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FSMA and Food Safety Systems: Understanding and Implementing the Rules

ISBN: 978-1-119-25807-0
234 pages
January 2017
FSMA and Food Safety Systems: Understanding and Implementing the Rules (1119258073) cover image

Description

The FDA's (Food and Drug Administration) FSMA (Food Safety Modernization Act) is the most sweeping reform of United States food safety laws in more than 70 years.  The key to successful implementation of FSMA rules depends on building a comprehensive Food Safety System with effective prerequisite programs in place and a well-designed Food Safety Plan that incorporates risk-based preventive controls to mitigate hazards.

This book provides essential guidance for small to mid-sized businesses on how to design, implement, and maintain a world-class Food Safety Plan that conforms to FSMA regulations. With practical and up-to-date advice, the author offers a straight forward approach for readers to successfully migrate into FSMA. The inclusion of fully developed Food Safety Plans as well as examples of hazards and preventative controls make this a must-read not only for those that are new to the regulations, but also those with a plan already in place.

FSMA and Food Safety Systems: A Guide to Understanding and Implementing the Rules is an indispensable resource for all those managing the manufacture of FDA regulated products, food safety regulators and educators, as well as scientists and students of food science and technology.

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Table of Contents

Preface xi

About the Author xiii

1 What is Modern Food Safety, and How is that Different from HACCP? 1

1.1 Introduction 1

1.2 FSMA Sanitation and cGMPs 3

1.3 FSMA Preventive Controls 4

1.4 Process Controls 5

1.5 Sanitation Controls 6

1.6 Supplier Controls 8

References 10

2 Why Is a Food Safety System the Best Path to Food Safety? 11

2.1 What are Biological Hazards and Their Controls? 11

2.2 What are Chemical Hazards, Including Allergens and Radioactivity, and Their Controls? 15

2.3 What are Physical Hazards and Their Controls? 17

References 19

3 What are the Essential Elements of a Food Safety System? 21

3.1 What are Prerequisite Programs, and What Do They Do? 22

3.2 What is a Hazard Analysis, and Why is it Performed? 23

3.3 What are Risk-Based Preventive Controls, and How are they Assigned? 25

3.3.1 What Controls are Used to Control Allergen-Related Hazards? 26

3.3.2 What Controls are Used to Control Sanitation-Related Hazards? 27

3.3.3 What Controls are Used to Control Process Hazards? 29

3.3.4 What Controls are Used to Control Supplier-Related Hazards? 30

3.4 What is a Food Safety Plan, and Who Develops It? 32

4 How is a Food Safety System Managed? 35

4.1 What is the Role of Management and Plant Operations in a Food Safety System? 35

4.2 How are SOPs Developed and Managed? 36

4.3 How are Preventive Controls Managed? 39

4.3.1 What are Performance Criteria for Controls, Including Critical Limits? 39

4.3.2 How are Preventive Controls Monitored? 40

4.3.3 If Preventive Controls Fail, What Corrective Actions are Needed? 41

4.3.4 How is the System and its Parts Verified as Being Compliant? 43

4.3.5 How are Process Preventive Controls Validated? 44

4.4 How are Records Established and Maintained? 46

4.5 Why and How is a Recall Plan Developed and Managed? 48

References 51

Supplemental References for Recalls 51

5 How is a Food Safety System Developed and Implemented? 53

5.1 Developing a Food Safety Plan 54

5.2 Assemble the Food Safety Team 55

5.3 Describe the Food and its Distribution 55

5.4 Describe the Intended Use and Consumers of the Food 55

5.5 Develop a Flow Diagram that Describes the Process 56

5.6 Verify the Flow Diagram 56

5.7 Conduct a Hazard Analysis 56

5.8 Essential Elements of the Food Safety Plan 58

6 What Triggers a Reanalysis of the Food Safety Plan? 61

7 Resources for Preparing Food Safety Preventive Controls Plans 63

7.1 Examples of Prerequisite Programs 63

7.2 Examples of Allergen Preventive Controls 65

7.3 Examples of Sanitation Preventive Controls 65

7.4 Examples of Process Preventive Controls 66

7.5 Examples of Supplier Controls 68

7.6 Useful Forms 68

7.7 FSMA Training and the Food Safety Preventive Controls Alliance 75

8 Example Food Safety Plans 77

Barbeque Sauce – Example Food Safety Plan 78

Company Overview 78

Process Narrative 79

Chocolate Chip Walnut Cookies – Example Food Safety Plan 88

Company Overview 88

Process Narrative 89

Deli Potato Salad – Example Food Safety Plan 102

Company Overview 102

Process Narrative 103

Macaroni & Cheese Frozen Meal – Example Food Safety Plan 118

Company Overview 118

Process Narrative 119

9 FSMA Regulations: cGMPs, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods 131

FDA Regulations on cGMP’s, Hazard Analysis and Risk-based Preventive Controls for Human Foods 132

Part 117—Current Good Manufacturing Practice, Hazard Analysis, and Risk–Based Preventive Controls for

Human Food 132

Subpart A—General Provisions 132

Subpart B—Current Good Manufacturing Practice 132

Subpart C—Hazard Analysis and Risk-Based Preventive Controls 132

Subpart D—Modified Requirements 133

Subpart E—Withdrawal of a Qualified Facility Exemption 133

Subpart F—Requirements Applying to Records That Must Be Established and Maintained 133

Subpart G—Supply-Chain Program 134

Subpart A—General Provisions 134

§ 117.1 Applicability and status. 134

§ 117.3 Definitions. 135

§ 117.4 Qualifications of individuals who manufacture, process, pack, or hold food. 141

§ 117.5 Exemptions. 141

§ 117.7 Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food. 149

§ 117.8 Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities. 150

§ 117.9 Records required for this subpart. 150

Subpart B—Current Good Manufacturing Practice 150

§ 117.10 Personnel. 150

§ 117.20 Plant and grounds. 151

§ 117.35 Sanitary operations. 153

§ 117.37 Sanitary facilities and controls. 154

§ 117.40 Equipment and utensils. 155

§ 117.80 Processes and controls. 156

§ 117.93 Warehousing and distribution. 159

§ 117.110 Defect action levels. 160

Subpart C—Hazard Analysis and Risk-Based Preventive Controls 160

§ 117.126 Food safety plan. 160

§ 117.130 Hazard analysis. 160

§ 117.135 Preventive controls. 161

§ 117.136 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control. 163

§ 117.137 Provision of assurances required under § 117.136(a)(2), (3), and (4). 164

§ 117.139 Recall plan. 164

§ 117.140 Preventive control management components. 165

§ 117.145 Monitoring. 165

§ 117.150 Corrective actions and corrections. 166

§ 117.155 Verification. 167

§ 117.160 Validation. 167

§ 117.165 Verification of implementation and effectiveness. 168

§ 117.170 Reanalysis. 170

§ 117.180 Requirements applicable to a preventive controls qualified individual and a qualified auditor. 171

§ 117.190 Implementation records required for this subpart. 172

Subpart D—Modified Requirements 172

§ 117.201 Modified requirements that apply to a qualified facility. 172

§ 117.206 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food. 174

Subpart E—Withdrawal of a Qualified Facility Exemption 175

§ 117.251 Circumstances that may lead FDA to withdraw a qualified facility exemption. 175

§ 117.254 Issuance of an order to withdraw a qualified facility exemption. 176

§ 117.257 Contents of an order to withdraw a qualified facility exemption. 176

§ 117.260 Compliance with, or appeal of, an order to withdraw a qualified facility exemption. 177

§ 117.264 Procedure for submitting an appeal. 177

§ 117.267 Procedure for requesting an informal hearing. 178

§ 117.270 Requirements applicable to an informal hearing. 178

§ 117.274 Presiding officer for an appeal and for an informal hearing. 179

§ 117.277 Timeframe for issuing a decision on an appeal. 179

§ 117.280 Revocation of an order to withdraw a qualified facility exemption. 179

§ 117.284 Final agency action. 180

§ 117.287 Reinstatement of a qualified facility exemption that was withdrawn. 180

Subpart F—Requirements Applying to Records That Must Be Established and Maintained 181

§ 117.301 Records subject to the requirements of this subpart. 181

§ 117.305 General requirements applying to records. 181

§ 117.310 Additional requirements applying to the food safety plan. 181

§ 117.315 Requirements for record retention. 182

§ 117.320 Requirements for official review. 182

§ 117.325 Public disclosure. 182

§ 117.330 Use of existing records. 182

§ 117.335 Special requirements applicable to a written assurance. 183

Subpart G—Supply-Chain Program 183

§ 117.405 Requirement to establish and implement a supply-chain program. 183

§ 117.410 General requirements applicable to a supply-chain program. 184

§ 117.415 Responsibilities of the receiving facility. 186

§ 117.420 Using approved suppliers. 186

§ 117.425 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity). 187

§ 117.430 Conducting supplier verification activities for raw materials and other ingredients. 187

§ 117.435 Onsite audit. 189

§ 117.475 Records documenting the supply-chain program. 190

Appendix A Food Safety Plan Checklist 193

Food Safety Plan Checklist 193

Introduction 193

Purpose 194

References 198

Appendix B HACCP Principles and Application Guidelines 199

National Advisory Committee on Microbiological Criteria for Foods 199

Executive Summary 199

Definitions 200

HACCP Principles 202

Guidelines for Application of HACCP Principles 203

Introduction 203

Prerequisite Programs 203

Education and Training 204

Developing a HACCP Plan 204

Implementation and Maintenance of the HACCP Plan 215

References 216

Glossary 217

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