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Published by: Food Institute Information and Research Center
Published: Jan. 1, 2000 - 462 Pages
Table of Contents
How to Use This Service
Purpose of the Guide
Organization of the Guide
Order of Chapters
Contents of Appendices
How Tabs and Sections are Numbered
How the Guide’s Pages are Numbered
Symbols and Abbreviations
Citations
Cross-References to Tabs, Sections, and Appendices
Updates to the Guide
Comments and Questions From Readers
Section 1
Introduction and Overview
1.0 Overview
1.1 History of Food Safety Regulation
1.1.1 Pure Food and Drugs Act of 1906
1.1.2 Federal Food, Drug, and Cosmetic Act
1.1.3 Amendments to the Food, Drug, and Cosmetic Act
1.1.4 The Federal Meat Inspection Act
1.1.5 The Poultry Products Inspection Act
1.2 The Role of Federal Agencies
1.2.1 The Food and Drug Administration (FDA)
1.2.2 The U.S. Department of Agriculture (USDA)
1.2.3 The Environmental Protection Agency (EPA)
1.2.4 Interagency Coordination
1.3 Biotechnology
Section 2
General Principles of Food Safety
2.0 Overview
2.1 Definition of Food Safety
2.2 Sources of Food Safety Hazards
2.3 Controlling Potential Hazards
2.4 Government Regulation of Food Safety
2.5 Enforcement Actions
2.6 Administrative Sanctions
2.6.1 Warning Letters
2.6.2 Adverse Publicity
2.6.3 Recalls
2.6.4 FDA Civil Money Penalties
2.6.5 USDA Administrative Sanctions
2.7 Judicial Sanctions Against Product
2.8 Judicial Actions Against a Company
2.8.1 Injunctions
2.8.2 Criminal Prosecution
Section 3
Environmental and Accidental Contaminants
3.0 Overview
3.1 The Basic Legal Standard
3.1.1 Inherent Substances
3.1.2 Added Substances
3.2 When a Poisonous or Deleterious Substance is “Added”
3.2.1 Litigation Involving Environmental and Accidental Contaminants
3.3 FDA Tolerances
3.4 FDA Action Levels
3.4.1 General Regulations Governing Action Levels
3.4.2 Criteria for Establishing Action Levels
3.4.3 Issuance and Modification of Action Levels
3.4.4 Legal Effect of Action Levels
3.4.5 Defect Action Levels
3.5 Types of Environmental and Accidental Contaminants
3.6 Microbiological Contamination
3.6.1 FDA Regulation of Microbiological Contaminants
3.6.2 Zero Tolerance Policy and Process Controls
3.6.3 USDA Regulation of Microbiological Contaminants
3.6.4 Potential Sources of Microbiological Contamination
3.7 Contamination From Mercury and Polychlorinated Biphenyls (PCBs)
3.7.1 Mercury Contamination
3.7.2 Contamination From Polychlorinated Biphenyls (PCBs)
3.8 Contamination of Crops by Aflatoxin
3.8.1 Potential Sources of Aflatoxin Contamination
3.9 Checklist: Responding to Potential Contamination
Section 4
Intentionally Added Substances
4.0 Overview
4.1 Pesticides
4.1.1 The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
4.1.2 Tolerances for Pesticide Residues
4.1.3 Pesticide Residues in Processed Foods
4.2 Checklist: Complying With Pesticide Regulations
4.3 Food Additives
4.3.1 The Roles of FDA & USDA Regarding Food Additives (& Color Additives) for Meat & Poultry
4.3.2 Definition of “Food Additive”
4.3.3 The Delaney Clause
4.3.4 Exclusions From the Food Additive Definition
4.3.5 Substances “Generally Recognized As Safe” (GRAS)
4.3.6 Prior Sanctioned Ingredients
4.3.7 Strategies for Gaining Exemptions
4.4 Checklist: Complying With Food Additive Regulations
4.5 Color Additives
4.5.1 Definition
4.5.2 Approval Process for Color Additives
4.6 Checklist: Complying With Color Additive Regulations
4.7 Animal Drugs
4.7.1 New Animal Drug Approval Process
4.7.2 The Delaney Clause and the DES Proviso
4.7.3 Extra-Label Use
4.7.4 Complying With New Animal Drug Provisions
Section 5
Food Irradiation and Food Biotechnology: Cutting Edge Technologies of the New Millennium
5.0 Overview
5.1 Food Irradiation
5.1.1 What is Food Irradiation?
5.1.2 FDA- and USDA-Approved Uses of Food Irradiation
5.1.3 Food Irradiation Petitions Pending at FDA
5.1.4 FDA Approvals for Irradiation of Packaging Materials; Premarket Notification Procedure for Food Contact Substances
5.1.5 Labeling Requirements for Irradiated Foods
5.1.6 Irradiation and HACCP
5.2 Food Biotechnology
5.2.1 What Is Food Biotechnology?
5.2.2 What Crops/Foods Are Genetically Modified?
5.2.3 Federal Regulation
5.2.4 Labeling of GM Foods
Section 6
Identifying Potential Food Safety Hazards
6.0 Overview
6.1 Good Manufacturing Practices (GMPs)
6.2 Quality Control Programs
6.3 Overview of Hazard Analysis Critical Control Point (HACCP) Systems
6.3.1 Hazard Analysis
6.3.2 Identification of Critical Control Points
6.3.3 Critical Limits
6.3.4 Monitoring
6.3.5 Corrective Action
6.3.6 Recordkeeping
6.3.7 Verification and Improvement
6.4 Checklist: Hazard Identification
6.4.1 Raw Materials Acquisition
6.4.2 Receipt and Storage of Raw Materials
6.4.3 Facility Where the Product is Stored and/or Processed
6.4.4 Processing
6.4.5 Personnel
6.4.6 Packaging Material
6.4.7 Storage and Shipment of Finished Food Products
Section 7
General Principles of HACCP
7.1 Overview
7.2 National Advisory Committee on Microbiological Criteria for Foods (NACMCF)
7.3 NACMCF Guidance on the Role of Regulatory Agencies in HACCP
Section 8
Applying HACCP in the Plant
8.0 Overview
8.1 Hazard Analysis
8.1.1 Sanitation/Good Manufacturing Practices as HACCP Precursors
8.1.2 Assembling the HACCP Team
8.1.3 Describing the Processor's Food Products
8.1.4 Identifying Intended Uses and Likely Consumers of Products
8.1.5 Developing a Processing Flow Chart
8.1.6 Verifying the Accuracy of the Flow Chart
8.1.7 Conducting a Hazard Analysis
8.2 Identifying the Critical Control Points
8.3 Setting Critical Limits for Each Identified Critical Control Point
8.3.1 Potential Sources of Data for Setting Critical Limits
8.4 Establishing Monitoring Requirements for Critical Control Points
8.4.1 Documenting Monitoring Activities
8.4.2 Implementing Monitoring Activities
8.5 Corrective Action for Deviations from Critical Limits
8.6 Verification Procedures to Assess the HACCP System
8.7 Establishing Effective Recordkeeping Procedures
8.8 Application of HACCP Steps in Developing a Hypothetical HACCP Plan for Cooked Beef Patties
Section 9
Meat and Poultry HACCP
9.0 Overview
9.1 Legal Authority
9.1.1 Authority to Adopt Sanitation Performance Standards/SSOP Requirements
9.1.2 Authority to Adopt HACCP Requirements
9.1.3 Authority to Adopt Microbial Testing Requirements
9.2 Prequisite Programs
9.2.1 Sanitation Performance Standards
9.2.1.1 The Performance Standards In General
9.2.1.2 Enforcement
9.2.2 Sanitation Standard Operating Procedure (SSOP)
9.2.2.1 The SSOP Requirements
9.2.2.2 Enforcement
9.2.3 Regulatory Non-recognition of Good Manufacturing Programs
9.3 Regulatory HACCP Principles
9.3.1 Hazard Analysis
9.3.1.1 General Regulatory Requirements
9.3.1.2 What Is A Hazard Reasonably Likely To Occur
9.3.1.3 HACCP Plans For Individual Products/Processes
9.3.2 Critical Control Points
9.3.3 Critical Limits
9.3.4 Monitoring
9.3.5 Corrective Actions
9.3.6 Verification, Including Agency Testing & In-Depth Verification
9.3.6.1 Establishment Verification
9.3.6.2 Agency Verification In General
9.3.6.3 Agency Testing Programs
9.3.6.3.1 E. coli Testing
9.3.6.3.2 Salmonella Performance Standards
9.3.6.4 In-Depth Verification (IDV) Audits
9.3.7 Recordkeeping
9.3.7.1 Regulatory Requirements
9.3.7.2 Practical Guide To Records
9.3.8 Miscellaneous Regulatory HACCP Requirements
9.3.8.1 Beyond Current HACCP Requirements: Future Trends
9.3.8.2 Food Safety After The Product Leaves The Establishment
9.3.8.3 New In-Plant Initiatives
9.3.8.4 Foodborne Outbreak Tracking Capabilities
9.4 ENFORCEMENT ACTIONS
9.4.1 In-Plant Enforcement - The Noncompliance Record
9.4.1.1 The NR in General
9.4.1.2 Appealing Nrs
9.4.1.3 NR Tracking
9.4.2 Enforcement - Threatened and Actual Suspension of Inspection
9.4.2.1 Initiation of Enforcement Action
9.4.2.1.1 Withholding of Inspection
9.4.2.1.1 Other Triggers
9.4.2.2 Procedures For Withholding Actions and Suspensions
9.4.2.3 Other Suspension Procedures
9.4.2.4 Scope of Action
9.4.3 Administrative Enforcement - Proceedings Before an Administrative Law Judge
9.4.4 Federal Court Appeal
Section 10
FDA HACCP Regulation
10.0 FDA HACCP Regulation
10.1 Implications of HACCP for FDA Inspection
10.2 FDA Requirements for HACCP Systems — Seafood
10.2.1 In General
10.2.2 Requirements Particular to Seafood Processors and Importers Under FDA’s Seafood HACCP Regulation
10.2.2.1 Scope of Regulation
10.2.2.2 Sanitation
10.2.2.3 Receipt of Product as a Critical Control Point
10.2.2.4 Importers
10.2.3 Compliance
10.2.4 Miscellaneuos Provisions
10.2.4.1 Training
10.2.4.2 Low Acid Canned Foods
10.3 Requirements Particular to Juice Processors and Importers Under FDA’s Juice HACCP Proposal
10.3.1 Scope
10.3.2 Prerequisite Program — SSOPs
10.3.3 HACCP Plan
10.3.3.1 Mandatory Performance Standard
10.3.3.2 Verification
10.3.3.3 Validation
10.3.3.4 Records Retention and Access
10.3.4 Imported Products
10.4 FDA Pilot Programs for Extension of HACCP Systems
Appendix I
Appendix II
AbstractAn easy-to-use manual (in loose-leaf form) providing clear explanations of the recent regulations and requirements issued by the FDA for seafood and the USDA for meat & poultry products. This text translates the bureaucratic legalese into plain English and also includes the actual statutes.
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