1Bumble Bee Foods, LLC Confidential and Proprietary
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Preparing For The
FSMA Intentional
Adulteration Rule
One Company’s Approach
2018 Food Sure Summit
2Bumble Bee Foods, LLC Confidential and Proprietary
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Steven MavitySVP – Technical Services &
Corporate Quality, Bumble Bee Seafoods
February 5, 2018
3Bumble Bee Foods, LLC Confidential and Proprietary
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Agenda
▪ Bumble Bee Background
▪ Summary Of The Requirements
▪ How We Got Started
▪ How We Are Developing and Implementing the
Plan
▪ Our Key Learnings to Date
▪ Our Next Steps
▪ Where You Can Find Help
▪ Questions
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Brands Selected Products
Bumble Bee Brands/Products
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LOINS POKESAKUSTEAKS VALUE ADDED
Beyond Shelf Stable Foods…
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MrFeed®… Feed for Life
And Into Aquaculture Feed
7Bumble Bee Foods, LLC Confidential and Proprietary
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Mauritius
(Albacore Loins)
Lyons, GA
(Canned Tuna)
Fiji
(Albacore
Loins)
Colombia
(Albacore Loins)
Cape May, NJ
(Clams)
Santa Fe
Springs, CA
(Canned Tuna)
Blacks Harbour, NB
(Sardines)
Bumble Bee Locations
Co-Pack Locations
Thailand
(Albacore, Lightmeat
loins, value added
tuna, Canadian tuna)
Ningbo
(Albacore Loins)
Alaska
(Canned Salmon)
Global Sourcing Matrix
Our Global Supply Matrix
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Summary of the Requirements
▪ Create a Food Defense Plan
– Conduct a written vulnerability assessment to identify significant
vulnerabilities and actionable process steps
– Develop and implement written mitigation strategies for
actionable process steps
– Develop and implement written food defense monitoring
procedures
– Develop and implement written food defense corrective action
procedures
– Develop and implement written food defense verification
procedures
▪ Engage in reanalysis periodically
▪ Document everything in records
▪ Train employees
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Key Points to Keep In Mind
▪ Vulnerability Assessments
– Must Evaluate Each Point, Step or Procedure
– Must Consider Public Health Impact, Degree of Access and
Probability of Success of an Attack
– Must Consider the Possibility of an Inside Attacker
– Must be Conducted by a Qualified Individual
▪ Training
– Qualified Individual & Those Developing & Reanalyzing the Plan
– Supervisors & Employees
o Awareness Training
o Implementation of Mitigation Strategies at Actionable Process
Steps
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How We Got Started
▪ Cross Functional Team
– 3rd Party Security Professional Consultant
– QA/Food Safety, Operations, HR, Engineering/Maintenance, IT
▪ Prepared for Holistic Site Security Assessment
– Existing Site Security Programs
– Common Criminal Threats
o People, assets and information
▪ Prepared for Vulnerability Assessment
o Leveraged HACCP Plan Flow Charts and Information
o Assembled & Reviewed Work Instructions
o Assembled Site Maps & Floor Plans
o Pre-populated a Vulnerability Assessment Tool
▪ Goal was To Leverage & Strengthen Existing Programs
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Conducting the VA
▪ Focused on Intentional Food Adulteration
– Identified Foundational Programs that Impacted Food Defense
– Recalibrated Expectations to Also Focus Upon Inside Attacker
▪ Vulnerability Assessment
– Significant Time on the Floor Observing Operations and
Conducting Numerous Management & Employee Interviews
– Evaluated Each Point Step or Procedure
– Is It a KAT? Which One? Becomes and Actionable Process Step
– Grouped APS from VA as Appropriate
– Used a Mathematical Model to Consider Degree of Public Health
Impact, Degree of Access and Likelihood of Success
o Not Used at this Point to Remove KATs
o Used to Score Effectiveness of Alternative Mitigation
Strategies
– Identified a Few Needed Process Flow Step Additions
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Selection of Mitigations
▪ Mitigation Strategies Selected for Each APS
– Evaluated Alternative Mitigation Strategies
– Facilitated by Scoring Tool
– Cross Functional Brainstorming & Consultant Experience
– FDA Mitigation Strategy Database
– Provided Written Rationale on Each MS
▪ Management Components Developed for Each MS
– Monitoring Methods/Frequencies
– Corrective Action Procedures
– Verification Procedures
– Records Developed or Modified as Needed
▪ Plan Documentation Looks Very Similar to Our HACCP
Documentation
– Utilized FDA’s IA Draft Guidance to Ensure Proper Modifications
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Key Learnings to Date
▪ The Use of Professional Security Personnel Is Important
▪ Identification of Threats and Vulnerabilities
▪ Identification of Efficient and Effective MSs
▪ The Use of a Cross Functional Team Augments the Security
Professional POV
▪ Existing FD Programs Needed to Be Enhanced
▪ There are Many Existing Foundational Programs That Can Be
Modified to Support Mitigation Strategies at Actionable Process Steps
▪ Protecting Against the Insider Threat Requires a Significant Shift in
Perspective and Approach
▪ We are Incorporating a Strong “See Something – Say Something”
Component into Our Plan Which Requires a Significant Cultural Shift
▪ We Will Utilize Camera Technology at APSs to Facilitate Corrective
Actions When MSs Are Not Followed or Are Missed
▪ Every Facility Will Likely Have Different Vulnerabilities & MSs
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Next Steps for Compliance
▪ Develop & Deliver Training
– FSPCA Courses for Qualified Individuals
– Supervisors & Employees
o Awareness Training
o Implementation of Mitigation Strategies at Actionable Process
Steps
▪ Develop Reanalysis Procedures
– Each Three Years
– Significant Change in Operations
– New Information Regarding Potential Vulnerabilities
– When FDA Requires Reanalysis Due to Credible Threats
▪ Review/Update Plan As Additional FDA Guidance is Released
▪ Complete Records & Documentation
– FD Plan, Monitoring, CAs, Verification & Training
▪ Incorporate Requirements Into Supplier & Co-packer Programs
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Where You Can Find Help
▪ If You Have Not Started Your IA Journey, You Are Behind!
▪ FDA Resources
– Final Rule https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm378628.htm
– FDA Guidance
o 1st Release - Conducting a VA Using the KAT Method,
Choosing Mitigation Strategies & Monitoring (Out Now)
o 2nd Release – Conducting a VA Using Other Methods,
Training & Qualifications (Coming Soon)
o 3rd Release - Corrective Actions, Verification, Reanalysis &
Recordkeeping (Coming Soon)
– Update Food Defense Plan Builder (Coming Soon)
– Updated Mitigation Strategies Database (Coming Soon)
– FDA FSMA Technical Assistance Network
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm
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Where You Can Find Help
▪ FSPCA Training Resources
– Food Defense Awareness for the IA Rule
– IA Rule Overview
– IA Key Activity Types Course
– IA Identification and Explanation of Mitigation Strategies Course
(Coming Soon)
– Vulnerability Assessments Face to Face Course (Coming Soon)
– Food Defense Plan Preparation and Reanalysis Course (Coming
Soon)
https://www.ifsh.iit.edu/fspca/courses/intentional-adulteration
▪ Other Resources
– 3rd Party Consultants
– Choose Carefully
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QUESTIONS?
Steven Mavity
Bumble Bee Seafoods
858-715-3005
