Jeff Chilton, VP of Consulting, Alchemy Systems

FSMA’s Final Rule for Food Defense: How to Comply by July Deadline

• Jeff Chilton• VP, Consulting Services

Today’s Speaker

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Agenda

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✓ Provide background information on Food Defense

✓ Understand the requirements of the Intentional Adulteration Final Rule

✓ Conduct your Vulnerability Assessment and Identify Mitigation Strategies

✓ Document your Food Defense Plan

✓ Learn best practices for preventing adulteration

✓ Ensure your Food Defense Plan is audit-ready

✓ Alchemy Resources to help with your Food Defense Plan

✓ Questions?

Why do we need Food Defense?

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• Food Defense focuses on protecting the food supply from intentional contamination!

• Protect food supply against Intentional Adulteration

• FDA focus on Intentional Adulteration sources from:

– Acts of Terrorism

– Disgruntled Employees

– Economically Motivated Adulteration

Who are we protecting our food supply from?

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1. Outside Attackers (Terrorists – Domestic and International)

2. Insider Attackers (from disgruntled employees)

3. Visitors

4. Contractors

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• United States March 2019 – Ready to Eat Pork Sausage Recall

– 200,000lbs produced by a USDA inspected establishment between January 16 - March 7, 2019

– Product contamination due to product tampering after the production process

Examples of why we need to protect our food supply

Note: The FBI has confirmed agriculture and food production are targets of terrorist.

• 2018 Australian Strawberry Needle Contamination

How Do We Protect Our Food Supply?

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• FDA has adopted a HACCP based approach for Food Defense based on Hazard Identification, Evaluation and Control

• The Mitigation Strategies To Protect Food Against Intentional Adulteration Final Rule requires all companies to develop a Food Defense Plan that must include:

– Vulnerability Assessment

– Mitigation Strategies

– Procedures for Monitoring, Corrective Action, Verification and Reanalysis

• Think like a criminal when completing this process!

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Intentional Adulteration Final Rule

Part 121 Mitigation Strategies To Protect Food Against Intentional Adulteration

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• Subpart A – General Provisions

• Subpart B – Reserved

• Subpart C – Food Defense Measures

• Subpart D – Requirements Applying To Records

• Subpart E - Compliance

Subpart A – General Provisions

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• Key definitions

– Qualified Individuals

– Actionable Process Steps

– Vulnerability Assessments

– Mitigation Strategies

• 121.4 Training Requirements

– Qualified Individual must: Prepare the Food Defense Plan, Conduct the Vulnerability Assessment, Identify Mitigation Measures, and Perform Reanalysis of the Food Defense Plan

– Each employee and supervisor of employees assigned to an Actionable Process Step must be a Qualified Individual and must receive training in Food Defense Awareness

• Actionable Procedure Step Definition: A point, step or procedure in a food process at which food defense measures can be applied and are essential to prevent or eliminate a significant vulnerability or reduce such vulnerability to an acceptable level (must be site specific)

Subpart C – Food Defense Plan

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• 124.126(a) All facilities must prepare and implement a Food Defense Plan

• 124.126(b) Contents required in a Food Defense Plan:

– Written Vulnerability Assessment

– Written Mitigation Strategies

– Written procedures for monitoring of mitigation strategies

– Written procedures for Food Defense Corrective Actions

Subpart C – Food Defense Plan – Vulnerability Assessment

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• 121.130 – Vulnerability Assessment methods must include a minimum of:

– Potential of public health impact including severity and scale if a contaminant were added

– Degree of the physical access to the product

– Ability of the attacker to successfully contaminate the product

– Consider the possibility of an Inside Attacker

• Vulnerability Assessment must be written and include an explanation why each step was or was not identified as a actionable process step

Subpart C – Food Defense Plan Mitigation Strategies

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• 121.135 – Must identify Mitigation Strategies for each Actionable Process Step to provide assurance that vulnerabilities will be minimized or prevented

• Must include written explanation how the strategy will reduce the vulnerabilities

• 121.138 – Mitigation Strategies Management Components must include Monitoring, Corrective Actions and Verification to ensure proper implementation

Subpart C – Food Defense Plan Verification

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• 121.140 – Must establish and implement written monitoring procedures with adequate frequencies identified for each mitigation strategy

• 121.145 – Must establish and implement written Corrective Action procedures in the event that a mitigation strategy is not properly implemented

• 121.150 – Must verify Food Defense monitoring is conducted as planned, Corrective Actions taken, mitigation strategies are working properly and monitoring and corrective action records

• 121.157 – Reanalysis of the Food Defense Plan must be performed every three years at a minimum and for significant changes, new information, improper implementation occurs or when FDA requires reanalysis

Compliance Dates Required

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• Large Facilities with > 500 employees – July 26, 2019

• Small Facilities with < 500 employees – July 2020

• Very Small Facilities < $10m – July 2021

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Vulnerability Assessment and Mitigation Strategies

FDA Key Activity Types and 3 Elements of Assessment

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Key Activity Types (KAT) should be identified and evaluated during the Vulnerability Assessment:

– Bulk liquid Receiving & Loading

– Liquid Storage and Handling

– Secondary Ingredient Handling

– Mixing and Similar Activities

– Others as needed based on site specific

3 Elements of Assessment to Consider:

1. Element 1 – Public Health Impact (Criticality)

2. Element 2 – Physical Access (Accessibility)

3. Element 3 – Likelihood of a Successful Attack (Vulnerability)

Vulnerability Assessment Considerations

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• Establish a multi-disciplinary Food Defense Team with representations from all major departments and shifts

• Review the FDA Food Defense Assessment Questionnaire and Food Defense Plan Builder https://www.fda.gov/food/fooddefense/toolseducationalmaterials/ucm349888.htm

• Review the FDA Mitigation Strategies Database https://www.fda.gov/Food/FoodDefense/ToolsEducationalMaterials/ucm295898.htm

• FDA Draft Guidance To Industry (March 2019) https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm610946.htm

• Assess current procedures for Food Defense Controls – Outside Access, Inside Access, Locks/Key Card Systems, Employee Access, Visitor/Contractor Access, Camera Systems, Operational Controls, Storage Controls, Receiving/Shipping Controls and other site specific controls

• Complete an Exterior and Interior Audit to evaluate controls effectiveness

Potential Mitigation Strategies

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1. Exterior security with locked doors, fences, and guards

2. Interior security with key card access, locked chemical cages, locked restricted access sensitive areas

3. Exterior & Interior camera systems

4. Employee Background Checks & Access Controls

5. Transportation security with seals/locks on incoming and outgoing trailers

6. Employee training & Awareness (See Something, Say Something)

7. Physical Barriers & Signage

8. Equipment considerations to enclose product flow where possible

9. Metal Detection & X-Ray Systems

10. Tamper resistant packaging seals

11. Product protection, identification, lot coding and testing

12. APS Monitoring, Corrective Actions and Verifications (must be specific to that step)

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Documenting Your Food Defense Plan

Documenting the Food Defense Plan

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✓ Document your Food Defense Team Member List with name, training and experience

✓ Use the Food Defense Plan Builder or internal worksheets that include the required information in the regulations

✓ Document the results of the Vulnerability Assessment

✓ Identify the Actionable Process Steps

✓ Identify Mitigation Strategies for each of the Actionable Process Steps

✓ Document Monitoring, Corrective Action and Verification Procedures for each Actionable Process Step

✓ Document the Food Defense Plan Review and Reanalysis Procedures

✓ Identify the Records required

FDA Food Defense Plan Guidance Worksheets

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• FDA Draft Guidance To Industry (March 2019)- Appendix 1 Worksheets https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm610946.htm

• 1-A Food Defense Plan Cover Sheet

• 1-B Product Description

• 1-C Vulnerability Assessment Analysis Summary

• 1-D Calculating Volume of Food At Risk

• 1-E Calculating Potential Public Health Impact Using a Representative Contaminant

• 1-F Identifying Actionable Process Steps Using the Three Fundamental Elements

• 1-H Mitigation Strategies (Note: There is not a worksheet 1-G in the guidance)

• 1-I Mitigation Strategies Management Components

Document Training Records

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• Qualified Individual Training for those responsible to document the Food Safety Plan

• Qualified Individual Training for employees assigned to Actionable Process Steps

• Training for Supervisors of Qualified Individuals

• Food Defense Team Member Training

Additional GFSI Considerations for Food Defense Plans

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• GFSI standards require the Food Defense Plan to be challenged with a test

• Examples of challenge tests

– Exterior door security checks

– Sending in a trailer or rail car without a seal to see if it is detected

– Sending an unauthorized employee in the plant

– Testing badge security controls

• GFSI standards require annual reviews of the Food Defense Plan

– Rather than the FDA three year reanalysis requirement

• Food Defense Team meetings must be conducted and documented at least annually

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Best Practices to Prevent Adulteration

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1. Exterior security with locked doors, fences, and guards

2. Interior security with key card access, locked chemical cages, locked restricted access sensitive areas

3. Exterior & Interior camera systems

4. Employee Background Checks & Access Controls

5. Transportation security with seals/locks on incoming and outgoing trailers

6. Employee training & Awareness (See Something, Say Something)

7. Physical Barriers & Signage

8. Equipment considerations to enclose product flow where possible

9. Metal Detection & X-Ray Systems

10. Tamper resistant packaging seals

11. Product protection, identification, lot coding and testing

12. APS Monitoring, Corrective Actions and Verifications

Best Practice Mitigation Strategies

Effective Food Defense Internal Audit Processes

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• Create and train an Internal Food Defense Team

• Create an Internal Audit Schedule for Food Defense with adequate frequencies for interior, exterior, facility and process inspections

• Complete a formal Food Defense Plan Audit Checklist

• Complete a detailed Plant Inspection to assess food defense requirements with pictures; Interview employees during Food Defense Plan audits

• Complete and verify Corrective Action Records for non-compliant areas identified during inspections.

• Report Food Defense Plan Audit Results to Senior Management

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Food Defense Plan Audit Readiness

Auditing Your Food Defense Plan

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• Complete daily monitoring of Actionable Process Steps

• Complete Facility Audits to check interior and exterior controls

• Complete Food Defense Plan internal audits at least annually or more often to assess if the written plan is still current, audit plant controls to verify effectiveness and assure records are maintained as required

• Complete the Challenge Tests at least annually, increase frequencies as needed if test results are inadequate

• Complete trend analysis of Customer Complaints to determine if evidence exists of potential intentional contamination

• Be prepared for Food Defense Plan evaluation during GFSI audits with documented Team Meetings, Vulnerability Assessments, Challenge Tests and well documented Food Defense Plan Reviews

• Be prepared for regulatory audits for compliance to the Mitigation Strategies to Protect Food Against Intentional Adulteration

Common Food Defense Plan Audit Non-Conformances

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• Exterior doors unsecured – left open or propped open intentionally

• Unlocked chemical storage areas

• Failure to document Food Defense Plan Challenge Tests

• Insufficient control of truck drivers, contractors, and visitors traffic

• Sensitive Processing Points not all identified

• Food Defense Plan Review not documented properly

• Incomplete or inadequate training of personnel

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Alchemy Resources

Confidential and Proprietary 32

Alchemy Drives Safety, Quality, & Productivity

Training• Train up to 150 employees at once

• Multilingual course libraries

• Easily customizable content

Reinforcement• App for on-the-floor observations

• Training-coordinated signage

• Supervisor guides for consistency

Compliance• Automated recordkeeping

• Paperless documentation

• Audit-ready reporting

Alchemy’s Consulting Solutions

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✓ Food Defense Plan Development / Validation – Receive assistance to develop, document and validate your Food Defense Plan

✓ SQF, BRC and FSSC 22000 Consulting – Gap Analysis, Program Development, Internal Audits, Audit Support

✓ HACCP Plan / Food Safety Plan Reassessment – Receive a detailed review of your HACCP system to verify accuracy and effectiveness

✓ Food Safety Training – On-site Basic HACCP, Advanced HACCP, Preventive Control for Human Food, Preventive Control for Animal Food, Internal Auditor Training

100% Client Satisfaction

Rate

Basic HACCP | Basic HACCP Juice & Beverage | Advanced HACCP

• Accredited by the International HACCP Alliance

• Receive a certificate of completion

• Teaches you how to develop & implement an effective food safety plan based on CODEX HACCP specifications, which is required by the four major GFSI schemes

– SQF, BRC, FSSC 22000, and IFS

Get Accredited Online HACCP Training

Learn more at: https://academy.alchemysystems.com/product-category/courses-exams/haccp/

Food Defense eLearning Course – Coming Soon!

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Meet FSMA RequirementsAlchemy Academy is launching a new one-hour course designed to help individuals meet the Food Safety Modernization Act (FSMA) requirement for Food Defense Awareness Training

This self-paced training course will help you:

• Recognize the difference between food defense and food safety

• Understand your role in protecting the food system from intentional adulteration

• Be able to identify food defense vulnerabilities in your workplace

• Learn the importance of the FSMA Intentional Adulteration Rule

Browse courses at https://academy.alchemysystems.com/

THANK YOUJeff Chilton

jeff.chilton@alchemysystems.com

Schedule a Free 30-minute consultationTelephone Andy Chilton: 706.483.4400

or email at andy.chilton@alchemysystems.com

https://www.alchemysystems.com/solutions/food-safety-consulting/