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Standards
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs
OMB Control No. 0910-XXXX
Expiration Date: XXX XX, 20XX
TABLE OF CONTENTS
INTRODUCTION ............................................................................................................................... 3
BACKGROUND .................................................................................................................................. 5
DEFINITIONS ..................................................................................................................................... 6
STANDARD No. 1 Regulatory Foundation ........................................................................................ 9
STANDARD No. 2 Training Program ...............................................................................................11
STANDARD No. 3 Inspection Program.............................................................................................16
STANDARD No. 4 Inspection Audit Program ..................................................................................21
STANDARD No. 5 Foodborne Illness, Outbreak, Response .............................................................24
STANDARD No. 6 Compliance and Enforcement Program.............................................................28
STANDARD No. 7 Outreach Activities .............................................................................................30
STANDARD No. 8 Program Resources .............................................................................................32
STANDARD No. 9 Program Assessment ...........................................................................................34
STANDARD No. 10 Laboratory Support ..........................................................................................36
Appendix 1.1: Self-Assessment Worksheet ........................................................................................38
Appendix 1.2 – Regulatory Foundation Worksheet ..........................................................................40
Appendix 2.1: Self-Assessment Worksheet ........................................................................................45
Appendix 2.2: Inspector Training Record .........................................................................................48
Appendix 3.1: Self-Assessment Worksheet ........................................................................................52
Appendix 4.1 – Self-Assessment Worksheet ......................................................................................57
Appendix 4.2: Field Inspection Audit Form ......................................................................................60
Appendix 4.2a: Summary of Field Inspection Audit Findings ..........................................................65
Appendix 4.3: Inspection Report Audit Form ...................................................................................67
Appendix 4.3a: Summary of Inspection Report Audit Findings .......................................................70
Appendix 4.4: Sample Report Audit Form ........................................................................................72
Appendix 4.4a: Summary of Sample Report Audit Findings............................................................75
Appendix 5.1: Self-Assessment Worksheet ........................................................................................77
Appendix 6.1: Self Assessment Worksheet ........................................................................................80
Appendix 6.2 – Evaluation of Conformance of Compliance/Enforcement Procedures ...................81
Appendix 7.1: Self-Assessment Worksheet ........................................................................................83
Appendix 7.2 – Outreach Activity and Self-Evaluation Worksheet..................................................84
Appendix 8.1: Self-Assessment Worksheet ........................................................................................86
Appendix 8.2: Resource Summary Report ........................................................................................88
Appendix 9.1: Self Assessment Worksheet ........................................................................................89
Appendix 9.2: Self-Assessment Summary Report .............................................................................91
Appendix 10.1: Self-Assessment Worksheet ......................................................................................94
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Introduction
INTRODUCTION
The Food Safety Modernization Act (FSMA) mandates that the 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 Produce Regulatory Program Standards (PRPS) is a critical component in establishing the FDA’s
IFSS. The PRPS (henceforth also referred to as “program standards”) establishes a uniform foundation
for regulatory agencies responsible for oversight of farms, produce commodities, and activities covered
under FDA's Produce Safety Rule (21 CFR Part 112). 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. PRPS conformance will facilitate a system of
mutual reliance between the FDA and other regulatory agencies and support continuous improvements
in regulatory oversight of produce 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 produce and produce-related
illness, injury, outbreaks and emergencies. The elements of these standards include: regulatory
foundation, training, inspection programs, audit programs, produce-related event response, compliance
and enforcement, industry and community outreach, program 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 be in conformance with 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 program uses the selfassessment 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.
FDA will use the program standards as a tool to continuously improve produce inspection funding. It
will also be used to promote the development and implementation of high-quality produce inspection
regulatory programs, 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 standards is voluntary. States enrolled in the
program standards under an 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
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Introduction
sustainable and implement plans that will result in the standards being maintained in conformance.
The goal of the PRPS is to implement a nationally integrated, risk-based, produce 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 produce 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 the number and
severity of produce-related incidents, thus improving the safety and security of the U.S. food supply.
Paperwork Reduction Act Statement: This program standards document contains information
collection provisions that are subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
The time required to complete this voluntary information collection is estimated to average 569 minutes
per reporting response and 40 minutes per recordkeeping response, including the time to review
instructions, search existing data sources, gather the data needed, and complete and review the
information collection. An agency may not conduct or sponsor, and a person is not required to respond
to, a collection of information unless it displays a currently valid OMB control number.
OMB Control No. 0910-XXXX
Expiration Date: XXX XX, 20XX
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Background
BACKGROUND
In the U.S., federal, state, and territorial government agencies ensure the safety of fresh, raw produce (as
defined in 21 CFR 112). 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 and territorial agencies conduct inspection and regulatory
activities that help ensure produce grown, harvested, packed, or held within their jurisdictions is safe.
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, states, and territories should maximize their resources,
particularly when their jurisdictions are overlapping. One of the foundational principles of an integrated
food safety system (IFSS) is the implementation and uniform application of model standards so that
federal, state, territorial, tribal and local regulatory agencies conduct inspections under the same set of
standards. The Produce Regulatory Program Standards (PRPS) 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),
Animal Feed Regulatory Program Standards (AFRPS), and Egg Regulatory Program Standards (ERPS).
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 2019, FDA awarded a cooperative agreement to the National Association of State Departments of
Agriculture (NASDA), with one outcome being to deliver a completed draft of recommended PRPS
content; NASDA sub-awarded the management of this objective to the Association of Food and Drug
Officials (AFDO). Beginning in March 2022, a committee comprised of officials from FDA, state
agencies, AFDO, and NASDA began work to develop the draft standards. The result of the committee’s
collaborative work is the development of the first edition of the PRPS, which will strengthen state and
territorial produce regulatory programs. These program standards reflect an effort in which FDA has
been engaged in partnering, leveraging and empowering agencies to move towards the vision of a
nationally integrated food safety system.
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Definitions
DEFINITIONS
CONFORMANCE: the fulfilment of a requirement, specifically a State PROGRAM is using and can
demonstrate the use of a particular element, system, or program listed in the Produce Standards.
CONSUMER COMPLAINT: complaints made by the public regarding produce commodities, produce
practices, labeling, and any other related activities.
CONTACT HOUR: one contact hour equals 60 minutes.
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. “Fitfor-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.
CURRENT EXPERIENCED STAFF: inspectors with a START DATE prior to the PROGRAM’s
enrollment date in the standards and as identified in the PROGRAM’s training plan.
DOCUMENT CONTROL: 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.
EQUIVALENT: state laws or regulations directly reference the relevant Federal regulation and/or
statutes.
EQUIVALENT IN EFFECT: state laws or regulations achieve the same regulatory effect as the
relevant Federal statutes and/or regulations.
EVALUATION: the process by which the ability of an inspector is assessed to determine if they are
competent to complete independent inspections.
FDA ASSESSMENT: conducted by the FDA, means a systematic, independent, and documented
process for obtaining objective evidence and evaluating it to determine the extent to which a
requirement is met.
FIELD INSPECTION AUDIT: an inspection in which a state inspector is accompanied by a
QUALIFIED FIELD INSPECTION AUDITOR (either the FDA or state) for the purpose of assessing
the quality and performance of inspections.
FOOD RELATED INCIDENT: an unintentional or deliberate contamination, threatened or actual, of
produce that may occur at any point in the produce production system (e.g., growing, harvesting,
packing, and holding) and may cause a food-related illness or injury.
IMPLEMENTATION: a PROGRAM has a particular element, system, program, and documentation as
required in the PRPS.
INDUSTRY COMPLAINT: complaints made by industry about inspections or inspectors.
JOINT FIELD TRAINING INSPECTION: an inspection conducted jointly by the FDA and/or state
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Definitions
personnel for the purposes of training.
LABORATORY: a facility that conducts measurements and analyses on produce and associated
physical samples, which result in qualitative or quantitative analytical findings that may be used as a
basis for regulatory action.
NO AUTHORITY: state program lacks statutory authorization for carrying out a specific area of work.
NOT EQUIVALENT: the state law and/or regulation is not EQUIVALENT or EQUIVALENT IN
EFFECT and does not have the same regulatory effect.
OUTREACH ACTIVITY: an activity related to produce safety topics that the PROGRAM participates
in to support education, engagement and/or communication among and between stakeholders, including
regulators, industry, academia, and consumer representatives.
PRODUCE OPERATION: a person or business that conducts one or more of the following activities
on produce raw agriculture commodities: growing, harvesting, packing, or holding.
PROGRAM: An operational unit(s) in a regulatory agency that is/are responsible for the regulatory
oversight of produce safety.
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 PROGRAM
management as having field experience and communication skills necessary to audit
inspectors/investigators and who has: successfully completed produce safety inspection training
coursework and field training, been assigned this auditing responsibility, and meets PROGRAM
requirements for auditors.
QUALIFIED FIELD INSPECTION TRAINER: an individual who is recognized by the PROGRAM
management as having field experience and communication skills necessary to train
inspectors/investigators and who has: successfully completed produce safety inspection training
coursework and field training, been assigned this training responsibility, and meets the PROGRAM
requirements for trainers.
RECALL AUDIT CHECK: are conducted to verify that the farm’s recall was successful as defined by
the State’s recall procedures.
REGULATORY FOUNDATION: laws, regulations, rules, ordinances, or other regulatory
requirements that govern a produce operation.
ROOT CAUSE INVESTIGATION (RCI): an in-depth, multi-disciplinary, systemsbased investigation of firms, products, and the environment, intending to determine how
the environment may have contributed to the introduction, proliferation, and transmission of pathogens
or other hazards that caused illnesses or fresh produce contamination. An RCI may also be referred to as
an environmental assessment (EA).
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Definitions
SAMPLING PROGRAM: a program in which the state collects samples as part of their produce safety
PROGRAM in one or more of the sampling types as defined in the Partnership for Food Protection’s
Food/Feed Testing Laboratories Best Practices Manual (current).
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.
WORKPLAN: a plan developed by the PROGRAM to identify, support, and conduct inspectional
activities for an effective produce regulatory program.
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Standard 1
STANDARD No. 1
Regulatory Foundation
1.1
Purpose
This standard describes the elements of the REGULATORY FOUNDATION used by a PROGRAM to
regulate produce.
1.2
Requirement Summary
The PROGRAM evaluates the scope of its legal authority and regulatory provisions to ensure the
protection of produce within its jurisdiction. The 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 Act) and Code of Federal Regulations (CFR) specified in Appendix 1.2
or equivalent form.
1.3
Program Elements
1.3.1 Evaluation of Legal Authority
The 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 of produce. The written
procedure must:
1.3.1.1
Include timeframes for a REGULATORY FOUNDATION assessment.
1.3.1.2
Describe the REGULATORY FOUNDATION evaluation process, to include
whenever significant changes are made to applicable federal and/or state laws
and regulations.
1.3.1.3
Address the statutes, regulations, rules, ordinances, and other prevailing
regulatory requirements that:
1.3.1.3.1 Apply to the regulation of produce.
1.3.1.3.2 Delegate authority to the PROGRAM.
1.3.1.3.3 Describe the PROGRAM’S administrative procedures for
rulemaking to protect public health.
1.3.1.3.4 Identify and list other federal or state agencies that have authority
for any area of the REGULATORY FOUNDATION that the
PROGRAM lacks.
1.3.2 REGULATORY FOUNDATION Assessment
The PROGRAM must complete Appendix 1.2 or equivalent form. The PROGRAM
conducts a baseline self-assessment to determine if they are EQUIVALENT,
EQUIVALENT IN EFFECT, NOT EQUIVALENT, or NO AUTHORITY to sections of
the current FD&C Act and CFR Title 21 specified in Appendix 1.2. or equivalent form.
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1.3.2.1
If the PROGRAM has laws and regulations pertinent to the regulation of
produce, for which there are no federal provisions, these laws and regulations
can also be listed in Appendix 1.2 or equivalent form.
1.3.2.2
If the PROGRAM has not adopted the current version of a CFR provision, the
state must provide the revision date of the CFR that was adopted for each
regulation.
Note: In conducting a self-assessment, the 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.
1.4
Outcome
The PROGRAM has conducted an assessment of the scope of their legal authority and has a
REGULATORY FOUNDATION adequate to protect public health by ensuring the safety of produce
within its jurisdiction. For any part of the REGULATORY FOUNDATION that the PROGRAM lacks,
the PROGRAM identifies another federal or state program with that regulatory authority to protect
public health.
1.5
Documentation
The PROGRAM maintains the records, or equivalent forms or worksheets, listed here.
1.5.1 Appendix 1.1 Self-Assessment Worksheet.
1.5.2 Appendix 1.2 Regulatory Foundation Worksheet.
1.5.3 PROGRAM’S written REGULATORY FOUNDATION assessment procedure.
1.5.4 The statutes, regulations, rules, ordinances, and other prevailing regulatory requirements
that: (1) apply to the regulation of produce, (2) delegate authority to the PROGRAM, (3)
describe the PROGRAM’s administrative procedures for rulemaking to protect public
health, and (4) identify and list other federal or state agencies that have authority for any
area of the REGULATORY FOUNDATION that the PROGRAM lacks.
1.5.5 If applicable, review by legal counsel.
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Standard 2
STANDARD No. 2
Training Program
2.1
Purpose
This standard describes the essential elements of a training program for inspectors to ensure they will
have the knowledge, skills, and abilities to adequately perform their work.
2.2
Requirement Summary
The PROGRAM establishes and maintains a written training plan that promotes development and
demonstrates that all inspectors complete coursework, field training, and continuing education to
adequately perform their work.
2.3
Program Elements
2.3.1 Training Plan and Training Records
2.3.1.1
The PROGRAM uses a written training plan that ensures all inspectors
receive training required to adequately perform their work. The training plan
includes curriculum which provides for training as well as continuing
education.
2.3.1.2
The PROGRAM maintains individual training records for active inspectors.
The individual training records for all inactive inspectors must be kept for a
minimum of three years after the date the inspector became inactive.
2.3.1.3
The PROGRAM maintains a training record summary documenting the
training completed by inspectors to adequately perform their work using
Appendix 2.2 or equivalent form.
2.3.1.4
The PROGRAM training record summary must include the inspector’s
START DATE.
2.3.1.5
The PROGRAM assesses all inspectors’ previous performance and experience
to determine if the inspectors have completed the required training or whether
additional training is needed to adequately perform their work.
2.3.2 Inspection Training
2.3.2.1
The PROGRAM requires that each inspector complete an inspection training
curriculum consisting of coursework and field training described here prior to
performing independent inspections.
2.3.2.2
Timeframe: The inspection training curriculum shall be successfully
completed within 24 months of the inspector’s START DATE.
2.3.2.3
Coursework: The inspection training consists of coursework in the following
subject areas.
2.3.2.3.1 Prevailing statutes, regulations, and ordinances
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2.3.2.3.2 Inspections, investigations, compliance, and enforcement
2.3.2.3.3 Public health principles
2.3.2.3.4 Biosecurity
2.3.2.3.5 Basic/introductory emergency management
2.3.2.3.6 Communications skills
2.3.2.3.7 Microbiology
2.3.2.3.8 Sampling technique, if applicable
2.3.2.4
Field Training: The PROGRAM has a written field training program to
complement the coursework curriculum. The PROGRAM shall have the
latitude to determine the number and types of activities to meet the elements
detailed below:
2.3.2.4.1 The inspector must complete the field training program prior to
performing independent inspections.
2.3.2.4.2 Field training checklist of competencies to be verified in the field
by the QUALIFIED FIELD INSPECTION TRAINER.
2.3.2.4.3 Written procedures for JOINT FIELD TRAINING
INSPECTIONS.
2.3.2.4.4 Number of JOINT FIELD TRAINING INSPECTIONS.
2.3.2.4.5 Number of field inspection EVALUATIONS.
2.3.2.4.6 Number of additional field training activities, if they are deemed
necessary by the PROGRAM.
2.3.2.4.7 The qualifications, education, and experience necessary to be
identified as a QUALIFIED FIELD INSPECTION TRAINER, to
include at a minimum, the training as described in 2.3.2.
2.3.3 Experienced Inspectors
For CURRENT EXPERIENCED STAFF or newly hired experienced inspection staff, a
PROGRAM’S training plan shall include the following unless it is determined in their
training plan that all inspection staff will be required to complete the program elements as
described in 2.3.2.
2.3.3.1
For CURRENT EXPERIENCED STAFF with missing training records, in
addition to a statement from the PROGRAM stating an assessment has
occurred and the outcomes of the assessment will satisfy the requirement for
documentation, the following apply:
2.3.3.1.1 If a record is missing for a JOINT FIELD TRAINING
INSPECTION, then a statement or affidavit explaining the
background or experience that justifies a waiver of JOINT FIELD
TRAINING INSPECTIONS must be included in the employee
training file.
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2.3.3.1.2 If a record is missing for coursework as described in 2.3.2.3, then
document and include in the employee training file training records
that are available and create a statement of affidavit explaining the
background or experience that justifies a waiver of the missing
coursework.
2.3.3.2
For newly hired experienced inspection staff with missing training records, in
addition to a statement from the PROGRAM stating an assessment has
occurred and the outcomes of the assessment will satisfy the requirement for
documentation, the following apply:
2.3.3.2.1 If a record is missing for a JOINT FIELD TRAINING
INSPECTION, then a statement or affidavit explaining the
background or experience that justifies a waiver of some or all of
the JOINT FIELD TRAINING INSPECTIONS must be included
in the employee training file. Conduct two successful
EVALUATIONS within six (6) months of the inspector’s
QUALIFIED DATE.
2.3.3.2.2 If a record is missing for coursework as described in 2.3.2.3, then
document and include in the employee training file training records
that are available and create a statement or affidavit explaining the
background or experience that justifies a waiver of the missing
coursework.
2.3.4 Continuing Education
The PROGRAM goal of continuing education is to build upon the inspector’s knowledge
base and enhance their skills and ability to perform inspections and investigations.
2.3.4.1
Each inspector must accumulate 20 CONTACT HOURS of continuing
education every 36 months.
2.3.4.2
The 36-month continuing education interval starts at the QUALIFIED DATE,
when the training cycle is completed.
2.3.4.3
The 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.
2.3.4.4
The inspector qualifies for CONTACT HOURS for participation in any of the
following activities or other activities related specifically to inspectional work
or PRODUCE OPERATIONS:
2.3.4.4.1 Attendance at national or regional seminars/technical conferences.
2.3.4.4.2 Professional symposiums/college courses.
2.3.4.4.3 Produce or food-related training provided by government agencies
(e.g., Food & Drug Administration (FDA), United States
Department of Agriculture (USDA), state, local).
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Standard 2
2.3.4.4.4 Food or produce safety related conferences and workshops.
2.3.4.4.5 Distance learning opportunities that pertain to food or produce
safety.
2.3.4.4.6 Training approved by the PROGRAM.
2.3.4.5
Of the accumulated 20 CONTACT HOURS of continuing education, a
maximum of 10 CONTACT HOURS may be accrued from the following
produce 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.
2.3.4.5.3 Publishing an original article in a peer-reviewed professional or
trade association journal/periodical.
2.3.4.5.4 Of the accumulated 20 CONTACT HOURS of continuing
education, a maximum of four (4) CONTACT HOURS may be
accrued for reading technical publications related to produce or
food safety.
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 Certificates of completion indicating the course date(s) and number
of hours attended or continuous education credits granted.
2.3.4.6.2 Transcripts from a college or university.
2.3.4.6.3 A letter from the administrator of the continuing education
program attended.
2.3.4.6.4 A copy of the peer-reviewed article or presentation made at a
professional conference; or documentation to verify technical
publications related to produce 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.
2.3.4.6.5 An agenda and attendance roster.
2.3.4.6.6 Documentation approved by the PROGRAM.
2.3.4.7
Coursework Sources
Training and continuing education coursework must be obtained from one of
the sources listed here:
2.3.4.7.1 Training provided by a government agency (including in-house
training).
2.3.4.7.2 Distance learning, for example, web-based training.
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2.3.4.7.3 Colleges, schools, research centers, and institutes.
2.3.4.7.4 Produce or Food Safety Alliances, associations or other
organizations recognized by FDA.
2.4
Outcome
The PROGRAM has trained inspectors with the knowledge, skills, and abilities to adequately perform
their work.
2.5
Documentation
The PROGRAM maintains the records, or equivalent forms or worksheets, listed here.
2.5.1 Appendix 2.1 Self-Assessment Worksheet or equivalent form.
2.5.2 Appendix 2.2 Inspector Training Record or equivalent form.
2.5.3 Written Training Plan.
2.5.4 Documents verifying successful completion of required courses.
2.5.5 EVALUATION for experienced inspectors.
2.5.6 Written procedures for JOINT FIELD TRAINING INSPECTIONS.
2.5.7 Documentation for continuing education credit.
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Standard 3
STANDARD No. 3
Inspection Program
3.1
Purpose
This standard describes the elements of an effective inspection PROGRAM.
3.2
Requirement Summary
The PROGRAM has written inspection procedures to determine compliance with federal and state
produce safety laws and regulations.
3.3
Program Elements
3.3.1 Risk-Based Inspection PROGRAM
The PROGRAM has written procedures to:
3.3.1.1
Define and establish an inventory of PRODUCE OPERATIONS which are
under PROGRAM jurisdiction and authority.
3.3.1.2
Maintain the inventory of PRODUCE OPERATIONS as described in 3.3.1.1.
3.3.1.3
Define and document risk categories. PROGRAMS may consider additional
criteria but must use the following minimum required factors for defining risk
categories:
3.3.1.3.1 Commodity.
3.3.1.3.2 Farm compliance history.
3.3.1.3.3 Farm size by average annual produce sales.
3.3.1.3.4 Agricultural water source and usage.
3.3.1.3.5 Biological soil amendments of animal origin and usage.
3.3.1.4
Prioritize inspections and assign frequencies based on defined risk categories
established by the PROGRAM.
3.3.2 Inspection Procedure
The PROGRAM has a written procedure for inspecting a PRODUCE OPERATION
which is under PROGRAM jurisdiction and authority that requires the inspector to:
3.3.2.1
Review the previous inspection report(s), CONSUMER COMPLAINT(S),
and compliance history.
3.3.2.2
Follow the pre-inspection call procedures required by the PROGRAM.
3.3.2.3
Have appropriate equipment and forms. Equipment must be verified,
operated, and maintained as defined by the PROGRAM.
3.3.2.4
Follow the biosecurity protocols required by the PRODUCE OPERATION
and the PROGRAM.
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Standard 3
3.3.2.5
Follow the safety protocols required by the PRODUCE OPERATION and the
PROGRAM.
3.3.2.6
Follow the procedure for the opening meeting required by the PROGRAM.
3.3.2.7
Assess personnel practices critical to the safe and sanitary growing,
harvesting, packing, and holding of produce.
3.3.2.8
Evaluate conditions, practices, components, and/or labeling that may cause the
produce to be deemed adulterated or misbranded or otherwise in violation of
applicable law(s).
3.3.2.9
Reference appropriate and available FDA guidance documents to evaluate
commodities and/or practices as applicable.
3.3.2.10
Explain findings throughout the inspection and describe the public health
significance.
3.3.2.11
Recognize significant violative conditions or practices, if present, and
document findings consistent with PROGRAM procedures.
3.3.2.12
Alert the PRODUCE OPERATION when an immediate corrective action is
necessary.
3.3.2.13
Review and verify that required records for the PRODUCE OPERATION are
being maintained.
3.3.2.14
Recognize deficiencies in the PRODUCE OPERATION’S required
monitoring activities.
3.3.2.15
Collect adequate evidence and documentation to support inspection
observations in accordance with PROGRAM procedures.
3.3.2.16
Verify correction of deficiencies that were identified during previous
inspection(s).
3.3.2.17
Demonstrate effective communication and interpersonal skills to effectively
support the inspection process.
3.3.3 Inspection Report Procedure
3.3.3.1
The PROGRAM has a written inspection report procedure that requires
inspectors to:
3.3.3.1.1 Document significant violative conditions or practices, if present.
3.3.3.1.2 Complete the inspection report(s) accurately.
3.3.3.1.3 Submit the inspection report within designated timeframes
consistent with PROGRAM’S procedures.
3.3.3.2
The PROGRAM has a written procedure to:
3.3.3.2.1 Review inspection reports with inspectional findings.
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3.3.3.2.2 Provide the applicable inspection report(s) to the PRODUCE
OPERATION within designated timeframes consistent with
PROGRAM’S procedures.
3.3.3.2.3 Follow up with corrective, compliance, and enforcement actions as
warranted.
3.3.4 Recalls
The PROGRAM has a recall system with written procedures to:
3.3.4.1
Receive information about recalls.
3.3.4.2
Share information about recalls with relevant industry and partner agencies.
3.3.4.3
Track the recall and work with recalling operation to remove affected product
from the market.
3.3.4.4
Perform RECALL AUDIT CHECKS, as applicable.
3.3.4.5
Maintain records.
3.3.5 Consumer Complaint
The PROGRAM has a system for handling CONSUMER COMPLAINTS. The system
includes written procedures to:
3.3.5.1
Receive.
3.3.5.2
Track.
3.3.5.3
Evaluate.
3.3.5.4
Answer.
3.3.5.5
Close.
3.3.5.6
Maintain records.
3.3.6 Industry Complaint
The PROGRAM has a system for handling an INDUSTRY COMPLAINT. The system
includes written procedures to:
3.3.6.1
Receive.
3.3.6.2
Track.
3.3.6.3
Evaluate.
3.3.6.4
Answer.
3.3.6.5
Close.
3.3.6.6
Maintain records.
3.3.7 Sampling Program
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A PROGRAM that conducts sampling must have a documented SAMPLING
PROGRAM. The SAMPLING PROGRAM must contain written procedures that:
3.3.7.1
Use the appropriate method and equipment to collect samples.
3.3.7.2
Maintain and document sample chain of custody.
3.3.7.3
Handle, package, and ship samples to ensure security and prevent
compromising condition of samples.
3.3.7.4
Deliver or ship samples to the appropriate LABORATORY program within
prescribed timeframes.
3.3.7.5
Follows the receiving LABORATORY procedures.
3.3.7.6
Provide instructions for documenting the sample collection which may
include:
3.3.7.6.1 Date of Sample Collection
3.3.7.6.2 Product Identification Including:
3.3.7.6.2.1
Name of Product
3.3.7.6.2.2
Sample type
3.3.7.6.2.3
Unique identification references
3.3.7.6.3 Description of the product
3.3.7.6.4 Collection information including:
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3.3.7.6.4.1
Method of Collection
3.3.7.6.4.2
Identification of lot sampled
3.3.7.6.4.3
Lot Size
3.3.7.6.4.4
Special Sample techniques if used to collect the
sample
3.3.7.6.4.5
Location where sample was collected
3.3.7.6.4.6
Name and address of responsible party, guarantor,
possessor, or distributor
3.3.7.6.4.7
Reason for sample collection
3.3.7.6.4.8
Analysis requested, if applicable
3.3.7.6.4.9
Product labels or specific labeling information that
is collected or reproduced per state procedure. This
information is not required for environmental
samples.
3.3.7.6.4.10
Identification of the sample with the unique sample
identifier.
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3.4
Outcome
The PROGRAM has implemented and maintains an inspection program that reduces the occurrence of a
FOOD RELATED INCIDENT.
3.5
Documentation
The PROGRAM maintains the records, or equivalent forms or worksheets, listed here.
3.5.1 Appendix 3.1 Self-Assessment Worksheet or equivalent form.
3.5.2 An inventory of PRODUCE OPERATIONS under the PROGRAM’S jurisdiction and
authority.
3.5.3 Written risk categorization criteria.
3.5.4 Written procedure for inspection prioritization and frequency based upon risk categories.
3.5.5 Written inspection procedure.
3.5.6 Written inspection report procedure.
3.5.7 Written inspection reports.
3.5.8 Written procedure for release of the inspection report to the PRODUCE OPERATION.
3.5.9 Written procedure to review inspection reports with inspectional findings.
3.5.10 Written procedure for follow-up activities and subsequent documentation.
3.5.11 Written recall procedure.
3.5.12 Essential recall information.
3.5.13 Written CONSUMER COMPLAINT procedure.
3.5.14 CONSUMER COMPLAINT information.
3.5.15 Written INDUSTRY COMPLAINT procedure.
3.5.16 INDUSTRY COMPLAINT information.
3.5.17 Written SAMPLING PROGRAM and sampling procedures if sampling is conducted by
the PROGRAM.
3.5.18 Sample reports and associated documentation, if conducted.
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Standard 4
STANDARD No. 4
Inspection Audit Program
4.1
Purpose
This standard describes auditing procedures necessary for a PROGRAM to (1) evaluate the effectiveness
and accuracy of the inspection PROGRAM and inspection records, and if applicable, the sample
collection and sampling records and (2) identify areas in need of corrective actions.
4.2
Requirement Summary
The PROGRAM has a written auditing procedure which includes processes to conduct audits to assess
the effectiveness and accuracy of its inspections and, if applicable, sample collections. The auditing
procedure has 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 if applicable,
sample collections.
4.3
Program Elements
4.3.1 Audit Program
The PROGRAM has written procedures for:
4.3.1.1
The qualifications, education, and experience necessary to be identified as a
QUALIFIED FIELD INSPECTION AUDITOR, to include at a minimum the
training as described in 2.3.
4.3.1.2
FIELD INSPECTION AUDITS as described in 4.3.3.
4.3.1.3
Inspection report audits as described in 4.3.4.
4.3.1.4
Sample report audits as described in 4.3.5, if applicable.
4.3.1.5
Corrective actions as described in 4.3.6.
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
A QUALIFIED FIELD INSPECTION AUDITOR conducts FIELD
INSPECTION AUDITS to verify that inspections are consistently performed
according to the PROGRAM’S written procedures described in Standard 3.
4.3.3.2
Frequency: A minimum of one FIELD INSPECTION AUDIT of each
inspector, after the QUALIFIED DATE, is conducted within 12 months and a
minimum of once every 36 months thereafter. The inspections selected for
audits must reflect the inspectors’ assignments and responsibilities.
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4.3.3.3
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 4.2, or equivalent form.
4.3.3.4
Performance is documented on Appendices 4.2 and 4.2a, or equivalent forms,
that meet the program elements as described in 3.3.2.
4.3.4 Inspection Report Audit
The PROGRAM conducts annual reviews of inspection reports to verify that inspectional
findings are documented according to the PROGRAM’S written procedures. The quality
of each inspection report is audited using the performance factors listed in Appendix 4.3
or equivalent form. An overall inspection report rating is calculated using Appendix 4.3a,
or equivalent form.
4.3.4.1
The PROGRAM will review a random selection of inspection reports based
on the overall number of inspections performed in the last 12 months using
the table below:
Number of Inspections Minimum Number of Maximum Number of
in Twelve Months*
Reports Required
Reports Required
Less than 20 reports
All
All
20-400 reports
20
20
More than 400
5% of reports
50
*Total number of inspections conducted by the PROGRAM in the last 12
months
4.3.4.2
Performance is documented on Appendices 4.3 and 4.3a, or equivalent
forms.
4.3.5 Sample Report Audit
The PROGRAM conducts annual reviews of sample reports to verify that sample
information is documented according to the PROGRAM’S written procedures. The quality
of each sample report is audited using the performance factors listed in Appendix 4.4 or
equivalent form. An overall sample report rating is calculated using Appendix 4.4a, or
equivalent form. Sample report audits do not need to be performed unless samples are
collected.
4.3.5.1
The PROGRAM will review a random selection of sample reports based on
the overall number of samples collected, if applicable, in the last 12 months
using the table below:
Number of Samples in Minimum Number of Maximum Number of
Twelve Months*
Reports Required
Reports Required
Less than 20 reports
All
All
20-400 reports
20
20
More than 400
5% of reports
50
*Total number of samples collected by the PROGRAM in the last 12 months
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4.3.5.2
Performance is documented on Appendices 4.4 and 4.4a, or equivalent
forms.
4.3.6 Corrective Actions
The PROGRAM shall initiate corrective actions for the FIELD INSPECTION AUDIT,
inspection report audit, and if applicable, sample report audit, when one or more of the
conditions below occurs:
4.4
4.3.6.1
An individual receives an overall rating of “needs improvement”;
4.3.6.2
A single performance factor for the PROGRAM falls below 80%; or
4.3.6.3
An overall rating for the PROGRAM falls below 80%.
Outcome
The PROGRAM systematically evaluates and improves its inspection PROGRAM, and if applicable, its
SAMPLING PROGRAM to ensure that activities and documentation are adequate, complete, and
comply with their procedures and policies.
4.5
Documentation
The PROGRAM maintains the records, or equivalent forms or worksheets, listed here.
4.5.1 Appendix 4.1 Self-Assessment Worksheet or equivalent form.
4.5.2 Appendix 4.2 Field Inspection Audit Form or equivalent form.
4.5.3 Appendix 4.2a Summary of Field Inspection Audit Findings or equivalent form.
4.5.4 Appendix 4.3 Inspection Report Audit Form or equivalent form.
4.5.5 Appendix 4.3a Summary of Inspection Report Audit Findings or equivalent form.
4.5.6 Appendix 4.4 Sample Report Audit Form or equivalent form.
4.5.7 Appendix 4.4a Summary of Sample Report Audit Findings or equivalent form.
4.5.8 Written auditing procedures.
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Standard 5
STANDARD No. 5
Foodborne Illness, Outbreak, Response
5.1
Purpose
This standard describes the functions to detect, identify, and respond to FOOD-RELATED INCIDENTS
to stop, control, and prevent foodborne illness, injury, or outbreak.
5.2
Requirement Summary
The PROGRAM has a written system to conduct a response to FOOD-RELATED INCIDENTS. The
PROGRAM describes surveillance, investigation activities, control measures, and post-response
activities in collaboration with other agencies and jurisdictions for responding to reports of FOODRELATED INCIDENTS, and for generating recommendations for foodborne illness prevention.
5.3
Program Elements
5.3.1 Coordination of FOOD-RELATED INCIDENTS
The PROGRAM:
5.3.1.1
Designates, in writing, a coordinator to guide investigation and response
efforts in collaboration with all agencies involved and manage events using
the Incident Command System (ICS)/Incident Management Team (IMT)
structure or a written response plan that includes:
5.3.1.1.1 Identifying and executing investigation objectives.
5.3.1.1.2 Managing communications.
5.3.1.1.3 Implementing control measures.
5.3.1.1.4 Conducting post-response activities.
5.3.1.2
Determines if Memorandums of Understanding or written agreements with
other state regulatory agencies is needed when the responsibility for FOOD
RELATED INCIDENTS and outbreak investigations is assigned to or shared
with another regulatory agency within the state. If a written agreement is
required, it is in effect.
5.3.1.3
Has a written procedure that includes:
5.3.1.3.1 Identifying and describing the roles, duties, and responsibilities for
each activity for the requirements as described in 5.3.2-5.3.5.
5.3.1.3.2 Describing PROGRAM collaboration as necessary with FDA and
other appropriate federal, state, or local authorities in multijurisdictional FOOD-RELATED INCIDENTS.
5.3.1.3.3 Describing communication with relevant agencies during FOODRELATED INCIDENTS, including defined timelines for initial
notification of the incident, communication of ongoing
developments, and sharing of relevant findings.
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5.3.1.3.4 Providing guidance for notification of appropriate law enforcement
agencies when intentional food contamination is suspected or
threatened.
5.3.1.3.5 Maintaining a list of relevant agencies and emergency contacts that
is reviewed and updated at least annually.
5.3.2 Surveillance
The PROGRAM:
5.3.2.1
Uses epidemiological information, CONSUMER COMPLAINTS, or other
incident-related information from appropriate departments or agencies
(federal, state, or local), to detect outbreaks or other FOOD-RELATED
INCIDENTS.
5.3.2.2
Maintains notifications of relevant outbreaks or other FOOD-RELATED
INCIDENTS that are reported to the PROGRAM in a log(s) or database(s).
5.3.3 Investigation
The PROGRAM:
5.3.3.1
Has a written procedure that includes:
5.3.3.1.1 Determining the appropriate response.
5.3.3.1.2 Initiating the response.
5.3.3.1.3 Completing the response.
5.3.3.2
Conducts an investigation using established processes similar to those found
in the current versions of:
5.3.3.2.1 International Association for Food Protection’s (IAFP)
“Procedures to Investigate Foodborne Illnesses."
5.3.3.2.2 Council to Improve Foodborne Outbreak Response’s (CIFOR)
“Guidelines for Foodborne Disease Outbreak Response” Chapter
5.
5.3.3.2.3 FDA IOM Chapter 4 and Chapter 8, as appropriate.
5.3.3.2.4 RRT Best Practices Manual Volume II, Chapter 12
“Environmental Sampling and Records Collection.”
5.3.3.3
Has a written procedure to coordinate the traceback and traceforward of
produce suspected or implicated in an illness, injury, or outbreak or found to
contain a hazard.
5.3.3.4
Has access to LABORATORY support for investigation of outbreaks or other
FOOD-RELATED INCIDENTS.
Note: Specific requirements for support are described in Standard 10
5.3.3.5
Analyzes ROOT CAUSE INVESTIGATION (RCI) data, if conducted.
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5.3.4 Control Measures
The PROGRAM has written procedures for:
5.3.4.1
Strategies to mitigate and contain outbreaks or other FOOD-RELATED
INCIDENTS that include enforcement, public awareness activities, industry
education, and outreach.
5.3.4.2
Releasing information to the public, including:
5.3.4.2.1 Identifying a point(s) of contact.
5.3.4.2.2 Developing guidelines for coordinating media information with
other jurisdictions.
5.3.5 Post Response
The PROGRAM has written procedures that include:
5.4
5.3.5.1
Maintaining investigational findings and reports.
5.3.5.2
Distributing final investigation report(s), including ROOT CAUSE
INVESTIGATION (RCI), if completed, to relevant agencies, as necessary.
5.3.5.3
Providing recommendations, when available, from investigation and ROOT
CAUSE INVESTIGATION (RCI) reports to relevant agencies and
stakeholders responsible for prevention, education, outreach, and research.
Outcome
The PROGRAM has a written system to document and investigate FOOD-RELATED INCIDENTS.
The PROGRAM has established communication pathways with appropriate parties to gather and share
information to stop, control, and prevent FOOD-RELATED INCIDENTS.
5.5
Documentation
The PROGRAM maintains the records, or equivalent forms or worksheets, listed here.
5.5.1 Appendix 5.1 Self-Assessment Worksheet.
5.5.2 Written response plan, if ICS/IMT management structure is not utilized.
5.5.3 Memorandums of understanding or written agreements, as applicable.
5.5.4 Written procedure for coordination of FOOD RELATED INCIDENTS, including
communication with other agencies.
5.5.5 Written contact list.
5.5.6 Notification log of relevant outbreaks or other FOOD-RELATED INCIDENTS.
5.5.7 Written procedure for response to an outbreak or other FOOD-RELATED INCIDENTS.
5.5.8 Written procedure for traceback/traceforward coordination and activities.
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5.5.9 Written strategies to mitigate and contain outbreaks or other FOOD-RELATED
INCIDENTS.
5.5.10 Written procedure for releasing information to the public.
5.5.11 Written procedure to maintain and distribute reports.
5.5.12 Investigational reports, including ROOT CAUSE INVESTIGATION (RCI) reports.
5.5.13 Written procedure to provide recommendations to stakeholders.
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Standard 6
STANDARD No. 6
Compliance and Enforcement Program
6.1
Purpose
This standard describes the elements of an effective compliance and enforcement program that includes
strategies, procedures, and actions to achieve compliance with laws and regulations, and to evaluate the
enforcement program.
6.2
Requirement Summary
The PROGRAM has a documented compliance and enforcement program which describes its strategies
and procedures. The PROGRAM conducts an annual evaluation of the enforcement activities to identify
potential improvements or modifications.
6.3
Program Elements
6.3.1 The PROGRAM has written compliance and enforcement procedures that includes:
6.3.1.1
Describing compliance and enforcement strategies, use of enforcement tool(s)
and progressive enforcement action(s).
6.3.1.2
Describing the process used to determine appropriate enforcement action(s).
6.3.2 The PROGRAM has a written procedure for conducting an annual evaluation of its
enforcement activities.
6.3.3 The PROGRAM conducts an annual evaluation of all enforcement activities, or uses a
statistical approach to determine a representative number of enforcement activities, that
includes:
6.4
6.3.3.1
Determining if enforcement actions follow procedures described in 6.3.1.
6.3.3.2
Implementing improvements or modifications related to the compliance and
enforcement procedures, if any.
6.3.3.3
Documenting results from 6.3.3.1 and 6.3.3.2 on Appendix 6.2 or equivalent
form.
Outcome
The PROGRAM has an effective compliance and enforcement program that has written procedures to
ensure that enforcement actions are in accordance with established procedures.
6.5
Documentation
The PROGRAM maintains the records, or equivalent forms or worksheets, listed here.
6.5.1 Appendix 6.1 Self-Assessment Worksheet.
6.5.2 Appendix 6.2 Calculation of the Level of Conformance to Compliance Procedures.
6.5.3 Written compliance and enforcement procedures.
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Standard 6
6.5.4 Written procedure for conducting an annual review of the compliance and enforcement
procedures.
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Standard 7
STANDARD No. 7
Outreach Activities
7.1
Purpose
This standard describes the elements of OUTREACH ACTIVITY developed or provided by the
PROGRAM.
7.2
Requirement Summary
The PROGRAM participates in OUTREACH ACTIVITY that supports communication and information
exchange among produce industry stakeholders such as regulators, academia, PRODUCE
OPERATIONS, consumer representatives, and consumers.
7.3
Program Elements
7.3.1 The PROGRAM has a written procedure of the methods that will be used for
communication with the produce industry stakeholders and consumers that includes:
7.3.1.1
Identifying the methods for communication such as on-farm education,
electronic sources, and mailings.
7.3.1.2
Interacting with produce industry stakeholders and consumers by sponsoring
or actively participating in OUTREACH ACTIVITY.
7.3.1.3
Tailoring outreach efforts to a target population. Consider target population
characteristics such as:
7.3.1.3.1 Geography
7.3.1.3.2 Language and/or learning needs
7.3.1.3.3 Coverage status
7.3.1.3.4 Growing, harvesting, packing, and holding practices
7.3.1.3.5 Commodity specific considerations
7.3.1.4
Tailoring outreach topics to a target population. Topics of outreach efforts
may include:
7.3.1.4.1 Regulatory requirements and guidance
7.3.1.4.2 Emerging issues
7.3.1.4.3 Regional specific considerations
7.3.1.5
7.4
Document and evaluate OUTREACH ACTIVITY using Appendix 7.2, or
equivalent form. Include documents such as agendas, meeting summaries, and
program evaluations.
Outcome
The PROGRAM uses OUTREACH ACTIVITY that will inform and educate produce industry
stakeholders on ways that may reduce the occurrence of a FOOD RELATED INCIDENT.
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Standard 7
7.5
Documentation
The PROGRAM maintains the records, or equivalent forms or worksheets, listed here.
7.5.1 Appendix 7.1 Self-Assessment Worksheet.
7.5.2 Appendix 7.2 Outreach Activity Event and Self-Evaluation Worksheet or equivalent
documentation for each OUTREACH ACTIVITY event.
7.5.3 Written procedure for the methods used for communication with produce industry
stakeholders and consumers.
7.5.4 Agendas, meeting summaries, program evaluations, or other records documenting
interaction with food industry stakeholders and consumers.
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Standard 8
STANDARD No. 8
Program Resources
8.1
Purpose
This standard describes the elements required for assessing and validating the WORKPLAN and
allocating resources needed to support a PROGRAM.
8.2
Requirement Summary
The PROGRAM has procedures for evaluating and validating the WORKPLAN. The PROGRAM
conducts an assessment of resource needs to fully implement the Produce Regulatory Program
Standards.
8.3
Program Elements
8.3.1 The PROGRAM has a written WORKPLAN that includes:
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 the PRODUCE OPERATION.
8.3.1.1.4 Frequency of inspection.
8.3.1.2
If there is a SAMPLING PROGRAM, a sampling plan is required.
8.3.2 The WORKPLAN has a timeframe that is applicable within a 12-month period.
8.3.3 The WORKPLAN has a written evaluation procedure that includes:
8.3.3.1
A documented annual review for alignment with PROGRAM objectives and
resources.
8.3.3.2
A documented review when PROGRAM objectives or resources change.
8.3.4 The PROGRAM has a written procedure for identifying and reviewing its resources to
accomplish the WORKPLAN within the applicable timeframe. The resource review must
include resources needed to fully support the WORKPLAN including:
8.3.4.1
Staffing.
8.3.4.2
Equipment.
8.3.4.3
Funding.
8.3.4.4
Administrative Support.
8.3.5 To validate the WORKPLAN, the PROGRAM calculates the number of staff needed to
accomplish the WORKPLAN based on the PROGRAM’S data.
Note: The PROGRAM should have the necessary staff to meet the requirements of the
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Standard 8
WORKPLAN.
8.3.6 A list of the equipment required for inspections and sample collections must be:
8.3.6.1
Established by the PROGRAM.
8.3.6.2
Maintained by the PROGRAM.
8.3.7 The PROGRAM conducts an annual review of the resources needed to fully implement
the Produce Regulatory Program Standards by using Appendix 8.2 or equivalent form.
8.4
Outcome
The PROGRAM has a written WORKPLAN and assesses and allocates resources needed to support the
IMPLEMENTATION of the Produce Regulatory Program Standards.
8.5
Documentation
The PROGRAM maintains the records, or equivalent forms or worksheets, listed here.
8.5.1 Appendix 8.1 Self-Assessment Worksheet.
8.5.2 Appendix 8.2 Resource Summary Report.
8.5.3 Written WORKPLAN.
8.5.4 Written procedure for evaluating the WORKPLAN.
8.5.5 Written procedure for identifying and reviewing resources to accomplish the
WORKPLAN within the applicable timeframe.
8.5.6 Supportive documentation for calculating the staff needed to accomplish the
WORKPLAN.
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Standard 9
STANDARD No. 9
Program Assessment
9.1
Purpose
This standard describes the process a PROGRAM uses to assess and demonstrate its CONFORMANCE
with each of the program standards.
9.2
Requirement Summary
The PROGRAM conducts a baseline self-assessment and subsequent periodic self-assessments against
the criteria established in each program standard. These self-assessments are designed to identify the
strengths and weaknesses of the PROGRAM. The baseline self-assessment identifies areas or functions
of the PROGRAM that need improvements and is used to develop a STRATEGIC IMPROVEMENT
PLAN and establish timeframes for making improvements. Subsequent periodic self-assessments track
progress toward achieving and maintaining CONFORMANCE with the program standards.
9.3
Program Elements
9.3.1 The PROGRAM:
9.3.1.1
Conducts a baseline self-assessment in the first year to determine if the
PROGRAM meets the program elements of each standard.
9.3.1.2
Completes the self-assessment worksheets, which are the first appendices for
each standard, to establish the baseline self-assessment.
9.3.1.3
Uses the results of its self-assessments to complete Appendix 9.2 SelfAssessment Summary Report, or equivalent form.
9.3.2 If the 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
The individual element or documentation requirement of the standard that was
not met.
9.3.2.2
Improvements needed to meet the program element or documentation
requirement of the standard.
9.3.2.3
Projected completion dates for each task.
9.3.2.4
Personnel responsible.
9.3.2.5
Date completed for each task.
9.3.3 The PROGRAM reviews and updates the self-assessment appendices and its
STRATEGIC IMPROVEMENT PLAN at least annually.
9.3.4 The PROGRAM participates in FDA ASSESSMENTS to determine
IMPLEMENTATION and CONFORMANCE to the standards. The PROGRAM
addresses FDA ASSESSMENT observations and establishes corrective action(s)
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Standard 9
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 PROGRAM shall demonstrate it:
9.3.5.1
Has a written DOCUMENT CONTROL procedure that ensures all guidance,
procedures, documents, and forms required by the standards are CURRENT
AND FIT FOR USE. All documents subject to this procedure are CURRENT
AND FIT FOR USE through maintenance of a master document list or other
systems that show:
9.3.5.1.1 Documents are reviewed for accuracy.
9.3.5.1.2 Documents are approved for release by authorized personnel and
signed/dated with an approval or revision date.
9.3.5.1.3 Documents are distributed to the applicable end user(s) and used at
the location where the prescribed activity is performed.
9.3.5.2
9.4
Retains records or procedures required under the Documentation section of
each standard for the three previous years, or per the PROGRAM’S record
retention policy, whichever is longer. Records or procedures can be retained
electronically or hard copy.
Outcome
The PROGRAM conforms to the program standards through well-defined and written evaluation
activities and a process for continuous improvement.
9.5
Documentation
The PROGRAM maintains the records, or equivalent forms or worksheets, listed here.
9.5.1 Appendix 9.1 Self-Assessment Worksheet.
9.5.2 Appendix 9.2 Self-Assessment Summary Report.
9.5.3 STRATEGIC IMPROVEMENT PLAN.
9.5.4 FDA ASSESSMENT reports.
9.5.5 Written DOCUMENT CONTROL procedure.
9.5.6 Record retention policy.
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Standard 10
STANDARD No. 10
Laboratory Support
10.1
Purpose
This standard describes the elements of utilizing LABORATORY services to support a PROGRAM.
10.2
Requirement Summary
If a PROGRAM collects samples, the PROGRAM has access to LABORATORY services needed to
support regulatory functions.
10.3
Program Elements
10.3.1 LABORATORY Support
10.3.1.1
The PROGRAM shall have access to a LABORATORY that is capable of
analyzing food and environmental samples.
10.3.1.2
The PROGRAM shall maintain a list of all analytical services the
LABORATORY can provide the PROGRAM.
10.3.1.3
The PROGRAM shall have a written agreement with each LABORATORY.
The agreement must contain, at a minimum, the components below:
10.3.1.3.1 Define the responsibilities of each party.
10.3.1.3.2 Describe the analytical services to be performed.
10.3.1.3.3 Describe how changes to planned work will be communicated by
each party.
10.3.1.3.4 Describe how results are reported to the PROGRAM.
10.3.2 LABORATORY Requirements
The PROGRAM utilizes a LABORATORY which:
10.3.2.1
Is accredited by a recognized accreditation body to the International
Organization for Standardization/International Electrotechnical Commission
ISO/IEC 17025:2017, or current version; or
10.3.2.2
Implements and complies with the ISO/IEC 17025:2017, or current version. If
the LABORATORY is not accredited to ISO/IEC 17025:2017 (or current
version), then the following must be provided to the PROGRAM:
10.3.2.2.1 A copy of the written LABORATORY quality manual.
10.3.2.2.2 A written attestation that the LABORATORY meets the
requirements of ISO/IEC 17025:2017 (or current version).
10.4
Outcome
The PROGRAM has access to LABORATORY services described in this standard to support regulatory
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Standard 10
functions.
10.5
Documentation
The PROGRAM maintains the records, or equivalent forms or worksheets, listed here.
10.5.1 Appendix 10.1 Self-assessment worksheet.
10.5.2 List of analytical services provided by the LABORATORY.
10.5.3 Written agreements with each LABORATORY.
10.5.4 For ISO Accredited LABORATORY: ISO/IEC 17025:2017 (or current version)
Certificate and Scope of Accreditation.
10.5.5 For Non-ISO Accredited LABORATORY:
10.5.5.1
Written LABORATORY quality manual.
10.5.5.2
Attestation from LABORATORY that it meets the requirements of ISO/IEC
17025:2017(or current version).
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Appendix 1.1
Appendix 1.1: Self-Assessment Worksheet
Instructions: The PROGRAM identifies if they have a specified component then evaluates if it includes the
associated components. If the PROGRAM has the main component and associated components indicate
“Yes”, if not, indicate “No”.
PROGRAM
Program Elements
Yes/No
If No, please explain why the
element is not met. Use this space for
additional notes.
1.3.1 Written Procedure for Evaluation of Legal Authority
Does the PROGRAM’S written procedure:
1. Describe the REGULATORY FOUNDATION
assessment process?
2. Include timeframes for conducting a
REGULATORY FOUNDATION assessment;
including whenever significant changes are made
to applicable federal and/or state laws and
regulations?
3. Address statutes, regulations, rules, ordinances,
and other prevailing regulatory requirements that:
a. Apply to the regulation of produce?
b. Delegate authority to the PROGRAM?
c. Describe the PROGRAM’S administrative
procedures for rulemaking to protect public
health?
d. Identify and list other federal or state agencies
that have authority for any area of the
REGULATORY FOUNDATION the
PROGRAM lacks?
1.3.2 REGULATORY FOUNDATION Assessment
Does the PROGRAM’S REGULATORY
FOUNDATION assessment include:
1. A baseline self-assessment using Appendix 1.2 or
equivalent form to determine if the PROGAM is
EQUIVALENT, EQUIVALENT IN EFFECT,
NOT EQUIVALENT, or NO AUTHORITY to
sections of the FD&C Act and CFRs as specified
in Appendix 1.2 or equivalent form?
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Appendix 1.1
Program Elements
Yes/No
2. Publication date of the CFR that was adopted or
served as the basis for each regulation, if the
PROGRAM has not utilized the current version of
a CFR provision?
If No, please explain why the
element is not met. Use this
space for additional notes.
Assessment completed by:
Name
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Appendix 1.2
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 PROGRAM does have authority, record the state law or regulations and the date it was published.
The Notes section shall be used in part to detail differences between federal and state laws and regulations. If regulatory responsibility for a FD&C
or CFR falls under the jurisdiction of another agency or program, that particular FD&C or CFR row should be left blank- with documentation
provided in the notes section of which agency or program has the jurisdiction.
To the extent that any federal statutes or regulations cited below reference FDA regulated products other than produce or human food that includes
produce, such references are not intended to be within the scope of this self-assessment which relates only to produce.
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-food- drug-and-cosmetic-act-fdc-act
The worksheet below is divided into two sections.
Section 1 - Core Regulatory Authorities - Authorities that are required by a PROGRAM to conduct regulatory activities under provisions of 21 CFR
112 are listed in this section. It is essential that PROGRAMS have these authorities within their regulatory framework to participate with FDA in the
implementation of the Produce Safety rule at the state level.
Section 2 - Supplemental Regulatory Authorities – The authorities outlined in this section, also found in 21 CFR, may be required, in addition to the
Core Regulatory Authorities listed in section 1, to conduct a fully functional PROGRAM.
Several options exist to create a fully functional PROGRAM at the state level, depending upon existing state programs and authorities. Jurisdictional
responsibilities may differ for PROGRAMS if similar state authority to the FD&C Act already exists for PROGRAMS administered within the same
agency or a different agency. A Memorandum of Understanding may be the appropriate mechanism to transfer specific and limited authority or
responsibility to another agency to create adequate authority for conducting a fully functional PROGRAM. Some states authorize a Memorandum of
Understanding, Memorandum of Agreement, or some other contractual agreement. If the authority does not exist at the state level, it will need to be
created.
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Appendix 1.2
PROGRAM:
Section 1 - Core Regulatory Authorities
Federal Food, Drug & Cosmetic Act/ US Code
FD&C Act /
US Code
201/321
301/331
304/334*
402/342
702/372
704/374 **
Date
Equivalency State Citation Incorporated
Status
into State Law
Title
Notes
Definitions (f), (k), (m)(r),
and (gg)
Prohibited acts (a), (b),
(e), (f), (kk), and (vv)
Seizure
Adulterated Food (a)(1),
(a)(2)(B),(a)(3), (a)(4),
(a)(6), (a)(7), (b), (c), and
(i)
Examinations and
Investigations (a)(1)(A)
Inspection
*Although the PROGRAM may not have authority for seizure, the 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
21 CFR
Part
112
Title
Standards for the
Growing, Harvesting,
Packing, and Holding of
Produce for Human
Consumption
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Equivalency State Citation Incorporated
Status
into State Law
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Notes
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Appendix 1.2
Section 2 - Supplemental Regulatory Authorities
Federal Food, Drug & Cosmetic Act
FD&C
Act /US
Code
303/333***
403/343
701/371
Title
Equivalency
Status
Penalties
Date
State Citation Incorporated
into State
Law
Notes
Misbranded Food (a),
(d), (e), (f), (l)
Authority to
promulgate regulations
(a)
*** Penalties may vary from Federal statute
Title 21 Code of Federal Regulations: Food and Drugs
21 CFR
Part
1
7
Title
General
enforcement
regulations
(§ 1.20, 1.21, 1.22,
1.24),
Sanitary Transport
(Subpart O § 1.9001.934)
Enforcement policy
(ONLY § 7.1-7.13
and § 7.40-7.59)
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Equivalency
Status
State Citation
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Date
Incorporated
into State Law
Notes
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Appendix 1.2
73
74
101
102
170
182
Listing of colors
exempt
from certification
ONLY § 73.1-§
73.615)
Listing of color
additives
subject to
certification
(ONLY § 74.101706)
Food labeling (ONLY
§101.1, 101.2,
101.3, 101.4,
101.5, 101.7,
101.13, 101.14,
101.15, 101.18,
101.54-101.65,
101.91and 101.100
Common or usual name
for non-standardized
foods (ONLY 102.5(a))
Food additives
EXCEPT § 170.6,
§ 170.15, and §
170.17)
Substances
generally
recognized as safe
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Appendix 1.2
Additional State Authorities:
Instructions: List any state authorities, laws, and/or regulations used by the PROGRAM that are pertinent to the regulation of produce but are
outside the scope of 21 CFR 112.
State authority
Title
Date Incorporated
Notes
Assessment Completed By:
Name
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Date:
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Appendix 2.1
Appendix 2.1: Self-Assessment Worksheet
Instructions: The PROGRAM identifies if they have a specified component, then evaluates if it includes the
associated components. If the PROGRAM has the main component and associated components indicate
“Yes”, if not, indicate “No”.
PROGRAM
Program Elements
Yes/No
If No, please explain why the
element is not met. Use this space
for additional notes.
2.3.1. Training Plan and Training Records
Does the PROGRAM:
1. Have a written training plan that includes training
and continuing education, to ensure all inspectors
receive training required to adequately perform
their work assignments?
2. Maintain individual training records for active
inspectors?
3. Maintain individual training records for all
inactive inspectors for a minimum of three years?
4. Use Appendix 2.2 or equivalent form to document
and summarize all training provided to inspectors?
5. Include the inspector’s START DATE in the
training record summary?
6. Assess all inspectors’ previous performance and
experience to determine if the inspectors have
completed required training, or determine if
additional training is needed?
2.3.2. Inspection Training
Does the PROGRAM require that each inspector:
1. Complete the training curriculum prior to
performing independent inspections?
2. Complete the training curriculum within 24
months of the inspector’s START DATE?
3. Complete the coursework in the subject areas
listed in 2.3.2.3.1 – 2.3.2.3.8?
4. Complete the field training program prior to
performing independent inspections that meet the
elements detailed in 2.3.2.4.1 - 2.3.2.4.6?
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Appendix 2.1
Program Elements
Yes/No
If No, please explain why the
element is not met. Use this space
for additional notes.
5. Have competencies been verified in the field by
the QUALIFIED FIELD INSPECTION
TRAINER?
Does the PROGRAM have written procedures for:
1. Competencies to be verified in the field?
2. JOINT FIELD TRAINING INSPECTIONS?
3. The number of JOINT FIELD INSPECTIONS to
be completed by the inspector?
4.
The number of field inspection
EVALUATIONS?
5. Additional field training activities, if deemed
necessary by the PROGRAM?
6. The qualifications, education, and experience
necessary to be identified as a QUALIFIED
FIELD INSPECTION TRAINER?
2.3.3 Experienced Inspectors
For CURRENT EXPERIENCED STAFF or newly
hired experienced inspection staff, does the
PROGRAM’S training plan include the following
unless the PROGRAM determines in their training
plan that all staff will be required to complete the
program elements in 2.3.2?
For CURRENT EXPERIENCED STAFF, does the
PROGRAM’S training plan include the following for
those who are missing training records?
1. A statement or affidavit from the PROGRAM
stating an assessment has occurred and the
outcomes of the assessment satisfy the
requirements for documentation?
2. A statement or affidavit from the PROGRAM
explaining that the CURRENT EXPERIENCED
STAFF’S background or experience justifies a
waiver of JOINT FIELD TRAINING
INSPECTIONS?
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Appendix 2.1
Program Elements
Yes/No
If No, please explain why the
element is not met. Use this space
for additional notes.
3. A statement or affidavit from the PROGRAM
explaining that the CURRENT EXPERIENCED
STAFF’S background or experience justifies a
waiver of coursework requirements?
For newly hired experienced inspection staff, does the
PROGRAM’S training plan include the following for
those who are missing training records?
1. A statement or affidavit from the PROGRAM
stating an assessment has occurred and the
outcomes of the assessment satisfy the
requirements for documentation?
2. A statement or affidavit from the PROGRAM
explaining the background or experience that
justifies a waiver of some or all of the JOINT
FIELD TRAINING INSPECTIONS?
3. A requirement that inspectors who are missing
JOINT FIELD TRAINING INSPECTION records
conduct two successful EVALUATIONS within
six (6) months of the inspector’s QUALIFIED
DATE?
4. A statement from the PROGRAM explaining that
the newly hired experienced inspection staff’s
background or experience justifies a waiver of
coursework requirements?
2.3.4 Continuing Education
1. Does each inspector conducting produce
inspections accumulate 20 CONTACT HOURS of
continuing education, in the manners outlined in
2.3.4.4 and 2.3.4.5, every 36 months, starting from
the QUALIFIED DATE?
2. Does the PROGRAM maintain documentation for
continuing education credit as outlined in 2.3.4.6?
3. Is all coursework obtained from sources listed in
2.3.4.7?
Assessment completed by:
Name
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Appendix 2.2
Appendix 2.2: Inspector Training Record
PROGRAM
Name of Inspector
Start Date
Note: If an assessment of the inspector’s previous performance and experience demonstrates adequate
training has been completed as referenced in 2.3.1, Mark the “Coursework Name and Location of
Training Column”, with “Met via Evaluation”.
Subject Areas
Date
Completed
Coursework Name and Location
of Training
Documentation
Verifying
Completion (Y/N)
Prevailing statutes,
regulations, and
ordinances
Inspections, compliance, and
enforcement
Public health
principles
Biosecurity
Basic/Introductory
emergency management
Communication skills
Microbiology
Sampling technique, if
applicable
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Appendix 2.2
JOINT FIELD TRAINING INSPECTIONS
As referenced in 2.3.2.4.4, the minimum Number of JOINT FIELD TRAINING INSPECTIONS
Required: ____
JOINT FIELD TRAINING INSPECTIONS
Date
Completed
Farm Name and Location
Documentation
Available for
Review
(Y/N)
As referenced in 2.3.2.4.2, the PROGRAM should determine a Field training checklist of competencies
to be verified in the field by the QUALIFIED FIELD INSPECTION TRAINER
COMPETENCIES
Date
Observed
Competency
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EVALUATION
Acceptable
(Y/N)
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Appendix 2.2
As referenced in 2.3.2.4.6, additional field training activities deemed necessary.
OTHER FIELD ACTIVITIES
Field Activity
Date
Completed
EVALUATION
Acceptable
(Y/N)
Documentation
Available for
Review
(Y/N)
As referenced in 2.3.2.4.5, the minimum Number of field inspection
EVALUATIONS Required: ____
EVALUATIONS
Farm Name and Location
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EVALUATION
Date
Acceptable
Completed
(Y/N)
50
Documentation
Available for
Review
(Y/N)
2024
Appendix 2.2
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
Maximum of 20 CONTACT HOURS
Documentation
Type of Activity
Date
Available for Review
(Provide Title and Brief Description) Completed
(Y/N)
CONTACT
HOURS
Earned
Subtotal
Presenting, Training, or Publishing (Program Element 2.3.4.6)
Maximum of 10 CONTACT HOURS
Type of Activity
(Provide Title and Brief Description)
Date
Completed
Documentation Available
for Review (Y/N)
CONTACT
HOURS
Earned
Subtotal
Total CONTACT HOURS Earned
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Appendix 3.1
Appendix 3.1: Self-Assessment Worksheet
Instructions: The PROGRAM identifies if they have a specified component, then evaluates if it includes
the associated components. If the PROGRAM has the main component and associated components
indicate “Yes”, if not, indicate “No”.
PROGRAM
Program Elements
Yes/No
If No, please explain why the element is
not met. Use this space for additional
notes.
3.3.1 Risk-Based Inspection PROGRAM
Does the PROGRAM have written procedures
to:
1. Define and establish an inventory of
PRODUCE OPERATIONS under the
PROGRAM’S jurisdiction and authority?
2. Maintain the inventory of PRODUCE
OPERATIONS?
3. Define and document risk categories, using
at least the minimum required risk factors
identified in 3.3.1.3.1 – 3.3.1.3.5?
4. Prioritize inspections and assign frequencies
based on the risk categories established?
3.3.2 Inspection Procedure
Does the PROGRAM have written procedures
that require the inspector to:
1. Review the previous inspection report(s),
CONSUMER COMPLAINT(S), and
compliance history?
2. Follow the pre-inspection call procedures
required by the PROGRAM?
3. Have appropriate equipment and forms, and
equipment verified, operated, and maintained
as defined by the PROGRAM?
4. Follow the biosecurity protocols required by
the PRODUCE OPERATION and the
PROGRAM?
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Appendix 3.1
Program Elements
Yes/No
If No, please explain why the element is
not met. Use this space for additional
notes.
5. Follow the safety protocols required by the
PRODUCE OPERATION and the
PROGRAM?
6. Follow the procedure for the opening
meeting required by the PROGRAM?
7. Assess personnel practices critical to the safe
and sanitary growing, harvesting, packing,
and holding of produce?
8. Evaluate conditions, practices, components,
and/or labeling that may cause the produce to
be deemed adulterated, misbranded, or
otherwise in violation of applicable law(s)?
9. Reference appropriate and available FDA
guidance documents, as applicable?
10. Explain findings throughout the inspection
and describe the public health significance?
11. Recognize significant violative conditions or
practices and document findings consistent
with PROGRAM procedures?
12. Alert the PRODUCE OPERATION when an
immediate corrective action is necessary?
13. Review and verify the required records for
the PRODUCE OPERATION are
maintained?
14. Recognize deficiencies in the PRODUCE
OPERATION’S required monitoring
activities?
15. Collect adequate evidence and
documentation to support inspection
observations in accordance with the
PROGRAM procedures?
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Appendix 3.1
Program Elements
Yes/No
If No, please explain why the element is
not met. Use this space for additional
notes.
16. Verify correction of deficiencies that were
identified during previous inspection(s)?
17. Demonstrate effective communication and
interpersonal skills?
3.3.3 Inspection Report Procedure
Does the PROGRAM have written inspection
report procedures that require inspectors to:
1. Document significant violative conditions or
practices?
2. Complete the inspection report(s) accurately?
3. Submit the inspection report within
designated timeframes?
Does the PROGRAM have written procedures
to:
1. Review inspection reports with inspectional
findings?
2. Provide the applicable inspection report(s) to
the PRODUCE OPERATION within
designated timeframes?
3. Follow up with corrective, compliance, and
enforcement actions as warranted?
3.3.4 Recalls
Does the PROGRAM have a recall system with
written procedures to:
1. Receive information about recalls?
2. Share information about recalls with relevant
industry and partner agencies?
3. Track the recall and work with the recalling
operation to remove affected product from
the market?
4. Perform RECALL AUDIT CHECKS as
applicable?
5. Maintain recall records?
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Appendix 3.1
Program Elements
Yes/No
If No, please explain why the element is
not met. Use this space for additional
notes.
3.3.5 Consumer Complaint
Does the PROGRAM have a CONSUMER
COMPLAINT system with written procedures
to:
1. Receive the complaint?
2. Track the complaint’s follow-up?
3. Evaluate the complaint?
4. Answer the complaint?
5. Close the complaint?
6. Maintain a record of the complaint?
3.3.6 Industry Complaint
Does the PROGRAM have an INDUSTRY
COMPLAINT system with written procedures
to:
1. Receive the complaint?
2. Track the complaint’s follow-up?
3. Evaluate the complaint?
4. Answer the complaint?
5. Close the complaint?
6. Maintain a record of the complaint?
3.3.7 Sampling
For PROGRAMS that conduct sampling, does
the PROGRAM have a SAMPLING
PROGRAM with written procedures that:
1. Use the appropriate method and equipment to
collect samples?
2. Maintain and document sample chain of
custody?
3. Handle, package, and ship samples to ensure
security and prevent compromising condition
of samples?
4. Deliver or ship samples to the appropriate
LABORATORY program within prescribed
timeframes?
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Appendix 3.1
Program Elements
Yes/No
5. Follow the receiving LABORATORY
procedures?
6. Provide instructions for documenting the
sample collection, if applicable, as described
in 3.3.7.6.1 – 3.3.7.6.4 (and all subelements)?
If No, please explain why the element is
not met. Use this space for additional
notes.
Assessment completed by:
Name
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Appendix 4.1
Appendix 4.1 – Self-Assessment Worksheet
Instructions: The PROGRAM identifies if they have a specified component then evaluates if it includes the
associated components. If the PROGRAM has the main component and associated components indicate
“Yes”, if not, indicate “No”.
PROGRAM
Program Elements
Yes/No
If No, please explain why the element is
not met. Use this space for additional
notes.
4.3.1 Audit Program
Does the PROGRAM have written procedures
for:
1. The qualifications, education, and experience
necessary to be identified as a QUALIFIED
FIELD INSPECTION AUDITOR?
2. FIELD INSPECTION AUDITS as described
in section 4.3.3?
3. Inspection report audits as described in
section 4.3.4?
4. Sample report audits as described in section
4.3.5?
5. Corrective actions as described in section
4.3.6?
4.3.2 Score Review
Does the PROGRAM review the performance
factor scores and cumulative scores for each type
of completed audit at least every 12 months?
4.3.3 Field Inspection Audit
Does the PROGRAM have written procedures for
conducting FIELD INSPECTION AUDITS that
include:
1. A QUALIFIED FIELD INSPECTION
AUDITOR conducts FIELD INSPECTION
AUDITS to verify that inspections are
consistently performed according to the
PROGRAM’S written procedures described
in Standard 3?
2. A minimum of one FIELD INSPECTION
AUDIT of each inspector is conducted within
twelve months and a minimum of once every
36 months after their QUALIFIED DATE?
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Appendix 4.1
Program Elements
Yes/No
3. Sample collection audits, if samples are
collected during the FIELD INSPECTION
AUDIT, and the appropriate question(s)
answered on Appendix 4.2, or equivalent
form?
4. Documentation in Appendices 4.2 and 4.2a,
or equivalent form, that demonstrate meeting
the PROGRAM elements in Standard 3,
section 3.3.2?
If No, please explain why the element is
not met. Use this space for additional
notes.
4.3.4 Inspection Report Audits
Does the PROGRAM have written procedures for
inspection report audits that include:
1. The PROGRAM conducts annual reviews of
inspection reports to verify that inspectional
findings are documented according to the
PROGRAMs written procedures?
2. The PROGRAM reviews a random selection
of inspection reports based on the number of
inspections performed in the last 12 months
using the table in 4.3.4.1?
3. Performance is documented using the factors
listed in Appendix 4.3 and 4.3.a, or equivalent
forms?
4.3.5 Sample Report Audit
Does the PROGRAM collect samples?
If samples were collected, does the PROGRAM
have written procedures for conducting sample
report audits that include:
1. An annual review of sample reports?
2. Reviewing a random selection of sample
reports based on the number of samples
collected in the last 12 months using the table
in 4.3.5.1?
3. The quality of each sample report is audited
using the performance factors listed in
Appendix 4.4, or equivalent form?
4. The overall sample report rating is calculated
using Appendix 4.4a, or equivalent form?
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Appendix 4.1
Program Elements
Yes/No
If No, please explain why the element is
not met. Use this space for additional
notes.
4.3.6 Corrective Actions
Does the 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
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Appendix 4.2
Appendix 4.2: Field Inspection Audit Form
PRODUCE REGULATORY PROGRAM STANDARDS
FIELD INSPECTION AUDIT FORM
AUDITOR:
INSPECTOR:
FIRM/FARM NAME:
FIRM /FARM ID:
FIRM/FARM ADDRESS:
PRODUCT(S) COVERED:
AUDIT DATE:
TIME IN:
TIME OUT:
TOTALS:
AUDIT RATING
Total # “Acceptable”:
☐Acceptable
Total # “Needs Improvement”:
☐Needs Improvement
Audit Score:
NOTE: All questions must be answered "Acceptable" or "Needs Improvement". Every
item marked “Needs Improvement” must be accompanied by an explanation of why the
item was judged as needing improvement.
INSTRUCTIONS TO THE AUDITOR
All performance factors must be rated “Acceptable” or “Needs Improvement.” The total
number of “Acceptable” and “Needs Improvement,” as well as the Audit Score and Audit
Rating, must be recorded in the space above.
To calculate the Audit Score:
Audit Score = [# Acceptable Performance Factors/ (# Acceptable Performance Factors + #
Needs Improvement Performance Factors)] x 100.
Audit Rating:
If the Audit Score is below 80%, the Audit Rating must be marked as “Needs Improvement.”
Corrective Action(s):
If the individual receives an overall rating of "needs improvement" from the audit, the
PROGRAM management must be notified by the QUALIFIED FIELD INSPECTION AUDITOR that
additional training or other performance improvement measures for the inspector being
audited should be initiated. All inspectors who receive an overall audit score of "needs
improvement" shall receive remedial training in deficient areas as determined by the
PROGRAM prior to resuming routine inspections in the field.
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I. PRE-INSPECTION ASSESSMENT
1. Did the inspector review the previous inspection report(s), CONSUMER
COMPLAINT(S), and compliance history?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
2. Did the inspector follow the pre-inspection call procedures required by the PROGRAM?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
3. Did the inspector have appropriate equipment and forms?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
II. INSPECTION OBSERVATIONS AND PERFORMANCE
1. Did the inspector follow the biosecurity protocols required by the PRODUCE
OPERATION and the PROGRAM?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
2. Did the inspector follow the safety protocols required by the PRODUCE OPERATION
and the PROGRAM?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
3. Did the inspector assess personnel practices critical to the safe and sanitary growing,
harvesting, packing, and holding of produce?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
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Appendix 4.2
4. Did the inspector evaluate conditions, practices, components, and/or labeling that may
cause the produce to be deemed adulterated or misbranded or otherwise in violation of
applicable law(s)?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
5. Did the inspector reference appropriate and available FDA guidance documents to
evaluate commodities and/or practices as applicable?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
6. Did the inspector review and verify that required records for the PRODUCE
OPERATION are being maintained?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
7. Did the inspector recognize deficiencies in the PRODUCE OPERATION required
monitoring activity?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
8. Did the inspector collect adequate evidence and documentation to support inspection
observations in accordance with PROGRAM procedures?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
9. Did the inspector verify correction of deficiencies that were identified during previous
inspection(s)?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
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Appendix 4.2
III. ORAL AND WRITTEN COMMUNICATION
1. Did the inspector demonstrate effective communication and interpersonal skills to
effectively support the inspection process?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
2. Did the inspector follow the procedure for the opening meeting required by the
PROGRAM?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
3. Did the inspector explain findings throughout the inspection and describe the public health
significance?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
4. Did the inspector alert the PRODUCE OPERATION when an immediate corrective action
is necessary?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement)
5. Did the inspector recognize significant violative conditions or practices, if present, and
document findings consistent with PROGRAM procedures?
☐Acceptable
☐Needs Improvement
Comments (required for Needs Improvement
IV. SAMPLE COLLECTION
Note: this section only needs to be completed if a sample is collected as a part of the audit.
1. Did the inspector follow the PROGRAM’S sampling policies and procedures to assure
sample integrity, security, accountability, and chain of custody?
☐Acceptable
☐Needs Improvement
☐Not Applicable
Comments (required for Needs Improvement
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Appendix 4.2
2. Did the inspector use the appropriate method and equipment to collect the sample?
☐Acceptable
☐Needs Improvement
☐Not Applicable
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
☐Not Applicable
Comments (required for Needs Improvement)
ADDITIONAL COMMENTS
SIGNATURE OF AUDITOR
DATE
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Appendix 4.2a
Appendix 4.2a: Summary of Field Inspection Audit Findings
Instructions for completing this form can be found at the end of this document.
PROGRAM:
Reviewed By:
Performance Period:
Cumulative Score
(5):
Date:
Inspector Initials and Date of Audit (1)
Initials
Date
Performance
Factors (2)
I.1
I.2
II.1
II.2
II.3
II.4
II.5
II.6
II.7
II.8
II.9
III.1
III.2
III.3
III.4
III.5
IV.1
IV.2
IV.3
Audit Score
(2)
Performance Ratings
At (3)
NIt
(3)
Performance
Factor Score
(3)
Subtotal (4) - Enter the sum of the totals from any continuation worksheets.
Total (4) - Enter the final sums (subtotal + sums of (3) on this form).
(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits. Use additional sheets if needed.
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Appendix 4.2a
INSTRUCTIONS:
1.
For each audit, record the Inspector’s initials and Date of Audit
2.
For each audit (vertical column) record the rating for each performance factor (A = acceptable; NI = needs improvement). Record the
individual audit score at the bottom of the column.
3.
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
4.
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.
5.
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
6.
Identify and make notes about trends and single performance factors rated as “NI” in multiple audits.
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Appendix 4.3
Appendix 4.3: Inspection Report Audit Form
PRODUCE REGULATORY PROGRAM STANDARDS
INSPECTION REPORT AUDIT FORM
AUDITOR:
DATE OF AUDIT:
FIRM/FARM NAME:
DATE OF INSPECTION:
FIRM/FARM ADDRESS:
Type of Inspection:
TOTALS:
AUDIT RATING
Total # “Acceptable”:
☐Acceptable
Total # “Needs Improvement”:
☐Needs Improvement
Audit Score:
NOTE: All questions must be answered "acceptable" or "needs improvement". Every
item marked “needs improvement” must be accompanied by an explanation of why the
item was judged as needing improvement.
INSTRUCTIONS TO THE AUDITOR
All performance factors must be rated “Acceptable” or “Needs Improvement.” The total
number of “Acceptable” and “Needs Improvement,” as well as the Audit Score and Audit
Rating, must be recorded in the space above.
To calculate the Audit Score: Audit Score = [# Acceptable Performance Factors/ (#
Acceptable Performance Factors + # Needs Improvement Performance Factors)] x 100.
Audit Rating:
If the Audit Score is below 80%, the Audit Rating must be marked as “Needs Improvement.”
I. ORGANIZATION AND RECORDS OF FINDINGS
1. The inspector submitted the report within designated timeframes.
☐ Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
2. The PROGRAM submitted the report within designated timeframes to the PRODUCE
OPERATION.
☐ Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
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Appendix 4.3
3. All required fields on inspection report or related forms were completed.
☐ Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
4. Written observations were clear and concise.
☐ Acceptable
☐ Needs improvement
Comments (required for Needs Improvement)
5. The inspector followed all current and applicable report writing and documentation
procedures.
☐ Acceptable
☐ Needs improvement
Comments (required for Needs Improvement)
6. The inspector identified violations based on federal and/or state regulations.
☐ Acceptable
☐ Needs improvement
Comments (required for Needs Improvement)
7. The inspector reviewed past inspection findings and acted on repeated or unresolved
violations.
☐ Acceptable
☐ Needs improvement
Comments (required for Needs Improvement)
8. The inspector recorded significant findings.
☐ Acceptable
☐ Needs improvement
Comments (required for Needs Improvement)
9. The inspector recorded the collection of adequate evidence and documentation to support
inspection observations. (e.g., samples, exhibits, photographs, or photocopies)
☐ Acceptable
☐ Needs improvement
Comments (required for Needs Improvement)
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Appendix 4.3
10. The inspector obtained and documented on-site corrective action at the time of inspection
as appropriate to the type of violation.
☐ Acceptable
☐ Needs improvement
Comments (required for Needs Improvement)
11. The inspector documented follow-up compliance activities per the PROGRAM policy.
☐ Acceptable
☐ Needs improvement
Comments (required for Needs Improvement)
GENERAL COMMENTS
Enter any general comments or recommendations as a result of this audit.
SIGNATURE OF AUDITOR
DATE
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Appendix 4.3a
Appendix 4.3a: Summary of Inspection Report Audit Findings
Instructions for completing this form can be found at the end of this document.
PROGRAM:
Reviewed By:
Performance Period:
Cumulative Score
(5):
Date:
Inspector Initials and Date of Audit (1)
Firm/Farm ID
Inspection Date
Performance
Factors (2)
I.1
I.2
I.3
I.4
I.5
I.6
I.7
I.8
I.9
I.10
I.11
Audit Score
(2)
At
(3)
Performance Ratings
NIt
(3)
Performance
Factor Score
(3)
Subtotal (4) - Enter the sum of the totals from any continuation worksheets.
Total (4) - Enter the final sums (subtotal + sums of (3) on this form).
(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits. Use additional sheets if needed.
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Appendix 4.3a
INSTRUCTIONS:
1.
For each audit, record the Inspector’s initials and Date of Audit
2.
For each audit (vertical column) record the rating for each performance factor (A = acceptable; NI = needs improvement). Record the
individual audit score at the bottom of the column.
3.
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
4.
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.
5.
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
6.
Identify and make notes about trends and single performance factors rated as “NI” in multiple audits.
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Appendix 4.4
Appendix 4.4: Sample Report Audit Form
PRODUCE REGULATORY PROGRAM STANDARDS
SAMPLE REPORT AUDIT FORM
AUDITOR:
FIRM/FARM NAME:
DATE OF AUDIT:
DATE OF INSPECTION:
FIRM /FARM ID:
DATE OF COLLECTION:
SAMPLE ID #:
TOTALS:
Total # “Acceptable”:
Total # “Needs Improvement”:
Audit Score:
AUDIT RATING:
☐Acceptable
☐Needs Improvement
NOTE: All questions must be answered "Acceptable" or "Needs Improvement". Every item
marked “Needs Improvement” must be accompanied by an explanation of why the item was
judged as needing improvement.
INSTRUCTIONS TO THE AUDITOR
All performance factors must be rated “Acceptable” or “Needs Improvement.” The total number of
“Acceptable” and “Needs Improvement,” as well as the Audit Score and Audit Rating, must be
recorded in the space above
To calculate the Audit Score:
Audit Score = [# Acceptable Performance Factors/ (# Acceptable Performance Factors + # Needs
Improvement Performance Factors)] x 100.
Audit Rating:
If the Audit Score is below 80%, the Audit Rating must be marked as “Needs Improvement.”.
I. SAMPLE OBSERVATIONS AND PERFORMANCE
1.
Method of collection and equipment was appropriate.
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
2.
Record sample chain of custody per state procedure.
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
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Appendix 4.4
3.
Sample was handled, packaged, and shipped to prevent compromising the condition or integrity
of the sample.
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
4.
Sample was submitted within prescribed timeframes.
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
II. SAMPLE COLLECTION
1.
Date of sample collection was recorded.
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
2.
Product identification name, sample type, and unique identification reference information
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
3.
Brief description of sample (soil, soil amendment, water, environmental, crop, etc.) including
sample size was recorded.
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
4.
Collection information (e.g., soil, soil amendment, water, environmental, crop, etc.), method of
collection (i.e., how the sample was collected), identification of lot sampled, lot size, and any special
techniques used to collect the sample was recorded.
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
5.
Location where sample was collected was recorded.
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
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Appendix 4.4
6.
Name and address of responsible party, produce operation, or packing shed if different from
produce operation were recorded. For environmental samples the physical location of the collection
site.
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
7.
Reason for sample collection (surveillance, compliance, investigational, or regulatory) was
recorded.
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
8.
The type of analysis requested was recorded, if applicable.
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
9.
Product labels or specific labeling information is collected or reproduced if required by state
procedures.
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
10. The identification of the sample with the unique sample identifier.
☐Acceptable
☐ Needs Improvement
Comments (required for Needs Improvement)
GENERAL COMMENTS
Enter any general comments or recommendations as a result of this audit.
SIGNATURE OF AUDITOR
DATE
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Appendix 4.4a
Appendix 4.4a: Summary of Sample Report Audit Findings
Instructions for completing this form can be found at the end of this document.
PROGRAM:
Reviewed By:
Performance Period:
Cumulative Score
(5):
Date:
Unique Sample Identifier and Date of Sample Collection (1)
Sample ID
Collection Date
Performance
Factors (2)
I.1
I.2
I.3
I.4
II.1
II.2
II.4
II.5
II.6
II.7
II.8
II.9
II.10
Audit Score (2)
Performance Ratings
At
(3)
NIt
(3)
Performance
Factor Score
(3)
Subtotal (4) - Enter the sum of the totals from any continuation worksheets.
Total (4) - Enter the final sums (subtotal + sums of (3) on this form).
(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits. Use additional sheets if needed.
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Appendix 4.4a
INSTRUCTIONS:
1.
For each audit, record the Inspector’s initials and Date of Audit
2.
For each audit (vertical column) record the rating for each performance factor (A = acceptable; NI = needs improvement). Record the
individual audit score at the bottom of the column.
3.
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
4.
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.
5.
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
6.
Identify and make notes about trends and single performance factors rated as “NI” in multiple audits.
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Appendix 5.1
Appendix 5.1: Self-Assessment Worksheet
Instructions: The PROGRAM identifies if they have a specified component, then evaluates if it includes
the associated components. If the PROGRAM has the main component and associated components
indicate “Yes”, if not, indicate “No”.
PROGRAM
Program Elements
Yes/No
If No, please explain why the
element is not met. Use this space
for additional notes.
5.3.1 Coordination of FOOD-RELATED INCIDENTS
Does the PROGRAM:
1. Have a coordinator, designated in writing, to
guide investigation and response efforts?
2. Manage events using the Incident Command
System (ICS)/Incident Management Team
(IMT)?
a. Have a written response plan with the
following components, if ICS/IMT is not
utilized?
i. Identify and execute investigation
objectives?
ii. Manage communications?
iii. Implement control measures?
iv. Conduct post-response activities?
3. Have a memorandum of understanding or
other written agreement with other state
agencies, if necessary?
4. Have a written procedure that identifies and
describes the roles, duties, and
responsibilities for each activity described in
5.3.2-5.3.5?
5. Have a written procedure that describes
PROGRAM collaboration as necessary with
FDA and other appropriate federal, state, and
local authorities in multi-jurisdictional
FOOD-RELATED INCIDENTS?
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Appendix 5.1
Program Elements
Yes/No
If No, please explain why the
element is not met. Use this space
for additional notes.
6. Have a written procedure that describes
communication with relevant agencies
during FOOD-RELATED INCIDENTS as
described in 5.3.1.3.3?
7. Have a written procedure that provides
guidance for notification of appropriate law
enforcement agencies when intentional food
contamination is suspected or threatened?
8. Have a written procedure that describes the
maintenance of a list of relevant agencies
and emergency contacts that is reviewed and
updated at least yearly?
5.3.2 Surveillance
Does the PROGRAM:
1. Use epidemiological information,
CONSUMER COMPLAINTS, or other
incident-related information from
appropriate departments or agencies to detect
outbreaks or other FOOD-RELATED
INCIDENTS?
2. Maintain notifications of relevant outbreaks
or other FOOD-RELATED INCIDENTS that
are reported to the PROGRAM in a log or
database?
5.3.3 Investigation
Does the PROGRAM:
1. Have a written procedure with criteria to:
a. Determine the appropriate response?
b. Initiate the response?
c. Complete the response?
2. Conduct investigations using established
processes 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 suspected or
implicated produce?
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Appendix 5.1
Program Elements
Yes/No
If No, please explain why the
element is not met. Use this space
for additional notes.
4. Have access to LABORATORY support for
investigation of outbreaks or other FOODRELATED INCIDENTS?
5. Analyze ROOT CAUSE INVESTIGATION
(RCI) data, if it is conducted?
5.3.4 Control Measures
Does the PROGRAM:
1. Have written strategies as described in
5.3.4.1 to mitigate and contain outbreaks or
other FOOD-RELATED INCIDENTS?
2. Have written procedures to release
information to the public, with the following
components?
a. Identify a point(s) of contact responsible
for releasing information to the public?
b. Have written procedures to develop
guidelines for coordinating media
information with other jurisdictions?
5.3.5 Post Response
Does the PROGRAM have written procedures
to:
1. Maintain investigational findings and
reports?
2. Distribute final investigation report(s),
including ROOT CAUSE INVESTIGATION
(RCI), if completed, to relevant agencies, as
necessary?
3. Provide recommendations, when available,
from investigation and ROOT CAUSE
INVESTIGATION (RCI) reports to relevant
agencies and stakeholders responsible for
prevention, education, outreach, and
research?
Assessment completed by:
Name
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Appendix 6.1
Appendix 6.1: Self Assessment Worksheet
Instructions: The PROGRAM identifies if they have a specified component then evaluates if it includes the
associated components. If the PROGRAM has the main component and associated components indicate
‘Yes’, if not, indicate ‘No’.
PROGRAM
Program Elements
Yes/No
If No, please explain why the
element is not met. Use this space for
additional notes.
6.3.1 Compliance and Enforcement Procedures
Does the PROGRAM have written procedures that:
1. Describe compliance and enforcement
strategies?
2. Describe use of enforcement tool(s)?
3. Describe progressive enforcement action(s)?
4. Describe the process used to determine
appropriate enforcement action(s)?
6.3.2 Annual Evaluation Procedures
1. Does the PROGRAM have a written procedure
for conducting an annual evaluation of its
enforcement activities?
6.3.3 Annual Evaluation
Does the PROGRAM:
1. Conduct an annual evaluation of all
enforcement actions, or a representative sample
of those actions?
2. Determine if enforcement actions follow
procedures described in 6.3.1?
3. Implement improvements or modifications
related to compliance and enforcement
procedures, if any?
4. Document the results of the evaluation on
Appendix 6.2 or equivalent form?
Assessment completed by:
Name
Produce Regulatory Program Standards
Date
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Appendix 6.2
Appendix 6.2 – Evaluation of Conformance of Compliance/Enforcement Procedures
PROGRAM
1
Identification
Number
2
Record the enforcement
action(s) taken
3
4
Procedures If no,
Followed? explain
Assessment completed by:
Name
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Improvements/
Modifications
Date
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Appendix 6.2
Instructions for Evaluation of Compliance/Enforcement Procedures
Appendix 6.2, or equivalent form, must be used to evaluate the PROGRAM’S conformance to its
compliance and enforcement procedures, as required in 6.3.1. All enforcement actions taken in the
previous 12 months must be reviewed as part of the evaluation; or a statistical approach must be used to
determine a representative number of enforcement actions taken. Supporting documents should be
referenced and maintained by the PROGRAM.
The following instructions correspond to the columns numbered in Appendix 6.2
1. Record the identification number (e.g., PRODUCE OPERATION identification number, case
number, etc.).
2. Record the enforcement action(s) taken, as described in the PROGRAM’S compliance and
enforcement
procedures.
3. For each enforcement action taken, record if compliance and enforcement procedures were
followed (Yes/No).
4. For enforcement actions identified as “No” in (3), explain the reason for the nonconformance.
5. Record identified improvements or modifications related to compliance and enforcement
procedures based on the results of this evaluation, if any.
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Appendix 7.1
Appendix 7.1: Self-Assessment Worksheet
Instructions: The PROGRAM identifies if they have a specified component, then evaluates if it includes
the associated components. If the PROGRAM has the main component and associated components
indicate “Yes”, if not, indicate “No”.
PROGRAM
Program Elements
Yes/No
If No, please explain why the element is
not met. Use this space for additional
notes.
7.3 Outreach Methods
Does the PROGRAM have a written procedure
that includes how the PROGRAM will:
1. Identify the methods for communication?
2. Interact with produce industry stakeholders
and consumers by sponsoring or actively
participating in OUTREACH ACTIVITY?
3. Tailor outreach efforts to a target
population?
4. Tailor outreach topics to a target
population?
5. Document and evaluate OUTREACH
ACTIVITY using Appendix 7.2 or
equivalent form? Include documents such
as agendas, meeting summaries, and
program evaluations.
Assessment completed by:
Name
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Appendix 7.2
Appendix 7.2 – Outreach Activity and Self-Evaluation Worksheet
PROGRAM:
This worksheet is completed by the PROGRAM to document OUTREACH ACTIVITY. Attach
verifying documents such as agendas, meeting summaries, and program evaluations to this form or
equivalent.
Section I: Overview of OUTREACH ACTIVITY
a. Type of OUTREACH ACTIVITY (check one):
On-Farm
Workshop
Training course
Other
b.
Subject or Name:
c.
Date:
d.
Objective(s):
e.
Target Population:
f.
Host Organization:
Section II. Self-Evaluation of OUTREACH ACTIVITY
Program Elements
Yes/No
If no, please explain.
a. The purpose and objective(s) were
clearly defined
b. The content of the OUTREACH ACTIVITY
was consistent with the objectives
c. The activity was sufficiently tailored to the
identified target population
d. An evaluation was completed or feedback was
otherwise received from the attendees
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2024
Appendix 7.2
Section III. Critique of OUTREACH ACTIVITY
Discuss what went well, what could be done better, and what more could be done to improve the
OUTREACH ACTIVITY. Address comments from attendees, if available.
Assessment Completed By:
Name
Produce Regulatory Program Standards
Date:
85
2024
Appendix 8.1
Appendix 8.1: Self-Assessment Worksheet
Instructions: The PROGRAM identifies if they have a specified component then evaluates if it includes the
associated components. If the PROGRAM has the main component and associated components check “Yes”
if not, check “No
PROGRAM
Program Elements
Yes/No
If No, please explain why the
element is not met. Use this space
for additional notes.
8.3.1 Workplan
Does the PROGAM have a written workplan?
Does the written workplan include:
1. Inspection plan
a. Number of inspections?
b. Type of inspection?
c. Risk category of PRODUCE
OPERATION?
d. Frequency?
2. If there is a SAMPLING PROGRAM, does the
PROGRAM have a sampling plan?
8.3.2 Workplan Timeframe
Does the WORKPLAN have a timeframe that is
applicable within a 12-month period?
8.3.3 Workplan Evaluation
Does the PROGRAM have a written procedure for
evaluating the WORKPLAN?
Does the written procedure include:
1. A documented annual review for alignment
with PROGRAM objectives and resources?
2. A documented review when PROGRAM
objectives or resources change?
8.3.4 Workplan Resources
Does the PROGRAM have a written procedure for
identifying and reviewing its resources to
accomplish the WORKPLAN within the applicable
timeframe?
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2024
Appendix 8.1
Program Elements
Yes/No
If No, please explain why the
element is not met. Use this space
for additional notes.
Does this include:
1. Staffing?
2. Equipment?
3. Funding?
4. Administrative Support?
8.3.5 PROGRAM Staff Calculation
Does the PROGRAM calculate the number of staff
needed to accomplish the PROGRAM
WORKPLAN based on the PROGRAM’S data?
8.3.6 Inspection and Sampling Equipment
Is a list of the equipment required for inspections
and sample collections:
1. Established by the PROGRAM?
2. Maintained by the PROGRAM?
8.3.7 Annual Resource Review
Does the PROGRAM conduct an annual review of
the resources needed to fully implement the PRPS
by using Appendix 8.2 or equivalent form?
Assessment completed by:
Name
Produce Regulatory Program Standards
Date
87
2024
Appendix 8.2
Appendix 8.2: Resource Summary Report
PROGRAM
Does the PROGRAM have sufficient staffing, equipment, funding, administrative support and other resources necessary to meet the PRPS? Answer
yes or no in each block. If “no”, please explain. Resources not related to staffing, equipment, funding, and administrative support should be in the
“Other Resources Needed” column. Use additional pages as needed.
Standard
1
Regulatory
Foundation
2
Training Program
3
Inspection Program
4
5
6
Staffing
Equipment
Funding
Administrative
Support
Other Resources Needed
Inspection Audit
Program
Foodborne Illness,
Outbreak, Response
Compliance and
Enforcement
7
Outreach Activities
8
Program Resources
9
Program Assessment
10
Laboratory Support
Assessment completed by:
Name
Produce Regulatory Program Standards
Date
88
2024
Appendix 9.1
Appendix 9.1: Self Assessment Worksheet
Instructions: The PROGRAM identifies if they have a specified component then evaluates if it includes the
associated components. If the PROGRAM has the main component and associated components indicate
“Yes”, if not, indicate “No”.
PROGRAM
Program Elements
Yes/No
If No, please explain why the element
is not met. Use this space for
additional notes.
9.3.1 Does the PROGRAM conduct a
baseline self-assessment:
1. Within the first year to determine if the
PROGRAM meets the elements of each
standard?
2. Using the self-assessment worksheets
associated with each standard?
3. Using the results of its self-assessments to
complete Appendix 9.2, or equivalent form?
9.3.2 If the PROGRAM fails to meet any of
the program elements or
documentation requirements, whether
identified through a self-assessment or
FDA ASSESSMENTS, did the
PROGRAM develop a STRATEGIC
IMPROVEMENT PLAN?
Does the STRATGIC IMPROVEMENT PLAN
include:
1. The individual element or documentation
requirement that was not met?
2. Improvements or correctionS needed to meet
the program element or documentation
requirement of the standard?
3. Projected completion dates for each task?
4. Personnel responsible?
5. Date completed for each task?
9.3.3 Does the PROGRAM review and
update the self-assessment appendices
and STRATEGIC IMPROVEMENT
PLAN at least annually?
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2024
Appendix 9.1
Program Elements
Yes/No
If No, please explain why the element
is not met. Use this space for
additional notes.
9.3.4 Does the PROGRAM:
1. Participate in FDA ASSESSMENTS to
determine IMPLEMENTATION and
COFORMANCE to the standards?
2. Address FDA ASSESSMENT observations
and establish corrective actions, unless
already identified in the STRATEGIC
IMPROVEMENT PLAN prior to the start of
the FDA ASSESSMENT?
9.3.5 Does the PROGRAM:
1. Have a written DOCUMENT CONTROL
procedure?
a. Is the PROGRAM able to demonstrate
that all documents are CURRENT AND
FIT-FOR-USE through maintaining a
master document list or other system?
b. Does the master document list or other
system show:
i)
Documents are reviewed for
accuracy?
ii) Documents are approved for release
by authorized personnel and
signed/dated with an approval or
revision date?
iii) Documents are distributed to the
applicable end user(s) 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 PROGRAM’S record retention
policy, whichever is longer?
Assessment completed by:
Name
Produce Regulatory Program Standards
Date
90
2024
Appendix 9.2
Appendix 9.2: Self-Assessment Summary Report
PROGRAM
This summary report shows the IMPLEMENTATION status of each standard and a brief description of
needed improvements. Appendix 9.2 can be used to develop the STRATEGIC IMPROVEMENT PLAN.
Standards that are “Incomplete” or “Partial” IMPLEMENTATION must be addressed in the
STRATEGIC IMPROVEMENT PLAN.
Instructions for completing the summary report can be found below the form.
Standard
Self-Assessment
IMPLEMENTATION
1. Regulatory
Foundation
Not Started
Complete
Incomplete
Not Started
Full
Partial
2. Training
Program
Not Started
Complete
Incomplete
Not Started
Full
Partial
3. Inspection
Program
Not Started
Complete
Incomplete
Not Started
Full
Partial
4. Inspection Audit
Program
Not Started
Complete
Incomplete
Not Started
Full
Partial
5. Foodborne
Illness,
Outbreak,
Response
Not Started
Complete
Incomplete
Not Started
Full
Partial
6. Compliance and
Enforcement
Not Started
Complete
Incomplete
Not Started
Full
Partial
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Explain improvements
needed for full
IMPLEMENTATION
(required for incomplete
self-assessment and partial
IMPLEMENTATION)
2024
Appendix 9.2
Standard
Self-Assessment
IMPLEMENTATION
7. Outreach
Activities
Not Started
Complete
Incomplete
Not Started
Full
Partial
8. Program
Resources
Not Started
Complete
Incomplete
Not Started
Full
Partial
9. Program
Assessment
Not Started
Complete
Incomplete
Not Started
Full
Partial
10. Laboratory
Support
Not Started
Complete
Incomplete
Not Started
Full
Partial
Assessment completed by:
Name
Explain improvements
needed for full
IMPLEMENTATION
(required for incomplete
self-assessment and partial
IMPLEMENTATION)
Date
INSTRUCTIONS
Complete Appendix 9.2 and mark each standard, as applicable. Each row has three sections that must
be completed. The numbers on the screenshot above correspond to each set of instructions for each
section of the appendix below:
Self-Assessment
Not Started – select “Not Started” if you have not initiated work to conduct the appropriate selfassessment worksheets or equivalent forms in each respective standard.
Complete - select “Complete” if you have conducted the appropriate self-assessment worksheets or
equivalent forms in each respective standard.
Incomplete - select “Incomplete” if you have started but not completed the appropriate self-assessment
worksheets or equivalent forms in each respective standard.
IMPLEMENTATION – Not Started versus Partial versus Full
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2024
Appendix 9.2
Check “Not Started” if the PROGRAM has not started IMPLEMENTATION of that standard.
Check “Partial” if the PROGRAM is missing any of the requirements of that standard.
Check “Full” if the PROGRAM has all the required elements listed in the program elements and
documentation sections of that standard.
Explain Improvements Needed to Fully Implement Standard
This section is required to be completed when a PROGRAM has an incomplete self-assessment and/or
partial IMPLEMENTATION. In this section, describe program elements that need to be developed or
modified to achieve “Full” IMPLEMENTATION. For example:
• No documented process for annual review of regulatory foundation
• Continuing education credits are not captured
• No documented sampling protocol
• Inspection Report Audits are not included in the Quality Assurance Program
• The compliance and enforcement program is not applied throughout the state
• MOU for food-related illness and outbreak response is in draft form or unsigned
Produce Regulatory Program Standards
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2024
Appendix 10.1
Appendix 10.1: Self-Assessment Worksheet
Instructions: The PROGRAM identifies if they have a specified component then evaluates if it includes
the associated components. If the PROGRAM has the main component and associated components
indicate “Yes”, if not, indicate “No”.
PROGRAM
Program Elements
Yes/No
If No, please explain why the
element is not met. Use this space
for additional notes.
10.3.1 LABORATORY Support
Does the PROGRAM:
1. Have access to a LABORATORY that is
capable of analyzing food and environmental
samples?
2. Maintain a list of all analytical services the
LABORATORY can provide the PROGRAM?
3. Have a written agreement with each
LABORATORY that includes the components
specified in 10.3.1.3.1-10.3.1.3.4?
10.3.2 LABORATORY Requirements
1. Does the PROGRAM use a LABORATORY
that is accredited by a recognized accreditation
body to the ISO/IEC 17025:2017 (or current
version)?
2. If No to Question 1, does the PROGRAM use a
LABORATORY that implements and complies
with the ISO/IEC 17025:2017 (or current
version)?
2a. If Yes to Question 2, has the
LABORATORY provided the PROGRAM
a copy of the written LABORATORY
quality manual?
2b. If Yes to Question 2, has the
LABORATORY provided the PROGRAM
a written attestation that the
LABORATORY meets the requirements of
ISO/IEC 17025:2017 (or current version)?
Assessment completed by:
Name
Produce Regulatory Program Standards
Date
94
2024
| File Type | application/pdf |
| File Title | Produce Regulatory Program Standards |
| Subject | U.S. Department of Health and Human Services |
| Author | OMB Control No. 0910-XXXX |
| File Modified | 2025-04-24 |
| File Created | 2024-04-09 |