[Title Page]

Contents

Monday 4

01. CFR 416 Sanitation 4

02. Eligibility of foreign countries for importation of products into USA 327.2 12

03. Regulation and directives development : compliance guideline for retained water 18

04. Compliance guideline for controlling Salmonella and Campylobacter in poultry 3rd.2010.5 34

Table of Contents 38

I. Summary of Guidance Material 40

II. Purpose 40

III. Background 41

Food Safety Systems 41

HACCP Plan 41

Sanitation Standard Operating Procedure (Sanitation SOP) or Other Prerequisite Programs 41

Food Safety Assessments: Common Findings 42

IV. Pre-Harvest 43

V. Live Receiving and Live Hanging 45

VI. Stunning and Bleeding 47

VII. Scalding 47

VIII. Picking 50

IX. Eviscerating 51

X. Chilling 54

Immersion Chilling 54

Air Chilling 56

XI. Reprocessing (On-line/Off-line) and Chilling: Antimicrobial Interventions 57

XII. Further Processing 59

XIII. Sanitation and Hygiene 60

XIV. New Technologies 62

XV. Validating 62

Example of a Validation Study (Stopforth, et al., 2007) 64

Examples of Case Studies 65

XVI. Current FSIS Policies 67

XVII. Web site References 71

XVIII. Appendix A 72

Measures to control Salmonella Enteritidis (SE) in Broiler Chickens 72

Breeding flocks 72

Hatchery 72

Production flocks 72

SE-contaminated houses 73

Broiler chicken slaughter 73

References 74

05. Retained water in raw meat and Poultry products : FSIS directive 6700.1 2002.11.27 88

I. Purpose 90

II. Reserved 90

III. Reserved 90

IV. References 90

V. Background 90

VI. Post-evisceration process 91

VII. Verification procedures 92

VIII. Labeling requirements 94

IX. Import product 94

Attachment 1. Additional Labeling Questions and Answers 96

Attachment 2. Product Examples 100

06. Guideline for E. coli testing for process control verification in poultry slaughter Est. 102

Introduction 104

Guidelines for sample collectors/microbiologists : Pre-sampling Preparation 106

Applying performance criteria to test results 118

07. CFR 430.4 control of Listeria monocytogenese in post : lethality exposed ready to eat products 124

08. 318.30 Canning and canned products 130

09. New performance standards for Salmonella and Campylobacter in chilled carcasses at young chicken and turkey slaughter Est. 164

I. Purpose 166

II. Background 167

III. Review of FSIS directives and video materials by IPP 167

IV. Awareness meeting with plant management 168

V. General sampling procedures for young chickens 169

VI. Specific procedures for collecting young chicken rinsate 170

VII. Sample storage prior to shipment 171

VIII. Shipping of samples 171

IX. Obtaining results of FSIS microbiological testing of young chicken (broiler) samples 172

X. General sampling procedures for Turkeys 172

XI. Specific procedures for collecting Turkey swabs 173

XII. Sample storage prior to shipment 175

XIII. Shipping of samples 175

XIV. Obtaining results of FSIS nationwide young Turkey microbiological data collection program samples 175

XV. Data analysis 176

Appendix 177

Appendix I. 177

Appendix II. New Performance standards for Salmonella and Campylobacter Questions and Answers 179

10. CFR 441.10 Retained water 182

11. CFR 417 HACCP 188

12. Preparing small and very small meat & poultry Est. for the future of HACCP / Diane Wright Hirsch ; Catherine Nettles Cutter 196

Table of Contents 199

Executive summary 200

Introduction 201

Acknowledgements 201

Description of the Situation 201

Email survey of training/information providers: Summary of findings 204

Training and consulting provided 204

Training tools and materials 204

Comments made by training survey participants 204

Conclusions from the trainer/academic survey 205

Mail survey of Northeast operations: Summary of findings 206

Background information 206

Training Needs Assessment 210

Knowledge Assessment 214

Comparing Training Assessment responses to knowledge responses, size of plant and years in business 219

Conclusions from the industry survey 221

National working meeting: Summary of findings 223

Summary statements from group meetings 223

Conclusions from meeting results 229

Recommendations 230

Recommendations to the USDA-FSIS (and state inspection programs, where appropriate) 230

Recommendations to academia, Extension personnel and others providing training and information 232

Recommendations to industry 233

Appendix 234

Appendix A: Email survey results 234

Table 1. Background of Respondents 235

Table 2. Training Program Needs Assessment 238

Table 3. Respondent's perception of knowledge/competency of small and very small meat and poultry food processors(N＝46) 241

Appendix B: Northeast processors survey results and tables 242

Table 1. Demographic Characteristics of Survey Respondents 243

Table 2. Training Needs Assessment 245

Table 3. Training topics requested, in order of interest (n＝301) 247

Table 4. Preferences for how respondents would like to receive training and information (n＝301) 248

Appendix C: Working Meeting Agenda and Summaries of Transcribed Group Discussions 249

References 267

Tuesday 270

13. Safe & suitable ingredients used in the production of meat, poultry and egg products : FSIS directive 7120.1 Rev.6 11.4.5 270

I. Purpose 272

II. Cancellation 272

III. Reason for reissuance 272

IV. References 272

V. Background 272

Table of Safe and Suitable Ingredients 274

Questions and Answers on the Use of Antimicrobial Agents in the Production of Meat and Poultry Products 311

14. Food standards and labeling policy book 318

Preface 321

Table of contents 322

Introduction 323

Updated entries since last publication 324

Abbreviations 327

A 328

B 332

C 345

D 366

E 370

F 375

G 381

H 389

I 398

J 401

K 404

L 407

M 422

N 435

O 444

P 446

Q 477

R 479

S 482

T 502

U 511

V 512

W 516

Y 521

15. FSIS PHIS directive 5000.1. 11.4.11 : verifying an Est's food safety system 522

CHAPTER I. General 524

I. Purpose 524

II. Reserved 525

III. Reserved 525

IV. References 525

V. Background 525

VI. Communicating with establishment management 526

VII. Entrance meeting 527

VIII. Weekly meeting 527

IX. General phis verification thought process 528

X. Supervisory responsibilities 531

CHAPTER II. Sanitation 532

PART I. Introduction 532

PART II. Sanitation performance standards (SPS) 533

PART III. Sanitation standard operating procedures (sanitation SOPs) 553

CHAPTER III. HACCP 563

PART I. Introduction 563

PART II. Verifying HACCP in phis 566

CHAPTER IV. Pathogen reduction activities 599

I. Testing for generic E. coli 599

II. Sample collection 600

III. Sampling frequency 602

IV. Sample analysis 603

V. Recording of test results 604

VI. Evaluation of results 605

CHAPTER V. Documentation and enforcement 607

I. Documenting verification results in phis 607

II. Documenting noncompliance 608

III. Documentation of SPS verification results 612

IV. Documentation of sanitation SOP verification results 613

V. Documenting HACCP verification results 614

VI. Documenting generic E. coli verification results 617

VII. Trends of noncompliance 617

CHAPTER VI. Rules of practice 620

I. Enforcement actions 620

II. Regulatory control action 620

III. Withholding actions and suspensions (prior notification not necessary) 622

IV. Withholding action or a suspension action (prior notification given) 623

V. NOIE 624

VI. Abeyance 626

VII. Verification plans 626

VIII. Analysis of data 628

Attachment 1. Use of microbial pathogen computer modeling (MPCM) in HACCP plans 629

Attachment 2. Import Establishment 631

Wednesday 634

16. Guidelines for validation of food safety control measurement 634

I. Introduction 636

II. Scope 636

III. Definitions 637

IV. Concept and nature of validation 637

V. Tasks prior to validation of control measures 638

VI. The validation process 640

VII. Need for re-validation 642

Annex I. Examples of validation of food safety control measures 644

17. HACCP system validation 652

[Preface] 654

1. Clarify the Elements of Validation 655

2. Explain the Relationship Between the Expectations and the Language of the Regulation 655

3. Explain Agency Expectations Regarding When Evidence of In-plant Process Effectiveness Data in not Required 655

4. Providing Guidance on How to Generate Evidence of In-Plant Effectiveness 657

5. Comments on the First Component of Validation: The Scientific or Other Support 658

6. General Comments on Implementation of the Three Issuances 658

Draft guidance: HACCP systems validation 659

ATTACHMENT 1. Validation examples for raw products 671

ATTACHMENT 2. Validation examples for processed products 673

ATTACHMENT 3. Potential sampling validation scenario for a low volume slaughter establishment 675

ATTACHMENT 4. Example of a potential sampling plan for low volume RTE establishment 678

18. Temperature distribution protocol 682

1. Processing equipment survey 684

1.1. Steam supply to the retorts 684

1.2. Retort room 684

1.3. Air supply to the retorts 685

1.4. Water supply to the retorts 685

1.5. Overflow/purge (air removal) 685

1.6. Drain 685

1.7. Retort loading considerations 685

2. Selection of the test retort(s) 685

3. Test retort documentation 686

3.1. Retort shell 686

3.2. Steam supply from main line to the retort 686

3.3. Steam introduction into the retort 686

3.4. Temperature control sensing device 686

3.5. Type of instrument well(s) 686

3.6. Water level indicator(s) 686

3.7. Pressure Sensing Device(s) 687

3.8. Reference temperature measuring device (TMD) 687

3.9. Temperature controller or recorder/controller 687

3.10. Air purge 687

3.11. Drain 687

3.12. Water circulation 687

3.13. Overpressure 687

3.14. Other equipment 688

4. Test equipment 688

4.1. Data acquisition system 688

4.2. Temperature measuring devices (TMDs) 688

4.3. Pressure indicating device(s) 688

4.4. Reference TMD 688

4.5. Packing gland (stuffing box) 688

4.6. Flow meters 688

5. Standardization of test equipment 688

5.1. Retort thermometer/TMD 688

5.2. Temperature measurement system 689

6. Placement of the temperature, pressure and flow measuring devices 689

6.1. Location of the TMDs in the retort 689

6.2. Location of pressure sensor(s) 690

6.3. Location of flow meter(s) 690

7. Preparing retort with containers 690

7.1. Container size 690

7.2. Container contents 690

7.3. Container placement 690

7.4. Operating procedures 690

8. The temperature distribution test 691

8.1. Set up 691

8.2. Data collection points 691

8.3. Miscellaneous non-critical observations 691

9. Conducting the test 692

9.1. Datalogger 692

9.2. Critical points 692

9.3. Testing time duration 692

9.4. Replication 692

9.5. Post-test inspection 692

19. Protocol for carrying out heat penetration studies 694

1. Nomenclature 696

2. Terminology 696

2.1. Ballast Containers 696

2.2. Cooling Time 697

2.3. Critical Factors 697

2.4. Fill, Drain and Net Weights 697

2.5. Heat Penetration Curve 697

2.6. Mercury-in-Glass Thermometer (MIG) 697

2.7. Resistance Temperature Detector (RTD) 697

2.8. Temperature Measuring Device (TMD) 697

2.9. Thermistor 697

2.10. Thermocouple 697

3. Design of a heat penetration study 697

4. Factors affecting heating behavior 698

4.1. Product 698

4.2. Container 699

4.3. Method of Fill 700

4.4. Closing or Sealing 700

4.5. Retort System 701

5. Temperature measurement and data acquisition 702

5.1. Data Acquisition System 702

5.2. Type of Thermocouple 702

5.3. Type of Connectors and Associated Errors 702

5.4. Thermocouple Calibration 702

5.5. Positioning of Thermocouple in the Container 702

5.6. Type and Placement of Containers 703

5.7. Temperature of the Heating Medium 703

5.8. Retort Pressure 703

5.9. Coldspot Determination 703

5.10. Initial Product Temperature 704

5.11. Number of Containers per Test Run 704

5.12. Number of Test Runs 704

6. Summary of documentation 704

6.1. Pre-test Documentation 704

6.2. Test-Phase Documentation 708

6.3. Post-Test documentation 708

7. Literature cited 709

20. HACCP 03.J poultry slaughter 712

General 714

General hazard analysis flow diagram and HACCP 714

Pre-Harvest 720

Live Receiving 722

General Processing 723

Scalding 724

Picking 725

Evisceration 726

Reprocessing 727

Chilling 728

Validation 730

General Microbial Testing 731

Antimicrobial Processes 732

Generic E. coli 733

Salmonella 736

ANIMAL DRUG and BIOLOGICAL RESIDUES 739

Miscellaneous 740

21. HACCP 03.D thermally processed commercially sterile 742

A. Canning Regulations used a prerequisite program 744

B. Establishment developed their own HACCP plan covering all food safety hazards 752

22. Processing in water in still retorts 758

Copyright 770