FSMA and Food Safety Systems

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