Attachment_14_-_Animal_Feed_Regulatory_Program_Standards_(AFRPS).pdf

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

Office of Regulatory Affairs

Table of Contents

Animal Feed Regulatory Program Standards Page 1 January 30, 2014

Table of Contents 1 Background 4 Introduction 5 Standard 1 Regulatory Foundation 6

Standard 2 Training 8

Standard 3 Inspection Program 14

Standard 4 Auditing 17

Standard 5 Feed-Related Illness or Death and Emergency Response 22

Standard 6 Enforcement Program 24

Standard 7 Outreach Activities 26

Standard 8 Planning and Resources 28

Standard 9 Assessment and Improvement 31

Standard 10 Laboratory Services 33

Standard 11 Sampling Program 35

Appendix 1 Self-Assessment Worksheet 38

Appendix 2.1 Self-Assessment Worksheet 43

Appendix 2.2 Inspector Training Record 44

Appendix 2.3 Field Training Competencies 49

Appendix 3.1 Self-Assessment Worksheet 51

Appendix 3.2 Risk Categorization for Feed Facilities 54

Appendix 4.1 Self-Assessment Worksheet 56

Appendix 4.2.1 Field Inspection Audit Form 58

Appendix 4.2.2 Completing the Field Inspection Audit Form 62

Appendix 4.3 Field Inspection Audit Worksheet 67

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Appendix 4.4 Instructions for Completing the Audit Worksheets 69

Appendix 4.5 Field Inspection Report Audit Form 70

Appendix 4.6 Field Inspection Report Audit Worksheet 73

Appendix 4.7.1 Sample Collection Audit Form 75

Appendix 4.7.2 Completing the Sample Collection Audit Form 77

Appendix 4.8 Sample Collection Audit Worksheet 79

Appendix 4.9 Sample Collection Report Audit Form 81

Appendix 4.10 Sample Collection Report Audit Worksheet 83

Appendix 4.11 Corrective Action Plan 85

Appendix 5.1 Self-Assessment Worksheet 86

Appendix 5.2 Emergency Contact List 87

Appendix 6.1 Self-Assessment Worksheet 91

Appendix 6.2 Enforcement Tools 92

Appendix 6.3 Factors, Descriptions, and Numerical Weights for Consideration When Selecting an Enforcement Tool

Appendix 6.4 Enforcement Matrix 96

Appendix 7.1 Self-Assessment Worksheet 98

Appendix 7.2 Outreach Plan 99

Appendix 7.3 Outreach Activity Event Overview and Evaluation 100

Appendix 8.1 Self-Assessment Worksheet 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 105

Appendix 8.4 Resources for Implementation of AFRPS 106

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Appendix 9.1 Assessment and Improvement Plan 107

Appendix 9.2 Implementation Status of Animal Feed Regulatory Program Standards 108

Appendix 10 Self-Assessment Worksheet 109

Appendix 11 Self-Assessment Worksheet 111

Background

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In the United States, Federal and State government agencies ensure the safety of animal feed1.

The Food and Drug Administration (FDA) is responsible for ensuring that all foods and feeds moving in interstate commerce, except those under the United States Department of Agriculture jurisdiction, are safe, wholesome, and labeled properly. State agencies are responsible for conducting inspections and regulatory activities that help ensure food and feed produced, processed, and distributed within their jurisdictions are safe and in compliance with State laws and regulations. State agencies primarily perform inspections under their own regulatory authority. Some State agencies conduct inspections of feed facilities under contract with the FDA. Because jurisdictions may overlap, FDA and States collaborate and share resources to protect animal feed. To better facilitate a partnership among regulatory authorities, regulatory programs should be equivalent in effect.

Maximizing resources between FDA and the States supports the ongoing work of the Partnership for Food Protection (PFP) to develop an Integrated Food Safety System (IFSS). The FDA and the Association of American Feed Control Officials (AAFCO) are members of the PFP. The draft vision for an IFSS was developed in 20092. 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.

2The 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

Introduction

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The Animal Feed Regulatory Program Standards (AFRPS) establish a uniform foundation for the design and management of State programs3 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 term “should” is used throughout the AFRPS. Program elements and corresponding conditions described as “should” are best practices but are optional and not required to fully implement a standard. To fully implement the AFRPS, the 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.

STANDARD 1

Regulatory Foundation

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1.1 Purpose

This standard describes the elements of the regulatory foundation4 used by a State program to regulate animal feed5.

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 specifies 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.

STANDARD 1

Regulatory Foundation

Animal Feed Regulatory Program Standards Page 7 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

STANDARD 2

Training

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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 provides documentation to support completion of basic and advanced curriculums. For subject areas where such documentation is not available, the State program conducts an evaluation of the inspector’s previous performance and experience to determine if the inspector has completed the required training or whether additional training is needed.

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

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• 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.

• In-house training provided by a government agency

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• Distance learning, for example, satellite downlinks, or web-based training6

• 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

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

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

http://www.fda.gov/ora/training/course_ora.html

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• 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.

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• Distance learning, for example, satellite downlinks, or web-based training7

• 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 hours8 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.

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

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

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

8 One contact hour equals 60 minutes.

http://www.fda.gov/ora/training/course_ora.html

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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

• 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

STANDARD 3

Inspection Program

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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 facilities9 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 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. Review the feed facility’s previous inspection report(s) and complaint(s)

2. Present appropriate credentials and written Notice of Inspection to the feed facility’s owner, operator, or agent in charge; make appropriate introductions;

explain the purpose and scope of the inspection; and determine inspection authority

3. Follow the safety protocols required by the feed facility and the State program

4. Follow the biosecurity protocols required by the feed facility and the State program

5. Use appropriate equipment and forms needed to conduct inspections

6. Establish interstate jurisdiction for FDA inspections, if applicable

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

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7. Recognize the relative risk (high to low) of feed facilities based on the State program’s risk-based inspection program and categorization assigned to a facility or product, the manufacturing processes, and the inspection history of the facility

8. Conduct inspection activities, appropriate for the level of risk, focused on those firms, products, and processes determined to be high risk

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

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

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

12. Distinguish between significant and insignificant observations and isolated incidents versus trends

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

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

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

16. Conduct activities in a professional manner

17. Use effective interviewing techniques

18. Explain findings clearly and adequately throughout the inspection

19. Alert the feed facility’s owner, operator, or agent in charge when an immediate corrective action is necessary

20. Document findings accurately, clearly, legibly, and concisely on the applicable form(s) and provide a copy to the feed facility’s owner, operator, or agent in charge

21. Answer questions and provide information as appropriate, and

22. 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.

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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 food10

• 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

• 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.

STANDARD 4

Auditing

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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.

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A. Field Inspection Audit

A qualified auditor conducts field inspection audits to verify that inspections are consistently performed according to established performance factors.

Frequency

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

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.

Performance Documentation

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.

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.

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.

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Performance Documentation

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.

Appendix 4.6, or comparable worksheet, must be used to calculate performance factor scores and a cumulative score.

C. Sample Collection Audit

A qualified auditor conducts sample collection audits to verify that sample collections are consistently performed according to established 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

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.

Performance Documentation

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.

Appendix 4.8, or comparable worksheet, must be used to calculate performance factor scores and a cumulative score.

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.

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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.

Performance Documentation

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.

Appendix 4.10, or comparable worksheet, must be used to calculate performance factor scores and a cumulative score.

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.

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4.5 Documentation

• 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)

STANDARD 5

Feed-Related Illness or Death and Emergency Response

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5.1 Purpose

This standard describes the functions to detect, identify, and respond to alleged feed-related illnesses, deaths, and emergencies11, 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 events12.

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.

STANDARD 5

Feed-Related Illness or Death and Emergency Response

Animal Feed Regulatory Program Standards Page 23 formalized Incident Command System structure or an official action plan13 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 is 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

• 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).

STANDARD 6

Enforcement Program

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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.

STANDARD 6

Enforcement Program

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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

• 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

STANDARD 7

Outreach Activities

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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, is 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, is 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

• Appendix 7.1: Self-Assessment Worksheet

• Outreach plan

STANDARD 7

Outreach Activities

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• Outreach activity event overview and evaluation

• Documents to verify the outreach activity event occurred

STANDARD 8

Planning and Resources

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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.

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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.