Food Code

U.S. Public Health Service

2005
U. S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service $ Food and Drug Administration
College Park, MD 20740

Contents
PREVIOUS EDITIONS OF CODES
INTRODUCTION
PREFACE
CHAPTER 1
PURPOSE AND DEFINITIONS
CHAPTER 2
MANAGEMENT AND PERSONNEL
CHAPTER 3
FOOD
CHAPTER 4
EQUIPMENT, UTENSILS, AND LINENS
CHAPTER 5
WATER, PLUMBING, AND WASTE
CHAPTER 6
PHYSICAL FACILITIES
CHAPTER 7
POISONOUS OR TOXIC MATERIALS
CHAPTER 8
COMPLIANCE AND ENFORCEMENT

iii
Preface i
1
23
47
101
145
165
181
189

INDEX
ANNEX 1
ANNEX 2
ANNEX 3

ANNEX 5
ANNEX 6
ANNEX 7

COMPLIANCE AND ENFORCEMENT

REFERENCES
PUBLIC HEALTH REASONS/ADMINISTRATIVE
GUIDELINES
MANAGEMENT OF FOOD PRACTICES ACHIEVING
ACTIVE MANAGERIAL CONTROL OF FOODBORNE
ILLNESS RISK FACTORS
CONDUCTING RISK-BASED INSPECTIONS
FOOD PROCESSING CRITERIA
MODEL FORMS, GUIDES, AND OTHER AIDS

SUMMARY

SUMMARY OF CHANGES IN THE FDA FOOD CODE

ANNEX 4

213
237
305

475
509
543

1-13

Chapter 1

Purpose and Definitions

1-1

1-2

TITLE, INTENT, SCOPE

1-101
1-102
1-103

1
1
1

Title
Intent
Scope

DEFINITIONS

1-201

Applicability and Terms Defined

Contents xiii

Chapter 2

Management and Personnel

2-1

2-2

SUPERVISION

23

2-101
2-102
2-103

23
23
26

EMPLOYEE HEALTH
2-201

2-3

2-4

Responsibility
Knowledge
Duties

28

Responsibilities of Permit Holder, Person in

Charge, Food Employees, and Conditional
Employees

28

PERSONAL CLEANLINESS

40

2-301
2-302
2-303
2-304

40
44
44
44

Hands and Arms

Fingernails
Jewelry
Outer Clothing

HYGIENIC PRACTICES

45

2-401
2-402
2-403

45
46
46

Food Contamination Prevention

Hair Restraints
Animals

Chapter 3

Food
3-1

3-2

CHARACTERISTICS

47

3-101

47

Condition

SOURCES, SPECIFICATIONS, AND ORIGINAL

CONTAINERS AND RECORDS

48

3-201
3-202
3-203

48
52
57

Sources
Specifications for Receiving
Original Containers and Records

Contents xiv

3-3

PROTECTION FROM CONTAMINATION AFTER

RECEIVING
3-301
3-302
3-303
3-304
3-305
3-306
3-307

3-4

3-5

3-6

3-7

3-8

Preventing Contamination by Employees

Preventing Food and Ingredient
Contamination
Preventing Contamination from Ice Used as
a Coolant
Preventing Contamination from Equipment,
Utensils, and Linens
Preventing Contamination from the
Premises
Preventing Contamination by Consumers
Preventing Contamination from Other
Sources

59
59
61
64
65
68
70
72

DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH

CONCERN

72

3-401
3-402
3-403
3-404

72
76
77
78

Cooking
Freezing
Reheating
Other Methods

LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC

HEALTH CONCERN

79

3-501
3-502

79
88

Temperature and Time Control

Specialized Processing Methods

FOOD IDENTITY, PRESENTATION, AND ON-PREMISES

LABELING

93

3-601
3-602
3-603

93
93
95

Accurate Representation
Labeling
Consumer Advisory

CONTAMINATED FOOD

96

3-701

96

Disposition

SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE

POPULATIONS

97

3-801

97

Additional Safeguards

Contents xv

Chapter 4

Equipment, Utensils, and Linens

4-1

4-2

4-3

4-4

4-5

4-6

4-7

MATERIALS FOR CONSTRUCTION AND REPAIR

101

4-101
4-102

101
104

Multiuse
Single-Service and Single-Use

DESIGN AND CONSTRUCTION

105

4-201
4-202
4-203
4-204
4-205

105
105
107
108
117

Durability and Strength

Cleanability
Accuracy
Functionality
Acceptability

NUMBERS AND CAPACITIES

117

4-301
4-302

117

Equipment
Utensils, Temperature Measuring Devices,
and Testing Devices

119

LOCATION AND INSTALLATION

120

4-401
4-402

120
121

Location
Installation

MAINTENANCE AND OPERATION

123

4-501
4-502

123

Equipment
Utensils and Temperature and Pressure
Measuring Devices

128

CLEANING OF EQUIPMENT AND UTENSILS

129

4-601
4-602
4-603

129
130
133

Objective
Frequency
Methods

SANITIZATION OF EQUIPMENT AND UTENSILS

137

4-701
4-702
4-703

137
137
137

Objective
Frequency
Methods

Contents xvi

4-8

4-9

LAUNDERING

138

4-801
4-802
4-803

138
138
139

Objective
Frequency
Methods

PROTECTION OF CLEAN ITEMS

140

4-901
4-902
4-903
4-904

140
140
141
142

Drying
Lubricating and Reassembling
Storing
Preventing Contamination

Chapter 5

Water, Plumbing, and Waste

5-1

WATER
5-101
5-102
5-103
5-104

5-2

5-3

5-4

145
Source
Quality
Quantity and Availability
Distribution, Delivery, and Retention

145
146
147
147

PLUMBING SYSTEM

148

5-201
5-202
5-203
5-204
5-205

148
148
150
151
151

Materials
Design, Construction, and Installation
Numbers and Capacities
Location and Placement
Operation and Maintenance

MOBILE WATER TANK AND MOBILE FOOD

ESTABLISHMENT WATER TANK

153

5-301
5-302
5-303
5-304

Materials
Design and Construction
Numbers and Capacities
Operation and Maintenance

153
153
155
156

SEWAGE, OTHER LIQUID WASTE, AND RAINWATER

156

5-401
5-402
5-403

156
157
158

Mobile Holding Tank

Retention, Drainage, and Delivery
Disposal Facility

Contents xvii

5-5

REFUSE, RECYCLABLES, AND RETURNABLES

159

5-501
5-502
5-503

159
163
164

Facilities on the Premises

Removal
Facilities for Disposal and Recycling

Chapter 6

Physical Facilities
6-1

6-2

6-3

6-4

6-5

MATERIALS FOR CONSTRUCTION AND REPAIR

165

6-101
6-102

165
170

Indoor Areas
Outdoor Areas

DESIGN, CONSTRUCTION, AND INSTALLATION

166

6-201
6-202

166
168

Cleanability
Functionability

NUMBERS AND CAPACITIES

172

6-301
6-302
6-303
6-304
6-305
6-306

172
174
174
174
175
175

Handwashing Sinks
Toilets and Urinals
Lighting
Ventilation
Dressing Areas and Lockers
Service Sinks

LOCATION AND PLACEMENT

175

6-401
6-402
6-403
6-404
6-405

175
175
175
176
176

Handwashing Sinks
Toilet Rooms
Employee Accommodations
Distressed Merchandise
Refuse, Recyclables, and Returnables

MAINTENANCE AND OPERATION

6-501

Premises, Structures, Attachments, and

Fixtures Methods

Contents xviii

176

176

Chapter 7

Poisonous or Toxic Materials

7-1

7-2

7-3

LABELING AND IDENTIFICATION

181

7-101
7-102

181
181

Original Containers
Working Containers

OPERATIONAL SUPPLIES AND APPLICATIONS

182

7-201
7-202
7-203
7-204
7-205
7-206
7-207
7-208
7-209

182
182
184
184
185
185
186
186
187

Storage
Presence and Use
Container Prohibitions
Chemicals
Lubricants
Pesticides
Medicines
First Aid Supplies
Other Personal Care Items

STOCK AND RETAIL SALE

187

7-301

187

Storage and Display

Chapter 8

Compliance and Enforcement

8-1

8-2

8-3

CODE APPLICABILITY

189

8-101
8-102
8-103

189
190
190

Use for Intended Purpose

Additional Requirements
Variances

PLAN SUBMISSION AND APPROVAL

192

8-201
8-202
8-203

192
195
195

Facility and Operating Plans

Confidentiality
Construction Inspection and Approval

PERMIT TO OPERATE

195

8-301
8-302
8-303
8-304

195
196
199
200

Requirement
Application Procedure
Issuance
Conditions of Retention

Contents xix

8-4

8-5

INSPECTION AND CORRECTION OF VIOLATIONS

202

8-401
8-402
8-403
8-404
8-405
8-406

202
204
206
208
208
209

Frequency
Access
Report of Findings
Imminent Health Hazard
Violation of Critical Item
Noncritical Violation

PREVENTION OF FOODBORNE DISEASE

TRANSMISSION BY EMPLOYEES

210

8-501

210

Investigation and Control

Annex 1

Compliance and Enforcement

1.
2.
3.
4.
5.

PURPOSE
EXPLANATION
PRINCIPLE
RECOMMENDATION
PARTS
8-6
CONSTITUTIONAL PROTECTION
8-7
NOTICES
8-8
REMEDIES

213
213
214
214
215
215
216
218

Annex 2

References
PART 1
PART 2
PREFACE
CHAPTER 1
CHAPTER 2
CHAPTER 3
CHAPTER 4

UNITED STATES CODE AND CODE OF

FEDERAL REGULATIONS
BIBLIOGRAPY

PURPOSE AND DEFINITIONS

MANAGEMENT AND PERSONNEL
FOOD
EQUIPMENT, UTENSILS, AND
LINENS
CHAPTER 5
WATER, PLUMBING, AND WASTE
CHAPTER 6
PHYSICAL FACILITIES
CHAPTER 7
POISONOUS OR TOXIC MATERIALS
PART 3
SUPPORTING DOCUMENTS
A . (Draft) Recommended National Voluntary Retail
Food Regulatory Program Standards

Contents xx

237
243
243
244
246
255
285
288
289
289
291
291

B. FDA Procedures for Standardization and

Certification of Retail Food Inspection/Training
Officers
C. Managing Food Safety: A Manual for the Voluntary
Use of HACCP Principles for Operators of Food
Service and Retail Establishments
D. Managing Food Safety: A Regulators Manual for
Applying HACCP Principles to Risk-based Retail
and Food Service Inspections and Evaluating
Voluntary Food Safety Management Systems
E. Food Establishment Plan Review Guidelines
F. FDA Report on the Occurrence of Foodborne Illness
Risk Factors in Selected Institutional Foodservice,
Restaurant, and Retail Food Store Facility Types
(2004)
G. Growing Sprouts in a Retail Food Establishment
H. Advisories for Retail Processing with Proper
Controls and Variances for Product Safety
I. Evaluation and Definition of Potentially Hazardous
Foods
J. The U.S. Equal Employment Opportunity
Commission (EEOC) Guide, How to Comply with
the Americans with Disabilities Act: A Guide for
Restaurants and Other Food Service Employers
October 28, 2004
K. Guidance for Retail Facilities Regarding Beef
Grinding Logs Tracking Supplier Information
L. Recommended Guidelines for Permanent Outdoor
Cooking Establishments, 2003
M. Comprehensive Guidelines for Food Recovery
PART 4
FOOD DEFENSE GUIDANCE FROM FARM
TO TABLE
FDA Publications
USDA Publications
Industry Publications
Guidance on Responding to Food Emergencies
Food Defense and Emergency Guidance of Interest to
Schools
Defense Guidance of Interest to Consumers

292

293

295

295
296
296
297

298
298
300
300
301
301
302
302
303
303
303

Annex 3

Public Health Reasons/Administrative Guidelines

CHAPTER 1
CHAPTER 2

PURPOSE AND DEFINITIONS

MANAGEMENT AND PERSONNEL
Contents xxi

305
313

CHAPTER 3
CHAPTER 4
CHAPTER 5
CHAPTER 6
CHAPTER 7
CHAPTER 8

FOOD
EQUIPMENT, UTENSILS, AND
LINENS
WATER, PLUMBING, AND WASTE
PHYSICAL FACILITIES
POISONOUS OR TOXIC MATERIALS
COMPLIANCE AND ENFORCEMENT

355
420
447
459
469
473

Annex 4

Management of Food Practices Achieving Active Managerial

Control of Foodborne Illness Risk Factors
1.
2.
3.
4.

5.
6.
7.
8.
9.

ACTIVE MANAGERIAL CONTROL

INTRODUCTION TO HACCP
THE HACCP PRINCIPLES
THE PROCESS APPROACH A PRACTICAL
APPLICATION OF HACCP AT RETAIL TO
ACHIEVE ACTIVE MANAGERIAL CONTROL
FDA RETAIL HACCP MANUALS
ADVANTAGES OF USING THE PRINCIPLES OF
HACCP
SUMMARY
ACKNOWLEDGEMENTS
RESOURCES AND REFERENCES

475
478
480

494
501
502
503
504
504

Annex 5

Conducting Risk-Based Inspections

1. PURPOSE AND SCOPE
2. RISK-BASED ROUTINE INSPECTIONS
3. WHAT IS NEEDED TO PROPERLY CONDUCT A
RISK-BASED INSPECTION?
4. RISK-BASED INSPECTION METHODOLOGY
5. ACHIEVING ON-SITE AND LONG-TERM
COMPLIANCE
6. INSPECTION FORM AND SCORING
7. CLOSING CONFERENCE
8. SUMMARY

Contents xxii

509
510
511
516
535
540
542
542

Annex 6

Food Processing Criteria

1. INTRODUCTION
2. REDUCED OXYGEN PACKAGING
3. SMOKING AND CURING

543
544
555

Annex 7

Model Forms, Guides, and Other Aids

1)

2)

Employee health information

a)
b)
c)

Form 1-A
Form 1-B
Form 1-C

d)

Form 1-D

Adoption information
a)
b)

3)

Form 2-A
Form 2-B

Adoption by Reference
Adoption by Section-by-Section Reference

Inspection information
a)
b)
c)

4)

Conditional Employee or Food Employee Interview

Conditional or Food Employee Reporting Agreement
Conditional Employee or Food Employee Medical
Referral
Application for Bare Hand Contact Procedure

Form 3-A
Guide 3-B
Guide 3-C

Food Establishment Inspection Report

Code Reference Sheet for the Food Inspection Report
Instructions for Marking the Food Establishment
Inspection Report

Summary information
a)

Chart 4-A

b)

Chart 4-B

c)

Chart 4-C

d)
e)

Chart 4-D
Summary

Summary Chart for Minimum Cooking Food

Temperatures and Holding Times Required by Chapter 3
Summary Chart for Minimum Food Temperatures and
Holding Times Required by Chapter 3 for Reheating
Foods for Hot Holding
Summary Chart Ready-to-eat, Potentially Hazardous
Food (Time/Temperature, Control for Safety Food) Date
Marking 3-501.17(A) (E) and Disposition 3-501.18
FDA Food Code Mobile Food Establishment Matrix
Summary of Changes in the FDA Food Code

Contents xxiii