How to Use This Service Page Purpose of the Guide... iii Organization of the Guide... iii Order of Chapters........................ iii Contents of Appendices... iv How Tabs and Sections are Numbered............... iv How the Guide s Pages are Numbered...............v Symbols and Abbreviations.................... v Citations... Cross-References to Tabs, Sections, and Appendices... Updates to the Guide... vi vi vi Comments and Questions From Readers... vii Section 1 Introduction and Overview 1.0 Overview... 3 1.1 History of Food Safety Regulation...4 1.1.1 Pure Food and Drugs Act of 1906.............4 1.1.2 Federal Food, Drug, and Cosmetic Act... 4 Page One
1.1.3 Amendments to the Food, Drug, and Cosmetic Act... 6 1.1.4 The Federal Meat Inspection Act..............9 1.1.5 The Poultry Products Inspection Act... 10 1.2 The Role of Federal Agencies... 11 1.2.1 The Food and Drug Administration (FDA)......... 11 1.2.2 The U.S. Department of Agriculture (USDA)... 13 1.2.3 The Environmental Protection Agency (EPA)... 14 1.2.4 Interagency Coordination... 15 1.3 Biotechnology... 17 Section 2 General Principles of Food Safety 2.0 Overview... 3 2.1 Definition of Food Safety................... 5 2.2 Sources of Food Safety Hazards... 7 2.3 Controlling Potential Hazards... 9 2.4 Government Regulation of Food Safety... 11 2.5 Enforcement Actions... 12 2.6 Administrative Sanctions... 13 2.6.1 Warning Letters... 13 2.6.2 Adverse Publicity.................... 13 2.6.3 Recalls......................... 14 2.6.4 FDA Civil Money Penalties... 15 Page Two
2.6.5 USDA Administrative Sanctions............. 15 2.7 Judicial Sanctions Against Product.............. 16 2.8 Judicial Actions Against a Company............. 17 2.8.1 Injunctions... 17 2.8.2 Criminal Prosecution... 18 Section 3 Environmental and Accidental Contaminants 3.0 Overview... 3 3.1 The Basic Legal Standard................... 5 3.1.1 Inherent Substances.................... 6 3.1.2 Added Substances... 6 3.2 When a Poisonous or Deleterious Substance is Added..... 9 3.2.1 Litigation Involving Environmental and Accidental Contaminants 10 3.3 FDA Tolerances... 12 3.4 FDA Action Levels... 14 3.4.1 General Regulations Governing Action Levels... 14 3.4.2 Criteria for Establishing Action Levels... 15 3.4.3 Issuance and Modification of Action Levels... 16 3.4.4 Legal Effect of Action Levels............... 17 3.4.5 Defect Action Levels... 18 3.5 Types of Environmental and Accidental Contaminants..... 19 3.6 Microbiological Contamination... 20 Page Three
3.6.1 FDA Regulation of Microbiological Contaminants... 20 3.6.2 Zero Tolerance Policy and Process Controls... 20 3.6.3 USDA Regulation of Microbiological Contaminants..... 22 3.6.4 Potential Sources of Microbiological Contamination..... 23 3.7 Contamination From Mercury and Polychlorinated Biphenyls (PCBs).............. 25 3.7.1 Mercury Contamination... 25 3.7.2 Contamination From Polychlorinated Biphenyls (PCBs)... 26 3.8 Contamination of Crops by Aflatoxin............. 28 3.8.1 Potential Sources of Aflatoxin Contamination... 28 3.9 Checklist: Responding to Potential Contamination... 29 Section 4 Intentionally Added Substances 4.0 Overview... 3 4.1 Pesticides... 5 4.1.1 The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 6 4.1.2 Tolerances for Pesticide Residues..............7 4.1.3 Pesticide Residues in Processed Foods... 9 4.2 Checklist: Complying With Pesticide Regulations... 10 4.3 Food Additives... 14 4.3.1 The Roles of FDA and USDA Regarding Food Additives (and Color Additives) for Meat and Poultry... 14 Page Four
4.3.2 Definition of Food Additive............... 15 4.3.3 The Delaney Clause.................... 18 4.3.4 Exclusions From the Food Additive Definition... 19 4.3.5 Substances Generally Recognized As Safe (GRAS)..... 19 4.3.6 Prior Sanctioned Ingredients... 21 4.3.7 Strategies for Gaining Exemptions............. 21 4.4 Checklist: Complying With Food Additive Regulations..... 23 4.5 Color Additives... 26 4.5.1 Definition......................... 26 4.5.2 Approval Process for Color Additives... 27 4.6 Checklist: Complying With Color Additive Regulations... 28 4.7 Animal Drugs... 29 4.7.1 New Animal Drug Approval Process... 29 4.7.2 The Delaney Clause and the DES Proviso.......... 30 4.7.3 Extra-Label Use... 30 4.7.4 Complying With New Animal Drug Provisions... 31 Section 5 Food Irradiation and Food Biotechnology: Cutting Edge Technologies of the New Millennium 5.0 Overview... 3 5.1 Food Irradiation... 4 5.1.1 What is Food Irradiation?... 5 Page Five
5.1.2 FDA- and USDA-Approved Uses of Food Irradiation... 5 5.1.3 Food Irradiation Petitions Pending at FDA... 7 5.1.4 FDA Approvals for Irradiation of Packaging Materials; Premarket Notification Procedure for Food Contact Substances... 9 5.1.5 Labeling Requirements for Irradiated Foods... 10 5.1.6 Irradiation and HACCP... 11 5.2 Food Biotechnology... 14 5.2.1 What Is Food Biotechnology?... 14 5.2.2 What Crops/Foods Are Genetically Modified?... 15 5.2.3 Federal Regulation... 16 5.2.4 Labeling of GM Foods... 18 Section 6 Identifying Potential Food Safety Hazards 6.0 Overview... 3 6.1 Good Manufacturing Practices (GMPs)............4 6.2 Quality Control Programs................... 6 6.3 Overview of Hazard Analysis Critical Control Point (HACCP) Systems............... 7 6.3.1 Hazard Analysis... 7 6.3.2 Identification of Critical Control Points... 8 6.3.3 Critical Limits... 8 6.3.4 Monitoring......................... 8 6.3.5 Corrective Action... 9 Page Six
6.3.6 Recordkeeping... 9 6.3.7 Verification and Improvement...9 6.4 Checklist: Hazard Identification............... 11 6.4.1 Raw Materials Acquisition... 12 6.4.2 Receipt and Storage of Raw Materials... 14 6.4.3 Facility Where the Product is Stored and/or Processed..... 16 6.4.4 Processing... 19 6.4.5 Personnel... 21 6.4.6 Packaging Material.................... 23 6.4.7 Storage and Shipment of Finished Food Products... 24 Section 7 General Principles of HACCP 7.1 Overview... 3 7.2 National Advisory Committee on Microbiological Criteria for Foods (NACMCF)............... 4 7.3 NACMCF Guidance on the Role of Regulatory Agencies in HACCP... 40 Section 8 Applying HACCP in the Plant 8.0 Overview... 3 8.1 Hazard Analysis... 6 Page Seven
8.1.1 Sanitation/Good Manufacturing Practices as HACCP Precursors. 6 8.1.2 Assembling the HACCP Team... 6 8.1.3 Describing the Processor 's Food Products... 7 8.1.4 Identifying Intended Uses and Likely Consumers of Products.. 8 8.1.5 Developing a Processing Flow Chart... 8 8.1.6 Verifying the Accuracy of the Flow Chart... 9 8.1.7 Conducting a Hazard Analysis...9 8.2 Identifying the Critical Control Points... 11 8.3 Setting Critical Limits for Each Identified Critical Control Point 15 8.3.1 Potential Sources of Data for Setting Critical Limits... 16 8.4 Establishing Monitoring Requirements for Critical Control Points 18 8.4.1 Documenting Monitoring Activities............. 19 8.4.2 Implementing Monitoring Activities............. 19 8.5 Corrective Action for Deviations from Critical Limits... 21 8.6 Verification Procedures to Assess the HACCP System..... 24 8.7 Establishing Effective Recordkeeping Procedures... 26 8.8 Application of HACCP Steps in Developing a Hypothetical HACCP Plan for Cooked Beef Patties... 29 Section 9 Meat and Poultry HACCP 9.0 Overview... 5 9.1 Legal Authority... 8 Page Eight
9.1.1 Authority to Adopt Sanitation Performance Standards/SSOP Requirements... 8 9.1.2 Authority to Adopt HACCP Requirements... 8 9.1.3 Authority to Adopt Microbial Testing Requirements... 9 9.2 Prequisite Programs... 10 9.2.1 Sanitation Performance Standards... 10 9.2.1.1 The Performance Standards In General... 10 9.2.1.2 Enforcement... 12 9.2.2 Sanitation Standard Operating Procedure (SSOP)... 13 9.2.2.1 The SSOP Requirements... 13 9.2.2.2 Enforcement... 15 9.2.3 Regulatory Non-recognition of Good Manufacturing Programs.. 16 9.3 Regulatory HACCP Principles... 17 9.3.1 Hazard Analysis... 17 9.3.1.1 General Regulatory Requirements... 17 9.3.1.2 What Is A Hazard Reasonably Likely To Occur... 17 9.3.1.3 HACCP Plans For Individual Products/Processes... 18 9.3.2 Critical Control Points... 19 9.3.3 Critical Limits... 20 9.3.4 Monitoring... 20 9.3.5 Corrective Actions... 21 9.3.6 Verification, Including Agency Testing & In-Depth Verification. 21 9.3.6.1 Establishment Verification... 22 Page Nine
9.3.6.2 Agency Verification In General... 23 9.3.6.3 Agency Testing Programs... 23 9.3.6.3.1 E. coli Testing... 24 9.3.6.3.2 Salmonella Performance Standards... 25 9.3.6.4 In-Depth Verification (IDV) Audits... 27 9.3.7 Recordkeeping... 27 9.3.7.1 Regulatory Requirements... 27 9.3.7.2 Practical Guide To Records... 29 9.3.8 Miscellaneous Regulatory HACCP Requirements... 30 9.3.8.1 Beyond Current HACCP Requirements: Future Trends... 31 9.3.8.2 Food Safety After The Product Leaves The Establishment... 31 9.3.8.3 New In-Plant Initiatives... 31 9.3.8.4 Foodborne Outbreak Tracking Capabilities... 32 9.4 ENFORCEMENT ACTIONS... 33 9.4.1 In-Plant Enforcement The Noncompliance Record... 33 9.4.1.1 The NR in General... 34 9.4.1.2 Appealing Nrs... 38 9.4.1.3 NR Tracking... 41 9.4.2 Enforcement Threatened and Actual Suspension of Inspection. 42 9.4.2.1 Initiation of Enforcement Action... 42 9.4.2.1.1 Withholding of Inspection... 42 9.4.2.1.1 Other Triggers... 43 9.4.2.2 Procedures For Withholding Actions and Suspensions... 43 Page Ten
9.4.2.3 Other Suspension Procedures... 47 9.4.2.4 Scope of Action... 49 9.4.3 Administrative Enforcement Proceedings Before an Administrative Law Judge... 49 9.4.4 Federal Court Appeal... 49 Section 10 FDA HACCP Regulation 10.0 FDA HACCP Regulation... 3 10.1 Implications of HACCP for FDA Inspection... 4 10.2 FDA Requirements for HACCP Systems Seafood... 5 10.2.1 In General... 5 10.2.2 Requirements Particular to Seafood Processors and Importers Under FDA s Seafood HACCP Regulation... 9 10.2.2.1 Scope of Regulation... 9 10.2.2.2 Sanitation... 10 10.2.2.3 Receipt of Product as a Critical Control Point... 11 10.2.2.4 Importers... 12 10.2.3 Compliance... 13 10.2.4 Miscellaneuos Provisions... 14 10.2.4.1 Training... 14 10.2.4.2 Low Acid Canned Foods... 14 10.3 Requirements Particular to Juice Processors and Importers Under FDA s Juice HACCP Proposal... 15 10.3.1 Scope... 15 Page Eleven
10.3.2 Prerequisite Program SSOPs... 16 10.3.3 HACCP Plan... 17 10.3.3.1 Mandatory Performance Standard... 17 10.3.3.2 Verification... 18 10.3.3.3 Validation... 18 10.3.3.4 Records Retention and Access... 19 10.3.4 Imported Products... 20 10.4 FDA Pilot Programs for Extension of HACCP Systems... 21 Appendix I United States Code Appendix II Code of Federal Regulations Appendix II I In-Depth Verification Protocol Page Twelve