2023 AFRPS DRAFT_Clean w PRA2
Federal-State Food Regulatory Program Standards
2023 AFRPS DRAFT_Clean w PRA2
OMB: 0910-0760
Animal Food Regulatory Program Standards
U.S. Department of Health and Human Services
Food and Drug Administration Office of Regulatory Affairs
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. 0910-0760
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Table of Contents
Animal
Food-Related Illnesses
or Death
and Emergency
Response 21
Compliance
and Enforcement
Program 23
Program
Planning and
Resources 26
Appendix 1.1: Self-Assessment Worksheet 36
Appendix 1.2: Regulatory Foundation Worksheet 37
Appendix 2.1: Self-Assessment Worksheet 43
Appendix 2.2: Inspector Training Record 47
Appendix 2.2: Inspector Training Record 48
Appendix 2.2: Inspector Training Record 49
Appendix 2.2: Inspector Training Record 50
Appendix 2.2: Inspector Training Record 51
Appendix 2.3: Field Training Competencies 52
Appendix 2.3: Field Training Competencies 53
Appendix 3.1: Self-Assessment Worksheet 54
Appendix 4.1: Self-Assessment Worksheet 59
Appendix 4.2: Field Inspection Audit Form 64
Appendix 4.3: Field Inspection Audit Worksheet 69
Appendix 4.4: Field Inspection Report Audit Form 71
Appendix 4.5: Field Inspection Report Audit Worksheet 74
Appendix 4.6: Sample Collection Audit Form 76
Appendix 4.7: Sample Collection Audit Worksheet 78
Appendix 4.8: Sample Collection Report Audit Form 80
Appendix 4.9: Sample Collection Report Audit Worksheet 84
Appendix 5.1: Self-Assessment Worksheet 86
Appendix 6.1: Self-Assessment Worksheet 88
Appendix 7.1: Self-Assessment Worksheet 90
Appendix 7.2: Outreach Event Overview and Evaluation 91
Appendix 8.1: Self-Assessment Worksheet 92
Appendix 8.2: Resources for Implementation of Animal Food Regulatory Program Standards 94
Appendix 9.1: Self-Assessment Worksheet 95
Background
In the U.S., federal, state, local, tribal, and territorial (SLTT) regulatory agencies ensure the safety of ANIMAL FOOD. The Food and Drug Administration (FDA) and state PROGRAMS are responsible for ensuring that ANIMAL FOOD moving within their jurisdiction is safe, wholesome, and/or labeled properly. These responsibilities can include conducting inspections and regulatory activities that help ensure ANIMAL FOOD manufactured, processed, packaged, held, and distributed within their jurisdictions are safe and in compliance with applicable laws and regulations. State PROGRAMS primarily perform inspections under their own regulatory authority. Some state PROGRAMS conduct inspections of ANIMAL FOOD establishments under contract with FDA. Because jurisdictions may overlap, FDA and state PROGRAMS collaborate and share resources to protect ANIMAL FOOD. To better facilitate a partnership among regulatory authorities, state PROGRAMS should achieve IMPLEMENTATION with the Animal Food Regulatory Program Standards (AFRPS).
The implementation of seamless partnerships between FDA and SLTTs enable programs with comparable regulatory public health systems, as trusted partners, to rely on, coordinate with, and leverage one another’s work, data, and actions to meet the public health goal of a safe national food supply. The FDA and the Association of American Feed Control Officials (AAFCO) are members of the Partnership of Food Protection (PFP). The vision for an Integrated Food Safety System (IFSS) was developed in 20091. One of the foundational principles of an IFSS is the IMPLEMENTATION and uniform application of model standards so that federal and SLTT regulatory agencies conduct regulatory activities under the same set of standards. Prior to 2010, the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) and the Manufactured Food Regulatory Program Standards (MFRPS) were examples of such model standards. However, the VNRFRPS and MFRPS were developed for human food only and did not apply to ANIMAL FOOD. As further development on the IFSS progressed, there was a recognized need to develop standards for ANIMAL FOOD state PROGRAMS. One of the key recommendations that came from the 2010 50- State workshop (“A United Approach to Public Health”) was the development of standards for ANIMAL FOOD state PROGRAMS. Standards provide a consistent, underlying foundation that is critical for uniformity across federal and SLTT agencies to ensure the credibility of all programs under an IFSS.
The Food Safety Modernization Act (FSMA) provides further support for developing AFRPS. FSMA was signed into law in January 2011 and calls for enhanced partnerships and integration with federal and SLTT agencies. The mutual reliance called for by FSMA will allow FDA to leverage capacity, inspections, and data collected by other agencies to support regulatory activities and further enhance the idea of an IFSS.
In 2011, FDA and AAFCO entered into a partnership to develop the AFRPS and was initially launched in January 2014. These standards are designed to promote uniformity and consistency among ANIMAL FOOD state PROGRAMS. This is consistent with the principles of the FSMA and the fundamental goal of AAFCO and FDA to provide a mechanism for developing and implementing uniform and equitable statutes, regulations, and standards to enhance the protection of the nation’s ANIMAL FOOD supply.
1 Link to the current PFP vision documents available at https://www.pfp-ifss.org/about/pfp-vision1/.
Introduction
The AFRPS establishes a uniform foundation for the design and management of state PROGRAMS responsible for the regulation of ANIMAL FOOD. Through IMPLEMENTATION of the AFRPS, a state PROGRAM is able to achieve and maintain programmatic improvements that help ensure the safety and integrity of the U.S. ANIMAL FOOD supply. IMPLEMENTATION of the AFRPS is voluntary. A state PROGRAM’S IMPLEMENTATION of the AFRPS helps ensure a uniform and consistent approach to ANIMAL FOOD regulation among jurisdictions including the sharing of information and the coordination of resources.
The AFRPS is composed of eleven standards that serve as an objective framework to evaluate and improve components of a state PROGRAM. The standards cover the state PROGRAM’S REGULATORY FOUNDATION, training program, inspection program, auditing program, ANIMAL FOOD-related
illnesses or death and emergency response, compliance and enforcement program, outreach program, planning and resources, laboratory services, sampling program, and assessment and improvement of standard IMPLEMENTATION.
Each standard is laid out in the following format to ensure uniformity: Purpose (x.1), Requirement Summary (x.2), Program Elements (x.3), Outcome (x.4), and Documentation (x.5). The program elements describe the best practices of a high-quality state PROGRAM. Required program elements and documentation requirements 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 sometimes in the AFRPS. Program elements and corresponding conditions described as “should” are best practices but are optional and not required to IMPLEMENT a standard. To IMPLEMENT the AFRPS, the state PROGRAM must IMPLEMENT all eleven standards. “Notes” are used sometimes to provide clarification, alternatives, and guidance that the state PROGRAM may use to help IMPLEMENT the AFRPS. “Notes” do not contain program elements and thus will not be subject to an FDA verification assessment.
Each standard has appendices designed to assist the state PROGRAM in achieving and maintaining IMPLEMENTATION. State PROGRAMS are not obligated to use the appendices provided in the AFRPS. Other manual or electronic generated forms, worksheets, and templates may be used if all program elements are present.
Each standard has a corresponding self-assessment worksheet (Appendix x.1). The state PROGRAM uses the self-assessment worksheets to determine if the program elements are, or remain, fully met, partially met, or not met. The self-assessment worksheets are used to develop a strategic improvement plan for IMPLEMENTATION of standards.
The state PROGRAM maintains CURRENT AND FIT-FOR-USE documents required in the standards to verify IMPLEMENTATION for the purposes of a verification assessment. The AFRPS is not intended to address the performance appraisal processes that an agency may use to evaluate individual employee performance.
FDA uses the AFRPS as a tool to promote and verify the development of a high-quality ANIMAL FOOD regulatory PROGRAM, which includes a process for continuous improvement based upon quality management systems. The AFRPS assists both FDA and the states in fulfilling their regulatory obligations. State PROGRAMS enrolled in the AFRPS under an FDA funding vehicle are expected to develop and IMPLEMENT a strategic improvement plan to demonstrate that they are moving toward IMPLEMENTATION and to participate in FDA assessments. State PROGRAMS are encouraged to build systems that are sustainable and IMPLEMENT plans that result in the standards being maintained.
The collection of information is approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. The OMB control number is 0910-0760.
Definitions
Animal Food: Used to represent the definitions for: (1) food and animal feed in the Federal Food, Drug, and Cosmetic Act (FD&C Act) sections 201(f) and 201(w), (2) for animal food in Title 21 of the Code of Federal Regulations (CFR) section 507.3 (21 CFR 507.3), and (3) for animal feed in the AAFCO Official Publication (AAFCO OP).
Contact Hour: One CONTACT HOUR equals 60 minutes.
Corrective Action: Action to correct a DEVIATION from the program elements of a standard.
Current and Fit-for-Use: “Current” indicates that documentation is signed and dated in accordance with state PROGRAM procedures that meet criteria in the most current standard. “Fit-for- use” is a quality term used to indicate that a product or service fits the customer’s defined purpose for that product or service. Documentation may be electronic or hard copy.
Curriculum: A plan which includes documented specific coursework and field training for both inspection and sample collection.
Deviation: Non-fulfillment of a program element.
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.
Emergency: An unforeseen or sudden occurrence requiring immediate action to protect against substantial risk to animal and/or public health, and that involves the safety, efficacy, and security of the ANIMAL FOOD supply.
Enforcement Strategy: Plans of action designed to prioritize and achieve enforcement goals and are developed by the state PROGRAM based on critical and chronic violations and violators and contain guidelines for selecting enforcement tools.
Equivalent: State law directly references the relevant FD&C Act provision or federal regulation.
Equivalent in Effect: State law has the same regulatory effect as the relevant FD&C Act provision or federal regulation.
Implement/Implementation: Means a state PROGRAM has a particular program element, system, or program as required in the Program Elements and Documentation sections of the AFRPS; and can demonstrate the use of that particular program element, system, or program.
Joint Field Training Inspection: An inspection conducted jointly by the FDA and/or state personnel for the purposes of training or enforcement. A joint inspection may be used to provide training during an inspection of an establishment which may either be trainer led or trainee led.
No Authority: Responsibility for enforcing a relevant FD&C Act provision or federal regulation lies with another program or agency and not the state PROGRAM. There is such a state law, but it does not apply to the state’s PROGRAM.
Not Equivalent: There is no state law EQUIVALENT to the relevant FD&C Act provision or federal regulation, or the federal and state laws address the same matter but are inconsistent and do not have the same regulatory effect.
Outreach Activity: A spontaneous or planned activity where the state PROGRAM provides materials or information that relates to ANIMAL FOOD topics to industry stakeholders, academia, other regulators, or consumers. Materials or information may include but is not limited to brochures, pamphlets, printed materials, websites, or other items.
Outreach Event: An OUTREACH EVENT which the state PROGRAM hosts, co-hosts, or is an invited presenter such as seminars, workshops, conferences, trainings, or meetings that relate to ANIMAL FOOD topics and that support communication and information exchange among industry stakeholders, academia, other regulators, or consumers.
Preventive Action: Action to prevent the recurrence of a DEVIATION requiring a CORRECTIVE ACTION.
Program: An operational unit in a regulatory agency that is responsible for the regulatory oversight of ANIMAL FOOD.
Qualified Field Inspection Auditor: An individual who is recognized by the state’s PROGRAM as having field experience and communication skills necessary to audit inspectors/investigators.
Qualified Field Inspection Trainer: An individual who is recognized by the state’s PROGRAM as having field experience and communication skills necessary to train inspectors/investigators.
Regulatory Foundation: The statutes, regulations, rules, ordinances, or other regulatory requirements that govern the operation of an ANIMAL FOOD establishment.
Regulatory Testing Laboratory: A laboratory that conducts measurements and analyses on food or ANIMAL FOOD and associated physical samples, which result in qualitative or quantitative analytical findings that may be used as a basis for regulatory action.
Sample Analysis Schedule: A schedule of analyses based on the sampling plan developed in cooperation with the REGULATORY TESTING LABORATORY performing routine services to ensure compatibility with REGULATORY TESTING LABORATORY capabilities and capacities.
Start Date: Date employee is hired or reassigned in or into the ANIMAL FOOD state PROGRAM as the beginning date for training timelines.
Regulatory Foundation
This standard describes the program elements used by a state PROGRAM to effectively evaluate and review the REGULATORY FOUNDATION to regulate ANIMAL FOOD.
Requirement
Summary
The state PROGRAM establishes an evaluation of its legal authority and regulatory provisions to perform inspections and investigations, gather evidence, collect samples, and take regulatory actions under state law to ensure the safety and security of ANIMAL FOOD.
This includes an evaluation of how the state’s legal authority and regulatory provisions correspond to the sections of the FD&C Act and CFR specified in Appendix 1.2.
Program
Elements
The state PROGRAM conducts an evaluation to determine whether the state’s legal authority and regulatory provisions are EQUIVALENT, EQUIVALENT IN EFFECT, NOT EQUIVALENT, or NO AUTHORITY to the specified sections of the current FD&C Act and CFR Title 21, and completes Appendix 1.2, or an equivalent form.
Note: In conducting such an evaluation, the state PROGRAM should consult with its legal counsel when state law or regulation 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.
Regulatory
Foundation Evaluation
The state PROGRAM has a procedure that includes:
Reviewing
the statutes,
regulations, rules,
ordinances, and
other prevailing regulatory requirements that:
Apply
to the
regulation of
ANIMAL
FOOD. Delegate authority to the state agency.
Describe
the state agency’s administrative procedure for establishing
its authority
and incorporating
rules by
reference.
Outcome
The state PROGRAM utilizes the evaluation its REGULATORY FOUNDATION to protect animal and public health by ensuring the safety and security of ANIMAL FOOD.
Documentation
The
state PROGRAM
maintains the
records, or
equivalent forms
or worksheets,
listed here:
Appendix 1.1: Self-Assessment Worksheet.
Appendix
1.2: Regulatory
Foundation Worksheet.
Procedure
for reviewing
appropriate statutes,
regulations, rules,
ordinances, and
other prevailing regulatory requirements.
The
statutes, regulations, rules, ordinances, and other prevailing
regulatory requirements that: (1) apply to the regulation of ANIMAL
FOOD, (2) delegate authority
to the
state agency,
and (3)
describe the
state agency’s
administrative procedure for establishing its authority and
incorporating rules by reference.
Training Program
This standard describes the program elements used by a state PROGRAM to have an effective
ANIMAL FOOD training program.
Requirement
Summary
The state PROGRAM establishes a training program that ensures that all inspectors complete coursework, field training, and continuing education to effectively perform their assignments and responsibilities.
Program
Elements
Training
Plan and
Training Records
The
state PROGRAM
has a documented training plan that includes training
and continuing
education, as
defined by
the state
PROGRAM,
that includes:
Description
of each
inspection type.
CURRICULUM
for
each
inspection
type.
For
inspectors with
greater than
five years
of experience
at the
date of
the initial self-assessment or at the inspectors START
DATE, where their training documentation is not
available, the state PROGRAM:
Documents
an evaluation
of the
inspector’s
performance and
experience to determine if additional training is needed.
Maintains
proper supporting
documents to
verify successful
completion of the requirement, if previous coursework is completed
before the
inspectors START
DATE and
utilized to meet coursework requirements.
The
state PROGRAM
maintains records documenting the training completed
by all
inspectors on
Appendix 2.2,
or an
equivalent form.
Basic
ANIMAL
FOOD
Inspector
Training
Timeframe
The state PROGRAM requires a basic inspector to successfully complete the basic coursework within 24 months from the START DATE.
Basic inspector training consists of basic coursework in the following subject areas:
Animal
and Public
Health Principles
Animal Food Defense
Basic
Ingredients, Processing,
and Technology
Basic
National Incident
Management System
and Incident
Command System (ICS)
Current
Statutes, Regulations,
and Policies
Inspections, Compliance,
and Enforcement
Labeling
Professionalism
Risk Awareness
Safety
Sample
Collection Field Training
The state PROGRAM requires basic field training to complement the basic coursework. The basic field training specifies the following:
The
procedure
for
JOINT
FIELD
TRAINING
INSPECTIONS.
The
number of JOINT
FIELD TRAINING INSPECTIONS that
are conducted
in
establishments
that
represent
the
state
PROGRAM
inventory and
the type of basic work that will be performed by the inspector.
List
the
competencies
and
the
minimum
number
of
JOINT
FIELD TRAINING INSPECTIONS on
Appendix 2.3, or an equivalent form.
The
QUALIFIED
FIELD INSPECTION TRAINER verifies
the
field training
checklist of competencies in the field for each inspection type.
The
inspector completes
the minimum
basic field
training requirements for the inspection type, prior to
performing independent work.
Advanced
ANIMAL
FOOD
Inspector
Training
Timeframe
The state PROGRAM requires an advanced inspector to successfully complete the advanced coursework within 60 months from the START DATE.
Advanced inspector training consists of advanced coursework in the following subject areas but not limited to:
Advanced
Ingredients, Processing, and Technology Advanced
Inspections, Compliance
and Enforcement
Advanced Labeling
Animal
Illness and Death Investigation Current
Statutes, Regulations,
and Policies
Epidemiology
Traceback
and Traceforward
Investigations Field Training
The state PROGRAM requires advanced field training to complement the advanced coursework. The advanced field training specifies the following:
The
procedure
for
JOINT
FIELD
TRAINING
INSPECTIONS.
The
number of JOINT
FIELD TRAINING INSPECTIONS that
are conducted
in
establishments
that
represent
the
state
PROGRAM
inventory and
the type of advanced work that will be performed by the inspector.
List
the
competencies
and
the
minimum
number
of
JOINT
FIELD TRAINING INSPECTIONS on
Appendix 2.3, or an equivalent form.
The
QUALIFIED
FIELD INSPECTION TRAINER verifies
the
field training
checklist of competencies in the field for each inspection type.
The
inspector completes
the minimum
advanced field
training for the
inspection type,
prior to
performing independent
work.
The state PROGRAM requires that each basic and advanced inspector participate in continuing education. The continuing education specifies the following:
Each
inspector receives
20 CONTACT
HOURS of
continuing education
every 36 months.
The
36-month continuing
education interval
starts, as
defined by
the state
PROGRAM,
when the required CURRICULUM
is complete. Documentation
accompanies each
activity submitted
for continuing
education.
Outcome
The state PROGRAM utilizes the training program to ensure inspectors have the knowledge, skills, and abilities to effectively inspect ANIMAL FOOD establishments, conduct investigations, gather evidence, collect samples, and take enforcement actions.
Documentation
The
state PROGRAM
maintains the
records, or
equivalent forms
or worksheets,
listed here:
Appendix 2.1: Self-Assessment Worksheet.
Appendix
2.2: Inspector Training Record. Appendix
2.3: Field
Training Competencies.
Documents
verifying successful
completion of
required coursework.
Documentation for continuing education.
Inspection Program
This standard describes the program elements used by a state PROGRAM to have an effective
ANIMAL FOOD inspection program.
Requirement
Summary
The state PROGRAM establishes a risk-based inspection program to determine compliance with ANIMAL FOOD laws. This includes procedures to handle recalls, consumer complaints, and complaints resulting from state PROGRAM inspection activities.
Program
Elements
The
state PROGRAM
has a procedure to define and maintain a current
inventory of
ANIMAL
FOOD
establishments
whose activities
fall under
the state PROGRAM’S
jurisdiction and authority.
The
state PROGRAM
has a
procedure for
risk categorization
of ANIMAL
FOOD establishments using the three minimum required
factors for defining risk categories:
Types
of
ANIMAL
FOOD
and
ANIMAL
FOOD
products. Types
of processing.
Compliance
history of
the establishment.
Based
on risk
categorization of
an ANIMAL
FOOD
establishment, inspections are:
Assigned
frequencies. Allocated resources.
The state PROGRAM has procedures for inspecting ANIMAL FOOD establishments that require the inspectors to:
Review
the ANIMAL
FOOD
establishment’s
history and
determine the
scope of the inspection.
Present
appropriate credentials and written Notice of Inspection to the
ANIMAL
FOOD establishment’s owner, operator, or agent in
charge; make appropriate introductions; explain the purpose and scope
of the inspection; confirm
inspection authority
and establish
FDA jurisdiction,
if applicable.
Follow
the
safety
protocols
required
by
the
ANIMAL
FOOD
establishment
and the state PROGRAM.
Follow
the biosecurity
protocols required
by the
ANIMAL
FOOD
establishment and the state PROGRAM.
Use
appropriate equipment
and forms
needed to
conduct inspections.
Recognize the relative risk categorization of the ANIMAL
FOOD establishment based on the risk-based inspection
program.
Conduct
comprehensive inspection activities, appropriate for the level of
risk, focused
on the
establishment’s
products and
processes determined
to be of higher risk.
Assess
employee activities
critical to
the safe
manufacturing,
processing, packaging, handling, holding, and distribution of
ANIMAL
FOOD. Properly
evaluate the potential that conditions, practices, processes,
components, or labeling could cause the product to become
adulterated, contaminated, or misbranded.
Recognize
significant non-compliant
conditions or
practices and
document findings consistent with state PROGRAM
procedure.
Distinguish
between significant
and insignificant
observations and
isolated incidents versus trends.
Review,
evaluate, and verify that the appropriate ANIMAL
FOOD establishment
records, plans,
programs, and/or
procedures are
established, maintained, and/or implemented.
Collect
adequate evidence
and documentation
to support
inspection observations in accordance with state PROGRAM
procedures.
Verify
deficiencies identified
during the
previous inspections
have been
addressed.
Conduct
activities in
a professional
manner. Use effective interviewing techniques.
Explain
findings clearly and adequately throughout the inspection. Alert
the ANIMAL
FOOD
establishment’s
owner, operator,
or agent
in charge when an immediate corrective action is necessary.
Document
findings accurately, clearly, legibly, and concisely on the
applicable forms
and provide
a copy
to the
ANIMAL
FOOD
establishment’s owner, operator, or agent in
charge.
Answer
questions and
provide information
as appropriate.
Submit
inspection report, samples where applicable, and supporting evidence
and documentation
within designated
timeframes consistent
with state PROGRAM
procedure.
The
state PROGRAM
has procedures
to handle
recalls that
includes: Receiving
Evaluating
recall notifications
Closing
Performing
recall effectiveness
checks, as
applicable
The
state PROGRAM
has a
procedure to
handle consumer
complaints that
includes: Receiving
Tracking
Evaluating Answering Closing
Complaints
Resulting from
State PROGRAM
Inspection
Activities
The state PROGRAM has a procedure to handle industry complaints resulting from state PROGRAM inspection activities that includes:
Receiving
Evaluating Maintaining
records
Outcome
The state PROGRAM utilizes the risk-based ANIMAL FOOD inspection program to significantly minimize or prevent the occurrence of ANIMAL FOOD adulteration, contamination, and misbranding.
Documentation
The
state PROGRAM
maintains the
records, or
equivalent forms
or worksheets,
listed here:
Appendix 3.1: Self-Assessment Worksheet.
An
inventory
of
ANIMAL
FOOD
establishments.
Procedure
for defining
and maintaining
the state
PROGRAM’S
current inventory
of
ANIMAL FOOD establishments.
Procedure
for categorizing
ANIMAL
FOOD
establishments
based on
risk, including
the inspection frequency assigned to each defined risk-based
category.
Procedures
for inspecting
ANIMAL
FOOD
establishments. Procedures for recall system.
Procedure
for consumer
complaints.
Procedure
for industry
complaints about
state PROGRAM
inspection
activities.
Audit Program
This standard describes the program elements used by a state PROGRAM to have an effective
ANIMAL FOOD audit program.
Requirement
Summary
The state PROGRAM establishes an audit program to document and evaluate the effectiveness of the state PROGRAM’S inspections and sample collections. This includes two components: (1) a field audit component, which is an on-site performance evaluation of inspection and sample collection procedures and (2) a report audit component, which is a performance evaluation of the inspection and sample collection reports, to verify they are consistently performed according to established performance factors.
Program
Elements
The
state PROGRAM
has procedures
for conducting
four types
of audits: Field
inspection audits as described in 4.3.3
Field
inspection report audits as described in 4.3.4 Sample collection
audits as described in 4.3.5 Sample
collection report
audits as
described in
4.3.6
Note: In general, each type of audit is composed of multiple performance factors. The performance factors are evaluated during an audit and then used to calculate an individual’s audit score. The audit score determines the audit rating, which is recorded as “acceptable” or “needs improvement”. Using the individual audits, the state PROGRAM calculates a performance factor score for each performance factor and a cumulative score for each type of audit. The state PROGRAM uses the audit scores, performance factor scores, and calculated scores to recognize trends in the field inspection and sample collection programs. The trends are used to identify specific areas that need improvement and to take CORRECTIVE ACTION to improve areas.
The state PROGRAM conducts a review of the performance factor scores and cumulative scores for each of the four types of audits at least every 12 months.
The state PROGRAM conducts field inspection audits using a QUALIFIED FIELD INSPECTION AUDITOR to verify that inspections are consistently performed according to the state’s PROGRAM procedures.
Conduct
a minimum
of two
field inspection
audits of
each inspector every 36 months.
Select
field inspections
for audits
that reflect
the inspector’s
assignments and responsibilities.
Evaluate performance factors listed in the inspection procedure as described in 3.3.2 and as listed in Appendix 4.2, or an equivalent form.
Record
the rating
of each
performance factor,
audit score,
and audit rating for each field inspection audit on Appendix
4.2, or an equivalent form. State PROGRAMS
may use the current Appendix C found in FMD-76 in lieu
of Appendix 4.2.
Calculate
performance factor
scores and
a cumulative
score for the state PROGRAM
on Appendix 4.3, or an equivalent worksheet.
The state PROGRAM conducts field inspection report audits to verify that inspectional findings are consistently reported according to the state PROGRAM’S procedures.
Review a random selection of field inspection reports to be audited based on the number of inspections completed in 12 months of performance using Table 1.
Table 1 Field Inspection Report Audit Requirements
-
# of Inspections in 12 Months
Min # Reports Required
Max # Reports Required
Less than 20 reports
All
All
20 – 400 reports
20
20
More than 400 reports
5% reports
50
Evaluate the performance factors listed in Appendix 4.4, or an equivalent form.
Record
the rating
of each
performance factor,
audit score,
and audit rating for each inspection report audit on Appendix
4.4, or an equivalent form.
Calculate
performance factor
scores and
a cumulative
score for the state PROGRAM
on Appendix 4.5, or an equivalent worksheet.
The state PROGRAM conducts sample collection audits using a QUALIFIED FIELD INSPECTION AUDITOR to verify that sample collections are consistently performed according to the state PROGRAM’S procedures.
Conduct
a minimum
of two
sample collection
audits of
each inspector every 36 months.
Select
sample collections
for audits
that reflect
the inspector’s
assignments and responsibilities.
Evaluate the performance factors listed in the sample collection procedure as described in 11.3.2 and as listed in Appendix 4.6, or an equivalent form.
Record
the rating
of each
performance factor,
audit score,
and audit rating
for each
sample collection
audit on
Appendix 4.6, or
an equivalent form.
Calculate
performance factor
scores and
a cumulative
score for the state PROGRAM
on Appendix 4.7, or an equivalent worksheet.
Sample
Collection Report
Audit
The state PROGRAM conducts sample collection report audits to verify that sample collection documentation is consistently performed according to the state PROGRAM’S procedures.
Review a random selection of sample collection reports to be audited based on the number of samples collected in 12 months of performance based using Table 2.
Table 2 Sample Collection Report Audit Requirements
-
# of Samples Collected in 12 Months
Min # Reports Required
Max # Reports Required
Less than 40 reports
All
All
40 – 800 reports
40
40
More than 800 reports
5% of reports
70
Evaluate the performance factors listed in Appendix 4.8, or an equivalent form.
Record
the rating
of each
performance factor,
audit score,
and audit rating for each sample collection report audit on
Appendix 4.8, or an equivalent form.
Calculate
performance factor
scores and
a cumulative
score for the state PROGRAM
on Appendix 4.9, or an equivalent worksheet.
The state PROGRAM documents CORRECTIVE ACTIONS as described in 9.3.2 for each of the four types of audits when any of the following conditions are met:
An
inspector receives
an overall
audit rating
of “needs
improvement” (audit score below 80 percent) for an
individual audit.
A
state PROGRAM
has a performance
factor score
(as a
result of
all audits in
12 months
of performance)
below 80
percent for
a single
performance factor.
A
state PROGRAM
has a
cumulative score
(as a
result of
all audits
in 12 months of
performance) below 80 percent.
Outcome
The state PROGRAM utilizes the audit program to evaluate its inspection and sample collection activities for effectiveness, to recognize trends, and to document CORRECTIVE ACTIONS, when necessary.
Documentation
The
state PROGRAM
maintains the
records, or
equivalent forms
or worksheets,
listed here:
Appendix 4.1: Self-Assessment Worksheet.
Procedure
for conducting four types of audits. Appendix 4.2: Field Inspection
Audit Form. Appendix 4.3: Field Inspection Audit Worksheet. Appendix
4.4: Field
Inspection Report
Audit Form.
Appendix
4.5: Field
Inspection Report
Audit Worksheet.
Appendix 4.6: Sample Collection Audit Form.
Appendix
4.7: Sample Collection Audit Worksheet. Appendix 4.8: Sample
Collection Report Audit Form. Appendix
4.9: Sample
Collection Report
Audit Worksheet.
Animal
Food-Related Illnesses
or Death
and Emergency
Response Purpose
This standard describes the program elements used by a state PROGRAM to effectively detect,
identify, and respond to ANIMAL FOOD-related illnesses or deaths and EMERGENCIES.
Requirement
Summary
The state PROGRAM establishes a system to conduct EMERGENCY response to ANIMAL FOOD-related illnesses or deaths and EMERGENCIES.
Program
Elements
Animal
Food-Related Illnesses or
Deaths and
Emergencies Procedure
The
state PROGRAM
has a procedure
to gather information to identify incidents
of
ANIMAL
FOOD-related
illnesses
or
deaths
and
EMERGENCIES.
The
state PROGRAM
has a procedure to communicate with the appropriate
agencies or
departments that
investigate ANIMAL
FOOD-related
illnesses or
deaths and EMERGENCIES.
For
ANIMAL
FOOD-related
illnesses
or
deaths
and
EMERGENCIES,
the
state
PROGRAM has a procedure to:
Determine
the appropriate
response. Initiate the response.
For ANIMAL FOOD-related EMERGENCIES, the state PROGRAM manages the event using:
An
Incident Command
System, or An
official action plan2.
The official action plan includes:
Containment
Communication Control
Correction
and/or Corrective
Actions After-action protocols
2 An example of an official action plan can be found in the AAFCO Emergency Response Preparedness Guidance Document (AAFCO Official Publication).
Animal
Food-Related Illnesses
or Deaths
and Emergencies
Notification Procedures
The
state PROGRAM
maintains a
current list
of relevant
agencies and
emergency contacts that is reviewed and updated at least every 12
months.
The
state PROGRAM
has a procedure to rapidly notify government agencies,
departments, and
appropriate parties
of relevant
findings.
The
state PROGRAM
has a procedure to rapidly notify law enforcement
agencies when
intentional ANIMAL
FOOD contamination
or ANIMAL
FOOD- related terrorism is suspected or threatened.
The
state PROGRAM
has a procedure for: Releasing
information to
the public.
Coordinating
media information
with other
jurisdictions to
reduce the impact of ANIMAL FOOD-related illnesses or deaths and EMERGENCIES.
Outcome
The state PROGRAM utilizes the EMERGENCY response system to work with government agencies, departments, and appropriate parties to gather and share information to reduce ANIMAL FOOD- related illnesses or deaths and EMERGENCIES.
Documentation
The
state PROGRAM
maintains
the records,
or equivalent
forms or
worksheets, listed
here: Appendix 5.1: Self-Assessment Worksheet.
Procedure
to
gather
information
to
identify
incidents
of
ANIMAL
FOOD-related
illnesses or deaths and EMERGENCIES.
Procedure
to communicate with
agency/departments.
Procedure
to determine
the appropriate
response, initiate
the response,
and complete the
response for ANIMAL
FOOD-related illnesses or deaths and EMERGENCIES.
Procedure using an Incident Command System or an
official action plan.
Procedure
to rapidly
notify government
agencies, departments,
and appropriate
parties of relevant findings.
Procedure
to rapidly notify law enforcement agencies when intentional ANIMAL
FOOD contamination
or ANIMAL
FOOD-related
terrorism is
suspected or
threatened. Procedure for releasing information to the public
and coordinating media information with other jurisdictions.
Compliance and Enforcement Program
This standard describes the program elements used by a state PROGRAM to have an effective
ANIMAL FOOD compliance and enforcement program.
Requirement
Summary
The state PROGRAM establishes a compliance and enforcement program with ENFORCEMENT STRATEGIES to achieve compliance with ANIMAL FOOD laws. This includes an annual evaluation of the ENFORCEMENT STRATEGIES to identify potential improvements or modifications.
Program
Elements
Compliance
and Enforcement
Program
The
state
PROGRAM
has
a
documented
compliance
and
enforcement
program that contains ENFORCEMENT
STRATEGIES.
The
state PROGRAM
selects an
appropriate enforcement
tool using
the following six factors:
Compliance
history Responsiveness
Scope
Nature
of the
Violation Impact of
the Violation
Resources
The
state PROGRAM
has a
documented description
for all
factors.
The
state PROGRAM
has documented
relative conditions
with an
assigned numerical weight for all factors.
The
state PROGRAM
has a documented enforcement matrix designed to
incorporate the
relative conditions
of each
factor and
the application
of enforcement tools.
The state PROGRAM has a procedure for conducting an evaluation of its
ENFORCEMENT STRATEGIES at least every 12 months to:
Determine
if
the
state
PROGRAM’S
ENFORCEMENT
STRATEGIES
were successful
in achieving compliance.
Identify
potential
improvements
or
modifications
of
the
ENFORCEMENT
STRATEGIES, if
any.
Determine
if the
enforcement priorities
remain the
same or
require modification.
Outcome
The state PROGRAM utilizes the compliance and enforcement program to achieve compliance with
ANIMAL FOOD laws.
Documentation
The
state PROGRAM
maintains the
records, or
equivalent forms
or worksheets,
listed here:
Appendix 6.1: Self-Assessment Worksheet.
The
ENFORCEMENT
STRATEGIES
factors including
the description,
relative conditions,
and associated numerical weight for each.
Procedure
for
conducting
an
evaluation
of
the
ENFORCEMENT
STRATEGIES.
Evaluation
of
the
ENFORCEMENT
STRATEGIES
at
least
every
12
months.
Outreach Program
This standard describes the program elements used by a state PROGRAM to effectively conduct an
ANIMAL FOOD outreach program.
Program
Elements
The state PROGRAM established an outreach program with OUTREACH ACTIVITIES or OUTREACH EVENTS to inform ANIMAL FOOD industry stakeholders, academia, other regulators, or consumers about ANIMAL FOOD topics.
Requirement
Summary
The state PROGRAM identifies the methods that will be used for outreach to inform ANIMAL FOOD industry stakeholders, academia, other regulators, or consumers about ANIMAL FOOD topics.
The state PROGRAM has a documented outreach plan at least every 12 months that supports the state PROGRAM mission and that includes:
Objectives
of an
outreach plan.
Target populations.
The
types
of
outreach
(including
OUTREACH
ACTIVITIES
or
OUTREACH
EVENTS).
The state PROGRAM documents and evaluates OUTREACH EVENTS using Appendix 7.2, or an equivalent form.
Outcome
The state PROGRAM utilizes an outreach plan to inform ANIMAL FOOD industry stakeholders, academia, other regulators, or consumers about ANIMAL FOOD topics.
Documentation
The
state PROGRAM
maintains the
records, or
equivalent forms
or worksheets,
listed here:
Appendix 7.1: Self-Assessment Worksheet.
Appendix
7.2: Outreach
Event Overview
and Evaluation.
Program Planning and Resources
This standard describes the program elements used by a state PROGRAM to effectively conduct the
ANIMAL FOOD work planning and resources evaluation.
Requirement
Summary
A state PROGRAM establishes a workplan to support its inspection and sample collection programs.
This includes an evaluation of resource needs for completing the workplan and to IMPLEMENT and maintain the AFRPS.
Program
Elements
The
state PROGRAM
has a
documented workplan
that includes
the: Inspection plan
Number
of inspections
Type of inspection
Risk
category of
establishment or
product Frequency
Number
of samples Type of
samples
Timeframe
that the
workplan is
applicable.
The
state PROGRAM
has a
procedure for
evaluating the
workplan that
includes:
Conducting
evaluations of
the workplan
at least
every 12 months.
Evaluating
alignment with
state PROGRAM
objectives and
resources.
The
state PROGRAM
has a procedure for identifying and evaluating its
resources to
accomplish the
workplan within
the applicable
timeframe.
Note: The resource evaluation should include staffing, equipment, and funding needed to support the inspection and sample collection activities identified in the workplan.
Note: The resources needed to train and audit field staff, to support laboratory services, compliance and enforcement program, outreach program, and to respond to ANIMAL FOOD-related illnesses, deaths, or EMERGENCIES should be determined by the state PROGRAM. The administrative functions needed to support all state PROGRAM areas should be considered when determining state PROGRAM resources.
The
state PROGRAM
develops a
formula and
calculates the
number of
staff needed to
accomplish the
state PROGRAM’S
ANIMAL
FOOD workplan
based on staff assignments, responsibilities, and work hours.
Note: The state PROGRAM should have adequate staff to inspect the state PROGRAM’S ANIMAL FOOD inventory and to conduct sample collections established in its workplan.
The state PROGRAM establishes and maintains a list of the equipment required for inspections and sample collections.
The
state PROGRAM
conducts a baseline evaluation of the resources
required to IMPLEMENT the
AFRPS, including the program elements and the
documentation
requirements in
the standards
to determine
whether the state
PROGRAM
has:
Adequate
staff Equipment Funding
The
state PROGRAM completes
subsequent resource evaluations to determine the resources necessary
for the state PROGRAM
to partially meet,
fully meet,
or maintain
IMPLEMENTATION of
the program
elements and documentation requirements within three years of
the previous evaluation.
The
state PROGRAM
records the
evaluation on
Appendix 8.2,
or an equivalent
form.
Outcome
The state PROGRAM utilizes the workplan to support its inspection and sample collection programs. The state PROGRAM evaluates the resources needed to support both the state PROGRAM and the IMPLEMENTATION and maintenance of the AFRPS.
Documentation
The
state PROGRAM
maintains the
records, or
equivalent forms
or worksheets,
listed here:
Appendix 8.1: Self-Assessment Worksheet.
Procedure
for evaluating the
workplan.
Procedure
for identifying
and evaluating
its resources
to accomplish
the workplan
within the applicable timeframe.
Formula
used to calculate the number of staff needed to accomplish the state
PROGRAM’S
ANIMAL
FOOD
workplan based
on the
state PROGRAM
staff assignments,
responsibilities, and work hours.
List
of required
equipment for
inspection and
sample collection.
Appendix
8.2: Resources
for Implementation
of Animal
Food Regulatory
Program Standards.
Assessment and Improvement
This standard describes the program elements used by a state PROGRAM to effectively evaluate and demonstrate IMPLEMENTATION with each of the program standards.
Requirement
Summary
The state PROGRAM establishes a baseline evaluation utilizing the self-assessment worksheets completed for each standard. This includes using the results to create a strategic improvement plan that aids the state PROGRAM in IMPLEMENTING the program elements of each standard.
Program
Elements
State
Program Baseline
Evaluation
The state PROGRAM conducts a baseline evaluation using the self-assessment worksheets from each standard to determine if a standard is fully met, partially met, or not met.
The state PROGRAM develops a strategic improvement plan to IMPLEMENT the program elements or documentation requirements of each standard. The strategic improvement plan includes the following, as applicable:
The
program element
or documentation
requirement of
the standard
that was not met.
Improvements
or
CORRECTIVE
ACTIONS
needed
to
IMPLEMENT the
program element or documentation requirement of the standard.
The
cause
for
any
DEVIATIONS
requiring
CORRECTIVE
ACTIONS when
the state
PROGRAM
was previously
in IMPLEMENTATION with
the program element or documentation requirement of a standard.
The
PREVENTIVE
ACTION
taken
to
prevent
future
similar
DEVIATIONS
when the state
PROGRAM
was previously
in IMPLEMENTATION with
the program element or documentation requirement of the standard that
was corrected. Projected completion date for each improvement or
CORRECTIVE
ACTION.
Personnel responsible.
Strategic
Improvement Plan
Review
The
state PROGRAM
reviews and
updates at
least every
12 months
the following: The
self-assessment worksheets.
The
strategic improvement
plan.
The
state
PROGRAM
has
a
procedure
for
DOCUMENT
CONTROL that
ensures all
guidance and procedures required by the standards are CURRENT
AND FIT-FOR-USE.
The
state PROGRAM
maintains a
master document list of all documents subject
to
this
procedure
to
demonstrate
they
are
CURRENT
AND
FIT-FOR- USE.
The state PROGRAM retains records required under x.5 of each standard for the three previous years, or per the state PROGRAM’S record retention policy.
Outcome
The state PROGRAM utilizes the strategic improvement plan to achieve and maintain IMPLEMENTATION of the required program elements and documentation requirements for all standards.
Documentation
The
state PROGRAM
maintains the
records, or
equivalent forms
or worksheets,
listed here:
Appendix 9.1: Self-Assessment Worksheet.
Strategic
Improvement Plan. Procedure for
Document Control.
Master Document List.
Laboratory Services
This standard describes the program elements used by a state PROGRAM to effectively utilize
REGULATORY TESTING LABORATORY services.
Requirement
Summary
The state PROGRAM establishes access to REGULATORY TESTING LABORATORY services that provide accurate, timely, reliable, and defensible analytical data.
Program
Elements
The
state PROGRAM
maintains a
list of
analytical services
the
REGULATORY TESTING LABORATORY provides for the state PROGRAM.
The
state PROGRAM
has a documented
formal agreement with the REGULATORY
TESTING
LABORATORY
that
conducts
routine
analytical
services unless under the same administrative agency.
Laboratory
Sample Integrity
Procedure
The state PROGRAM has procedures developed by the REGULATORY TESTING LABORATORY to maintain the integrity of the samples sent to the REGULATORY TESTING LABORATORY for analytical testing that includes:
Chain
of custody. Report of
analysis.
Methods
to communicate
information between
the state
PROGRAM
and
REGULATORY TESTING LABORATORY.
Laboratory
Quality Assurance
Program
The state PROGRAM utilizes REGULATORY TESTING LABORATORIES that:
Are
accredited by
a recognized
accreditation body
to ISO/IEC
17025:20173, or current
version, or
Implement
and comply
with the
AAFCO Quality
Assurance/Quality Control guidelines, or
Implement
and comply with
the ISO/IEC
17025:2017, or
current version.
3 A recognized accreditation body must be signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA).
Outcome
The state PROGRAM utilizes valid and defensible REGULATORY TESTING LABORATORY data to protect animal and public health and to enforce ANIMAL FOOD laws.
Documentation
The
state PROGRAM
maintains the
records, or
equivalent forms
or worksheets,
listed here:
Appendix 10.1: Self-Assessment Worksheet.
A
list
of
all
analytical
services
provided
by
the
REGULATORY
TESTING
LABORATORY
for the state PROGRAM.
A
formal agreement with REGULATORY
TESTING LABORATORYIES that
provide routine
analytical
services
unless
the
laboratory
is
under
the
same
administrative
agency.
Procedure
to
maintain
the
integrity
of
the
samples
sent
to
the
REGULATORY
TESTING
LABORATORY.
ISO
Accredited Laboratory: ISO/IEC 17025:2017, or current version,
Certificate and Scope
of Accreditation,
or documentation
for non-ISO
REGULATORY
TESTING
LABORATORIES.
Sampling Program
This standard describes the program elements used by a state PROGRAM to have an effective
ANIMAL FOOD sampling program.
Requirement
Summary
The state PROGRAM established a sampling program to determine compliance with ANIMAL FOOD laws. This includes a sampling plan, sample collection procedures, and procedures for completing the sample collection report.
Program
Elements
The state PROGRAM has a documented sampling plan, at least every 12 months, for collecting surveillance, compliance, investigational, regulatory samples, or other samples4.
The
state PROGRAM
and REGULATORY
TESTING LABORATORY jointly develops and amends the
sampling plan, at least every 12 months, for performing
routine analytical
services to
allow for
advanced planning
and scheduling of work.
The
sampling plan
includes the:
Availability
or coordination
of analytical
support. Sample priorities.
The SAMPLE ANALYSIS SCHEDULE includes the:
11.3.1.2.3.1 Types of ANIMAL FOOD to be analyzed. 11.3.1.2.3.2 Number of samples to be collected.
11.3.1.2.3.3 Estimated timeframe for collection. 11.3.1.2.3.4 Types of analyses to be performed.
The state PROGRAM has procedures for collecting, storing, and transporting samples that includes:
Following
safety
precautions
on
ANIMAL
FOOD
labels.
Following
the state PROGRAM’S
safety protocols for collecting samples. Using
appropriate method,
sample collection
procedures, and
equipment to collect the sample.
Sealing
the sample
to initiate
chain of
custody.
4 Regulatory samples may be used to support inspection observations.
Maintaining
and documenting
sample integrity,
security, and
chain of custody.
Issuing
receipt5
for the sample.
Handling6,
packaging, and
shipping samples
to prevent
compromising the
condition of the sample.
Delivering
or
shipping
samples
to
the
appropriate
REGULATORY
TESTING
LABORATORY within
designated timeframes.
The state PROGRAM has a procedure for completing the sample collection report that includes the:
Identification
of sample
collector. Date of the sample collection.
The product identification includes the:
Lot
numbers or
any other
codes referencing
manufacture identification.
Method
of collection
and any
special techniques
used to
collect sample.
Lot sampled.
Location
where sample
was collected.
Name
and address
of responsible
party, guarantor,
possessor, or
distributor.
Sample
type (example:
surveillance, compliance,
investigational, regulatory, or other).
Analysis
requested, if
applicable.
Collection
or reproduction
of product
label, including
customer-formula label.
Receiving
and distribution
information.
Outcome
The state PROGRAM utilizes the sampling program to align sampling resources to collect, store, transport, and document samples to achieve compliance with ANIMAL FOOD laws.
5 Receipt could include cost of sample and method of payment.
Documentation
The
state PROGRAM
maintains the
records, or
equivalent forms
or worksheets,
listed here:
Appendix 11.1: Self-Assessment Worksheet.
Sampling
collection procedure.
Procedure
for completing the
sample collection
report.
Appendix 1.1: Self-Assessment Worksheet
Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it includes the associated program elements. If the state PROGRAM has the main program element and associated program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met in the Notes column. The Notes column may be used for additional notes.
State Agency
Implementation
Status
Fully
Met
Partially
Met
Not
Met
Program Elements |
Yes/No |
Notes |
1.3.1 Evaluation of Legal Authority |
||
Does the state PROGRAM conduct an evaluation to determine whether the state’s legal authority and regulatory provisions are EQUIVALENT, EQUIVALENT IN EFFECT, NOT EQUIVALENT, or NO AUTHORITY to the specified sections of the current FD&C Act and CFR Title 21, and completes Appendix 1.2, or an equivalent form? |
|
|
1.3.2 Regulatory Foundation Evaluation |
||
Does the state PROGRAM have a procedure that includes: |
|
|
1. Reviewing the statutes, regulations, rules, ordinances, and other prevailing regulatory requirements that: |
|
|
1.1 Apply to the regulation of ANIMAL FOOD? |
|
|
1.2 Delegate authority to the state agency? |
|
|
1.3 Describe the state agency’s administrative procedure for establishing its authority and incorporating rules by reference? |
|
|
2. Timeframe for the review? |
|
|
Assessment Completed By:
Name |
|
Date |
Appendix 1.2: Regulatory Foundation Worksheet
Instructions: Determine if state laws and regulations are EQUIVALENT, EQUIVALENT IN EFFECT, NOT EQUIVALENT, or NO AUTHORITY to the specified sections of the current FD&C Act and CFR Title 21.
A state law or regulation may have the same regulatory effect as the relevant FD&C Act provision or federal regulation if either a single state law or regulation has the same regulatory effect as the federal statute or regulation, or when multiple laws of that state are combined and deemed EQUIVALENT IN EFFECT to a single federal statute or regulation.
If there is no state law or regulation EQUIVALENT to the relevant FD&C Act provision or federal regulation or the federal and state laws or regulations address the same matter but are inconsistent and do not have the same regulatory effect, please select NOT EQUIVALENT.
Select NO AUTHORITY if regulatory responsibility for a FD&C Act provision or federal regulation falls under the jurisdiction of another agency.
If the state has laws and regulations pertinent to the regulation of ANIMAL FOOD for which there are no comparable relevant FD&C Act provision or federal regulation, these laws or regulations should be listed on Appendix 1.2 or equivalent form.
For those laws and regulations for which the state PROGRAM does have authority, record the state law or regulations and the date it was incorporated. The Notes section can be used to detail differences between state and federal laws and regulations.
Note: The FD&C Act reference links direct you to the relevant U.S. Code section number. For a cross reference of FD&C Act and U.S. Code sections please visit FDA's website: https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
State Agency
FD&C Act |
Title |
Equivalency Status |
State Citation |
Date Incorporated into State Law |
Notes |
Definitions (f), (g), (k), (m), (s), (v) and (w) |
|
|
|
|
|
Prohibited acts (a), (b), (c), (d), (e), (f), and (k) |
|
|
|
|
|
Penalties |
|
|
|
|
|
Seizure |
|
|
|
|
|
Definitions and standards for food |
|
|
|
|
|
Adulterated food (a)-(c) |
|
|
|
|
|
Misbranded food (a)-(n) |
|
|
|
|
|
Emergency permit control |
|
|
|
|
|
Tolerances for poisonous ingredients in food |
|
|
|
|
|
Tolerances and exemptions for pesticide chemical residues |
|
|
|
|
|
Food Additives |
|
|
|
|
|
Adulterated drugs and devices (ONLY: 501(a)(2)(B) and 501(a)(6)) |
|
|
|
|
|
Veterinary feed directive drugs |
|
|
|
|
|
New animal drugs (ONLY: 512(a)(2)) |
|
|
|
|
|
Regulations and hearings |
|
|
|
|
|
Inspection |
|
|
|
|
CFR Part |
Title |
Equivalency Status |
State Citation |
Date Incorporated into State Law |
Notes |
|
General enforcement regulations (ONLY §1.20-1.23, Subpart L (§1.500- 1.514), Subpart M (§1.600-1.695), and Subpart O (§1.900-1.934)) |
|
|
|
|
Enforcement policy (ONLY §7.1-7.13 and 7.40-7.59) |
|
|
|
|
|
Color additives (ONLY §70.20-70.25) |
|
|
|
|
|
Listing of colors exempt from certification (ONLY §73.1-73.615) |
|
|
|
|
|
Listing of color additives subject to certification (ONLY §74.101-74.706) |
|
|
|
|
|
|
General specifications and general restrictions for provisional color additives for use in foods, drugs, and cosmetics |
|
|
|
|
|
Listing of certified provisionally listed colors and specifications (ONLY §82.3-82.706) |
|
|
|
|
Current good manufacturing practice for medicated feeds |
|
|
|
|
|
Current good manufacturing practice for Type A medicated articles |
|
|
|
|
|
|
Thermally processed low-acid foods packaged in hermitically sealed containers (refers to 21 CFR 113 and 21 CFR 507) |
|
|
|
|
CFR Part |
Title |
Equivalency Status |
State Citation |
Date Incorporated into State Law |
Notes |
|
Emergency permit control (refers to 21 CFR 108 - ONLY §108.25- 108.35) |
|
|
|
|
Gentian violet for use in animal feed |
|
|
|
|
|
|
Use of polychlorinated biphenyls (PCB's) in the production, handling, and storage of animal feed |
|
|
|
|
Propylene glycol in or on cat food |
|
|
|
|
|
Regulation of carcinogenic compounds used in food-producing animals |
|
|
|
|
|
Animal food labeling |
|
|
|
|
|
Common or usual name for non- standardized animal foods |
|
|
|
|
|
|
Current good manufacturing practice, hazard analysis, and risk-based preventive controls for food for animals |
|
|
|
|
Unavoidable contaminants in animal food and food-packaging material |
|
|
|
|
|
New animal drugs (ONLY Subpart D - Records and Reports) |
|
|
|
|
|
New animal drugs for use in animal feeds |
|
|
|
|
CFR Part |
Title |
Equivalency Status |
State Citation |
Date Incorporated into State Law |
Notes |
Food additives (EXCEPT §570.6, §570.15, and §570.17) |
|
|
|
|
|
Food additives permitted in feed and drinking water of animals |
|
|
|
|
|
|
Irradiation in the production, processing, and handling of animal feed and pet food |
|
|
|
|
Substances generally recognized as safe |
|
|
|
|
|
|
Food substances affirmed as generally recognized as safe in feed and drinking water of animals |
|
|
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Substances prohibited from use in animal food or feed |
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Instructions: List any state laws and/or regulations used by the state PROGRAM that are pertinent to the regulation of ANIMAL FOOD for which there are no comparable relevant FD&C Act provision or federal regulation (examples: tolerance for mycotoxins, fluorine, or noxious weeds in ANIMAL FOOD).
Additional State Authorities (optional):
Additional
notes
and
comments:
Assessment Completed By:
Name |
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Date |
Appendix 2.1: Self-Assessment Worksheet
Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it includes the associated program elements. If the state PROGRAM has the main program element and associated program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met in the Notes column. The Notes column may be used for additional notes.
State Agency
Implementation
Status
Fully
Met
Partially
Met
Not
Met
Program Elements |
Yes/No |
Notes |
2.3.1 Training Plan and Training Records |
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1. Does the state PROGRAM have a documented training plan that includes training and continuing education, as defined by the state PROGRAM, that includes: |
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1.1 Description of each inspection type? |
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1.2 CURRICULUM for each inspection type? |
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2. For inspectors with greater than five years of experience at the date of the initial self-assessment or at the inspectors START DATE, where their training documentation is not available, does the state PROGRAM: |
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2.1 Document an evaluation of the inspector’s performance and experience to determine if additional training is needed? |
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2.2 Maintain proper supporting documents to verify successful completion of the requirement, if previous coursework is completed before the inspectors START DATE and utilized to meet coursework requirements? |
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3. Does the state PROGRAM maintain records documenting the training completed by all inspectors on Appendix 2.2, or an equivalent form? |
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Program Elements |
Yes/No |
Notes |
2.3.2 Basic ANIMAL FOOD Inspector Training |
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1. Timeframe |
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Does the state PROGRAM require a basic inspector to successfully complete the basic coursework within 24 months from the START DATE? |
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2. Coursework |
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Does the basic inspector training consist of basic coursework in the subject areas listed in 2.3.2.2.1 – 2.3.2.2.13? |
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3. Field Training |
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Does the state PROGRAM require basic field training to complement the basic coursework? Does the basic field training specify the following: |
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3.1 The procedure for JOINT FIELD TRAINING INSPECTIONS? |
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3.2 The number of JOINT FIELD TRAINING INSPECTIONS that are conducted in establishments that represent the state PROGRAM inventory and the type of basic work that will be performed by the inspector? |
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3.3 List the competencies and the minimum number of JOINT FIELD TRAINING INSPECTIONS on Appendix 2.3, or an equivalent form? |
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3.4 The QUALIFIED FIELD INSPECTION TRAINER verifies the field training checklist of competencies in the field for each inspection type? |
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3.5 The inspector completes the minimum basic field training requirements for the inspection type, prior to performing independent work? |
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Program Elements |
Yes/No |
Notes |
2.3.3 Advanced ANIMAL FOOD Inspector Training |
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1. Timeframe |
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Does the state PROGRAM require an advanced inspector to successfully complete the advanced coursework within 60 months from the START DATE? |
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2. Coursework |
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Does the advanced inspector training consist of advanced coursework in the subject areas listed in 2.3.3.2.1 – 2.3.3.2.8, but not limited to? |
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3. Field Training |
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Does the state PROGRAM require advanced field training to complement the advanced coursework? Does the advanced field training specify the following: |
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3.1 The procedure for JOINT FIELD TRAINING INSPECTIONS? |
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3.2 The number of JOINT FIELD TRAINING INSPECTIONS that are conducted in establishments that represent the state PROGRAM inventory and the type of advanced work that will be performed by the inspector? |
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3.3 List the competencies and the minimum number of JOINT FIELD TRAINING INSPECTIONS on Appendix 2.3, or an equivalent form? |
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3.4 The QUALIFIED FIELD INSPECTION TRAINER verifies the field training checklist of competencies in the field for each inspection type? |
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3.5 The inspector completes the minimum advanced field training for the inspection type, prior to performing independent work? |
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Program Elements |
Yes/No |
Notes |
2.3.4 Continuing Education |
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Does the state PROGRAM require that each basic and advanced inspector participate in continuing education? Does the continuing education specify the following: |
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1. Each inspector receives 20 CONTACT HOURS of continuing education every 36 months? |
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2. The 36-month continuing education interval starts, as defined by the state PROGRAM, when the required CURRICULUM is complete? |
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3. Documentation accompanies each activity submitted for continuing education? |
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Assessment Completed By:
Name |
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Date |
Appendix 2.2: Inspector Training Record
Basic Animal Food Inspector Training
Instructions: If the inspector has greater than five years of experience and an evaluation of the inspector’s previous performance and experience shows adequate training has been completed, mark the Name and Location of Training Column, with “Met via Evaluation.”
Inspector Name: |
Employment Start Date: |
Subject Areas |
Name and Location of Training |
Completion Date |
Documentation Verifying Completion |
Animal and Public Health Principles |
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Animal Food Defense |
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Basic Animal Nutrition |
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Basic Ingredients, Processing, and Technology |
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Basic National Incident Management System and Incident Command System (ICS) |
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Communication |
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Current Statutes, Regulations, and Policies |
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Inspections, Compliance, and Enforcement |
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Labeling |
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Professionalism |
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Risk Awareness |
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Safety |
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Sample Collection |
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Appendix 2.2: Inspector Training Record
Instructions: Record the name of the establishment where the joint training inspection took place as well as the competencies covered.
Inspector Name: |
Employment Start Date: |
Basic Field Training (Name and Location of Establishment) |
Competencies Covered |
Completion Date |
Verified (Y/N) |
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Appendix 2.2: Inspector Training Record
Advanced Animal Food Inspector Training
Instructions: If the inspector has greater than five years of experience and an evaluation of the inspector’s previous performance and experience shows adequate training has been completed, mark the Name and Location of Training Column, with “Met via Evaluation.”
Inspector Name: |
Employment Start Date: |
Subject Areas |
Name and Location of Training |
Completion Date |
Documentation Verifying Completion |
Advanced Ingredients, Processing, and Technology |
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Advanced Inspections, Compliance, and Enforcement |
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Advanced Labeling |
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Animal Illness and Death Investigation |
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Current Statutes, Regulations, and Policies |
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Epidemiology |
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Microbiological Pathogens |
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Traceback and Tracefoward Investigations |
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Appendix 2.2: Inspector Training Record
Instructions: Record the name of the establishment where the joint training inspection took place as well as the competencies covered.
Inspector Name: |
Employment Start Date: |
Advanced Field Training (Name and Location of Establishment) |
Competencies Covered |
Completion Date |
Verified (Y/N) |
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Appendix 2.2: Inspector Training Record
Continuing Education
Instructions: Record the continuing education activity as well as the name and location of the activity.
Inspector Name: |
Employment Start Date: |
Type of Activity |
Name and Location of Activity |
Completion Date |
Contact Hours Earned |
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Appendix 2.3: Field Training Competencies
Basic Field Training Competencies
Instructions: List the competencies to be covered in the state PROGRAM’S basic field training and provide a short description.
Competency |
Description |
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Minimum Number of Joint Field Training Inspections Required:
Appendix 2.3: Field Training Competencies
Advanced Field Training Competencies
Instructions: List the competencies to be covered in the state PROGRAM’S advanced field training and provide a short description.
Competency |
Description |
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Minimum Number of Joint Field Training Inspections Required:
Appendix 3.1: Self-Assessment Worksheet
Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it includes the associated program elements. If the state PROGRAM has the main program element and associated program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met in the Notes column. The Notes column may be used for additional notes.
State Agency
Implementation
Status
Fully
Met
Partially
Met
Not
Met
Program Elements |
Yes/No |
Notes |
3.3.1 Risk-Based Inspection Program |
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1. Does the state PROGRAM have a procedure to define and maintain a current inventory of ANIMAL FOOD establishments whose activities fall under the state PROGRAM’S jurisdiction and authority? |
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2. Does the state PROGRAM have a procedure for risk categorization of ANIMAL FOOD establishments using the three minimum required factors for defining risk categories: |
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2.1 Types of ANIMAL FOOD and ANIMAL FOOD products? |
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2.2 Types of processing? |
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2.3 Compliance history of the establishment? |
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3. Based on risk categorization of an ANIMAL FOOD establishment, are inspections: |
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3.1 Prioritized? |
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3.2 Assigned frequencies? |
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3.3 Allocated resources? |
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Program Elements |
Yes/No |
Notes |
3.3.2 Inspection Procedure |
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1. Does the state PROGRAM have procedures for inspecting ANIMAL FOOD establishments that require the inspectors to: |
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1.1 Review the ANIMAL FOOD establishment’s history and determine the scope of inspection? |
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1.2 Present appropriate credentials and written Notice of Inspection to the ANIMAL FOOD establishment’s owner, operator, or agent in charge; make appropriate introductions; explain the purpose and scope of the inspection; confirm inspection authority and establish FDA jurisdiction, if applicable? |
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1.3 Follow the safety protocols required by the ANIMAL FOOD establishment and the state PROGRAM? |
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1.4 Follow the biosecurity protocols required by the ANIMAL FOOD establishment and the state PROGRAM? |
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1.5 Use appropriate equipment and forms needed to conduct inspections? |
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1.6 Recognize the relative risk categorization of the ANIMAL FOOD establishment based on the risk-based inspection program? |
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1.7 Conduct comprehensive inspection activities appropriate for the level of risk, focused on the establishment’s products and processes determined to be of higher risk? |
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1.8 Assess employee activities critical to the safe manufacturing, processing, packaging, handling, holding, and distribution of ANIMAL FOOD? |
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1.9 Properly evaluate the potential that conditions, practices, processes, components, or labeling could cause the product to become adulterated, contaminated, or misbranded? |
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Program Elements |
Yes/No |
Notes |
1.10 Recognize significant non-compliant conditions or practices and document findings consistent with state PROGRAM procedures? |
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1.11 Distinguish between significant and insignificant observations and isolated incidents versus trends? |
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1.12 Review, evaluate and verify that the appropriate ANIMAL FOOD establishment records, plans, programs, and/or procedures are established, maintained, and/or implemented? |
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1.13 Collect adequate evidence and documentation to support inspection observations in accordance with state PROGRAM procedures? |
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1.14 Verify deficiencies identified during the previous inspections have been addressed? |
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1.15 Conduct activities in a professional manner? |
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1.16 Use effective interviewing techniques? |
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1.17 Explain findings clearly and adequately throughout the inspection? |
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1.18 Alert the ANIMAL FOOD establishment’s owner, operator, or agent in charge when an immediate corrective action is necessary? |
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1.19 Document findings accurately, clearly, legibly, and concisely on the applicable forms and provide a copy to the ANIMAL FOOD establishment’s owner, operator, or agent in charge? |
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1.20 Answer questions and provide information as appropriate? |
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1.21 Submit inspection report, samples where applicable, and supporting evidence and documentation within designated timeframes consistent with state PROGRAM procedure? |
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Program Elements |
Yes/No |
Notes |
3.3.3 Recall System |
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Does the state PROGRAM have procedures to handle recalls that includes: |
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1. Receiving? |
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2. Tracking? |
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3. Evaluating recall notifications? |
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4. Closing? |
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5. Maintaining records? |
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6. Performing recall effectiveness checks, as applicable? |
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3.3.4 Consumer Complaints |
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Does the state PROGRAM have a procedure to handle consumer complaints that includes: |
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1. Receiving? |
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2. Tracking? |
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3. Evaluating? |
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4. Answering? |
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5. Closing? |
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6. Maintaining records? |
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Program Elements |
Yes/No |
Notes |
3.3.5 Complaints Resulting from state PROGRAM Inspection Activities |
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Does the state PROGRAM have a procedure to handle industry complaints resulting from state PROGRAM inspection activities that includes: |
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1. Receiving? |
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2. Evaluating? |
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3. Maintaining records? |
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Assessment Completed By:
Name |
|
Date |
Appendix 4.1: Self-Assessment Worksheet
Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it includes the associated program elements. If the state PROGRAM has the main program element and associated program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met in the Notes column. The Notes column may be used for additional notes.
State Agency
Implementation
Status
Fully
Met
Partially
Met
Not
Met
Program Elements |
Yes/No |
Notes |
4.3.1 Audit Program |
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Does the state PROGRAM have procedures for conducting four types of audits: |
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1. Field inspection audits as described in 4.3.3? |
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2. Field inspection report audits as described in 4.3.4? |
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3. Sample collection audits as described in 4.3.5? |
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4. Sample collection report audits as described in 4.3.6? |
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4.3.2 Audit Program Review |
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Does the state program conduct a review of the performance factor scores and cumulative scores for each of the four types of audits at least every 12 months? |
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4.3.3 Field Inspection Audit |
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Does the state PROGRAM conduct field inspection audits using a QUALIFIED FIELD AUDITOR to verify that inspections are consistently performed according to the state’s PROGRAM procedures? |
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1. Frequency |
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Program Elements |
Yes/No |
Notes |
1.1 Are a minimum of two field inspection audits of each inspector conducted every 36 months? |
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1.2 Do the field inspections selected for audits reflect the inspector’s assignments and responsibilities? |
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2. Performance Factors |
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Are performance factors listed in the inspection procedure as described in 3.3.2 and as listed in Appendix 4.2, or an equivalent form, evaluated? |
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3. Performance Documentation |
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3.1 Is the rating of each performance factor, audit score, and audit rating for each field inspection audit recorded on Appendix 4.2, or an equivalent form? |
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3.2 Are the performance factor scores and a cumulative score for the state PROGRAM calculated on Appendix 4.3, or an equivalent worksheet? |
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4.3.4 Field Inspection Report Audit |
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Does the state PROGRAM conduct field inspection report audits to verify that inspectional findings are consistently reported according to the state PROGRAM’S procedures? |
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1. Frequency |
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Is the review a random selection of field inspection reports to be audited based on the number of inspections completed in 12 months of performance using Table 1? |
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2. Performance Factors |
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Program Elements |
Yes/No |
Notes |
Are the performance factors listed in Appendix 4.4, or an equivalent form, evaluated? |
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3. Performance Documentation: |
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3.1 Is the rating of each performance factor, audit score, and audit rating for each inspection report audit recorded on Appendix 4.4, or an equivalent form? |
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3.2 Are the performance factor scores and a cumulative score for the state PROGRAM calculated on Appendix 4.5, or an equivalent worksheet? |
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4.3.5 Sample Collection Audit |
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Does the state PROGRAM conduct sample collection audits using a QUALIFIED FIELD AUDITOR to verify that sample collections are consistently performed according to the state PROGRAM’S procedures? |
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1. Frequency |
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1.1 Are a minimum of two sample collection audits of each inspector conducted every 36 months? |
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1.2 Do sample collections selected for audits reflect the inspector’s assignments and responsibilities? |
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2. Performance Factors |
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Are performance factors listed in the sample collection procedure as described in 11.3.2 and as listed in Appendix 4.6, or an equivalent form, evaluated? |
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3. Performance Documentation: |
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Program Elements |
Yes/No |
Notes |
3.1 Is the rating of each performance factor, audit score, and audit rating for each sample collection audit recorded on Appendix 4.6, or an equivalent form? |
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3.2 Are the performance factor scores and a cumulative score for the state PROGRAM calculated on Appendix 4.7, or an equivalent worksheet. |
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4.3.6 Sample Collection Report Audit |
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Does the state PROGRAM conduct sample collection report audits to verify that sample collection documentation is consistently performed according to the state PROGRAM’S procedures? |
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1. Frequency |
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Is the review a random selection of sample collection reports to be audited based on the number of samples collected in 12 months of performance based using Table 2? |
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2. Performance Factors |
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Are the performance factors listed in Appendix 4.8, or an equivalent form, evaluated? |
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3. Performance Documentation: |
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3.1 Is the rating of each performance factor, audit score, and audit rating for each sample collection report audit recorded on Appendix 4.8, or an equivalent form? |
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3.2 Are the performance factor scores and a cumulative score for the state PROGRAM calculated on Appendix 4.9, or an equivalent worksheet? |
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Program Elements |
Yes/No |
Notes |
4.3.7 Corrective Action Plan |
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Does the state PROGRAM document CORRECTIVE ACTIONS as described in 9.3.2 for each of the four types of audits when any of the following conditions are met: |
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1. An inspector receives an overall audit rating of “needs improvement” (audit score below 80 percent) for an individual audit? |
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2. A state PROGRAM has a performance factor score (as a result of all audits in 12 months of performance) below 80 percent for a single performance factor? |
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3. A state PROGRAM has a cumulative score (as a result of all audits in 12 months of performance) below 80 percent? |
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Assessment Completed By:
Name |
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Date |
Appendix
4.2: Field
Inspection Audit
Form
Field Inspection Audit |
|
Inspector: |
Auditor: Date of Audit: |
Establishment Name: Establishment Address: |
Type of Inspection: BSE GMP Tissue Residue Complaint Other: |
Total Number of: Acceptable Needs Improvement
Audit Score: |
Audit Rating: Acceptable Needs 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/ (# Acceptable + # Needs Improvement)] x 100. If the audit score is below eighty percent, the audit rating must be marked as ‘Needs Improvement’. |
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I. Pre-Inspection Assessment |
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1. Did the inspector review the animal food establishment’s history and determine scope of the inspection? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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2. Did the inspector use appropriate equipment and forms needed to conduct the inspection? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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II. Inspection Observations and Performance |
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1. Did the inspector present appropriate credentials and written Notice of Inspection to the animal food establishment’s owner, operator, or agent in charge; make appropriate introductions; explain the purpose and scope of the inspection; confirm inspection authority and establish FDA jurisdiction, if applicable? Acceptable Needs Improvement Comments (required for Needs Improvement) |
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2. Did the inspector follow safety protocols required by the animal food establishment and the state program? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
3. Did the inspector follow the biosecurity protocols required by the animal food establishment and the state program? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
4. Did the inspector recognize the relative risk categorization of the animal food establishment based on the risk-based inspection program? Acceptable Needs Improvement Comments (required for Needs Improvement) |
5. Did the inspector conduct comprehensive inspection activities, appropriate for the level of risk, focused on the establishment’s products and processes determined to be of higher risk? Acceptable Needs Improvement Comments (required for Needs Improvement) |
6. Did the inspector assess employee activities critical to the safe manufacturing, processing, packaging, handling, holding, and distribution of animal food? Acceptable Needs Improvement Comments (required for Needs Improvement) |
7. Did the inspector properly evaluate the potential that conditions, practices, processes, components, or labeling could cause the product to become adulterated, contaminated, or misbranded? Acceptable Needs Improvement Comments (required for Needs Improvement) |
8. Did the inspector recognize significant non-compliant conditions or practices and document findings consistent with state program procedure? Acceptable Needs Improvement Comments (required for Needs Improvement) |
9. Did the inspector distinguish between significant and insignificant observations and isolated incidents versus trends? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
10. Did the inspector review, evaluate, and verify that the appropriate animal food establishment records, plans, programs, and/or procedures are established, maintained, and/or implemented? Acceptable Needs Improvement Comments (required for Needs Improvement) |
11. Did the inspector collect adequate evidence and documentation to support inspection observations in accordance with state program procedures? Acceptable Needs Improvement Comments (required for Needs Improvement) |
12. Did the inspector verify deficiencies identified during the previous inspections have been addressed? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
13. Did the inspector conduct activities in a professional manner? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
III. Oral and Written Communications |
1. Did the inspector use effective interviewing techniques? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
2. Did the inspector explain findings clearly and adequately throughout the inspection? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
3. Did the inspector alert the animal food establishment’s owner, operator, or agent in charge when an immediate corrective action is necessary? Acceptable Needs Improvement Comments (required for Needs Improvement) |
4. Did the inspector document findings accurately, clearly, legibly, and concisely on the applicable forms and provide a copy to the animal food establishment’s owner, operator, or agent in charge? Acceptable Needs Improvement Comments (required for Needs Improvement) |
5. Did the inspector answer questions and provide information as appropriate? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
6. Did the inspector submit inspection report, samples where applicable, and supporting evidence and documentation within designated timeframes consistent with state program procedure? Acceptable Needs Improvement Comments (required for Needs Improvement) |
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IV. General Comments |
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Enter any general comments or recommendations as a result of this audit. |
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Name of Auditor |
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Signature of Auditor |
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Date |
Appendix 4.3: Field Inspection Audit Worksheet
State Program: |
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Reviewed By: |
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Performance Period: |
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Date: |
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Cumulative Score (5): |
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Auditor Initials and Date of Audit (1) |
At (3) |
NIt (3) |
Performance Factor Score (3) |
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Initials |
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Date |
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Performance Factors (2) |
Performance Ratings |
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I.1 |
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I.2 |
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II.1 |
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II.2 |
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II.3 |
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II.4 |
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II.5 |
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II.6 |
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II.7 |
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II.8 |
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II.9 |
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II.10 |
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II.11 |
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II.12 |
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II.13 |
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III.1 |
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III.2 |
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III.3 |
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III.4 |
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III.5 |
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III.6 |
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Audit Score (2) |
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Subtotal - Enter the sum of the totals from all continuation worksheets. |
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Total (4) - Enter the final sums (subtotal + sums of (3) on this form). |
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(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits. |
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State Program: |
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Reviewed By: |
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Auditor Initials and Date of Audit (1) |
At (3) |
NIt (3) |
Performance Factor Score (3) |
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Initials |
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Date |
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Performance Factors (2) |
Performance Ratings |
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I.1 |
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I.2 |
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II.1 |
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II.2 |
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II.3 |
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II.4 |
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II.5 |
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II.6 |
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II.7 |
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II.8 |
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II.9 |
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II.10 |
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II.11 |
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II.12 |
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II.13 |
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III.1 |
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III.2 |
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III.3 |
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III.4 |
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III.5 |
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III.6 |
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Audit Score (2) |
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Subtotal - Enter the sum of the totals from all continuation worksheets. |
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Total (4) - Enter the final sums (subtotal + sums of (3) on this form). |
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(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits. |
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Appendix
4.4: Field
Inspection Report
Audit Form
Field Inspection Report Audit |
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Auditor: |
Date of Audit: Date of Inspection: |
Establishment Name: Establishment Address: |
Type of Inspection: BSE GMP Tissue Residue Complaint Other: |
Total Number of: Acceptable Needs Improvement
Audit Score: |
Audit Rating: Acceptable Needs 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/ (# Acceptable + # Needs Improvement)] x 100. If the audit score is below eighty percent, the audit rating must be marked as ‘Needs Improvement’. |
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I. Organization of the Report |
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1. Format of the inspection report followed the state program’s current procedures. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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2. Required fields on inspection report or related report forms are completed. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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3. Written observations were clear and concise. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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4. Submitted report within timeframes. Acceptable Needs Improvement Comments (required for Needs Improvement) |
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II. Record of Findings |
1. Recorded name and title of establishment managers and key personnel. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
2. Recorded name and title of personnel interviewed during the inspection. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
3. Recorded findings not in compliance with statutes and regulations. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
4. Recorded significant findings, if any. Acceptable Needs Improvement Comments (required for Needs Improvement) |
5. Recorded the collection of all samples, exhibits, photographs, or photocopies to support findings. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
6. Recorded any refusals encountered during the inspection. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
III. Communication with Establishment Personnel |
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1. Provided a summary of findings. Acceptable Needs Improvement Comments (required for Needs Improvement) |
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2. Recorded responses, replies, or corrective action commitments. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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IV. General Comments |
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Enter any general comments or recommendations as a result of this audit. |
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Name of Auditor |
Signature of Auditor |
Date |
Appendix 4.5: Field Inspection Report Audit Worksheet
State Program: |
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Reviewed By: |
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Performance Period: |
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Date: |
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Cumulative Score (5): |
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Auditor Initials and Date of Audit (1) |
At (3) |
NIt (3) |
Performance Factor Score (3) |
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Initials |
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Date |
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Performance Factors (2) |
Performance Ratings |
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I.1 |
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I.2 |
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I.3 |
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I.4 |
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II.1 |
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II.2 |
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II.3 |
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II.4 |
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II.5 |
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II.6 |
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III.1 |
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III.2 |
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Audit Score (2) |
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Subtotal - Enter the sum of the totals from all continuation worksheets. |
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Total (4) - Enter the final sums (subtotal + sums of (3) on this form). |
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(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits. |
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State Program: |
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Reviewed By: |
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Auditor Initials and Date of Audit (1) |
At (3) |
NIt (3) |
Performance Factor Score (3) |
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Initials |
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Date |
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Performance Factors (2) |
Performance Ratings |
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I.1 |
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I.2 |
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I.3 |
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I.4 |
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II.1 |
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II.2 |
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II.3 |
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II.4 |
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II.5 |
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II.6 |
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III.1 |
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III.2 |
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Audit Score (2) |
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Subtotal - Enter the sum of the totals from all continuation worksheets. |
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Total (4) - Enter the final sums (subtotal + sums of (3) on this form). |
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(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits. |
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||||||||||||||||||||||
Appendix
4.6: Sample
Collection Audit
Form
Sample Collection Audit |
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Inspector: |
Auditor: Date of Audit: |
Establishment Name: Establishment Address: |
Type of Sample Collection: Surveillance Compliance Investigational Regulatory Other: |
Total Number of: Acceptable Needs Improvement
Audit Score: |
Audit Rating: Acceptable Needs 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/ (# Acceptable + # Needs Improvement)] x 100. If the audit score is below eighty percent, the audit rating must be marked as ‘Needs Improvement’. |
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I. Sample Collection Observations and Performance |
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1. Did the inspector follow safety precautions on the animal food label? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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2. Did the inspector follow the state program’s safety protocols for collecting samples? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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3. Did the inspector use the appropriate method, sample collection procedures, and equipment to collect the sample? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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4. Did the inspector seal the sample to initiate chain of custody? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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5. Did the inspector maintain and document sample integrity, security, and chain of custody? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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6. Did the inspector issue a receipt for the sample? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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7. Did the inspector handle, package, and ship samples to prevent compromising the condition of the samples? Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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8. Did the inspector deliver or ship samples to the appropriate regulatory testing laboratory within designated timeframes? Acceptable Needs Improvement Comments (required for Needs Improvement) |
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II. General Comments |
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Enter any general comments or recommendations as a result of this audit. |
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Name of Auditor |
Signature of Auditor |
Date |
Appendix 4.7: Sample Collection Audit Worksheet
State Program: |
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Reviewed By: |
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Performance Period: |
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Date: |
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Cumulative Score (5): |
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Auditor Initials and Date of Audit (1) |
At (3) |
NIt (3) |
Performance Factor Score (3) |
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Initials |
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Date |
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Performance Factors (2) |
Performance Ratings |
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I.1 |
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I.2 |
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I.3 |
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I.4 |
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I.5 |
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I.6 |
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I.7 |
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I.8 |
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Audit Score (2) |
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Subtotal - Enter the sum of the totals from all continuation worksheets. |
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||||||||||||||||||
Total (4) - Enter the final sums (subtotal + sums of (3) on this form). |
|
|
|||||||||||||||||||
(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits. |
|||||||||||||||||||||
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State Program: |
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Reviewed By: |
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Auditor Initials and Date of Audit (1) |
At (3) |
NIt (3) |
Performance Factor Score (3) |
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Initials |
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Performance Factors (2) |
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I.2 |
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I.3 |
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I.4 |
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I.5 |
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I.6 |
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I.7 |
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I.8 |
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Audit Score (2) |
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Subtotal - Enter the sum of the totals from all continuation worksheets. |
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Total (4) - Enter the final sums (subtotal + sums of (3) on this form). |
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(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits. |
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Appendix
4.8: Sample
Collection Report
Audit Form
Sample Collection Report Audit |
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Auditor: |
Date of Audit: Date of Sample Collection: |
Establishment Name: Establishment Address: |
Type of Sample Collection: Surveillance Compliance Investigational Regulatory Other: |
Number of: Acceptable Needs Improvement
Audit Score: |
Audit Rating: Acceptable Needs 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/ (# Acceptable + # Needs Improvement)] x 100. If the audit score is below eighty percent, the audit rating must be marked as ‘Needs Improvement’. |
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I. Sample Collection Report |
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1. Identification of sample collector was recorded. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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2. Date of the sample collection was recorded. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
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II. Product Identification |
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1. Product name was recorded. Acceptable Needs Improvement Comments (required for Needs Improvement) |
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2. Lot numbers or any other codes referencing manufacture identification was recorded. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
3. Description of product was recorded. Acceptable Needs Improvement Comments (required for Needs Improvement) |
4. Method of collection and any special techniques used to collet sample was recorded. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
5. Lot sampled was recorded. Acceptable Needs Improvement Comments (required for Needs Improvement) |
6. Lot size was recorded. Acceptable Needs Improvement Comments (required for Needs Improvement) |
7. Location where sample was collected was recorded. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
8. Name and address of responsible party, guarantor, possessor, or distributor was recorded. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
9. Sample type (example: surveillance, compliance, investigational, regulatory, or other) was recorded. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
10. Analysis requested was recorded, if applicable. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
11. Collection or reproduction of product label, including customer-formula animal food label was recorded. Acceptable Needs Improvement
Comments (required for Needs Improvement) |
12.
Receiving and
distribution information
was recorded.
Acceptable Needs
Improvement
Comments (required for Needs Improvement)
III. General Comments
Enter any general comments or recommendations as a result of this audit.
Name of Auditor Signature of Auditor Date
Appendix 4.9: Sample Collection Report Audit Worksheet
State Program: |
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Reviewed By: |
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Performance Period: |
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Date: |
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Cumulative Score (5): |
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Auditor Initials and Date of Audit (1) |
At (3) |
NIt (3) |
Performance Factor Score (3) |
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Initials |
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Date |
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Performance Factors (2) |
Performance Ratings |
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I.1 |
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I.2 |
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II.1 |
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II.2 |
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II.3 |
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II.4 |
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II.5 |
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II.6 |
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II.7 |
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II.8 |
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II.9 |
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II.10 |
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II.11 |
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II.12 |
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Audit Score (2) |
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Subtotal - Enter the sum of the totals from all continuation worksheets. |
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Total (4) - Enter the final sums (subtotal + sums of (3) on this form). |
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(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits. |
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State Program: |
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Reviewed By: |
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Auditor Initials and Date of Audit (1) |
At (3) |
NIt (3) |
Performance Factor Score (3) |
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Initials |
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Date |
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Performance Factors (2) |
Performance Ratings |
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I.1 |
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I.2 |
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II.1 |
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II.2 |
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II.3 |
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II.4 |
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II.5 |
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II.6 |
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II.7 |
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II.8 |
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II.9 |
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II.10 |
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II.11 |
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II.12 |
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Audit Score (2) |
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Subtotal - Enter the sum of the totals from all continuation worksheets. |
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Total (4) - Enter the final sums (subtotal + sums of (3) on this form). |
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(6) Use this space to identify and make notes about trends and single performance factors rated as “Needs Improvement” in multiple audits. |
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Appendix 5.1: Self-Assessment Worksheet
Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it includes the associated program elements. If the state PROGRAM has the main program element and associated program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met in the Notes column. The Notes column may be used for additional notes.
State Agency
Implementation
Status
Fully
Met
Partially
Met
Not
Met
Program Elements |
Yes/No |
Notes |
5.3.1 Animal Food-Related Illnesses or Deaths and Emergencies Procedure |
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1. Does the state PROGRAM have a procedure to gather information to identify incidents of ANIMAL FOOD- related illnesses or deaths and EMERGENCIES? |
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2. Does the state PROGRAM have a procedure to communicate with the appropriate agencies or departments that investigate ANIMAL FOOD-related illnesses or deaths and EMERGENCIES? |
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3. For ANIMAL FOOD-related illnesses or deaths and EMERGENCIES, does the state PROGRAM have a procedure to: |
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3.1 Determine the appropriate response? |
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3.2 Initiate the response? |
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3.3 Complete the response? |
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5.3.2 Emergency Event Management |
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1. For ANIMAL FOOD-related EMERGENCIES, does the state PROGRAM manage the event using: |
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1.1 An Incident Command System? or |
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1.2 An official action plan? |
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Program Elements |
Yes/No |
Notes |
Does the official action plan include: |
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1.2.1 Containment? |
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1.2.2 Communication? |
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1.2.3 Control? |
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1.2.4 Correction and/or Corrective Actions? |
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1.2.5 After-action protocols? |
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5.3.3 Animal Food-Related Illnesses or Deaths and Emergencies Notification Procedures |
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1. Does the state PROGRAM maintain a current list of relevant agencies and emergency contacts that is reviewed and updated at least every 12 months? |
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2. Does the state PROGRAM have a procedure to rapidly notify government agencies, departments, and appropriate parties of relevant findings? |
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3. Does the state PROGRAM have a procedure to rapidly notify law enforcement agencies when intentional ANIMAL FOOD contamination or ANIMAL FOOD- related terrorism is suspected or threatened? |
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4. Does the state PROGRAM have a procedure for: |
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4.1 Releasing information to the public? |
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4.2 Coordinating media information with other jurisdictions to reduce the impact of ANIMAL FOOD-related illnesses or deaths and EMERGENCIES? |
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Assessment Completed By:
Name |
|
Date |
Appendix 6.1: Self-Assessment Worksheet
Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it includes the associated program elements. If the state PROGRAM has the main program element and associated program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met in the Notes column. The Notes column may be used for additional notes.
State Agency
Implementation
Status
Fully
Met
Partially
Met
Not
Met
Program Elements |
Yes/No |
Notes |
6.3.1 Compliance and Enforcement Program |
||
1. Does the state PROGRAM have a documented compliance and enforcement program that contains ENFORCEMENTSTRATEGIES? |
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2. Does the state PROGRAM select an appropriate enforcement tool using the following six factors? |
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2.1 Compliance history? |
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2.2 Responsiveness? |
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2.3 Scope? |
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2.4 Nature of the Violation? |
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2.5 Impact of the Violation? |
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2.6 Resources? |
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3. Does the state PROGRAM have a documented description for all factors? |
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4. Does the state PROGRAM have documented relative conditions with an assigned numerical weight for all factors? |
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5. Does the state PROGRAM have a documented enforcement matrix designed to incorporate the relative conditions of each factor and the application of enforcement tools? |
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Program Elements |
Yes/No |
Notes |
6.3.2 Performance Review |
||
1. Does the state PROGRAM have a procedure for conducting an evaluation of its ENFORCEMENT STRATEGIES at least every 12 months to: |
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1.1 Determine if the state PROGRAM’S ENFORCEMENT STRATEGIES were successful in achieving compliance? |
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1.2 Identify potential improvements or modifications of the ENFORCEMENT STRATEGIES, if any? |
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1.3 Determine if the enforcement priorities remain the same or require modification? |
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Assessment Completed By:
Name |
|
Date |
Appendix 7.1: Self-Assessment Worksheet
Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it includes the associated program elements. If the state PROGRAM has the main program element and associated program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met in the Notes column. The Notes column may be used for additional notes.
State Agency
Implementation Status |
Fully Met |
Partially Met |
Not Met |
Program Elements |
Yes/No |
Notes |
7.3.1 Outreach Methods |
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Does the state PROGRAM identify the methods that will be used for outreach to inform ANIMAL FOOD industry stakeholders, academia, other regulators, or consumers about ANIMAL FOOD topics? |
|
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7.3.2 Outreach Plan |
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Does the state PROGRAM have a documented outreach plan at least every 12 months that supports the state PROGRAM mission? And that includes: |
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1. Objectives of an outreach plan? |
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2. Target populations? |
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3. The types of outreach (including OUTREACH ACTIVITIES or OUTREACH EVENTS)? |
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7.3.3 Outreach Events |
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Does the state PROGRAM document and evaluate OUTREACH EVENTS using Appendix 7.2, or an equivalent form? |
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Assessment Completed By:
Name |
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Date |
Appendix 7.2: Outreach Event Overview and Evaluation
Instructions: Attach documents such as agendas, meeting summaries, and program evaluations to this form.
Section I. Overview of Outreach Event
A. Type of outreach event (select all that apply): |
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Meeting |
Workshop |
Extension Event |
Other |
Task Force/Committee |
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B. Date of outreach event |
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C. Objective of outreach event |
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D. Target population for outreach event |
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Section II. Evaluation of Outreach Event
Program Elements |
Yes/No |
If no, please explain |
A. The purpose and objectives were clearly defined |
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B. The context of the outreach event was consistent with the objectives |
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C. An evaluation was completed by attendees |
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D. State program reviewed and discussed comments from attendees |
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Describe what went well, what could be done better, and what more could be done to improve the outreach event.
|
Completed By:
Name |
|
Date |
Appendix 8.1: Self-Assessment Worksheet
Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it includes the associated program elements. If the state PROGRAM has the main program element and associated program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met in the Notes column. The Notes column may be used for additional notes.
State Agency
Implementation
Status
Fully
Met
Partially
Met
Not
Met
Program Elements |
Yes/No |
Notes |
8.3.1 Workplan |
||
Does the state PROGRAM have a documented workplan that includes the? |
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1. Inspection plan? |
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1.1 Number of inspections? |
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1.2 Type of inspection? |
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1.3 Risk category of establishment or product? |
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1.4 Frequency? |
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2. Sample plan? |
|
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2.1 Number of samples? |
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2.2 Type of samples? |
|
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3. Timeframe that the workplan is applicable? |
|
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8.3.2 Workplan Procedure |
||
4. Does the state PROGRAM have a procedure for evaluating the workplan that includes? |
|
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4.1 Conducting evaluations of the workplan at least every 12 months? |
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4.2 Evaluating alignment with state PROGRAM objectives and resources? |
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Program Elements |
Yes/No |
Notes |
5. Does the state PROGRAM have a procedure for identifying and evaluating its resources to accomplish the workplan within the applicable timeframe? |
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6. Has the state PROGRAM developed a formula and calculated the number of staff needed to accomplish the state PROGRAM’S ANIMAL FOOD workplan based on staff assignments, responsibilities, and work hours? |
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8.3.3 Equipment |
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Does the state PROGRAM establish and maintain a list of the equipment required for inspections and sample collections? |
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8.3.4 Resource Review |
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1. Has the state PROGRAM conducted a baseline evaluation of the resources required to IMPLEMENT the AFRPS? Including the program elements and the documentation requirements in the standards to determine whether the state PROGRAM has: |
|
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1.1 Adequate staff? |
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1.2 Equipment? |
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1.3 Funding? |
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2. Does the state PROGRAM complete subsequent resource evaluations to determine the resources necessary for the state PROGRAM to partially meet, fully meet, or maintain IMPLEMENTATION of the program elements and documentation requirements within three years of the previous evaluation? |
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3. Is the evaluation recorded on Appendix 8.2, or an equivalent form? |
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Assessment Completed By:
Name |
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Date |
Appendix 8.2
Appendix 8.2: Resources for Implementation of Animal Food Regulatory Program Standards
Instructions: This table provides an overview of a state PROGRAM’S evaluation of the resources needed to IMPLEMENT the Animal Food Regulatory Program Standards. Based on the evaluation, indicate for each standard whether the state PROGRAM has the resources needed for funding, staffing, and equipment by inserting ‘Yes’ or ‘No’ in the corresponding block. If ‘No’, please explain. Resources not related to funding, staffing, and equipment needed for IMPLEMENTATION should be in the “Other Resources Needed” column.
Note: Information technology may be considered as part of the state PROGRAM’S resource needs.
Standard |
Funding |
Staffing |
Equipment |
Other resources needed |
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1 |
Regulatory Foundation |
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2 |
Training Program |
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3 |
Inspection Program |
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4 |
Audit Program |
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5 |
Animal Food-Related Illness or Death and Emergency Response |
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6 |
Compliance and Enforcement Program |
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7 |
Outreach Program |
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8 |
Program Planning and Resources |
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9 |
Assessment and Improvement |
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10 |
Laboratory Services |
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11 |
Sampling Program |
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|
|
Appendix 9.1: Self-Assessment Worksheet
Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it includes the associated program elements. If the state PROGRAM has the main program element and associated program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met in the Notes column. The Notes column may be used for additional notes.
State Agency
Implementation
Status
Fully
Met
Partially
Met
Not
Met
Program Elements |
Yes/No |
Notes |
9.3.1 Self-Assessment Worksheets |
||
Has the state PROGRAM conducted a baseline evaluation using the self-assessment worksheets from each standard to determine if a standard is fully met, partially met, or not met? |
|
|
9.3.2 Strategic Improvement Plan |
||
Has the state PROGRAM developed a strategic improvement plan to IMPLEMENT the program elements or documentation requirements of each standard? Does the strategic improvement plan include the following, as applicable? |
|
|
1. The program element or documentation requirement of the standard that was not met? |
|
|
2. Improvements or CORRECTIVE ACTIONS needed to IMPLEMENT the program element or documentation requirement of the standard? |
|
|
3. The cause for any DEVIATIONS requiring CORRECTIVE ACTIONS when the state PROGRAM was previously in IMPLEMENTATION with the program element or documentation requirement of a standard? |
|
|
4. The PREVENTIVE ACTION taken to prevent future similar DEVIATIONS when the state PROGRAM was previously in IMPLEMENTATION with the program element or documentation requirement of the standard that was corrected? |
|
|
Program Elements |
Yes/No |
Notes |
5. Projected completion date for each improvement or CORRECTIVE ACTION? |
|
|
6. Personnel responsible? |
|
|
7. Date completed? |
|
|
9.3.3 Strategic Improvement Plan Review |
||
Does the state PROGRAM review and update at least every 12 months the following? |
|
|
1. The self-assessment worksheets? |
|
|
2. The strategic improvement plan? |
|
|
9.3.4 Document Control Procedure |
||
3. Does the state PROGRAM have a procedure for DOCUMENT CONTROL that ensures all guidance and procedures required by the standards are CURRENT AND FIT-FOR-USE? |
|
|
4. Does the state PROGRAM maintain a master document list of all documents subject to this procedure to demonstrate they are CURRENT AND FIT-FOR-USE? |
|
|
9.3.5 Record Retention |
||
Does the state PROGRAM retain records required under x.5 of each standard for the three previous years, or per the state PROGRAM’S record retention policy? |
|
|
Assessment Completed By:
Name |
|
Date |
Appendix 10.1: Self-Assessment Worksheet
Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it includes the associated program elements. If the state PROGRAM has the main program element and associated program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met in the Notes column. The Notes column may be used for additional notes.
State Agency
Implementation
Status
Fully
Met
Partially
Met
Not
Met
Program Elements |
Yes/No |
Notes |
10.3.1 Laboratory Support |
||
1. Does the state PROGRAM maintain a list of analytical services the REGULATORY TESTING LABORATORIES provides for the state PROGRAM? |
|
|
2. Does the state PROGRAM have a documented formal agreement with the REGULATORY TESTING LABORATORY that conducts routine analytical services unless under the same administrative agency? |
|
|
10.3.2 Laboratory Sample Integrity Procedure |
||
Does the state PROGRAM have procedures developed by the REGULATORY TESTING LABORATORY to maintain the integrity of the samples sent to the REGULATORY TESTING LABORATORY for analytical testing that includes: |
|
|
1. Sample receipt? |
|
|
2. Preservation? |
|
|
3. Storage? |
|
|
4. Retention? |
|
|
5. Disposal? |
|
|
6. Chain of custody? |
|
|
7. Report of analysis? |
|
|
Program Elements |
Yes/No |
Notes |
8. Methods used to communicate information between the state PROGRAM and REGULATORY TESTING LABORATORY? |
|
|
10.3.3 Laboratory Quality Assurance Program |
||
Does the state PROGRAM utilize REGULATORY TESTING LABORATORIES that: |
|
|
1. Are accredited by a recognized accreditation body to ISO/IEC17025:2017 or current version? or |
|
|
2. Implement and comply with the AAFCO Quality Assurance/Quality Control guidelines? or |
|
|
3. Implement and comply with the ISO/IEC 17025:2017 or current version? |
|
|
Assessment Completed By:
Name |
|
Date |
Appendix 11.1: Self-Assessment Worksheet
Instructions: The state PROGRAM identifies if they have a specified program element then evaluates if it includes the associated program elements. If the state PROGRAM has the main program element and associated program elements check ‘Yes’, if not, check ’No’. If “No”, please explain why the program element is not met in the Notes column. The Notes column may be used for additional notes.
State Agency
Implementation
Status
Fully
Met
Partially
Met
Not
Met
-
Program Elements
Yes/No
Notes
11.3.1 Sampling Plan
Does the state PROGRAM have a documented sampling plan, at least every 12 months, for collecting surveillance, compliance, investigational, regulatory samples, or other samples?
1. Do the state PROGRAM and REGULATORY TESTING LABORATORY jointly develop and amend the sampling plan, at least every 12 months, for performing routine analytical services to allow for advanced planning and scheduling of work?
2. Does the sampling plan includes the:
2.1 Availability or coordination of analytical support?
2.2 Sampling priorities?
2.3 SAMPLE ANALYIS SCHEDULE
Does the SAMPLE ANALYIS SCHEDULE
includes the:
2.3.1 Types of ANIMAL FOOD to be analyzed?
2.3.2 Number of samples to be collected?
2.3.3 Estimated timeframe for collection?
2.3.4 Types of analysis to be performed?
-
Program Elements
Yes/No
Notes
11.3.2 Sampling Procedure
Does the state PROGRAM have procedures for collecting, storing, and transporting samples that includes:
1. Following safety precautions on ANIMAL FOOD
labels?
2. Following the state PROGRAM’S safety protocols for collecting samples?
3. Using appropriate method, sampling collection procedures, and equipment to collect the sample?
4. Sealing the sample to initiate chain of custody?
5. Maintaining and documenting sample integrity, security, and chain of custody?
6. Issuing receipt for the sample?
7. Handling, packaging, and shipping samples to prevent compromising the condition of sample?
8. Delivering or shipping samples to the appropriate
REGULATORY TESTING LABORATORY within
designated timeframes?
11.3.3 Sample Collection Report
Does the state PROGRAM have a procedure for completing the sample collection report that includes the:
1. Identification of sample collector?
2. Date of the sample collection?
3. Product identification?
Does the production identification include the:
-
Program Elements
Yes/No
Notes
3.1 Name?
3.2 Lot numbers or any other codes referencing manufacture identification?
4. Description of product?
5. Method of collection and any special techniques used to collect sample?
6. Lot sampled?
7. Lot size?
8. Location where sample was collected?
9. Name and address of responsible party, guarantor, possessor, or distributor?
10. Sample type (example: surveillance, compliance, investigational, regulatory, or other)?
11. Analysis requested, if applicable?
12. Collection or reproduction of product label, including customer-formula label?
13. Receiving and distribution information?
Assessment Completed By:
Name |
|
Date |
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Modified | 0000-00-00 |
| File Created | 0000-00-00 |
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