State Egg Regulatory Standards Program

Federal-State Regulatory Program Standards

Egg Standards Regulatory Program 07.21.21

State Egg Regulatory Standards Program

OMB: 0910-0760

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

The collection of information has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.
OMB Control No. (To be entered after assigned)
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TABLE OF CONTENTS
INTRODUCTION .......................................................................................................................... 3
BACKGROUND ............................................................................................................................ 5
DEFINITIONS................................................................................................................................ 6
STANDARD No. 1 Regulatory Foundation ................................................................................. 10
STANDARD No. 2 Training Program ......................................................................................... 12
STANDARD No. 3 Inspection Program ...................................................................................... 18
STANDARD No. 4 Inspection Audit Program ............................................................................ 24
STANDARD No. 5 Egg-Related Illness, Outbreak and Emergency Response ........................... 27
STANDARD No. 6 Compliance and Enforcement Program ....................................................... 31
STANDARD No. 7 Outreach Activities....................................................................................... 33
STANDARD No. 8 Program Resources....................................................................................... 35
STANDARD No. 9 Program Assessment .................................................................................... 38
STANDARD No. 10 Laboratory Support .................................................................................... 41
Appendix 1.1 – Self-Assessment Worksheet ................................................................................ 44
Appendix 1.2 – Regulatory Foundation Worksheet ..................................................................... 46
Appendix 2.1 – Self-Assessment Worksheet ................................................................................ 50
Appendix 2.2 – Inspector Training Record .................................................................................. 55
Appendix 2.3 – Field Training Competencies .............................................................................. 59
Appendix 3.1 – Self Assessment Worksheet ................................................................................ 60
Appendix 4.1 – Self-Assessment Worksheet ................................................................................ 66
Appendix 4.2 – Instructions for Performance Ratings of Audit Findings .................................... 69
Appendix 4.3 – Field Inspection Audit Form ............................................................................... 70
Appendix 4.3a – Performance Rating for the Field Inspection Audits ......................................... 75
Appendix 4.3b – Guidance for Completing the Field Inspection Audit Form ............................. 77
Appendix 4.4 – Inspection Report Audit Form ............................................................................ 86
Appendix 4.4a – Performance Rating for Inspection Report Audits ............................................ 89
Appendix 4.5 – Sample Report Audit Form ................................................................................. 90
Appendix 4.5a – Performance Rating for Sample Report Audits................................................. 93
Appendix 5.1 – Self-Assessment Worksheet ................................................................................ 95
Appendix 6.1 – Self-Assessment Worksheet ................................................................................ 99
Appendix 6.2 – Examples of Enforcement Tools and Progressive Enforcement Actions ......... 100
Appendix 6.3 – Calculation of the Level of Conformance to Compliance Procedures .............. 102
Appendix 6.3a – Instructions for Review of Compliance and Enforcement Procedure ............. 103
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Appendix 7.1 – Self-Assessment Worksheet .............................................................................. 104
Appendix 7.2 – Outreach Activity Event and Self-Evaluation Worksheet ................................ 106
Appendix 7.3 – Outreach Plan .................................................................................................... 107
Appendix 8.1 – Self-Assessment Worksheet .............................................................................. 108
Appendix 8.2 – Example Formula for Calculating the Number of Inspectors Required to Conduct
Inspections of Egg Establishments ................................................................... 110
Appendix 8.3 – Example List of Equipment Used for Inspections and Sample Collections ..... 112
Appendix 8.4 – Resource Summary Report ............................................................................... 114
Appendix 9.1 – Self-Assessment Worksheet .............................................................................. 115
Appendix 9.2 – Self-Assessment Summary Report.................................................................... 118
Appendix 10.1 – Self-Assessment Worksheet ............................................................................ 120

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INTRODUCTION

The Food Safety Modernization Act (FSMA) mandates that the U.S. Food and Drug
Administration (FDA) establish an Integrated Food Safety System (IFSS). An IFSS requires
partnerships between federal, state, local, and tribal agencies to collaborate and leverage
resources to ensure the protection of public health.
The Egg Regulatory Program Standards (ERPS) is a critical component in establishing FDA’s
IFSS. The ERPS, henceforth also referred to as “program standards,” establishes a uniform
foundation for regulatory agencies responsible for oversight of eggs and egg products. When
fully implemented, the program standards define a set of best practices of a regulatory system.
Conformance with the program standards requires a regulatory agency to continuously assess,
evaluate, and take necessary corrective actions to address gaps. ERPS conformance will facilitate
a system of mutual reliance between the FDA and other regulatory agencies and support
continuous improvements in regulatory oversight of eggs and egg products throughout the
nation.
The program standards are comprised of ten standards that establish requirements for the critical
elements of a regulatory program designed to protect the public from egg and egg productrelated illness, injury, outbreaks and emergencies. The elements of these standards include:
regulatory foundation, staff training, inspections, quality assurance, egg and egg product-related
incident response, enforcement, industry outreach, resource management, program assessment
and laboratory support.
Each standard is laid out in the following format to ensure uniformity: purpose statement (x.1),
requirement summary (x.2), description of program elements (x.3), projected outcomes (x.4),
and a list of required documentation (x.5). The program elements describe the best practices of a
quality regulatory program. Required elements for implementation are found in the program
elements (x.3) and documentation (x.5) sections for each standard. Terms in all capital letters
correspond to a defined term in the definition section of the document. The term “should” is
used throughout the program standards. 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 program standards, the regulatory program must implement
all ten standards. “Notes” are used throughout the program standards to provide clarification,
alternatives, and guidance that the state program may use to help implement the program
standards. “Notes” do not contain requirements and thus will not be subject to an FDA
assessment.
The program standards have corresponding self-assessment and supplemental worksheets
designed to assist the regulatory program in achieving and sustaining conformance. 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 program standards.

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FDA will use the program standards as a tool to continuously improve egg inspection contracts
and promote the development of a high-quality egg inspection regulatory program, which
includes a process for continuous improvement based upon quality management systems. The
program standards will assist both FDA and the states in fulfilling their regulatory obligations.
implementation of the program is voluntary. States enrolled in the program standards under a
FDA funding vehicle will be expected to develop and implement improvement plans to
demonstrate that they are moving toward full implementation and to participate in FDA
assessments to determine the level of conformance. States are encouraged to build systems that
are sustainable and implement plans that will result in the standards being maintained in
conformance.
The goal of the ERPS is to implement a nationally integrated, risk-based, egg safety system
focused on protecting public health. The program standards establish a uniform basis for
measuring and improving the performance of prevention, intervention, and response activities of
egg inspection programs in the United States. The development and implementation of these
program standards will help federal and state programs better direct their regulatory activities
toward reducing egg and egg product-related incidents. Consequently, the safety and security of
the U.S. food supply will improve as greater focus is placed on prevention.
The collection of information is approved by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995. The OMB control number is xxxx.

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BACKGROUND

In the U.S., federal and state government agencies ensure the safety of eggs and egg products.
The FDA is responsible for ensuring that all foods moving in interstate commerce, except those
under United States Department of Agriculture (USDA) jurisdiction, are safe, wholesome, and
labeled properly. State agencies conduct inspection and regulatory activities that help ensure
food produced, processed, or sold within their jurisdictions is safe. Many state agencies also
conduct egg inspections under contract with the FDA. These inspections either are performed
under the states’ laws and authorities or the provisions of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) or both.
In an effort towards mutual reliance, FDA and the states should maximize their resources,
particularly when their jurisdictions are overlapping. 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 conducting inspections under the same set of
standards. The ERPS is the newest of several sets of national standards, each with a key role in
strengthening the IFSS: Manufactured Food Regulatory Program Standards (MFRPS), Voluntary
National Retail Food Regulatory Program Standards (VNRFRPS), and the Animal Feed
Regulatory Program Standards (AFRPS). All these 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.
In 2016, FDA awarded cooperative agreements to two state programs with one outcome being to
provide recommendations for national egg regulatory program standards. In 2019 a committee
comprised of officials from FDA, state agencies, academia, industry and the National Egg
Regulatory Officials (NERO) was established to review the recommendations of the awardees.
The result of the committee’s collaborative work is the development of the first edition of the
ERPS, which will strengthen states’ egg regulatory programs. These program standards reflect an
effort in which FDA has been engaged in partnering, leveraging and empowering agencies to
move the vision of a nationally integrated food safety system.

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DEFINITIONS

CONFORMANCE: the fulfillment of a requirement, specifically a state program is using and
can demonstrate the use of a particular element, system, or program listed in the ERPS.
CONSUMER COMPLAINT: are complaints made by the public regarding food products,
facility, practices, labeling, and any other related activities.
CONTACT HOUR: one contact hour equals 60 minutes. An inspector qualifies for one contact
hour of continuing education for each clock hour of participation.
CORRECTION: action to eliminate a detected non-CONFORMANCE.
CORRECTIVE ACTION: action to eliminate the cause of a non-CONFORMANCE and to
prevent recurrence.
CURRENT AND FIT-FOR-USE: “current” indicates that documentation is signed and dated in
accordance with program policies and procedures that meet criteria in the most current standard.
“Fit-for-use” is a quality term used to indicate that a product or service fits the customer’s
defined purpose for that product or service. Documentation may be electronic or hard copy.
DOCUMENT CONTROL: ensures that documents are reviewed for adequacy, approved for
release by authorized personnel and distributed to and used at the location where the prescribed
activity is performed.
EGG: the shell egg of a domesticated avian species such as chicken, duck, goose, guinea, quail,
ratites or turkey. Egg does not include: (a) a balut; or (b) the egg of reptile species, such as
alligator.
EGG AND EGG PRODUCT RELATED INCIDENT: contamination or adulteration
(threatened or actual) of EGG and EGG PRODUCTs that may occur at any point in the
production system (e.g., production, processing, distribution). These incidents may be
unintentional or deliberate and may cause EGG and EGG PRODUCT-related illness, injury,
outbreaks or emergencies from an unforeseen or sudden occurrence requiring immediate action
to protect against substantial risk to animal and/or public health.
EGG HANDLER: any person, excluding the household consumer, who engages in any business
in commerce that involves buying or selling any EGGS or processing any EGG PRODUCTS, or
otherwise using any EGGS in the preparation of human food.
EGG PRODUCER: any person, firm, or corporation that produces EGGS.
EGG PRODUCTS: all, or a portion of, the contents found inside EGGS separated from the shell
and pasteurized in an ESTABLISHMENT, with or without added ingredients, intended for

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human consumption, such as dried, frozen or liquid eggs. Egg Product does not include food
which contains EGGS only in a relatively small proportion such as cake mixes.
ENVIRONMENTAL ASSESSMENT (Also referred to as an “Environmental Health
Assessment”): an on-site EGG and EGG PRODUCT investigation to assess and rule out the
potential that the contaminant of concern was introduced at a particular point in the distribution
or production system. This is achieved by identifying contributing factors and environmental
antecedents.
EQUIVALENT: state law directly references the relevant federal regulation and/or statutes.
EQUIVALENT IN EFFECT: state law can achieve the same regulatory effect as the federal
statutes and/or regulation.
ESTABLISHMENT: a corporate office, factory, outlet, EGG PRODUCER, or other facility
manufacturing, processing, packing, holding, transporting, preparing or selling EGGS at
wholesale or retail.
EVALUATION: an inspection in which the ability of an inspector is assessed to determine if
they are competent to complete independent inspections. The evaluation should assess an
inspector’s ability to: prepare for an inspection, conduct an inspection, follow procedures
identified by the state for the specific type of inspection and communicate during the inspection
and on the inspection report.
FDA ASSESSMENT: a systematic, independent, and documented process for obtaining
objective evidence and evaluating it to determine the extent to which a requirement is met. The
FDA will determine IMPLEMENTATION and CONFORMANCE during each ASSESSMENT.
FIELD INSPECTION AUDIT: an inspection in which a state inspector is accompanied by a
QUALIFIED FIELD INSPECTION AUDITOR (either FDA or state) for the purpose of
assessing the quality and performance of inspections either contract or state. These inspections
may be counted under 2.3.2.3 and 2.3.3.3 Field Training as evaluations, and under 4.3.3 FIELD
INSPECTION AUDIT if Appendix 4.3 is used.
IMPLEMENTATION: means a state program has a particular element, system, or program as
required in the Program Elements and documentation requirements for the ERPS.
INDUSTRY COMPLAINT: complaints made by industry about inspections or inspectors.
JOINT FIELD TRAINING INSPECTION: an inspection conducted jointly by the FDA
and/or state personnel for the purposes of training or enforcement. A joint inspection may be
used to provide training to a state inspector during an inspection of a firm and may either be
trainer led or trainee led.

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LABORATORY: a lab that conducts measurements and analyses on EGG and associated
physical samples, which result in qualitative or quantitative analytical findings that may be used
as a basis for regulatory action.
NO AUTHORITY: responsibility for enforcing a specific section of the federal statutes and/or
regulations lies with another program or agency and not the state program. There is such a state
law, but it does not apply to the state’s program.
NOT EQUIVALENT: (1) There is no state law EQUIVALENT to the relevant federal law or
regulation, or (2) the federal and state laws address the same matter but are inconsistent and do
not have the same regulatory effect.
OUTREACH ACTIVITY EVENT: an outreach activity which the state program hosts, cohosts, or is an invited presenter such as seminars, workshops, conferences, trainings, or meetings
that relate to EGG and EGG PRODUCT topics and that support communication and information
exchange among the EGG industry stakeholders, academia, other regulators, or consumers.
PREVENTIVE ACTION: action to eliminate the cause of a potential non-CONFORMANCE.
QUALIFIED DATE: the qualified date begins when an inspector has completed all course and
field elements and has been signed off to perform independent inspections. This date is used to
calculate the start of the continuing education hours.
QUALIFIED FIELD INSPECTION AUDITOR: an individual who is recognized by the
regulatory jurisdiction’s EGG safety program manager as having field experience and
communication skills necessary to audit other inspectors/investigators and who has: successfully
completed EGG safety inspection training coursework and field training, been assigned this
auditing responsibility, and completed the required audit training per the State program
requirements.
QUALIFIED FIELD INSPECTION TRAINER: an individual who is recognized by the
regulatory jurisdiction’s EGG safety program manager as having field experience and
communication skills necessary to train or supervise other inspectors/investigators and who has:
successfully completed EGG safety inspection training coursework and field training, been
assigned this training responsibility, and state program includes a definition of “qualified trainer”
within their training plan.
REGULATORY FOUNDATION: the law, regulations, rules, ordinances, or other regulatory
requirements that govern an EGG facility.
RECALL AUDIT CHECK: are conducted by the state program to verify the firm’s recall was
successful as defined by the State’s recall procedures.
SAMPLING PROGRAM: a program in which the state collects samples as part of their egg
safety program in one or more of the sampling types as defined in the Partnership for Food
Protection’s (PFP) Food/Feed Testing Laboratories Best Practices Manual (most current
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version). 1 The program can be based on state defined sampling frequency and does not have to
be continuous or routine.
SMALL EGG PRODUCER: any EGG PRODUCER with less than 3,000 hens.
START DATE: date an employee is hired or reassigned in or into the state program as the
beginning date for training timelines.
STRATEGIC IMPROVEMENT PLAN: a type of improvement plan that includes the
following information: (1) the individual element or documentation requirement of the standard
that was not met, (2) improvements needed to meet the program element or documentation
requirement of the standard, (3) projected completion dates for each task, (4) personnel
responsible, and (5) date completed.
VERIFICATION AUDIT INSPECTION: an inspection in which a qualified FDA or state
auditor observes a state qualified auditor performing an audit of a state inspector conducting an
inspection.

Reference: PFP Food/Feed Testing Laboratories Best Practices Manual: https://www.pfp-ifss.org/ifss-resources/human-and-animal-foodtesting-laboratories-best-practices-manual-december-2018/

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STANDARD No. 1
Regulatory Foundation
Purpose
This standard describes the elements of the REGULATORY FOUNDATION used by the
state program to regulate EGGS.
Requirement Summary
The state program evaluates the scope of its legal authority and regulatory provisions to
ensure the protection of EGGS within its jurisdiction. The state program’s 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) and
Code of Federal Regulations (CFR) specified in Appendix 1.2.
Program Elements
1.3.1

Evaluation of Legal Authority
The state program has a written procedure to evaluate the legal authority and
regulatory provisions to inspect and investigate, gather evidence, collect and
analyze samples and take regulatory actions under state law to ensure the safety
and security of EGGS. The written procedure must:
1.3.1.1
1.3.1.2

1.3.1.3

Include timeframes for a REGULATORY FOUNDATION evaluation.
Describe the REGULATORY FOUNDATION evaluation process, to
include whenever significant changes are made to applicable federal
and/or state laws and regulations; and
Address the statutes, regulations, rules, ordinances, and other
prevailing regulatory requirements that:
1.3.1.3.1 Apply to the regulation of EGGS;
1.3.1.3.2 Delegate authority to the state program;
1.3.1.3.3 Describe the state program’s administrative procedures for
rulemaking to protect public health; and
1.3.1.3.4 Identifies and lists other state or federal agencies that have
authority for any area of the REGULATORY
FOUNDATION that the state program lacks.

1.3.2

REGULATORY FOUNDATION Evaluation
1.3.2.1

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The state program must complete Appendix 1.2 or equivalent form.
The state program conducts an evaluation to determine if they are
EQUIVALENT, EQUIVALENT IN EFFECT, NOT EQUIVALENT,

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1.3.2.2

or NO AUTHORITY to sections of the current FD&C Act and CFR
Title 21 specified in Appendix 1.2.
If the state program has laws and regulations pertinent to the
regulation of EGGS, for which there are no federal provisions, these
laws and regulations can also be listed in Appendix 1.2 or equivalent
form.

Note: In conducting an evaluation, the state program should consult with legal counsel when
state law does not provide for incorporation of subsequent revisions of the FD&C Act and CFR,
the revision date of the CFR is unknown, or the federal law or regulation is partially written into
state law or regulation.
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 EGGS.
Documentation
The state program maintains the records listed here.
1.5.1 State program’s written REGULATORY FOUNDATION evaluation procedure.
1.5.2 The statutes, regulations, rules, ordinances, and other prevailing regulatory
requirements that: (1) apply to the regulation of EGGS, (2) delegate authority to
the state program, (3) describe the state program’s administrative procedures for
rulemaking to protect public health, (4) identify and list other state or federal
agencies that have authority for any area of the REGULATORY FOUNDATION
that the state program lacks.
1.5.3 Appendix 1.1 Self-Assessment Worksheet (or equivalent forms)
1.5.4 Appendix 1.2 Regulatory Foundation Worksheet (or equivalent forms)
1.5.5 If applicable, review by legal counsel

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STANDARD No. 2
Training Program
Purpose
This standard defines the essential elements of a training program for inspectors in a state
program to ensure they will have the knowledge, skills, and capabilities to competently
inspect ESTABLISHMENTS.
Requirement Summary
The state program establishes a written training plan that promotes development and
demonstrates that all inspectors who will conduct inspections complete coursework, field
training, and continuing education to adequately perform their work.
Program Elements
2.3.1

Training Plan and Training Records
2.3.1.1

2.3.1.2

2.3.1.3
2.3.1.4
2.3.1.5

The state program uses a written training plan that ensures all
inspectors receive training required to adequately perform their work
assignments. The training plan includes curriculum for basic and
advanced inspection training and continuing education. Curriculum
consists of coursework and field training.
The state program maintains a training history for active inspectors.
The training history for all inactive inspectors must be kept for three
years or per the state’s record retention policy.
The state program maintains records documenting the training
completed by all inspectors using Appendix 2.2, or an equivalent form.
The state program’s training record summary and individual training
records must include the inspector’s START DATE.
For inspectors with greater than five years of experience at the date of
the initial self-assessment, where their training documentation is not
available the state program will:
2.3.1.5.1

2.3.1.5.2
2.3.2

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; and
Document the results of the EVALUATION.

Basic Inspection Training: The state program requires that each inspector
completes inspection training curriculum.

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2.3.2.1

2.3.2.2

Timeframe: The basic inspection training curriculum shall be
successfully completed within 24 months of the inspector’s START
DATE with the state program.
Coursework: The basic inspection training consists of coursework in
the subject areas listed in this section.
2.3.2.2.1
2.3.2.2.2
2.3.2.2.3
2.3.2.2.4
2.3.2.2.5
2.3.2.2.6
2.3.2.2.7
2.3.2.2.8
2.3.2.2.9

2.3.2.3

Field Training: The state program has an established basic field
training program to complement the coursework curriculum which
specifies the following:
2.3.2.3.1
2.3.2.3.2

2.3.2.3.3
2.3.2.3.4

2.3.2.3.5

2.3.2.3.6

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Prevailing statutes, regulations, and ordinances
Public health principles
Biosecurity protocols and procedures
Emergency management
Communications skills
Basic microbiology
Basics of HACCP
Basic sampling technique and preparation
State program EGG safety inspection manuals and
guidance

The inspector must complete the field training program
prior to performing basic independent inspections;
Field training checklist of competencies to be mastered and
verified in the field by the QUALIFIED FIELD
INSPECTION TRAINER or QUALIFIED FIELD
INSPECTION AUDITOR;
Written procedures for JOINT FIELD TRAINING
INSPECTIONS;
Number of JOINT FIELD TRAINING INSPECTIONS or
FIELD INSPECTION AUDITS that are conducted in
ESTABLISHMENTS that are representative of the
ESTABLISHMENTS in the state program inventory, as
well as the type of work that will be performed by the
inspector;
The qualifications, education, and experience necessary to
be identified as a QUALIFIED FIELD INSPECTOR
TRAINER and/or QUALIFIED FIELD INSPECTION
AUDITOR;
Appendix 2.3 or an equivalent form must be used to list the
competencies and the minimum number of JOINT FIELD
TRAINING INSPECTIONS.

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2.3.3

Advanced Training: The advanced inspection training consists of curriculum in
the subject areas listed in this section. Each inspector who will conduct advanced
EGG inspections will complete the relevant coursework and field training as
described below.
2.3.3.1

2.3.3.2

Timeframe: The advanced inspection training curriculum shall be
successfully completed within the timeframe specified by the state
program.
Coursework: The advanced inspection training consists of coursework
in the subject areas listed in this section.
2.3.3.2.1

EGG Safety Inspections: Complete coursework required to
conduct inspections of ESTABLISHMENTS under the
oversight of the state program, which may include the EGG
safety regulations (21 CFR 115 and 21 CFR 118).
2.3.3.2.2 Traceback investigations
2.3.3.2.3 Foodborne illness investigations
2.3.3.2.4 Other training as developed by the state program
Note: Traceback investigations and foodborne illness investigations advanced training courses
are not subject to 2.3.2.2 Field Training requirements.
2.3.3.3

Field Training: The state program has an established advanced field
training program to complement the coursework curriculum which
specifies the following:
2.3.3.3.1
2.3.3.3.2
2.3.3.3.3

2.3.3.3.4

The inspector must complete the field training program
prior to performing advanced independent inspections;
Participate in two JOINT FIELD TRAINING
INSPECTIONS;
After successful completion of the coursework, participate
in one EVALUATION or FIELD INSPECTION AUDIT
that is found to be acceptable by a QUALIFIED FIELD
INSPECTION TRAINER or QUALIFIED FIELD
INSPECTION AUDITOR; and
Within one year after being released to do advanced
inspections complete a second EVALUATION or FIELD
INSPECTION AUDIT that is found to be acceptable by
QUALIFIED FIELD INSPECTION TRAINER or
QUALIFIED FIELD INSPECTION AUDITOR.

Note: Should the course used to satisfy 2.3.2.2.1 include hands-on training at an
ESTABLISHMENT, the participation may be counted as one of the two JOINT FIELD
TRAINING INSPECTIONS required under 2.3.2.3.1.

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Note: States may add or further subdivide their training by identifying coursework required for
inspectors who only inspect EGG distribution/warehouses/retail facilities. The coursework must
be clearly defined in the state program training plan.
2.3.4

Continuing Education
The goal of continuing education is to build upon the inspector’s knowledge base
and enhance their skills and ability to perform inspections. The training plan must
include:
2.3.4.1
2.3.4.2
2.3.4.3

2.3.4.4

Each inspector must accumulate 20 CONTACT HOURS of continuing
education every 36 months.
The 36-month continuing education interval starts at the QUALIFIED
DATE, when the training cycle is completed.
The state program may establish an alternate timeframe to track
continuing education as long as the alternate timeframe and how that
timeframe still meets or exceeds the intent of the standard (at least 20
CONTACT HOURS every 36 months) are clearly identified in
program procedures.
The inspector qualifies for CONTACT HOURS by participation in any
of the following activities that are related specifically to EGG
inspectional work:
2.3.4.4.1

2.3.4.4.2
2.3.4.4.3
2.3.4.4.4
2.3.4.4.5
2.3.4.4.6
2.3.4.4.7

2.3.4.5

Attendance at national or regional seminars/technical
conferences, such as National Egg Quality School (NEQS)
or National Egg Regulatory Officials (NERO);
Professional symposiums/college courses;
Training provided by government agencies (e.g., FDA,
USDA, state, local);
In-house training provided by state government agencies;
Conferences and workshops;
Distance learning opportunities; or
Training approved by a QUALIFIED FIELD
INSPECTION TRAINER.

Of the accumulated 20 CONTACT HOURS of continuing education, a
maximum of 10 CONTACT HOURS may be accrued from the
following EGG-related activities:
2.3.4.5.1 Delivering presentations at professional conferences;
2.3.4.5.2 Providing classroom and/or field training to inspectors, or
being a course instructor; or
2.3.4.5.3 Publishing an original article in a peer-reviewed
professional or trade association journal/periodical.

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2.3.4.6

Documentation must accompany each activity submitted for
continuing education credit. Examples of acceptable documentation
may include:
2.3.4.6.1

2.3.4.6.2
2.3.4.6.3
2.3.4.6.4

2.3.4.6.5
2.3.4.6.6

2.3.5

Certificates of completion indicating the course date(s)
and number of hours attended or continuous education
credits granted;
Transcripts from a college or university;
A letter from the administrator of the continuing education
program attended;
A copy of the peer-reviewed article or presentation made
at a professional conference; or documentation to verify
technical publications related to EGG safety have been
read including completion of self-assessment quizzes that
accompany journal articles, written summaries of key
points/findings presented in technical publications, and/or
written book reports;
An agenda and attendance roster; or
Documentation approved by the QUALIFIED FIELD
INSPECTION TRAINER or QUALIFIED FIELD
INSPECTION AUDITOR.

Coursework Sources: Basic, advanced, and continuing education coursework
must be obtained from one of the sources listed here:
2.3.5.1
2.3.5.2
2.3.5.3

Training provided by a government agency (including in-house
training);
Distance learning, for example, satellite downlinks or web-based
training;
Colleges, schools, research centers, and institutes.

Outcome
The state program has trained inspectors with the knowledge, skills, and abilities to
competently inspect, conduct investigations, gather evidence, collect samples, and take
enforcement actions regarding EGG PRODUCERS.
Documentation
The state program maintains the records listed here.
2.5.1 Written Training Plan
2.5.2 Appendix 2.1 Self-Assessment Worksheet (or equivalent form)
2.5.3 Appendix 2.2 Inspector Training Record (or equivalent form)
2.5.4 Appendix 2.3 Field Training Competencies (or equivalent form)
Egg Regulatory Program Standards

December 2020

2.5.5
2.5.6
2.5.7
2.5.8

Documents verifying successful completion of required courses
Evaluation for experienced inspectors
FIELD TRAINING INSPECTIONS, EVALUATIONS or FIELD INSPECTION
AUDITS
Documentation for continuing education credit

Egg Regulatory Program Standards

December 2020

STANDARD No. 3
Inspection Program
3.1

Purpose
This standard describes the elements of an effective EGG safety inspection program.

3.2

Requirement Summary
The state program has written EGG safety inspection and sampling procedures. These
procedures provide the foundation for inspecting and sampling at EGG PRODUCERS and
EGG HANDLERS to determine compliance with the laws administered by Federal and
State jurisdictions.

3.3

Program Elements
3.3.1

Risk-based Inspection Program
The state program has written procedures to:
3.3.1.1

3.3.1.2

Define an up-to-date inventory of registered EGG PRODUCERS and
EGG HANDLERS for which the state has regulatory oversight. The
inventory is categorized by the risk associated with the likelihood that
an EGG AND EGG PRODUCT RELATED INCIDENT will occur.
Determine a firm’s level of associated risk and the program’s
inspectional priorities. The state program must use the risk factors and
associated criteria as described in:
3.3.1.2.1

FDA’s Multi-Criteria Decision Analysis Methodology
Used to Prioritize Inspections of Egg Farms for Monitoring
Compliance with the Egg Safety Rule; 2 or
3.3.1.2.2 FD&C Act, Section 421 (a)(1); or
3.3.1.2.3 The state program may choose to develop its own riskbased assessment. If the state program chooses to develop
its own risk factor and classification criteria a written
rationale must be provided that demonstrates how public
health is protected.

3.3.1.3

3.3.2

Prioritize and assign inspection frequencies based on established risk
categories.

Inspection Procedure

FDA’s Multi-Criteria Decision Analysis Methodology Used to Prioritize Inspections of Egg Farms for Monitoring Compliance with the Egg
Safety Rule: https://www.fda.gov/media/81379/download

Egg Regulatory Program Standards

December 2020

The state program has a written procedure for inspecting EGG PRODUCERS and
EGG HANDLERS that require the inspectors to:
3.3.2.1
3.3.2.2

3.3.2.3

Review the ESTABLISHMENT’S previous inspection report,
CONSUMER COMPLAINTS, and current disease status;
Have appropriate equipment and forms. Equipment must be verified,
operated and maintained as defined by the state program’s procedures
which may include manufacturer’s recommendations;
Behave professionally and demonstrate proper biosecurity practices
during the inspection similar to those found in:
3.3.2.3.1 Compliance Policy Guidance Manual (CPGM); 3 or
3.3.2.3.2 FDA Investigation Operations Manual (IOM). 4

3.3.2.4
3.3.2.5
3.3.2.6
3.3.2.7
3.3.2.8
3.3.2.9
3.3.2.10

3.3.2.11
3.3.2.12
3.3.2.13
3.3.2.14
3.3.2.15
3.3.2.16

Follow safety protocols required by the facility and the state program;
Make appropriate introductions and explain the purpose and scope of
the inspection;
Establish jurisdiction;
Determine the ESTABLISHMENT registration status;
Use suitable interviewing techniques;
Assess employee practices critical to the safe and sanitary production,
processing and storage of EGGS;
Evaluate conditions, practices, components, and/or labeling that could
cause the product to be adulterated or misbranded or otherwise in
violation of applicable law(s);
Recognize significant violative conditions or practices, if present, and
record findings consistent with state program procedures;
Review and verify that records and procedures for the
ESTABLISHMENT’S operation are being kept and properly followed;
Collect adequate evidence and documentation to support inspection
observations in accordance with state program procedures;
Verify correction of deficiencies that were identified during previous
inspections;
Evaluate the ESTABLISHMENT operations through on-site
inspectional observations;
Alert the ESTABLISHMENT’S person in charge when an immediate
action is necessary to correct a violation;

Reference: FDA Compliance Program Guidance Manual 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg Safety
Rule” can be found: https://www.fda.gov/downloads/Food/ComplianceEnforcement/FoodCompliancePrograms/UCM555664.pdf

Reference: FDA’s IOM contains several relevant chapters including the following: Chapter 4- Sampling, Chapter 5- Establishment Inspections
(includes biosecurity requirements) and Chapter 7- Recall Activities: https://www.fda.gov/inspections-compliance-enforcement-and-criminalinvestigations/inspection-references/investigations-operations-manual

Egg Regulatory Program Standards

December 2020

3.3.2.17
3.3.2.18
3.3.2.19

3.3.3

Explain findings clearly and adequately throughout the inspection;
Answer questions and provide information in an appropriate manner;
and
Write findings accurately, clearly and concisely and provide a copy to
the ESTABLISHMENT’S person in charge.

Inspection Report Procedure
The state program has a written inspection report procedure that requires
inspectors to:
3.3.3.1
3.3.3.2
3.3.3.3
3.3.3.4

3.3.4

Document significant violative conditions or practices, if present,
consistent with state program procedures;
Accurately complete the inspection report;
Submit the inspection report within designated timeframes consistent
with state program procedures;
Follow up with corrective, compliance, and enforcement actions as
warranted.

Recalls 5
The state program has a recall system with written recall procedures for:
3.3.4.1
3.3.4.2
3.3.4.3

3.3.5

Sharing information about recalls with relevant industry and partner
agencies; and
Ensuring recalled products are removed promptly from the market;
and
Performing RECALL AUDIT CHECKS.

Complaints
3.3.5.1

The state program has a written system for handling CONSUMER
COMPLAINTS. The system contains procedures for:
3.3.5.1.1
3.3.5.1.2
3.3.5.1.3
3.3.5.1.4
3.3.5.1.5
3.3.5.1.6

3.3.5.2

Receiving;
Tracking;
Evaluating;
Responding to;
Closing; and
Maintaining records of CONSUMER COMPLAINTS.

The state program has a written system for handling INDUSTRY
COMPLAINTS. The system contains written procedures for:

Reference: PFP Best Practices for Improving FDA and State Communication During Recalls https://www.pfp-ifss.org/ifss-resources/bestpractices-for-improving-fda-and-state-communications-during-recalls-summer-2015/
Egg Regulatory Program Standards

December 2020

3.3.5.2.1
3.3.5.2.2
3.3.5.2.3
3.3.5.2.4
3.3.6

Receiving;
Evaluating;
Responding to; and
Maintaining records of INDUSTRY COMPLAINTS.

SAMPLING PROGRAM
3.3.6.1

State programs that conduct EGG and/or environmental sampling,
must have a written sampling plan in place. 6 The state program shall
develop, coordinate, and document a written annual sampling plan that
includes:
3.3.6.1.1
3.3.6.1.2
3.3.6.1.3
3.3.6.1.4
3.3.6.1.5

3.3.6.2

Sampling priorities;
Number of samples;
Type of samples;
The sample analysis schedule; and
Availability or coordination of analytical LABORATORY
support.

For the state programs that conduct environmental or EGG sampling, a
SAMPLING PROGRAM must have written sampling procedures that
include:
3.3.6.2.1

Methods for Collecting Storing/Transporting and
Documenting Samples
3.3.6.2.1.1

3.3.6.2.1.2
3.3.6.2.1.3
3.3.6.2.1.4
3.3.6.2.1.5

Follow the state program’s sampling
policies, and procedures to assure sample
integrity, security, accountability, and chain
of custody;
Use appropriate method and equipment to
collect the sample;
Seal sample to initiate chain of custody;
Maintain and document sample integrity,
security and chain of custody;
Handle, package, and ship sample to ensure
sample integrity and prevent compromising
condition of sample; and

Reference: FDA’s Environmental Sampling and Detection of Salmonella in Poultry Houses:
https://www.fda.gov/food/foodscienceresearch/laboratorymethods/ucm114716.htm

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December 2020

3.3.6.2.1.6

3.3.6.2.2

Instructions for documenting the sample collection must
include the following elements when applicable to the
States’ SAMPLING PROGRAM
3.3.6.2.2.1
3.3.6.2.2.2

3.3.6.2.2.3
3.3.6.2.2.4
3.3.6.2.2.5

3.3.6.2.2.6
3.3.6.2.2.7
3.3.6.2.2.8
3.3.6.2.2.9

3.3.6.3

3.4

Deliver or ship sample to the appropriate
LABORATORY within acceptable
timeframes.

Date of sample collection;
Sample identification which may include:
name, firm, house, sample number assigned
by the sampler at the time of collection and
type (EGG, belt, manure, walkway, etc.);
Method of collection and any special
techniques used to collect sample;
Location where sample was collected;
Reason for collection (surveillance,
compliance, investigational, regulatory or
other);
Analysis requested;
Receiving and distribution information;
Observations recorded at the time of
collection; and
Product labels or specific labeling
information that is collected or reproduced
per state policies.

State programs are not required to have a written sampling procedure
or sampling plan unless they collect samples. However, these
programs must have a statement in lieu of sampling procedures that
explains why a SAMPLING PROGRAM is not supported and how the
public health is protected because another state or federal agency
collects samples and fulfills this need. The statement should include
the name of the agency and the type of samples that it collects.

Outcome
The state program is based on an inspection program that reduces the occurrence of EGG
AND EGG PRODUCT RELATED INCIDENTS.

3.5

Documentation
The state program maintains the records listed here.
3.5.1

Appendix 3.1 Self-Assessment Worksheet (or equivalent form)

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3.5.2
3.5.3
3.5.4
3.5.5
3.5.6
3.5.7
3.5.8
3.5.9
3.5.10
3.5.11

An inventory of EGG PRODUCERS and EGG HANDLERS
Written procedures of a risk-based inspection program
Written inspectional report findings
Written inspectional report procedure
Written recall system which includes written recall procedures
Written procedures for CONSUMER COMPLAINTS
Written procedures for INDUSTRY COMPLAINTS
Written sampling plan
Written sampling procedures
Written statement stating how public health is protected in lieu of written
sampling plan and sampling procedures

Egg Regulatory Program Standards

December 2020

STANDARD No. 4
Inspection Audit Program
Purpose
This standard describes auditing procedures necessary for a state program to (1) evaluate
the effectiveness and accuracy of the inspection program, inspection records, and
sampling records; and (2) identify best practices used to achieve quality inspections and
sample collections.
Requirement Summary
The state program has a written process that conducts audits to assess the effectiveness
and accuracy of its inspections and sample collections. The auditing procedures have two
components: (1) a FIELD INSPECTION AUDIT component, which is an on-site
performance evaluation of inspections and, if applicable, sample collections, and (2) a
desk audit component, which is a performance review of the written reports of inspections
and sample collections.
Program Elements
4.3.1

Audit Program
The state program has written procedures for:
4.3.1.1
4.3.1.2
4.3.1.3
4.3.1.4
4.3.1.5

FIELD INSPECTION AUDITS as described in section 4.3.3;
Inspection report audits as described in section 4.3.4;
Sample report audits as described in section 4.3.5;
CORRECTIVE ACTIONS as described in section 4.3.6; and
VERIFICATION AUDIT INSPECTIONS of QUALIFIED FIELD
INSPECTION AUDITORS.

4.3.2

A review of the performance factor scores and cumulative scores for each type of
audit is completed at least every 12 months.

4.3.3

FIELD INSPECTION AUDIT
4.3.3.1

4.3.3.2

Egg Regulatory Program Standards

A QUALIFIED FIELD INSPECTION AUDITOR conducts FIELD
INSPECTION AUDITS to verify that inspections are consistently
performed according to the state’s written procedures described in
Standard 3.
Frequency: A minimum of one FIELD INSPECTION AUDIT of each
inspector is conducted every 36 months. Inspections selected for audits
should include the highest risk firms that the inspector is trained for
including advanced EGG inspections.

December 2020

4.3.3.3

4.3.3.4

4.3.4

If samples are collected during the FIELD INSPECTION AUDIT, the
collection of the samples shall also be audited, and the appropriate
question(s) answered on Appendix 4.3.
Performance is documented on Appendices 4.3 and 4.3a or equivalent
forms that meet the program elements in Standard 3, section 3.3.2.

Inspection Report Audit
4.3.4.1

4.3.4.2

The state program conducts annual reviews of inspection reports to
verify that inspectional findings are obtained and reported according to
established written procedure. The quality of each inspection report is
audited using the performance factors listed in Appendix 4.4 or
equivalent form.
The state program will review a random selection of inspection reports
based on the number of inspections performed in the last 12 months
using the table below:
Number of
inspections in 12
Months
Less than 40
inspections
40 – 800
inspections
More than 800
inspections

4.3.4.3
4.3.4.4

4.3.5

Minimum Number
of Reports
Required

Maximum Number
of Reports
Required

All

5% of reports

Seven percent (7%) of the inspection reports reviewed must be taken
from field inspections that were audited.
Performance is documented on Appendices 4.4 and 4.4a, or equivalent
forms.

Sample Report Audit
4.3.5.1

4.3.5.2

Egg Regulatory Program Standards

If samples are collected by the EGG program, the auditing procedures
require an annual review of sample reports to verify that sample
information is obtained and reported according to the established
written procedure described in Standard 3.
The state program will review a random selection of sample reports
based on the number of samples collected in the last 12 months using
the table below:

December 2020

Number of
samples in 12
Months
Less than 40
reports
40 – 800 reports
More than 800
reports
4.3.5.3
4.3.5.4

4.3.6

Minimum Number
of Reports
Required

Maximum Number
of Reports
Required

All

5% of reports

Performance is documented on Appendices 4.5 and 4.5a, or equivalent
forms.
Sample report audits do not need to be performed unless samples are
collected.

CORRECTIVE ACTIONS
The state program shall initiate CORRECTIVE ACTIONS as described in 9.3.5
for the FIELD INSPECTION AUDIT, inspection report audit, and sample report
audit, when one or more of the conditions below are met:
4.3.6.1
4.3.6.2
4.3.6.3

An individual receives an overall rating of “needs improvement”;
A single performance factor for the program falls below 80%; or
An overall rating for the program falls below 80%.

Outcome
The state program systematically evaluates and improves its inspection and sample
collection systems to ensure that activities and information are adequate, complete, and
comply with their procedures and policies.
Documentation
The state program maintains the records listed here.
4.5.1 Written auditing procedures
4.5.2 Appendix 4.1 Self-Assessment Worksheet (or equivalent form)
4.5.3 Appendix 4.3 Field Inspection Audit Form (or equivalent form)
4.5.4 Appendix 4.3a Performance Rating for Field Inspection Audits (or equivalent
form)
4.5.5 Appendix 4.4 Inspection Report Audit Form (or equivalent form)
4.5.6 Appendix 4.4a Performance Rating for Inspection Report Audits (or equivalent
form)
4.5.7 Appendix 4.5 Sample Report Audit Form (or equivalent form)
4.5.8 Appendix 4.5a Performance Rating for Sample Report Audits (or equivalent
form)

Egg Regulatory Program Standards

December 2020

STANDARD No. 5
Egg-Related Illness, Outbreak and Emergency Response
5.1

Purpose
This standard describes the functions to detect, identify, and respond to alleged EGG
AND EGG PRODUCT RELATED INCIDENTS including coordinating roles and
responsibilities with other jurisdictions and communicating with appropriate parties.

5.2

Requirement Summary
The state program has written procedures to conduct a response to EGG AND EGG
PRODUCT RELATED INCIDENTS. The state program describes surveillance,
investigation/ENVIRONMENTAL ASSESSMENT, control measures and post-response
activities in collaboration with other agencies and jurisdictions for responding to reports
of EGG AND EGG PRODUCT RELATED INCIDENTS, whether unintentional or
deliberate, and for generating recommendations for foodborne illness prevention related to
EGG and EGG PRODUCTS.

5.3

Program Elements
5.3.1

Coordination of EGG AND EGG PRODUCT RELATED INCIDENTS Response
Activities with Other Authorities.
5.3.1.1

5.3.1.2

Memorandum of understanding with other state agencies. If the
responsibility for state EGG AND EGG PRODUCT RELATED
INCIDENTS is assigned to another state agency, a memorandum of
understanding with this agency is required to fulfill the requirements
of this standard.
The state program has a written procedure that:
5.3.1.2.1

Identifies and describes the roles, duties, and
responsibilities of each program for the requirements in
5.3.2 through 5.3.5;
5.3.1.2.2 Describes agency collaboration as necessary with FDA and
other appropriate local, state and federal authorities in
multi-jurisdictional EGG AND EGG PRODUCT
RELATED INCIDENTS;
5.3.1.2.3 Designates response coordinator(s) to guide program
investigation efforts in collaboration with all agencies
involved and manage events using a formalized Incident
Command System (ICS) structure or an response action
plan that includes:
5.3.1.2.3.1

Egg Regulatory Program Standards

Identifying and executing investigation
objectives;
December 2020

5.3.1.2.3.2
5.3.1.2.3.3
5.3.1.2.3.4
5.3.1.2.4

5.3.1.2.5

Managing communications;
Implementing control measures; and
Conducting post-response activities.

Describes how all government agencies, departments, or
appropriate parties are rapidly notified of relevant findings
in cases of EGG AND EGG PRODUCT RELATED
INCIDENTS; and
Provides guidance for the immediate notification of law
enforcement agencies when intentional EGG AND EGG
PRODUCT RELATED INCIDENTS or terrorism are
suspected or threatened.

Note: These procedures facilitate sharing of information to identify potential EGG AND EGG
PRODUCT RELATED INCIDENTS, and cross-sector events.
5.3.1.3

5.3.1.4

5.3.2

The state program maintains a list of relevant agencies and emergency
contacts that is reviewed and updated according to a frequency defined
by the state.
The state program maintains records associated with procedures
required in Program Elements 5.3.1-5.3.5.

Surveillance
The state program has written procedures to:
5.3.2.1

5.3.2.2

5.3.3

Uses epidemiological information from appropriate departments or
agencies (federal, state, or local) to detect EGG AND EGG
PRODUCT RELATED INCIDENTS; and
Maintains notifications of EGG AND EGG PRODUCT RELATED
INCIDENTS that are reported to the program in a log or database.

Investigation/ENVIRONMENTAL ASSESSMENT
The state program:
5.3.3.1

Has a written procedure with recommended timeframes and criteria to
investigate EGG AND EGG PRODUCT RELATED INCIDENTS that
include:
5.3.3.1.1 Determining the appropriate response;
5.3.3.1.2 Initiating the response; and
5.3.3.1.3 Completing the response.

5.3.3.2

Egg Regulatory Program Standards

Has a written procedure to collect environmental data similar to those
found in:
28

December 2020

5.3.3.2.1

International Association for Food Protection’s (IAFP)
“Procedures to Investigate a Foodborne Illnesses"
5.3.3.2.2 Council to Improve Foodborne Outbreak Response’s
(CIFOR) “Guidelines for Foodborne Disease Outbreak
Response” 7
5.3.3.2.3 FDA CPGM 7303.836 “Inspection of Egg Farms for
Monitoring Compliance with Egg Safety Rule”2
5.3.3.2.4 FDA IOM Chapter 4 “Sampling” and IOM Chapter 5
“Establishment Inspection” Subchapter 5.2.10 “Routine
Biosecurity Procedures for Visits to Facilities Housing and
Transporting Domestic or Wild Animals”3
5.3.3.3

5.3.3.4

Has a written procedure to coordinate the traceback and traceforward
of EGG and EGG PRODUCTS found to contain a hazard or that are
implicated in an illness, injury, or outbreak.
Has access to LABORATORY support for investigation of reports of
EGG AND EGG PRODUCT RELATED INCIDENTS.

Note: Specific requirements for support are contained in Standard 10.
5.3.3.5

5.3.4

Correlates and analyzes ENVIRONMENTAL ASSESSMENT data to
identify contributing factors and antecedents that led to EGG AND
EGG PRODUCT RELATED INCIDENTS.

Control Measures
The state program:
5.3.4.1

5.3.4.2

5.3.5

Mitigates and contains EGG AND EGG PRODUCT RELATED
INCIDENTS through strategies that include industry education and
outreach, enforcement and public awareness activities; and
Maintains a written procedure for releasing prevention guidance and
information to the public (includes identifying a media person and
developing guidelines for coordinating media information with other
jurisdictions) to reduce the impact of EGG AND EGG PRODUCT
RELATED INCIDENTS.

Post-Response
The state program has written procedures to:
5.3.5.1

Maintain program investigation and ENVIRONMENTAL
ASSESSMENT findings and reports;

Council to Improve Foodborne Outbreak Response (CIFOR). Guidelines for Foodborne Disease Outbreak Response:
https://cifor.us/clearinghouse/cifor-guidelines-for-foodborne-disease-outbreak-response

Egg Regulatory Program Standards

December 2020

5.3.5.2

5.3.5.3

5.4

Distribute final program investigation report(s), including an
ENVIRONMENTAL ASSESSMENT, if completed, to relevant
agencies responsible for reporting contributing factors and antecedents
to CDC; and
Distribute recommendations, when available, from investigation and
ENVIRONMENTAL ASSESSMENT findings and reports to relevant
agencies and stakeholders responsible for prevention, education and
outreach.

Outcome
The state program has written procedures for documenting and investigating EGG AND
EGG PRODUCT RELATED INCIDENTS within the program’s authority. The program
has established communication pathways with government agencies, departments, or
appropriate parties to gather and share information to stop, control and prevent EGG AND
EGG PRODUCT RELATED INCIDENTS.

5.5

Documentation
The program maintains the records listed here:
5.5.1
5.5.2
5.5.3
5.5.4
5.5.5
5.5.6
5.5.7
5.5.8
5.5.9
5.5.10
5.5.11

Appendix 5.1 Self-Assessment Worksheet (or equivalent form)
Memorandums of Understanding, if applicable
Written procedures for coordination
Emergency contact list
Records associated with procedures required in Program Elements 5.3.1-5.3.5
Written procedures for surveillance
Log(s) or database(s) that tracks notification of EGG AND EGG PRODUCT
RELATED INCIDENTS
Written procedures for investigation/ENVIRONMENTAL ASSESSMENT
Written procedures for control measures
Written procedures for post-response
Investigation/ ENVIRONMENTAL ASSESSMENT reports and summaries

Egg Regulatory Program Standards

December 2020

STANDARD No. 6
Compliance and Enforcement Program
Purpose
This standard describes the elements of an effective enforcement program that includes
strategies, procedures, and actions to enforce laws and regulations to achieve compliance.
Requirement Summary
The state program has a documented enforcement program which describes its compliance
strategies and procedures. The program conducts an annual evaluation of the enforcement
strategies to identify potential improvements or modifications.
Program Elements
6.3.1

The state program has a written compliance and enforcement procedure that
describes the enforcement strategies, use of enforcement tools and progressive
enforcement actions.

Note: Appendix 6.2 provides examples of common enforcement tools and progressive
enforcement actions.
6.3.2

The state program has a written procedure for conducting an annual review of its
compliance and enforcement procedure to:
6.3.2.1
6.3.2.2
6.3.2.3
6.3.2.4

Determine if the program’s enforcement actions were successful in
achieving compliance;
Identify potential improvements or modifications of the compliance
and enforcement procedures, if any;
Either review all cases or use a statistical approach to determine a
representative number of cases; and
Document results of the annual review on Appendix 6.3 or equivalent
form.

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 review of the enforcement program is conducted to identify potential
improvements or modifications.
Documentation
The state program maintains the records listed here.
6.5.1
6.5.2

Appendix 6.1 Self-Assessment Worksheet (or equivalent form)
Written compliance and enforcement procedure

Egg Regulatory Program Standards

December 2020

6.5.3
6.5.4

Written procedure for conducting an annual review of the compliance and
enforcement procedure
Appendix 6.3 Calculation of the Level of Conformance to Compliance Procedures
(or equivalent form)

Egg Regulatory Program Standards

December 2020

STANDARD No. 7
Outreach Activities
Purpose
This standard describes the elements of outreach activities or OUTREACH ACTIVITY
EVENTS developed or provided by the state program.
Requirement Summary
The state program participates in outreach activities or OUTREACH ACTIVITY
EVENTS that support communication and information exchange among regulators,
industry, academia, SMALL EGG PRODUCERS and consumer representatives. The state
program also coordinates or participates in outreach activities or OUTREACH
ACTIVITY EVENTS that provide educational information about EGG topics.
Program Elements
7.3.1

The state program has a written procedure of the methods that will be used for
communication with the EGG industry stakeholders (may include SMALL EGG
PRODUCERS), academia, other regulators, and consumers. The written
procedure includes how the State program will:
7.3.1.1
7.3.1.2

7.3.1.3

7.3.1.4

7.3.1.5

7.3.2

Identify the methods for communication with the EGG industry
stakeholders, academia, other regulators, and consumers.
Interact with industry and consumers by sponsoring or actively
participating in meetings such as task forces, advisory boards, or
advisory committees.
Tailor outreach efforts to a target population which may include
dissemination of information using electronic sources and traditional
methods such as mailings.
Document and evaluate OUTREACH ACTIVITY EVENTS using
Appendix 7.2 or equivalent form. Include documents such as agendas
and meeting summaries and program evaluations.
Implement an outreach and training program that will include SMALL
EGG PRODUCERS within the State. It will be inclusive of basic
biosecurity and sanitation requirements to reduce the potential of an
EGG AND EGG PRODUCT RELATED INCIDENT.

The state program develops an outreach plan that supports the state program
mission and includes:
7.3.2.1
7.3.2.2
7.3.2.3
7.3.2.4

Egg Regulatory Program Standards

Objectives of the outreach plan;
Target population;
Types of outreach activities and OUTREACH ACTIVITY EVENTS;
Delivery method; and
33

December 2020

7.3.2.5

The templates provided in Appendix 7.3, or equivalent forms, are used
to record the outreach plan.

Outcome
The state program uses outreach activities that will inform and educate varied populations
on ways to reduce the occurrence of an EGG AND EGG PRODUCT RELATED
INCIDENT.
Documentation
The state program maintains the records listed here.
7.5.1

Written procedure for methods used to communicate with EGG industry
stakeholders and consumers
7.5.2 Appendix 7.1 Self-Assessment Worksheet (or equivalent forms)
7.5.3 Appendix 7.2 Outreach Activity Event and Self-Evaluation Worksheet (or
equivalent forms)
7.5.4 Appendix 7.3 Outreach Plan or equivalent documentation
7.5.5 Meeting summaries, agendas, or other records documenting OUTREACH
ACTIVITY EVENTS with EGG industry, stakeholders, and consumers

Egg Regulatory Program Standards

December 2020

STANDARD No. 8
Program Resources
Purpose
This standard describes the elements for assessing the resources needed to support an
EGG safety regulatory program.
Requirement Summary
The state program conducts an assessment of resource needs for staffing, equipment,
funding and sampling for the EGG safety regulatory program. The state program has
procedures for evaluating and validating the workplan.
Program Elements
8.3.1

The state program has a written workplan. The workplan must include:
8.3.1.1

Inspection plan
8.3.1.1.1 Number of inspections;
8.3.1.1.2 Type of inspection;
8.3.1.1.3 Risk category of ESTABLISHMENT; and
8.3.1.1.4 Frequency.

8.3.1.2
8.3.1.3
8.3.2

Sample plan as described in Standard 3, section 3.3.6.1 and section
3.3.6.3.
Timeframe that the workplan is applicable within a 12-month period.

The state program has a written procedure for evaluating the workplan that
includes:
8.3.2.1
8.3.2.2

Conducting periodic and annual reviews of the workplan; and
Reviewing the workplan for alignment with State program objectives
and resources.

Note: FDA and the state program may meet periodically and develop a coordinated workplan.
8.3.3

The state program has a written procedure for identifying and reviewing its
resources to accomplish the workplan within the applicable timeframe.

Note: The resource review should include staffing, equipment, and funding needed to support the
inspection and sample collection activities identified in the workplan. The resources needed to
train and audit field staff, to support LABORATORY services, compliance, education and
outreach, and to respond to EGG AND EGG PRODUCT RELATED INCIDENTS should be
determined by the state program. The administrative functions needed to support all program
areas should be considered when determining program resources.
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December 2020

8.3.4

To validate the workplan, the state program develops a formula that:
8.3.4.1
8.3.4.2
8.3.4.3

Calculates the number of staff needed to accomplish the state
programs workplan;
Uses numerical values that are based on the state programs data; and
Must be used by the state program.

Note: The state program should have adequate staff to inspect the state program’s
ESTABLISHMENT inventory and to conduct sample collections, based on risk categorization
and inspection frequency established by the program in its workplan.
Note: Appendix 8.2 provides example formulas that can be used as a baseline for a state
program’s workplan. The formulas in Appendix 8.2 do not include methods for estimating staff
numbers needed for sample collections, compliance activities, administrative, or other
programmatic activities.
8.3.5

A list of the equipment required for inspections and sample collections must be:
8.3.5.1
8.3.5.2

Established by the state program; and
Maintained by the state program.

Note: Appendix 8.3 provides an example list of equipment that may be used for inspections and
sample collections.
8.3.6

The state program must conduct a review of the resources required to fully
implement the ERPS, including each of the program elements in the individual
standards. The review recorded in Appendix 8.4 or equivalent form must
determine whether the program has adequate:
8.3.6.1
8.3.6.2
8.3.6.3

Staff;
Equipment; and
Funding.

Note: Information technology may be considered as part of the state program’s resource needs.
8.3.7

Subsequent resource evaluations must be completed to determine the resources
necessary for the state program to achieve and maintain full
IMPLEMENTATION and full CONFORMANCE with each Standard.

Outcome
The state program has a written workplan and assesses and allocates resources needed to
support an EGG regulatory program.
Documentation
The state program maintains the records listed here.

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December 2020

8.5.1 Appendix 8.1 Self-Assessment Worksheet (or equivalent form)
8.5.2 Written workplan
8.5.3 Written procedure for evaluating the workplan
8.5.4 Written procedure for identifying and reviewing its resources to accomplish the
workplan within the applicable timeframe
8.5.5 State Program’s Formula for Calculating the Number of Inspectors Required to
Conduct Inspections of Egg Facilities
8.5.6 State Program’s List of Equipment Used for Inspections and Sample Collections
8.5.7 Appendix 8.4 Resource Summary Report (or equivalent form)

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December 2020

STANDARD No. 9
Program Assessment
Purpose
This standard describes the process a state program uses to assess and demonstrate its
CONFORMANCE with each of the program standards.
Requirement Summary
The state program conducts periodic self-assessments of the EGG safety regulatory
program against the criteria established in each program standard. These self-assessments
are designed to identify the strengths and weaknesses of the state program by using the
program standards. The results of the self-assessments are used to determine areas or
functions of the state program that need improvement. The results of the baseline selfassessment are used to develop a STRATEGIC IMPROVEMENT PLAN and establish
timeframes for making improvements. Subsequent self-assessments are used to track
progress toward achieving and maintain CONFORMANCE with the program standards.
The state program establishes written CORRECTIVE ACTION and PREVENTIVE
ACTION (CAPA) procedure(s) for identification and management of nonCONFORMANCE(S) and potential non-CONFORMANCE(S).
Program Elements
9.3.1

9.3.2

In the first year the state program conducts a baseline self-assessment to
determine if the program meets the elements of each standard. The SelfAssessment Worksheets, which are the first appendices for each standard, should
be completed to establish the baseline self-assessment. The state program uses the
results of its self-assessments to complete Appendix 9.2 or equivalent form.
If the State program fails to meet any of the program elements and documentation
requirements of a standard, it develops and maintains a STRATEGIC
IMPROVEMENT PLAN that includes the following information:
9.3.2.1
9.3.2.2
9.3.2.3
9.3.2.4
9.3.2.5

9.3.3

The individual element or documentation requirement of the standard
that was not met;
Improvements needed to meet individual element or documentation
requirement of the standard that are under development;
Projected completion dates for each task;
Personnel responsible; and
Date completed for each task.

The state program shall review and update the self-assessment appendices and its
STRATEGIC IMPROVEMENT PLAN at least annually.

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9.3.4

The state program participates in FDA ASSESSMENTS to determine
IMPLEMENTATION and CONFORMANCE to the standards. The state program
addresses FDA ASSESSMENT observations and establishes CORRECTIVE
ACTION(S) following the requirements listed in 9.3.5, unless already identified
in the STRATEGIC IMPROVEMENT PLAN prior to the start of the FDA
ASSESSMENT.

9.3.5

The state program shall establish written CORRECTIVE ACION and
PREVENTIVE ACTION (CAPA) procedure(s) for identification, elimination,
and documentation of non-CONFORMANCE(S) and potential nonCONFORMANCE(S).
9.3.5.1

The state program’s CAPA procedure(s) shall include:
9.3.5.1.1
9.3.5.1.2
9.3.5.1.3
9.3.5.1.4

9.3.5.1.5
9.3.5.1.6

9.3.5.2

9.3.6

Identification of any non-CONFORMANCE(S) or potential
non-CONFORMANCE(S);
The cause(s) of the non-CONFORMANCE(S) or potential
non-CONFORMANCE(S);
The CORRECTION(S) needed to eliminate the nonCONFORMANCE(S);
CORRECTIVE ACTION(S) or PREVENTIVE
ACTION(S) to eliminate the cause of the nonCONFORMANCE(S) or potential nonCONFORMANCE(S);
The results of CORRECTIVE ACTION(S) or
PREVENTIVE ACTION(S) taken; and
Review of the effectiveness of the CORRECTIVE
ACTION(S) or PREVENTIVE ACTIONS(S).

The state program shall maintain written CAPA records that include
the criteria found in 9.3.2.1 – 9.3.2.5 and 9.3.5.1.1 – 9.3.5.1.6.

The state program shall:
9.3.6.1

Have a written DOCUMENT CONTROL procedure that ensures all
guidance, procedures, documents, and forms required by the standards
are CURRENT AND FIT-FOR-USE.
9.3.6.1.1

All documents subject to this procedure can demonstrate
they are CURRENT AND FIT-FOR-USE through
maintenance of a master document list or other system that
show:
9.3.6.1.1.1

Egg Regulatory Program Standards

Documents are reviewed for accuracy;
December 2020

9.3.6.1.1.2

9.3.6.1.1.3

9.3.6.2

Documents are approved for release by
authorized personnel and signed/dated with
an approval or revision date; and
Documents are distributed to and used at the
location where the prescribed activity is
performed.

Retain records or procedures required under each standard for the three
previous years, or per the state program’s record retention policy,
whichever is longer. Records or procedures can be maintained either
electronically or in hardcopy.

Outcome
The state program conforms to the program standards through well-defined and written
evaluation activities and a process for continuous improvement.
Documentation
The state program maintains records listed here:
9.5.1
9.5.2
9.5.3
9.5.4
9.5.5

Appendix 9.1 Self-Assessment Worksheet (or equivalent form)
Appendix 9.2 Self-Assessment Summary Report (or equivalent form)
STRATEGIC IMPROVEMENT PLAN
FDA ASSESSMENT reports
Written CORRECTIVE ACTION and PREVENTIVE ACTION (CAPA)
procedure
9.5.6 CAPA records
9.5.7 Written DOCUMENT CONTROL procedure
9.5.8 Record retention policy

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STANDARD No. 10
Laboratory Support
Purpose
This standard describes the elements of LABORATORY support for an EGG regulatory
program.
Requirement Summary
The state program has access to the LABORATORY services needed to support program
functions and documents its LABORATORY capabilities including agreements with
external LABORATORIES.
Program Elements
10.3.1 LABORATORY Support
10.3.1.1

10.3.1.2
10.3.1.3

The state program shall have access to a LABORATORY that is
capable of analyzing a variety of samples such as: EGG,
environmental, or veterinary clinical samples.
The state program shall maintain a list of all analytical services the
LABORATORY provides for the state program.
The state program shall have a contract or written agreement with each
LABORATORY and contracted LABORATORIES unless under the
same administrative agency. The contract or written agreement can be
a memorandum of understanding, e-mail, or any written format but
must contain the components below:
10.3.1.3.1 Define the responsibilities of each party;
10.3.1.3.2 Describe the types of testing services to be performed; and
10.3.1.3.3 Describe how exceptions to planned work will be
communicated.

10.3.2 ISO Accredited LABORATORIES
The state program utilizes LABORATORIES that have a current accreditation to
the International Organization for Standardization/International Electrotechnical
Commission ISO/IEC 17025 (2017 or current version) to analyze EGG or
environmental samples. 8 The accreditation body of the LABORATORY must be
a full member of the International Laboratory Accreditation Cooperation (ILAC)
and a signatory to the ILAC Mutual Recognition Arrangement (MRA).
8

Reference: International Organization for Standardization – ISO/IEC 17025:2017 – General Requirements of Testing and Calibration
Laboratories: https://www.iso.org/ISO-IEC-17025-testing-and-calibration-laboratories.html

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December 2020

10.3.3 Non-ISO Accredited LABORATORIES
10.3.3.1

If state programs do not use LABORATORIES holding accreditation
to ISO/IEC 17025 (2017 or current version), for the analysis of EGG
and environmental and/or veterinary clinical samples, then the
program must utilize LABORATORIES that have in place a quality
system which incorporates the following management and technical
requirements of ISO/IEC 17025 (2017 or current version) at a
minimum:
10.3.3.1.1 Written quality system which incorporates management
and technical requirements of ISO/IEC 17025 (2017 or
current version) and associated procedures, that include but
are not limited to:
10.3.3.1.1.1 Calibration and maintenance of equipment;
10.3.3.1.1.2 Analyses are performed using validated and
verified test procedures; 9
10.3.3.1.1.3 Documentation of sample traceability;
10.3.3.1.1.4 Documentation of analytical results and
analysts performing work;
10.3.3.1.1.5 Analysts that are trained and authorized to
perform technical procedures;
10.3.3.1.1.6 Periodic audits; and
10.3.3.1.1.7 Chain of Custody/Records.
10.3.3.1.2 A written procedure that defines the activities necessary
when non-conforming work occurs. The procedure must
describe how quality control data are assessed to assure that
test results from non-conforming work are not released.
The procedure must describe how cause analysis and
problem resolution are recorded.
10.3.3.1.3 A DOCUMENT CONTROL procedure that assures
documents issued to personnel are current, suitable, and
reviewed and approved by authorized personnel prior to
release. The procedure must also assure that obsolete
documents are removed from use.

Reference: Bacteriological Analytical Manual (BAM) Chapter 5: Salmonella: https://www.fda.gov/food/laboratory-methods-food/bam-chapter5-salmonella

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December 2020

10.3.3.1.4 A written record keeping process that assures that records
of original observations and data collection are maintained
and sufficient to establish traceability of test results, to
sample handling and storage, to sample analysis including
data collection, to equipment calibration and maintenance,
and to the review of test results prior to release.
10.3.3.1.5 A written process to assure that reference materials and
reference cultures are fit for purpose, are not outdated, and
are traceable to a lot number or other unique indicator.
10.3.3.1.6 A written process to assure that the LABORATORY
participates in relevant and available proficiency testing
activities.
10.3.3.1.7 A written process for reporting regulatory data results.1
Outcome
The state program has access to LABORATORY services described in this standard.
Documentation
The state program maintains records listed here.
10.5.1
10.5.2
10.5.3
10.5.4

Appendix 10.1 Self-assessment worksheet (or equivalent form)
Contracts or written agreements with participating LABORATORIES
List of services provided by LABORATORIES
ISO Accredited LABORATORY: ISO/IEC 17025 (2017 or current version)
Certificate and Scope of Accreditation.
10.5.5 Non-ISO Accredited LABORATORIES Documents:
10.5.5.1
10.5.5.2
10.5.5.3
10.5.5.4
10.5.5.5
10.5.5.6
10.5.5.7

Egg Regulatory Program Standards

Written Quality System
Written procedure for non-conforming work
DOCUMENT CONTROL Procedure
Record Keeping Process
Process for Ensuring Quality of Reference Materials and Cultures
Process for LABORATORY Proficiency Testing Activities
Process for Reporting Data Results

December 2020

Appendix 1.1 – Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluate if it
includes the associated components. If the state program has the main component and associated
components indicate “Yes”, if not, indicate “No”.
State Agency
Program Elements
1.3.1

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

Evaluation of Legal Authority

1. Does the state program have a written
procedure to evaluate the legal authority and
regulatory provisions to inspect and
investigate, gather evidence, collect and
analyze samples and take regulatory actions
under state law to ensure the safety and
security of EGGS?
Does the written procedure include:
1. Timeframes for a REGULATORY
FOUNDATION evaluation?
2. REGULATORY FOUNDATION evaluation
process, to include whenever significant
changes are made to applicable Federal
and/or state laws and regulations?
3. Address the statutes, regulations, rules,
ordinances, and other prevailing regulatory
requirements that:
a. Apply to the regulation of EGGS?
b. Delegate authority to the state program?
c. Describe the state program’s
administrative procedures for rulemaking
to protect public health?
d. Identifies and lists other state or federal
agencies that have authority for any area
of the REGULATORY FOUNDATION
that the state program lacks?
1.3.2 Regulatory Foundation Evaluation

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December 2020

Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

1. The state program must complete Appendix
1.2 or equivalent form. The state program
conducts an evaluation to determine if they
are EQUIVALENT, EQUIVALENT IN
EFFECT, NOT EQUIVALENT, or NO
AUTHORITY to sections of the current
Federal Food, Drug, and Cosmetic Act
(FD&C Act) and Code of Federal
Regulations (CFR) Title 21 specified in
Appendix 1.2.
2. If the state program has laws and regulations
pertinent to the regulation of EGGS, for
which there are no Federal provisions, these
laws and regulations can also be listed in
Appendix 1.2 or equivalent form.
Assessment Completed By:
Name

Egg Regulatory Program Standards

Date

December 2020

Appendix 1.2 – Regulatory Foundation Worksheet
Instructions: Determine if state laws and regulations are EQUIVALENT, EQUIVALENT IN EFFECT, or NOT EQUIVALENT
to federal statutes and regulations. Select "NO AUTHORITY" if regulatory responsibility for a statue or regulation falls under
the jurisdiction of another agency.
For those statutes and regulations for which the state program does have authority, record the state law or regulations and the
date it was incorporated. The Notes section shall be used in part to detail differences between state and federal laws and
regulations. This self-assessment relates only to human food, animal food and public health. Any commodities within the statutes
and regulations outside this scope do not need to be included on the self-assessment.
Note: the FD&C Act reference links direct you to the relevant U.S. Code section number. For a cross reference of FD&C Act
and U.S. Code sections please visit FDA's website: https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-fooddrug-and-cosmetic-act-fdc-act
State Agency
Federal Food, Drug & Cosmetic Act
FD&C
Act
201
301

Title

Equivalency
Status

State Citation

Date
Incorporated
into State Law

Notes

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

303*

Penalties

304**

Seizure

401

Definitions and
standards for food

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December 2020

FD&C
Act
402
403
404
406
701
703***
704

Equivalency
Status

Title

State Citation

Date
Incorporated
into State Law

Notes

Adulterated food
Misbranded food (a)(s)
Emergency permit
control
Tolerances for
poisonous ingredients
in food
Regulations and
hearings
Records of interstate
shipments
Inspection

*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.
*** This section covers records in interstate commerce. State laws should include intrastate records.

Title 21 Code of Federal Regulations: Food and Drugs
CFR
Part

Title

General enforcement
regulations
(§ 1.20-1.24)
and (Subpart O §
1.900-1.934)

Egg Regulatory Program Standards

Equivalency
Status

State Citation

Date
Incorporated
into State Law

Notes

December 2020

CFR
Part
7
101
105

109

110 10

115

Title

Equivalency
Status

State Citation

Date
Incorporated
into State Law

Notes

Enforcement policy
(ONLY § 7.1-7.13
and § 7.40-7.59)
Food labeling
(EXCEPT § 101.108)
Foods for special
dietary use
Unavoidable
contaminants in food
for human
consumption and
food- packaging
materials
Current good
manufacturing
practice in
manufacturing,
packing, or holding
human food
Shell eggs

Part 110 was modernized and codified in Part 117 by the current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventative Controls for
Human Food Rule (21 CFR Part 117).

Egg Regulatory Program Standards

December 2020

CFR
Part

117

118

Title

Equivalency
Status

State Citation

Date
Incorporated
into State Law

Notes

Current Good
Manufacturing
Practice and Hazard
Analysis and RiskBased Preventive
Controls for Human
Food
Production, Storage,
And Transportation
of Shell Eggs

State law and regulations:
State laws and regulations used by the program to address regulatory responsibilities outside of FDA jurisdiction are listed below.

Assessment Completed By:

Name
Egg Regulatory Program Standards

Date
49

December 2020

Appendix 2.1 – Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluate if it
includes the associated components. If the state program has the main component and associated
components indicate “Yes”, if not, indicate “No”.
State Agency
Program Elements
2.3.1

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

Training Plan and Training Records

Does the state program:
1. Use a written training plan that ensures all
inspectors receive training required to
adequately perform their work assignments?
a. Training plan includes curriculum for
basic and advanced inspection training
and continuing education?
b. Training plan curriculum consists of
coursework and field training?
2. Maintain a training history for active
inspectors?
3. Keep the training history for all inactive
inspectors for three years or per the state’s
record retention policy?
4. Maintains records documenting the training
completed by all inspectors using Appendix
2.2 or an equivalent form?
5. Training record summary and individual
training records include the inspector’s
START DATE?
6. For inspectors with greater than five years of
experience at the date of the initial selfassessment, where their training
documentation is not available, does the state
program:
a. 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?

Egg Regulatory Program Standards

December 2020

Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

b. Document the results of the
EVALUATION?
2.3.2

Basic Inspection Training

Does the state program training plan require:
1. Basic inspection training curriculum to be
successfully completed within 24 months of
the inspector’s START DATE with the state
program?
2. Coursework in the subject areas:
a. Prevailing statutes, regulations, and
ordinances?
b. Public health principles?
c. Biosecurity protocols and procedures?
d. Emergency Management?
e. Communications skills?
f. Basic Microbiology?
g. Basics of HACCP?
h. Basic sampling technique and
preparation?
i. State program EGG safety inspection
manuals and guidance?
3. An established basic field training program to
complement the coursework curriculum that
includes:
a. The inspector must complete the basic
field training program prior to performing
independent inspections?
b. Field training checklist of competencies
to be mastered and verified in the field by
the QUALIFIED FIELD INSPECTION
TRAINER or QUALIFIED FIELD
INSPECTION AUDITOR?
c. Written procedures for JOINT FIELD
TRAINING INSPECTIONS?

Egg Regulatory Program Standards

December 2020

Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

d. Number of JOINT FIELD TRAINING
INSPECTIONS or FIELD INSPECTION
AUDITS that are conducted in
ESTABLISHMENTS that are
representative of the
ESTABLISHMENTS in the state
program inventory, as well as the type of
work that will be performed by the
inspector?
e. The qualifications, education, and
experience necessary to be identified as a
QUALIFIED FIELD INSPECTOR
TRAINER and/or QUALIFIED FIELD
INSPECTION AUDITOR?
f. Using Appendix 2.3 or an equivalent
form to list the competencies and the
minimum number of JOINT FIELD
TRAINING INSPECTIONS?
2.3.3

Advanced Training

Does the state program training plan require:
1. Each inspector who will conduct advanced
EGG inspections will complete the relevant
coursework and field training?
2. That advanced inspection training curriculum
shall be successfully completed within the
timeframe specified by the state program?
3. The advanced inspection training consists of
coursework in the subject areas listed in this
section.
a. EGG Safety Inspections: Complete
coursework required to conduct
inspections of ESTABLISHMENTS
under the oversight of the state program,
which may include the Egg Safety Rule
regulations (21 CFR 115 and 21 CFR
118)?
b. Traceback Investigations?
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December 2020

Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

c. Foodborne Illness Investigations?
d. Other training as developed by the state
program?
4. An established advanced field training
program to complement the coursework
curriculum that includes:
a. Requiring the inspector to complete the
field training program prior to performing
advanced independent inspections?
b. Participating in two JOINT FIELD
TRAINING INSPECTIONS?
c. After successful completion of the course
participate in one EVALUATION or
FIELD INSPECTION AUDIT that is
found to be acceptable by a QUALIFIED
FIELD INSPECTION TRAINER or
QUALIFIED FIELD INSPECTION
AUDITOR prior to conducting
independent inspections?
d. Within one year after being released to do
advanced inspections complete a second
EVALUATION or FIELD INSPECTION
AUDIT that is found to be acceptable by
QUALIFIED FIELD INSPECTION
TRAINER or QUALIFIED FIELD
INSPECTION AUDITOR?
2.3.4

Continuing Education

Does the state program training plan include:
1. Each inspector must accumulate 20
CONTACT HOURS of continuing education
every 36 months?
2. The 36 month continuing education interval
starts at the QUALIFIED DATE, when the
training cycle is completed?
3. An alternate timeframe to track continuing
education as long as the alternate timeframe
and how that timeframe still meets or exceeds
the intent of the standard (at least 20
Egg Regulatory Program Standards

December 2020

Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

CONTACT HOURS every 36 months) are
clearly identified in program procedures?
4. The inspector qualifies for CONTACT
HOURS by participation in any of the
activities listed in 2.3.4.4.1 – 2.3.4.4.7 that
are related specifically to EGG inspectional
work?
5. A maximum of 10 CONTACT HOURS may
be accrued from the activities listed in
2.3.4.5.1 – 2.3.4.5.3?
6. Documentation must accompany each
activity submitted for continuing education
credit?
2.3.5

Coursework Sources

1. Is basic, advanced, and continuing education
coursework obtained from one of the sources
listed in 2.3.5.1 – 2.3.5.3?
Assessment Completed By:
Name

Egg Regulatory Program Standards

Date

December 2020

Appendix 2.2 – Inspector Training Record
State Agency: _________________________________________________________________
Name of Inspector ______________________________________ START DATE _________
Note: 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”.
Coursework Curriculum Areas

Subject Areas

Date
Completed

Coursework Name and Location
of Training

Documentation
Verifying
Completion
(Yes/No)

Basic
Prevailing statutes,
regulations, and
ordinances
Public health
principles
Biosecurity protocols
and procedures
Emergency
management
Communication
skills
Basic microbiology
Basics of HACCP
Basic sampling
technique and
preparation
State program EGG
safety inspection
manuals and
guidance

Egg Regulatory Program Standards

December 2020

Subject Areas

Date
Completed

Coursework Name and Location
of Training

Documentation
Verifying
Completion
(Yes/No)

Advanced
EGG safety
inspections
Traceback
investigations
Foodborne illness
investigations
Other training as
developed by the
state program

Egg Regulatory Program Standards

December 2020

Appendix 2.2 – Inspector Training Record (continued)
Name of Inspector __________________________________ QUALIFIED DATE _________
JOINT FIELD TRAINING INSPECTION
Minimum Number of JOINT FIELD TRAINING INSPECTIONS Required:_______

Date
Completed

ESTABLISHMENT Name and Location

Documentation
Available for
Review
(Yes/No)

EVALUATIONS
Date
ESTABLISHMENT Name and Location
Completed

EVALUATION
Acceptable
(Yes/No)

Documentation
Available for
Review
(Yes/No)

FIELD INSPECTION AUDITS
Minimum Number of FIELD INSPECTION AUDITS Required:_______

Date
Acceptable
Completed (Yes/No)

ESTABLISHMENT Name and Location

Egg Regulatory Program Standards

Documentation
Available for
Review
(Yes/No)

December 2020

Appendix 2.2 – Inspector Training Record (continued)
Name of Inspector __________________________________ QUALIFIED DATE _________
CONTINUING EDUCATION
A total of 20 CONTACT HOURS required every 36 months. Total CONTACT HOURS is the sum
of both charts below.
Activities in Program Element 2.3.4.4
Maximum of 20 CONTACT HOURS
Type of Activity
(Provide Title and Brief Description)

Date
Completed

Documentation
Available for Review
(Yes/No)

CONTACT
HOURS
Earned

Subtotal
Total CONTACT HOURS
Earned
Presenting, Training, or Publishing (Program Element 2.3.4.5)
Maximum of 10 CONTACT HOURS
Type of Activity
(Provide Title and Brief Description)

Date
Completed

Documentation
Available for Review
(Yes/No)

CONTACT
HOURS
Earned

Subtotal

Egg Regulatory Program Standards

December 2020

Appendix 2.3 – Field Training Competencies
State Agency: _________________________________________________________________
Name of Inspector: ____________________________________ START DATE: _________
Instructions: List the competencies to be covered in the state program’s basic field training and
provide a short description.
Competency

Egg Regulatory Program Standards

Description

December 2020

Appendix 3.1 – Self Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluate if it
includes the associated components. If the state program has the main component and associated
components indicate “Yes”, if not, indicate “No”.
State Agency
Program Elements
3.3.1

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

Risk-based inspection program

Does the state program have written procedures
to:
1. Define an up-to-date inventory of registered
EGG PRODUCERS and EGG HANDLERS
for which the State has regulatory oversight?
2. Categorize the inventory by the risk
associated with the likelihood that an EGG
AND EGG PRODUCT RELATED
INCIDENT will occur?
3. Determine a firm’s level of associated risk
and the program’s inspectional priorities?
4. Use the risk factors and associated criteria as
described in 3.3.1.2.1 – 3.3.1.2.3?
5. Prioritize and assign inspection frequencies
based on established risk categories?
3.3.2

Inspection Procedure

Does the state program have written procedures
for inspecting EGG PRODUCERS and EGG
HANDLERS that require the inspectors to:
1. Review the ESTABLISHMENT’S previous
inspection report, CONSUMER
COMPLAINTS, and current disease status?
2. Have appropriate equipment and forms?
3. Use equipment that has been verified,
operated and maintained as defined by the
state program’s procedures which may
include manufacturer’s recommendations?
Egg Regulatory Program Standards

December 2020

Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

4. Behave professionally and demonstrate
proper biosecurity practices during the
inspection similar to those listed in 3.3.2.3.1 –
3.3.2.3.2?
5. Follow safety protocols required by the
facility and the State program?
6. Make appropriate introductions and explain
the purpose and scope of the inspection?
7. Establish jurisdiction?
8. Determine the ESTABLISHMENT
registration status?
9. Use suitable interviewing techniques?
10. Assess employee practices critical to the safe
and sanitary production, processing and
storage of EGGS?
11. Evaluate conditions, practices, components,
and/or labeling that could cause the product to
be adulterated or misbranded or otherwise in
violation of applicable law(s)?
12. Recognize significant violative conditions or
practices, if present, and record findings
consistent with state program procedures?
13. Review and verify that records and
procedures for the ESTABLISHMENT’S
operation are being kept and properly
followed?
14. Collect adequate evidence and documentation
to support inspection observations in
accordance with state program procedures?
15. Verify correction of deficiencies that were
identified during previous inspections?
16. Evaluate the ESTABLISHMENT operations
through on-site inspectional observations?
17. Alert the ESTABLISHMENT’S person in
charge when an immediate action is necessary
to correct a violation?

Egg Regulatory Program Standards

December 2020

Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

18. Explain findings clearly and adequately
throughout the inspection?
19. Answer questions and provide information in
an appropriate manner?
20. Write findings accurately, clearly and
concisely and provide a copy to the
ESTABLISHMENT’S person in charge?
3.3.3

Inspection Report Procedure

Does the State program have a written inspection
report procedure that requires inspectors to:
1. Document significant violative conditions or
practices, if present, consistent with State
program procedures?
2. Accurately complete the inspection report?
3. Submit the inspection report within
designated timeframes consistent with State
program procedures?
4. Follow up with corrective, compliance, and
enforcement actions as warranted?
3.3.4

Recalls

Does the state program have a recall system with
written recall procedures for:
1. Sharing information about recalls with
relevant industry and partner agencies?
2. Ensuring recalled products are removed
promptly from the market?
3. Performing RECALL AUDIT CHECKS?
3.3.5

Complaints

Does the state program have a written system for
handling CONSUMER COMPLAINTS that
contains procedures for:
1. Receiving?
2. Tracking?
3. Evaluating?

Egg Regulatory Program Standards

December 2020

Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

4. Responding to?
5. Closing?
6. Maintaining records of CONSUMER
COMPLAINTS?
Does the state program have a written system for
handling INDUSTRY COMPLAINTS that
contains procedures for:
1. Receiving?
2. Evaluating?
3. Responding to?
4. Maintaining records of INDUSTRY
COMPLAINTS?
3.3.6 Sampling Program
1. Does the state program that conducts EGG
and/or environmental sampling have a written
annual sampling plan?
2. For state programs that conduct sampling,
does the written sampling plan include:
a. Sampling priorities?
b. The sample analysis schedule?
c. Availability or coordination of analytical
LABORATORY support?
3. Does the state program that conducts
environmental or EGG sampling have written
sampling procedures that include:
a. Methods for collecting
storing/Transporting and documenting
samples that include:
i)
Following the state program’s
sampling policies and procedures to
assure sample integrity, security,
accountability, and chain of
custody?
ii) Using appropriate method and
equipment to collect the sample?

Egg Regulatory Program Standards

December 2020

Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

iii) Sealing sample to initiate chain of
custody?
iv) Maintaining and documenting
sample integrity, security and chain
of custody?
v) Handling, packaging, and shipping
sample to ensure sample integrity
and prevent compromising condition
of sample?
vi) Delivering or shipping sample to the
appropriate LABORATORY within
acceptable timeframes?
b. Instructions for documenting the sample
collection including the following
elements when applicable to the states’
SAMPLING PROGRAM:
i)
Date of sample collection?
ii) Sample identification which may
include: name, firm, house, sample
number assigned by the sampler at
the time of collection and type
(EGG, belt, manure, walkway, etc.)?
iii) Method of collection and any special
techniques used to collect sample?
iv) Location where sample was
collected?
v) Sample type/reason for collection
(surveillance, compliance,
investigational, regulatory or other)?
vi)

Analysis requested?

vii)

Receiving and distribution
information?
viii) Observations recorded at the time of
collection?
ix) Product labels or specific labeling
information that is collected or
reproduced per state policies?
4. If the state program does not collect samples:
a. Is there a statement in lieu of sampling
procedures that explains why a
Egg Regulatory Program Standards

December 2020

Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

SAMPLING PROGRAM is not supported
and how the public health is protected
because another state or federal agency
collects samples and fulfills this need?
b. Does the statement include the name of
the agency and the type of samples that it
collects?
Assessment Completed By:
Name

Egg Regulatory Program Standards

Date

December 2020

Appendix 4.1 – Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluate if it
includes the associated components. If the state program has the main component and associated
components indicate “Yes”, if not, indicate “No”.
State Agency
Program Elements
4.3.1

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

Audit Program

Does the state program have written procedures
for:
1. FIELD INSPECTION AUDITS as described
in section 4.3.3?
2. Inspection report audits as described in
section 4.3.4?
3. Sample report audits as described in section
4.3.5?
4. CORRECTIVE ACTIONS as described in
section 4.3.6?
5. VERIFICATION AUDIT INSPECTIONS of
QUALIFIED FIELD INSPECITON
AUDITORS?
4.3.2 Does the state program review the
scores for completed audits at least
every 12 months?
4.3.3

Field Inspection Audit

Does the state program have written procedures
for conducting FIELD INSPECTION AUDITS
that include:
1. A QUALIFIED FIELD INSPECTION
AUDITOR conducts FIELD INSPECTION
AUDITS?
2. A minimum of one FIELD INSPECTION
AUDIT of each inspector is conducted every
36 months?
3. Selecting inspections for audits that include
the highest risk firms the inspector is trained
for such as advanced EGG inspections?

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December 2020

Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

4. If samples are collected during the FIELD
INSPECTION AUDIT, the collection of the
samples shall also be audited, and the
appropriate question(s) answered on
Appendix 4.3?
5. Performance is documented on Appendices
4.3 and 4.3a or equivalent forms that meet the
program elements in Standard 3, section
3.3.2?
4.3.4

Inspection Report Audits

Does the state program have written procedures
for inspection report audits that include:
1. The state program conducts annual reviews of
inspection reports to verify that inspectional
findings are obtained and reported according
to established written procedure?
2. The state program will review a random
selection of inspection reports based on the
number of inspections performed in the last
12 months using the table in 4.3.4.2?
3. Seven percent (7%) of the inspection reports
reviewed must be taken from field inspections
that were audited?
4. The quality of each inspection report is
audited using the performance factors listed in
Appendix 4.4, or equivalent?
5. An overall inspection report rating is
calculated using Appendix 4.4a, or
equivalent?
4.3.5

Sample Report Audit

1. Does the state program collect samples?
If samples were collected, does the state program
have written procedures for conducting sample
report audits that include:
1. An annual review of sample reports?

Egg Regulatory Program Standards

December 2020

Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

2. Reviewing a random selection of sample
reports based on the number of samples
collected in the last 12 months using the table
in 4.3.4.1?
3. The quality of each sample report is audited
using the performance factors listed in
Appendix 4.5, or equivalent form?
4. The overall sample report rating is calculated
using Appendix 4.5a, or equivalent form?
4.3.6

CORRECTIVE ACTIONS

Does the state program initiate CORRECTIVE
ACTIONS when:
1. An individual receives an overall rating of
“needs improvement”?
2. A single performance factor for the program
falls below 80%?
3. An overall rating for the program falls below
80%?
Assessment Completed By:
Name

Egg Regulatory Program Standards

Date

December 2020

Appendix 4.2 – Instructions for Performance Ratings of Audit Findings

The three performance rating of audit findings summary appendices (4.3a, 4.4a and 4.5a) allow
the State program to recognize trends and identify specific areas in their audit program that may
need improvement.
These summary appendices are used to calculate an overall rating during the performance period
and identify areas for improvement. The State program shall initiate CORRECTIVE ACTIONS
as described in 9.3.5 when one or more of the conditions below are met: (a) an individual
receives an overall rating of “needs improvement”; (b) a single performance factor for the
program falls below 80%; or (c) an overall rating for the program falls below 80%.

INSTRUCTIONS:

(1) For each audit, record the firm identification number, inspection date,
auditor’s initials and date of audit.
(3) For each audit (vertical column), record the rating for each
performance factor (A = acceptable; NI = needs improvement).
Record the individual audit score on the row indicated.
(4) Count the number of “A” and “NI” for each performance factor
(horizontal) and record the total number of “A” and “NI” ratings.
Calculate the performance factor score using the formula below:
At = horizontal total of acceptable ratings.
NIt = horizontal total of needs improvement ratings.
Performance Factor Score = [At/(At + Nit)] x 100
(5) Sum the Total Number of “A” and “NI” ratings for all audits.
∑ At = vertical sum of acceptable ratings.
∑ NIt = vertical sum of needs improvement ratings.
NOTE: ∑ is the statistical symbol for the sum of all numbers.
(6) Calculate the cumulative score for all audits. Record the cumulative
score in the space provided at the top of the worksheet.
Cumulative Score = [ ∑ At / ( ∑ At + ∑ NIt )] x 100
(7) Identify and make notes about trends and single performance factors
rated as “NI” in multiple audits.

Egg Regulatory Program Standards

December 2020

Appendix 4.3 – Field Inspection Audit Form

Auditor

EGG REGULATORY PROGRAM STANDARDS
FIELD INSPECTION AUDIT FORM
State inspector

Firm

License #

FDA FEI # (if applicable)
Firm address
Inspection dates
Time in

Type of inspection
Time out

Overall rating
Acceptable

Needs Improvement

NOTE: Every item marked “Needs Improvements” must be accompanied by an explanation
of why the item was identified as needing improvement.
Overall Rating: If three or less items are marked "Needs Improvement," the overall rating is
"Acceptable." If four or more items are marked "Needs Improvement," the overall rating is
"Needs Improvement." The overall rating must be marked in the space provided in the
header on the first page.
Each performance factor needs to be evaluated and rated as “Acceptable” or “Needs
Improvement” by the state program auditor except for sections:
IV. Sample Collection. If samples are not collected during this FIELD INSPECTION
AUDIT leave the scoring for these three questions blank.

I. Pre - Inspection Assessment
1. Did the inspector review the state’s ESTABLISHMENT file for the previous inspection

reports and possible complaints, or access other available resources in preparation for the
inspections?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

Egg Regulatory Program Standards

December 2020

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

Needs Improvement

Comments (required for Needs Improvement)

II. Inspection Observations
1. Was FDA/state jurisdiction established?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

2. Did the inspector determine if the firm is registered as an EGG PRODUCER within the
FDA and/or state if applicable?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

3. Did the inspector assess the employee practices critical to the safe and sanitary production
and storage of EGGS?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

4. Did the inspector properly evaluate the likelihood that conditions, practices, components,
and/or labeling could cause the product to be adulterated or misbranded?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

5. Did the inspector recognize significant violative conditions or practices if present and record
findings consistent with state and/or FDA procedures?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

Egg Regulatory Program Standards

December 2020

6. Did the inspector distinguish between significant versus insignificant observations, and
isolated incidents versus trends?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

7. Did the inspector review and evaluate the appropriate records and procedures for this
ESTABLISHMENT’s operations and effectively apply the information obtained from the
review?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

8. Did the inspector collect adequate evidence and documentation in accordance with state
procedures given the nature of the inspectional findings?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

9. Did the inspector verify correction of deficiencies identified during the previous inspection?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

10. Did the inspector act in a professional manner and demonstrate proper sanitary and
biosecurity practices during the inspection?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

III. Oral and Written Communication
1. Did the inspector identify himself/herself and make appropriate introductions, which
include explaining the purpose and scope or the inspection?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

Egg Regulatory Program Standards

December 2020

2. Did the inspector use suitable interviewing techniques?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

3. Did the inspector explain findings clearly and adequately throughout the inspections?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

4. Did the inspector alert the firm’s appropriate management when immediate CORRECTIVE
ACTION was necessary?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

5. Did the inspector answer questions and provide information in an appropriate manner?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

6. Did the inspector write their findings accurately, clearly and concisely on the state
form/document or Form FDA 483 left with the firm?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

IV. Sample Collection
Note to Auditor: These three questions are only answered if samples are collected as part of
the FIELD INSPECTION AUDIT. These three questions should be left blank if no samples
were collected.
1. Did the inspector follow the state’s program sampling policies and procedures to assure
sample integrity, security, accountability, and chain of custody?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

Egg Regulatory Program Standards

December 2020

2. Did the inspector use the appropriate method and equipment to collect the sample?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

3. Did the inspector seal the sample and initiate chain of custody to maintain and document
sample integrity and security?
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

Additional Comments

SIGNATURE OF AUDITOR

Egg Regulatory Program Standards

DATE

December 2020

Appendix 4.3a – Performance Rating for the Field Inspection Audits

State Program:
Reviewed by:
Date Reviewed:

Performance Period:
Cumulative Score:

Notes: A = acceptable, NI = needs improvement
Firm ID #
Inspection
Date
Auditor’s
Initials
Date of Audit
Performance
Factors

Performance ratings

Nit

Performa
nce Factor
Score

I.1
I.2
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
II.10
III.1
III.2
III.3
III.4
III.5
III.6
Egg Regulatory Program Standards

December 2020

IV.1
IV.2
IV.3
Audit Score
Subtotal
Total – Enter the final sums (subtotal + all continuation sheets)

USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.

Egg Regulatory Program Standards

December 2020

Appendix 4.3b – Guidance for Completing the Field Inspection Audit Form

This document provides guidance on assigning ratings during an audit for each of the
performance factors listed on Appendix 4.3 Field Inspection Audit Form. For each performance
factor examples of actions and observations that would likely result in a “needs improvement”
rating are provided.
I. PREINSPECTION ASSESSMENT
1. Did the inspector review the State’s ESTABLISHMENT file for the previous inspection
reports and possible complaints or access other available resources in preparation for
the inspection?
References:
•
•
•
•

State program’s ESTABLISHMENT files and/or FDA ESTABLISHMENT files
FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
FDA IOM, Subchapter 5.2 “Inspection Procedures”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. The inspector does not review the previous inspection report.
b. The inspector does not review the firm’s response letter that promised CORRECTIVE
ACTIONS after the last inspection.
c. The inspector does not follow-up on a CONSUMER COMPLAINT.
2. Did the inspector use appropriate equipment and forms to conduct the inspection?
References:
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
FDA IOM, Subchapter 5.2 “Inspection Procedures”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. The inspector does not present appropriate credentials and written Notice of Inspection
(when required) to the owner, operator, or agent in charge.
b. The inspector does not don appropriate disposable personal protective equipment.
c. The inspector does not have a flashlight to examine conditions within low lit poultry
houses.

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December 2020

II. INSPECTION OBSERVATIONS AND PERFORMANCE
1. Was FDA/state jurisdiction established?
References:
•
•
•
•

IOM, Subchapter 5.1 “Inspection Information”
State program’s standard operating procedures
FD&C Act
State law (if applicable)

Examples of a “needs improvement” rating:
a. The inspector does not confirm whether the EGG PRODUCER is producing EGGS for
the table EGG market.
b. The inspector does not inquire about the interstate movement of EGGS.
2. Did the inspector determine if the firm is registered as an EGG PRODUCER with the
FDA (and/or state if applicable)?
References:
•
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
State program’s standard operating procedures
21 CFR Part 118.11
State law (if applicable)

Examples of a “needs improvement” rating:
a. The inspector does not confirm whether the firm is registered as an EGG PRODUCER
with the FDA (and the state if applicable).
3. Did the inspector assess employee practices critical to the safe and sanitary production
and storage of EGGS?
References:
•
•
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
State program’s standard operating procedures
21 CFR Part 118
Food Drug & Cosmetic Act, Section 402(a)(4)
State law (if applicable)

Examples of a “needs improvement” rating:
a. The inspector does not evaluate biosecurity measures of employees working within a
poultry house.
Egg Regulatory Program Standards

December 2020

b. The inspector does not assess sanitation practices conducted by employees working
within the on-site packing facility that is not actively enrolled in the USDA/AMS
voluntary EGG grading program.
c. The EGG PRODUCER holds EGGS for the table market within a refrigerated trailer
beginning 36 hours after the time of lay. The inspector does not check the ambient
temperature of the trailer where EGGS are stored.
4. Did the inspector properly evaluate the likelihood that conditions, practices,
components, and/or labeling could cause the product to be adulterated or misbranded?
References:
•
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
State program’s standard operating procedures
21 CFR Part 118
State law (if applicable)

Examples of a “needs improvement” rating:
a. The inspector does not recognize the gross amount of rodent activity seen within the
poultry house.
b. Although the EGG PRODUCER monitors for flies within the poultry house, the inspector
does not recognize the use of parasitic wasps as a biological control method that is not an
acceptable control method to lower the fly population.
c. The inspector does not perform his/her own flock age calculation to determine
compliance when evaluating whether environmental testing for Salmonella Enteritidis
(SE) was performed by the EGG PRODUCER when the flock was between 40 to 45
weeks of age.
5. Did the inspector recognize significant violative conditions or practices if present and
record findings consistent with State and/or FDA procedures?
References:
•
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
State program’s standard operating procedures
21 CFR Part 118
State law (if applicable)

Examples of a “needs improvement” rating:
a. The inspector is aware the EGG PRODUCER did not disinfect the cleaned poultry house
after an environmental test was positive for SE. The EGG PRODUCER had previously
repopulated the poultry house and is selling the EGGS to the table EGG market. The
Egg Regulatory Program Standards

December 2020

inspector did not recognize the poultry house was not cleaned and disinfected properly
prior to housing a new flock which makes the environment within the poultry house
positive for SE.
b. The inspector discovers the EGG PROUDCER does not have an SE prevention plan as
required by the Egg Safety Rule based upon operations. The EGG PRODUCER has
operated in this manner for at least five years. The inspector does not record this finding
as a violation.
6. Did the inspector distinguish between significant versus insignificant observations and
isolated incidents versus trends?
References:
•
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
State program’s standard operating procedures
21 CFR Part 118
State law (if applicable)

Examples of a “needs improvement” rating:
a. The inspector notes a minor record keeping deficiency pertaining to one out of 600
refrigeration records showing the time of the refrigeration check was not documented.
b. During the inspection of a poultry house, the inspector focuses on a mortality pile stored
against the back wall without evidence showing it was attracting rodents and/or flies.
The inspector objects to this daily practice without properly considering that mortality
checks occur daily, and piles are picked up daily by a third-party trucking company.
c. The inspector notices the EGG PRODUCER uses an environmental sampling drag swab
pre-moistened with skim milk and does not recognize the significance of this finding as
the sampling methodology does not comply with the Egg Safety Rule.
7. Did the inspector review and evaluate the appropriate records and procedures for this
ESTABLISHMENT’s operation and effectively apply the information obtained from
this review?
References:
•
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
State’s Standard Operating Procedures
21 CFR Part 118
State law (if applicable)

Examples of a “needs improvement” rating:

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December 2020

a. The inspector does not review the SE prevention plan, which is required based upon the
EGG PRODUCER’s applicability to the Egg Safety Rule.
b. The inspector does not review refrigeration records when inspecting an EGG
PRODUCER that sends 100% of EGGS to a treatment plant.
c. The inspector reviews the SE prevention plan which indicates 12 mechanical traps are
located around the inside perimeter of the poultry house. However, the inspector does
not verify there are 12 mechanical traps around the inside perimeter when he/she inspects
the poultry house.
8. Did the inspector collect adequate evidence and documentation in accordance with state
procedures given the nature of the inspectional findings?
References:
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
IOM, Subchapter 5.3 “Evidence Development”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. The inspector does not capture photographic evidence showing pest control deficiencies
within the poultry house.
b. The inspector does not collect a copy of the SE prevention plan as evidence to
substantiate deficiencies.
9. Did the inspector verify correction of deficiencies identified during the previous
inspections?
References:
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
IOM, Subchapter 5.2 “Inspection Procedures”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. Although improper refrigeration of EGGS was identified during the previous inspection,
the inspector does not determine if the deficiency was corrected.
b. During the previous inspection, the inspector documented a gross rodent infestation
inside a poultry house. During the current inspection, the manager tells the inspector that
the rodent problem was properly dealt with. The inspector reviews pest control records
but does not visually verify the current environment within the poultry house to ascertain
whether corrective action was achieved.

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10. Did the inspector act in a professional manner and demonstrate proper sanitary and
biosecurity practices during the inspection?
References:
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
IOM, Subchapter 5.2 “Inspection Procedures”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. The inspector has combative behavior during the inspection.
b. The inspector does not follow FDA and/or state biosecurity procedures.
c. The inspector does not follow the EGG PRODUCER’s biosecurity procedures while
inspecting between poultry houses.

III. ORAL AND WRITTEN COMMUNICATION
1. Did the inspector identify himself/herself and make appropriate introductions, which
include explaining the purpose and scope of the inspection?
References:
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
IOM, Subchapter 5.1 “Inspection Information”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. The inspector does not explain why he/she is at the firm.
b. The inspector enters through the back door and begins examining a storage area without
notifying anyone at the firm.
2. Did the inspector use suitable interviewing techniques?
References:
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
IOM, Subchapter 5.2 “Inspection Procedures”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. The inspector’s requests for information are vague; consequently, the firm provides
documents that are unrelated to the inspection.

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b. The EGG PRODUCER is unable to respond to a request for information, because the
inspector spoke in unfamiliar and confusing jargon.
c. When the EGG PRODUCER’s responses are evasive, the inspector does not ask followup questions to obtain the necessary information. Consequently, the answers to the
questions are incomplete.
3. Did the inspector explain findings clearly and adequately throughout the inspection?
References:
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
IOM, Subchapter 5.2 “Inspection Procedures”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. The inspector does not discuss a significant observation at the close-out meeting.
b. The inspector is vague during his/her discussion with the EGG PRODUCER at the end of
the inspection. Therefore, the EGG PRODUCER is unaware of the significance of the
observations and that corrective actions are needed.
4. Did the inspector alert the firm’s appropriate management when an immediate
corrective action was necessary?
References:
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
IOM, Subchapter 5.2 “Inspection Procedures”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. The inspector does not notify the EGG PRODUCER the poultry house environment is
still considered SE positive when becoming aware the poultry house was not cleaned and
disinfected after an SE positive environment test in accordance to the Egg Safety Rule.
b. The inspector didn’t notify the EGG PRODUCER when he/she saw a swarm of flies
above a pile of cracked EGGS dropped from an EGG belt.
c. The inspector does not discuss with the EGG PRODUCER a significant deficiency
observed in the poultry house before leaving the firm that day.
5. Did the inspector answer questions and provide information in an appropriate manner?
References:

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December 2020

•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
IOM, Subchapter 5.2 “Inspection Procedures”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. The inspector fabricates an answer to a policy question that could lead the firm to take an
inappropriate corrective action.
b. The inspector dictates an inappropriate corrective action for a deficiency.
6. Did the inspector write their findings accurately, clearly and concisely on the state
form/document or FDA 483 left with the firm?
References:
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
IOM, Subchapter 5.2 “Inspection Procedures”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. The list of findings shows that the “firm did not follow SE prevention measures” with no
further explanation.
b. The inspector fails to write on the list of findings that he/she observed gross rodent
infestation in one of the houses.

IV. SAMPLE COLLECTION
Note: These three questions are only answered if samples are collected as part of the FIELD
INSPECTION AUDIT. Leave blank if no samples were collected.
1. Did the inspector follow the state program’s sampling policies and procedures to assure
sample integrity, security, accountability, and chain of custody?
References:
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
IOM, Subchapter 4.3 “Sampling: Collection Technique”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. The inspector collected an environmental sample within a poultry house, however didn’t
drive the sample to the laboratory until two days after collection.

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b. The inspector collected environmental samples from three poultry houses. After
collecting each sample, the inspector left the unsealed samples outside his/her vehicle and
without proper refrigeration.
2. Did the inspector use the appropriate method and equipment to collect the sample?
References:
•
•
•

FDA CPGM 7303.836 “Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule”
IOM, Subchapter 4.3 “Sampling: Collection Technique”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. The inspector did not collect the environmental sample by drag swabbing the manure
even though the manure was suitable for collection purposes.
b. The inspector did not aseptically moisten the sterile gauze pad with canned evaporated
milk prior to use.
c. The inspector pooled sub samples.
3. Did the inspector seal the sample and initiate chain of custody to maintain and
document sample integrity and security?
References:
•
•
•

FDA CPGM 7303.836 - Inspection of Egg Farms for Monitoring Compliance with Egg
Safety Rule
IOM, Subchapter 4.5 “Sampling: Preparation, Handling, Shipping”
State program’s standard operating procedures

Examples of a “needs improvement” rating:
a. The inspector did not officially seal the environmental sample after collection as required
by policy.
b. The inspector did not create chain of custody documentation as required by policy.

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Appendix 4.4 – Inspection Report Audit Form

EGG SAFETY REGULATORY PROGRAM STANDARDS
INSPECTION REPORT AUDIT FORM
Auditor:

Date of audit:

State inspector:

Date of inspection:

License #:

FDA FEI # (if applicable):

Firm Name:

Type of Inspection:
FDA Targeted Inspection

Firm address:

FDA Comprehensive Inspection
State Inspection

Total number:

Other:

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. If the audit score is below eighty percent, the audit rating must be
marked as “Needs Improvement.”
To calculate the audit score: Audit Score = [# Acceptable/ (# Acceptable + # Needs Improvement)] x
100.
I. Inspection Report Observations and Performance
1. The inspector submitted the report within designated timeframes.
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

2. All required fields on inspection report or related forms are completed.
Acceptable

Needs Improvement

Comments (required for Needs Improvement)

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3. Written observations were clear and concise.
Acceptable

Needs improvement

Comments (required for Needs Improvement)

4. The inspector followed all current and applicable report writing and documentation procedures.
Acceptable

Needs improvement

Comments (required for Needs Improvement)

5. The violations identified by the inspector are based on state and/or federal regulations.
Acceptable

Needs improvement

Comments (required for Needs Improvement)

6. The inspector reviewed past inspection findings and acts on repeated or unresolved violations.
Acceptable

Needs improvement

Comments (required for Needs Improvement)

7. The inspector correctly recorded significant findings (if any).
Acceptable

Needs improvement

Comments (required for Needs Improvement)

8. The inspector recorded the collection of all samples, exhibits, photographs, or photocopies to
support findings.
Acceptable

Needs improvement

Comments (required for Needs Improvement)

9. The inspector obtains and documents on-site CORRECTIVE ACTION at the time of inspection
as appropriate to the type of violation.
Acceptable

Needs improvement

Comments (required for Needs Improvement)

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10. The inspector followed through and documented compliance activities per state policy.
Acceptable

Needs improvement

Comments (required for Needs Improvement)

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

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Appendix 4.4a – Performance Rating for Inspection Report Audits
State Program:
Reviewed by:
Date Reviewed:

Performance Period:
Cumulative Score:

Notes: A = acceptable, NI = needs improvement
Firm ID #
Inspection
Date
Auditor’s
Initials
Date of Audit
Performance
Factors

Performance ratings

Nit

Performa
nce Factor
Score

I.1
I.2
I.3
I.4
I.5
I.6
I.7
I.8
I.9
I.10
Audit Score
Subtotal
Total – Enter the final sums (subtotal + all continuation sheets)

USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.

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Appendix 4.5 – Sample Report Audit Form

EGG SAFETY REGULATORY PROGRAM STANDARDS
SAMPLE REPORT AUDIT FORM
Auditor:

Date of audit:

License #:

FDA FEI (if applicable) #:

Firm name:

Date of sample collection:

Firm address:

Sample ID #:

Total number:

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.
Sample report audits do not need to be performed unless samples are collected.
To calculate the audit score: Audit Score = [# Acceptable/ (# Acceptable + # Needs Improvement)] x
100.
If the audit score is below eighty percent, the audit rating must be marked as “Needs Improvement.”
I. Sample Report Observations and Performance
1. Method of collection and equipment was appropriate.
Acceptable

Needs improvement

Comments (required for Needs Improvement)
2. Recorded sample seal application per state procedure.
Acceptable

Needs improvement

Comments (required for Needs Improvement)

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December 2020

3. Maintain and document sample integrity, security and chain of custody.
Acceptable

Needs improvement

Comments (required for Needs Improvement)
4. Sample was handled, packaged, and shipped to prevent compromising the condition or integrity of
the sample, as evidenced by acceptance and testing by the receiving laboratory.
Acceptable

Needs improvement

Comments (required for Needs Improvement)
5. Sample was delivered or shipped to an appropriate laboratory within acceptable timeframes.
Acceptable

Needs improvement

Comments (required for Needs Improvement)

II. Sample Report
1. Date of sample collection was recorded.
Acceptable

Needs improvement

Comments (required for Needs Improvement)
2. Sample identification which may include: name, firm, house, sample number assigned by the
sampler at the time of collection, and sample type (i.e., EGG, belt, manure, walkway, etc.) was
recorded.
Acceptable

Needs improvement

Comments (required for Needs Improvement)
3. Method of collection and any special techniques used to collect sample was recorded.
Acceptable

Needs improvement

Comments (required for Needs Improvement)
4. Location where sample was collected was recorded.
Acceptable

Needs improvement

Comments (required for Needs Improvement)

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5. Reason for collection was recorded (surveillance, compliance, investigational, regulatory, or
other).
Acceptable

Needs improvement

Comments (required for Needs Improvement)
6. Analysis requested was recorded.
Acceptable

Needs improvement

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

Needs improvement

Comments (required for Needs Improvement)
8. Observations regarding the sample were recorded, if any.
Acceptable

Needs improvement

Comments (required for Needs Improvement)
9. Product labels and/or labeling information was collected per state policies.
Acceptable

Needs improvement

Comments (required for Needs Improvement)

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

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Appendix 4.5a – Performance Rating for Sample Report Audits
State Program:
Reviewed by:
Date Reviewed:

Performance Period:
Cumulative Score:

Notes: A = acceptable, NI = needs improvement Sample report audits do not need to be performed unless samples are collected.
Firm ID #
Inspection
Date
Auditor’s
Initials
Date of Audit
Performance
Factors

Performance ratings

Nit

Performa
nce Factor
Score

I.1
I.2
I.3
I.4
I.5
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
Audit Score
Subtotal
Total – Enter the final sums (subtotal + all continuation sheets)

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USE THIS SPACE TO IDENTIFY AND MAKE NOTES ABOUT SINGLE PERFORMANCE FACTORS RATED AS “NEEDS
IMPROVEMENT” IN MULTIPLE AUDITS.

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Appendix 5.1 – Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluate if it
includes the associated components. If the state program has the main component and associated
components indicate “Yes”, if not, indicate “No”.
State Agency
Program Elements
5.3.1

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

Coordination of EGG AND EGG
PRODUCT RELATED INCIDENTS
Response Activities with Other
Authorities

Does the state program have:
1. A memorandum of understanding with other
state agencies?
2. A written procedure that:
a. Identifies and describes the roles, duties,
and responsibilities of each program for
the requirements in 5.3.2-5.3.5?
b. Describes agency collaboration as
necessary with FDA and other
appropriate local, state and federal
authorities in multi-jurisdictional EGG
AND EGG PRODUCT RELATED
INCIDENTS?
c. Designates response coordinator(s) to
guide program investigation efforts in
collaboration with all agencies involved
and manage events using a formalized
Incident Command System (ICS)
structure or an official action plan that
includes:
i) Outlining containment?
ii) Communication?
iii) Control?
iv) CORRECTION?
v) After action protocol?
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Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

d. Describes how all government agencies,
departments, or appropriate parties are
rapidly notified of relevant findings in
cases of EGG AND EGG PRODUCT
RELATED INCIDENTS?
e. Provides guidance for the immediate
notification of law enforcement agencies
when intentional EGG AND EGG
PRODUCT RELATED INCIDENTS or
terrorism is suspected or threatened?
3. A list of relevant agencies and emergency
contacts that is reviewed and updated
according to a frequency defined by the
state?
5.3.2

Surveillance

Does the state program:
1. Use epidemiological information from
appropriate departments or agencies (federal,
state, or local) to detect incidents of EGG
AND EGG PRODUCT RELATED
INCIDENTS?
2. Maintain notifications of EGG AND EGG
PRODUCT RELATED INCIDENTS that are
reported to the program in a log or database?
5.3.3 Investigation/ ENVIRONMENTAL
ASSESSMENT
Does the state program:
1. Have a written procedure with recommended
timeframes and criteria to investigate EGG
AND EGG PRODUCT RELATED
INCIDENTS that include:
a.

Determining the appropriate response?

Initiating the response?

Completing the response?

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Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

2. Have a written procedure to collect
environmental data similar to those found in
the documents listed in 5.3.3.2.1 - 5.3.3.2.4?
3. Have a written procedure to coordinate the
traceback and traceforward of EGG and
EGG PRODUCTS found to contain a hazard
or that are implicated in an illness, injury,
outbreak?
4. Have access to LABORATORY support for
investigation of reports of EGG AND EGG
PRODUCT RELATED INCIDENTS?
5. Correlate and analyze ENVIRONMENTAL
ASSESSMENT data to identify contributing
factors and antecedents that led to EGG
AND EGG PRODUCT RELATED
INCIDENTS?
5.3.4

Control Measures

Does the state program:
1. Mitigate and contain EGG AND EGG
PRODUCT RELATED INCIDENTS and
EMERGENCIES through strategies that
include industry education and outreach,
enforcement and public awareness activities?
2. Maintain a written procedure for releasing
prevention guidance and information to the
public (includes identifying a media person
and developing guidelines for coordinating
media information with other jurisdictions)
to reduce the impact of EGG AND EGG
PRODUCT RELATED INCIDENTS?
5.3.5

Post-Response

Does the state program have written procedures
to:
1. Maintain program investigation and
ENVIRONMENTAL ASSESSMENT
findings and reports?
2. Distribute final program investigation
report(s), including an ENVIRONMENTAL
ASSESSMENT if completed, to relevant
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Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

agencies responsible for reporting
contributing factors and antecedents to
CDC?
3. Distribute recommendations, when available,
from investigation and ENVIRONMENTAL
ASSESSMENT findings and reports to
relevant agencies and stakeholders
responsible for prevention, education and
outreach?
Assessment Completed By:
Name

Egg Regulatory Program Standards

Date

December 2020

Appendix 6.1 – Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluate if it
includes the associated components. If the state program has the main component and associated
components indicate “Yes”, if not, indicate “No”.
State Agency
Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

6.3.1 Does the state program have a written
compliance and enforcement
procedure that describes the
enforcement strategies, use of
enforcement tools and progressive
enforcement actions?
6.3.2 Does the state program have a written
procedure for conducting an annual
review of its compliance and
enforcement procedures to:
1. Determine if the state program’s
enforcement actions were successful in
achieving compliance?
2. Identify potential improvements or
modifications of the compliance and
enforcement procedures, if any?
3. Review all cases, otherwise, a statistical
approach should be used?
4. Document the results of the annual review
on Appendix 6.3, or equivalent form?
Assessment Completed By:
Name

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Date

December 2020

Appendix 6.2 – Examples of Enforcement Tools and Progressive Enforcement Actions
Below is a list of common enforcement tools that may be used by state programs. An explanation
of each tool has been provided. An example of how to apply these tools in a progressive
enforcement action is included below this list.
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 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.
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.
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.
Denial, suspension, or revocation of an EGG HANDLER registration certificates – the
program may refuse to issue, or may deny, suspend or revoke a registration certificate based on
the severity of the violation(s), including creating a hazard to human health or the environment
or in the distribution of the marketing of EGGS intended for human consumption, repetitive
failure to comply with statutes and/or regulations, and/or unregistered persons marketing EGGS.
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.
EGGS held off-sale and seized – EGGS that are held off sale and/or seized are determined to be
a public nuisance by an enforcement officer. If the violator refuses or fails within a reasonable
time specified by the enforcement officer to commence to bring the EGGS and their containers
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in compliance with these regulations, the EGGS and their containers may be seized by an
enforcement officer.
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 EGG safety regulation.
This tool can be used for any violation, but other tools may be appropriate.
Example of Progressive Enforcement Actions:
1. Each violation falls into one of four levels: compliant, low, moderate, and high; with the
compliant level having no penalties associated with it and the high level having the most
serious penalties enforced. As the violation levels increase from compliant to high, there may
be a higher human health risk associated with it.
2. Each violation is discussed with the firm, and an enforcement tool(s) selected and enforced.
Choose the appropriate enforcement tool(s) for the violation level based on relevant factor(s)
(i.e. history of violator, high economic benefit gained by non-compliance, non-cooperation of
the violator, and/or high risk to human health).
3. The more factors determined to be relevant, the higher possible penalty of enforcement
tool(s) should be selected and enforced for each violation.
4. The enforcement tools are listed for each violation level ranging from the lowest possible
penalty to highest possible penalty.

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Appendix 6.3 – Calculation of the Level of Conformance to Compliance Procedures

State Agency

Rating for CONFORMANCE to compliance procedures:

Firm
identification
number

Enforcement action
recommended

Compliance
procedures
followed (A/NI)

Subtotal

Enter the sum of
the totals from all
continuation sheets

At =

NIt =

Total

Enter the final sums
--subtotal + sums on At =
this form

NIt =

Use this space to explain
improvements needed to follow
compliance procedures

Assessment Completed By:
Name

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Date

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Appendix 6.3a – Instructions for Review of Compliance and Enforcement Procedure
Appendix 6.3 is used to record the enforcement actions recommended in the past 12 months and
to calculate the state program’s rating for conformance to compliance procedures. Supporting
documents should be referenced and maintained by the state program. Please indicate if an action
was taken because voluntary compliance was not achieved. Document if changes are need to the
compliance and enforcement procedure.
All cases must be reviewed; otherwise, a statistical approach is used to determine a
representative number of cases. Use continuation sheets as necessary.
INSTRUCTIONS:

(1) Record the firm’s identification number and the recommended
enforcement action.
(2) For each type of enforcement action, record the level of conformance
to compliance procedures.
A = acceptable; NI = needs improvement
(3) Record the At and NIt.
At = vertical sum of acceptable ratings.
NIt = vertical sum of needs improvement ratings.
(4) Calculate the overall rating for the state program’s conformance to
compliance procedures. Record the rating in the box located at the top
of Appendix 6.3.
Formula: Performance factor rating = [ At / ( At + NIt )] x 100

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Appendix 7.1 – Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluate if it
includes the associated components. If the state program has the main component and associated
components indicate “Yes”, if not, indicate “No”.
State Agency
Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

7.3.1 Does the state program have a written
procedure of the methods that will be
used for communication with the EGG
industry stakeholders (may include
SMALL EGG PRODUCERS),
academia, other regulators, and
consumers?
Does the written procedure include how the state
program will:
1. Identify the methods for communication with
the EGG industry stakeholders, academia,
other regulators, and consumers?
2. Interact with industry and consumers by
sponsoring or actively participating in
meetings such as task forces, advisory
boards, or advisory committees?
3. Tailor outreach efforts to a target population
which may include dissemination of
information using electronic sources and
traditional methods such as mailings?
4. Document and evaluate OUTREACH
ACTIVITY EVENTS using Appendix 7.2 or
equivalent form?
5. Maintain documents such as agendas and
meeting summaries and program
evaluations?
6. Implement an outreach and training program
that will include SMALL EGG
PRODUCERS within the state and be
inclusive of basic biosecurity and sanitation
requirements to reduce the potential of an
EGG AND EGG PRODUCT RELATED
INCIDENT?
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7.3.2 Does the state program develop an
outreach plan that supports the state
program mission and includes:
1. Objectives of the outreach plan?
2. Target population?
3. Types of outreach activities and
OUTREACH ACTIVITY EVENTS?
4. Delivery method?
5. The templates provided in Appendix 7.3, or
equivalent forms, are used to record the
outreach plan?
Assessment Completed By:
Name

Egg Regulatory Program Standards

Date

105

December 2020

Appendix 7.2 – Outreach Activity Event and Self-Evaluation Worksheet
This worksheet is completed by the state program to document OUTREACH ACTIVITY EVENTS.
Attach verifying documents such as agendas and meeting summaries and program evaluations to
this form.
Section I. Overview of OUTREACH ACTIVITY EVENT
a. Type of OUTREACH ACTIVITY EVENT (check one):

Seminar

Workshop

Training course

Other: _____________________________________________
b. Subject or name of OUTREACH ACTIVITY EVENT:
c. Date of OUTREACH ACTIVITY EVENT:
d. Host organization:

Section II. Self-Evaluation of OUTREACH ACTIVITY EVENT
Program Elements

Yes/No

If no, please explain.

a. The purpose and objectives were clearly
defined
b. The content of the OUTREACH ACTIVITY
EVENT was consistent with the objectives
c. The activity was tailored to a target population
Identify target population:
d. An evaluation was completed by attendees
Section III. Critique of OUTREACH ACTIVITY EVENT
Discuss what went well, what could be done better, and what more could be done to improve the
OUTREACH ACTIVITY EVENT. Address comments from attendees, if available.

Assessment Completed By:
Name

Egg Regulatory Program Standards

Date

106

December 2020

Appendix 7.3 – Outreach Plan
When developing the Outreach Plan the state program may choose to use one of the following
templates or another equivalent form. The content, design, and frequency of update should be
determined by the state program.
A. Outreach Plan in Chart Format
Effective Date(s)
Objective

Target Population

Type of Outreach
Activity

Delivery Method

Completed By:
Name

Date

B. Outreach Plan in Paragraph Format
Effective Date(s)
Outreach Objective(s):
List and provide details of outreach activities and OUTREACH ACTIVITY EVENTS
that will be used to help support each objective, including the target population and the
method of delivery.

Completed By:
Name

Egg Regulatory Program Standards

Date

107

December 2020

Appendix 8.1 – Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluate if it
includes the associated components. If the state program has the main component and associated
components indicate “Yes”, if not, indicate “No”.
State Agency
Program Elements
8.3.1

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

Does the State program have a written
workplan?

Does the written workplan include:
1. Inspection plan
a. Number of inspections?
b. Type of inspection?
c. Risk category of ESTABLISHMENT?
d. Frequency?
2. Sample plan as described in Standard 3,
section 3.3.6.1?
3. Timeframe that the workplan is applicable
within a 12-month period?
8.3.2 Does the state program have a written
procedure for evaluating the
workplan?
Does the written procedure include:
1. Conducting periodic and annual reviews of
the workplan?
2. Reviewing the workplan for alignment with
State program objectives and resources?
8.3.3 Does the state program have a written
procedure for identifying and
reviewing its resources to accomplish
the workplan within the applicable
timeframe?
8.3.4 Does the state program develop a
formula to validate the workplan that:
1. Calculates the number of staff needed to
accomplish the state programs workplan?

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Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

2. Uses numerical values that are based on the
state programs data?
3. Must be used by the state program?
8.3.5

Is a list of the equipment required for
inspections and sample collections must
be:

1. Established by the state program?
2. Maintained by the state program?
8.3.6

The state program must:

1. Conduct a review of the resources required to
fully implement the ERPS, including each of
the program elements in the individual
Standards?
2. Is the review recorded on Appendix 8.4 or
equivalent form?
3. Did the resource review determine if the state
program has adequate:
a. Staff?
b. Equipment?
c. Funding?
8.3.7 Are subsequent resource evaluations
completed to determine the resources
necessary for the state program to
achieve and maintain full
IMPLEMENTATION and full
CONFORMANCE with each
Standard?
Assessment Completed By:
Name

Egg Regulatory Program Standards

Date

109

December 2020

Appendix 8.2 – Example Formula for Calculating the Number of Inspectors Required to Conduct
Inspections of Egg Establishments
This appendix is an example of how to calculate the number of inspectors required to conduct
inspections of EGG ESTABLISHMENTS. A state program may use this example to develop a
formula that is suitable for the state program’s needs and based on data that can be verified.
This formula is not applicable to staff needs for other state 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 EGG ESTABLISHMENTS (example categorization: high risk,
medium risk, and low risk)
Number of EGG ESTABLISHMENTS in each risk category
Percent of ESTABLISHMENTS to be inspected each year in each risk category (in
percent)
Percent of ESTABLISHMENTS to be re-inspected each year in each risk category (in
percent)
Average inspection time, including travel time, of EGG ESTABLISHMENTS 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 programs 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 EGG ESTABLISHMENTS in each risk
category.
The following examples utilize three risk categories: high risk, medium risk, and low
risk.

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December 2020

•

For High Risk EGG ESTABLISHMENTS:

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

Description
Number of High Risk ESTABLISHMENTS
Percent of High Risk ESTABLISHMENTS to be Inspected
per Year (%)
Percent of High Risk ESTABLISHMENTS to be ReInspected per Year (%)
High Risk ESTABLISHMENTS Average Inspection Time (h)
Total Hours of High Risk Inspections per Year

For Medium Risk EGG ESTABLISHMENTS:

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

Description
Number of Medium Risk ESTABLISHMENTS
Percent of Medium Risk ESTABLISHMENTS to be
Inspected per Year (%)
Percent of Medium Risk ESTABLISHMENTS to be ReInspected per Year (%)
Medium Risk ESTABLISHMENTS Average Inspection Time
(h)
Total Hours of Medium Risk Inspections per Year (h)

For Low Risk EGG ESTABLISHMENTS:

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

Description
Number of Low Risk ESTABLISHMENT
Percent of Low Risk ESTABLISHMENT to be Inspected per
Year (%)
Percent of Low Risk ESTABLISHMENT to be Re-Inspected
per Year (%)
Low Risk ESTABLISHMENT 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 state program’s ESTABLISHMENT inventory.
(hHRI per year + hMRI per year + hLRI per year) / AIT = Number of Inspectors
Needed
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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 when applicable. The list provided below is an example equipment list for
inspections and sample collections. The state program may use the chart below to record
whether the equipment is assigned, available to inspectors, or not available.

Equipment

Assigned

Available

Not Available

Alcohol swabs and wipes
Lysol or other approved spray sanitizers
Hand sanitizer
Disinfectant approved for car tires and undercarriage
Measuring tape
Camera
Cell phone
Clipboard
Computer and printer
Credentials
Eye protection
Flashlight (head lamp) and holder
Hearing protection
Official seals
Paper, pen, masking tape, and marker
Protective clothing (Tyvek suit, gloves, and shoe covers)
Garbage and Ziplock bags
Regulations, policies, and designated reference material
Required forms
Disposable respirators/masks
Hairnet
Shipping containers (OPTIONAL)
Thermometer
Egg candler
Scales
Egg Regulatory Program Standards

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December 2020

Air cell gauge
Vehicle
OPTIONAL EQUIPMENT FOR SAMPLES
Sampling equipment (sterile containers, bags, or swabs,
evaporated milk, labels, marker, sterilized & nitrile
gloves)
Bus tub
Knife and scissors
Can opener
Coolant (ice and freezer packs)
Paper towels
Garbage and Ziplock bags
Sterile gauze packages
Ice chest
Whirl Paks

Egg Regulatory Program Standards

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Appendix 8.4 – Resource Summary Report
This table provides an overview of a state program’s evaluation of the resources needed to implement the
Egg Regulatory Program Standards. Based on the review, 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
should be in the “Other Resources Needed” column. The administrative functions needed to support all
program areas should be considered when determining program resources.

State Agency
No.

Standard

Regulatory Foundation

Training Program

Inspection Program

Inspection Audit
Program

Egg-Related Illness,
Outbreak, and
Emergency Response

Compliance and
Enforcement

Outreach Activities

Program Resources

Program Assessment

Laboratory Support

Funding

Staffing

Equipment

Other Resources Needed

Assessment Completed By:
Name

Egg Regulatory Program Standards

Date

114

December 2020

Appendix 9.1 – Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluate if it
includes the associated components. If the state program has the main component and associated
components indicate “Yes”, if not, indicate “No”.
State Agency
Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

9.3.1 Does the state program conduct a
baseline self-assessment:
1. Within the first year?
2. Using the self-assessment worksheets
associated with each standard?
3. Using the results of its self-assessments to
complete Appendix 9.2?
9.3.2 If the state program fails to meet any of
the program elements or
documentation requirements, did the
state program develop a STRATEGIC
IMPROVEMENT PLAN?
Does the STRATEGIC IMPROVEMENT PLAN
include:
1. The individual element or documentation
requirement that was not met?
2. Improvements needed to meet individual
element or documentation requirement of the
standard that are under development?
3. Projected completion dates for each task?
4. Personnel responsible?
5. Date completed for each task?
9.3.3 Does the state program review and
update the self-assessment appendices
and STRATEGIC IMPROVEMENT
PLAN at least annually?
9.3.4 Does the state program:

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December 2020

Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

1. Participate in FDA ASSESSMENTS to
determine IMPLEMENTATION and
CONFORMANCE to the standards?
2. Address FDA ASSESSMENT observations
and establish CORRECTIVE ACTIONS?
9.3.5 Does the state program have written
CORRECTIVE ACTION and
PREVENTIVE ACTION (CAPA)
procedure(s)?
1. Do the CAPA procedure(s) include:
a. Identification of any nonCONFORMANCE(S) or potential nonCONFORMANCE(S)?
b. The cause(s) of the nonCONFORMANCE(S) or potential nonCONFORMANCE(S)?
c. The CORRECTION(S) needed to
eliminate the non-CONFORMANCE(S)?
d. CORRECTIVE ACTION(S) or
PREVENTIVE ACTION(S) to eliminate
the cause of the nonCONFORMANCE(S) or potential nonCONFORMANCE(S)?
e. The results of CORRECTIVE
ACTION(S) or PREVENTIVE
ACTION(S) taken?
f. Review of the effectiveness of the
CORRECTIVE ACTION(S) or
PREVENTIVE ACTION(S)?
2. Does the state program maintain written
CAPA records that include the criteria found
in 9.3.2.1 – 9.3.2.5 and 9.3.5.1.1 – 9.3.5.1.6?
9.3.6

Does the state program:

1. Have a written DOCUMENT CONTROL
procedure?

Egg Regulatory Program Standards

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Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

a. Is the state program able to demonstrate
that all documents are CURRENT AND
FIT-FOR-USE though maintaining a
master document list or other system?
b. Does the master document list or other
system show:
i)
ii)

iii)

Documents are reviewed for
accuracy?
Documents are approved for release
by authorized personnel and
signed/dated with an approval or
revision date?
Documents are distributed to and
used at the location where the
prescribed activity is performed?

2. Retain records or procedures required under
each standard for the three previous years, or
per the state program’s record retention
policy, whichever is longer?
Assessment Completed By:
Name

Egg Regulatory Program Standards

Date

117

December 2020

Appendix 9.2 – Self-Assessment Summary Report

State agency: _________________________________________________________________________
Report completed by: __________________________________________________________________
(NAME)
(DATE)

Standard

1. Regulatory
Foundation

Self-Assessment

Complete
Incomplete

6. Compliance and
Enforcement

____

Complete
Incomplete

Full
Partial
____

Complete
Incomplete

Full
Partial

Hours used
5. Egg-Related
Illness, Outbreak
& Emergency
Response

Full
Partial

Hours used

4. Inspection Audit
Program

____

Complete
Incomplete
Hours used

3. Inspection
Program

Full
Partial

Hours used

2. Training
Program

IMPLEMENTATION

Explain improvements needed to
fully IMPLEMENT standards
(required for incomplete selfassessment and partial
IMPLEMENTATION)

____

Complete
Incomplete

Full
Partial

Hours used

____

Complete
Incomplete

Full
Partial

Hours used

Egg Regulatory Program Standards

____

118

December 2020

Standard

7. Outreach
Activities

Self-Assessment

Complete
Incomplete

Full
Partial
____

Complete
Incomplete

Full
Partial

Hours used

10. Laboratory
Support

____

Complete
Incomplete
Hours used

9. Program
Assessment

Full
Partial

Hours used

8. Program
Resources

IMPLEMENTATION

Explain improvements needed to
fully IMPLEMENT standards
(required for incomplete selfassessment and partial
IMPLEMENTATION)

____

Complete
Incomplete

Full
Partial

Hours used

Egg Regulatory Program Standards

____

119

December 2020

Appendix 10.1 – Self-Assessment Worksheet
Instructions: The state program identifies if they have a specified component then evaluate if it
includes the associated components. If the state program has the main component and associated
components indicate “Yes”, if not, indicate “No”.
State Agency
Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

10.3.1 Laboratory Support
Does the state program:
1. Have access to a LABORATORY that is
capable of analyzing a variety of samples such
as: EGG, environmental, or veterinary clinical
samples?
2. Maintain a list of all analytical services the
LABORATORY provides for the state
program?
3. Have a contract or written agreement with
each LABORATORY and contracted
LABORATORIES unless under the same
administrative agency?
4. Maintain contracts or written agreements
with each LABORATORY that:
a. Define the responsibilities of each party?
b. Describe the types of testing services to be
performed?
c. Describe how exceptions to planned work
will be communicated?
10.3.2 ISO Accredited Laboratories
1. Does the state program utilize
LABORATORIES that have a current
accreditation to the International Organization
for Standardization/International
Electrotechnical Commission ISO/IEC 17025
(2017 or current version) to analyze EGG or
environmental samples?

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Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

2. Is the accreditation body of the
LABORATORY a full member of the
International Laboratory Accreditation
Cooperation (ILAC) and a signatory to the
ILAC Mutual Recognition Arrangement
(MRA)?
10.3.3 Non-ISO Accredited Laboratories
If the state program is not using
LABORATORIES holding accreditation to
ISO/IEC 17025 (2017 or current version), is the
program utilizing laboratories that have:
1. A written quality system which incorporates
management and technical requirements of
ISO/IEC 17025 (2017 or current version) and
associated procedures?
Does the written quality system include:
a. Calibration and maintenance of
equipment?
b. Analyses are performed using validated
and verified test procedures?
c. Documentation of sample traceability?
d. Documentation of analytical results and
analysts performing work?
e. Analysts that are trained and authorized to
perform technical procedures?
f. Periodic audits?
g. Chain of Custody/Records?
2. A written procedure that defines the activities
necessary when non-conforming work occurs?
Does the written procedure describe:
a. How quality control data are assessed to
assure that test results from nonconforming work are not released?
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Program Elements

Yes/No

If no, please explain why element is not
met. May use this space for additional
notes.

b. How cause analysis and problem
resolution are recorded?
3. A DOCUMENT CONTROL procedure that
assures documents issued to personnel are
current, suitable, and reviewed and approved
by authorized personnel prior to release and
assures that obsolete documents are removed
from use?
4. A written record keeping process that assures
that records of original observations and data
collection are maintained and sufficient to
establish traceability of test results, to sample
handling and storage, to sample analysis
including data collection, to equipment
calibration and maintenance, and to the review
of test results prior to release?
5. A written process to assure that reference
materials and reference cultures are fit for
purpose, are not outdated, and are traceable to
a lot number or other unique indicator?
6. A written process to assure that the
LABORATORY participates in relevant and
available proficiency testing activities?
7. A written process for reporting regulatory data
results?
Assessment Completed By:
Name

Egg Regulatory Program Standards

Date

122

December 2020

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Author	Reed, Maria
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