Guidance for Industry Hazard Analysis and Risk-Based ...

#245

Hazard Analysis and Risk-Based Preventive Controls

for Food for Animals

Guidance for Industry

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Submit comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit electronic comments to . Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify your comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact Jenny Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-6246, e-mail: Jenny.Murphy@fda..

Additional copies of this draft guidance document may be requested from the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at either or .

U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine January 2018

Contains Nonbinding Recommendations Draft--Not for Implementation

Table of Contents

INTRODUCTION....................................................................................................... 6 PURPOSE.................................................................................................................... 8

CHAPTER 1 ? THE FOOD SAFETY PLAN .............................................................. 10 1.1 Purpose of this Chapter ........................................................................................ 10 1.2 What is a Food Safety Plan? ................................................................................ 10 1.3 Who Prepares the Food Safety Plan for a Facility? ............................................. 11 1.4 Who Signs the Food Safety Plan for a Facility? .................................................. 11 1.5 Is the Food Safety Plan the Same as a HACCP Plan? ......................................... 11 1.6 What if a Facility Already has a HACCP Plan? .................................................. 12 1.7 Is there a Required Format for a Food Safety Plan? ............................................ 12 1.8 What Circumstances Require Review (Reanalysis) of My Food Safety Plan? ... 12 1.9 References for Chapter 1...................................................................................... 13

CHAPTER 2 ? CONDUCTING A HAZARD ANALYSIS ......................................... 14 2.1 Purpose of this Chapter ........................................................................................ 14 2.2 Overview of a Hazard Analysis ........................................................................... 14 2.3 Recommended Activities in Conducting Your Hazard Analysis ........................ 15 2.3.1 Conduct Preliminary Steps ......................................................................... 15 2.3.2 Hazard Analysis Worksheet........................................................................ 16 2.4 Conducting a Hazard Analysis............................................................................. 18 2.4.1 Identify Known or Reasonably Foreseeable Hazards (Hazard Identification) ............................................................................................................................... 18 2.4.2 Evaluate Known or Reasonably Foreseeable Hazards (Hazard Evaluation) ............................................................................................................................... 19 Assessing severity of the illness or injury................................................. 20 Assessing probability the hazard will occur ............................................. 20 2.4.3 Assessing the Combination of Severity and Probability............................. 24 2.4.4 Evaluating Environmental Pathogens When Animal Food is Exposed to the Environment.......................................................................................................... 25 2.4.5 Evaluation of Other Factors ........................................................................ 25 2.5 Use of Your Written Evaluation as Explanation/Justification Whether a Hazard Requires a Preventive Control .................................................................................... 27 2.6 Identifying Preventive Controls ........................................................................... 28 2.7 Is the Preventive Control Applied at this Step? ................................................... 29 2.8 References for Chapter 2...................................................................................... 29

CHAPTER 3 ? HAZARDS ASSOCIATED WITH THE MANUFACTURING, PROCESSING, PACKING, AND HOLDING OF ANIMAL FOOD .................. 31 3.1 Purpose of this Chapter ........................................................................................ 31 3.2 Known or Reasonably Foreseeable Hazards........................................................ 31 3.3 Biological Hazards ............................................................................................... 33 3.3.1 Foodborne Pathogens Associated with Animal Food ................................. 34 Bacterial pathogens ................................................................................... 34 Other pathogens ........................................................................................ 37

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Contains Nonbinding Recommendations Draft--Not for Implementation

3.3.2 Ingredient-Related Biological Hazards ....................................................... 38 3.3.3 Process-Related Biological Hazards ........................................................... 38

Bacterial pathogens that survive process controls .................................... 38 Bacterial pathogens that grow................................................................... 39 Bacterial pathogens in ingredients added after applying process controls 41 Bacterial pathogens introduced after packaging due to lack of container integrity ..................................................................................................... 41 3.3.4 Facility-Related Biological Hazards ........................................................... 41 Sources of facility-related biological hazards ........................................... 42 Transient and resident facility-related environmental pathogens ............. 43 Facility-related environmental pathogens associated with wet and dry processing environments........................................................................... 44 Wet processing environments ................................................................... 45 Dry processing environments.................................................................... 46 3.4 Chemical Hazards ................................................................................................ 47 3.4.1 Ingredient-Related Chemical Hazards ........................................................ 49 Pesticides................................................................................................... 49 Heavy metals............................................................................................. 49 Natural toxins ............................................................................................ 50 Animal drugs............................................................................................. 52 Unapproved color and food additives ....................................................... 54 Chemical hazards that may be intentionally introduced for purposes of economic gain ........................................................................................... 54 Radiological hazards ................................................................................. 55 Environmental chemical contaminants ..................................................... 55 3.4.2 Process-Related Chemical Hazards ............................................................ 56 Animal drug carryover in animal food...................................................... 56 Nutrient deficiencies or toxicities as chemical hazards ............................ 57 3.4.3 Facility-Related Chemical Hazards ............................................................ 58 3.5 Physical Hazards .................................................................................................. 58 3.6 References for Chapter 3...................................................................................... 59

CHAPTER 4 ? PREVENTIVE CONTROLS .............................................................. 69

4.1 Purpose of this Chapter ........................................................................................ 69 4.2 Overview of Preventive Controls......................................................................... 69 4.3 Preventive Control Considerations ...................................................................... 69 4.4 Process Controls................................................................................................... 70

4.4.1 Use of Parameter Values and Operating Limits in Process Controls ......... 71 4.5 Process Controls for Biological Hazards ............................................................. 72

4.5.1 Use of Lethality Treatments as Process Controls ....................................... 73 Heat treatment (thermal processing) ......................................................... 73 High pressure processing (HPP) ............................................................... 78 Irradiation.................................................................................................. 79

4.5.2 Use of Time and Low Temperature as Process Controls............................ 81 Refrigeration ............................................................................................. 82 Freezing..................................................................................................... 83

4.5.3 Use of Product Formulation as Process Controls ....................................... 84

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Contains Nonbinding Recommendations Draft--Not for Implementation

Water activity (aw) .................................................................................... 84 Acidity (pH) .............................................................................................. 86 Preservatives ............................................................................................. 87 4.5.4 Use of Dehydration/Drying as Process Controls ........................................ 88 4.6 Preventive Controls for Chemical Hazards.......................................................... 88 4.6.1 Preventive Controls for Nutrient Deficiencies and Toxicities .................... 88 4.6.2 Drying and Storage Conditions as Preventive Controls for Mycotoxins.... 90 4.6.3 Sequencing and Flushing as Preventive Controls for Drug Carryover ....... 90 4.7 Preventive Controls for Physical Hazards ........................................................... 91 4.7.1 Preventive Controls for Metal Hazards....................................................... 91 4.7.2 Preventive Controls for Glass Hazards ....................................................... 92 4.7.3 Preventive Controls for Hard Plastic Hazards ............................................ 92 4.7.4 Preventive Controls for Conditions of Animal Food That Can be Hazards 92 4.8 Sanitation Controls............................................................................................... 93 4.8.1 Cleaning Strategies and Sanitation Controls............................................... 94 4.8.2 Use of Sanitation Controls to Prevent Cross-Contamination ..................... 97 4.9 Supply-Chain Controls......................................................................................... 98 4.10 Recall Plan ......................................................................................................... 98 4.11 References for Chapter 4.................................................................................... 99

CHAPTER 5 ? OVERVIEW OF PREVENTIVE CONTROL MANAGEMENT COMPONENTS ...................................................................................................... 103

5.1 Purpose of this Chapter ...................................................................................... 103 5.2 Overview of Preventive Control Management Components ............................. 103 5.3 Who is Responsible for Conducting Preventive Control Management Component Activities? ................................................................................................................. 103 5.4 Recordkeeping Requirements for Preventive Control Management Components ................................................................................................................................... 104 5.5 Preventive Control Management Components Examples ................................. 104 5.6 Monitoring ......................................................................................................... 105

5.6.1 What Will Be Monitored?......................................................................... 106 5.6.2 How Will Monitoring Be Done?............................................................... 106 5.6.3 How Often Will Monitoring Be Done (Frequency)? ................................ 106 5.6.4 Who Will Do the Monitoring? .................................................................. 107 5.6.5 What Records Do I Need to Document Monitoring? ............................... 107 5.7 Corrective Actions and Corrections ................................................................... 108 5.7.1 Corrective Actions .................................................................................... 108 5.7.2 Corrections ................................................................................................ 110 5.7.3 Corrective Action and Correction Records ............................................... 110 5.8 Verification Activities........................................................................................ 112 5.8.1 Verification ............................................................................................... 112 5.8.2 Validation.................................................................................................. 113 5.8.3 Verification of Monitoring........................................................................ 115 5.8.4 Verification of Decisions about Corrective Actions ................................. 116 5.8.5 Verification of Implementation and Effectiveness ................................... 117

Calibration............................................................................................... 117 Product testing......................................................................................... 119

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Contains Nonbinding Recommendations Draft--Not for Implementation

Environmental monitoring ...................................................................... 120 Record review ......................................................................................... 121 5.8.6 Reanalysis ................................................................................................. 123 5.9 References for Chapter 5.................................................................................... 125 APPENDIX A ? Glossary of Terms ............................................................................ 126 APPENDIX B ? Table of Abbreviations and Acronyms Used in this Guidance .... 131 APPENDIX C ? Flowchart ? Hazard Analysis .......................................................... 134 APPENDIX D ? Example Hazard Analysis Worksheet............................................ 136 APPENDIX E ? Aid to Identifying Animal Food Hazards ....................................... 138 References for Appendix E....................................................................................... 155

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Contains Nonbinding Recommendations Draft--Not for Implementation

Hazard Analysis and Risk-Based Preventive Controls for

Food for Animals

Draft Guidance For Industry

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

INTRODUCTION

In Title 21 of the Code of Federal Regulations (21 CFR) part 507 (part 507), we have established our regulation entitled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals". We published the final rule establishing part 507 in the Federal Register of September 17, 2015 (80 FR 56170). Part 507 establishes requirements for current good manufacturing practice for animal food (CGMPs), for hazard analysis and riskbased preventive controls for animal food (PCAF), and related requirements as shown in Table 1.

Table 1. Subparts Established in 21 CFR Part 507

SUBPART A B C D E F

TITLE General Provisions Current Good Manufacturing Practice Hazard Analysis and Risk-Based Preventive Controls Withdrawal of a Qualified Facility Exemption Supply-Chain Program Requirements Applying to Records That Must be Established and Maintained

Part 507, subparts A, C, D, E, and F contain the complete animal food preventive controls requirements (the PCAF requirements). This guidance document focuses on subpart C, the primary preventive controls requirements, and also discusses relevant recordkeeping requirements of subpart F. Although subpart E, the supply-chain program, is a type of preventive control, we intend to address subpart E in future guidance.

The PCAF requirements implement certain provisions of the FDA Food Safety Modernization Act (FSMA) established in section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350g). Part 507 includes several complete or partial exemptions from the PCAF requirements. See 21 CFR 507.5 for these exemptions.

In part 507, "you" means the owner, operator, or agent in charge of a facility (see 21 CFR 507.3). However, for the purposes of this guidance document, where appropriate, "you" also

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