FDA Food Defense Activities in the U.S. and Abroad Ryan Newkirk, - PowerPoint PPT Presentation

FDA Food Defense Activities in the U.S. and Abroad Ryan Newkirk, PhD, MPH Senior Advisor for Intentional Adulteration FDA, CFSAN 1

Why should we protect against IA? • In any country, intentional adulteration has the potential to cause: – Significant public health consequences – Widespread public fear – Devastating economic impacts – Loss of public confidence in the safety of food and effectiveness of governments – Disruption of trade 2 www.fda.gov

Main Categories of FDA Food Defense Activities • Regulation and guidance – Applies to domestic and foreign facilities required to register with FDA • Education and outreach – Can be used by, and applied to, domestic and foreign entities • Tools and resources – Can be used by, and applied to, domestic and foreign entities 3 www.fda.gov

Regulation and Guidance: Food Safety Modernization Act Rule “Mitigation Strategies to Protect Food Against Intentional Adulteration” 4

Regulation: FSMA IA Rule • Establishes requirements to prevent or significantly minimize acts intended to cause wide-scale public health harm • Coverage – Domestic and foreign facilities, required to register with FDA, that manufacture, process, pack or hold human food 5 www.fda.gov

Regulation: FSMA IA Rule • Very small businesses • Holding of food, except holding of food in liquid storage tanks • Packing, repacking, labeling, or relabeling of food where the container that directly contacts the food remains intact • Activities of a farm subject to FSMA Produce Safety Rule • Manufacturing, processing, packing, or holding food for animals • Alcoholic beverages at certain facilities (under specified conditions) 6 www.fda.gov

Regulation: FSMA IA Rule • Requirements – Food defense plan • Vulnerability assessment • Mitigation strategies • Procedures for food defense monitoring • Food defense corrective action procedures • Food defense verification procedures • Reanalysis – Training – Records 7 www.fda.gov

Regulation: FSMA IA Rule • Compliance dates – Very small businesses : July 26, 2021 – Small businesses (a business with fewer than 500 full-time equivalent employees): July 27, 2020 – All other businesses : July 26, 2019 8 www.fda.gov

Guidance: IA Rule • 1 st installment – published 6/18 – Background and definitions – Relatively simple and cost-effective method to identify vulnerable points (i.e., KAT Method) – Numerous ways to reduce vulnerabilities – Numerous ways to check that strategies are functioning as intended – Worksheets to assist industry in thinking through, and documenting, requirements 9 www.fda.gov

Guidance: IA Rule • 2 nd installment - published 3/19 – Identifying vulnerabilities in a way that includes an in-depth analysis and can be tailored to a facility (i.e., 3 Fundamental Elements) – Identifying vulnerabilities in a way that combines strengths of KAT and 3 Element approaches (i.e., Hybrid Approach) – Education, training, or experience – Additional examples of worksheets – VA examples 10 10 www.fda.gov

Guidance: IA Rule • 3 rd installment – Food defense corrective actions – Food defense verification – Reanalysis – Records – Appendices 11 11 www.fda.gov

Education and Outreach 12 12

Education, Training, or Experience: IA Rule • Individuals assigned to APSs – Food defense awareness – flexibility – Proper implementation of mitigation strategy – flexibility • Food Defense Qualified Individuals – Must be qualified to perform certain activities through education, training, or experience • Food Safety Preventive Controls Alliance (FSPCA) – Working with FSPCA International Subcommittee 13 13 www.fda.gov

Education, Training, or Experience FSPCA Training Delivery Intended Audience Course Method • Workers at Actionable Process Steps (e.g., front line food workers) Food Defense Supervisors of Workers at Actionable Process • Awareness Steps Satisfies requirement in § 121.4(b)(2) • • Any stakeholder interested in learning more about the IA rule requirements Overview of IA Rule • This course is not associated with any IA rule training requirement 14 14

Education, Training, or Experience Intended Audience – Delivery Food Professionals who do the FSPCA Training Course Method following: Conducting Vulnerability • Conduct VAs using the KAT Assessments (VAs) Method only using Key Activity Types (KAT) • Conduct VAs using the 3 Conducting Vulnerability Fundamental Elements Assessments This 1-day course must be taught by • trained FSPCA VA Lead Instructors • Identify Mitigation Strategies to Identification and Explanation implement at Actionable Process of Mitigation Strategies Steps Food Defense Plan Preparation • Prepare the Food Defense Plan and Reanalysis Conduct Reanalysis activities • 15 15

Education and Outreach • Public meetings • Conferences • Trade associations • Companies • Government interactions 16 16 www.fda.gov

International Food Defense Collaborative Activity 17 17

Food Defense Tools and Resources 18 18

FDA Food Defense Plan Builder v1.0 • Desktop software tool to assist food industry with developing food defense plans • Released in 2013 • Developed under voluntary food defense framework – does not fully align with IA rule • Over 56,500 downloads from all over the world 19 19 www.fda.gov

FDA Food Defense Plan Builder v2.0 • Updated content and functionality to align with FDP requirements of the IA Rule • Conducted usability study with food industry participants April 2019 • New sections for monitoring, corrective actions, verification procedures, signature, etc. • Coming soon! 20 20 www.fda.gov

Mitigation Strategies Database • Assists in identifying mitigation strategies to protect food against intentional adulteration • Provides a range of strategies for individuals to consider implementing at points, steps or procedures to minimize the vulnerability to an intentional attack 21 21 www.fda.gov

FREE-B Exercises • Food Related Emergency Exercise Bundle • Scenarios based on both intentional and unintentional food contamination events • Assists agencies in assessing food emergency response plans, protocols and procedures • Includes facilitator’s guide, a lead planner’s guide and a situation manual 22 22 www.fda.gov

Need more information? • FDA Food Defense • FDA FSMA IA Rule • FDA Technical Assistance Network 23 23 www.fda.gov