appendix 6.3 is an example of
factor descriptions, relative conditions, and the associated numerical weights.
The State program has a documented enforcement matrix that is designed to incorporate the
relative conditions of each factor and the application of enforcement tools. Appendix 6.4 is an
example enforcement matrix.

Animal Feed Regulatory Program Standards
June 2013

Page 24

STANDARD 6
Enforcement Program
The State program conducts an annual evaluation of its enforcement strategies to identify
potential improvements or modifications. The State program has a documented process for
conducting this evaluation.
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.
•
•
•
•
•

Appendix 6.1: Self-Assessment Worksheet
Documented factors including the description, relative conditions, and associated
numerical weight for each
Enforcement matrix
Documented enforcement strategies
Documented process for annual evaluation

Animal Feed Regulatory Program Standards
June 2013

Page 25

STANDARD 7
Outreach Activities
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 to inform feed industry
stakeholders, academia, or consumers about feed topics.
The State program has a plan for outreach activities.
For those outreach activities that are in the form of an event, referred to as an outreach activity
event, the State program documents and evaluates such events.
7.3 Program Elements
The State program identifies the methods that will be used for communication with feed industry
stakeholders, academia, or consumers.
The State program develops an outreach plan that supports the State program mission and
includes the types of activities, target populations, and objectives. The content and design of the
plan will vary depending on the State program priorities and mission.
The templates provided in appendix 7.2, or comparable form, should be used to record the types
of activities (including outreach activity events), target populations, and objectives of an
outreach plan.
The State program documents and evaluates outreach activity events. Appendix 7.3, or
comparable form, should be used to document and evaluate outreach activity events.
7.4 Outcome
The State program uses outreach activities to inform feed industry stakeholders, academia, or
consumers about feed topics.
7.5 Documentation
The State program maintains the records listed here.
•
•
•

Appendix 7.1: Self-Assessment Worksheet
Outreach plan
Outreach activity event overview and evaluation

Animal Feed Regulatory Program Standards
June 2013

Page 26

STANDARD 7
Outreach Activities
•

Documents to verify the outreach activity event occurred

Animal Feed Regulatory Program Standards
June 2013

Page 27

STANDARD 8
Planning and Resources
8.1 Purpose
This standard describes the elements of workplanning and resource evaluation used by a State
animal feed regulatory 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
A. Workplan
The State program has a documented workplan. The workplan must include:
•

Inspection projections and plan (number, type of inspection, risk category of
facility or product, frequency, and completion time),

•

Sample projections and plan (number and type of sample), and

•

Timeframe that the workplan is applicable.

The State program has a documented procedure for evaluating the workplan. The
procedure will detail how the State program conducts periodic and annual evaluations of
the workplan and its alignment with program objectives and resources.
FDA and the State program may meet periodically and develop a coordinated workplan.
B. Resources for Inspections, Sample Collections, and Other Program Work
The State program conducts a review of its resources to accomplish the workplan and
meet its inspection and sample projections for the applicable workplan timeframe. The
resource review should include staffing, equipment, and funding needed to support the
inspection and sample collection activities.

Animal Feed Regulatory Program Standards
June 2013

Page 28

STANDARD 8
Planning and Resources
The State program should have adequate staff to inspect the animal feed facilities in its
establishment inventory based on the risk categorization and inspection frequency
established by the program in its workplan. The State program must develop and use a
formula to calculate the number of inspectors needed to conduct inspections. The
numerical values in the formula must be verified with data tracked by the State program.
The formulas in appendix 8.2 are provided as examples for calculating the number of
inspectors needed to conduct inspections. The formulas in appendix 8.2 only include
staff numbers needed to conduct inspections and do not include methods for estimating
staff numbers needed for sample collections, compliance activities, administrative, or
other programmatic activities.
The State program should have adequate staff to conduct sample collections identified in
the workplan.
The inspection and sample collection staff must have the equipment needed to conduct
inspections and sample collections. A list of the equipment required for inspections and
sample collections must be established and maintained by the State program. Appendix
8.3 provides an example list of equipment that may be used for inspections and sample
collections.
In addition, 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.
C. Resources for Implementing the AFRPS
The State program must conduct a review of the resources required to implement the
AFRPS. The resource assessment must be done to determine if the program has adequate
staff, equipment, and funding to fully implement each of the program elements in the
individual standards. Information technology may be considered as part of the State
program’s resource needs. Funding, staffing, equipment, and other resources needed to
fully implement the individual standards should be identified and recorded in appendix
8.4. A baseline resource evaluation must be made concurrently with the baseline
evaluation required for AFRPS Standard 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.

Animal Feed Regulatory Program Standards
June 2013

Page 29

STANDARD 8
Planning and Resources
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 Animal Feed Regulatory Program Standards.
8.5 Documentation
The State program maintains the records listed here.
•
•
•
•
•
•

Appendix 8.1: Self-assessment worksheet
Workplan
Documented procedure for evaluating the workplan
Formula used to calculate number of inspectors and verifying data
List of required equipment for inspection and sample collection
Appendix 8.4: Resources for Implementation of AFRPS

Animal Feed Regulatory Program Standards
June 2013

Page 30

STANDARD 9
Assessment and Improvement
9.1 Purpose
This standard describes the processes used to evaluate a State program’s fulfillment of the
requirements in each standard within the Animal Feed Regulatory Program Standards
(henceforth referred to as the standards) and develop improvement plans to address requirements
that have not been met.
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
The State program uses the self-assessment worksheets 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.
Following the baseline evaluation, the State program develops an improvement plan for
requirements of the standards that are not fully met. The improvement plan includes the
following:
•

The 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,

•

Lists of individual tasks that will be used to address the improvement, and

•

A projected completion date for each task.

Appendix 9.1, or comparable form, must be used to develop an improvement plan for each
standard with the exception of Standard 9: Assessment and Improvement. The State program
reviews and updates its improvement plan on an annual basis.
The State program completes an evaluation by reviewing and updating the self-assessment
worksheets and required documentation for each standard at least every three years. This
evaluation is necessary to determine if each standard’s requirements are, or remain, fully met,

Animal Feed Regulatory Program Standards
June 2013

Page 31

STANDARD 9
Assessment and Improvement
partially met, or not met. The State program revises the improvement plan based upon this
evaluation.
Appendix 9.2, or comparable form, should be used to track implementation status of all the
standards.
Documentation related to the evaluation and improvement plans should be maintained by the
State program.
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.
•
•
•

Appendix 9.1: Assessment and Improvement Plan
Completed self-assessment worksheets for each standard
Improvement plan

Animal Feed Regulatory Program Standards
June 2013

Page 32

STANDARD 10
Laboratory Services
10.1 Purpose
This standard describes the elements of utilizing regulatory testing laboratory 14 services that
support the State animal feed 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, and reliable data from the regulatory testing
laboratory.
10.3 Program Elements
The State program maintains a list of routine and non-routine analytical services provided by
regulatory testing laboratories as required by the program.
The State program has a documented formal agreement with the laboratory(ies) that conduct
routine analytical services, unless the laboratory is managed within the program.
The State program prepares a sample analysis schedule based on a sampling plan 15 in
cooperation with laboratories performing routine services to ensure compatibility with laboratory
capabilities and capacities. At a minimum, the sample analysis schedule must include the type(s)
of feed to be analyzed, number of samples to be collected, estimated timeframe for collection,
and type(s) of analysis to be performed.
Standard procedures and a means to communicate necessary information for sample submission,
shipping, preservation, storage, retention, disposal, chain of custody, and report of analysis
should be established in collaboration with the laboratories performing routine services to protect
the integrity and identity of the samples sent to the laboratory for analytical testing.
State program utilizes regulatory testing laboratories that:
•

Follow AAFCO Quality Assurance /Quality Control guidelines,

•

Meet the managerial and technical requirements of ISO/IEC 17025:2005 16, or

•

Are accredited by a recognized accreditation body for the appropriate sampling or
analytical testing methodology or methodologies.

14

For purposes of this standard, a “regulatory testing laboratory” is 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.
15
A description of a sampling plan can be found in Animal Feed Regulatory Program Standard 11: Sampling Program.
16
ISO/IEC 17025:2005(E) Second Edition 2005-05-15 Case postale 56. CH-1211 Geneva 20. www.iso.org.

Animal Feed Regulatory Program Standards
June 2013

Page 33

STANDARD 10
Laboratory Services
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.
•
•
•
•
•

Appendix 10: Self-Assessment Worksheet
A list of routine and non-routine analytical services and participating routine regulatory
testing laboratories
An agreement with regulatory testing laboratories that provide routine analytical services
unless the laboratory is managed within the program
A current sample analysis schedule based on a sampling plan
Standard procedures and means to communicate necessary information for sample
submission, shipping, preservation, storage, retention, disposal, chain of custody, and
report of analysis

Animal Feed Regulatory Program Standards
June 2013

Page 34

STANDARD 11
Sampling Program
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

The State program has a documented sampling plan and procedures for collecting surveillance,
compliance, investigational, or regulatory samples 17.
A. Sampling Plan
The State program develops, documents, and coordinates an annual sampling plan. This
plan is jointly developed and amended by the State program and laboratories performing
routine services within a timeframe sufficient to allow for advanced planning and
scheduling of work. The sampling plan outlines the State program’s sampling priorities,
the sample analysis schedule, and availability or coordination of analytical support. The
sampling plan may include estimates of analytical costs.
B. Sampling Procedures
The sampling procedures must include: (1) methods for collecting, storing, and
transporting samples and (2) instructions for documenting the sample collection.
1. Methods for Collecting, Storing, and Transporting Samples
a. Follow safety precautions on feed labels
b. Follow the State program’s safety protocol for collecting samples
c. Use appropriate method and equipment to collect the sample
d. Seal sample to initiate chain of custody
e. Maintain and document sample integrity, security, and chain of custody
f. Issue receipt 18 for sample

17
18

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

Animal Feed Regulatory Program Standards
June 2013

Page 35

STANDARD 11
Sampling Program

g. Handle 19, package, and ship sample using procedures appropriate to
prevent compromising condition of sample
h. Deliver or ship sample to the appropriate laboratory within acceptable
timeframes
2. Instructions for Documenting the Sample Collection
a. Date of the sample collection
b. Product identification including name, manufacturing codes, date codes,
lot numbers, batch codes, expiration dates, and any other referencing
manufacture identification
c. Description of product
d. Method of collection, lot sampled, lot size, and any special techniques
used to collect sample
e. Location where sample was collected
f. Name and address of responsible party, guarantor, possessor, or distributor
g. Sample type (surveillance, compliance, investigational, or regulatory)
h. Analysis requested, if applicable
i. Product labels, including customer-formula feed labels, are collected or
reproduced
j. Receiving and distribution information
11.4 Outcome
The State program has a sampling program that aligns sampling resources with State program
priorities. The 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.

19

Includes storing sample.

Animal Feed Regulatory Program Standards
June 2013

Page 36

STANDARD 11
Sampling Program

11.5 Documentation
The State program maintains the records listed here.
•
•
•

Appendix 11: Self-Assessment Worksheet
Documented sampling plan
Documented sampling procedures

Animal Feed Regulatory Program Standards
June 2013

Page 37

Appendix 1: Self-Assessment 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 box; otherwise list the
State law or regulation citation and complete the columns for either Equivalent or Equivalent in Effect as appropriate. The Notes section can
be used to detail differences between State and Federal laws and regulations.
Equivalent
in Effect

Equivalent
Not
Equivalent

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
409

Date
Incorporated
into State
Law
Federal Food, Drug & Cosmetic Act

State Citation

Revision Date of
Federal
Law/Regulation

Partial/
Full

Legal
Review
Date

Notes

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

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

Animal Feed Regulatory Program Standards
June 2013

Page 38

Appendix 1: Self-Assessment Worksheet (continued)
Equivalent
in Effect

Equivalent
Not
Equivalent

501

504
512

State Citation

Revision Date of
Federal
Law/Regulation

Date
Incorporated
into State
Law

Partial/
Full

Legal
Review
Date

Notes

Adulterated drugs and
devices
(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 (2011)

1

General enforcement
regulations
(ONLY §§ 1.20-1.23)

Enforcement policy
7
70
73

(ONLY §§ 7.1-7.13 and §§
7.40-7.59)

Color additives
(ONLY §§ 70.20-70.25)

Listing of colors exempt
from certification (ONLY
§§ 73.1-73.615)

74

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

81

General specifications and
general restrictions for
provisional color
additives for use in foods,
drugs, and cosmetics

Animal Feed Regulatory Program Standards
June 2013

Page 39

Appendix 1: Self-Assessment Worksheet (continued)
Equivalent
in Effect

Equivalent
Not
Equivalent

82

State Citation

Revision Date of
Federal
Law/Regulation

Date
Incorporated
into State
Law

Partial/
Full

Legal
Review
Date

Notes

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 lowacid foods packaged in
hermitically sealed
containers (refers to
regulations in 21 CFR 113)

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 food-producing
animals
Animal food labeling

Animal Feed Regulatory Program Standards
June 2013

Page 40

Appendix 1: Self-Assessment Worksheet (continued)
Equivalent
in Effect

Equivalent
Not
Equivalent

502

509

510
558
570

573

579

582

584

589

State Citation

Revision Date of
Federal
Law/Regulation

Date
Incorporated
into State
Law

Partial/
Full

Legal
Review
Date

Notes

Common or usual name
for nonstandardized
animal foods
Unavoidable
contaminants in animal
food and food-packaging
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
June 2013

Page 41

Appendix 1: Self-Assessment 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

Animal Feed Regulatory Program Standards
June 2013

Date

Page 42

Appendix 2.1: Self-Assessment Worksheet
Inspector Training Record Summary
Instructions: This chart is used to document and track inspectors’ training status. Enter the name of all active
inspectors. Include the start date of employment, and record the date the inspector completed the coursework and field
training for the basic and advanced curriculums. For continuing education, indicate the number of contact hours
completed. For training record column, indicate if there is a training record (appendix 2.2) for the inspector as well as
all documents verifying completion of courses.
Employee Name

Start Date

Basic Curriculum
Course

Field

Advanced Curriculum
Course

Field

Contact
Hours

Training
Record

Field Training Program
Instructions: Indicate with a Y(Yes) or N(No) if the following components have been developed and documented for both
the basic and advanced field training programs.
Component
Checklist of Competencies
Number of Joint Inspections

Basic Field

Advanced Field

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards
June 2013

Date

Page 43

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

Inspector
Initials

Supervisor
Initials

Documentation
Verifying
Completion
(Y/N)

Animal and Public Health
Principles
Basic Animal Nutrition
Basic Feed Ingredients,
Processing, and Technology
Basic National Incident
Management System and
Incident Command System
BSE Awareness

Communication

Feed Defense
Inspections, Compliance, and
Enforcement
Labeling
Prevailing Statutes,
Regulations, and Policies
Professionalism

Safety

Sampling
Inspector Name:
Animal Feed Regulatory Program Standards
June 2013

Page 44

Appendix 2.2: Inspector Training Record (continued)

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

Completion
Date

Inspectors
Initials

Supervisor
Initials

Mastered
(Y/N)

Inspector Name:
Animal Feed Regulatory Program Standards
June 2013

Page 45

Appendix 2.2: Inspector Training Record (continued)

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

Inspector
Initials

Supervisor
Initials

Documentation
Verifying
Completion
(Y/N)

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

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

Inspector Name:
Animal Feed Regulatory Program Standards
June 2013

Page 46

Appendix 2.2: Inspector Training Record (continued)

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
June 2013

Completion
Date

Inspectors
Initials

Supervisor
Initials

Mastered
(Y/N)

Page 47

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

C. Continuing Education

Type of Activity

Animal Feed Regulatory Program Standards
June 2013

Name and Location of
Activity

Completion
Date

Inspectors
Initials

Supervisor
Initials

Contact
Hours
Earned

Page 48

Appendix 2.3: Field Training Competencies
A. Basic Field 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
June 2013

Page 49

Appendix 2.3: Field Training Competencies (continued)
B. 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
June 2013

Page 50

Appendix 3.1: Self-Assessment Worksheet

Program Elements

Yes/No

Specific
Reference

Notes

20

Section I. Risk-Based Inspection Program
a. Has the State program defined a feed facility
inventory?
• Is the State program defined feed facility
inventory updated?
• Is there contact information for firms listed
in the inventory?
b. Does the State program define risk categories for
feed facilities according to risk-based factors of
the facility or product, manufacturing process,
and inspection history of the facility?
c. Does the State program assign risk
categorization to feed facilities according to riskbased factors of the facility or product,
manufacturing process, and inspection history of
the facility?
d. Are risk categories used to prioritize inspections,
assign inspection frequencies, and allocate
resources?
Section II. Inspection Protocol
Does the program’s inspection protocol require inspectors to:
a. Review the feed facility’s previous inspection
report(s) and complaints?
b. 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?
c. Follow the safety protocols required by the feed
facility and the State program?
d. Follow the biosecurity protocols required by the
feed facility and the State program?
e. Use appropriate equipment and forms needed to
conduct inspections?
f. Establish interstate jurisdiction for FDA
inspections, if applicable?
g. 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?

20

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
June 2013

Page 51

Appendix 3.1: Self-Assessment Worksheet (continued)
h. Conduct inspection activities focused on those
firms, products, and processes determined to be
high risk?
Program Elements

Yes/No

Specific
Reference

Notes

i. Assess employee activities critical to the safe
manufacture, distribution, storage, handling, and
disposition of feed?

j. Properly evaluate the likelihood that conditions,
practices, processes, components, or labeling
could cause the product to become adulterated or
misbranded?

k. Recognize significant non-compliant conditions
or practices and document findings consistent
with program procedures?

l. Distinguish between significant and insignificant
observations and isolated incidents versus
trends?

m. Review and evaluate the appropriate feed facility
records and procedures and verify that the
procedures are being followed?

n. Collect adequate evidence and documentation to
support inspection observations in accordance
with program procedures?

o. Verify correction of deficiencies identified
during the previous inspection(s)?

p. Conduct activities in a professional manner?
q. Use effective interviewing techniques?
r. Explain findings clearly and adequately
throughout the inspection?

s. Alert the feed facility’s owner, operator, or agent
in charge when an immediate corrective action is
necessary?
t. 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?
u. Answer questions and provide information as
appropriate?

v. Submit inspection report, sample(s), and
supporting documents to headquarters or
supervisor in a timely manner?
Section III. Feed Recall Effectiveness Audits

Animal Feed Regulatory Program Standards
June 2013

Page 52

Appendix 3.1: Self-Assessment Worksheet (continued)
a. Does the recall system include documented
procedures for receiving, tracking, evaluating,
closing, and maintaining records of feed recall
effectiveness audits?

Program Elements

Yes/No

Specific
Reference

Notes

Section IV. Consumer Complaints

a. Does the consumer complaint system include
documented procedures for receiving, tracking,
evaluating, answering, closing, and maintaining
records of consumer complaints?
Section V. Complaints Resulting from State Program Inspection Activities
a. Does the industry complaint response system
include documented procedures for receiving,
evaluating, and maintaining records of industry
complaints about State program inspections?

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards
June 2013

Date

Page 53

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) the type of processing, (2)
type of feed, 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.
•
•
•
•
•
•
•
•
•

Mixed 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
June 2013

Page 54

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
High
3
regulations
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
June 2013

Page 55

Appendix 4.1: Self-Assessment Worksheet
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 4.2.1
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 inspection report audits
12- month period of performance:
Number of inspection reports completed:
Number of inspection reports audited:
Number of corrective action plans required:
A minimum of 5 percent of inspection reports were audited
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
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 4.7.1
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

Animal Feed Regulatory Program Standards
June 2013

Page 56

Appendix 4.1: Self-Assessment Worksheet (continued)
Sample Collection Report Audit
Yes No
Program conducts 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:
A minimum of 5 percent of sample collection reports were audited
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
Corrective Action Plan
Yes No
Program develops corrective action plans 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
The corrective active plan includes:
Yes No
Performance factor(s) in need of correction
Description of the deficiency
Corrective actions to address the deficiency
Date of next audit

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards
June 2013

Date

Page 57

Appendix 4.2.1: 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 should be marked as ‘Needs Improvement.’
I.
Pre-Inspection Assessment
1. Did the inspector review the feed facility’s previous inspection report(s) and complaints?
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 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)

3. Did the inspector follow the bio-security protocols required by the feed facility and the state program?
Animal Feed Regulatory Program Standards
June 2013

Page 58

Appendix 4.2.1: Field Inspection Audit Form (continued)
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
June 2013

Page 59

Appendix 4.2.1: 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
June 2013

Page 60

Appendix 4.2.1: 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
June 2013

Signature of Auditor

Date

Page 61

Appendix 4.2.2: 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 complaints?
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
June 2013

Page 62

Appendix 4.2.2: 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.

8. Did the inspector properly evaluate the likelihood that conditions, practices, processes, components, or labeling
could cause the product to be adulterated or misbranded?
Animal Feed Regulatory Program Standards
June 2013

Page 63

Appendix 4.2.2: Completing the Field Inspection Audit Form (continued)

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.
12. Did the inspector collect adequate evidence and documentation to support inspection observations in
accordance with program procedures?
Animal Feed Regulatory Program Standards
June 2013

Page 64

Appendix 4.2.2: Completing the Field Inspection Audit Form (continued)

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.
2. Did the inspector explain findings clearly and adequately throughout the inspection?
Examples of a “needs improvement” rating
Animal Feed Regulatory Program Standards
June 2013

Page 65

Appendix 4.2.2: Completing the Field Inspection Audit Form (continued)

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 are 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.

Animal Feed Regulatory Program Standards
June 2013

Page 66

Appendix 4.3: Field Inspection Audit Worksheet
State Program:

Reviewed By:

Performance Period:

Date:

Cumulative Score (5):
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)

NIt
(3)

Performance
Factor Score
(3)

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.

Animal Feed Regulatory Program Standards
June 2013

Page 67

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)

NIt
(3)

Performance
Factor Score
(3)

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.

Animal Feed Regulatory Program Standards
June 2013

Page 68

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 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.

Animal Feed Regulatory Program Standards
June 2013

Page 69

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 should 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)

Animal Feed Regulatory Program Standards
June 2013

Page 70

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)

Animal Feed Regulatory Program Standards
June 2013

Page 71

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
June 2013

Signature of Auditor

Date

Page 72

Appendix 4.6: Field Inspection Report Audit Worksheet
State Program:

Reviewed By:

Performance Period:

Date:

Cumulative Score (5):
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)

NIt
(3)

Performance
Factor Score
(3)

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.

Animal Feed Regulatory Program Standards
June 2013

Page 73

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)

NIt
(3)

Performance
Factor Score
(3)

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.

Animal Feed Regulatory Program Standards
June 2013

Page 74

Appendix 4.7.1: 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 should 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)

Animal Feed Regulatory Program Standards
June 2013

Page 75

Appendix 4.7.1: Sample Collection Audit Form (continued)
5. Did the inspector maintain and document sample integrity and security?
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

6. Did the inspector issue a receipt for samples?
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
June 2013

Signature of Auditor

Date

Page 76

Appendix 4.7.2: 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.

Animal Feed Regulatory Program Standards
June 2013

Page 77

Appendix 4.7.2: Completing the Sample Collection Audit Form (continued)

5. Did the inspector maintain and document sample integrity and security?
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 samples?
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.

Animal Feed Regulatory Program Standards
June 2013

Page 78

Appendix 4.8: Sample Collection Audit Worksheet
State Program:

Reviewed By:

Performance Period:

Date:

Cumulative Score (5):
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)

NIt
(3)

Performance
Factor Score
(3)

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.

Animal Feed Regulatory Program Standards
June 2013

Page 79

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)

NIt
(3)

Performance
Factor Score
(3)

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.

Animal Feed Regulatory Program Standards
June 2013

Page 80

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 should 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, manufacturing codes, date codes, lot numbers, batch codes, expiration dates,
and any other referencing manufacture identification was recorded.
Acceptable
Needs Improvement
Comments (required for Needs Improvement)

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

4. 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)

Animal Feed Regulatory Program Standards
June 2013

Page 81

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, or regulatory) 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
June 2013

Signature of Auditor

Date

Page 82

Appendix 4.10: Sample Collection Report Audit Worksheet
State Program:

Reviewed By:

Performance Period:

Date:

Cumulative Score (5):
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)

NIt
(3)

Performance
Factor Score
(3)

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.

Animal Feed Regulatory Program Standards
June 2013

Page 83

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)

NIt
(3)

Performance
Factor Score
(3)

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.

Animal Feed Regulatory Program Standards
June 2013

Page 84

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 reported during an audit should 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
June 2013

Date

Page 85

Appendix 5.1: Self-Assessment Worksheet
Instructions: Specify if each item has been developed. If yes, specify the document reference.
Gathering Information
State program has
Procedure to communicate with
Agency/Department(s) investigating animal illness
Agency/Department(s) investigating animal deaths
Agency/Department(s) investigating feed emergencies
Agency/Department(s) investigating food-related illness
Evaluation and Response
State program has
Standard operating procedure to evaluate incoming information
Documented criteria that determines appropriate response
Incident management via (select one)
Formalized Incident Command System structure
Official action plan
Communication
State program has
List of relevant agencies and emergency contacts
Procedures to
Notify government agencies and departments
Notify law enforcement
Notify appropriate parties
Release information to public*
Guidelines for coordinating media information with other
Jurisdictions

Yes

No

Document Reference

Yes

No

Document Reference

Yes

No

Document Reference

*Includes guidance to consumers and industry to reduce impact of feed-related illnesses, deaths, or emergencies

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards
June 2013

Date

Page 86

Appendix 5.2: Emergency Contact List
This template may be used to develop an emergency contact list. The content, design, and frequency of update should be 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
June 2013

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)

Email

Page 87

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
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
June 2013

Contact Name

Phone Number

Email

(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)

Page 88

Appendix 5.2: Emergency Contact List (continued)
Agency
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)
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
June 2013

Contact Name

Phone Number

Email

(w)
(c)
(w)
(c)
(w)
(c)
(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)

Page 89

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

Update Completed By:
Name

Animal Feed Regulatory Program Standards
June 2013

Date

Page 90

Appendix 6.1: Self-Assessment Worksheet
Instructions: The State program should identify 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.’ The State program should maintain the documented procedures listed in this appendix.
Yes

No
Documented enforcement strategies (plans of action)
Yes

No

Enforcement Strategies

Based on critical and chronic violations and violators
Contain guidelines for selecting enforcement tools
Notes:

Yes

No
Utilize the following factors for selecting enforcement tools
• Compliance history
• Nature of Violation
• Responsiveness
• Impact of Violation
• Scope
• Resources
Yes

No

Each factor has a documented factor description
Each factor has relative conditions
Numerical weight is assigned to each relative condition
Notes:

Yes

No
Documented enforcement matrix
Notes:

Yes

No
Documented process for evaluating enforcement strategies
Notes:

Yes

No
Conducted annual evaluation of enforcement strategies
Date Completed:
Notes:

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards
June 2013

Date

Page 91

Appendix 6.2: Enforcement Tools
This appendix is a list of common enforcement tools that may be used by State feed inspection 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

June 2013

Page 92

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 weights21 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

21

Source of the factors, descriptions, and numerical weights is the AAFCO Enforcement Guidelines-Factor Application section of the
AAFCO 2011 Official Publication (pp. 288-290).
Animal Feed Regulatory Program Standards
Page 93
June 2013

Appendix 6.3: Factors, Descriptions, and Numerical Weights for Consideration When Selecting an
Enforcement Tool (continued)
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.
(1) very limited distribution, quantity, or limited purchaser; violation is limited to a single lot
(2) 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
(3) 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

Animal Feed Regulatory Program Standards

June 2013

Page 94

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

June 2013

Page 95

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 should be
determined by the State program.
Directions for Use of the Enforcement Matrix:
1. Determine the violation categories. The Example Enforcement Matrix 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
June 2013

Page 96

Appendix 6.4: Enforcement Matrix (continued)
Example Enforcement Matrix 22
Factor Value Range
Violation Category
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

22

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

The example enforcement matrix was derived from the Example Violation Chart found in the AAFCO Enforcement GuidelinesFactor Application section of the AAFCO 2011 Official Publication (pp. 288-290).
Animal Feed Regulatory Program Standards
Page 97

June 2013

Appendix 7.1: Self-Assessment Worksheet
Instructions: The State program should identify 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 to communicate with feed
industry, stakeholders, academia, or consumers
Notes:

Yes

No
The State program has an outreach plan
Yes

No

The outreach plan includes:

Types of activities
Target populations
Objectives
Notes:

Yes

No
The State program documents outreach activities
Notes:

Yes

No
The State program documents and evaluates outreach activity events
Notes:

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards

June 2013

Date

Page 98

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:
Type of Outreach
Activity

Target Population

Objective

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

June 2013

Date

Page 99

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.

Completed By:
Name

Animal Feed Regulatory Program Standards

June 2013

Date

Page 100

Appendix 8.1: Self-Assessment Worksheet
Instructions: The State program should identify 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.’ The State program should maintain the documented procedures listed in this appendix.
Yes

No
Documented workplan
Yes

No

Workplan Details

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

Yes

No
Documented procedure for evaluating the workplan
Yes

No

Procedure Details How

Program conducts periodic evaluations
Program conducts annual evaluations
Program evaluates alignment with program objectives and resources
Notes:

Yes

No
Review resources needed to accomplish the workplan and meet inspection and sample projections for
the applicable workplan timeframe
Notes:

Yes

No
Formula to calculate the number of inspectors needed to conduct inspections
Notes:

Yes

No
Numerical values in the formula are verified with data tracked by the State Program
Notes:

Animal Feed Regulatory Program Standards
June 2013

Page 101

Appendix 8.1: Self-Assessment Worksheet (continued)
Yes

No
Inspection and sample collection staff have equipment needed to conduct inspections and sample
collections
Notes:

Yes

No
List of equipment required for inspections and sample collections
Yes

No

List of equipment was

Established by the State program
Maintained by the State program
Notes:

Yes

No
Review resources required to implement the AFRPS
Yes

No

Date

Resource review was

Made concurrently with the baseline evaluation required for AFRPS Standard 9
Reevaluated within three years of previous evaluation
Notes:

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards
June 2013

Date

Page 102

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 %HRI) + (#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

Animal Feed Regulatory Program Standards
June 2013

Page 103

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

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:

[(#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
June 2013

Page 104

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

Animal Feed Regulatory Program Standards
June 2013

Assigned

Available

Not Available

Page 105

Appendix 8.4: Resources for Implementation of AFRPS
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 Illness 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
June 2013

Funding

Staffing

Equipment

Other resources needed

Page 106

Appendix 9.1: Assessment and Improvement Plan
Instructions: This appendix, or a comparable form, must be completed for each standard with the exception of Standard 9: Assessment and Improvement.
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 must be 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

Date Task
Completed

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards
June 2013

Date

Page 107

Appendix 9.2: 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 9.1: Assessment and Improvement Plan should be used
to complete this appendix.
Standard
Number

Self-Assessment
Completion Date

Implementation Status

1

Fully Met

Partially Met

Not Met

2

Fully Met

Partially Met

Not Met

3

Fully Met

Partially Met

Not Met

4

Fully Met

Partially Met

Not Met

5

Fully Met

Partially Met

Not Met

6

Fully Met

Partially Met

Not Met

7

Fully Met

Partially Met

Not Met

8

Fully Met

Partially Met

Not Met

9

Not applicable

10

Fully Met

Partially Met

Not Met

11

Fully Met

Partially Met

Not Met

Evaluation Completed By:
Name

Animal Feed Regulatory Program Standards
June 2013

Date

Page 108

Appendix 10: Self-Assessment Worksheet
Instructions: The State program should identify 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 formal agreements with laboratories outside the program that conduct routine
analytical services
Notes:

Yes

No
The State program has a sample analysis schedule with each laboratory performing routine services
Yes

No

The sample analysis schedule includes:

Type(s) of feed to be analyzed
Number of samples to be collected
Estimated time period for collection
Type(s) of analysis to be performed
Notes:

Yes

No
The State program has standard procedures and a means to communicate that have been developed
by
the program and each laboratory performing routine services
Yes

No

The procedures includes sample:

Submission
Shipping
Preservation
Storage
Retention
Disposal
Change of Custody
Report of Analysis
Notes:

Animal Feed Regulatory Program Standards
June 2013

Page 109

Appendix 10: Self-Assessment Worksheet (continued)

Yes

No
The State program has documentation for each regulatory testing laboratory that verifies it follows
AAFCO QA/QC guidelines, ISO/IEC 17025-2005, or is accredited
Notes:

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards
June 2013

Date

Page 110

Appendix 11: Self-Assessment Worksheet
Program Elements

Yes/No

Specific
Reference 23

Notes

Section I. Sampling Plan
a. Does the State program have a documented
annual sampling plan?
b. Was the sampling plan jointly developed
by the State program and laboratories
performing routine services?
c. Is the sampling plan jointly amended by
the State program and laboratories
performing routine services?
d. Does the sampling plan outline
• The sampling priorities?
• The sampling and analysis schedule?
• Availability/Coordination of laboratory
support?
Section II. Sampling Procedure
Does the State program’s sampling procedure require sample collectors to
a. Follow safety precautions on feed labels?
b. Follow the State program’s safety protocol
for collecting samples?
c. Use appropriate method and equipment to
collect the sample?
d. Seal sample to initiate chain of custody?
e. Maintain and document sample integrity
and security?
f. Issue receipt for sample?
g. Handle, package, and ship sample using
procedures appropriate to prevent
compromising condition of sample?
h. Deliver or ship sample to the appropriate
laboratory within acceptable timeframes?
Does the State program’s sampling procedure provide instructions for documenting the sample collection, including
a. Date of the sample collection?
b. Product identification including
• Name?
• Manufacturing codes?
• Date codes?
• Lot numbers?
• Batch codes?
• Expiration dates?
• Other referencing manufacture
identification?
c. Description of product?
Program Elements

Yes/No

Specific Reference

Notes

23

Reference the document (include section and page number) in which the program element is found.
Animal Feed Regulatory Program Standards
June 2013

Page 111

Appendix 11: Self-Assessment Worksheet (continued)
Section II. Sampling Procedure (continued)
d. Collection information including
• Method of collection?
• Lot sampled?
• Lot size?
• Special techniques used to collect
sample?
e. Location where sample was collected?
f. Name and address of responsible party,
guarantor, possessor, or distributor?
g. Sample type (surveillance, compliance,
investigational, or regulatory)?
h. Analysis requested, if applicable?
i. Product labels, including customer-formula
feed labels, are collected or reproduced?
j. Receiving and distribution information?

Assessment Completed By:
Name

Animal Feed Regulatory Program Standards
June 2013

Date

Page 112