© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 CONFIDENTIAL. This document contains trade secret information. Disclosure, use or reproduction outside Cargill or inside Cargill, to or by those employees who do not have a need to know is prohibited except as authorized by Cargill in writing. © 2013 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration Joseph Scimeca, PhD VP, Global Regulatory & Scientific Affairs Corporate Food Safety, Quality and Regulatory GMA Science Forum April, 2015

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 Agenda GMA Economic Adulteration WG GFSI Food Fraud Prevention Why FSMA Matters Designing a Food Fraud Protection Plan Creating a Vulnerability Assessment Tool An Integrated Future Key Takeaways 2

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 GMA Economic Adulteration WG Initially formed in Dec 2008 Identified WG Priorities: Increase industry awareness Stakeholder and expert collaboration NMSU Predict (Bob Silver) A-CAPPP MSU (John Spink) NCFPD UMN (Amy Kircher, Karen Everstine) USP (Markus Lipp, Jeff Moore) Battelle Roundtable meeting Information sharing: actual incidents, potential incidents, sharing analytical info/methods Alignment of Industry/Academia/Government Alignment of analytical vendors 3

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 GMA EA WG – Awareness/Education Published AT Kearney/GMA Science Education Foundation Report in 2010 – “Consumer Product Fraud: Deterrence and Detection” Held a webinar Oct 2010 Strategies for Managing Risk Case studies 4

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April In Association With in association with 2010 CONSUMER PRODUCT FRAUD: DETERRENCE AND DETECTION Strengthening Collaboration to Advance Brand Integrity and Product Safety

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 GFSI – Food Fraud 6

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April Food Fraud Think Tank New concept for GFSI 7 ‘Think like a Criminal’

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 Many ongoing initiatives on food fraud Leading role for GFSI Direction & Alignment Many ongoing initiatives on food fraud Leading role for GFSI Direction & Alignment Schemes and companies need time for this new challenge GFSI Position

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 Key Elements for Food Fraud Prevention Clause NameRequirement Food Fraud Vulnerability Assessment The standard shall require that the organisation have a documented food fraud vulnerability assessment in place to identify potential vulnerability and prioritise food fraud vulnerability control measures. Food Fraud Vulnerability Control Plan The standard shall require that the organisation have a documented plan in place that specifies the control measures the organisation has implemented to minimize the public health risks from the identified food fraud vulnerabilities. This plan shall cover the relevant GFSI scope and shall be supported by the organisation’s Food Safety Management System. GFSI Food Fraud Requirements

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 Supply Chain Mapping Socio-economic Behavioural Geo-political Historical Vulnerability Assessments Monitoring strategy Origin/Label verification Specification management Supplier audits Analytical testing strategy Anti-counterfeit technologies Vulnerability Control Plan Food Fraud Prevention 10

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 Implementation of Food Fraud Mitigation Incorporation in GFSI Guidance Document Vs. 7 (2016) Incorporation in Food Safety Management Schemes Implementation and execution in companies’ FS Management System Certification via third party audits GFSI Food Fraud Strategic Plan

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 PAS 96: Provides guidance on approaches and procedures to improve resilience to deliberate attack Combines Food Defense and Food Fraud (EMA) Introduces a new risk management methodology – Threat Assessment Critical Control Point (TACCP)

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 FSMA 13 Things that might have seemed like just a good idea before, are now going to be mandatory, require records to support compliance, and those records are going to be available to FDA

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 FSMA - Intentional Adulteration 14 In the re-proposed regulations for preventive controls, the hazard identification must consider hazards that may be intentionally introduced for purposes of economic gain Applies to human food, animal food and FSVP Focus is on adulterants that are “reasonably likely to cause illness or injury” Not focused on adulterants that solely affect quality and value FDA believes that it is practicable to determine whether EMA is reasonably foreseeable by focusing on circumstances where there has been a pattern of adulteration in the past However, the vast majority of EMA events are not food safety related

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 Designing a Food Fraud Protection Plan 15

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 Three questions can help inform your company's economic adulteration strategy 16 Do you have viable detection and deterrence strategies and deploy cutting-edge tools… Do you understand your product portfolio’s vulnerabilities… Do you have a dedicated anti-economic adulteration / counterfeiting program… Source: A.T. Kearney analysis, 2009

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 Key Elements of Food Fraud Protection 17 Food Fraud Prevention System FF Assessments FF Prevention Plan Supply Chain Mapping (incl. prioritization) Vulnerability Assessments Awareness & Training Monitoring Plan Food Fraud Policy Origin/Label Verification Analytical Testing Determine Critical Points FF Incident Management Suppliers Audit Strategy Assessment Strategy (inc. auditing strategy) Detection Plan

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 GOAL: Develop a tool similar to “Carver + Shock” to quantitatively assess vulnerability of supply chains to EMA 18 EMA Vulnerability Assessment Tool Design a tool that integrates various approaches through input from multiple experts that: uses surveillance/historical data incorporates “real-time” environmental events considers criminalistic-type approach involves predictive modeling resulting in semi-quantitative vulnerability risk determinations

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 GOAL: Develop a tool similar to “Carver + Shock” to quantitatively assess vulnerability of supply chains to EMA 19 EMA Vulnerability Assessment Tool Will need to define key elements that drive EMA: Economic Product value Volume Scarcity Ease Testing Governance Inherent properties Cultural Historic Sourcing/origination Must also consider: Dynamic vs Static Weighting Factors

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 Integrate information into EMA Vulnerability Assessment Tool Capture trend analysis information that helps to predict vulnerabilities e.g., trade flow, economic information, climate change Consider various models EMA Database Info Open Source Info Utilize US Pharmacopeia Resource FCC Monograph Evaluation GMA EA WG – Designing the blueprint 20

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 GMA EA WG Activities Design blueprint for EMA Vulnerability Assessment Tool Send out RFP to solicit/select vendor to develop Model Validate the tool Supply chain’s known high risk foods (e.g., fruit juice, olive oil, etc) Ensure usefulness in the supply chain Make tool available for utilization across food industry 21 EMA Vulnerability Assessment Tool

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 Example Visual of Tool 22

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 GFSI Position - Integral Part of FSMS Mitigation of intentional adulteration Economically motivated Mitigation of intentional adulteration Ideologically motivated Prevention of unintentional / accidental adulteration Science based Food SafetyFood DefenceFood Fraud An Integrated Future

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 Key Takeaways Need to develop EMA Protection Plan Gain visibility of supply chain down through origination Perform vulnerability assessment Map supply chain vulnerability identifying key priorities for mitigation Trust but verify throughout the supply chain 24

© 2014 Cargill, Incorporated. All rights reserved. Managing Economically Motivated Adulteration – April 2015 Thank You 25