Contains Nonbinding Recommendations Draft-Not for Implementation Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry Revised Draft Guidance This guidance is being distributed for comment purposes only. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 120 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2018-D-1398 listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-3712. U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition March 2019 Contains Nonbinding Recommendations Draft-Not for Implementation Table of Contents I. Introduction............................................................................................................................ 7 II. Purpose of this Guidance.................................................................................................. 9 III. Glossary of Terms Used in This Guidance ................................................................... 10 A. Definitions Established in 21 CFR 121 .......................................................................... 10 B. Other Terms Used in this Guidance ............................................................................... 12 C. Table of Abbreviations Used in This Guidance ............................................................. 15 IV. Exemptions ...................................................................................................................... 16 A. Very Small Business ...................................................................................................... 16 B. Holding of Food ............................................................................................................. 16 C. Packing and Labeling ..................................................................................................... 16 D. Farm Activities Covered by Standards for Produce Safety ........................................... 16 E. Alcoholic Beverages ....................................................................................................... 16 F. Animal Food ................................................................................................................... 17 G. Low-Risk Activities at Farm Mixed-Type Facilities ..................................................... 17 Chapter 1: The Food Defense Plan ........................................................................................... 18 A. What is a Food Defense Plan? ....................................................................................... 18 B. Individuals to Assist with Developing Your Facility’s Food Defense Plan ................... 19 C. Formatting a Food Defense Plan .................................................................................... 20 D. Determining When to Make Changes to a Food Defense Plan ...................................... 20 E. Maintaining a Food Defense Plan .................................................................................. 21 Chapter 2: Vulnerability Assessment to Identify Significant Vulnerabilities and Actionable Process Steps................................................................................................................................ 22 2 Contains Nonbinding Recommendations Draft-Not for Implementation A. What is a Vulnerability Assessment? ............................................................................. 22 B. Recommended Activities Prior to Conducting a Vulnerability Assessment .................. 23 C. Key Activity Types as an Appropriate Method for Conducting a Vulnerability Assessment to Identify Significant Vulnerabilities and Actionable Process Steps ............... 25 D. Key Activity Type Descriptions ..................................................................................... 26 E. Identifying Actionable Process Steps Using the Key Activity Types Method ............... 28 F. Evaluating the Three Fundamental Elements [New March 2019] ................................. 36 1. Considerations in Evaluating the Three Fundamental Elements ............................... 37 2. Potential Public Health Impact (Element 1) ............................................................... 40 3. Degree of Physical Access to the Product (Element 2) .............................................. 52 4. Ability of Attacker to Successfully Contaminate the Product (Element 3) ............... 54 G. Identifying Significant Vulnerabilities and Actionable Process Steps Using the Three Fundamental Elements [New March 2019] ................................................................. 58 1. Using the Scores from the Three Fundamental Elements to Identify Significant Vulnerabilities and Actionable Process Steps ................................................ 59 2. Written Explanation for Identification of Actionable Process Steps ......................... 64 H. Identifying Actionable Process Steps Using the Hybrid Approach: Combining the Key Activity Types and the Three Fundamental Elements [New March 2019] ................... 65 Chapter 3: Mitigation Strategies for Actionable Process Steps .............................................. 67 A. Mitigation Strategies Requirement ................................................................................ 67 B. Identifying Mitigation Strategies .................................................................................... 68 1. Minimizing the Accessibility of the Product to an Inside Attacker ........................... 69 2. Reducing the Ability of an Inside Attacker to Contaminate the Product ................... 73 C. Using Multiple Mitigation Strategies ............................................................................. 75 D. Facility-wide Security Measures and Their Role in a Facility’s Food Defense System.................................................................................................................................... 76 3 Contains Nonbinding Recommendations Draft-Not for Implementation E. The Role of Existing Measures ...................................................................................... 77 F. Accompanying Explanation for Mitigation Strategies in the Food Defense Plan .......... 79 G. Mitigation Strategy Example Scenarios ......................................................................... 80 1. Scenario 1 ................................................................................................................... 80 2. Scenario 2 ................................................................................................................... 81 3. Scenario 3 ................................................................................................................... 81 4. Scenario 4 ................................................................................................................... 82 Chapter 4: Mitigation Strategies Management Components: Food Defense Monitoring ... 89 A. Overview of Food Defense Monitoring ......................................................................... 89 B. How Food Defense Monitoring Differs from Food Safety Monitoring ......................... 89 C. What to Monitor ............................................................................................................. 90 D. How to Monitor .............................................................................................................. 91 1. How Often to Monitor (Frequency of Monitoring) .................................................... 91 2. Who Performs the Monitoring ................................................................................... 93 E. Food Defense Monitoring Records................................................................................. 93 F. Exception Records .......................................................................................................... 94 Chapter 5: Mitigation Strategies Management Components: Food Defense Corrective Actions (coming soon) ............................................................................................................... 103 Chapter 6: Mitigation Strategies Management Components: Food Defense Verification (coming soon) ............................................................................................................................. 104 Chapter 7: Reanalysis (coming soon) ...................................................................................... 105 Chapter 8: Education, Training, or Experience [New March 2019] ................................... 106 A. Individuals Who Perform Activities Required by Subpart C ....................................... 106 B. Individuals Assigned to an Actionable Process Step ................................................... 107 4 Contains