Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food

Document ID: FDA-2011-N-0920-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2013-00125
CFR Citation: 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 211
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Details Information

Abstract: Cosmetics;Drugs;Exports;Food Labeling;Imports;Labeling;Reporting and Recordkeeping Requirements;Administrative Practices and Procedures;Food Grades and Standards;Infants and Children;Nutrition;Food Packaging;Foods;Fruit Juices;Fish;Seafood;Beverages;Food Additives;Radiation Protection;Signs and Symbols;Laboratories;Packaging and Containers;Prescription Drugs;Warehouses
Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: January 16 2013, at 12:00 AM Eastern Standard Time
Start-End Page: 3646 - 3824
Page Count: 1
Comment Start Date: January 16 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: May 16 2013, at 11:59 PM Eastern Standard Time

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Appendix Referemce 39 FDA Lab Results Positive for Listeria at SanGar Fresh Produce

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Appendix Reference 1 Hazard Analysis and Critical Control Point Principles and Application Guidelines NACMCF 1998

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Appendix Reference 10 Union International Food Company Recall Widened Again

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Appendix Reference 11 A Survey of 18 Dry Product Processing Planet Environments for for Salmonella Listeria and Yersinia

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Appendix Reference 12 Recalls of Spices Due to Bacterial Contamination Monitored by the U.S. Food and Drug Administration: The Predominance of Salmonellae

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Appendix Reference 13 FDA Foods Program The Reportable Food Registry A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration. First Annual Report September 8 2009 September 7 2010

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Appendix Reference 14 Listeria monocytogenes Risk Assessment VII Interpretation and Conclusions

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Appendix Reference 15 Risk Assessment of Listeria monocytogenes in Ready to Eat Foods Technical Report

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Appendix Reference 16 Sampling to Assess Control of the Environment

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Appendix Reference 17 Guidelines to Prevent Post Processing Contamination from Listeria monocytogenes

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Appendix Reference 18 Control of Listeria monocytogenes in the Food Processing Environment

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Appendix Reference 19 Review: Persistence of Listeria monocytogenes in Food Industry Equipment and Premises

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Appendix Reference 2 Principles for the Establishment and Application of Microbiological Criteria for Foods CAC GL 21 1997

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Appendix Reference 20 CDC Investigations The May 1998 Outbreak of Salmonella Agona Linked to Cereal

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Appendix Reference 21 EPI AID 98 60 Trip Report Multistate Outbreak of Salmonella Agona Infection Linked to Consumption of Oat Cereal April through June 1997

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Appendix Reference 22 Foodborne Outbreak Online Database FOOD Search Results Highlighted for 1998 Salmonella Agona Outbreak in Dry Cereal

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Appendix Reference 23 Investigation of Outbreak of Infections Caused by Salmonella Agona

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Appendix Reference 24 Foodborne Outbreak Online Database FOOD Search Results Highlighted for 2006 2007 Salmonella Tennessee Outbreak in Peanut Butter

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Appendix Reference 25 Multistate Outbreak of Salmonella Serotype Tennessee Infections Associated with Peanut Butter United States 2006 2007

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Appendix Reference 26 Peanut Products Recall

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Appendix Reference 27 Hydrolyzed Vegetable Protein Product Recalls

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Appendix Reference 28 Multistate Outbreak of Salmonella Infections Associated with Peanut Butter and Peanut Butter Containing Products United States 2008 2009

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Appendix Reference 29 Salmonella Typhimurium Infections Associated with Peanut Products

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Appendix Reference 3 Microbiological Hazards and Their Control

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Appendix Reference 30 Amended Form 483 Inspectional Observations for Peanut Corporation of America Blakely GA 02 05 2009

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Appendix Reference 31 Form 483 Inspectional Observations for Peanut Corporation of America Plainview TX 02 26 2009

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Appendix Reference 32 Foodborne Outbreak Online Database FOOD Search Results Highlighted for 2008 Salmonella Typhimurium Outbreak in Peanut Butter and Peanut Paste

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Appendix Reference 33 Company Recalls Various Products Due to Potential Salmonella Contamination FDA USDA CDC Investigating No Link to Human Illnesses at This Time

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Appendix Reference 34 FDA Form 483 Inspectional Observations for Plainview Milk Products Cooperative

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Appendix Reference 35 Peanut Butter and Other Peanut Containing Products Recall List

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Appendix Reference 36 Multistate Outbreak of Listeria monocytogenes Associated with Mexican Style Cheese Made from Pasteurized Milk Among Pregnant Hispanic Women

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Appendix Reference 37 DSHS Orders Sangar Produce to Close Recall Products

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Appendix Reference 38 FDA Form 483 Inspectional Observations for Sangar Fresh Cut Produce Co LLC

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Appendix Reference 4 Selection and Use of Acceptance Criteria

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Appendix Reference 40 Information on the Recalled Jensen Farms Whole Cantaloupes

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Appendix Reference 41 Multistate Outbreak of Listeriosis Linked to Whole Cantaloupes from Jensen Farms, Colorado

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Appendix Reference 42 Listeria monocytogenes Risk Assessment II Hazard Identification

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Appendix Reference 43 An Outbreak of Listeria monocytogenes Serotype 3a Infections from Butter in Finland

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Appendix Reference 44 Quargel

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Appendix Reference 45 River Ranch Recalls Products Because of Possible Health Risk

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Appendix Reference 46 Taylor Farms Retail Inc Initiates a Precautionary Recall Because of Possible Health Risk

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Appendix Reference 47 Del Bueno Recalls Queso Fresco Casero Cheese Because of Possible Health Risk

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Appendix Reference 48 Fine Mexican Food Products Inc Recalls 2 2 lb Frozen Avocado Pulp and 3 lb IQF Avocado Halves from Peru Because of Possible Health Risk

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Appendix Reference 49 Listeria spp in Food Processing Non Food and Domestic Environments

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Appendix Reference 5 Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient

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Appendix Reference 50 Where Are Listeria Likely to be Found in Dairy Plants

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Appendix Reference 51 Comparison of the Incidence of Listeria on Equipment Versus Environmental Sites Within Dairy Processing Plants

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Appendix Reference 52 Characterization of Listeria monocytogenes from an Ice Cream Plant by Serotyping and Pulsed Field Gel Electrophoresis

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Appendix Reference 53 Identification of Listeria monocytogenes Contamination Sources in Two Fresh Sauce Production Plants by Pulsed-Field Gel Electrophoresis

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Appendix Reference 54 Phenotypic and Molecular Typing of Listeria monocytogenes Isolated from the Processing Environment and Products of a Sandwich Producing Plant

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Appendix Reference 55 Monitoring Hygiene On and At Line Is Critical for Controlling Listeria monocytogenes During Produce Processing

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Appendix Reference 56 Characterization of Listeria monocytogenes and Listeria innocua from a Vegetable Processing Plant by RAPD and REA

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Appendix Reference 57 Guidelines on the Application of General Principles of Food Hygiene to the Control of Listeria monocytogenes in Ready to Eat Foods CAC GL 61 2007

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Appendix Reference 58 Guidelines for Listeria Testing of Environmental, Raw Product and Finished Product Samples in Smoked Seafood Processing Facilities

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Appendix Reference 59 Control of Salmonella in Low Moisture Foods III Process Validation and Environmental Monitoring

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Appendix Reference 6 Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient

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Appendix Reference 60 Influence of Drying Plant Environment on Salmonellae Contamination of Dry Milk Products

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Appendix Reference 61 Acquisition of Microbiological Data to Enhance Food Safety

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Appendix Reference 62 Response to the Questions Posed by FSIS Regarding Performance Standards with Particular Reference to Ground Beef Products

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Appendix Reference 63 Microbiological Monitoring of the Food Processing Environment

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Appendix Reference 64 FSIS Compliance Guideline Controlling Listeria monocytogenes in Post-Lethality Exposed Ready to Eat Meat and Poultry Products

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Appendix Reference 65 Re Docket No 2007D 0494 Draft Guidance for Industry Control of Listeria monocytogenes in Refrigerated or Frozen Ready to Eat Foods Availability

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Appendix Reference 66 Appendix Comments on the FDA Guidance for Industry Control of Listeria monocytogenes in Refrigerated or Frozen Ready to Eat Foods

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Appendix Reference 67 Re Docket No 2007 D 0494 Draft Guidance for Industry Control of Listeria monocytogenes in Refrigerated or Frozen Ready to Eat Foods Availability

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Appendix Reference 68 Re Docket No 2007 D 0494 Draft Guidance for Industry Control of Listeria monocytogenes in Refrigerated or Frozen Ready to Eat Foods Availability

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Appendix Reference 69 Re Docket No 2004N 0230 Food Current Good Manufacturing Practice Regulations

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Appendix Reference 7 General Information Escherichia coli E coli

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Appendix Reference 70 Scientific Opinion of BIOHAZ Panel on the Request from the Commission for Review of the Opinion on Microbiological Risks in Infant Formulae and Follow on Formulae with Regard to Enterobacteriaceae As Indicators

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Appendix Reference 71 Drying Foods for Infants and Young Children

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Appendix Reference 72 Cereal and Cereal Products

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Appendix Reference 73 Spice Dry Soups and Asian Flavorings

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Appendix Reference 74 Cereal and Cereal Products

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Appendix Reference 75 Nuts Oilseeds Dried Legumes and Coffee

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Appendix Reference 76 Cocoa Chocolate and Confectionery

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Appendix Reference 77 Milk and Dairy Products

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Appendix Reference 78 Tracing of Enterobacter sakazakii Isolates in Infant Milk Formula Processing by BOX PCR Genotyping

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Appendix Reference 79 Application of Pulsed Field Gel Electrophoresis to Characterise and Trace the Prevalence of Enterobacter sakazakii in an Infant Formula Processing Facility

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Appendix Reference 8 Control of Salmonella in Low Moisture Foods I Minimizing Entry of Salmonella into a Processing Facility

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Appendix Reference 80 Establishment of Microbiologial Criteria for Lot Acceptance

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Appendix Reference 81 Investigations Operations Manual IOM

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Appendix Reference 82 Bacteriological Analytical Manual 8th Edition Revision A 1998

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Appendix Reference 83 Bacteriological Analytical Manual BAM Chapter 1 Food Sampling and Preparation of Sample Homogenate

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Appendix Reference 84 Recall: Products Containing Hydrolyzed Vegetable Protein

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Appendix Reference 85 Principles and Guidelines for the Conduct of Microbiological Risk Management MRM CAC GL 63 2007

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Appendix Reference 86 Codex Alimentarius Commission Procedural Manual Twentieth Edition

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Appendix Reference 87 Pistachios and Other Pistachio Containing Products Recall List

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Appendix Reference 88 Plainview Milk Cooperative Ingredient Recall

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Appendix Reference 89 Plainview Milk Cooperative Ingredient Recall Product List

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Appendix Reference 9 Chen et al Control of Salmonella in Low Moisture Foods II Hygiene Practices to Minimize Salmonella Contamination and Growth

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Appendix Reference 90 For Consumers The HVP Recall Updated

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Appendix Reference 91 Analysis of Food Recalls Initiated in 2008 2009 by an FDA CGMP Working Group

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Appendix Reference 92 Food Supply Chain Handbook

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Appendix Reference 93 Clean Safe Spices

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Appendix Reference 94 General Principles of Food Hygiene CAC RCP 1 1969 Rev 4 2003

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Appendix Reference 95 Guidance for Industry Voluntary Third Party Certification Programs for Foods and Feeds

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Appendix Reference 96 GFSI Guidance Document Version 6 1

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Appendix Reference List 1 Thru 96

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Reference 1 Food CGMP Modernization A Focus on Food Safety

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Reference 10 Regulatory Procedures Manual Chapter 4 Advisory Actions

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Reference 100 Epidemiology of Anaphylaxis in Olmsted County A Population-Based Study

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Reference 101 Food Allergy Among U.S. Children Trends in Prevalence and Hospitalizations

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Reference 102 Food Allergy

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Reference 103 Nationwide Milk Allergen Recall of Kroger Meals Made Simple Shrimp Linguini

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Reference 104 Brand Castle LLC Issues Allergy Alert on Undeclared Egg in Icing of Licensed Rice Krispies Treats Holiday Village Kit Distributed Through Michaels Retail Stores Only

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Reference 105 The Pictsweet Company Announces a Voluntary Recall of Frozen Green Peas Due to Possible Health Risk

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Reference 106 Flowers Foods Issues Voluntary Recall on Certain English Muffins and One Bread Item

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Reference 107 Occurrence of Uranium and 222Radon in Glacial and Bedrock Aquifers in the Northern United States 1993 2003 US Geological Survey Scientific Investigations Report 2007 5037

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Reference 108 Occurrence of Selected Radionuclides in Ground Water Used for Drinking Water in the United States A Targeted Reconnaissance Survey 1998 US Geological Survey Water Resources Investigations Report 00 4273

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Reference 109 FAQs: Japan Nuclear Concerns

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Reference 11 Regulatory Procedures Manual Chapter 5 Adminstrative Actions

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Reference 110 Principles for the Establishment and Application of Microbiological Criteria for Foods CAC GL 21 1997

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Reference 111 Microbiological Hazards and Their Control

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Reference 112 Selection and Use of Acceptance Criteria

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Reference 113 Transcript Public Meeting on the Food Safety Modernization Act Focus on Preventive Controls for Facilities

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Reference 114 Webcast Videos Public Meeting on the Food Safety Modernization Act Focus on Preventive Controls for Facilities

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Reference 115 Draft Qualitative Risk Assessment Risk of Activity Food Combinations for Activities Outside the Farm Definition Conducted in a Facility Co Located on a Farm

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Reference 116 Guidance for Industry Questions and Answers Regarding Registration of Food Facilities Edition 4 Final Guidance

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Reference 117 Guidance for Industry Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture Process Pack Transport Distribute Receive Hold or Import Food Edition 5

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Reference 118 Guidance for Industry Antimicrobial Food Additives

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Reference 119 Codex Alimentarius Commission Procedural Manual Twentieth Edition

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Reference 12 Regulatory Procedures Manual Chapter 6 Judicial Actions

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Reference 120 FDA Allergy Warning Letter Notice to Manufacturers Label Declaration of Allergenic Substances in Foods

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Reference 121 A Comprehensive Approach to Reducing the Risk of Allergens in Foods

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Reference 122 Cross-Contamination of Foods and Implications for Food Allergic Patients

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Reference 123 Components of an Effective Allergen Control Plan A Framework for Food Processors

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Reference 124 Cleaning and Other Control and Validation Strategies to Prevent Allergen Cross Contact in Food-Processing Operations

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Reference 125 Sanitizing

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Reference 126 Draft Guidance for Industry Control of Listeria monocytogenes in Refrigerated or Frozen Ready to Eat Foods

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Reference 127 Guideline for the Validation of Food Safety Control Measures CAC GL 69 2008

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Reference 128 Persistence of Serological and Biological Activities of Staphylococcal Enterotoxin A in Canned Mushrooms

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Reference 129 Serological Reactivity and in Vivo Toxicity of Staphylococcus aureus Enterotoxins A and D in Selected Canned Foods

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Reference 13 Foodborne Disease Outbreak Surveillance

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Reference 130 Guidance for Industry Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act

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Reference 131 MOU 225-88-2000 Memorandum of Understanding Between the Food and Drug Administration and the Bureau of Alcohol, Tobacco and Firearms

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Reference 132 Guide to Produce Farm Investigations 11 05

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Reference 133 Guidance for Industry Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables

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Reference 134 Emerging Foodborne Diseases an Evolving Public Health Challenge

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Reference 135 Environmental Assessment: Factors Potentially Contributing to the Contamination of Fresh Whole Cantaloupe Implicated in a Multi State Outbreak of Listeriosis

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Reference 136 Multistate Outbreaks of Salmonella Infections Associated with Raw Tomatoes Eaten in Restaurants United States 2005 2006

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Reference 137 Food Code 2009 Chapter 1 Purpose and Definitions

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Reference 138 Food Code 2009 Annex 3 Public Health Reasons Administrative Guidelines Chapter 1 Purpose and Definitions

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Reference 139 Food Code 2009 Annex 3 Public Health Reasons Administrative Guidelines Chapter 3 Food

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Reference 14 Frequently Asked Questions About CDCs Foodborne Outbreak Online Database

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Reference 140 Evaluation and Definition of Potentially Hazardous Foods

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Reference 141 Defect Levels Handbook

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Reference 142 Safe Food Handling What You Need to Know

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Reference 143 In HACCP A Systematic Approach to Food Safety

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Reference 144 Guidelines to Prevent Post Processing Contamination from Listeria monocytogenes

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Reference 145 Control of Salmonella in Low Moisture Foods I Minimizing Entry of Salmonella into a Processing Facility

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Reference 146 M I 05 5 Tolerance and or Safe Levels of Animal Drug Residues in Milk Replaces M I 03 9 June 30 2003 and Identifies It as INACTIVE and also Identifies M I 92 1 as INACTIVE

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Reference 147 Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food

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Reference 148 CPG Sec 555 425 Foods Adulteration Involving Hard or Sharp Foreign Objects

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Reference 149 Regulatory Action Criteria for Filth and Other Extraneous Materials 1 Review of Hard or Sharp Foreign Objects as Physical Hazards in Foods

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Reference 15 FoodNet Foodborne Diseases Active Surveillance Network

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Reference 150 Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies

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Reference 151 CPG Sec 560 750 Radionuclides in Imported Foods Levels of Concern

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Reference 152 Pistachios and Other Pistachio Containing Products Recall List

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Reference 153 For Consumers The HVP Recall Updated

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Reference 154 Pacific Coast Fruit Company Voluntarily Recalls Spinach Salad Products and Pizza Because of Possible Health Risk

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Reference 155 Company Recalls Various Products Due to Potential Salmonella Contamination FDA USDA CDC Investigating No Link to Human Illnesses at This Time

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Reference 156 Guidance for Industry Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient

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Reference 157 Interstate Food Transportation Assessment Project

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Reference 158 Guidance for Industry Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory

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Reference 159 Meat and Poultry Hazards and Controls Guide

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Reference 16 Questions and Answers About Vital Signs FoodNet MMWR 2010

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Reference 161 Staphylococcus aureus

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Reference 162 Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease Part 1 Description of the Problem Methods and Agents Involved

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Reference 163 Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease Part 3 Factors Contributing to Outbreaks and Description of Outbreak Categories

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Reference 164 Industry Guidance Information on Recalls of FDA Regulated Products

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Reference 165 Model Recall Letter Generic All Centers

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Reference 166 Recalls Market Withdrawals and Safety Alerts

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Reference 167 Allergens Model Press Release

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Reference 168 Listeria monocytogenes Model Press Release

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Reference 169 Salmonella Model Press Release All Serotypes

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Reference 17 Food Emergency Response Network

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Reference 170 Model Effectiveness Check Letter Industry

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Reference 171 Model Effectiveness Check Response Format Industry

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Reference 172 Model Effectiveness Check Questionnaire for Telephone or Personal Visits Industry

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Reference 173 Fish and Fishery Products Hazards and Controls Guidance Fourth Edition Appendix 4 Bacterial Pathogen Growth and Inactivation

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Reference 174 Food Code 2009

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Reference 175 Parameters for Determining Inoculated Pack Challenge Study Protocols

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Reference 176 Requisite Scientific Parameters for Establishing the Equivalence of Alternative Methods of Pasteurization

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Reference 177 Pesticide Registration Manual Chapter 4 Additional Considerations for Antimicrobial Products

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Reference 178 Listeria monocytogenes Risk Assessment I Introduction

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Reference 179 Control of Salmonella in Low-Moisture Foods II: Hygiene Practices to Minimize Salmonella Contamination and Growth

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Reference 18 Welcome to ELEXNET

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Reference 180 Sampling Considerations and Statistical Aspects of Sampling Plans

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Reference 181 Selection of Cases and Attributes Plans

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Reference 182 Sampling Plans

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Reference 183 Codex Standard for Natural Mineral Waters CODEX STAN 108 1981

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Reference 184 Control of Salmonella in Low Moisture Foods III Process Validation and Environmental Monitoring

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Reference 185 Control of Listeria monocytogenes in the Food-Processing Environment

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Reference 186 Guidelines for Listeria Testing of Environmental, Raw Product and Finished Product Samples in Smoked Seafood Processing Facilities

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Reference 187 Influence of Drying Plant Environment on Salmonellae Contamination of Dry Milk Products

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Reference 188 River Ranch Recalls Products Because of Possible Health Risk

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Reference 189 Taylor Farms Retail Inc Initiates a Precautionary Recall Because of Possible Health Risk

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Reference 19 Peanut Products Recall

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Reference 190 Del Bueno Recalls Queso Fresco Casero Cheese Because of Possible Health Risk

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Reference 191 Food Code 2009 Chapter 3 Food

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Reference 192 Grade A Pasteurized Milk Ordinance 2011 Revision Appendix K HACCP Program

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Reference 193 Comparison of Proposed Subpart C Hazard Analysis and Risk Based Preventive Controls to Various Existing Domestic and International HACCP Based Standards

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Reference 194 Preliminary Regulatory Impact Analysis PRIA FDA 2013

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Reference 2 Botulism in the United States: A Clinical and Epidemiologic Review

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Reference 20 Peanut Butter and Other Peanut Containing Products Recall List

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Reference 21 Plainview Milk Cooperative Ingredient Recall

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Reference 22 Plainview Milk Cooperative Ingredient Recall Product List

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Reference 23 Hydrolyzed Vegetable Protein Product Recalls

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Reference 24 Recall Products Containing Hydrolyzed Vegetable Protein

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Reference 25 Guidelines for Foodborne Disease Outbreak Response

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Reference 26 State Contracts

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Reference 27 FoodSafetyGov

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Reference 28 Fight Bac

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Reference 29 Consumers Food Safety Nutrition Information and Campaigns

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Reference 3 Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition

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Reference 30 Health Educators Food Safety & Nutrition Education Campaigns

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Reference 31 Consultation with USDA on Food Processing Sector Study

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Reference 32 Food Processing Sector Study

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Reference 33 National Advisory Committee on Microbiological Criteria for Foods About NACMCF

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Reference 34 Hazard Analysis and Critical Control Point Principles and Application Guidelines

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Reference 35 Hazard Analysis and Critical Control Point HACCP System and Guidelines for Its Application Annex to CAC RCP 1 1969 Rev 4 2003

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Reference 36 Hazard Analysis and Critical Control Point System

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Reference 37 Grade A Pasteurized Milk Ordinance 2011 Revision

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Reference 38 Regulation EC No 852 2004 of the European Parliament and of the Council

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Reference 39 Standard 3 2 1 Food Safety Programs

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Reference 4 Guidance for Industry Juice HACCP Hazards and Controls Guidance First Edition Final Guidance

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Reference 40 Food Safety Enhancement Program Hazard Analysis Critical Control Points

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Reference 41 Enhancing Food Safety Through Third Party Certification

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Reference 42 Hazard Analysis Critical Control Point System HACCP

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Reference 43 Manual on the Application of the HACCP System in Mycotoxin Prevention and Control

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Reference 44 General Principles of Food Hygiene CAC RCP 1 1969 Rev. 4-2003

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Reference 45 Foodborne Illness Acquired in the United States Major Pathogens

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Reference 46 Foodborne Illness Acquired in the United States Unspecified Agents

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Reference 47 CDC 2011 Estimates: Method

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Reference 48 Characteristics of the Enteroaggregative Shiga Toxin Verotoxin Producing Escherichia coli O104 H4 Strain Causing the 7 Outbreak of Haemolytic Uraemic Syndrome in Germany May to June 2011

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Reference 49 Bad Bug Book Foodborne Pathogenic Microorganisms and Natural Toxins Handbook. Second Edition

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Reference 5 Guidance for Industry Lead in Candy Likely To Be Consumed Frequently by Small Children Recommended Maximum Level and Enforcement Policy

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Reference 50 Vital Signs: Incidence and Trends of Infection with Pathogens Transmitted Commonly Through Food Foodborne Diseases Active Surveillance Network 10 US Sites 1996 2010

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Reference 51 What Is Salmonellosis

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Reference 52 Guidelines on the Application of General Principles of Food Hygiene to the Control of Listeria monocytogenes in Ready to Eat Foods CAC GL 61 2007

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Reference 53 Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready to Eat Foods

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Reference 54 Risk Assessment of Listeria monocytogenese in Ready to Eat Foods Technical Report

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Reference 55 Listeria monocytogenes Risk Assessment Executive Summary

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Reference 56 Listeria monocytogenes Risk Assessment VII Interpretation and Conclusions

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Reference 57 Norovirus Clinical Overview

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Reference 58 Food GMP Modernization Working Group Summary of Food Recalls 1999 2003

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Reference 59 Analysis of Food Recalls Initiated in 2008 2009 by an FDA CGMP Working Group

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Reference 6 Guidance for Industry Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut Derived Product as an Ingredient

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Reference 60 FDA Foods Program The Reportable Food Registry A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration First Annual Report September 8 2009 September 7 2010

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Reference 61 FDA Foods Program The Reportable Food Registry A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration Second Annual Report September 8 2010 September 7 2011

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Reference 62 Foodborne Outbreak Online Database FOOD Search Results Highlighted for 2006 2007 Salmonella Tennessee Outbreak in Peanut Butter

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Reference 63 Multistate Outbreak of Salmonella Serotype Tennessee Infections Associated with Peanut Butter United States 2006 2007

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Reference 64 Establishment Inspection Report Conagra Grocery Products 02 14 2007

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Reference 65 Establishment Inspection Report Conagra Foods 08 20 2007

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Reference 66 Multistate Outbreak of Salmonella Infections Associated with Peanut Butter and Peanut Butter Containing Products United States, 2008 2009

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Reference 67 Salmonella Typhimurium Infections Associated with Peanut Products

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Reference 68 Amended Form 483 Inspectional Observations for Peanut Corporation of America Blakely GA 02 05 2009

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Reference 69 Form 483 Inspectional Observations for Peanut Corporation of America Plainview TX 02 26 2009

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Reference 7 Compliance Policy Guide Sec 527 300 Dairy Products Microbial Contaminants and Alkaline Phosphatase Activity

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Reference 70 Foodborne Outbreak Online Database FOOD Search Results Highlighted for 2007 Salmonella Wandsworth and Salmonella Typhimurium Outbreak in Puffed Snacks

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Reference 71 Foodborne Outbreak Online Database FOOD Search Results Highlighted for 2008 2009 Listeria Outbreak in Mexican Style Cheese

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Reference 72 Multistate Outbreak of Listeria monocytogenes Associated with Mexican Style Cheese Made from Pasteurized Milk Among Pregnant Hispanic Women

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Reference 73 Outbreak of Salmonella Rissen Associated with Ground White Pepper

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Reference 74 Foodborne Outbreak Online Database FOOD Search Results Highlighted for 2008 Salmonella Rissen Outbreak in Ground White Pepper

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Reference 75 Warning Letter to UF Union International Food Company 11 24 2009

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Reference 76 Multistate Outbreak of E coli O157 H7 Infections Linked to Eating Raw Refrigerated Prepackaged Cookie Dough

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Reference 77 E coli in Nestlé Toll House Cookie Dough

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Reference 78 Nestlé USAs Baking Division Initiates Voluntary Recall

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Reference 79 Information on the Recalled Jensen Farms Whole Cantaloupes

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Reference 8 Compliance Policy Guide Sec 555 300 Foods, Except Dairy Products Adulteration with Salmonella

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Reference 80 Multistate Outbreak of Listeriosis Linked to Whole Cantaloupes from Jensen Farms Colorado

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Reference 81 Pesticide Monitoring Program FY 2008

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Reference 82 CPG Sec 570 375 Aflatoxin in Peanuts and Peanut Products

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Reference 83 CPG Sec 570 200 Brazil Nuts Adulteration with Aflatoxin

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Reference 84 CPG Sec 570 500 Pistachio Nuts Aflatoxin Adulteration

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Reference 85 CPG Sec 510 150 Apple Juice Apple Juice Concentrates and Apple Juice Products Adulteration with Patulin

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Reference 86 Histamine Poisoning Associated with Fish, Cheese, and Other Foods

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Reference 87 Biogenic Amines in Cheese and Other Fermented Foods: A Review

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Reference 88 Supporting Document for Recommended Maximum Level for Lead in Candy Likely To Be Consumed Frequently by Small Children

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Reference 89 Human Aflatoxicosis in Developing Countries: a Review of Toxicology Exposure Potential Health Consequences and Interventions

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Reference 9 Establishment Inspection Report EIR

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Reference 90 Risk Assessment of Aflatoxins in Food in Africa

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Reference 91 Update on Food Allergy

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Reference 92 Food Allergy Accurately Identifying Clinical Reactivity

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Reference 93 Food Allergy

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Reference 94 Food Allergy Among Children in the United States

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Reference 95 Can We Determine a Threshold Level for Allergenic Foods by Statistical Analysis of Published Data in the Literature

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Reference 96 Allergen Immunoassays Considerations for Use of Naturally Incurred Standards

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Reference 97 Threshold Dose for Peanut Risk Characterization Based upon Diagnostic Oral Challenge of a Series of 286 Peanut Allergic Individuals

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Reference 98 Analysis of Food-Allergic and Anaphylactic Events in the National Electronic Injury Surveillance System

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Reference 99 A Population-Based Epidemiologic Analysis of Deaths from Anaphylaxis in Florida

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Reference List 1 Thru 194

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Reference160 Risk Assessment of Listeria monocytogenes in Ready-to-Eat Foods Technical Report Part 5 Risk Characterization Response to Codex Questions

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Comments

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Total: 111
Daniel A. Andrews (Dan Andrews Farms LLC) - Comment
Posted: 01/16/2013     ID: FDA-2011-N-0920-0002

May 16,2013 11:59 PM ET
Jean Public - Comment
Posted: 01/16/2013     ID: FDA-2011-N-0920-0003

May 16,2013 11:59 PM ET
Anonymous - Comment
Posted: 01/23/2013     ID: FDA-2011-N-0920-0008

May 16,2013 11:59 PM ET
Thomas D. McCracken - Comment
Posted: 01/24/2013     ID: FDA-2011-N-0920-0010

May 16,2013 11:59 PM ET
Anonymous - Comment
Posted: 01/23/2013     ID: FDA-2011-N-0920-0005

May 16,2013 11:59 PM ET

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