FDA Procedures for Standardization of Retail Food Safety Inspection Officers

FDA Procedures for

Standardization of Retail Food

Safety Inspection Officers

U.S. Public Health Service

Procedures Manual

Updated to the 2017 FDA Food Code and

The Supplement to the 2017 Food Code

U.S. Department of Health and Human Services

Public Health Service

Food and Drug Administration

College Park, MD 20740

Revised November 22, 2021

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Table of Contents

CHAPTER ....................................................................................................................................................................... 5

1 PURPOSE AND DEFINITIONS ................................................................................................................................... 5

1-1 INTRODUCTION................................................................................................................................................................. 5

1-101 Background............................................................................................................................................................. 5

1-102 Introduction. ........................................................................................................................................................... 6

1-103 Purpose. .................................................................................................................................................................. 6

1-104 S

COPE. ...................................................................................................................................................................... 7

1-2 DEFINITIONS ..................................................................................................................................................................... 8

1-201 A

PPLICABILITY AND TERMS DEFINED. ............................................................................................................................... 8

CHAPTER 2 QUALIFYINGFOR

STANDARDIZATION ..........................................................................................................11

2-1 PREREQUISITE TRAINING AND EXPERIENCE.................................................................................................................... 11

2-101 O

BJECTIVE. ............................................................................................................................................................... 11

2-102 E

LIGIBILITY. .............................................................................................................................................................. 11

CHAPTER 3 STANDARDIZATION: FIELD REQUIREMENTS AND ADMINISTRATION .................................13

3-101 OBJECTIVE. ............................................................................................................................................................... 13

3-102 P

ERFORMANCE AREAS. ............................................................................................................................................... 13

3-103 M

ETHODOLOGY......................................................................................................................................................... 14

3-201 E

QUIPMENT USE. ...................................................................................................................................................... 17

3-202 E

QUIPMENT LIST. ....................................................................................................................................................... 17

3-301 F

IELD EXERCISE.......................................................................................................................................................... 18

3-302 P

ERFORMANCE CRITERIA. ............................................................................................................................................ 21

3-303 A

SSESSMENT - LEVEL OF AGREEMENT WITH PERFORMANCE CRITERIA ................................................................................ 26

3-401 CERTIFICATE I

SSUANCE............................................................................................................................................ 28

3-402 STANDARDIZATION E

XPIRATION. ............................................................................................................................. 28

3-403 STANDARDIZATION M

AINTENANCE. ......................................................................................................................... 28

3-501 R

EQUIREMENTS. ........................................................................................................................................................ 29

3-502 E

XPIRED STANDARDIZATION. .................................................................................................................................. 30

3-601 T

ERMINATION OF FIELD EXERCISE.................................................................................................................................. 30

3-602 STANDARDIZATION S

USPENSION OR REVOCATION. ...................................................................................................... 31

3-603R

EQUESTS FOR RE-STANDARDIZATION AFTER TERMINATION, SUSPENSION, OR REVOCATION. .............................................. 31

3-701 A

PPEALS BOARD MEMBERS. ........................................................................................................................................ 32

3-702 F

ILING AN APPEAL. ..................................................................................................................................................... 32

3-703 A

PPEALS BOARD MEETING. ......................................................................................................................................... 32

3-704 H

EARINGS. ............................................................................................................................................................... 32

CHAPTER 4 COMMUNICATION SKILLS

............................................................................................................................35

4-1 APPLICATION .................................................................................................................................................................. 35

4-101 O

BJECTIVE. ............................................................................................................................................................... 35

4-102 I

NTRODUCTION. ......................................................................................................................................................... 35

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4-103 D

IALOGUE AND DISCUSSION WITH THE PERSON IN CHARGE................................................................................................ 36

4-104 E

XIT CONFERENCE...................................................................................................................................................... 36

ANNEX 1 FDA STANDARDIZATION NOMINATION FORM ................................................................................................39

ANNEX 2-1 FDA STANDARDIZATION INSPECTION REPORT .............................................................................................41

ANNEX 2-2 REPORT MARKING INSTRUCTIONS WITH FOOD CODE REFERENCES...............................................................51

ANNEX 3-1 RISK CONTROL PLAN ................................................................................................................................. 105

ANNEX 3-2 RISK CONTROL PLAN EXAMPLE .................................................................................................................107

ANNEX 4-1 HACCP PLAN VERIFICATION WORKSHEET...................................................................................................109

ANNEX 4-2 HACCP PLAN VERIFICATION SUMMARY .....................................................................................................113

SANNEX 5 SCORING FORM AND INSTRUCTIONS FOR SCORING AND DETERMINING PERFORMANCE ............................115

SCORING FORM AND INSTRUCTIONS FOR SCORING..................................................................................................... 116

AND DETERMINING PERFORMANCE............................................................................................................................. 116

SCORING FORM (EXAMPLE #1) ..................................................................................................................................... 117

SCORING FORM (EXAMPLE #2) ..................................................................................................................................... 117

FINAL SCORING REPORT................................................................................................................................................ 118

ANNEX 6-1 CHECKLIST FOR STANDARDIZATION PERFORMANCE AREAS .......................................................................119

TEMPLATE FOR CONDUCTING A RISK-BASED INSPECTION ........................................................................................... 122

RESOURCES AND ADDITIONAL INFORMATION:............................................................................................................129

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Chapter

1 Purpose and Definitions

Parts

1-1 INTRODUCTION

1-2 DEFINITIONS

1-1 INTRODUCTION

Subparts

1-101 Background

1-102 Introduction

1-103 Purpose

1-104 Scope

1-101 Background.

Under the authority of the Public Health Service Act as amended, the U.S.

Food and Drug Administration (FDA) has a responsibility to provide

assistance to state and local retail food protection programs [42 USC 243].

FDA provides assistance to federal agency retail food protection programs

under authority of the Economy Act [31 USC 1535]. Assistance provided

to federal, state, and local governmental bodies is also pursuant to FDA's

authorities and responsibilities under the Federal Food, Drug, and

Cosmetic Act [21 USC 301].

Historically, FDA has met this responsibility by offering a variety of

training opportunities and technical assistance based on model codes

addressing recommended sanitation and food safety criteria for retail food

and foodservice establishments. Providing the model FDA Food Code

and model code interpretations and opinions is the mechanism through

which FDA, as a lead federal food protection agency, promotes uniform

implementation of national food regulatory policy among federal, state,

tribal, and local agencies that have primary responsibility for retail food

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safety oversight or regulation. To ensure greater uniformity, FDA

recommends that regulatory jurisdictions adopt the model FDA Food

Code as law or regulation.

1-102 Introduction.

The main goal of a national food safety program is the reduction and

prevention of foodborne illness. To that end, FDA provides several

pathways, one of which is the STANDARDIZATION of retail food inspection

personnel. This process provides regulatory personnel with the

opportunity to subject their knowledge and skills related to the Code’s

provisions to a uniform system of measurement. The process and criteria

for demonstrating proficiency in the required performance areas are

described in the FDA Procedures for Standardization of Retail Food

Safety Inspection Officers.

The procedures are based on the FDA Food Code and are updated to

reflect current Food Code provisions and to include a more refined focus

on FOODBORNE ILLNESS RISK FACTORS, FOOD CODE INTERVENTIONS, and

application of the principles of Hazard Analysis and Critical Control Point

(HACCP).

It is critical that food safety personnel become standardized through this

process to ensure that retail foods are safe, unadulterated, and honestly

presented throughout the United States. A CERTIFICATE of

STANDARDIZATION as an FDA STANDARDIZED FOOD SAFETY INSPECTION

OFFICER

is issued to all CANDIDATES who successfully complete the

STANDARDIZATION process.

1-103 Purpose.

The purpose of the FDA STANDARDIZATION procedure is to promote

uniformity of regulatory retail food inspections among federal, state, local

and tribal agencies. In addition, it is used to reduce the risk of foodborne

illness based on a science-based interpretation of the Food Code and

effective principles to achieve compliance. The application of the

STANDARDIZATION procedure will ensure that the CANDIDATE recognizes

FOODBORNE ILLNESS RISK FACTORS, FOOD CODE

INTERVENTIONS

,

and GOOD

RETAIL PRACTICES

. The procedure will confirm that the CANDIDATE can

achieve practical and immediate correction of Out of Compliance (OOC)

FOODBORNE ILLNESS risk factors during the inspection, can

effectively communicate with the establishment’s staff, can understand

and apply HACCP principles and use necessary inspection equipment in a

risk-based, real-time regulatory inspection.

This procedure is not intended to provide basic training to individual

CANDIDATEs but rather is intended to confirm a high level of knowledge,

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understanding and application of food safety principles.

The CANDIDATE shall meet all the requirements of the procedure in order

to be standardized by FDA. Chapter 2 of the procedure describes the

qualifications required of the CANDIDATE; Chapter 3 describes the field

requirements; and Chapter 4 describes the communication requirements to

convey the purpose and findings of the inspection as well as achieve

corrective action and compliance. A template for a RISK-BASED

STANDARDIZATION INSPECTION

can be found in Annex 6.

The template (Annex 6-2) provides a list of recommended inspection

activities for both standardization CANDIDATES and regulatory inspectors.

Both types of inspection should contain aspects of evaluation/auditing and

education/training for short term and long term correction of violations.

The primary focus of either type of inspection should be on provisions of

the Food Code that directly eliminate, prevent or reduce to an acceptable

level, hazards associated with foodborne illness or injury or on provisions

that support or facilitate them. The Food Code designates these provisions

as Priority and Priority Foundation Items, respectively. Earlier versions of

the Food Code referred to critical and non-critical items.

CANDIDATES who are successful in achieving STANDARDIZATION by FDA

are expected to use the procedure to train or standardize other inspectors

within their regulatory agency in a manner that is consistent with routine

regulatory inspections.

1-104 Scope.

The procedures in this manual describe the process used by the FDA

STANDARD in standardizing qualified food safety inspection personnel in

retail food establishment inspection techniques based on the FDA Food

Code. Successful completion of the process results in STANDARDIZATION

as a FDA STANDARDIZED FOOD SAFETY INSPECTION OFFICER.

The STANDARDIZATION process encompasses both auditing the

performance of the CANDIDATE and training to improve the performance

of the CANDIDATE. The FDA STANDARD evaluates the APPLICANT’s

understanding and application of the Food Code provisions during

inspections of food establishments. In addition, the FDA STANDARD

evaluates the inspection technique used by the applicant, and he or she

imparts knowledge during the STANDARDIZATION exercise to assist

the CANDIDATE with becoming more proficient in the understanding

and application of the FOOD CODE AND RISK-BASED INSPECTION

technique. The STANDARD will discuss, explain and correct

interpretations and marking of the inspection report after each inspection.

The STANDARD may also take the opportunity through “teaching

moments” during the inspection to point out examples that illustrate new

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Code provisions, interpretations or industry changes.

The procedures used in the STANDARDIZATION process are intended as a

template for a regulatory inspection conducted by federal, state, local and

tribal governing bodies that directly regulate food establishments at the

retail level. The process of questioning to clarify procedures and methods

helps understanding of operations before and after the inspection and is

especially useful during foodborne outbreak investigations.

1-2 DEFINITIONS

Subpart

1-201 Applicability and Terms Defined

1-201 Applicability and Terms Defined.

(A) Terms defined in this document appear in SMALL CAPS and are

defined in (B) below. These definitions apply in the interpretation

and application of this procedure.

(B) Terms Defined:

(1) “APPLICANT” means an employee of FDA, state, or other

regulatory authority who applies for STANDARDIZATION or re-

STANDARDIZATION and is recommended to the FDA for

STANDARDIZATION or re-STANDARDIZATION by the person’s

supervisor.

(2) “CANDIDATE” means a regulatory officer whose duties

include the inspection of retail food and foodservice

establishments, may also include STANDARDIZATION of other

Food Safety Inspection Officers, and is:

(a) An APPLICANT who successfully completes the eligibility

requirements for initial STANDARDIZATION, or

(b) An FDA STANDARDIZED FOOD SAFETY INSPECTION

OFFICER

who is applying for re-STANDARDIZATION.

(3)

“

CERTIFICATE

”

means the official document issued by FDA

to a STANDARDIZED FOOD SAFETY INSPECTION

OFFICER

.

(4) “CRITICAL CONTROL POINT (CCP)” means a point or

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procedure in a specific food system where loss of control may

result in an unacceptable health risk.

(5) “CRITICAL LIMIT (CL)” means the maximum or minimum

value to which a physical, biological, or chemical parameter

must be controlled at a CRITICAL CONTROL POINT to minimize

the risk that the identified food safety hazard may occur.

(6) “FOODBORNE ILLNESS RISK FACTORS” means improper

practices or procedures which are most frequently identified

by epidemiologic investigation as a cause of foodborne illness

or injury at the retail level:

•

Improper holding temperatures;

•

Inadequate cooking;

•

Contaminated equipment;

•

Unsafe source; and

•

Poor personal hygiene.

(7) “GOOD RETAIL PRACTICES (GRP)” means the preventive

measures that include practices and procedures which

effectively control the introduction of pathogens, chemicals,

and physical objects into food. GOOD RETAIL PRACTICES are

prerequisites to instituting a HACCP plan or RISK CONTROL

PLAN

and are not addressed by the FOOD CODE INTERVENTIONS

or FOODBORNE ILLNESS RISK FACTORS.

(8) “INTERSTATE CERTIFIED SHELLFISH SHIPPERS LIST (ICSSL)”

means an FDA publication of shellfish dealers, domestic and

foreign, who have been certified by a state or foreign

authority as meeting the public health control measures

specified in the National Shellfish Sanitation Program

(NSSP).

(9) “FOOD CODE

INTERVENTIONS

”

means the preventive

measures identified in the FDA Food Code to protect

consumer health:

•

Management’s demonstration of knowledge;

•

Employee health controls;

•

Controlling hands as a vehicle of contamination;

•

Time/temperature parameters for controlling pathogens;

and

•

Consumer advisory.

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(10) “RISK-BASED INSPECTION” means a food establishment

inspection approach that utilizes the technical skills and

attributes identified in the five performance areas,

FOODBORNE ILLNESS RISK FACTORS and FOOD CODE

INTERVENTIONS

, Good Retail Practices, Application of

HACCP, Inspection Equipment, and Communication as

specified in Subpart 3-102 with particular emphasis on FOOD

CODE INTERVENTIONS and FOODBORNE ILLNESS

RISK FACTORS.

(11) “RISK CONTROL PLAN (RCP)” means a mutually agreed upon

written plan (between the CANDIDATE and the management of

the food establishment) that describes a management system

for control of FOODBORNE ILLNESS RISK FACTORS. The plan

delineates necessary records, responsible personnel, what

needs to be controlled, and how it will be controlled.

(12) “STANDARD” means a person employed by FDA who is

responsible for standardizing a CANDIDATE. This person shall

be standardized by the National STANDARD from FDA’s

Center for Food Safety and Applied Nutrition (CFSAN) or

their designee. The STANDARD represents the FDA position

on all issues during the STANDARDIZATION process.

(13) “STANDARDIZATION” means the process whereby a

CANDIDATE demonstrates the knowledge and skills to satisfy

requirements for a STANDARDIZED FOOD SAFETY INSPECTION

OFFICER

as stated in this procedure

(14) “STANDARDIZED FOOD SAFETY INSPECTION OFFICER” means a

person who has been standardized by FDA and has

successfully met all requirements for STANDARDIZATION.

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Chapter

2 Qualifying for

Standardization

Part

2-1 PREREQUISITE TRAINING AND EXPERIENCE

Subparts

2-101 Objective

2-102 Eligibility

2-101 Objective.

This chapter explains the prerequisite training and experience requirements

for CANDIDATES to qualify for FDA STANDARDIZATION. In order for FDA

to engage in the process of field inspections for the purpose of

STANDARDIZATION, the CANDIDATE must qualify by fulfilling the training

and experience requirements specified in this chapter. These eligibility

requirements only apply to first time APPLICANTS for FDA

STANDARDIZATION. Once standardized, CANDIDATES for re-

STANDARDIZATION only need to meet the STANDARDIZATION maintenance

requirements (see Section 3-403).

2-102 Eligibility.

(A) APPLICANTS for initial FDA STANDARDIZATION must:

(1) Be routinely engaged in retail food protection program work;

(2) Have job responsibility for conducting retail food safety

training and STANDARDIZATION of other regulatory

personnel;

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(3) Have successfully completed the “pre” and “post” curriculum

coursework for new hires cited in Trained Regulatory Staff

(Standard 2) in the Voluntary National Retail Food

Regulatory Program Standards

1

through ORA-U on-line

training

2

.

a) Evidence of completion of equivalent training and

experience for any of these courses may be verified by the

STANDARD.

b) CANDIDATES can demonstrate equivalency by showing

that the course objectives for each course meet 80% of the

ORA-U training objectives and evidence of successful

completion is provided; and

(4) Have fulfilled one or more of the following prerequisites:

a) At least one year of full-time experience in retail food

establishment inspections within the past three years; or

b) At least 100 retail food establishment inspections

performed within the past three years, such as regulatory,

training, or consultation inspections.

(5) Have successfully completed, for re-STANDARDIZATION,

within the preceding three years at least 20 contact hours of

training in the application of food science and related studies

such as microbiology, epidemiology, regulations, plan review

or Hazard Analysis and Critical Control Point (HACCP)

principles.

1

Voluntary National Retail Food Regulatory Program Standards, available at

http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandards/d

efault.htm

2

ORA-U On-Line Training, available at

http://www.fda.gov/Training/ForStateLocalTribalRegulators/default.htm

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Chapter

3 Standardization: Field

Requirements and

Administration

Parts

3-1 SCOPE

3-2 INSPECTION EQUIPMENT REQUIREMENTS

3-3 INSPECTIONS

3-4 FDA STANDARDIZATION

3-5 STANDARDIZATION RENEWAL

3-6 TERMINATION OF FIELD EXERCISE OR

STANDARDIZATION SUSPENSION OR REVOCATION

3-7 APPEALS

3-1 SCOPE

Subparts

3-101 Objective

3-102 Performance Areas

3-103 Methodology

3-101 Objective.

This chapter explains the field requirements leading to FDA

STANDARDIZATION.

3-102 Performance Areas.

The following areas of performance shall be addressed by the CANDIDATE

during the food establishment inspections and evaluated by the

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STANDARD

:

(A) FOODBORNE ILLNESS RISK FACTORS and FOOD CODE

INTERVENTIONS

:

The CANDIDATE shall demonstrate knowledge of current FDA

Food Code provisions related to FOOD CODE INTERVENTIONS and

FOODBORNE ILLNESS RISK FACTORS and the ability to interpret and

apply them.

(B) GOOD RETAIL PRACTICES:

The CANDIDATE shall demonstrate knowledge of current FDA

Food Code provisions related to GOOD RETAIL PRACTICES and the

ability to interpret and apply them.

(C) Application of HACCP Principles:

The CANDIDATE shall demonstrate the ability to verify compliance

with an existing HACCP plan and apply HACCP principles in the

development of flow charts and RISK CONTROL PLANS (RCPs). In

the absence of a HACCP Plan, the CANDIDATE shall demonstrate

the ability to apply all seven HACCP principles to the inspection

process.

(D) Inspection Equipment:

The CANDIDATE shall be equipped and familiar with inspection

equipment essential to each food establishment inspection. During

the inspection, the CANDIDATE shall demonstrate knowledge of

proper use of essential inspection equipment.

(E) Communication:

The CANDIDATE shall demonstrate the ability to effectively

communicate with the person in charge and food employees during

all phases of the inspection and explain significant inspection

findings to the person in charge at the conclusion of the inspection.

3-103 Methodology.

(A) Initial STANDARDIZATION:

The FDA STANDARD and the CANDIDATE shall conduct eight joint

field inspections of food establishments (including at least one

with a HACCP plan) selected by the STANDARD. The food

establishments selected for inspection during STANDARDIZATION

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should be in risk categories 2, 3, or 4 as described in Annex 5 of

the Food Code and shall include the observation of such processes

as cooking, cooling, hot/cold holding, reheating, and complex food

preparation. All eight inspections for initial

STANDARDIZATION should be completed within a reasonable period

of time, not to exceed 12 months.

(B) Re-STANDARDIZATION:

The FDA STANDARD and the CANDIDATE will conduct six joint

field inspections of food establishments (including at least one

with a HACCP Plan) selected by the STANDARD. The food

establishments selected for inspection during re-STANDARDIZATION

should be in risk category 2, 3, or 4 as described in Annex 5 of the

Food Code. All six inspections for re-STANDARDIZATION should

be completed within a reasonable period of time, not to exceed

three years.

(C) Options of the STANDARD:

The STANDARD has the option of adjusting the time period, type of

facility selected, and methodology for inspection at any time to

enhance the effectiveness of the STANDARDIZATION process.

(D) Performance Evaluation Methods:

The performance of the CANDIDATE shall be evaluated by the FDA

STANDARD using the methods outlined in Table 1.

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Table 1. Summary of Evaluation Methods for Each Performance Area.

PERFORMANCE

AREA

INITIAL STANDARDIZATION

1

RE-STANDARDIZATION

2

FOODBORNE ILLNESS RISK

FACTORS

and FOOD CODE

INTERVENTIONS

Joint Inspections Joint Inspections

GOOD RETAIL PRACTICES

Joint Inspections Joint Inspections

Application of HACCP

Principles

•

RISK CONTROL PLAN;

•

Process Flow Charts;

•

Verification of existing

HACCP Plan; and

•

Orally communicates the Seven

Principles of HACCP.

•

RISK CONTROL PLAN;

•

Process Flow Charts

(optional); and

•

Verification of existing

HACCP Plan.

Inspection Equipment

Field Observations Field Observations

Communication

Field Observations Field Observations

NOTE:

1.

All of the initial STANDARDIZATION requirements are to be completed during a total of 8 joint

inspections with the FDA

STANDARD, over a period not to exceed 12 months.

2.

The re-STANDARDIZATION requirements are to be completed during a total of 6 joint inspections with the

FDA

STANDARD over a period not to exceed 3 years.

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3-2 INSPECTION EQUIPMENT REQUIREMENTS

Subparts

3-201 Equipment Use

3-202 Equipment List

3-201 Equipment Use.

Specific inspection equipment is required to effectively and accurately

conduct an inspection and evaluate risk factors that contribute to

foodborne illness in retail food operations. The CANDIDATE shall be

evaluated on the proper use of the inspection equipment during all

inspections [refer to Subpart 3-302(C)]. Even though some equipment is

listed as optional, it may be essential for some food establishment

inspections, depending on the circumstances (FDA Food Code, Annex 5).

3-202 Equipment List.

(A) The following is a list of the essential equipment recommended to

evaluate a retail food or foodservice operation:

(1) Necessary inspection forms and administrative materials;

(2) Head cover: baseball cap, hair net, or equivalent;

(3) Thermocouple temperature measuring device;

(4) Maximum registering thermometer or temperature-sensitive

tape for verifying hot water warewashing final rinse

temperature;

(5) Chemical test kit for different chemical sanitizer types;

(6) Flashlight; and

(7) Alcohol swabs.

(B) The following is a list of optional equipment recommended to

evaluate a retail food or foodservice operation:

(1) Light meter;

(2) Pressure gauge;

(3) Measuring tape;

(4) Time-temperature data logger;

(5) pH meter;

(6) Water activity meter;

(7) Camera; and

(8) Lab coat or equivalent protection to cover street clothes.

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3-3 INSPECTIONS

Subparts

3-301 Field Exercise

3-302 Performance Criteria

3-303 Assessment – Level of Agreement with Performance

Criteria

3-301 Field Exercise.

(A) Roles:

(1) Role of the CANDIDATE.

During all joint field food establishment inspections, the

CANDIDATE shall take the lead. The CANDIDATE shall make

introductions and determine who the person in charge is at the

beginning of each inspection.

The CANDIDATE shall record all observations and inspection data

collected during the inspection. For the purpose of tracking

temperature patterns, it is recommended that the CANDIDATE

perform a preliminary survey of food temperatures early in each

inspection.

At various times during the field exercise the CANDIDATE shall be

directed to perform specific tasks, such as explaining code

requirements, citing FDA Food Code provisions, calibrating

inspection equipment, and preparing flow charts or reviewing

HACCP records to demonstrate proficiency in each area.

(2) Role of the STANDARD.

FDA STANDARDIZATION is not a joint training exercise. It is an

assessment with an auditing and training component. The role of

the STANDARD is to confirm the CANDIDATE’s ability to conduct a

routine inspection in realistic timeframes recognizing the

FOODBORNE ILLNESS RISK FACTORS that most frequently contribute

to foodborne illness, the FOOD CODE INTERVENTIONS that prevent

foodborne illness, and GOOD RETAIL PRACTICES. The STANDARD

will also confirm that the CANDIDATE can achieve immediate

correction of Out of Compliance (OOC) risk factors, practically

apply HACCP principles, demonstrate effective communication

skills and correctly use inspection equipment.

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The STANDARD’s role is primarily to observe the CANDIDATE

during the performance of a routine inspection and evaluate his/her

performance during the STANDARDIZATION exercise. The

STANDARD may offer procedural guidance to instruct the

CANDIDATE to focus on specific performance areas or demonstrate

specific technical skills during the course of the exercise. The

STANDARD will provide constructive corrective action in the

interest of STANDARDIZATION as appropriate throughout the

exercise.

The STANDARD will ensure that the CANDIDATE is briefed prior to

beginning the exercise on expectations before and during the

exercise. Areas that will be covered include the following:

•

The need for the CANDIDATE to contact the jurisdiction in

the work area for permission to conduct inspections, if

necessary

•

An understanding that the STANDARDIZATION exercise will

be based on the requirements in the current version of the

FDA Food Code and most recent version of the

Standardization Procedures

•

Calibrating thermocouples and thermometers before the

STANDARDIZATION exercise

•

Having all inspection equipment and clothing [lab coat

(optional), closed toed shoes, hat or hair net, etc.].

•

Selecting food establishments in risk category 2, 3, or 4 as

described in ANNEX 5 of the Food Code

•

Conducting RISK-BASED INSPECTIONs which emphasizes the

evaluation of FOODBORNE ILLNESS RISK FACTORS and FOOD

CODE INTERVENTIONS

but also demonstrates knowledge and

application of GRPs

•

Taking final cooking temperatures of all types of animal

food cooked in the establishment when possible

•

Achieving corrective action for Out of Compliance (OOC)

FOODBORNE ILLNESS RISK FACTORS before leaving the

facility

•

Developing a RISK CONTROL PLAN with

management/person-in-charge

•

Preparing three food preparation process flow diagrams

based on observed practices (one for each of the three food

preparation processes)

•

Explaining the seven HACCP principles.

•

Citing the Food Code requirements for any OOC

FOODBORNE ILLNESS RISK FACTORS or FOOD CODE

INTERVENTIONS

on the inspection report

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•

Using appropriate inspection equipment

•

Demonstrating effective communication skills

•

Conducting an inspection as closely as possible to a real-

time regulatory inspection by the end of the exercise

(B) Performance Areas:

The STANDARD will evaluate the CANDIDATE’s ability to conduct a

RISK-BASED INSPECTION and apply Food Code requirements and

principles in the following performance areas: (a more detailed

guide to the concepts considered under each performance area is

found in Annex 6 of this procedure).

(1) FOODBORNE ILLNESS RISK FACTORS and FOOD CODE

INTERVENTIONS

– utilize an approach that effectively

identifies high risk operations and behaviors in the food

establishment and focuses an inspection on determining the

compliance status of those related FOODBORNE ILLNESS RISK

FACTORS

and/or FOOD CODE INTERVENTIONS.;

(2) GOOD RETAIL PRACTICES – demonstrates knowledge of the

Food Code by recognizing and properly citing the provisions

of the Code not designated as FOODBORNE ILLNESS RISK

FACTORS

and FOOD CODE INTERVENTIONS;

(3) Application of HACCP (Hazard Analysis and Critical Control

Point) principles – demonstrates the ability to verify

compliance with an existing HACCP plan and apply HACCP

principles in the development of flow charts and RISK

CONTROL PLAN

s (RCPs). In the absence of a HACCP plan,

the CANDIDATE shall demonstrate the ability to apply all

seven HACCP principles to the inspection process;

(4) Inspection equipment – the CANDIDATE shall be equipped and

familiar with inspection equipment essential to each food

establishment inspection. During the inspection, the

CANDIDATE shall demonstrate knowledge of proper use of

essential inspection equipment; and

(5) Communication – the CANDIDATE shall demonstrate the

ability to effectively communicate with the person in charge

and food employees and explain significant inspection

findings to the person in charge at the conclusion of the

inspection.

(C) Determining Code Citations:

The STANDARD will make the final determination of the Food Code

citation for any observed violations.

Page | 20

(D) Comparison of Findings:

Following each inspection, the CANDIDATE and STANDARD will

compare findings to determine any disagreements for FOODBORNE

ILLNESS RISK FACTORS

, FOOD CODE INTERVENTIONS and GOOD

RETAIL PRACTICES

.

At the conclusion of the field exercise, the STANDARD shall

tabulate and review the CANDIDATE’S inspection results and other

observations to determine if the CANDIDATE has successfully

completed the requirements for STANDARDIZATION (See Table 2).

The checklist for STANDARDIZATION performance areas (Annex 6-

1) can be used as an aid in this determination.

(E) Termination of the Exercise/Inspection.

When the STANDARD terminates the STANDARDIZATION exercise

before completing the eight (initial) or six (re-STANDARDIZATION)

inspections because of the CANDIDATE’s inability to meet (or the

likelihood of not meeting) the performance criteria, the STANDARD

will work with the CANDIDATE and his/her supervisor to develop

an action plan to help the CANDIDATE meet the performance

criteria.

3-302 Performance Criteria.

To be standardized by FDA, a CANDIDATE shall meet the following

criteria for each performance area:

(A) FOODBORNE ILLNESS RISK FACTORS and FOOD CODE

INTERVENTIONS

and GOOD RETAIL PRACTICES:

(1) Inspection Report:

At the conclusion of each RISK-BASED INSPECTION, the

CANDIDATE shall complete the FDA STANDARDIZATION

Inspection Report (Annex 2, Section 1), based on

observations and data collected during the inspection. The

CANDIDATE shall determine which items on the inspection

report form were in or out of compliance, not observed,

and/or not applicable based on the observations.

(2) CANDIDATE Scoring:

The STANDARD shall grade each FDA STANDARDIZATION

Inspection Report (Annex 2, Section 1), by circling each

incorrectly marked item and discussing these items with the

CANDIDATE after each inspection. The STANDARD may mark

Page | 21

an item “S” to reflect a disagreement in a case where the

CANDIDATE has the opportunity to make an observation or

take a measurement and fails to do so, and intervention by

the STANDARD would alert the CANDIDATE of the missed

opportunity. A scoring of “S” should be used in instances

such as when there is an opportunity to take a cooking

temperature of a hamburger, but the CANDIDATE does not

take the temperature and subsequently marks 18 (B) as NO.

The STANDARD’s scoring of an item as “S” represents a

disagreement between the CANDIDATE and the STANDARD.

At the conclusion of each inspection, the STANDARD shall

determine the number of disagreements on items and record

that number in the chart provided in Annex 5. At the

completion of the final inspection, the STANDARD shall total

the number of disagreements for all food establishments

inspected.

(a) To satisfy the “FOODBORNE ILLNESS RISK FACTORS and

FOOD CODE INTERVENTIONS” performance area, the

CANDIDATE shall not disagree with the STANDARD on

more than 12 items in any one establishment in this

section of the STANDARDIZATION Inspection Report and

have an average score of at least 90%.

(b) To satisfy the “GOOD RETAIL PRACTICES” performance

area, the CANDIDATE shall not disagree with the

STANDARD on more than 5 items in any one

establishment in this section of the STANDARDIZATION

Inspection Report and have an average score of at least

85%.

(B) Application of HACCP Principles:

During the food establishment inspections, the CANDIDATE shall

demonstrate the proper inspection approach for food

establishments with pre-existing HACCP plans and those without

HACCP plans. Each Candidate shall demonstrate an understanding

of HACCP by:

(1) Flow Charts: (Required for initial STANDARDIZATIONS;

optional for re-STANDARDIZATIONS)

(a) Preparing Process Flow Charts:

During the joint inspections, the STANDARD shall select a

total of three food preparation processes for the

CANDIDATE to describe on a flow chart, to include:

(i) Process 1 – “No Cook Step”

Page | 22

(ii) Process 2 – “Same Day Service”

(iii) Process 3 – “Complex Food Preparation”

The CANDIDATE shall develop each flow chart using

information gained through actual observations of

operational steps during an inspection. Information

gained through discussions with the person in charge

and/or food employees should be used to substitute for a

lack of actual observations, i.e. when operational steps in

the process do not occur during the inspection. On each

flow chart, the CANDIDATE shall identify the hazards,

each CRITICAL CONTROL POINT, and the CRITICAL LIMITS.

The CANDIDATE shall indicate the CRITICAL LIMITS as

stated by the FDA Food Code and by the establishment

(if the establishment’s CRITICAL LIMITS differ from those

in the Food Code). In addition, the CANDIDATE shall

also indicate to the STANDARD any CRITICAL CONTROL

POINTS

that the establishment did not control.

(b) Requirements:

The STANDARD shall grade the three flow charts based on

the correct identification of hazards, CRITICAL CONTROL

POINTS

, and the CRITICAL LIMITS. To satisfy this

requirement, the three flow charts may contain no more

than two errors or omissions. The FDA Retail HACCP

Manual entitled, Managing Food Safety: A Regulator’s

Manual for Applying HACCP Principles to Risk-based

Retail and Food Service Inspections and Evaluating

Voluntary Food Safety Management Systems, and the

current edition of the FDA Food Code will be the

reference documents for this exercise.

(2) RISK CONTROL PLAN: (Required for both initial

STANDARDIZATION and re-STANDARDIZATION)

(a) Developing a RISK CONTROL PLAN:

During at least one of the joint inspections, the

STANDARD will select a CRITICAL CONTROL POINT that the

CANDIDATE has determined is not in compliance with

CRITICAL LIMITS set by the FDA Food Code. The Risk

Control Plan must adequately address the control of

identified critical limits and subsequent corrective actions

through a food safety management system consisting of

procedural and monitoring elements. The CANDIDATE

shall complete Annex 3-1, in order to demonstrate a clear

Page | 23

understanding of the observation, process used,

associated hazards, CRITICAL LIMITS, and corrective

actions that are being targeted for a RISK CONTROL PLAN.

The CANDIDATE shall guide the person

in charge in developing a RISK CONTROL PLAN. The RISK

CONTROL PLAN

should stress simple control measures

that can be integrated into the daily routine of the food

establishment. The plan should be brief and address the

following points:

(i) Specific observation(s) noted during inspection

(ii) Applicable code violation(s) (optional)

(iii) FOODBORNE ILLNESS RISK FACTOR to be controlled

(iv) Hazard (most common, significant);

(v) What must be achieved to gain compliance in the

future;

(vi) How active managerial control will be achieved (Who

is responsible for the control, what monitoring and

record keeping is required, who is responsible for

monitoring and completing records, what corrective

actions should be taken when deviations are noted,

and how long the plan is to continue); and

(vii) How the results of implementing the RISK CONTROL

PLAN

will be communicated back to the inspector.

(b) Requirements:

To satisfy the requirements, all seven points (i through

vii) shall be addressed in the RISK CONTROL PLAN. The

CANDIDATE is not required to ask the person in charge to

commit to implementation of the RISK CONTROL PLAN

(Annex 3, Section 1).

(3) HACCP Plans: (Required for both initial

STANDARDIZATION and re-STANDARDIZATION)

(a) Verification of HACCP Plans:

During the joint inspections, the CANDIDATE shall select

at least one food establishment to inspect that has

implemented a HACCP Plan. The CANDIDATE shall

demonstrate the ability to verify that the HACCP Plan is

properly implemented by reviewing the food

establishment’s monitoring procedures and record

keeping, verifying that the CRITICAL LIMITS are met, and

substantiating that corrective actions are taken when the

CRITICAL LIMITS are not met. The STANDARD shall select

at least one CRITICAL CONTROL POINT for the CANDIDATE

to verify.

Page | 24

The CANDIDATE shall review the records for the selected

CRITICAL CONTROL POINT(S) for three specific 24 hour

periods, which shall include records for the current day, if

possible, and two additional days selected at random. Based on

this review, the CANDIDATE shall make the following

determinations regarding monitoring, record keeping, and the

performance of corrective action for a total of nine HACCP

Plan record answers (Annex 4, Chart 2):

(i) Required monitoring was performed on the three

selected dates;

(ii) Accurate and consistent records appear for the three

selected dates; and

(iii) Corrective action was documented in accordance with

the plan when CRITICAL LIMITS were not met on each of

the three selected dates (CANDIDATE shall select the

three days of records through discussions with the

establishment’s management. One of the days selected

must be the current day).

(b) HACCP Principles (For initial STANDARDIZATION

only):

The CANDIDATE shall orally communicate to the STANDARD

the HACCP principles and how they would apply to the food

establishment’s operation.

(c) Requirement:

The CANDIDATE shall document the findings on the HACCP

Plan Verification Summary Chart (Annex 4, Section 2, Chart

2). To satisfy this requirement, the CANDIDATE and the

STANDARD shall be in agreement with at least eight out of the

nine answers on the HACCP Plan Verification Summary

Chart.

(C) Inspection Equipment:

The CANDIDATE shall have essential equipment (listed in 3-202)

available for use during each inspection and shall demonstrate

knowledge of necessary equipment to conduct food establishment

inspections. The CANDIDATE shall know how to properly use and

maintain the equipment. Specifically, the CANDIDATE shall demonstrate

that the temperature measuring device is accurate at 0ºC (32ºF) and

100ºC (212ºF).

Page | 25

(D) Communication:

In accordance with Chapter 4 of this procedure, the CANDIDATE shall take

the lead in communicating with industry personnel during each of the

inspections in three areas:

1) Introduction;

2) Open Dialogue and Discussion with the Person in Charge; and

3) Exit Conference.

During the inspections, the CANDIDATE shall demonstrate by example

the concepts of food safety such as seeking immediate, appropriate

correction of risk factors, eliciting responses about employee health,

washing hands at the appropriate place and time, and wearing the proper

inspection apparel. The STANDARD shall observe and evaluate the

CANDIDATE by focusing attention on communication skills that relay to

the person in charge, the compliance status and any observations,

concerns, and alternatives for compliance. Satisfactory performance is

achieved if this information is conveyed in a way that is understood,

accepted, and acted upon. The STANDARD can assess this using the

checklist in ANNEX 6-1 and the Template in ANNEX 6-2.

3-303 Assessment - Level of Agreement with Performance

Criteria.

(A) Chart 3 in Annex 5 of this procedure can be used to tally the number of

disagreements on the items between the STANDARD and the CANDIDATE in

the “FOODBORNE ILLNESS RISK FACTORS and FOOD CODE

INTERVENTIONS

”

and “GOOD RETAIL PRACTICES” sections of the STANDARDIZATION

Inspection Report.

(B) Criteria for Success:

(1) To achieve

STANDARDIZATION

,

the CANDIDATE shall meet minimum

requirements for the three (3) Performance Areas described in 3-302

(A) and (B). The CANDIDATE may receive a “Needs Improvement”

classification in the “Equipment” and “Communication”

Performance Areas and still be standardized.

(2) When one or both of these Performance Areas is classified as “Needs

Improvement,” the CANDIDATE and the CANDIDATE’S supervisor shall

be notified that the “Needs Improvement” area must be satisfactorily

addressed before re-STANDARDIZATION is granted. Prior to re-

STANDARDIZATION, the CANDIDATE’S supervisor must notify the

STANDARD that the area(s) of

concern have been addressed.

Page | 26

Table 2. SUMMARY OF LEVEL OF AGREEMENT REQUIRED

FOR EACH PERFORMANCE AREA.

PERFORMANCE

AREA

LEVEL OF AGREEMENT

FOODBORNE ILLNESS RISK

FACTORS

and FOOD CODE

INTERVENTIONS

•

No more than 12 disagreements in any one food establishment

and an average score of 90% for all inspections in the

STANDARDIZATION. (Minimum of 80= No more than 12

disagreements out of a total of 62 items)

GOOD RETAIL PRACTICES

•

No more than five disagreements in any one food

establishment and an average score of 85% for all inspections

in the STANDARDIZATION. (Minimum of 80 = No more than

five disagreements out of a total of 27 items)

Application of HACCP

Principles

•

3 Process Flow Charts: (optional for re-STANDARDIZATION)

Maximum of two errors or omissions [3-302(B)(1)]

•

1 RISK CONTROL PLAN: four parts accurately addressed [3-

302(B)(2)]

•

1 HACCP Plan Verification: Correctly review documentation

records on three different dates for a food establishment with

a HACCP Plan [3-302(B)(3)] with agreement on at least

eight out of the nine answers on Chart 2 (Annex 4, Section 2)

Knowledge of HACCP principles: Accurately lists the seven

principles and explains how each applies to a food

establishment (initial STANDARDIZATION only)

Inspection Equipment**

•

CANDIDATE has equipment from the essential equipment list

•

CANDIDATE demonstrates knowledge and use of essential

equipment

(Rate as Satisfactory or Needs Improvement)

Communication**

Observations of:

•

Introductions to person in charge (4-102)

•

Fact finding questions through interview with person in charge

(4-103)

•

CANDIDATE setting an example [4-102(B)]

•

Exit conference with person in charge (4-104)

(Rate as Satisfactory or Needs Improvement)

** Performance Areas deemed in need of improvement shall be satisfactorily addressed before re-

STANDARDIZATION

.

Page | 27

3-4 FDA STANDARDIZATION

Subparts

3-401

CERTIFICATE Issuance

3-402

STANDARDIZATION Expiration

3-403

STANDARDIZATION Maintenance

3-401 CERTIFICATE Issuance.

Upon achieving the required level of agreement with the STANDARD, the

CANDIDATE is awarded the CERTIFICATE of an FDA STANDARDIZED FOOD

SAFETY INSPECTION OFFICER

. A CERTIFICATE recognizing the

accomplishment is forwarded to the CANDIDATE and notification is sent to

the CANDIDATE’S supervisor within 60 days.

3-402 STANDARDIZATION Expiration.

STANDARDIZATION is valid for a period of three years. The date that

STANDARDIZATION is issued and the date that it expires appear on the

CERTIFICATE issued by the STANDARD.

3-403 STANDARDIZATION Maintenance.

(A) Official records of all STANDARDIZATIONS in retail food inspection

shall be maintained by the STANDARD for at least three years.

(B) STANDARDIZATION shall be maintained in good standing for the

three-year period when the STANDARDIZED FOOD SAFETY

INSPECTION OFFICER

:

(1) Each year, attends the annual FDA Retail Food Protection

Seminar;

(2) Continuing Education and Training – Each CANDIDATE that is

standardized will accumulate 20 contact hours of food safety-

related continuing education every 36 months after initial

STANDARDIZATION is completed. The CANDIDATE qualifies for

one contact hour for each hour’s participation in any of the

following food safety-related activities:

(a) Professional symposiums/college courses,

(b) Workshops, and

Page | 28

(c) Training;

(3) Annually conducts and documents STANDARDIZATION

exercises, in accordance with this document, with at least five

retail food program inspection personnel; and

(4) Annually accomplishes and documents at least one of the

following activities:

(a) Assists at least five retail food establishments in the

development of RISK CONTROL PLANS (RCP). The

STANDARDIZED FOOD SAFETY INSPECTION OFFICER shall

submit a report describing the outcome of the RCP to the

STANDARD, or

(b) Conducts or coordinates and documents to the

STANDARD at least five training courses related to the

retail food protection program, or

(c) Performs and documents to the STANDARD any

combination of training courses or RISK CONTROL PLANS

that equals five.

(C) Upon written request by the STANDARDIZED FOOD SAFETY

INSPECTION OFFICER

, the requirements listed in Paragraph 3-403(B)

may be adjusted by the STANDARD due to special situations or

circumstances.

3-5 STANDARDIZATION RENEWAL

Subparts

3-501 Requirements

3-502 Expired

STANDARDIZATION

3-501 Requirements.

In order to renew a person’s STANDARDIZATION, the STANDARD and the

STANDARDIZED FOOD SAFETY INSPECTION OFFICER shall conduct six

STANDARDIZATION inspections as described in: Table 1, Part 3-3, Chapter

4, and has complied with the STANDARDIZATION maintenance criteria listed

in Part 3-4.

Page | 29

3-502 Expired STANDARDIZATION.

If a person’s STANDARDIZATION expires and is not renewed and the person

subsequently reapplies for STANDARDIZATION, the person shall apply in

writing to the STANDARD for re-STANDARDIZATION giving the reasons why

the person is qualified and should be re-STANDARDIZED. The person shall

submit a nomination form signed by the person’s program supervisor. The

STANDARD shall respond in writing to the program supervisor advising

whether or not FDA will proceed with re-STANDARDIZATION and the

conditions under which STANDARDIZATION renewal may be accomplished.

3-6 TERMINATION OF THE FIELD EXERCISE OR

STANDARDIZATION SUSPENSION OR REVOCATION

Subparts

3-601 Termination of Field Exercise

3-602

STANDARDIZATION Suspension or Revocation

3-603 Request for Re-

STANDARDIZATION After

Termination, Suspension, or Revocation

3-601 Termination of Field Exercise.

(A) The STANDARD has the option to terminate the field exercise at any

time during the STANDARDIZATION procedure if the CANDIDATE is

not properly prepared to achieve the required level of agreement.

(B) The STANDARD shall notify the CANDIDATE and the CANDIDATE’S

supervisor in writing with the reasons for termination of the field

exercise. The STANDARD may offer the CANDIDATE and his/her

supervisor the opportunity to develop a follow-up action plan

designed to prepare the CANDIDATE for a successful

STANDARDIZATION exercise. The CANDIDATE and his/her

supervisor may choose to pursue this avenue or not. If the

CANDIDATE declines the option described in paragraph (B) above

or fails the completed field exercise, the STANDARD shall document

the results of the field exercise, with the reasons for termination of

the field exercise. This information shall be forwarded to the

CANDIDATE’s supervisor and a copy shall be placed in the FDA

file. All evidence and conclusions reached by the Agency shall be

documented in writing by the STANDARD and shall be kept for 3

years in accordance with the Freedom of Information Act.

Page | 30

3-602 STANDARDIZATION Suspension or Revocation.

(A) When a STANDARDIZED FOOD SAFETY INSPECTION OFFICER fails to

fulfill the required maintenance activities described in Part 3-4, and

a waiver has not been requested or approved for the activities, the

STANDARD shall consult with the STANDARDIZED FOOD SAFETY

INSPECTION OFFICER

and regulatory program management to fully

examine the reasons for the failure. If it is determined that a waiver

cannot be approved subsequent to the consultation, or regulatory

program management does not agree to voluntarily remove the

STANDARDIZED FOOD SAFETY INSPECTION OFFICER from the

program and listing, the Standard may pursue revocation of the

STANDARDIZATION.

(B) Before suspension or revocation, the STANDARD may consult with

other appropriate personnel in the STANDARDIZED FOOD SAFETY

INSPECTION OFFICER

’S agency and within FDA including: the

Center for Food Safety and Applied Nutrition (CFSAN), Retail

Food Policy Team (RFPT); and the Office of State Cooperative

Programs (OSCP) Retail Management.

(C) The STANDARD, and the OSCP Retail Management shall reach a

decision as to whether:

(1) No action should be taken;

(2) A warning letter should be sent to the STANDARDIZED FOOD

SAFETY INSPECTION OFFICER

and the person’s supervisor or

agency;

(3) The STANDARDIZATION should be suspended temporarily, with

notice regarding conditions required for reinstatement; or

(4) The STANDARDIZATION should be revoked.

(D) The STANDARD shall notify the STANDARDIZED FOOD SAFETY

INSPECTION OFFICER

and the supervisor of the STANDARDIZED FOOD

SAFETY INSPECTION OFFICER

, in writing, of the Agency’s decision.

(E) All evidence and conclusions reached by the Agency shall be

documented in writing by the STANDARD and shall be kept for 3

years in accordance with the Freedom of Information Act.

3-603 Requests for Re-STANDARDIZATION after Termination,

Suspension, or Revocation.

CANDIDATES may apply for another opportunity to become standardized

when an unsuccessful field exercise is terminated by the STANDARD or a

STANDARDIZATION suspension or revocation occurs. Before reapplying,

CANDIDATES should improve their skills and areas of weakness.

Page | 31

3-7 APPEALS

Subparts

3-701 Appeals Board Members

3-702 Filing an Appeal

3-703 Appeals Board Meeting

3-704 Hearings

3-701 Appeals Board Members.

Representatives from the following organizations will comprise the

STANDANDIZATION Appeals Board (Appeals Board):

(A) A Retail Food Specialist (other than the involved

STANDARD);

(B) A CFSAN Retail Food Policy Team representative; and

(C) An Office of Partnerships representative.

3-702 Filing an Appeal.

The CANDIDATE, after being notified of the CANDIDATE’S failure to

successfully achieve STANDARDIZATION or re-STANDARDIZATION, may

appeal the decision. Should the CANDIDATE elect to submit an appeal,

this action must be initiated within thirty days of the date of the written

notification of the termination, suspension, or revocation.

3-703 Appeals Board Meeting.

Upon receipt of a CANDIDATE’S appeal by the FDA, a meeting of the

Appeals Board will be held to determine if the argument regarding the

failed STANDARDIZATION process is worthy of being heard.

3-704 Hearings.

(A) Preliminary Hearing:

If the appeal is not convincing, the decision of the FDA STANDARD

to terminate the field exercise will stand. If the Appeals Board

determines that the CANDIDATE’S argument holds merit, the

CANDIDATE and the FDA STANDARD shall be notified in writing

that a hearing will be held, including a date and time for the

hearing.

Page | 32

(B) Hearing Procedure:

At the hearing, the following procedure will be followed:

(1) The CANDIDATE will present the CANDIDATE’S argument for

reversing the STANDARD’S decision;

(2) The Appeals Board will have the opportunity to question the

action or conduct of the CANDIDATE and the STANDARD; and

(3) The Appeals Board will make a decision regarding the FDA

STANDARD’S decision. The Appeals Board decision will be

either to let the decision stand or to consider conducting an

additional standardization exercise.

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Chapter

4 Communication Skills

Part

4-1 APPLICATION

Subparts

4-101 Objective

4-102 Introduction

4-103 Dialogue and Discussion with the Person in Charge

4-104 Exit Conference

4-101 Objective.

Skillful communication is essential to the inspection process in order to

effectuate needed changes by the person in charge. This chapter

highlights the importance of communication skills during an inspection.

Activities and responsibilities involved in a retail food inspection program

require a person to speak and to listen effectively.

Many different types of communication skills and approaches are

necessary and valuable during the inspection process. The CANDIDATE

shall be required to take the lead in communicating with industry

personnel during all inspections and the STANDARD shall evaluate the

CANDIDATE’S communication skills.

4-102 Introduction.

(A) The CANDIDATE shall be required to make all introductions. A

complete introduction consists of:

(1) Introducing all persons participating in the inspection;

(2) Presenting credentials or identification;

Page | 35

(3) Describing the purpose and flow of the inspection;

(4) Identifying and explaining to the person in charge that it will

be necessary to ask questions about the operation during the

inspection; and

(5) Explaining that this is not intended as a regulatory inspection

and that there will be no written report left at the end of the

inspection; however, significant findings will be brought to

the attention of the person in charge. Where required by the

jurisdiction, a regulatory inspection can also be made and a

report left with the person in charge.

(B) In addition to verbal and written communication, the CANDIDATE

shall also use the inspection process to communicate and

demonstrate food safety concepts by example. Activities such as

immediate correction of risk factors, focusing inspection activities

on FOODBORNE ILLNESS risk factors and FOOD CODE interventions,

proper handwashing, sanitizing thermometers before probing

foods, and wearing the proper inspection apparel should be used to

reinforce spoken and written communications.

4-103 Dialogue and Discussion with the Person in Charge.

The CANDIDATE shall have a discussion with the person in charge to

determine:

(A) If a HACCP plan exists, and if so, whether the person in charge

understands the principles of the HACCP plan and is ensuring that

the employees are effectively using the plan;

(B) What training is provided for employees and managers that is

relevant to applying the FOOD CODE INTERVENTIONS and controlling

FOODBORNE ILLNESS RISK FACTORS;

(C) Specific responses to key employee health related activities; and

(D) What Potentially Hazardous Foods/Time-Temperature Control for

Safety Foods are on the menu and what production activities are

ongoing at the time of inspection.

4-104 Exit Conference.

At the exit conference, the CANDIDATE shall clearly:

Page | 36

(A) Convey and discuss in detail with the person in charge the

inspection findings including:

(1) The compliance status of the food establishment describing

each significant violative condition and, where appropriate,

acceptable compliance alternatives,

(2) The response and plans of the person in charge for correcting

violations, including a RISK CONTROL PLAN, and

(3) Corrective actions observed during the inspection. Such

proactive food safety measures should be commended;

however, the CANDIDATE should use this as an opportunity to

explain what might have happened if an inspection had not

occurred and the corrective action had not been identified.

(B) Explain the public health significance of the FOODBORNE ILLNESS

RISK FACTORS

and FOOD CODE

INTERVENTIONS

,

GOOD RETAIL

PRACTICES

, and the CRITICAL CONTROL POINTS which do not meet

the CRITICAL LIMITS as established in the FDA Food Code; and

(C) Demonstrate the ability to discuss and resolve issues that the

person in charge might not agree with or clearly understand in a

courteous and professional manner.

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Page | 38

ANNEX

1

TO:

FROM:

FDA STANDARDIZATION NOMINATION FORM

FDA RETAIL FOOD BRANCH DIRECTOR

SUBJECT: REQUEST FOR FDA STANDARDIZATION

DATE:

APPLICANT INFORMATION

Candidate’s

Name:

Title:

Office Telephone Number:

Home Telephone Number:

Office Fax Number:

Office Email Address:

Agency:

Office Address:

City:

State:

Zip:

Home Address:

City:

State:

Zip:

BACKGROUND INFORMATION

Length of Service With Agency:

Present Duties / Date Assigned:

Page | 39

FDA STANDARDIZATION NOMINATION FORM

Prior Retail Food Safety Experience:

Dates:

Formal Education/ Training Background:

Continuing Education:

(List hours of education with course titles/dates, within the last 2 years) Note: 20

contact hours minimum to qualify for nomination.

Other Prerequisites Completed:

SUPERVISOR’S SIGNATURE (Confirming request for nomination):

NAME (Print):

NAME (Signature):_ Date:

TITLE:

Page | 40

ANNEX

2-1

FDA STANDARDIZATION INSPECTION REPORT

Establishment Name:

Type of Facility:

Physical Address:

Person in Charge:

City:

State:

Zip:

County:

Inspection Time In:

Inspection Time

Out:

Date:

Candidate’s Name:

Agency:

Standard’s Name:

Person Completing Form:

(circle one)

Candidate OR Standard

Foodborne Illness Risk Factors Food Code Interventions

Food from Unsafe Sources Demonstration of Knowledge

Improper Holding Temperatures Hands as a Vehicle of Contamination

Poor Personal Hygiene Employee Health

Inadequate Cooking Temperatures Time/Temperature Relationships

Contaminated Equipment/ Cross- Consumer Advisory

Contamination

For each item, indicate one of the following for OBSERVATIONAL STATUS:

IN – Item found in compliance NO – Not observed

OUT – Item found out of compliance NA – Not applicable

The Standard may mark an item “S” to reflect a disagreement in a case where the Candidate has the

opportunity to make an observation or take a measurement and fails to do so, and intervention by the

Standard would alert the Candidate to the missed opportunity.

ABBREVIATIONS

“CCP” means Critical Control Point

“CL” means Critical Limit

“GRP” means Good Retail Practice

“HACCP” means Hazard Analysis and Critical Control Point

“HSP” means Highly Susceptible Population

“ICSSL” means Interstate Certified Shellfish Shippers List “TCS Food” means

Time/Temperature Control for Safety Food “RTE” means Ready-to-Eat

Page | 41

FOODBORNE ILLNESS RISK FACTORS AND FOOD CODE INTERVENTIONS

Supervision

STATUS

1. Person in charge present, demonstrates knowledge, and performs

duties

IN OUT A. Assignment – PIC

IN OUT B. Demonstration

IN OUT C. Duties of PIC

IN OUT 2. Certified Food Protection Manager – Establishment has a Certified

NA Food Protection Manager

Employee Health

IN OUT

3.

Management, food employee and conditional employee; Knowledge,

responsibilities and reporting

IN OUT 4. Proper use of restriction and exclusion and reporting

IN OUT 5. Clean-up of Vomiting and Diarrheal Events

Good Hygienic Practices

IN OUT 6. Proper eating, tasting, drinking, or tobacco use

NO

IN OUT 7. No discharge from eyes, nose, and mouth

NO

Preventing Contamination by Hands

IN OUT 8. Hands clean & properly washed

NO

IN OUT

9.

No bare hand contact with RTE foods or a pre-approved alternative

NA NO

procedure properly followed

10. Adequate handwashing sinks properly supplied and accessible

IN OUT

A. Adequate handwashing sinks conveniently located and accessible for

employees

Page | 42

IN OUT B. Handwashing sinks supplied with hand cleanser/sanitary towels/hand

drying devices/signage

Approved Source

11. Food obtained from approved source

IN OUT

A.

All food from regulated food processing plants/no home prepared or

canned foods/standards for eggs, milk, juice

IN OUT

B. All fish commercially caught/raised or approved by the Regulatory

NA NO

Authority/all Molluscan shellfish from ICSSL listed sources/no

recreationally caught shellfish received or sold.

IN OUT

C.

Game animals and wild mushrooms approved by regulatory authority

NA NO

IN OUT

12.

Food received at proper temperature

NA NO

IN OUT 13. Food in good condition, safe, and unadulterated

14. Required records available: shellstock tags, parasite destruction

IN OUT

A. Written documentation of parasite destruction maintained for 90 days f

or

NA NO

fish products that are intended for raw or undercooked consumption

IN OUT

B.

Shellstock tags maintained for 90 days in chronological order

NA NO

Protection from Contamination

15. Food separated and protected

IN OUT

A.

Separating raw animal foods from raw RTE food and separating raw

NA NO

animal food from cooked RTE food

IN OUT

B. Raw animal foods separated from each other during storage, prepara

tion,

NA NO

holding, and display

IN OUT

C. Food protected from environmental contamination

IN OUT 16. Food-contact surfaces: cleaned and sanitized

NA

Page | 43

17.

Proper disposition of returned, previously served, reconditioned, and

unsafe food

IN OUT

A. After being served or sold to a consumer, food is not reserved

IN OUT

B. Discarding or reconditioning unsafe, adulterated, or contaminated food

Time/Temperature Control for Safety (TCS Food)

18. Proper cooking time & temperatures

IN OUT

A.

Raw eggs broken on request and prepared for immediate service cooked to

NA NO

63°C (145°F) for 15 seconds

IN OUT

B. Comminuted fish, meat, game animals commercially raised for food and

NA NO

raw eggs not prepared for immediate service and comminuted meat on a

child’s menu cooked to 68°C (155°F) for 17 seconds or the

time/temperature relationship specified in the chart in the Food Code.

IN OUT

C. Whole meat roast, including beef, corned beef, lamb, pork, cured pork

NA NO

roasts and formed roasts, cooked to 54°C (130°F) for 112 minutes or as

chart specifies and according to oven parameters per chart

IN OUT

D. Ratites and injected meats or mechanically tenderized meats cooked to

NA NO

68°C (155°F) for 17 seconds or the time/temperature relationship

specified in the chart in the Food Code.

IN OUT

E. Poultry; baluts; stuffed fish/meat/poultry/ratites/pasta or stuffing

NA NO

containing fish, meat, poultry, or ratites; cooked to 74°C (165°F) for <

1 second (instantaneous)

IN OUT

F.

Wild game animals cooked to 74°C (165°F) for <1 second

NA NO

IN OUT

G. Whole-muscle, intact beef steaks cooked to surface temperature of 3°C

NA NO

(145°F) on top and bottom and a cooked color changes is achieved on all

external surfaces.

IN OUT

H. Raw animal foods rotated, stirred, covered, and heated to 74°C (165°F)

in

NA NO

microwave. Food stands for 2 minutes after cooking.

IN OUT

I.

All other raw animal foods cooked to 63°C (145°F) for 15 seconds

NA NO

IN OUT

J. Raw animal foods cooked, using a non-continuous-cooking process,

NA NO

cooked to the time/temperature requirements specified for the particular

raw animal food.

Page | 44

19. Proper reheating procedures for hot holding

IN OUT

NA NO

IN OUT

NA NO

IN OUT

NA NO

IN OUT

NA NO

IN OUT

NA NO

IN OUT

NA NO

IN OUT

NA NO

IN OUT

NA NO

IN OUT

NA NO

IN OUT

NA NO

IN OUT

NA

IN OUT

NA NO

A. TCS Food that is cooked and cooled on premises is rapidly reheated

within 2 hours to 74°C (165°F) or above for 15 seconds for hot holding

B. Food reheated to 74°C (165°F) or above in microwave for hot holding

C. Commercially processed, RTE food reheated to 57°C (135°F) or above for

hot holding

D. Remaining unsliced portions of roasts reheated for hot holding using

minimum over parameters

20. Proper cooling time & temperatures

A. Cooked TCS Food cooled from 57°C (135°F) to 21°C (70°F) within 2

hours and from 57°C (135°F) to 5°C (41°F) or below within a total of

6 hours

B. TCS Food prepared from ambient temperature and/or pre-chilled

ingredients) cooled to 5°C (41°F) or below in 4 hours

C. Foods (milk/molluscan shellfish) received at a temperature according to

law cooled to 5°C (41°F) or below in 4 hours

D. Immediately upon receiving, raw eggs placed under refrigeration that

maintains ambient air temperature of 7°C (45°F)

21. Proper hot holding temperatures

A. TCS Food maintained at 57°C (135°F) or above, except during

preparation, cooking, or cooling, or when time is used as a public health

control

B. Whole meat roasts held at a temperature of 54°C (130°F) or above

22. Proper cold holding temperatures

A. TCS Food maintained at 5°C (41°F) or below, except during preparation,

cooking, cooling, or when time is used as a public health control

B. Untreated raw eggs stored in 7°C (45°F) ambient air temperature

Page | 45

23. Proper date marking & disposition

IN OUT

A.

Date marking for RTE, TCS Food prepared on-site or opened commercial

NA NO

container held for more than 24 hours

IN OUT

B. Discarding RTE, TCS Food prepared on-site or opened commercial

NA NO

container held at ≤5°C (41°F) for ≤ 7 days

IN OUT

24.

Time as a public health control: procedures & records

NA NO

Consumer Advisory

IN OUT 25. Consumer advisory provided for raw or undercooked animal foods

NA

Highly Susceptible Populations

26. Pasteurized foods used; prohibited foods not offered

IN OUT

A.

Prepackaged juice/beverage containing juice with a warning label [21

NA

CFR, Section 101.17 (g)] not served

IN OUT

B. Using pasteurized eggs in recipes if eggs are to be undercooked; or are

NA

combined unless: cooked to order & immediately served; used

immediately before baking and thoroughly cooked; or prepared under a

HACCP plan controlling Salmonella Enteritidis

IN OUT

C.

Raw or partially cooked animal food and raw seed sprouts not served

NA

IN OUT

D.

Foods not re-served under certain conditions

NA

Chemical

IN OUT 27. Food additives: approved and properly used

NA

28. Toxic substances properly identified, stored, and used

IN OUT

A. Poisonous or toxic materials, chemicals, lubricants, pesticides, medicines,

first aid supplies, and other personal care items properly identified, stored,

and used

IN OUT

B.

Poisonous or toxic materials held for retail sale properly stored

NA

Page | 46

Conformance with Approved Procedures

29. Compliance with variance, specialized process, ROP Criteria or

HACCP plan

IN OUT

A. Reduced Oxygen Packaging (ROP) as specified in 3-502.12 permitted

NA

without a variance under certain specified conditions in accordance

with a

required HACCP plan or without a required HACCP Plan

IN OUT

B. Operating in accordance with approved variance and/or HACCP plan as

NA

required

IN OUT

C. When packaged in a food establishment, juice is treated under a HACCP

NA

plan to reduce pathogens or labeled as specified in the Food Code

Score: Number of disagreements for Intervention/Risk Factors

GOOD RETAIL PRACTICES (GRPs)

Safe Food and Water

IN OUT 30. Pasteurized eggs used where required

NA

IN OUT 31. Water and ice from approved source

IN OUT 32. Variance obtained for specialized processing methods

NA

Food Temperature Control

IN OUT 33. Proper cooling methods used; adequate equipment for temperature

control

IN OUT 34. Plant food properly cooked for hot holding

NA NO

IN OUT 35. Approved thawing methods used

NA NO

IN OUT 36. Thermometers provided & accurate

Page | 47

Food

Identification

IN OUT 37. Food properly labeled; original container

Prevention of Food

Contamination

IN OUT 38. Insects, rodents, & animals not present

IN OUT 39. Contamination prevented during food preparation, storage & display

IN OUT 40. Personal cleanliness

IN OUT 41. Wiping cloths: properly used & stored

IN OUT 42. Washing fruits & vegetables

Proper Use of

Utensils

IN OUT 43. In-use utensils: properly stored

IN OUT 44. Utensils, equipment & linens: properly stored, dried, & handled

IN OUT 45. Single-use/single-service articles: properly stored & used

IN OUT 46. Slash-resistant and cloth gloves used properly

Utensils, Equipment and Vending

IN OUT

47.

Food & non-food contact surfaces cleanable, properly designed,

constructed, & used

IN OUT

48.

Warewashing facilities: installed, maintained, & used; test strips

IN OUT 49. Non-food contact surfaces clean

Physical

Facilities

IN OUT 50. Hot & cold water available; adequate pressure

IN OUT 51. Plumbing installed; proper backflow devices

Page | 48

IN OUT 52. Sewage & waste water properly disposed

IN OUT 53. Toilet facilities: properly constructed, supplied, & cleaned

IN OUT 54. Garbage & refuse properly disposed; facilities maintained

IN OUT 55. Physical facilities installed, maintained, & clean

IN OUT 56. Adequate ventilation & lighting; designated areas used

Score: Number of disagreements for Good Retail Practices

Page | 49

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Page | 50

ANNEX 2-2

REPORT MARKING INSTRUCTIONS WITH FOOD CODE REFERENCES

The following provides guidance to the CANDIDATE on marking the form.

Compliance Status

For each item on the form, indicate one of the following for COMPLIANCE STATUS

IN - Item found in compliance NO - Not observed

OUT - Item found out of compliance NA - Not applicable

Where no option occurs for marking NO or NA, these have been removed from the Marking

Instructions.

The STANDARD may mark an item “S” to reflect a disagreement in a case where the CANDIDATE

has the opportunity to make an observation or take a measurement and fails to do so, and

intervention by the STANDARD would alert the CANDIDATE to the missed opportunity.

The Reliance of Statements made by the Person In Charge in Determining

Compliance with the Provisions of the Food Code

The FDA Procedures for Standardization of Food Safety Inspection Officers stresses open

communication between the CANDIDATE and Person in Charge and food employees. To be an

effective communicator, the CANDIDATE is expected to ask questions relative to the flow of food

through the establishment, preparation and cooking procedures, as well as employee health and

normal everyday operation of the facility. Responses to questions give the CANDIDATE a better

idea of the FOODBORNE ILLNESS RISK FACTORS that could be present in the establishment and

allows for better budgeting of time while conducting the inspection. In addition, comments

made by these individuals can often be used to support or augment direct observations and, in

some very limited cases, can be used as the sole basis for determining compliance with

provisions of the Food Code.

By assessing FOODBORNE ILLNESS RISK FACTORS that are suspected of being uncontrolled at times

other than the inspection (i.e., before or after the inspection), time can be better spent on

troubleshooting problems and bringing the FOODBORNE ILLNESS RISK FACTORS back under control

through proper intervention strategies. The CANDIDATE is expected to relay deficiencies in the

operation to the Person in Charge so that on-site and long-term corrective action can be initiated.

Page | 51

Guidelines for Using Statements Made by the Person in Charge or Food

Employees to Determine Compliance

(Further guidance is provided in the Marking Instructions)

•

Marking IN and OUT of Compliance

Generally, a mark of OUT must be based on actual observations noted in the

establishment at the time of the inspection. Regulatory action must be based on evidence

gathered during an inspection and not based solely on a Person in Charge’s incorrect

answer to a question asked by the CANDIDATE. For instance, the Person in Charge tells

the inspector, “I slice ham using my bare hands.” This would most definitely be an item

for discussion with management but would not, in and of itself, justify a mark of OUT for

no bare contact with RTE food. In this case, the CANDIDATE must actually observe a

food employee touching ready-to-eat food with his or her bare hands before marking

OUT of compliance.

There are some items on the inspection report for which the CANDIDATE may rely solely

on discussions with management or food employees to determine the compliance status.

These items relate to policies, including those that relate to the establishment’s employee

health policy and also those that address Part 3-8 of the Food Code (highly susceptible

populations).

Frequently, observations are made while a food is undergoing a process, i.e. cooling and

reheating, when the CANDIDATE must ask the Person in Charge or food employees

questions to support or augment actual observations made. For instance, if a food item is

observed cooling in a walk-in cooler and a temperature check reveals a temperature

greater than 41°F, questions should be asked regarding the length of time the food has

been cooling to properly determine compliance with the time/temp requirements of the

Food Code. Also, this information is vital to determine the most appropriate on-site

corrective action.

•

Marking Not Observed (NO) or Not Applicable (NA)

In order to fully complete the inspection form as required, the CANDIDATE should

question the Person in Charge and food employees, as appropriate, concerning the types

of food served and food preparation processes conducted in the establishment even at

times when the inspector is not there. For instance, if thawing is not actually observed,

the CANDIDATE should ask questions about whether or not thawing is actually conducted

in the establishment at any time to properly mark thawing as either NO or NA.

Page | 52

FOODBORNE ILLNESS RISK FACTORS AND FOOD CODE INTERVENTIONS

Supervision

STATUS

1. Person in charge present, demonstrates knowledge, and performs

duties

This item must be marked IN or OUT of compliance. The person in

charge (PIC) has three assigned responsibilities - Presence; Demonstration

of Knowledge; and Duties.

IN OUT A. Assignment – PIC

Person in charge is present. This item is marked OUT of compliance if

there is no PIC per - ¶¶ 2-101.11 (A) and (B).

NA Do Not Mark this item NA

NO Do Not Mark this item NO

2-101.11 Assignment

(PF)

IN OUT B. Demonstration

This item must be marked IN or OUT of compliance. The PIC has three

options for demonstrating knowledge.

This item is marked IN compliance if the PIC meets at least one of the

options. The three options for demonstration of knowledge allowed by the

Food Code are:

1. Certification by an accredited program as specified in ¶ 2-102.20 (A).

2. Complying with this Code by having no violations of Priority items

during the current inspection; or

3. Correct responses to the CANDIDATE’s questions regarding public

health practices and principles applicable to the operation. The

inspector should assess this item by asking open-ended questions to

evaluate the PIC's knowledge in each of the areas enumerated in

Subparagraphs 2-102.11 (C) (1) and (4-16). Questions can be asked

during the initial interview, menu review, or throughout the inspection

as appropriate. The CANDIDATE should ask a sufficient number of

questions to enable the inspector to make an informed decision

concerning the PIC's knowledge of the Code requirements and public

health principles as they apply to the operation. The dialogue should

be extensive enough to reveal whether or not that person is enabled by

a clear understanding of the Code and its public health principles to

follow sound food safety practices and to produce food that are safe,

wholesome, unadulterated, and accurately represented.

NA Do Not Mark this item NA

Page | 53

NO Do Not Mark this item NO

2-102.11 (A) - (B) and (C) (1) and (4-16) Demonstration

(PF)

2-102.20 (A) Food Protection Manager Certification (Non-Debitable)

NOTE 1: “Incorrect” responses to questions regarding public health practices and Principles [except for

Subparagraphs 2-102.11 (C) (2) (3), which are captured under Item 3], in and of themselves, are not sufficient

for marking other items on this inspection form OUT. For instance, if the PIC does not know the Food Code

requirement for cooling, yet no actual OUT of compliance observations are made with regard to cooling

during the inspection, then OUT of compliance cannot be marked for Item 20.

IN OUT C. Duties of PIC

This item must be marked IN or OUT of compliance based on the

interaction and observation with the PIC and food employees. The

CANDIDATE needs to determine the systems or controls the PIC has put

into practice regarding oversight and/or routine monitoring of the Duties

listed in § 2-103.11. This is accomplished by 1) discussion with the PIC,

and 2) verified through observation that the systems or controls are

actually being implemented. This concept is commonly referred to as

Active Managerial Control.

This item is marked OUT of compliance when there is a pattern of non-

compliance and obvious failure by the PIC to ensure employees are

complying with the duties listed in § 2-103.11. Since marking this item

out of compliance requires judgment, it is important that this item not be

marked for an isolated incident, but rather for an overall evaluation of the

PIC's ability to ensure compliance with the duties described in § 2-103.11.

NA Do Not Mark this item NA

NO Do Not Mark this item NO

2-103.11 (A-N) and (P) Person in Charge - Duties

(PF)

IN OUT 2. Certified Food Protection Manager – Establishment has a Certified

Food Protection Manager

This item must be marked IN or OUT of compliance. This item is marked IN

compliance when it is observed that the person in charge is a certified food

protection manager. This item is marked OUT when it is observed that there

is no person in charge that is deemed a certified food protection manager, or

the certified food protection manager certificate is deemed not to be from an

accredited program

1

Accredited Program: (1) "Accredited program" means a food protection manager certification program that has been evaluated

and listed by an accrediting agency as conforming to national standards for organizations that certify

individuals.

(2) "Accredited program" refers to the certification process and is a designation based upon an

independent evaluation of factors such as the sponsor's mission; organizational structure; staff resources;

revenue sources; policies; public information regarding program scope, eligibility requirements, re-

certification, discipline and grievance procedures; and test development and administration.

(3) "Accredited program" does not refer to training functions or educational programs.

Page | 54

2-102.20 (B). This item is marked OUT of compliance if the

establishment has no Certified Food Protection Manager.

NA This item may be marked N.A. if the establishment is deemed by the

Regulatory Authority to not apply due to the minimal risk of causing or

contributing to foodborne illness based on the nature of the operation and

extent of food operation.

NO Do not Mark this item NO

2-102.12 (A) Certified Food Protection Manager

(C)

Employee Health

NOTE 2: One may rely solely on discussions, questions, and documentation to

determine the compliance status of this item.

IN OUT 3. Management, food employee and conditional employee;

knowledge, responsibilities and reporting

This item must be marked IN or OUT of compliance.

This item is marked IN compliance when the following criteria are met:

•

The PIC is aware of his or her responsibility to inform food

employees and conditional employees of their responsibility to report

information about their health and activities as they relate to diseases

that are transmissible through food (i.e., certain symptoms and

diagnosis) to the person in charge and for the PIC to report to the

regulatory authority as specified under ¶ 2-103.11 (O) and ¶¶ 2-

201.11 (A) - (C), and (E); and

•

The PIC provides documentation or otherwise satisfactorily

demonstrates during the inspection, that all food employees and

conditional employees are informed of their responsibility to report to

management information about their health and activities as it relates

to diseases that are transmissible through food, as specified under ¶ 2-

201.11 (A). Satisfactory compliance may be documented by

completion of Form 1-B, Conditional Employees or Food Employees

Reporting Agreement, in Annex 7 of the Food Code for each

employee or other similar state or local form containing the same

information; or

•

In lieu of Form 1-B, compliance may be demonstrated by:

a) Presenting evidence such as a curriculum and attendance rosters

documenting that each employee has completed a training program

Page | 55

which includes all the information required on Form 1-B regarding

their reporting responsibilities; or

b) Implementation of an employee health policy which includes a

system of employee notification using a combination of training,

signs, pocket cards, or other means to convey all of the required

information on Form 1-B to all food employees and conditional

employees. A signed acknowledgement by the employee should

be part of any employee health policy.

The Regulatory Authority is encouraged to establish a policy of

selecting one employee at random during each inspection and

requesting the PIC verify, by one of the previously listed methods,

that the selected employee has been informed of his or her

responsibility to report symptoms, exposures, and diagnosed

illnesses to management. The PIC is not expected to quote

symptoms and diseases from memory, but should be able to locate

that information on Form 1-B or similar documents used to

demonstrate compliance.

Additional information is provided in Annex 3 of the Public Health

Reasons for Subpart 2-201, including a number of questions,

which may be used as a reference to assist the Regulatory

Authority in determining compliance with this item.

NA Do Not Mark this item NA

NO Do Not Mark this item NO

2-102.11 (C) (2) - (3) and (17) Demonstration

(PF)

2-103.11 (O) Person in Charge, Duties

(PF)

2-201.11 (A), (B), (C), and (E) Responsibility of Permit Holder, Person in

Charge and Conditional Employees

(P, PF)

IN OUT 4. Proper use of restriction and exclusion and reporting

This item must be marked IN or OUT of compliance. Compliance must

be based on first hand observations or information and cannot be based

solely on responses from the PIC to questions regarding hypothetical

situations

or knowledge of the Food Code.

This item is marked IN compliance when the following criteria

are observed at the time of the inspection:

•

There are no ill food/conditional employees.

•

There are no food/conditional employees experiencing

symptoms, with or without a diagnosis, that require reporting,

or reason for the PIC to exclude or restrict an employee.

•

A food employee has been excluded/restricted and will return

Page | 56

to work restricted/unrestricted as specified in §2-201.13 or a

conditional employee is allowed to return to work as a food

employee.

This item is marked OUT of compliance when:

•

The inspector observes a working employee with a

reportable symptom specified in Subparagraph 2-201.11

(A) (1); or

•

The inspector becomes aware that an employee has reported

information about his or her health and activities as it relates

to diseases that are transmissible through food and the PIC has

not acted to restrict/exclude a food/conditional employee as

required by § 2-201.12; and 2-201.13 or

•

The inspector becomes aware that the PIC has not notified the

Regulatory Authority that an employee is jaundiced or

diagnosed with an illness due to a pathogen as specified under

Subparagraph

2-201.11 (A) (2) (a) - (f); or

•

There are food employees working in the food establishment

that have been diagnosed with an illness, exposed to, or is the

suspected source of a confirmed disease outbreak as specified

in Subparagraphs 2-201.11 (A) (2-5); or

•

A food employee with an active sore throat with fever is working

in a food establishment that exclusively serves a highly

susceptible population, as specified in ¶ 2-201.12 (H). Food

employees with a sore throat and fever must be restricted when

working in facilities not serving a HSP.

NA Do Not Mark this item NA

NO Do Not Mark this item NO

2-201.11 (D) and (F) Responsibility of the Person in Charge to exclude

or restrict and the responsibility of the Food Employees and

Conditional Employees to Comply with Exclusions and Restrictions

(P)

2-201.12 Exclusions & Restrictions

(P)

2-201.13 Removal, Adjustment, or Retention of Exclusions &

Restrictions

(P)

IN OUT 5. Clean-up of Vomiting and Diarrheal Events

This item must be marked IN or OUT of compliance.

This item is marked IN compliance when the food establishment

demonstrates they have written procedures for employees to follow when

responding to vomiting or diarrheal events that involve the discharge of

vomitus or fecal matter onto surfaces in the food establishment. Refer

to the Public Health Reasons (§ 2-501.11 Clean-up of Vomiting and

Diarrheal Events) for suggested recommendations as to what the food

Page | 57

establishment can include within their plan (this is not an exhaustive list).

This item is marked OUT of compliance if the food establishment cannot

demonstrate they have written procedures for employees to follow when

responding to vomiting or diarrheal events that involve the discharge of

vomitus or fecal matter onto surfaces in the food establishment.

NA Do Not Mark this item NA

NO Do Not Mark this item NO

2-501.11 Clean-up of Vomiting and Diarrheal Events

(PF)

Good Hygienic Practices

IN OUT 6. Proper eating, tasting, drinking, or tobacco use

This item should be marked IN or OUT of compliance based on direct

observation of the appropriate hygienic practices of food employees.

This item is marked IN compliance when a food employee is observed

drinking from a closed beverage container subsequently stored on a

non-food contact surface and separate from exposed food, clean

equipment, and unwrapped single-service and single-use articles.

This item is marked OUT of compliance when food employees are

observed improperly tasting food, eating, drinking, or smoking, or there is

supporting evidence of these activities taking place in non-designated

areas of the establishment. An open container of liquid in the kitchen

preparation area does not necessarily constitute marking this item OUT.

Further discussion with a food employee or the PIC may be needed to

determine if the liquid, if labeled, is used as an ingredient in food or may

be an employee beverage that is consumed in another designated area. If

the liquid is an open beverage that is consumed in a designated area, it

must still be stored in a manner to prevent the contamination of food,

equipment, utensils, linens and single-service/single-use articles.

NA Do Not Mark this item NA

NO This item may be marked NO only in the RARE case when no food

workers are present at the time of inspection.

2-401.11 Eating, Drinking or Using Tobacco

(C)

3-301.12 Preventing Contamination When Tasting

(P)

IN OUT 7. No discharge from eyes, nose, and mouth

This item should be marked IN or OUT of compliance based on direct

Page | 58

observation of food employees.

This item is marked IN compliance when no food employees are observed

having persistent sneezing, coughing, or a runny nose that causes

discharge from the eyes, nose or mouth.

This item is marked OUT of compliance when a food employee has

persistent sneezing, coughing, or a runny nose that causes discharges from

the eyes, nose or mouth, subjecting food and food-contact surfaces to

potential contamination.

NA Do Not Mark this item NA

NO This item may be marked NO only in the RARE case when no food

workers are present at the time of inspection.

2-401.12 Discharges from the Eyes, Nose, and Mouth

(C)

Preventing Contamination by Hands

IN OUT 8. Hands clean & properly washed

NOTE 3: This section (Preventing Contamination by Hands) is to be marked based on

actual observations only.

This item should be marked IN or OUT of compliance.

This item marked IN compliance when employees are observed using

proper handwashing techniques at appropriate times and places. Hands

are not required to be washed between each change of gloves if there is no

change in the task being performed and there are no activities which could

potentially result in cross contamination.

NA Do Not Mark this item NA

NO This item may be marked NO only in the RARE case when food workers

are not present at the time of inspection. If no food workers are present,

but the PIC accompanies the inspector on the inspection and touches food,

clean equipment, or utensils without washing his/her hands, this item is

marked OUT.

2-301.11 Clean Condition-Hands and Arms

(P)

2-301.12 Cleaning Procedure

(P)

2-301.14 When to Wash

(P)

2-301.15 Where to Wash

(PF)

2-301.16 Hand Antiseptics

(PF)

IN OUT 9. No bare hand contact with RTE food or a pre-approved alternate

Page | 59

properly followed

This item should be marked IN or OUT of compliance.

This item is marked IN compliance when food employees are observed

using suitable utensils or gloves to prevent bare hand (or arm) contact with

ready-to-eat food or if the food employee contacts exposed RTE food with

bare hands at the time the RTE food is being added as an ingredient to a

food that:

•

contains a raw animal food and is to be cooked in the food

establishment to heat all parts of the food to the minimum

temperatures specified in ¶¶ 3-401.11 (A) - (B) or §3-401.12; or

•

does not contain a raw animal food but is to be cooked in the food

establishment to heat all parts of the food to a temperature of at

least 145°F

This item is also marked IN compliance when food employees are

observed properly following a pre-approved alternative procedure to no

bare hand contact.

This item is marked OUT of compliance if one food employee is observed

handling ready-to-eat food with their bare hands in the absence of a prior

approval and written procedures for bare hand contact. Refer to

Subparagraph 3-301.11 (E) (1) - (7) for a listing of conditions that must be

met in order to receive prior approval by the Regulatory Authority. Bare

hand contact by food employees serving a Highly Susceptible Population

is prohibited and no alternative to bare hand contact is allowed. This item

is also marked OUT when food employees contact exposed RTE food

with bare hands at the time the RTE food is being added as an ingredient

to a food that is not properly heat treated as specified in Subparagraphs 3-

301.11 (D) (1) - (2).

NA This item may be marked NA if the establishment provides only

packaged or bulk food items that are not ready-to-eat.

NO This item may be marked NO if the establishments prepares ready-to-eat

food, but no food preparation occurs at the time of inspection.

3-301.11 Preventing Contamination from Hands

(P, PF, C)

3-801.11 (D) Pasteurized Foods, Prohibited Re-Service, and Prohibited

Food

(P)

10. Adequate handwashing sinks properly supplied and accessible

IN OUT A. Adequate handwashing sinks conveniently located and accessible

This item must be marked IN or OUT of compliance based on the direct

observation of conveniently located handwashing sinks, for use by food

employees, in food preparation, food dispensing and warewashing areas as

Page | 60

well as in or immediately adjacent to toilet rooms.

This item is marked OUT of compliance if a handwashing sink is not

accessible to food employees who are working in food preparation, food

dispensing and warewashing areas, is blocked by portable equipment or

stacked full of soiled utensils or other items, or is unavailable for regular

employee use.

NA Do Not Mark this item NA

NO Do Not Mark this item NO

5-202.12 Handwashing Sink, Installation

(PF, C)

5-203.11 Handwashing Sinks - Numbers and Capacities

(PF)

5-204.11 Handwashing Sinks - Location and Placement)

(PF)

5-205.11 Using a Handwashing Sink - Operation and Maintenance

(PF)

IN OUT B. Handwashing sinks supplied with hand cleanser/sanitary

towels/hand drying devices/ signage

This item must be marked IN or OUT of compliance based on the direct

observation of properly equipped handwashing sinks for food employee

use.

This item is marked OUT of compliance when handwashing sinks are not

stocked with soap, hand drying provisions or equipped with the required

signage.

NA Do Not Mark this item NA

NO Do Not Mark this item NO

6-301.11 Handwashing Cleanser, Availability

(PF)

6-301.12 Hand Drying Provision

(PF)

6-301.13 Handwashing Aids and Devices, Use Restrictions

(C)

6-301.14 Handwashing Signage

(C)

Approved Source

11. Food obtained from approved source

IN OUT A. All food from regulated food processing plants/no home prepared or

canned food/standards for eggs, milk, juice

This item must be marked IN or OUT of compliance based on direct

observation of food products, food labels and packaging, water analyses,

and discussion with the PIC or other food employees.

This item is marked IN compliance when the regulatory authority is able

to determine approved food sources. A review of supplier names,

shipment invoices, buyer specification plans, proof of regulatory

Page | 61

permit/licensure of a food source, etc. can be used to document approved

food sources. Milk and milk products must comply with Grade A

Standards.

This item is marked OUT of compliance when an approved food source

cannot be determined.

NA Do Not Mark this item NA

NO Do Not Mark this item NO

3-201.11 Compliance with Food Law

(P, PF, C)

3-201.12 Food in a Hermetically Sealed Container

(P)

3-201.13 Fluid Milk and Milk Products

(P)

3-202.13 Eggs

(P)

3-202.14 Eggs and Milk Products, Pasteurized

(P)

3-202.110 Juice Treated - Commercially Processed

(P, PF)

5-101.13 Bottled Drinking Water

(P)

IN OUT B. All fish commercially caught/raised or approved by the Regulatory

Authority/all molluscan shellfish from ICSSL listed sources/no

recreationally caught shellfish received or sold.

This item is should be marked IN or OUT of compliance based on direct

observation of molluscan shellfish or fish, labels and packaging, and

discussion with the PIC or other food employees.

This item is marked IN compliance when the regulatory authority is able

to determine approved food sources. A review of supplier names,

shipment invoices, buyer specification plans, molluscan shellfish tags,

proof of regulatory permit/licensure of a food source, etc. can be used to

document approved food sources.

This item is marked OUT of compliance when an approved food source

cannot be determined.

NA This item may be marked NA if molluscan shellfish or fish, are not used

or offered for sale or service in the establishment.

NO This item may be marked NO if molluscan shellfish or fish, are served or

sold periodically in the establishment, but are not present at the time of the

inspection and you are unable to determine prior compliance through tags,

invoices or purchase records.

3-201.14 Fish

(P)

3-201.15 Molluscan Shellfish

(P)

IN OUT C. Game animals and wild mushrooms approved by regulatory

Authority

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NOTE 4: The 2013 Food Code prohibits the sale of wild mushrooms unless a food

establishment gets approval from the Regulatory authority.

This item should be marked IN or OUT of compliance based on direct

observation of food products, food labels and packaging, and discussion

with the PIC or other food employees.

This item is marked IN compliance when the regulatory authority is able

to determine approved food sources. A review of supplier names,

shipment invoices, buyer specification plans, and proof of regulatory

permit/licensure of a food source, etc. can be used to document approved

food sources.

This item is marked OUT of compliance when an approved food source

cannot be determined.

NA This item may be marked NA if game animals or wild mushrooms are not

used or offered for sale or service in the establishment.

NO This item may be marked NO if game animals or wild mushrooms are served or

sold periodically in the establishment, but are not present at the time of inspection

or you are unable to determine prior compliance through invoices or purchase

records.

3-201.16 Wild Mushrooms

(P)

3-201.17 Game Animals

(P, C)

IN OUT 12. Food received at proper temperature

This item should be marked IN or OUT of compliance based on actual

food temperature measurements of TCS food being received.

This item is marked IN compliance when food is received and found at

proper temperatures during the inspection (i.e. catered meal for child care

center arrives during the inspection and the regulatory authority verifies

receiving temperature).

This item is marked OUT of compliance if food is received and accepted,

but an actual food temperature measurement of a TCS food by the

regulatory authority at the time of delivery exceeds the temperature

specifications for receiving as prescribed by the Code.

NA This item may be marked NA when the establishment receives only non-

TCS food and that are not frozen

NO This item may be marked NO if the establishment does receive TCS food,

but TCS food is not received at the time of inspection.

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3-202.11 Temperature

(P, PF)

IN OUT 13. Food in good condition, safe, and unadulterated

This item must be marked IN or OUT of compliance based on direct

observation of the integrity of product packaging, wholesomeness, and

signs of adulteration.

This item is marked IN compliance when a dent in a canned food has not

compromised the hermetic seal; cuts made in outer cardboard packaging

during opening of the case do not enter the inner product packaging; the

true appearance, color, or quality of a food is not misrepresented; and food

is honestly presented.

This item is marked OUT of compliance when the integrity of food

packaging has been compromised or the true appearance, color, or quality

of a food has been intentionally altered, or the food is not honestly

presented.

NA Do Not Mark this item NA

NO Do Not Mark this item NO

3-101.11 Safe, Unadulterated, and Honestly Presented

(P)

3-202.15 Package Integrity

(PF)

14. Required records available: shellstock tags, parasite

destruction

IN OUT A. Written documentation of parasite destruction maintained for 90

days for fish products that are intended for raw or undercooked

consumption

This item should be marked IN or OUT of compliance based on direct

observation of fish in storage, and records of freezing of fish for

parasite destruction.

This item is marked IN compliance if the permit holder provides a

statement from the supplier(s) identifying that fish sold as raw, raw-

marinated or undercooked is frozen by the supplier for parasite

destruction; or there are freeze records maintained by the permit

holder when fish are frozen for parasite destruction on the premises

or has documentation stipulating that the fish were raised and fed a

formulated feed.

This item is marked OUT of compliance when no records of freezing

of fish for parasite destruction are available.

Page | 64

NA This item may be marked NA when no raw, raw-marinated, or

undercooked fish are sold or served in RTE form or the only fish sold

as raw, raw-marinated are tuna species (such as Yellowfin, Southern

and Northern Bluefin and Bigeye), molluscan shellfish, fish eggs

removed from their skein and rinsed, or aquacultured fish such as

salmon that are

exempted from freezing because they are fed formulated feed that does

not contain live parasites infective to that fish.

NO This item may be marked NO when raw, raw-marinated or

undercooked fish are sold periodically in the establishment, but are not

present at the time of the inspection and prior compliance through

tags, invoices, or purchase records cannot be verified.

3-402.11 Parasite Destruction

(P, C)

3-402.12 Records, Creation and Retention

(PF)

IN OUT B. Shellstock tags maintained for 90 days and in chronological order

This item should be marked IN or OUT of compliance based on

direct observation of shellstock tags.

This item is marked OUT of compliance if shellstock tags are not

available or are incomplete, when no date is recorded on the tag or label

toindicate the last day the shellstock was sold or served, when tags or

labels are not maintained in chronological order correlated to the date that

is recorded on the tag or label, or when there is evidence of commingling

of shellstock.

NA This item may be marked NA when shellstock are not sold or served in the

establishment.

NO This item may be marked NO when shellstock are sold or served in the

establishment, but are not present at the time of the inspection and prior

compliance through tags, invoices, buyer specifications, or purchase

records cannot be verified.

3-202.18 Shellstock Identification

(PF, C)

3-203.12 Shellstock, Maintaining Identification

(PF)

Protection from Contamination

15. Food separated & protected

IN OUT A. Separating raw animal food from raw RTE food and separating

Raw animal food from cooked RTE food

This item should be marked IN or OUT of compliance based on direct

Page | 65

observation of food storage and food handling practices.

This item is marked IN compliance when frozen, sealed/intact

commercially packaged raw animal food stored or displayed with or above

frozen, sealed/intact commercially packaged RTE food.

This item is marked OUT of compliance when raw animal food is not

separated from raw or cooked RTE food or unwashed fruits and

vegetables.

NA This item may be marked NA when raw animal foods are not

prepared/served in the establishment or if only prepackaged raw animal

foods are sold. This item may be marked NA when there are no raw

animal foods used in the facility and only prepackaged foods are sold.

NO This item may be marked NO when raw animal foods are prepared/served

in the establishment, but are not present at the time of the inspection. This

item is marked NO when raw animal foods are used or served seasonally

and you are unable to determine compliance.

3-302.11 (A) (1) Packaged and Unpackaged Food - Separation, Packaging

and Segregation

(P)

IN OUT B. Raw animal food separated from each other during storage,

preparation, holding, and display

This item should be marked IN or OUT of compliance based on direct

observation of food storage and food handling practices.

This item is marked OUT of compliance when raw animal food are subject

to potential contamination by other raw animal food; or raw animal food

are observed not separated by type based on minimum cook temperatures

by spacing or placing in separate containers.

NA This item may be marked NA when raw animal foods are not prepared or

served, when only one species of raw animal food is prepared/served, or

when only prepackaged raw animal foods are sold in the establishment.

NO This item is marked NO when raw animal foods are prepared/served/or

sold in the establishment, but are not present at the time of the inspection.

3-302.11 (A) (2) Packaged and Unpackaged Food - Separation, Packaging

and Segregation

(P)

IN OUT C. Food protected from environmental contamination

This item must be marked IN or OUT of compliance based on direct

observations of food storage and food handling practices.

Page | 66

This item is marked OUT of compliance if food is not packaged or

covered during storage (unless in the process of cooling); or food is in

contact with soiled equipment and utensils; or single-use gloves used for

more than one task.

NA Do not Mark this item NA

NO Do not Mark this item NO

3-304.11 Food Contact with Equipment and Utensils

(P)

3-304.15 (A) Gloves, Use Limitation

(P)

3-306.13 (A) Consumer Self - Service Operations

(P)

IN OUT 16. Food-contact surfaces: cleaned & sanitized

NOTE 5: This item will require some judgment to be used when marking it IN or OUT

of compliance. You must provide notes concerning the reason it is marked OUT of

compliance.

This item should be marked IN or OUT of compliance based on direct

observation of food-contact surfaces of equipment and utensils; actual

measurements/readings of chemical sanitizer concentration, hot water

sanitizing temperature, pH, hardness, water pressure, etc. using test strips,

heat-sensitive tapes, and equipment gauges; observations of cleaning

and sanitizing procedures; and discussion of cleaning and sanitizing

procedures and frequency with the PIC or other food employees.

This item is marked IN compliance when manual and/or mechanical

methods of cleaning and sanitizing are effective, and performed at the

prescribed frequency. There should be an overall assessment of the

food- contact surfaces of equipment and utensils in clean storage and in

use to determine compliance. For example, this item is not marked OUT

of compliance based on one visibly soiled utensil, such as a plate or

knife or if one sanitizer container is without sanitizer.

This item is marked OUT of compliance if observations are made that

support a pattern of noncompliance with this item, when manual and/or

mechanical methods of cleaning and sanitizing food-contact surfaces of

equipment and utensils are ineffective, or if one multiuse piece of

equipment such as a slicer or can opener is visibly soiled and being used

at the time of the inspection. This item is also marked OUT of

compliance if it is observed that equipment or utensils that have come into

contact with a major food allergen such as fish was not cleaned and

sanitized prior to use for other types of raw animal food.

NA This item may be marked NA only when cleaning and sanitizing of

equipment and utensils is not required (such as when only

prepackaged food is sold).

NO Do Not Mark this item NO

Page | 67

4-501.111 Manual Warewashing Equipment, Hot Water Sanitization

Temperatures

(P)

4-501.112 Mechanical Warewashing Equipment, Hot Water Sanitization

Temperatures

(PF)

4-501.113 Mechanical Warewashing Equipment, Sanitization Pressure

(C)

4-501.114 Manual and Mechanical Warewashing Equipment, Chemical

Sanitization - Temperature, pH, Concentration and Hardness

(P, PF)

4-501.115 Manual Warewashing Equipment, Chemical Sanitization Using

Detergent - Sanitizers

(C)

4-601.11 (A) Equipment, Food - Contact Surfaces, Nonfood

Contact surfaces and Utensils

(PF)

4-602.11 Equipment Food - Contact Surfaces and Utensils - Frequency

(P, C)

4-602.12 Cooking and Baking Equipment

(C)

4-702.11 Before Use After Cleaning

(P)

4-703.11 Hot Water and Chemical - Methods

(P)

17. Proper disposition of returned, previously served, reconditioned and

unsafe food

IN OUT A. After being served or sold to a consumer, food is not reserved

This item must be marked IN or OUT of compliance.

This item is marked OUT of compliance if previously served unwrapped,

unprotected food is observed being re-served.

NA Do Not Mark this item NA

NO Do Not Mark this item NO

3-306.14 Returned Food and Re-Service of Food

(P)

IN OUT B. Discarding or Reconditioning Unsafe, Adulterated, or

Contaminated Food

This item must be marked IN or OUT of compliance.

This item is marked OUT of compliance if food is found unsafe,

adulterated, not honestly presented, from an unapproved source, or ready-

to-eat food is contaminated by employees and is not discarded or

reconditioned according to an approved procedure.

NA Do Not Mark this item NA

NO Do Not Mark this item NO

3-701.11 Discarding or Reconditioning Unsafe, Adulterated, or

Contaminated Food

(P)

Page | 68

Time/Temperature Control for Safety (TCS Food)

18. Proper cooking time & temperatures

NOTE 6: The cooking temperatures of foods must be measured to determine compliance

or noncompliance. Do not rely upon discussions with managers or cooks to make a

determination of compliance or noncompliance. The temperature of raw animal food in

each species cooked during the inspection should be taken. For instance, if the

establishment fries chicken, scrambles eggs, bakes fish, grills hamburgers and slow-

roasts prime rib during the inspection - the cook temperatures of all of the products

should be measured and recorded. Both IN and OUT of compliance temperatures should

be recorded. Also, refer to cooking chart below. If a roast of any type is cooked (in any

manner other than the pre-heated oven parameters) it would be marked under 18C.

IN OUT A. Raw Eggs broken on request and prepared for immediate service

cooked to 63°C (145°F) for 15 seconds

This item should be marked IN or OUT of compliance based on actual

cooking temperature measurements using a calibrated food temperature

measuring device.

This item is marked IN compliance if a food item meets the

time/temperature requirements for cooking, or if a food is cooked below

the required temperature but the establishment has an approved consumer

advisory or an approved variance with a HACCP plan for that food item

(record the temperature and document the reason it is IN compliance).

This item is marked OUT of compliance if a food item does not meet the

time/temperature requirements for cooking and the determination is made

that the employee doing the cooking intends to serve the product before

completing the cooking process unless requested undercooked by the

consumer.

NA This item may be marked NA when raw eggs are not cooked or used in the

establishment (including raw eggs not used in recipes).

NO This item may be marked NO when raw eggs are cooked or used in the

establishment, but you are unable to determine the cooking temperature or

they are not cooked at the time of inspection. The inspection should be

arranged at an optimum time for measuring at least one cooked item.

3-401.11 (A) (1) Raw Animal Foods

(P)

IN OUT B. Comminuted fish, meat, game animals commercially raised for food,

and raw eggs not prepared for immediate service and comminuted

meat on a child’s menu cooked to 68°C (155°F) for 17 seconds or the

time/temperature relationship specified in the chart in the Food Code

Page | 69

This item should be marked IN or OUT of compliance based on actual

cooking temperature measurements using a calibrated food temperature

measuring device.

This item is marked IN compliance if a food item meets the

time/temperature requirements for cooking, or if a food is cooked below

the required temperature but the establishment has an approved consumer

advisory or an approved variance with a HACCP plan for that food item

(record the temperature and document the reason it is IN compliance).

This item is marked OUT of compliance if a food item does not meet the

time/temperature requirements for cooking and the determination is made

that the employee doing the cooking intends to serve the product before

completing the cooking process. Undercooked comminuted meat, with a

consumer advisory, on a child’s menu is marked OUT of compliance.

NA This item may be marked NA if comminuted fish, meat, commercially

raised game animal, and raw eggs (not prepared for immediate service) are

not cooked in the establishment.

NO This item may be marked NO when one or more types of comminuted

fish, meat, commercially raised game animal, or raw eggs (not prepared

for immediate service) are cooked in the establishment, but you are unable

to determine the cooking temperature of any of them or they are not

cooked at the time of inspection. The inspection should be arranged at an

optimum time for measuring at least one cooked item.

3-401.11 (A) (2) and (D) (2) Raw Animal Food

(P, PF)

IN OUT C. Whole meat roasts, including beef, corned beef, lamb, pork, cured pork

roasts and formed roasts, cooked to 54°C (130°F) for 112 minutes, or

as chart specifies and according to oven parameter per chart.

This item should be marked IN or OUT of compliance based on actual

cooking temperature measurements obtained using a calibrated food

temperature measuring device. This item is marked IN compliance if a

food item meets the time/temperature requirements for cooking, or if a

food is cooked below the required temperature but the establishment has

an approved consumer advisory or an approved variance with a HACCP

plan for that food item (record the temperature and document the reason it

is IN compliance).

This item is marked OUT of compliance if a food item does not meet the

time/temperature requirements for cooking and the determination is made

that the employee doing the cooking intends to serve the product before

completing the cooking process.

NA This item may be marked NA when meat roasts or formed roasts are

Page | 70

not cooked in the establishment.

NO This item may be marked NO when one or more meat roasts or formed

roasts are cooked in the establishment, but they are not cooked at the

time of inspection. The inspection should be arranged at an optimum

time for measuring at least one cooked item.

3-401.11 (B) (1) and (2) Raw Animal Foods

(P, PF)

IN OUT D. Ratites and injected meat or mechanically tenderized meats cooked to

68°C (155°F) for 17 seconds or the time/temperature relationship

specified in the corresponding chart in the Food Code

This item should be marked IN or OUT of compliance based on actual

cooking temperature measurements using a calibrated food

temperature measuring device.

This item is marked IN compliance if a food item meets the

time/temperature requirements for cooking, or if a food is cooked below

the required temperature but the establishment has an approved

consumer advisory or an approved variance with a HACCP plan for that

food item (record the temperature and document the reason it is IN

compliance).

This item is marked OUT of compliance if a food item does not meet the

time/temperature requirements for cooking and the determination is

made that the employee doing the cooking intends to serve the product

before completing the cooking process.

NA This item may be marked NA when none of the food items are cooked

in the establishment

NO This item may be marked NO when one or more of the food items are

cooked in the establishment, but you are unable to determine the

cooking temperature of any of them.

3-401.11 (A) (2) Raw Animal Foods

(P)

IN OUT E. Poultry, baluts; stuffed fish/meat/poultry/ratites/pasta or stuffing

containing fish, meat, poultry, or ratites cooked to 74°C (165°F) for < 1

second (instantaneous).

This item should be marked IN or OUT of compliance based on actual

cooking temperature measurements using a calibrated food temperature

measuring device.

This item is marked IN compliance if a food item meets the

time/temperature requirements for cooking, or if a food is cooked below

Page | 71

the required temperature but the establishment has an approved consumer

advisory or an approved variance with a HACCP plan for that food item

(record the temperature and document the reason it is IN compliance).

This item is marked OUT of compliance if a food item does not meet the

time/temperature requirements for cooking and the determination is made

that the employee doing the cooking intends to serve the product before

completing the cooking process.

NA This item may be marked NA when none of the food items are cooked in

the establishment.

NO This item may be marked NO when one or more of the food items are

cooked in the establishment but you are unable to determine the cooking

temperature of any of them. The inspection should be arranged at an

optimum time for measuring at least one cooked item.

3-401.11 (A) (3) Raw Animal Foods

(P)

IN OUT F. Wild game animals cooked to 74°C (165°F) for < 1 second

(instantaneous)

This item should be marked IN or OUT of compliance based on actual

cooking temperature measurements using a calibrated food temperature

measuring device.

This item is marked IN compliance if a food item meets the

time/temperature requirements for cooking, or if a food is cooked below

the required temperature but the establishment has an approved consumer

advisory or an approved variance with a HACCP plan for that food item

(record the temperature and document the reason it is IN compliance).

This item is marked OUT of compliance if a food item does not meet the

time/temperature requirements for cooking and the determination is made

that the employee doing the cooking intends to serve the product before

completing the cooking process.

NA This item may be marked NA when wild game animals are not cooked in

the establishment.

NO This item may be marked NO when wild game animals are cooked in the

establishment, but you are unable to determine the cooking temperature of

any of them or are not cooked at the time of inspection. The inspection

should be arranged at an optimum time for measuring at least one cooked

item.

3-401.11 (A) (3) Raw Animal Foods

(P)

Page | 72

IN OUT G. Whole-muscle, intact beef steaks cooked to surface temperature of

63°C (145°F) on top and bottom and a cooked color change is

achieved on all external surfaces

This item should be marked IN or OUT of compliance based on actual

cooking temperature measurements using a calibrated food temperature

measuring device.

This item is marked IN compliance if a food item meets the

time/temperature requirements for cooking, or if a food is cooked below

the required temperature but the establishment has an approved consumer

advisory or an approved variance with a HACCP plan for that food item

(record the temperature and document the reason it is IN compliance).

This item is marked OUT of compliance if a food item does not meet the

time/temperature requirements for cooking and the determination is made

that the employee doing the cooking intends to serve the product before

completing the cooking process.

NA This item may be marked NA when whole-muscle, intact beef steaks are

not cooked in the establishment, or undercooked steaks are not offered.

NO This item may be marked NO when whole-muscle, intact beef steaks are

cooked in the establishment, but you are unable to determine the cooking

temperature. The inspection should be arranged at an optimum time for

measuring at least one cooked item.

3-401.11 (C) (3) Raw Animal Foods

(P)

IN OUT H. Raw animal foods rotated, stirred, covered, and heated to 74°C

(165°F) in a microwave. Food stands for 2 minutes after cooking

This item should be marked IN or OUT of compliance based on actual

cooking temperature measurements using a calibrated food temperature

measuring device.

This item is marked IN compliance if a food item meets the time /

temperature requirements for cooking, or if a food is cooked below the

required temperature but the establishment has an approved consumer

advisory or an approved variance with a HACCP plan for that food

item (record the temperature and document the reason it is IN

compliance).

This item is marked OUT of compliance if a food item does not meet the

time/temperature requirements for cooking and the determination is made

that the employee doing the cooking intends to serve the product before

completing the cooking process.

NA This item may be marked NA when the establishment does not cook raw

Page | 73

animal foods in the microwave.

NO This item may be marked NO when the establishment does cook raw

animal foods in the microwave, but you are unable to determine the

cooking temperature of any item at the time of inspection. The inspection

should be arranged at an optimum time for measuring at least one cooked

item.

3-401.12 Microwave Cooking

(P, C)

IN OUT I. All other raw animal foods cooked to 63°C (145°F) for 15 seconds